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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