Download Applicant - Environmental Protection Authority

ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under s67A on 16 August 2007
Application Codes
GMD00166, GMD00167,
Date 15 September 2000
GMD00168
Consideration Date
15 September 2000
Considered by
Chief Executive, ERMA New Zealand
Application Details
New Zealand Dairy Research Institute
Applicant
Purposes
Date Received
GMD00166
To update GMO99/DR006 to include cloning vectors, reporter genes and a
modified lactococcal transposon for laboratory scale experiments or
fermentations of GM L. lactis, in order to determine the effects of
overexpressed enzymes or other proteins.
GMD00167
To update GMO00/DR007 to include cloning vectors, reporter genes and a
modified lactococcal transposon to carry out small-scale fermentations of
modified Lactobacillus bacteria in order to determine the effects of those
proteins on dairy product industrial properties.
GMD00168
To update GMO98/DR001 to include additional cloning vectors or cloning
systems for research into the properties of enzymes or other proteins cloned
into E.coli from cheese starter (L lactis) and non-starter (lactobacilli) bacteria.
14 August 2000
Decision
The applications are Approved with controls.
The organisms approved are the genetically modified microorganisms as listed below:
GMD00166
2. Lactococcus lactis strains, including strains containing Tn5276 or deletion derivatives thereof, as
modified by pFX2, pFX3, pCI3340, pCP12 or pCP13 containing a beta-glucanase or betaglucuronidase reporter gene and/or DNA cloned from Lactococcus lactis or Lactobacillus species
or from bacteriophage isolated from L. lactis.
3. L. lactis strain NZ9000 as modified by pNZ8037 or pNZ8048 containing a beta-glucanase or
beta-glucuronidase reporter gene and/or DNA cloned from Lactococcus lactis or Lactobacillus
species or from a bacteriophage isolated from L. lactis.
The development of these genetically modified organisms shall meet the requirements of
Category B experiments in the Hazardous Substances and New Organisms (Low-Risk Genetic
Modification) Regulations 1998.
GMD00167
Lactobacillus spp. strains, including strains containing Tn5276 or deletion derivatives thereof, as
modified by pFX2, pFX3, pCI3340, pCP12 or pCP13 containing a beta-glucanase or betaglucuronidase reporter gene and/or DNA cloned from Lactococcus lactis or Lactobacillus species.
The development of these genetically modified organisms shall meet the requirements of
Category B experiments in the Hazardous Substances and New Organisms (Low-Risk Genetic
Modification) Regulations 1998.
GMD00168
Escherichia coli K12 or B derivatives that do not contain conjugative plasmids or generalised
transducing bacteriophage as modified by pFX2, pFX3, pCI3340, pTRK-L2, pTRK-H2 or
commercially available non-conjugative plasmid vectors based on the ColE1 or R6K origin of
replication containing DNA cloned from Lactococcus lactis or Lactobacillus spp.
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.
Application Process
Applications GMD00167 and 168 were formally received on 14 August 2000 and verified on 30
August 2000. Application GMD00166 was received on 14 August 2000, stalled under section 52
on 31 August 2000 and verified on 4 September 2000. Waivers were obtained from the applicant
(signed 24 August 2000) to allow additional time to request further information under section 52
and the evaluation and consideration of the applications.
The documents available for the evaluation and review of the applications by the external
reviewer Associate Professor Clive Ronson were the applications, 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.
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.
The developments described in GMD00168 meet the requirements of Category A of the HSNO
(Low-Risk Genetic Modification) Regulations 1998 and are therefore appropriately carried out
Environmental Risk Management Authority Decision: Applications GMD00166, GMD00167, GMD00168
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under Physical Containment Level 1 (PC1), as in the Australian/New Zealand Standard
AS/NZS 2243.3:1995 Safety in Laboratories Part 3: Microbiology.
The developments described in GMD00166 and GMD00167 meet the requirements of Category
B(b)(iv)(A) of the HSNO (Low-Risk Genetic Modification) Regulations 1998 and are therefore
appropriately carried out under Physical Containment Level 2 (PC2), as in the Australian/New
Zealand Standard AS/NZS 2243.3:1995 Safety in Laboratories Part 3: Microbiology.
Controls: GMD00168
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 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.
Controls: GMD00166 and GMD00167
Physical Containment 2
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 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).
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: Applications GMD00166, GMD00167, GMD00168
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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: 15 September 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: Applications GMD00166, GMD00167, GMD00168
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