Download Submission of Notification

Office use:
Ref No. ………………………..
Date Received. …………………..
Notification of Intention to Handle Potentially Hazardous Biological
Agents
This form is to be completed by all staff and students undertaking research where potentially
hazardous biological agents are involved. This will ensure that staff and students will comply
with all the legislation that regulates the manipulation of biological agents and ensure the
Institute Biosafety Committee (IBC) is kept informed of the nature and range of biological agents
on campus and those risks associated with the proposed work have been identified and
adequately controlled. This form should be completed in conjunction with careful reading of the
Biological Safety Manual and Making the Workplace Safe
Please answer the questions in each section by clicking in the check boxes () and provide all
information where indicated. Then you and your supervisor should sign and date this form and
submit all documents to the Chair of the IBC for consideration.
Personal Details
Name:
Student/Staff No:
Position:
Division:
Supervisor:
Phone:
Email:
Section A
Description of Biological Agent(s)
(Please answer by clicking the check box )
Origin:
Human
Animal
Plant
Microorganism
Blood
Sputum
Urine
Tissue
Other
Please specify:
Faeces Other
Please specify:
Infectious microorganisms: please only include infectious microorganisms
Bacterium
Virus
Fungus/Yeast
Parasite
Other
Please specify:
Please list the infectious agents, specify their genus and species and risk category (consult Biological Safety Manual, Appendix A)
Genus
Species
Risk Category
Animals; please list all animals, probable numbers and indicate if any of the animals are likely to be infected and, if so, by
which infectious agent
Genus
Species
Numbers
Infected?
Infectious agent?
No
Yes
Unsure
No
Yes
Unsure
No
Yes
Unsure
No
Yes
Unsure
Plants; please list all plants, probable numbers and indicate if any of the plants are likely to be infected and, if so, by which
infectious agent
Genus
Species
Numbers
Infected?
Infectious agent?
No
Yes
Unsure
No
Yes
Unsure
No
Yes
Unsure
No
Yes
Unsure
Section B
Description of Project
Project Title / Unit of Study
Brief Project Description
Location(s):
Commencement date:
Completion Date:
Section C
Security Sensitive Biological Agents (SSBAs)
SSBAs are biological agents that may be deliberately misused by terrorists to harm human health
or the Australian economy. The acquisition, isolation, storage, handling, transport and disposal of
SSBAs is governed by National Health Security Act 2007 (NHS Act) and implemented by the
Federal Department of Health and Ageing (DoHA). Non-compliance may be prosecuted with an
offence under the NHS Act. SSBAs are grouped into two tiers.
Tier 1
Agent
Abrin
Bacillus anthracis
Botulinum toxin
Ebolavirus
Foot-and-mouth disease
virus
Influenza virus
Marburgvirus
Ricin
Rinderpest virus
SARS coronavirus
Variola virus (Smallpox)
Yersinis pestis (Plague
bacillus)
Quantity
5 mg
0.5 mg
Comments
Virulent strains of anthrax
Does not apply to forms of toxin approved for use
under Therapeutic Goods Act 1989, eg BotoxTM
Only highly pathogenic strains infecting humans
5 mg
Tier 2
Agent
African swine fever virus
Capripoxvirus
Classical swine fever virus
Clostridium botulinum (Botulism)
Francisella tularensis (Tularæmia)
Lumpy skin disease virus
Peste-des-petits-ruminants virus
Salmonella typhi (Typhoid fever)
Vibrio choleræ (Cholera)
Yellow fever virus
Comment
Sheep pox virus and Goat pox virus
Toxin-producing strains
Serotypes O1 and O139 only
Non-vaccine strains
Question 1
Do you intend to acquire, isolate, store, handle, transport or dispose of any of
the SSBAs listed in Tier1 or Tier 2?
(Please answer by clicking the check box )
No
 Go to Question 2
Yes
 Carefully read the chapter “Security Sensitive Biological Agents” in the
Biological Safety Manual
 Fill in the appropriate forms as recommended by the Biological Safety
Manual and submit copies to the DoHA and Chair of the IBC
 You must not commence work involving the SSBAs until you (the entity)
and your laboratory (the facility) have been registered with DoHA
Question 2
In the course of your normal testing and experimental procedures is it possible
that you may
a) Handle biological specimens containing a presumptive SSBA?
b) Isolate a presumptive SSBA?
c) Conduct tests on samples taken from a source known to have a
presumptive SSBA?
No
 Go to Section D
Yes
When you become aware of the presence of a presumptive SSBA you have
three options:



Option 1: Immediately notify the Chair of the IBC and destroy all samples
and cultures
Option 2: Immediately notify the Chair of the IBC and transfer all samples
and cultures to a reference laboratory registered to handle these SSBAs
Option 3: Immediately notify the Chair of the IBC and report your
holdings to the DoHA within 2 business days.
 Fill in the appropriate forms as recommended by the Biological Safety
Manual and submit copies to the DoHA and Chair of the IBC
Section D
Importing biological material into Australia subject to Quarantine
Regulations
The Australian quarantine system is designed to prevent the importation and consequent
introduction, establishment or spread of human, animal or plant pests and diseases. As a general
rule any biological material imported into Australia and derived from water, soil, plant, insect or
animal tissue will require an import permit issued by the Australian Quarantine and Inspection
Service (AQIS).
Question 3
Do you intend to import any biological material into Australia?
(Please answer by clicking the check box )
No
 Go to Question 4
Yes
 Carefully read the chapter “Biological Material Subject to Quarantine
Regulations” in the Biological Safety Manual
 Apply for an import permit from AQIS and nominate one of the Quarantine
Approved Facilities at Curtin for storage and handling of the imported
material
 Email a copy of the form to the Chair of the IBC and post the form along
with payment to:
Australian Quarantine and Inspection Service
GPO Box 858
Canberra ACT 2601
Working with biological material subject to an AQIS permit
All work with biological material imported with an AQIS permit is subject to AQIS regulations
whether you were the primary importer or it was imported by someone else. Also AQIS approves
facilities where work on a range of imported plants, animals and plant and animal products may
be carried out so that it can be sure that these activities are performed with a minimal degree of
risk.
Question 4
Do you intend to work with biological material imported into Australia and
required by AQIS to be stored and handled in Quarantine Approved Premises
(QAP)?
(Please answer by clicking the check box )
No
 Go to Question 5
Yes
 Carefully read the chapter “Biological Material Subject to Quarantine
Regulations” in the Biological Safety Manual
 You must comply with AQIS regulations and maintain the level of
containment approved by AQIS for the original importation.
Question 5
Do you intend to transport quarantined biological material between QAPs?
(Please answer by clicking the check box )
No
 Go to Section E
Yes
 Carefully read the chapters “Biological Material Subject to Quarantine
Regulations” and “Transport and Shipping of Infectious and Other
Biological Materials” in the Biological Safety Manual
 You must obtain approval to transport biological material between QAPs
by filling in the appropriate form, send a copy to the Chair of the IBC post
the original to:
Australian Quarantine and Inspection Service
GPO Box 858
Canberra ACT 2601
Section E
Handling Genetically Modified Organisms (GMOs)
A GMO is a viable biological entity capable of reproduction or transferring genetic material that
has had its genetic material modified by any technique apart from:
 sexual reproduction
 homologous recombination
 somatic cell nuclear transfer
Note this definition of a GMO does not include hybridomas, plants formed by protoplast fusion
and organisms resulting from naturally occurring DNA exchange.
Question 6
Do you intend to use, culture, import, store and/or construct a GMO?
(Please answer by clicking the check box )
No
 Go to Section F
Yes
 Carefully read the chapter “Genetically Modified Organisms (GMOs)” in
the Biological Safety Manual
 Go to Question 7
Question 7
What type of dealing(s) will you be conducting with a GMO?
(Please answer by clicking the check box )
Exempt
dealing
 Prior to or at the time of commencing work with the GMO you must fill in
the appropriate form and send a copy to the Chair of the IBC for
confirmation of the dealing.
NLRD
(Notifiable
Low Risk
Dealing)
 You must fill in the appropriate form and submit a copy to the Chair of the
IBC. You must not commence work with the GMO until you have received
written approval from the IBC. If you have not been trained to handle
GMOs you must book yourself into one of the training workshops provided
by Curtin Health and Safety.
DNIR
(Dealings Not
Involving
Intentional
Release)
 An application for a DNIR licence must be completed, a copy sent to the
Chair of the IBC and the original posted to:
Office of the Gene Technology Regulator
Commonwealth Department of Health and Ageing
MDP 54, PO Box 100
Woden ACT 2606
A decision on your application will be made by the OGTR within 90
working days. Work with a DNIR must not commence until a licence has
been issued by the OGTR. If you have not been trained to handle GMOs
you must book yourself into one of the training workshops provided by
Curtin Health and Safety.
DIR (Dealings
Involving
Intentional Re
lease)
 An application for a DIR licence must be completed, a copy sent to the
Chair of the IBC and the original posted to:
Office of the Gene Technology Regulator
Commonwealth Department of Health and Ageing
MDP 54, PO Box 100
Woden ACT 2606
Notification of the decision will be made within 150-255 working days
depending on details of the dealing. Work with a DIR must not commence
until a licence has been issued by the OGTR. A DIR licence will be issued
subject to statutory conditions with which you must comply.
Section F
Risk Assessment
If you are able to determine the level of risk associated with this biological agent(s) (see
Appendix A in the Biological Safety Manual) and you will be conducting all work with
appropriate safety protocols and within a laboratory designed to handle this level of risk then you
do not need to carry out a biological risk assessment.
Question 8
Will you be conducting all work with the biological agent(s) in a
laboratory classified to handle the level of risk associated with the
biological agent?
(Please answer by clicking the check box )
No
 Complete the Risk Assessment Sheet below
Yes
 You do not need to complete a biological risk assessment. If there
are other physical and/or chemical risks associated with your
project then you should complete a risk assessment sheet.
Risk Assessment Sheet
To complete this risk assessment please consult ‘Making the Workplace Safe’ for guidance and
an explanation of terms.
Hazards:
Ranking:
Controls:
Identify potential sources of
Rank potential risks with
Use the hierarchy of controls to
harm or ill-health to
respect to the likelihood of a
determine the best methods to
staff/students or others.
hazard causing an incident
control the hazards identified.
and the consequence of that
Eliminations
incident.
Substitution
E – Extreme risk
Isolation
H – High risk
Engineering
M – Medium risk
Administration
L – Low risk
Personal Protective
Equipment
Continue on additional sheet if necessary
Section G
Acknowledgement and Signature of Applicant
I,
, hereby acknowledge that I have read and understood all legislation and regulations
concerning the biological agents declared in this notification. I also undertake to comply with all
regulations and conditions imposed by regulatory authorities and the IBC.
Signature:
Date:
Acknowledgement and Signature of Supervisor
I,
, hereby acknowledge that I have read and understood all legislation and regulations
concerning the biological agents declared in this notification. I also acknowledge that I have read
and approved the project and its risk assessment.
Signature:
Date:
Submission of Notification
Forward a copy of your Notification to the Chair of the IBC in order to obtain necessary approvals.
Submit applications, reports and registration forms to relevant authorities as required by Legislation and
Regulations.
Keep a copy of all your documents for your records