Download ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION

ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under s67A on 16 August 2007
Application Codes
GMD00026
GMD00063
Date 18 July 2000
Consideration Date
18 July 2000
Considered by
Chief Executive, ERMA New Zealand
Application Details
Applicant
Associate Professor Khris Mahanty,
University of Canterbury
Purposes
GMD00026
To develop in containment genetically modified
variants of Escherichia coli, Pseudomonas, Erwinia and
Serratia species. which are central to our understanding
of the natural mechanisms by which these potential
biocontrol agents interact with various
phytopathogens.
GMD00063
Demonstration of basic molecular/microbial genetic
techniques to second year students in the Plant and
Microbial Sciences and Zoology departments involving
experiments to determine the presence of transforming
DNA by expression of marker genes and properties
under investigation.
Date Received
24 May 2000
Decision
The applications are Approved with controls.
The organisms approved are the genetically modified microorganisms as listed below:
A.
Application GMD00026
The organisms approved are:
A1.
Escherichia coli strain K12 derivativesa modified by the pLAFR3 cosmid vector,
pBR322/pUC-derived plasmid vectorsb, or pACYC184b containing DNA from:
i.
ii.
iii.
iv.
v.
Serratia entomophila
Pseudomonas aureofaciens
Pseudomonas viridflava
Erwinia herbicola
Erwinia amylovora
The development of these genetically modified organisms shall meet the requirements of
Category B experiments – “B(b)(v)(B)” -in the Hazardous Substances and New Organisms (LowRisk Genetic Modification) Regulations 1998.
Containment A1:
The development of organisms described in A1, where conjugative
plasmids are not involved requires PC1 level containment, plus the additional requirements as
listed in the controls.
The vectors and donor DNA listed above can be transferred from their E. coli hosts only to the
host cells as described below, using conjugative plasmids derived from plasmid RP4:
A2.
Mutated strains of Serratia entomophila as modified by pLAFR3, pBR322/pUCderived plasmid vectorsb, or pACYC184b containing DNA from Serratia entomophila.
A3.
Mutated strains of Pseudomonas aureofaciens as modified by pLAFR3, pBR322/pUCderived plasmid vectorsb, or pACYC184b containing DNA from Pseudomonas aureofaciens.
A4.
Mutated strains of Pseudomonas viridflava as modified by pLAFR3, pBR322/pUCderived plasmid vectorsb, or pACYC184b containing DNA from Pseudomonas viridflava.
A5.
Mutated strains of Erwinia herbicola as modified by pLAFR3, pBR322/pUC-derived
plasmid vectorsb, or pACYC184b containing DNA from Erwinia herbicola.
A6.
Mutated strains of Erwinia amylovora as modified by pLAFR3, pBR322/pUC-derived
plasmid vectorsb, or pACYC184b containing DNA from Erwinia amylovora.
The development of these genetically modified organisms shall meet the requirements of
Category B experiments – “B(b)(i)” -in the Hazardous Substances and New Organisms (LowRisk Genetic Modification) Regulations 1998.
a
b
The host cells shall not contain generalized transducing phages
These vectors shall be non-conjugative
Containment A2-A6: The development of organisms described in A2-A6, involving the use of
hosts not in Schedule 2 of the low risk genetic modification regulations and conjugative plasmids
(as described above), require PC2 level containment, plus the additional requirements as listed in
the controls.
B.
Application GMD00063
The organisms approved are:
B1.
Escherichia coli strain K12 derivativesa modified by the non-conjugative plasmids
pHK11, pHK11-1, pHK11-2, pHK11-3, pHK11-4, or pHK11-5, and not containing any
additional foreign DNA, where the development of these genetically modified organisms meet
the requirements of Category A experiments – “A(a)” -in the Hazardous Substances and New
Organisms (Low-Risk Genetic Modification) Regulations 1998.
a
The host cells shall not contain conjugative plasmids or generalized transducing phages
Environmental Risk Management Authority Decision: Application GMD00026, GMD00063
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Containment B1::
The development of organisms described in B1, which does not involve
the use of conjugative plasmids, requires PC1 level containment, plus the additional requirements
as listed in the controls.
B2.
Escherichia coli strain K12 derivativesa modified by the conjugative plasmid pColVK30, and where the development of the genetically modified organisms meet the requirements of
Category A or B experiments – “B(b)(iv)A” - in the Hazardous Substances and New Organisms
(Low-Risk Genetic Modification) Regulations 1998.
a
The host cells shall not contain generalized transducing phages
Containment B2:
The development of organisms described in B2, involving conjugative
plasmids, shall be conducted under PC2 level containment, plus the additional requirements as
listed in the controls.
B3.
Salmonella typhimurium strain DB7136 as modified by the transducing phage P22
derived from S. typhimurium strain LT2, and where the development of the genetically
modified organisms meet the requirements of Category B experiments –“B(b)(i)” - in the
Hazardous Substances and New Organisms (Low-Risk Genetic Modification) Regulations
1998.
Containment B3:
The development of organisms described in B3, involving a host that is
not in Schedule 2 of the low-risk regulations, requires PC2 level containment, plus the additional
requirements as listed in the controls.
Application Process
Application GMD00026 was formally received on 22 May 2000, stalled on 8 June 2000 for
further information, resubmitted on 14 June 2000 and verified on 20 June 2000. Application
GMD00063 was formally received on 24 May 2000 and verified on 21 June 2000. The documents
available for the evaluation and review of the applications by ERMA New Zealand included: the
applications, appendices, and a review of the applications by an expert panel of the University of
Canterbury.
The applications were determined by Dr Bas Walker, Chief Executive, ERMA New Zealand
under delegation from the Authority as provided for by section 19 of the Act.
Relevant Legislative Criteria
The applications were lodged pursuant to section 40(1)(b) HSNO Act 1996, and determined in
accordance with section 42, and those relevant matters in Part II of the Act.
Consideration of the applications followed the relevant provisions of the Hazardous Substances
and New Organisms (Methodology) Order 1998 (the Methodology).
Assessment against the Criteria for Low-Risk Genetic Modifications
The Chief Executive (holder of delegated decision making power) is satisfied that the
development of each of the genetically modified organisms described above meets the criteria for
a low-risk genetic modification specified in regulations made under section 41, being the HSNO
(Low-Risk Genetic Modification) Regulations 1998.
Environmental Risk Management Authority Decision: Application GMD00026, GMD00063
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The developments meet the requirements of Category A or Category B of the HSNO (Low-Risk
Genetic Modification) Regulations 1998 and are therefore appropriately carried out under
Physical Containment Level 1 or 2 (PC1 or PC2), as in the Australian/New Zealand Standard
AS/NZS 2243.3:1995 Safety in Laboratories Part 3: Microbiology.
Controls:
Physical Containment 1 (Organisms A1 and B1 as listed above)
In considering all the matters to be addressed detailed in the Third Schedule Part I Containment
Controls for Development and Field Testing of Genetically Modified Organisms of the Act, the Authority’s
approvals of the organisms requiring PC1 containment are subject to the following controls:
1.
The operation, management and construction of the facility shall be in accordance with the:
a)
Ministry of Agriculture and Forestry (MAF)/ERMA New Zealand Standard
154.03.021: Containment Facilities for Microorganisms.
b) Australian/New Zealand Standard (AS/NZS) 2243.3:19951 Safety in Laboratories: Part 3:
Microbiology, at Physical Containment Level 1 (PC1).
2.
The facility shall be approved and registered by MAF as a containment facility under section
39 of the Biosecurity Act, in accordance with the MAF/ERMA New Zealand Standard
154.03.021, and controls imposed by the Authority.
3.
If a breach of containment occurs, the facility operator must ensure that the MAF
Inspector responsible for supervision of the facility has received notification of the breach
within 24 hours.
Physical Containment 2 (Organisms A2-A6, B2 and B3 as listed above)
In considering all the matters to be addressed detailed in the Third Schedule Part I Containment
Controls for Development and Field Testing of Genetically Modified Organisms2 of the Act, the Authority’s
approvals of the organisms requiring PC2 containment are subject to the following controls:
1.
The operation, management and construction of the facility shall be in accordance with the:
a)
Ministry of Agriculture and Forestry (MAF)/ERMA New Zealand Standard
154.03.021: Containment Facilities for Microorganisms.
b) Australian/New Zealand Standard (AS/NZS) 2243.3:19951 Safety in Laboratories: Part 3:
Microbiology, at Physical Containment Level 2 (PC2).
2.
The facility shall be approved and registered by MAF as a containment facility under
section 39 of the Biosecurity Act, in accordance with the MAF/ERMA New Zealand
Standard 154.03.021, and controls imposed by the Authority.
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by ERMA
New Zealand
2 Bold headings refer to Matters to be Addressed by Containment Controls for Development and Field Testing of Genetically
Modified Organisms, specified in the Third Schedule of the HSNO Act 1996.
1
Environmental Risk Management Authority Decision: Application GMD00026, GMD00063
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3.
If a breach of containment occurs, the facility operator must ensure that the MAF
Inspector responsible for supervision of the facility has received notification of the breach
within 24 hours.
Dr Bas Walker
Chief Executive, ERMA New Zealand
Date: 18 July 2000
Amendment: November 2006
Changes to controls:
 Addition of footnotes to the containment facility references and the Australian/New
Zealand containment facility references to “future proof” the decision
 Standardise the wording of the breach of containment control
 Removal of the control regarding inspection of facilities by the Authority, its agent or
enforcement officers
____________________________
Mr Rob Forlong
Chief Executive, ERMA New Zealand
16 August 2007
Date:
Environmental Risk Management Authority Decision: Application GMD00026, GMD00063
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