Team:SDU-Denmark/safety-c

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(Difference between revisions)
(Laws and Guidelines to be Considered in Denmark)
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To be allowed to work in a level 1 laboratory, it is required that there at all times is a suitable instructed person present. At level 2, all personnel in the laboratory are required to have been suitable instructed in lab safety and procedure. All access to the lab by non-members of this group or the lab-staff is to be restricted.
To be allowed to work in a level 1 laboratory, it is required that there at all times is a suitable instructed person present. At level 2, all personnel in the laboratory are required to have been suitable instructed in lab safety and procedure. All access to the lab by non-members of this group or the lab-staff is to be restricted.
All members of our team have in the time prior to the work in the laboratory received a lab-safety-course, thus fulfilling the requirement. See appendix II for the actual safety guidelines lay down by our local work-safety group.
All members of our team have in the time prior to the work in the laboratory received a lab-safety-course, thus fulfilling the requirement. See appendix II for the actual safety guidelines lay down by our local work-safety group.
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==Substitution==
==Substitution==
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Further, it is not allowed to work with any host, donor or vector-system, should another, safer, system, containing the same basic features, be available. If it is possible to find a suitable system, compatible with the intended work, that is safer for humans, animals and plants, or the environment at large, it must always substitute the other, more dangerous system. It is in other words prohibited to take unnecessary risks, or use unnecessarily risky setups. Should a possible substitute system be unreasonably difficult or expensive to acquire, then the risks and benefits must be weighted out against each other, favoring safety above economical issues.
Further, it is not allowed to work with any host, donor or vector-system, should another, safer, system, containing the same basic features, be available. If it is possible to find a suitable system, compatible with the intended work, that is safer for humans, animals and plants, or the environment at large, it must always substitute the other, more dangerous system. It is in other words prohibited to take unnecessary risks, or use unnecessarily risky setups. Should a possible substitute system be unreasonably difficult or expensive to acquire, then the risks and benefits must be weighted out against each other, favoring safety above economical issues.
As we're working with relatively harmless strains of ''E. coli'' (MG1655 and TOP10 strains), it has not been necessary to locate a safer, compatible host, donor or system, but we have nonetheless attempted to locate such systems for wholesomeness, although without luck.
As we're working with relatively harmless strains of ''E. coli'' (MG1655 and TOP10 strains), it has not been necessary to locate a safer, compatible host, donor or system, but we have nonetheless attempted to locate such systems for wholesomeness, although without luck.
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==Assessment by Local Bio-safety Group==
==Assessment by Local Bio-safety Group==
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===The Group===
===The Group===
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“Arbejdsmiljøgruppen” (eng. The Working Environment Group) is the local bio-safety group associated with the University of Southern Denmark. During an interview with a representative from this group we explained the project, its scope, parts and procedure. The following is a number of questions concerning the safety and security issues relating to our project, and the essence of their replies.
“Arbejdsmiljøgruppen” (eng. The Working Environment Group) is the local bio-safety group associated with the University of Southern Denmark. During an interview with a representative from this group we explained the project, its scope, parts and procedure. The following is a number of questions concerning the safety and security issues relating to our project, and the essence of their replies.
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''If they perceived an increased risk due to work being performed by relatively inexperienced students''
''If they perceived an increased risk due to work being performed by relatively inexperienced students''
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The project is not considered any more dangerous due to the fact that most of the work in the lab is performed by relative inexperienced students. As long as the lab's safety protocol is followed, and the fact that the risk-assessment of the work safety group put our project firmly on level 1, they believe that there should be little to no risk to lab personnel or the outside environment. As all students participating in the lab has successfully completed the lab safety course provided by The Working Environment Group, they perceived no increased risk.
The project is not considered any more dangerous due to the fact that most of the work in the lab is performed by relative inexperienced students. As long as the lab's safety protocol is followed, and the fact that the risk-assessment of the work safety group put our project firmly on level 1, they believe that there should be little to no risk to lab personnel or the outside environment. As all students participating in the lab has successfully completed the lab safety course provided by The Working Environment Group, they perceived no increased risk.
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''If they perceived any danger should the bacteria get out of the lab''
''If they perceived any danger should the bacteria get out of the lab''
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They perceived no danger to the environment or the well being of animals, plants or human being should the bacteria be released into the environment. This is due to the extremely fragile nature of the ''E. coli'' strain that we are using in our project. Should it somehow find its way outside of the lab, it would die within a very short time.
They perceived no danger to the environment or the well being of animals, plants or human being should the bacteria be released into the environment. This is due to the extremely fragile nature of the ''E. coli'' strain that we are using in our project. Should it somehow find its way outside of the lab, it would die within a very short time.
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''If there exists an emergency safety protocol in case of accident (i.e. unintentional release of GMM's into environment)''
''If there exists an emergency safety protocol in case of accident (i.e. unintentional release of GMM's into environment)''
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The emergency protocol is still a work in progress, but although it is unfinished it should not pose a breach in safety, as we're only working with a level 1 GMM, which due to its extremely fragile nature cannot survive outside of laboratory environment. This coupled with adherence to the standard laboratory safety protocol, should at all times ensure the safety of the environment.
The emergency protocol is still a work in progress, but although it is unfinished it should not pose a breach in safety, as we're only working with a level 1 GMM, which due to its extremely fragile nature cannot survive outside of laboratory environment. This coupled with adherence to the standard laboratory safety protocol, should at all times ensure the safety of the environment.
===Overall  Assessment===
===Overall  Assessment===
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We have at all times upheld the laws and regulations imposed upon us by UN and by the Working Environment Group. We have performed a risk-assessment of our project as required by the UN, as well as following the laws regarding to personal safety and to substitution of potentially harmful host and donor organisms. The work safety group has assessed our project to be a class 1 project, as they have perceived no risk associated with our work.
We have at all times upheld the laws and regulations imposed upon us by UN and by the Working Environment Group. We have performed a risk-assessment of our project as required by the UN, as well as following the laws regarding to personal safety and to substitution of potentially harmful host and donor organisms. The work safety group has assessed our project to be a class 1 project, as they have perceived no risk associated with our work.
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As long as the normative work safety protocols were followed they could not perceive any danger due to the work being performed by relatively inexperienced students.
As long as the normative work safety protocols were followed they could not perceive any danger due to the work being performed by relatively inexperienced students.
Thus they perceived neither security nor safety issues with our project.
Thus they perceived neither security nor safety issues with our project.
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References:
References:
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[2]: http://www.bmwf.gv.at/fileadmin/user_upload/forschung/gentechnik/2009-41-EC.pdf <br />
[2]: http://www.bmwf.gv.at/fileadmin/user_upload/forschung/gentechnik/2009-41-EC.pdf <br />
[3]: https://www.retsinformation.dk/Forms/R0710.aspx?id=121099 <br />
[3]: https://www.retsinformation.dk/Forms/R0710.aspx?id=121099 <br />
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=Appendix 1=
=Appendix 1=
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</div>
</div>
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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 11:53, 26 October 2010