Download Institution Biosafety Committee (IBC)

Institution Biosafety Committee (IBC)
STORAGE OF A NOTIFIABLE LOW RISK DEALING (NLRD)-APPLICATION
1
Project Title
The title should be concise and convey the purpose of the dealing.
2
IBC Project Identifier (IBC office use only)
3a
Project Supervisor Details
Surname
First Name
Job Title
School/Section
Phone No.
Email
3b
Practitioners or Alternate Contact
Surname
First Name
Job Title
School/Section
Phone No.
Email
4a
Title
Title
Description of the Dealing and GMO(s)
Briefly describe the proposed dealing(s) and the purpose of conducting these dealing(s). Please use
plain English. Please attach any references.
University of Tasmania/NLRD Application Form/Version 1/Sep 2009
1
This table is intended to generate a concise, accurate record of all the GMOs to be generated or used
and the purpose of the proposed dealings.
Refer to Attachment 1 for information relating to the column headed “NLRD type”.
Note: “Parent Organism” means organism(s) (or tissue derived from organism) that you propose to
genetically modify. “Host” equates to “Parent”.
54b
Common name
Scientific name
Vector(s) &
What are
What are the
of parent
of parent
organism(s)
organism(s)
From what organism were
method of
the
identities or classes
the gene(s) responsible
transfer
modified
of the gene (s)
for the modified trait(s)
traits (s) ?
responsible for the
isolated
modified trait
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
YES / NO
University of Tasmania/NLRD Application Form/Version 1/Sep 2009
2
5
Containment facilities
Provide information for all the facilities to be used in conjunction with this dealing. This information
can be found on the orange sticker displayed on the door of the certified facility.
FACILITY NAME
BUILDING NAME
TYPE e.g. PC2 lab
University of Tasmania/NLRD Application Form/Version 1/Sep 2009
OGTR I.D.
EXPIRY DATE
3
6
Risk Assessment and Risk Management Plan
What are the risks to the health and safety of people from the proposed dealing(s)?
Address possible risks to the health and safety of people, even if they are considered to be minimal. Include
information about how these risks will be managed.
What are the risks to the environment from the proposed dealing(s)?
Address possible risks to the environment, even if they are considered to be minimal. Include information about how
these risks will be managed.
What do you intend to do in the event of the unintentional release of the GMO(s) into the environment?
Include information about steps that will be taken to prevent the unintentional release of the GMO(s) into the
environment.
Does the dealing involve the importation of GMOs into Australia? Is a permit to import into Tasmania required?
No
Yes - Attach copy of permit (s)
Will GMOs stored outside certified facilities be stored in locked storage units in restricted access areas?
Yes
No – Attach Details
Do personnel involved in the dealing have appropriate training and experience?
Yes
No
Is the parent organism a weed or closely related to plants that are weeds? Please identify any closely related weeds.
Yes
No
To what stage of development will the plants be grown at the time of storage? (e.g. seeds)
University of Tasmania/NLRD Application Form/Version 1/Sep 2009
4
OGTR expects laboratories to keep records of the storage place of all dealings under NLRD (s) permits such that the
investigator or other practitioners can take auditors directly to any given GMO. Please indicate how this will be done
for this NLRD (s) in your laboratory.
Please provide the titles and reference numbers of the Standard
Operating Procedures (SOPs) for
transport and
disposal of the GMO(s).
You may be asked to produce these documents during the annual inspection of certified facilities.
Have all the personnel (staff and students) involved in this project received training against the SOPs related to this
dealing?
Yes
No
You will be asked to produce training records during the annual inspection of certified facilities.
7
Declaration
To be signed by the Applicant
I DECLARE THAT:

I am the applicant and principal research person;

The dealings listed in this notification are Notifiable Low Risk Dealings (NLRDs);

No additional work or extension of this dealing (bracket creep to another classification of a GMO dealing) will be
undertaken without the permission of the IBC;

Personnel involved in the dealings have appropriate training and experience.
Name of Institute/School/Section (Please sign and initial every page)
Printed Name
Signature
Job Title
Date
8
Declaration
To be signed by the Head of Institute/School/Section
I DECLARE THAT:

I am duly authorised to sign this declaration;

The dealings listed in this notification are Notifiable Low Risk Dealings (NLRDs);

No additional work or extension of this dealing (bracket creep to another classification of a GMO dealing) will be
undertaken without the permission of the IBC;

Personnel involved in the dealings have appropriate training and experience.
Name of Institute/School/Section (Please sign and initial every page)
Printed Name
Signature
Job Title
Date
University of Tasmania/NLRD Application Form/Version 1/Sep 2009
5
9
Declaration
To be signed by the Chair, Institutional Biosafety Committee (IBC)
I DECLARE THAT:

I am duly authorised to sign this declaration;

The dealings listed in this notification are Notifiable Low Risk Dealings (NLRDs).
Chair, University of Tasmania Institutional Biosafety Committee (IBC)
Printed Name
Signature
Job Title
Date
University of Tasmania/NLRD Application Form/Version 1/Sep 2009
6
Table 2 - Examples of responses to Part 4: The description of the GMO(s)
The “parent organism” means the organism(s) (or tissue derived from organisms) that you propose to genetically
modify and “host” equates to “parent”. If the host/vector system is not exempt please provide details of the system.
4.A
4.5
4.C
4.D
4.E and 4.F
4.G
Common
name of
parent
organism
Scientific
name of
parent
organism
Vector(s)
or
method of
transfer
Exempt Host/vector system?
(if no please provide details
Modified
trait
Identity or class
of gene(s) and
organism of
origin
NLRD
kind
Mouse
Mus
musculus
no (whole animals are not
exempt unless listed under
Schedule 2 Part 1)
IGFII
protein
expressio
n
IGFII from
Macropus eugenii
(Tammar
Wallaby)
a)
Thale
cress
Arabidopsis
thaliana
DNA
Microinjecte
d into
mouse
embryos
Non
tumorigenic
disarmed Ti
plasmid via
vacuum
infiltration
no (although original
transformation is of plant cell
culture, the plantlets will be
grown to maturity. Whole GM
plants are not an exempt host)
GFP gene from
Aequorea victoria
b)
Bacteria
Escherichia
coli B
strains
Conjugative
plasmids
no (plasmids are capable of
conjugation)
bla gene
(betalactamase,
present on the
plasmids)
c)
Tissue
culture
cells
CHO and
COS cell
lines
Vaccinia
virus
no (vaccinia virus is not a
defective
viral vector)
E. coli K12
Nonconjugative
plasmids
yes
(Note: Dealings may only be
type E if the host/vector
system is listed in Part 2 of
Schedule 2 of the Regulations)
Fibronectin genes
from various
mammalian
species, GFP
from A. victoria
Unknown. Genes
have a putative
roles in
oncogenesis and
cell cycle
regulation
d)
Bacteria
Fluoresce
nce expressio
n of green
fluoresce
nt protein
(GFP).
Expressio
n
Ampicillin
resistance
gene
Expressio
n of
fibronecti
n genes
and GFP
As-yet
unidentifie
d genes
will be
overexpre
ssed.
Attachment 1 – Types of NLRDs
University of Tasmania/NLRD Application Form/Version 1/Sep 2009
7
e)
What is or are the kind(s) of notifiable low risk dealing?
Below are the kind of NLRD dealings that are listed in the Regulations. Please tick the box(s) next to the statement
that best describes the GMO(s) or methods that were used to produce the GMOs. (ie. if you were notifying the OGTR
of a dealing to produce these GMOs, what type of NLRD would the dealing be classified as?)
a. Any dealing involving whole animals (including non-vertebrates) that:
(i) involves genetic modification of the genome of the oocyte or zygote or early embryo by any means to produce
a novel whole organism; and
(ii) does not involve gene-knockout mice
b. Any dealing involving the production of a genetically modified flowering plant if:
(i)
the dealing does not involve the plant being grown to flowering stage; or
(ii) for a dealing that does involve the plant being grown to flowering stage:
(A) the plant is male sterile and is unable to set seed; or
(B) if the plant is male sterile and can set seed —all vents and drains in the facility are screened with mesh or
filters that block the escape of viable pollen and seed; or
(C) before flowering, all inflorescences are wholly enclosed in bags designed to prevent escape of viable
pollen and seed; or
(D) if the plant can be wind-pollinated —all vents and drains in the facility are screened with mesh or filters
that block the escape of viable pollen and seed; or
(E) if the plant can be vector-pollinated only —all vents and drains in the facility are screened with mesh or
filters that block the escape of viable seed and exclude pollen vector from the facility;
c. Any dealing involving a host and vector that are not mentioned as a host/vector system in Part 2 of Schedule 2, if:
(i) the host is incapable of causing disease in human beings, animals, plants or fungi; and
(ii) the vector is incapable of causing disease in human beings, animals, plants or fungi
d. Any dealing involving a host and vector that are not mentioned as a host/vector system in Part 2 of Schedule 2, if,
although the host and vector are capable of causing disease in human beings, animals, plants or fungi, the donor
DNA is fully characterised and will not increase the virulence of the host or vector.
e. Any dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the gene inserted:
(i) is a pathogenic determinant; or
(ii) is uncharacterised DNA from a micro-organism that is capable of causing disease in human beings, animals,
plants or fungi; or
(iii) is an oncogene.
General Information
Notification of a notifiable low risk dealing (NLRD)
This notification is for a new NLRD under the Commonwealth Gene Technology Act 2000 (the Act) and corresponding
State law.
Regulation 13 of the Gene Technology Regulations 2001 (as amended with effect from I July 2007 by the Gene
Technology Amendment Regulations 2006) requires that an Institutional Biosafety Committee (i) confirms that an
NLRD is a dealing of a kind mentioned in Part 1 of Schedule 3 of the Regulations; and (ii) considers that the personnel
to be involved in the proposed dealing have appropriate training and experience.
According to the Act, to “deal with” in relation to a GMO, means any of the following: (a) conduct experiments with the
GMO; (b) make, develop, produce or manufacture the GMO; (c) breed the GMO; (d) propagate the GMO; (e) use the
GMO in the course of manufacture of a thing that is not a GMO; (f) grow, raise or culture the GMO; (g) import the
GMO; and includes the possession, supply, use transport or disposal of the GMO for the purposes of, or in the course
of, a dealing mentioned in any of (a) to (g).
Accuracy of information
Please answer all questions unless otherwise indicated. Please check that the information provided in this notification
is true and accurate. The Act provides for penalties to a person who knowingly gives information to the Regulator that
is false or misleading.
Confidentiality
University of Tasmania/NLRD Application Form/Version 1/Sep 2009
8
If you wish to make an application for a declaration that specifies information is Confidential Commercial Information
(CCI) for the purposes of the Act, you must also complete the CCI application form available at www.ogtr.gov.au and
submit it at the same time as this notification.
Privacy
Any personal information is safeguarded by the Privacy Act 1988. This prevents the submitted personal information
from being used for purposes other than assessing the certification application, or other circumstances specified by
the Gene Technology Act 2000 (Commonwealth). In certain circumstances information supplied as part of a
notification may, according to their specific needs, be given to the following:
 an officer or employee of the Department of Health and Ageing;
 an officer or employee of a State government agency or organisation;
 Courts, Tribunals and/or other Commonwealth agencies where it is an obligation under law to provide it;
 law enforcement authorities; and
 the relevant Minister.
Authorisation
Please ensure that if you are completing this notification on behalf of the organisation, you hold the proper authority to
submit this application on behalf of the organisation.
University of Tasmania/NLRD Application Form/Version 1/Sep 2009
9