Download NLRD Application Form - University of Canberra

Notifiable Low Risk Dealing Application Form
Please fill out the NLRD form below and provide all required information. The form must be signed by the
applicant and it will be held on file in the Research Services Office.
1
Title of Project
2
Is this notification to replace an existing NLRD(s)?
No
Yes
If yes, please provide the NLRD number(s) here:
3
Dealing Information
3.1
Project Supervisor
Project Supervisor’s name
including title
Visiting Fellow,
Postdoctoral Fellow
or term appointment?
No
Yes
Workplace Street Address
Workplace Telephone
Number
Mobile Telephone Number
Workplace Email Address
If yes, dates of appointment:
Relevant experience with
GMOs or more specifically
GMOs or parent organisms
of the kind listed in this
application.
3.2
List of researchers (including the chief investigator) who will work on this project and are
authorised to undertake dealings with the GMO(s).
The Biological Safety and Gene Technology Practices courses are compulsory for all UC researchers
listed (academic staff and students). Indicate the year these courses were last completed by each
researcher. Courses must be refreshed every 5 years (completion of exam only is sufficient for senior
researchers). If courses not yet completed, indicate when the researcher is registered for the courses.
Name
Biological Safety Course
completed
Gene Technology Practices
Course completed
2
3.3
Briefly describe the project, including its purpose and aims, and the proposed use of
GMOs. Please include a brief description of all GMOs (including exempt GMOs) that will be used
in this dealing. Please take no more than one page for this answer.
3
4
Description of the GMO(s)
In this part, a description is required of all non-exempt GMO(s) to be generated and/or used during the
proposed dealings.
4.1
Name(s) of the organism(s) being modified (e.g. virus, bacterium, animal, plant)
4.2
Vector(s) and methods used for transfer of genetic material.
4.3
Modified trait(s) and gene(s) responsible (e.g. antibiotic resistance, attenuation, protein
expression, disease resistance).
4.4
Organism of origin and function of the gene(s) responsible for the modified trait(s).
4.5
Other organisms or tissues (if any) to be used in association with the GMO(s)? (e.g. non-GM
mice, cell lines or plants, or GMOs covered by another NLRD or licenced dealing)
4.5
Type of Dealing
Below are the kinds of Notifiable Low Risk Dealings that are listed in the Gene Technology Regulations
2001 (amended 1 September 2011). More detailed information can be found in Appendix 1 and also in
Parts 1 and 2 in Schedule 3 of the Gene Technology Regulations 2001 available on the OGTR website at
www.ogtr.gov.au.
Type of Notifiable Low Risk Dealings
(a)
PC 1 NLRD Type (a) – (c);
(b)
PC 2 NLRD Type (a) – (m)
(c)
PC 3 NLRD Type
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Additional information for a GMO that is a whole plant or is to be used in conjunction with a
whole plant.
5.1
Is the plant being modified a weed?
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No
Yes
If yes, please provide details.
5.2
Is the plant being modified able to cross pollinate plants that are weeds?
No
Yes
If yes, please list cross compatible weeds.
5.3
Will GM plants be propagated vegetatively, grown to flowering for pollen production or
grown to maturity for seed production? This relates to the potential spread of the GMO (e.g. if
the plant produces pollen or seed).
No
Yes
If yes, please provide a risk assessment for all potential dispersal routes (e.g. dispersal of vegetative
propagules in used soil; wind or insect dispersal of pollen; or seed dispersal associated with shattering of
seed pods) including measures that will be taken to minimise the risk of dispersal. Any hazards associated
with an unintentional release of vegetative propagules, pollen or seed must be addressed in Part 6C.
5.4
What method(s) will be used to sterilize or dispose of the soil or soil substitute used for
growing the plants?
6
Risk assessment and management
6.1
Health and Safety of People: What are the possible hazard(s) to the staff performing the
proposed genetic modification(s) or handling the resulting GMO(s)? What is the likelihood of these
hazards and the consequences if they occur?
6.2
Health and Safety of People: What are the possible hazards to the general public arising from
an unintentional release of the GMO(s) into the environment? What is the likelihood of these
hazards and the consequences if they occur?
6.3
Environment: What are the possible hazards to the environment arising from an unintentional
release of the GMO(s) into the environment? What is the likelihood of these hazards and the
consequences if they occur?
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6.4
Please list the facility type (laboratory, animal house, etc.) and certification numbers for all
the facilities to be used in this dealing.
6.5
What is the risk of backflow contamination of the water supply to each of the certified
facilities listed in Part 6D by the GMOs listed in Part 4? How will this risk be managed?
N.B. Backflow risk assessments and management procedures must be documented in your
facility manuals.
6.6
Do you intend crossing GMOs expressing different transgenes to one another?
No
Yes
If yes, list the kinds of crosses proposed.
Exclude crosses required as part of the procedure to generate a GMO e.g. using the Cre/Lox
system to generate knockout mice, which should be listed in Part 4B.
Exclude crosses required for the maintenance of the GMO or crosses to non-GMOs. The progeny
of these crosses are considered the same as the original GMO.
Exclude crosses to gene knockouts e.g. T-DNA insertional inactivation mutants in plants.
Exclude crosses to GMOs expressing only selectable markers and/or commonly used reporter
genes e.g. GFP, luciferase, galactosidase, glucuronidase.
N.B. All crosses (including those excluded above) should be recorded and the crossing record
made available for inspection if required.
6.7
Are the risks to health and safety of people, to the environment or of backflow
contamination predicted to be different for the progeny of any crosses listed in Part 6F than
the combined risks for the parent GMOs?
Not applicable
Not known
No
Yes
If yes, what are the altered risks?
N.B. Any additional actions and procedures required to manage altered risks must be listed in
Parts 6E and 6K.
N.B. If you discover the progeny have a different phenotype, and therefore different associated
risks than expected, you must discontinue any further experimental work with the progeny and
notify the Recombinant DNA Monitoring Committee to have your dealing re-evaluated.
6.8
If relevant, please outline any training required for animal handling: training programs
administered by your laboratory/School or training provided by other facilities e.g. ABRF
Basic Mouse Handling.
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6.9
Will the dealing(s) involve the injection of GM micro-organisms into animals?
No
Yes
If yes, the training records in the laboratory must provide documentation that staff members have
attended a formal training course (e.g. an ABRF course in IP injections) OR a signed and dated
statement by the principal researcher that each staff member has been trained and demonstrated
competence with the injection methods used in this dealing.
Please attach copies of relevant risk assessments and experimental protocols involving injection
of GM micro-organisms into animals to this application.
6.10
Do you propose to transport the GMO(s) outside a certified facility? e.g. transportation
between facilities, transportation of waste to the autoclave, transportation to incubators or
freezers, or import or export.
N.B. GMOs must be transported in accordance with the Guidelines for the Transport, Storage and
Disposal of GMOs.
6.11
Please list the proposed storage location(s) of non-exempt GMOs.
6.12
How will the GMO(s) be disposed of? e.g. autoclaving, incineration or chemical
disinfection. If using chemical disinfection, please provide details of chemical
concentrations and procedures.
6.13
What are the steps you will take in the event of an unintentional release of the GMO(s)?
6.14
Are there any other actions or precautions you will take to minimise risks posed by the
proposed dealing(s) e.g. vaccinations?
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Signature
I declare that to the best of my knowledge, having made reasonable inquiries, the information herein is
true and correct. I understand that providing misleading information to the OGTR, deliberately or
otherwise, is an offence under Commonwealth law.
I confirm that I have read and understood the relevant Acts, Regulations and Guidelines and also confirm
that as the Chief Investigator I will ensure all personnel working on the project are appropriately trained
and will comply with the relevant Acts, Regulations and Guidelines. I confirm that training records are
retained within the laboratory.
I accept responsibility for the conduct of the research detailed above in accordance with the Gene
Technology Act 2000 and Regulations 2001 and subsequent Amendments. I will conduct this research
project in accordance with the behavioural requirements set out in the Guidelines for Certification of a
Physical Containment Facility and the Guidelines for Transport, Storage and Disposal of GMOs and
ensure safe work practices at all times.
I will submit an annual review once every 12 months during the life of this project and understand that
ongoing IBC approval of this dealing is subject to meeting the IBC annual reporting requirements. I agree
to maintain a register of all GMOs and records of all dealings.
On completion of this project or termination of my employment, I will ensure that all GMOs covered by this
NLRD are destroyed or stored under an appropriate NLRD or transferred to another researcher with an
appropriate NLRD. I will complete a Dealing Expiry/Discontinuation report at the end of my research or by
the expiry date of my NLRD. I will ensure that the location of stored or transferred GMOs is clearly
documented in my report.
I will inform the IBC of any proposed changes to the scope of the work described in this application.
Project Supervisor
Signature: __________________________________ Date: ______________________
Printed Name:
Senior Manager Declaration: Required if the Project Manager is a Visiting Fellow, Post-doctoral Fellow
or Term Appointment.
As the Senior Manager responsible for the research activities of the project supervisor, I acknowledge my
responsibility to ensure that all GMOs covered by this NLRD are appropriately destroyed, stored or
transferred at the end of the project supervisor’s tenure. I will ensure that a Dealing Expiry/Discontinuation
report is completed for this project and that the location of all GMOs from this project is clearly
documented and communicated to the IBC.
Signature: __________________________________ Date: ______________________
Printed Name:
Submitting your form:
Please submit an electronic version of the completed form as an email attachment to the Secretary of the
University of Canberra Biosafety Committee at [email protected]. Hard copies will not be
accepted.
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IBC Declaration
The IBC has evaluated this dealing and agrees that it is a NLRD as specified by Schedule 3 Part 1 or Part
2 of the Gene Technology Regulations 2001 (Amended 2011).
Name of IBC
The University of Canberra Biosafety Committee
Name of IBC Chair
Dr Dianne Gleeson
Signature of IBC Chair
Date:
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Appendix 1
Notifiable Low Risk Dealings that may be conducted in certified Physical Containment Level 1
facilities.
(a)
(b)
(c)
A dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory
mouse, a genetically modified laboratory rabbit or a genetically modified laboratory rat, unless:
(i) an advantage is conferred on the animal by the genetic modification; or
(ii) the animal is capable of secreting or producing an infectious agent as a result of
the genetic modification;
unused
A dealing involving a replication defective vector derived from Human adenovirus or Adeno
associated virus in a host mentioned in item 4 of Part 2 of Schedule 2, if the donor nucleic acid:
(i) cannot restore replication competence to the vector; and
(ii) does not:
(A) confer an oncogenic modification in humans; or
(B) encode a protein with immunomodulatory activity in humans.
Notifiable Low Risk Dealings that may be conducted in certified Physical Containment Level 2
facilities.
(a)
(aa)
(b)
(c)
(d)
A 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 any of the following:
(A) a genetically modified laboratory guinea pig;
(B) a genetically modified laboratory mouse;
(C) a genetically modified laboratory rabbit;
(D) a genetically modified laboratory rat;
(E) a genetically modified Caenorhabditis elegans;
A dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory
mouse, a genetically modified laboratory rabbit, a genetically modified laboratory rat, or a genetically
modified Caenorhabditis elegans, if:
(i) the genetic modification confers an advantage on the animal; and
(ii) the animal is not capable of secreting or producing an infectious agent as a result of the
genetic modification;
A dealing involving a genetically modified plant;
A dealing involving a host/vector system not mentioned in paragraph 1.1(c) or Part 2 of Schedule 2,
if neither host nor vector has been implicated in, or has a history of causing, disease in otherwise
healthy:
(i) human beings; or
(ii) animals; or
(iii) plants; or
(iv) fungi;
A dealing involving a host and vector not mentioned as a host/vector system in Part 2 of Schedule
2, if:
(i) the host or vector has been implicated in, or has a history of causing, disease in
otherwise healthy:
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi; and
(ii) the donor nucleic acid is characterized; and
(iii) the characterization of the donor nucleic acid shows that it is unlikely to increase the
capacity of the host or vector to cause harm;
Example
Donor nucleic acid would not comply with subparagraph (iii) if, in relation to the capacity of
the host or vector to cause harm, it:
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(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(a) provides an advantage; or
(b) adds a potential host species or mode of transmission; or
(c) increases virulence, pathogenicity or transmissibility.
A dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor
nucleic acid:
(i) encodes a pathogenic determinant; or
(ii) is uncharacterised nucleic acid from an organism that has been implicated in, or
has a history of causing, disease in otherwise healthy;
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi;
A dealing involving a host/vector system mentioned in Part 2 of Schedule 2 and producing
more than 25 litres of GMO culture in each vessel containing the resultant culture, if:
(i) the dealing is undertaken in a facility that is certified by the Regulator as a large scale
facility; and
(ii) the donor nucleic acid satisfies the conditions set out in subitem 4 (2) of Part 1 of
Schedule 2;
A dealing involving complementation of knocked-out genes, if the complementation is
unlikely to increase the capacity of the GMO to cause harm compared to the capacity of
the parent organism before the genes were knocked out;
Example
A dealing would not comply with paragraph (g) if it involved complementation that, in
relation to the parent organism:
(a) provides an advantage; or
(b) adds a potential host species or mode of transmission; or
(c) increases its virulence, pathogenicity or transmissibility.
A dealing involving shot-gun cloning, or the preparation of a cDNA library, in a host/vector system
mentioned in item 1 of Part 2 of Schedule 2, if the donor nucleic acid is derived from either:
(i) a pathogen; or
(ii) a toxin-producing organism;
A dealing involving the introduction of a replication defective viral vector unable to transduce human
cells into a host not mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore
replication competence to the vector;
A dealing involving the introduction of a replication defective non-retroviral vector able to
transduce human cells, other than a dealing mentioned in paragraph 1.1 (c), into a host
mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication
competence to the vector;
A dealing involving the introduction of a replication defective non-retroviral vector able to
transduce human cells into a host not mentioned in Part 2 of Schedule 2, if:
(i) the donor nucleic acid cannot restore replication competence to the vector; and
(ii) the donor nucleic acid does not:
(A) confer an oncogenic modification in humans; or
(B) encode a protein with immunomodulatory activity in humans;
A dealing involving the introduction of a replication defective retroviral vector able to
transduce human cells into a host mentioned in Part 2 of Schedule 2, if:
(i) all viral genes have been removed from the retroviral vector so that it cannot
replicate or assemble into a virion without these functions being supplied in trans;
and
(ii) viral genes needed for virion production in the packaging cell line are expressed
from independent, unlinked loci with minimal sequence overlap with the vector to
limit or prevent recombination; and
(iii) either:
(A) the retroviral vector includes a deletion in the Long Terminal Repeat sequence of
DNA that prevents transcription of genomic RNA following integration into the host
cell DNA; or
(B) the packaging cell line and packaging plasmids express only viral genes gagpol,
rev and an envelope protein gene, or a subset of these;
A dealing involving the introduction of a replication defective retroviral vector able to
transduce human cells into a host not mentioned in Part 2 of Schedule 2, if:
(i) the donor nucleic acid does not:
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(A) confer an oncogenic modification in humans; or
(B) encode a protein with immunomodulatory activity in humans; and
(ii) all viral genes have been removed from the retroviral vector so that it cannot
replicate or assemble into a virion without these functions being supplied in
trans; and
(iii) viral genes needed for virion production in the packaging cell line are expressed
from independent, unlinked loci with minimal sequence overlap with the vector to
limit or prevent recombination; and
(iv) either:
(A) the retroviral vector includes a deletion in the Long Terminal Repeat
sequence of DNA that prevents transcription of genomic RNA following
integration into the host cell DNA; or
(B) the packaging cell line and packaging plasmids express only viral genes
gagpol, rev and an envelope protein gene, or a subset of these.
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