Team:SDU-Denmark/safety-c

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(Laws and Guidelines to be Considered in Denmark)
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=Appendix 1=
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==Risk-assessment==
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Title: Synthesis of hyper-flagellated phototaxic ''E. coli''.
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Purpose: To create a bacteria that can induce a micro-flow regulated by light.
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Host: Bacteria, ''E. coli''.
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Strains: Mg1655 and TOP10.
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Donor:
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Coding regions amplified from naturally occurent organism.
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Photosensor: ''N. Pharaonis'', ''S. Enterica serovar typhimurium''. These create a fusion protein. Sr2 + Htr2 fra N. P. tar CheW from S. E.
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Retinal: ''D. Melanogaster'' fra cDNA gen ninaB?
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Flagella: ''E. Coli'': gen flhDC
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Vektors:
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pSB3TS
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pSB3CS
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pSB3K3
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pSB1A2
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Insert:
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Risk-assessment
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Host:
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Bacteria:
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''E. coli'' is naturally occurring and the strains used for amplifying vector-DNA/proteins is not reported pathogenic
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Al material used in bacterial work is autoclaved and/or Inactivated with Iodofor
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Stains:
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A cell-culture from a higher eucaryot which does not contain any endogene vectors that would be able to mobilize parts of the transferred genetic material
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The strains used have not been reported pathogenic
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The cellular strain is very fragile and is unable to procreate or survive outside of laboratory conditions, as they need the correct temperature, humidity, pH, CO2, O2 and nourishment
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Al material used in bacterial work is autoclaved and/or inactivated with iodofor
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Donor:
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Naturally occurring healthy genes of insect origin and it is not believed to be able to transform/infect human cells in vitro/vivo. The risk is therefore considered to be minimal. The S.E. gene has homology in E. coli and is therefore not considered to pose any threat.
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Vector:
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Vectors are of pUC or pOt2 origin and nothing from the vector has human recombinations/infection potential and the risk of working with these strains are therefore believed to be minimal.
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Our vector is in addition equipped with resistance to antibiotics and cannot exist without it. Should discard the resistance if not within a antibiotic environment.
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Insert:.
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Is naturally occurring genes with well-defined tags and it is believed that they cannot transform/infect human cells in vitro/vivo. The fusion-protein has had limited testing, but is also considered safe. The risk is therefore believed to be minimal.
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Health-aspects of the final GMO:
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Bacteria not exposed to antibiotics will discard the plasmids within a very short timespan.
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The bacteria are modified with plasmids, and will return to a non-GMO state within a short time-span. The modification is not infective/self-reproductive in humans. It is not believed to pose any threat towards human health.
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We have at no point worked with any self-reproductive or pathogenic material
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Assessment: Class 1
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=Appendix II=
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A description of the modified organism
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A full description of the modified organism should ideally contain the following information. This is only ideally, as it would be a far too time-consuming procedure to fill out all the following information. The lists are supposed to be mere guidelines.
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A. characteristics of the host and donor organisms
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1. Name(s) of the organism(s) in question
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2. Origin of organism(s) in question
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3. Information on the reproductive cycle of the parental organisms as well as the host
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4. Description of any previous genetic modification
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5. Stability
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6. Details concerning pathogenesis, virulence, infectivity or toxicity
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7. Characteristics of endogene vectors:
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a.    Sequence
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b.    Mobilization
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c.    Specificity
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d.    The    presence of resistance-genes                 
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8. Host spectrum
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9. Potentially significant physiological traits and the stability of these traits
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10. Natural habitat
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11. Significant role in environmental processes
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12. Competition or symbiosis with other naturally occurring organisms
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13. Ability to create survival structures (i.e. the ability to create spores)
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B. characteristics of the genetically modified organism
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1. Origin of the genetic material used to modify the organism, as well as the intended functions of this material
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2. Description of the modification, including the method of vector insertion in the host organism, as well as the method used to create the genetically modified production-organism
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3. The function of the genetic modification
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4. Origin and characteristics of the vector
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5. Structure and size of vector in the genetically modified production-organism
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6. Stability of the organism with respect to genetic traits
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7. Mobilization frequency of the inserted vector and/or the organism’s ability to transfer genetic material
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8. Activity of the expressed protein
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C. Health concerns
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1. Toxic or allergenic properties
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2. Product risks
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3. The genetic modified organism’s pathogenic properties compared with the donor – or the host organisms or possibly the donor organism
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4. Colonization ability
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5. If the organism is pathogenic to humans, who are immune competent:
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a.    Cause                    illness and the pathogenic mechanism, including invasiveness and virulence
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b.    Infectivity
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c.    Infective dose
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d.    Host range, possibility of change
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e.    Possibility for survival outside the human host
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f.    The presence of vectors or other distribution areas
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g.    Biological stability
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h.    Resistance patterns against antibiotics
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i.      Allergenicity
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j.      Chance for suitable disease treatment
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D. Environmental concerns
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1. Factors that might affect the organism’s ability for survival, reproduction and it’s ability to spread in the environment.
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2. Techniques for detection, identification and surveillance of the modified organism
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3. Techniques for detection of transfer of genetic material to other organisms
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4. Known and expected habitats of the modified organism
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5. Description of ecosystems into which the organism could spread in the event of an accident
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6. Expected result of interaction between the modified organism and naturally occurring bacteria that would be affected in the event of an accident
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7. Known and expected effects on animals and plants, with regards to pathogenesis, virulence, infectivity, toxicity, allergenicity, colonization
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8. Known or expected contribution to bio-geo-chemic processes
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9. Methods for decontamination of the area in the event of an accident
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The above list is from https://www.retsinformation.dk/Forms/R0710.aspx?id=12325
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Revision as of 11:52, 26 October 2010