Download ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION

ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under s67A on 16 August 2007
Application Codes
GMD00056
GMD00058
GMD00059
GMD00060
GMD00061
GMD00062
GMD00074
Consideration Date
18 July 2000
Considered by
Chief Executive, ERMA New Zealand
Date 18 July 2000
Application Details
Applicant
Purposes
Date received
Victoria University of Wellington
GMD00056
To modify Escherichia coli for the purpose of propogating
recombinant DNA, required to make diagnostic probes for the
detection of human mutations and polymorphisms, and to generate
target sequences to validate the probes (positive controls).
GMD00058
To study the function and regulation of the epithelial sodium
channel.
GMD00059
To apply mammalian cell transfection to produce proteins in
mammalian cells to study the function and regulation of the
epithelial sodium channel.
GMD00060
To apply recombinant DNA technology to clone and express genes
of interest as tools to produce proteins in either mammalian cells or
oocytes to study the function and regulation of the epithelial sodium
channel.
GMD00061
To apply routine recombinant DNA technology to clone and
express genes of interest as tools to produce protein in either
bacterial or mammalian cells to study the function and regulation of
H-cadherin.
GMD00062
Transient transfection of mammalian cells.
GMD00074
To modify E. coli for the purpose of propagating recombinant DNA.
The recombinant DNA is required to make diagnostic probes for
the production of FISH probes. The probes will be used in studies
analysing development expression patters in rats.
20 June 2000
Decision
The applications are Approved with controls.
The organisms approved are the genetically modified microorganisms as listed below:
GMD00056
The organisms approved are:
Escherichia coli strain K12 and derivativesa as modified by non-conjugative plasmid cloning
vectors containing DNA for the following sequences sourced from humansb, and where the
development of the genetically modified organisms meet the requirements of Category A
experiments in the Hazardous Substances and New Organisms (Low-Risk Genetic Modification)
Regulations 1998:
a)
b)
c)
d)
Human 21-hydroxylase genes (CYP21/CYP21P)
CFTR gene
Centromeric alphoid repeat sequences
Telomeric repeat sequences
Approved for use under PC1 level containment.
a
The host cells shall not contain conjugative plasmids or generalized transducing phages
b
Genetic material sourced from Mäori shall not be used.
GMD00058-62
The organisms approved are:
1.
Escherichia coli strain K12 and derivatives that do not contain conjugative plasmids or
generalized transducing phage, as modified by non-conjugative plasmid vectors of the following
types:
i. General E. coli cloning vectors e.g., pBluescript, pGEM, pCRII vectors
ii. E. coli expression plasmid vectors e.g., pProEx HT, pRSET, pGEX series vectors
iii. E. coli/mammalian expression plasmid vectors e.g., pMT3, pHM6, pcDNA3, pGL3
iv. E. coli/yeast shuttle vectors e.g., pGAD424, pGBT9
And containing:
i. genomic or cDNA from humana, rat, mouse or sheep for the purposes of identifying
and/or expressing:
e) genes associated with sodium channel function; or
f) genes associated with H-cadherin function
Environmental Risk Management Authority Decision: Application GMD00056-GMD00062, GMD00074
Page 2 of 6
ii. The Saccharomyces cerevisiae ubiquitin gene
iii. Genomic or cDNA from chicken (Gallus gallus) genes associated with H-cadherin
function
The development of these genetically modified organisms shall meet the requirements of
Category A experiments in the Hazardous Substances and New Organisms (Low-Risk Genetic
Modification) Regulations 1998.
Approved for use under PC1 level containment.
a
Genetic material sourced from Mäori shall not be used.
2.
Laboratory strains of Saccharomyces cerevisiae as modified by yeast plasmid vectors
containing:
i. genomic or cDNA from humana, rat, mouse or sheep for the purposes of identifying
and/or expressing:
a) genes associated with sodium channel function; or
b) genes associated with H-cadherin function
ii. The Saccharomyces cerevisiae ubiquitin gene
iii. Genomic or cDNA from chicken (Gallus gallus) genes associated with H-cadherin
function
The development of these genetically modified organisms shall meet the requirements of
Category A experiments in the Hazardous Substances and New Organisms (Low-Risk Genetic
Modification) Regulations 1998.
Approved for use under PC1 level containment.
a
Genetic material sourced from Mäori shall not be used.
3.
Mammalian cell linesa derived from:
i.
ii.
iii.
iv.
v.
vi.
Dog (Canis familiaris), e.g., MDCK (Mardin-Darby canine kidney)
Pig (Sus scrofa), e.g., LLC-PK1 pig proximal kidney
Mouse (Mus musculus), e.g., CommaD mouse mammary
Rat (Rattus norvegicus)
Sheep (Ovis aries)
The Cos-7 green monkey kidney cell line
Human cell lines will also be used but since human beings and genetic structures derived
from human beings are not organisms for the purposes of the HSNO Act, approval for
the genetic modification of human cell lines is not required under the HSNO Act.
As modified by mammalian expression plasmid vectors containing:
Environmental Risk Management Authority Decision: Application GMD00056-GMD00062, GMD00074
Page 3 of 6
i. genomic or cDNA from humanb, rat, mouse or sheep for the purposes of expressing:
a) genes associated with sodium channel function; or
b) genes associated with H-cadherin function
ii. The Saccharomyces cerevisiae ubiquitin gene
iii. Genomic or cDNA from chicken (Gallus gallus) genes associated with H-cadherin
function
The development of these genetically modified organisms shall meet the requirements of
Category A experiments in the Hazardous Substances and New Organisms (Low-Risk Genetic
Modification) Regulations 1998.
Approved for use under PC1 level containment.
a
b
Cell lines shall be free of viruses or viral vectors that are capable of infecting humans
Genetic material sourced from Mäori shall not be used.
GMD00074
The organisms approved are:
Escherichia coli strain K12 and derivativesa as modified by non-conjugative plasmid cloning
vectors containing genomic or cDNA sourced from laboratory rat (Rattus norvegicus) brains, where
the development of the genetically modified organisms meet the requirements of Category A
experiments in the Hazardous Substances and New Organisms (Low-Risk Genetic Modification)
Regulations 1998.
Approved for use under PC1 level containment.
a
The host cells shall not contain conjugative plasmids or generalized transducing phages
Application Process
The applications were formally received on 20 June 2000. The documents available for the
evaluation and review of the applications by ERMA New Zealand included: the application and
appendices.
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.
Environmental Risk Management Authority Decision: Application GMD00056-GMD00062, GMD00074
Page 4 of 6
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 in Schedule 1 meet the criteria for a
low-risk genetic modification specified in regulations made under section 41, being the HSNO
(Low-Risk Genetic Modification) Regulations 1998.
The developments meet the requirements of Category A of the HSNO (Low-Risk Genetic
Modification) Regulations 1998 and are therefore appropriately carried out under Physical
Containment Level 1 (PC1), as in the Australian/New Zealand Standard AS/NZS 2243.3:1995
Safety in Laboratories Part 3: Microbiology. 2243.3:1995, as detailed in Schedule 1.
A.
Controls: Physical Containment 1
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.
Dr Bas Walker
Chief Executive, ERMA New Zealand
Date: 18 July 2000
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by ERMA
New Zealand
1
Environmental Risk Management Authority Decision: Application GMD00056-GMD00062, GMD00074
Page 5 of 6
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 GMD00056-GMD00062, GMD00074
Page 6 of 6