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ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION Amended under s67A on 16 August 2007 Application code Application type Applicant Purpose Date received Consideration date Considered by Date signed: 13 February 2006 GMD05124 To develop in containment genetically modified organisms under sections 40(1)(b) and 42A of the Hazardous Substances and New Organisms (HSNO) Act 1996. Institute of Environmental Science Research Limited To develop genetically modified Escherichia coli strains containing cloned genetic material from bacteriophages that infect foodborne bacteria 13 February 2006 13 February 2006 Chief Executive, ERMA New Zealand 1 Summary of decision 1.1 Application GMD05124 to develop, as a project, genetically modified organisms (as described in Table 1 of this decision) in containment is approved, with controls (see Appendix 1 of this decision), having been considered in accordance with the relevant provisions of the Hazardous Substances and New Organisms (HSNO) Act 1996 (the Act), the HSNO (LowRisk Genetic Modification) Regulations 2003 (the Low-Risk Regulations), and the HSNO (Methodology) Order 1998 (the Methodology). The organism approved is: 1.2 The organism approved for development is the genetically modified organism described in Table 1: Table 1: Organism as recorded on ERMA New Zealand Register Host organism Category of Modified by: host organism Escherichia coli (Migula 1895) Castellani and Chalmers 1919 nonpathogenic laboratory strains 1 Standard non-conjugative Escherichia coli cloning and expression plasmid vectors containing genomic DNA, cDNA or PCR products derived from bacteriophage that infect foodborne bacteria. Genetic material selected for specific gene expression will encode open reading frames of interest with bactericidal activity. The vectors may also contain any of a number of other standard regulatory elements including: Promoter, operator, regulatory element binding, enhancer and termination sequences; Selectable marker genes that confer an ability to be resistant against antibiotics, or deactivate metabolic inhibitors, or deactivate other selective bactericidal or bacteriostatic agents; Origins of replication from bacterial plasmids or single-stranded bacteriophage; Multiple cloning sites; Primer recognition sequences; Sequences enabling the detection, purification and cleavage of expressed proteins; Covalently bound Topoisomerase I; and sequences encoding carbohydrate synthesis and regulation genes. Genetic material will not be sourced from bacteriophage known to be lysogenic, filamentous or contain vertebrate toxin genes. 2 Legislative criteria for application 2.1 The application was lodged pursuant to section 40(1)(b) of the Act and determined according to the rapid assessment provisions of section 42A of the Act. Environmental Risk Management Authority Decision: GMD05124 Page 2 of 10 Category of modification/ containment level A/PC1 2.2 The application has been approved with controls (see Appendix 1 of this decision) by Rob Forlong, Chief Executive of ERMA New Zealand, under delegation from the Authority as provided for in section 19 of the Act. 3 Consideration Sequence of the consideration 3.1 The application was formally received and verified as containing sufficient information on 13 February 2006. 3.2 The decision was based on the information supplied by the applicant in their application form: Develop in containment a project of low risk genetically modified organisms by rapid assessment (NO3P). 3.3 The application was considered by the Chief Executive of ERMA New Zealand. Relevant staff within ERMA New Zealand, including the Acting Manager, Māori, were involved in providing advice on the consideration of the application. 3.4 The development of the genetically modified organism described above (Table 1) meets the criteria of a low-risk genetic modification specified in the Regulations made under section 41 of the Act, being the HSNO (Low-Risk Genetic Modification) Regulations 2003 (see sections 3.11 - 3.12 of this decision). 3.5 In reaching my decision I have used information that is relevant and appropriate to the scale and significance of the risks, costs, and benefits associated with the genetic modifications and matters relevant to the purpose of the Act, as specified in Part II, and followed the relevant provisions of the Methodology. 3.6 In accordance with section 42A of the Act for rapid assessment, the approach adopted was to identify the circumstances of the genetic modification, to evaluate these against the criteria specified in section 41 of the Act, and to consider whether there are any residual risks that require further consideration. This approach covered the following issues: Purpose of the application (section 39 of the Act); Assessment against the criteria for low-risk genetic modifications (section 42A of the Act); Identification and assessment of the risks and other impacts of the organism; Precedents; and Proposed controls. 3.7 The Department of Conservation (DoC) was notified upon receipt of this application. Environmental Risk Management Authority Decision: GMD05124 Page 3 of 10 3.8 DoC responded with comments on the application by email on 4 February 2006, and concluded with the following statement: “The Department considers that the overall risk these organisms pose to the Department's mission to be negligible…” Purpose of the application 3.9 The purpose of the work covered by this application is to develop libraries of genetic material from bacteriophages that are capable of killing foodborne bacteria in Escherichia coli. The applicant is interested in developing new tools to control foodborne bacteria. This project will enable the applicant to better understand the biology of bacteriophages and to test if individual gene products of these bacteriophages are lethal to selected bacteria. 3.10 I have determined that this application is for a valid purpose being the development of any [new] organism as provided for in section 39(1)(a) of the Act. Assessment against the criteria for low-risk genetic modification 3.11 Category of host organism: The non-pathogenic laboratory strains of Escherichia coli to be used by the applicant are not capable of causing disease in humans, animals, plants or fungi nor do they produce desiccation-resistant structures, such as spores or cysts. As such, non-pathogenic laboratory strains of Escherichia coli are considered Category 1 host organisms as defined in clause 7(1) of the HSNO (Low-Risk Genetic Modification) Regulations 2003. 3.12 Category of genetic modification: The genetic modifications to non-pathogenic laboratory strains of Escherichia coli (described in Table 1) are not expected to increase the pathogenicity, virulence or infectivity of the organism to laboratory personnel, the community, or the environment. In addition, the developments will not result in the organism having a greater ability to escape from containment than the unmodified organism. Therefore, the genetic modifications as described in Table 1 of this decision are Category A genetic modifications as defined in clause 5(1) of the HSNO (Low-Risk Genetic Modification) Regulations 2003 and shall be contained at a minimum of Physical Containment Level 1 (PC1). I am satisfied that the developments meet the criteria for low-risk genetic modification specified in the Low-Risk Regulations, made under section 41 of the Act. The experiments meet the requirements of Category A modifications as defined in clause 5(1) of the Low-Risk Regulations in that the modifications involve a Category 1 host organism and are to be carried out under a minimum of PC1 containment. Environmental Risk Management Authority Decision: GMD05124 Page 4 of 10 Identification and assessment of the risks, costs and other impacts of the organism 3.13 I consider that the information provided by the applicant is relevant and appropriate to the scale and significance of the risks, costs, and benefits associated with the application (as required by clause 8 of the Methodology). In accordance with clauses 9 and 10 of the Methodology (which incorporate sections 5, 6, and 8 of the Act) the information supplied by the applicant has been evaluated as follows: 3.14 I consider that, given the biological characteristics of the organism, the containment system and the controls attached to this approval (see Appendix 1 of this decision), there is no evidence for, nor any reason to expect, any nonnegligible adverse effects of the proposed genetically modified organism on humans, animals, plants, other organisms or the environment. 3.15 I have considered the potential Māori cultural effects in accordance with sections 6(d) and 8 of the Act and clauses 9(b)(i) and 9(c)(iv) of the Methodology, incorporating advice provided by the Acting Manager, Māori. 3.16 I note that bacteriophages to be used in this research will be isolated from food and environmental samples from the Canterbury region. The Agency considered it appropriate for the applicant to contact the local Iwi, Ngai Tahu, to determine if they envisaged any cultural interests or concerns arising from the proposed research, however no response was received. 3.17 I recognise that Māori maintain an ongoing interest and concern in the potential long term cultural implications of genetic modification. However, taking into account that this research will be conducted in containment under all relevant associated regulations, conditions and controls, I consider that this application poses negligible risk to the relationship of Māori culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga. Precedents 3.18 I must consider each application on its merits, and am therefore not bound by the stance taken in previous decisions. However, in reflecting on previous decisions that involved similar genetic modifications to those proposed by this application, I note that genetic developments of non-pathogenic laboratory strains of Escherichia coli conforming to the HSNO (Low-Risk Genetic Modification) Regulations 2003, have been considered and approved on several occasions by both Institutional Biological Safety Committees (IBSCs) and the Chief Executive of ERMA New Zealand, under delegated authority. 3.19 I consider that this current application does not raise any novel issues and there are no residual risks that require further consideration. Environmental Risk Management Authority Decision: GMD05124 Page 5 of 10 Controls 3.20 The experiments proposed in this application, to develop genetically modified non-pathogenic laboratory strains of Escherichia coli meet the requirements of Category A genetic modification as defined in clause 5(1) of the HSNO (LowRisk Genetic Modification) Regulations 2003. Category A experiments are required to be contained within a Physical Containment level 1 facility (PC1). The facility to be used shall be approved and registered as a containment facility under section 39 of the Biosecurity Act, in accordance with MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.02: Containment Facilities for Microorganisms. This containment regime contains clear guidelines for the safe handling and disposal of cultures. 3.21 The facility in which the organisms will be maintained shall comply with the requirements of the Australian/New Zealand Standard AS/NZS 2243.3:2002 Safety in laboratories: Part 3: Microbiological aspects and containment facilities, except for the deviations specified in the MAF/ERMA New Zealand Standard 154.03.02. 4 Decision 4.1 I am satisfied that this application is for one of the purposes specified in section 39(1) of the Hazardous Substances and New Organisms Act 1996, being section 39(1)(a): the development of any [new] organism. 4.2 Based on consideration and analysis of the information provided, and having considered the characteristics of the organism that is the subject of this approval, the modification and the criteria for low-risk genetic modification detailed in the HSNO (Low-Risk Genetic Modification) Regulations 2003, I am of the view that the organism meets the criteria for rapid assessment under section 42A of the Hazardous Substances and New Organisms Act 1996. 4.3 I am satisfied that the proposed containment regime and the controls imposed in accordance with section 42A(3)(b) of the Hazardous Substances and New Organisms Act 1996, as set out in Appendix 1 of this decision, will adequately contain the organism. 4.4 Pursuant to section 42A(3)(a) of the Hazardous Substances and New Organisms Act 1996, and acting under delegation from the Authority provided for in section 19 of the Act, I have approved this project application for genetically modified Escherichia coli described in Table 1 of this decision, subject to the controls specified in Appendix 1 of this decision. Environmental Risk Management Authority Decision: GMD05124 Page 6 of 10 4.5 In reaching this decision I have relied upon the following criteria in the Act and the Methodology: Criteria for assessing the purpose of the application (section 39 of the Act); Criteria for rapid assessment of adverse effects for the development of a genetically modified organism in containment (section 42A of the Act); Criteria for a low-risk genetic modification specified in the HSNO (LowRisk Genetic Modification) Regulations 2003, made under section 41 of the Act; The information provided by the applicant was assessed against the criteria in clauses 9, 10 and 12 of the HSNO (Methodology) Order 1998; and Matters to be addressed by containment controls for developing genetically modified organisms specified in Part 1 of the Third Schedule to the Act. Environmental Risk Management Authority Decision: GMD05124 Page 7 of 10 Appendix 1: Controls required by this approval In order to provide for the matters detailed in Part 1 of the Third Schedule of the Act1, Containment Controls for Importation, Development and Field Testing of Genetically Modified Organisms, and other matters in order to give effect to the purpose of the Act, the approved organism is subject to the following controls: 1 To limit the likelihood of any accidental release of any organism or any viable genetic material2. 1.1 The approved organism shall be developed and maintained within a containment facility which complies with these controls. 1.2 The person responsible for a particular research area and/or the person responsible for the operation of the containment facility shall inform all personnel involved in the handling of the organism of the Authority’s controls. 1.3 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 (below), and controls imposed by the Authority (as follows): 1.4 The construction, operation and management of the containment facility shall be in accordance with the: a) MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.023: Containment Facilities for Microorganisms. b) Australian/New Zealand Standard AS/NZS 2243.3:20023: Safety in laboratories: Part 3: Microbiological aspects and containment facilities; and c) Physical Containment level 1 (PC1) requirements of the above Standards. 1 Bold headings in the following text refer to Matters to be Addressed by Containment Controls for Import, Development and Field Testing of Genetically Modified Organisms, specified in the Third Schedule of the Act. 2 Viable Genetic Material is biological material that can be resuscitated to grow into tissues or organisms. It can be defined to mean biological material capable of growth even though resuscitation procedures may be required, e.g. when organisms or parts thereof are sub-lethally damaged by being frozen, dried, heated, or affected by chemical. 3 Any reference to this standard in these controls refers to any subsequent version approved or endorsed by ERMA New Zealand Environmental Risk Management Authority Decision: GMD05124 Page 8 of 10 2 To exclude unauthorised people from the facility. 2.1 Construction and operation of the containment facility shall comply with the requirements of the standards listed in control 1.4 relating to the identification of entrances, numbers of and access to entrances and security requirements for the entrances and the facility. 3 To exclude other organisms from the facility and to control undesirable and unwanted organisms within the facility. 3.1 Construction and operation of the containment facility shall comply with the requirements of the standards listed in control 1.4 relating to the exclusion of other organisms from the facility and the control of undesirable and unwanted organisms within the facility. 4 To prevent unintended release of the organism by experimenters working with the organism. 4.1 Construction and operation of the containment facility shall comply with the requirements of the standards listed in control 1.4 relating to the prevention of unintended release of the organism by experimenters working with the organism. 5 To control the effects of any accidental release or escape of an organism. 5.1 Construction and operation of the containment facility shall comply with the requirements of the standards listed in control 1.4 relating to controlling the effects of any accidental release or escape of an organism. 5.2 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. 5.3 In the event of any breach of containment of the organism, the contingency plan for the attempted retrieval or destruction of any viable material of the organism that has escaped shall be implemented immediately. The contingency plan shall be included in the containment manual in accordance with the requirements of standards listed in control 1.4. 6 Inspection and monitoring requirements for containment facilities. 6.1 The operation of the containment facilities shall comply with the requirements contained in the standards listed in control 1.4 relating to the inspection and monitoring requirements for containment facilities. 6.2 The containment manual shall be updated, as necessary, to address the implementation of the controls imposed by this approval, in accordance with the standards listed in control 1.4. Environmental Risk Management Authority Decision: GMD05124 Page 9 of 10 7 Qualifications required of the persons responsible for implementing those controls. 7.1 The training of personnel working in the facility shall be in compliance with the standards listed in control 1.4. _____________________ _______________ Rob Forlong Date 13 February 2006 Chief Executive, ERMA New Zealand Approval code (BCH code): GMD004158 (11681) 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 Environmental Risk Management Authority Decision: GMD05124 16 August 2007 Date: Page 10 of 10