Griffith University Biosafety Committee
The purpose of the High Risk Biological Dealing (HRBD) registration form, is to inform the University
Biosafety Committee (UBC) of projects or activities that may involve organisms, substances or other
materials of biological origin that may be classified as high risk, but which may not have been explicitly
assessed within a licensed dealing application. The types of dealings classified as high risk are defined
in this guide.
REGISTRATION PROCESS
Upon submission of the registration form, the UBC will review the information and confirm that
appropriate risk management practices are in place before endorsing the activity. It is anticipated that
each application will be reviewed promptly, however depending on the nature of the application further
advice may be sought from field specific experts which may impact on the evaluation time. The
information will be used to inform the UBC to assist in the monitoring of biosafety and incident
management.
UBC APPLICATION TYPES
 If the activity or project involves multiple numbers or types of high risk dealings they can be
submitted on the same application.
 Storage of high risk material will also be considered as a dealing.
 The HRBD form should not be used for dealings involving genetically modified organisms
(GMOs).
 In instances where a High Risk Biological Dealing has been assessed as part of GMO dealing
application then a separate HRBD application is not required.
The flow chart below outlines the type of UBC form required:
Research, Teaching or Field Work Project or Activity involving
biological material
Activity Involves Low
Risk GMO Dealing
Complete Exempt
Dealing (ED)
Application and
submit to the UBC
Committee for
Approval
Activity Involves
Moderate or High
Risk GMO and other
high risk biological
Dealing
Complete Notifiable
Low Risk Dealing
(NLRD) Application
and submit to UBC
for approval.
Complete Dealing Not
Involving Intentional
Release (DNIR)
Application and
submit to UBC for
approval.
UBC to submit
to OGTR for approval
Activity Involves High
Risk Biological
Dealing but does NOT
involve a GMO
Dealing
Complete a High Risk
Biological Dealing
Registration and
submit to Head of
Element or delegate
Submit to UBC for
consideration and
approval
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TYPES OF HIGH RISK DEALINGS (SECTION 1)
This form is relevant for all research, teaching or fieldwork activities that involve one or more of the
following categories:
A. Wild type microorganisms from risk group 3 or 4 (and risk group 2 that require ‘special
precautions’)
Activities involving the use or storage of these organisms will be considered to be high risk
dealing.
Special precautions: refers to additional safeguards required for microbes that due to their
specific characteristics may present increased risk in specific circumstances.
For instance, Microorganisms that;

are transmissible by respiratory route,

require a low infectious dose with high pathogenicity,

can penetrate intact skin,

may be dangerous for pregnant or immunocompromised persons,

have high risk of aerosol spread,

are classified as Prions
(refer to AS/NZS2243.3 Section 3 via Library/SAI Global).
Dealings with risk group 2 microorganisms that don’t require special precautions, will generally
not be considered as high risk dealing unless they are in large volumes (see category B below).
If however, a risk group 2 microorganism is deemed by a risk assessment to present a high risk
it can be referred to the UBC for consideration.
Organism risk group classifications are as listed in AS2243.3 2010, Section 3 or any
microorganism categorised as Dangerous Goods Class 6.2 (Infectious Substances) or those
falling under the Dangerous Goods Regulations (IATA).
B. Large volumes of risk group 2 microorganisms (greater than 10 Litres);
Where microorganisms of risk group 2 (or higher) are cultured in volumes greater than 10 Litres,
this will be considered to be as a high risk dealing.
C. Potentially infectious animals, tissues or fluids (Risk Groups 3 or 4 only);
Where an activity involves animals, tissues, fluids or other materials that are suspected of
containing viable pathogenic risk group 3 or 4 microorganisms the dealing will be considered as
high risk. This includes tissue or body fluids that could contain zoonotic organisms or have not
been screened for such (e.g. Bats).
D. Unscreened infectious human specimens, tissues or fluids;
Where an activity involves unscreened human specimens, tissues or fluids that may contain
viable pathogenic risk group 3 or 4 microorganisms the dealing will be considered as high risk.
E. Activities involving poisonous or venomous animals;
Where an activity or project involves the handling of poisonous animals, invertebrates, fish or
other organism that produces venom or other toxin that has the potential to cause significant
injury to humans the dealing will be considered as high risk. Examples include venomous
snakes, spiders and cone shells.
F. Biological Toxins;
Where an activity or project involves the handling or use of a biological toxin (or biotoxin), that
has the potential and is likely to cause significant illness or death to humans then the dealing will
be classified as high risk. For example snake venom. The term biotoxin generally describes any
toxic material that originated from a biological source such as venoms, but may also synthesised
molecules. Activities involving endotoxins or toxoids will not normally be considered as high risk,
unless they are being used in such a way or in sufficient quantity to present a significant risk to
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individuals or the community. For further clarification email the UBC or consult with the Griffith
Biosafety Advisors to determine if registration is necessary for a particular circumstance.
G. Biological material that appears on the Defence Strategic Goods List (DSGL);
Some Biological materials are listed on the Defence Strategic Goods List. Activities involving
biological materials appearing on the DSGL will be considered as high risk dealings. These
materials may include microorganisms or toxins that potentially have military applications and
therefore may present a security risk to Australia. Further information on the Defence Strategic
Goods List is available at http://www.defence.gov.au/deco/DSGL.asp or consult with the Griffith
Biosafety Advisors.
H. Biological material involving Security Sensitive Biological Material (SSBA’s).
The Department of Health classifies some microorganisms as Security Sensitive Biological
Material. Activities involving biological materials classified as an SSBA will be considered as
high risk dealings. A List of SSBA’s is available at http://www.health.gov.au/ssba or consult with
the Griffith Biosafety Advisors.
PROJECT/ACTIVITY LEADER INFORMATION (SECTION 2)
Details of the person taking primary responsibility for overseeing the activity or project involving the high
risk biological material as well as confirmation that they are suitably experienced. A list of key staff or
students handling the material is required.
PROJECT/ACTIVITY INFORMATION (SECTION 3)
The applicant must outline the nature and objectives of the project or activity. A detailed list of the all the
high risk organisms or materials to be used in the activity must be included as well any approvals
granted from the Human or Animal Ethics Committees.
ASSESSMENT AND RISK MANAGEMENT (SECTION 4)
A brief summary of the risks to individuals, the community or environment must be stated in this section.
Please provide details on infection control, waste disposal procedures, transport requirements and
unintentional release plans.
A comprehensive risk assessment for the project or activity must also be submitted with the registration
form in order to provide confirmation to the UBC that hazards have been identified, assessed and
appropriate controls considered and implemented. If the dealing involves Biotoxins, provide details of
stock concentrations as well as any information on lethal doses in vertebrate (LDL), as well as a safety
data sheet (SDS), where available.
FACILITIES FOR HIGH RISK DEALINGS (SECTION 5)
As most activities involving high risk biologicals must be undertaken in an appropriate physical
containment facility as stipulated by AS/NZS2243.3 2010, the primary facility in which the dealing will be
undertaken must be indicated, as well as where any material will be stored. Secondary or contingency
locations should also be listed if applicable.
In instances, where fieldwork is involved the location and other relevant information must be detailed in
the risk assessment.
DECLARATION OF COMPLIANCE (SECTION 6)
The principal project/activity coordinator or supervisor as well as a senior representative of the
organisational unit such as a Head of School, Dean or Director must sign the registration form.
UBC EVALUATION (SECTION 7)
Leave this section blank. This will be completed by the UBC during the review of the project/activity.
Reviewed April 2015
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