Team:Bielefeld-Germany/Safety

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= Biosafety and Biosecurity (English) =
= Biosafety and Biosecurity (English) =
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It is important to discriminate between Biosafety and Biosecurity in the context of working with genetically modified organisms. Biosecurity comprises the safety of the lab. The [http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6.pdf WHO] defines Biosecurity as a task of organisation and administration.The term Biosafety deals with the biological risks of the samples for the user, the enviroment and the lab. In this article, we are mostly summarizing the German law on Biosecurity and Biosafety regarding to the [http://www.bvl.bund.de/nn_495478/DE/06__Gentechnik/093__ZKBS/gentechnik__zkbs__node.html__nnn=true ZKBS (zentrale Kommission für Biologische Sicherheit)] and [http://www.bvl.bund.de/cln_027/nn_491872/DE/06__Gentechnik/00__doks__downloads/06__Register__Datenbanken/organismenliste,templateId=raw,property=publicationFile.pdf/organismenliste.pdf their list of unhazardous organisms] plus the comment on safety of the [http://www.dfg.de/download/pdf/dfg_im_profil/reden_stellungnahmen/2009/stellungnahme_synthetische_biologie.pdf DFG (Deutsche Forschungsgemeinschaft)].
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It is important to discriminate between biosafety and biosecurity in the context of working with genetically modified organisms. Biosecurity comprises the safety of the lab. The [http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6.pdf WHO] defines biosecurity as a task of organisation and administration. The term biosafety deals with the biological risks of the samples for the user, the enviroment and the lab. In this article, we are mostly summarizing the German law on biosecurity and biosafety regarding to the [http://www.bvl.bund.de/nn_495478/DE/06__Gentechnik/093__ZKBS/gentechnik__zkbs__node.html__nnn=true ZKBS (zentrale Kommission für Biologische Sicherheit)] and [http://www.bvl.bund.de/cln_027/nn_491872/DE/06__Gentechnik/00__doks__downloads/06__Register__Datenbanken/organismenliste,templateId=raw,property=publicationFile.pdf/organismenliste.pdf their list of unhazardous organisms] plus the comment on safety of the [http://www.dfg.de/download/pdf/dfg_im_profil/reden_stellungnahmen/2009/stellungnahme_synthetische_biologie.pdf DFG (Deutsche Forschungsgemeinschaft)].
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Furthermore we crosslinked the laws of the United States of America and the European law of Biosecurity and Biosafety in this article. We marked this statement in the text, so the reader can discrimante between the law systems. This kind of differentiation makes sense, because our experimental work was done in Germany, shipped in europe (SDU Denmark) and used as a biobrick in United States of America.
+
Furthermore we crosslinked the laws of the United States of America and the European law of biosecurity and biosafety in this article. We marked this statement in the text, so the reader can discrimante between the law systems. This kind of differentiation makes sense, because our experimental work was done in Germany, shipped in Europe (to SDU Denmark) and used as a BioBrick in the United States of America.
== Biosecurity ==
== Biosecurity ==
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[[Image:Keypad.JPG|200px|thumb|left| Figure 1: Security entrance to the lab. Every Member of the Team needs a key-token in order to get acces to the lab]]
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[[Image:Keypad.JPG|200px|thumb|left| Figure 1: Security entrance to the lab. Every member of the team needs a key-token in order to get acces to the lab]]
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In the context of "genetically engineered" it is quite important to keep unqualified personnel and trespassers away from your laboratory and your samples. In our case we secure our lab with a keypad. Every staff member needs a key to open the laboratory door. Nobody is able to open the door without the proper keys. Staff members receive a key, after beeing briefed by the safety officer on safety issues. You can only get a key for the safety stage you are working in. The labs with higher safety stages are cut off from the lower ones. Staff members need a continuative safety guide to receive a key for the higher security levels. Concludingly no unqualified personel can pass the door to the laboratory.
+
In the context of "genetically engineering" it is quite important to keep unqualified personnel and trespassers away from your laboratory and your samples. In our case we secure our lab with a keypad. Every staff member needs a key to open the laboratory door. Nobody is able to open the door without the proper keys. Staff members receive a key after beeing briefed by the safety officer on safety issues. You can only get a key for the safety stage you are working in. The labs with higher safety stages are cut off from the lower ones. Staff members need a continuative safety guide to receive a key for the higher security levels. Concludingly no unqualified personel can pass the door to the laboratory.
Figure 1 shows the keypad in front of the lab.
Figure 1 shows the keypad in front of the lab.
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The laboratories, which are in use for our iGEM project are security stage 1 (S1). For the safety of the staff our labs are equiped with fire extinguishers, emergency showers and a heart defibrillator.
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The laboratories, which are in use for our iGEM project are security stage 1 (S1). For the safety of the staff our labs are equiped with fire extinguishers, emergency showers, eye showers and a heart defibrillator.
 +
 
== Biosafety ==
== Biosafety ==
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The term "biological safety" defines the effort to reduce or eliminate any potential risks caused by biotechnolgy or genetical engineering. The laboratories are scaled into four different saftey stages. The stage "S1" defines working with organsims and methods, which do no proved harm neither to the enviroment nor mankind. The stages rise up to biosafety stage four, which defines working with proved humanpathogenous organisms. The WHO defines for the United states the same safety stages, which are called risk groups [http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf Manual of Biosecurity, WHO, page 1].
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The term "biological safety" defines the effort to reduce or eliminate any potential risks caused by biotechnolgy or genetical engineering. The laboratories are scaled into four different saftey stages. The stage "S1" defines working with organisms and methods, which do no proved harm - neither to the environment nor to mankind. The stages rise up to biosafety stage four, which defines working with proved humanpathogenous organisms. The WHO defines for the United States the same safety stages, which are called risk groups [http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf Manual of Biosecurity, WHO, page 1].
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The Biosafety is ruled by the "Zentrale Kommission für Biologische Sicherheit" (ZKBS) in Germany. The ZKBS reviewed and verified all commercial, research or privat laboratories about their safety issues. The iGEM Team Bielefeld is currently working with the organisms ''Agrobacterium tumefaciens'' and a derivate of ''Escherichia coli'' K12 in a ZKBS reviewed S1-lab. The organisms strains are declared as riskfactor 1 by the german act of genetics (GenTSV, § 5; 15.06.2010). The act contains that the organisms (abstract):
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The Biosafety is ruled by the "Zentrale Kommission für Biologische Sicherheit" (ZKBS) in Germany. The ZKBS reviewed and verified all commercial, research or privat laboratories about their safety issues. The iGEM Team Bielefeld is currently working with the organisms ''Agrobacterium tumefaciens'' and a derivate of ''Escherichia coli'' K12 in a ZKBS reviewed S1-lab. The organism strains are declared as risk factor 1 by the german act of genetics (GenTSV, § 5; 15.06.2010), so:  
1. The act contains that the organisms (abstract):
1. The act contains that the organisms (abstract):
: - are not human-, phyto- or animalpathogen
: - are not human-, phyto- or animalpathogen
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: - do not contain or release organism containing to a higher risk stage
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: - do not contain or release organisms containing to a higher risk stage
: - are approved by experiments or long term evaluation or do not proliferate in the enviroment because of biological implanted boundaries
: - are approved by experiments or long term evaluation or do not proliferate in the enviroment because of biological implanted boundaries
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2. Organisms, which confirm the paragraph 1, are defined by $6 of the act of genetics (GenTSV):
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2. Organisms, which confirm the paragraph 1, are defined by §6 of the act of genetics (GenTSV):
: a) as biological safe organisms
: a) as biological safe organisms
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: b) as organims or strains, which are not contaminated by organisms or strains of a higher security level
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: b) as organisms or strains, which are not contaminated by organisms or strains of a higher security level
: c) organisms defined by the risk level S1 (list of organisms used for genetically engineering research)
: c) organisms defined by the risk level S1 (list of organisms used for genetically engineering research)
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The [http://www.bvl.bund.de/cln_027/nn_491872/DE/06__Gentechnik/00__doks__downloads/06__Register__Datenbanken/organismenliste,templateId=raw,property=publicationFile.pdf/organismenliste.pdf list of organisms] categorize the strains ''E. coli'' K12  and ''Agrobacterium tumefaciens'' as biological safety risk 1 (S1). The strain [http://www.bvl.bund.de/cln_007/nn_520774/DE/06__Gentechnik/093__ZKBS/01__Allg__Stellungnahmen/02__bakterien/zkbs__bakterien__agrobacterium__tumefaciens,templateId=raw,property=publicationFile.pdf/zkbs_bakterien_agrobacterium_tumefaciens.pdf ''Agrobacterium tumefaciens''] is a known phytopathogen. Because of its frequent appearence in the earth (500 bacteria in 1g earth) it is generally regarded as safe.
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The [http://www.bvl.bund.de/cln_027/nn_491872/DE/06__Gentechnik/00__doks__downloads/06__Register__Datenbanken/organismenliste,templateId=raw,property=publicationFile.pdf/organismenliste.pdf list of organisms] categorize the strains ''E. coli'' K12  and ''A. tumefaciens'' as biological safety risk 1 (S1). The strain [http://www.bvl.bund.de/cln_007/nn_520774/DE/06__Gentechnik/093__ZKBS/01__Allg__Stellungnahmen/02__bakterien/zkbs__bakterien__agrobacterium__tumefaciens,templateId=raw,property=publicationFile.pdf/zkbs_bakterien_agrobacterium_tumefaciens.pdf ''A. tumefaciens''] is a known phytopathogen. Because of its frequent appearence on earth (500 bacteria in 1 g of soil) it is generally regarded as safe.
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The WHO defines "security assessments" has the highest priority for the work with organisms. This includes a proper theoretically background of the organism. Further the WHO defines rules for good molecular practice and proper lab security ([http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf WHO Manual Biosafety, page 9 following]). They note that most of the security guidelines are not quite necessary for organisms of risk stage 1. Anyway, we play by the rules and work as carefully as possible (compare: [[#What we do to protect | what we do to protect]]).
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The WHO defines "security assesments" has the highest priority for the work with organisms. This includes a proper theoretically background of the organism. Further the WHO defines rules for good molecular practice and proper lab security [http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf WHO Manual Biosafety, page 9 following]. They note that most of the security guidelines are not quite neccessary for organism of risk stage 1. Although we play by the rules and work as carefully as possible ([[#What_we_do_to_protect|what we do to protect]]).
 
= Biosafety und Biosecurity (German)=
= Biosafety und Biosecurity (German)=
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Es ist bei der Inbetriebnahme und Nutzung einer Gentechnischen Anlagen darauf zu achten, dass Vorkehrungen sowohl für den Betriebsschutz (Biosecurity) als auch für die biologische Sicherheit (Biosafety) getroffen werden. Biosecurity wird von der [http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6.pdf WHO] als Aufgabe der Adminstrative des Labors definiert.
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Es ist bei der Inbetriebnahme und Nutzung einer Gentechnischen Anlagen darauf zu achten, dass Vorkehrungen sowohl für den Betriebsschutz (Biosecurity) als auch für die biologische Sicherheit (Biosafety) getroffen werden. Biosecurity wird von der [http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6.pdf WHO] als Aufgabe der Administrative des Labors definiert.
== Biosecurity ==
== Biosecurity ==
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Der Biosecurity wird Sorge getragen, indem kein unbefugter Zugang zum Laborplatz hat. Die Türen sind nur per Schlüssel zu öffnen. Jeder Mitarbeiten muss eine Sicherheitsbelehrung beim Sicherheitsbeauftragten ablegen, ehe er Zugang zu den Laboratorien bekommt. Die Labore sind je nach Sicherheitsgefährdung gekennzeichnet und verschlossen, so dass keine unautorisiert Person in ein höheres Sicherheitslevel eindringen kann. Das vom iGEM Team genutzte Labor ist als Genlaboratorium Sicherheitstufe S1 ausgewiesen. Die WHO definiert die gleichen Sicherheitsstufen, hier "risk group" genannt. [http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf Manual of Biosecurity, WHO, page 1].
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Der Biosecurity wird Sorge getragen, indem kein unbefugter Zugang zum Laborplatz hat. Die Türen sind nur per Schlüssel zu öffnen. Jeder Mitarbeiten muss eine Sicherheitsbelehrung beim Sicherheitsbeauftragten ablegen, ehe er Zugang zu den Laboratorien bekommt. Die Labore sind je nach Sicherheitsgefährdung gekennzeichnet und verschlossen, so dass keine unautorisiert Person in ein höheres Sicherheitslevel eindringen kann. Das vom iGEM Team genutzte Labor ist als Genlaboratorium Sicherheitsstufe S1 ausgewiesen. Die WHO definiert die gleichen Sicherheitsstufen, hier "risk group" genannt. [http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf Manual of Biosecurity, WHO, page 1].
== Biosafety ==
== Biosafety ==
[[Image:Bielefeld Sign.JPG|200px|thumb|left| Figure 3: The Sign says: No Trespassing, Security stage 1.]]
[[Image:Bielefeld Sign.JPG|200px|thumb|left| Figure 3: The Sign says: No Trespassing, Security stage 1.]]
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Als Biologische Sicherheit (Biosafety) wird der Versuch zur Reduzierung bzw. Eleminierung potentieller Gefahren durch Biotechnologie definiert. In Deutschland werden die unterschiedlichen Organismen in vier Sicherheitstufen von S1 für keine bekannte Gefährdung, bis S4 für erwiesene humanpathogene Gefährdung eingeteilt. Die zentrale Kommussion für Biologische Sicherheit (ZKBS) überprüft alle Laboratorien, ob privat, gewerblich oder für die Forschung, vor in Betriebnahme auf Sicherheitsmängel und Einhaltung der rechtlichen Grundlagen. Das iGEM Team Bielefeld nutzt die Stämme ''Agrobacterium tumefaciens'' und einen Ableger von ''Escherichia coli'' K12 in einem ZKBS geprüften Labor der Sicherheitstufe S1 für gentechnische Arbeiten. Die Stämme sind nach dem Gentechnik Gesetz (GenTSV) § 5 Absatz 1 Satz 1 und Anhang Nummer 1 GenTSV der Risikogruppe 1 zu zuordnen (Stand 15.06.2010).  
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Als Biologische Sicherheit (Biosafety) wird der Versuch zur Reduzierung bzw. Eliminierung potentieller Gefahren durch Biotechnologie definiert. In Deutschland werden die unterschiedlichen Organismen in vier Sicherheitsstufen von S1 für keine bekannte Gefährdung, bis S4 für erwiesene humanpathogene Gefährdung eingeteilt. Die zentrale Kommission für Biologische Sicherheit (ZKBS) überprüft alle Laboratorien, ob privat, gewerblich oder für die Forschung, vor Inbetriebnahme auf Sicherheitsmängel und Einhaltung der rechtlichen Grundlagen. Das iGEM Team Bielefeld nutzt die Stämme ''Agrobacterium tumefaciens'' und einen Ableger von ''Escherichia coli'' K12 in einem ZKBS geprüften Labor der Sicherheitsstufe S1 für gentechnische Arbeiten. Die Stämme sind nach dem Gentechnik Gesetz (GenTSV) § 5 Absatz 1 Satz 1 und Anhang Nummer 1 GenTSV der Risikogruppe 1 zu zuordnen (Stand 15.06.2010).  
1. Das beinhaltet, dass die Organismen (Auszug):
1. Das beinhaltet, dass die Organismen (Auszug):
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Die verwendeten Stämme ''E. coli'' K12 und  ''Agrobacterium tumefaciens'' werden nach [http://www.bvl.bund.de/cln_027/nn_491872/DE/06__Gentechnik/00__doks__downloads/06__Register__Datenbanken/organismenliste,templateId=raw,property=publicationFile.pdf/organismenliste.pdf dieser Organismenliste] als Risikogruppe 1 klassifiziert. [http://www.bvl.bund.de/cln_007/nn_520774/DE/06__Gentechnik/093__ZKBS/01__Allg__Stellungnahmen/02__bakterien/zkbs__bakterien__agrobacterium__tumefaciens,templateId=raw,property=publicationFile.pdf/zkbs_bakterien_agrobacterium_tumefaciens.pdf ''Agrobacterium tumefaciens''] ist zwar als phytopathogen vermerkt, ist jedoch ubiquitär, d.h. weltweit im Boden (ca. 500 Bakterien / 1 g Boden) verbreitet und wurde aus diesem Grund der Risikogruppe 1 zugeordnet.  
Die verwendeten Stämme ''E. coli'' K12 und  ''Agrobacterium tumefaciens'' werden nach [http://www.bvl.bund.de/cln_027/nn_491872/DE/06__Gentechnik/00__doks__downloads/06__Register__Datenbanken/organismenliste,templateId=raw,property=publicationFile.pdf/organismenliste.pdf dieser Organismenliste] als Risikogruppe 1 klassifiziert. [http://www.bvl.bund.de/cln_007/nn_520774/DE/06__Gentechnik/093__ZKBS/01__Allg__Stellungnahmen/02__bakterien/zkbs__bakterien__agrobacterium__tumefaciens,templateId=raw,property=publicationFile.pdf/zkbs_bakterien_agrobacterium_tumefaciens.pdf ''Agrobacterium tumefaciens''] ist zwar als phytopathogen vermerkt, ist jedoch ubiquitär, d.h. weltweit im Boden (ca. 500 Bakterien / 1 g Boden) verbreitet und wurde aus diesem Grund der Risikogruppe 1 zugeordnet.  
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Zur Sicherheit des Personals und der Umwelt herrscht ein konstanter leichter Unterdruck in den Laboratorien und die Fenster sind geschlossen zu halten, so dass weder Organismen weder hinaus noch hineingelangen können. Zudem wird der anfallende Organismen-Müll in speziellen Säcken gesammelt, autoklaviert und entsorgt. Die Organismen werden abgetötet. Zudem werden benutzen Flächen vor und nach der Arbeit desinfiziert.
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Zur Sicherheit des Personals und der Umwelt herrscht ein konstanter leichter Unterdruck in den Laboratorien und die Fenster sind geschlossen zu halten, so dass weder Organismen weder hinaus noch hinein gelangen können. Zudem wird der anfallende Organismen-Müll in speziellen Säcken gesammelt, autoklaviert und entsorgt. Die Organismen werden abgetötet. Zudem werden benutzen Flächen vor und nach der Arbeit desinfiziert.
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= Risk Assesment =
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= Risk Assessment =
== What we do to protect ==
== What we do to protect ==
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:*No unqualified personal has access to the lab.
:*No unqualified personal has access to the lab.
:*No public access to the lab.
:*No public access to the lab.
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:*We reduced the risk of contamination of the environment or staff members by disinfection, autoclavation and using of protecting clothes.
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:*We reduced the risk of contamination of the environment or staff members by desinfection, autoclavation and using of protection clothes.
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:*In case of emergency there are telephones, fire extinguisher, defibrillator and alarm buttons around the lab
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:*In case of emergency there are telephones, fire extinguishers, defibrillators and alarm buttons around the lab.
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:*We only used organism of the risk stage 1, which do not harm neither mankind nor the environment.
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:*We only used organisms of the risk stage 1, which do not harm neither mankind nor the environment.
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:*We modifed a unharzadous organism with specific, identified and characterized biobricks. So we can appraise the risk causing by the modified organisms.
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:*We modifed an unhazardous organism with specific, identified and characterized BioBricks. So we can appraise the risk causing by the modified organisms.
:*Constantly low pressure, no open windows => no organism can get in or out
:*Constantly low pressure, no open windows => no organism can get in or out
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:*Desinfection after work of all working places (everyday)
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:*Desinfection of all working places after work (everyday)
:*Autoclavation of waste (solid/liquid)
:*Autoclavation of waste (solid/liquid)
:*No pipetting with the mouth
:*No pipetting with the mouth
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== Unsere Schutzmaßnahmen ==
== Unsere Schutzmaßnahmen ==
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:*Kein  unqualifiziertes Personal gelangt in eine höhere Sicherheitsstufe, als ihr erlaubt.
:*Kein  unqualifiziertes Personal gelangt in eine höhere Sicherheitsstufe, als ihr erlaubt.
:*Kein öffentlicher Zugang zum Labor möglich.
:*Kein öffentlicher Zugang zum Labor möglich.
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:*We reduzieren das Kontaminationsrisiko für Arbeiter und Umwelt durch Autoklavieren, Desinfizieren und das Nutzen von protektiver Arbeitskleidung auf ein Minimum.
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:*Wir reduzieren das Kontaminationsrisiko für Arbeiter und Umwelt durch Autoklavieren, Desinfizieren und das Nutzen von protektiver Arbeitskleidung auf ein Minimum.
:*Im Falle eines Notfalls gibt es ein Telefon zum Hilferuf, Feuerlöscher, Defibrilatoren und Feueralarmschalter in Reichweite.
:*Im Falle eines Notfalls gibt es ein Telefon zum Hilferuf, Feuerlöscher, Defibrilatoren und Feueralarmschalter in Reichweite.
:*Wir benutzen ausschließlich Organismen der Sicherheitsstufe 1.
:*Wir benutzen ausschließlich Organismen der Sicherheitsstufe 1.
 +
= Short Summary =
= Short Summary =
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: 1'''.  Would any of your project ideas raise safety issues ?'''
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: 1'''.  Would any of your project ideas raise safety issues? Researcher safety, public safety, or environmental safety?'''
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          researcher safety,
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-
          public safety, or
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          environmental safety?
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:The bacteria we are currently working with are defined as bio security stage 1 (S1). Our produced GMOs (genetically modified organisms) are therefore harmless to the user, mankind and the environment. Thus they are GRAS - generally regarded as safe.
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:The bacteria we are currently working with are defined as biosecurity stage 1 (S1). Our produced GMOs (genetically modified organisms) are therefore harmless to the user, mankind and the environment. Thus they are GRAS - generally regarded as safe.
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:Further we are working in a bio security laboratory of the stage 1 (S1). There is no possible access for the public. :Every person working in the lab is trained and instructed by the safety rules for laboratories S1.  
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:Further we are working in a biosecurity laboratory of the stage 1 (S1). There is no possible access for the public. :Every person working in the lab is trained and instructed by the safety rules for laboratories S1.  
:  '''2. Do any of the new BioBrick parts (or devices) that you made this year raise any safety issues?'''  
:  '''2. Do any of the new BioBrick parts (or devices) that you made this year raise any safety issues?'''  
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:No. All GMOs are S1 biosafety level. We did a risk assesement and know what kind of modulation we did on the GMOs. There are no risks of hazard or biological safety issues to mankind. We used phage activators as sensitivities tuners. Hence the user of our sensivity biobricks must be aware of the risks concerning working with phage dna.
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:No. All GMOs are S1 biosafety level. We did a risk assesement and know what kind of modulation we did on the GMOs. There are no risks of hazard or biological safety issues to mankind. We used phage activators as sensitivities tuners. Hence the user of our sensitivity BioBricks must be aware of the risks concerning working with phage DNA.
:  ''' 3. Is there a local biosafety group, committee, or review board at your institution?'''
:  ''' 3. Is there a local biosafety group, committee, or review board at your institution?'''
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:There is no specific group. There is a safety and a desinfection officer at our institution, which support our project.
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:There is no specifical group. There is a safety and a desinfection officer at our institution who support our project.
: '''4.Do you have any other ideas how to deal with safety issues that could be useful for future iGEM competitions? How could parts, devices and systems be made even safer through biosafety engineering?'''  
: '''4.Do you have any other ideas how to deal with safety issues that could be useful for future iGEM competitions? How could parts, devices and systems be made even safer through biosafety engineering?'''  
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: Every team must be aware of the risk that might be based in the organisms they use and they modify. Maybe a general safety instruction, which can be downlaoded from the igem.org page will be helpful to secure the research done in this competition. Moreover a list of risk organisms, with easy acces on the igem.safety page, would be a great benefit. Additional the safety page could be tidied up to ease the acces to the key facts. Hence a small safety summary would be usefull. Some kind of a checklist.
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: Every team must be aware of the risk that might be based in the organisms they use and they modify. Maybe a general safety instruction, which can be downlaoded from the igem.org page will be helpful to secure the research done in this competition. Moreover a list of risk organisms, with easy acces on the igem.safety page, would be a great benefit. Additional the safety page could be tidied up to ease the acces to the key facts. Hence a small safety summary, like a checklist would be useful.
:Certainly, it has to be said that the safety of the project must be reviewed by the team performing the experiments.
:Certainly, it has to be said that the safety of the project must be reviewed by the team performing the experiments.
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= Referenzen / References =
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= References =

Latest revision as of 00:04, 28 October 2010

http://igem-bielefeld.de/img/banner_safety.png

Contents

Biosafety and Biosecurity (English)

It is important to discriminate between biosafety and biosecurity in the context of working with genetically modified organisms. Biosecurity comprises the safety of the lab. The WHO defines biosecurity as a task of organisation and administration. The term biosafety deals with the biological risks of the samples for the user, the enviroment and the lab. In this article, we are mostly summarizing the German law on biosecurity and biosafety regarding to the ZKBS (zentrale Kommission für Biologische Sicherheit) and their list of unhazardous organisms plus the comment on safety of the DFG (Deutsche Forschungsgemeinschaft). Furthermore we crosslinked the laws of the United States of America and the European law of biosecurity and biosafety in this article. We marked this statement in the text, so the reader can discrimante between the law systems. This kind of differentiation makes sense, because our experimental work was done in Germany, shipped in Europe (to SDU Denmark) and used as a BioBrick in the United States of America.

Biosecurity

Figure 1: Security entrance to the lab. Every member of the team needs a key-token in order to get acces to the lab


In the context of "genetically engineering" it is quite important to keep unqualified personnel and trespassers away from your laboratory and your samples. In our case we secure our lab with a keypad. Every staff member needs a key to open the laboratory door. Nobody is able to open the door without the proper keys. Staff members receive a key after beeing briefed by the safety officer on safety issues. You can only get a key for the safety stage you are working in. The labs with higher safety stages are cut off from the lower ones. Staff members need a continuative safety guide to receive a key for the higher security levels. Concludingly no unqualified personel can pass the door to the laboratory. Figure 1 shows the keypad in front of the lab.

The laboratories, which are in use for our iGEM project are security stage 1 (S1). For the safety of the staff our labs are equiped with fire extinguishers, emergency showers, eye showers and a heart defibrillator.


Biosafety

Figure 2: We are using a cleanbench to avoid any contamination of our samples. A proper use of the cleanbench can only be achieved by placing all the big things in the rear of the bench, by not disturbing the air circulation and by avoiding any kind of aerosoles. Use gloves for your own protection.


The term "biological safety" defines the effort to reduce or eliminate any potential risks caused by biotechnolgy or genetical engineering. The laboratories are scaled into four different saftey stages. The stage "S1" defines working with organisms and methods, which do no proved harm - neither to the environment nor to mankind. The stages rise up to biosafety stage four, which defines working with proved humanpathogenous organisms. The WHO defines for the United States the same safety stages, which are called risk groups Manual of Biosecurity, WHO, page 1.

The Biosafety is ruled by the "Zentrale Kommission für Biologische Sicherheit" (ZKBS) in Germany. The ZKBS reviewed and verified all commercial, research or privat laboratories about their safety issues. The iGEM Team Bielefeld is currently working with the organisms Agrobacterium tumefaciens and a derivate of Escherichia coli K12 in a ZKBS reviewed S1-lab. The organism strains are declared as risk factor 1 by the german act of genetics (GenTSV, § 5; 15.06.2010), so:

1. The act contains that the organisms (abstract):

- are not human-, phyto- or animalpathogen
- do not contain or release organisms containing to a higher risk stage
- are approved by experiments or long term evaluation or do not proliferate in the enviroment because of biological implanted boundaries


2. Organisms, which confirm the paragraph 1, are defined by §6 of the act of genetics (GenTSV):

a) as biological safe organisms
b) as organisms or strains, which are not contaminated by organisms or strains of a higher security level
c) organisms defined by the risk level S1 (list of organisms used for genetically engineering research)


The list of organisms categorize the strains E. coli K12 and A. tumefaciens as biological safety risk 1 (S1). The strain A. tumefaciens is a known phytopathogen. Because of its frequent appearence on earth (500 bacteria in 1 g of soil) it is generally regarded as safe.

The WHO defines "security assessments" has the highest priority for the work with organisms. This includes a proper theoretically background of the organism. Further the WHO defines rules for good molecular practice and proper lab security (WHO Manual Biosafety, page 9 following). They note that most of the security guidelines are not quite necessary for organisms of risk stage 1. Anyway, we play by the rules and work as carefully as possible (compare: what we do to protect).


Biosafety und Biosecurity (German)

Es ist bei der Inbetriebnahme und Nutzung einer Gentechnischen Anlagen darauf zu achten, dass Vorkehrungen sowohl für den Betriebsschutz (Biosecurity) als auch für die biologische Sicherheit (Biosafety) getroffen werden. Biosecurity wird von der WHO als Aufgabe der Administrative des Labors definiert.

Biosecurity

Der Biosecurity wird Sorge getragen, indem kein unbefugter Zugang zum Laborplatz hat. Die Türen sind nur per Schlüssel zu öffnen. Jeder Mitarbeiten muss eine Sicherheitsbelehrung beim Sicherheitsbeauftragten ablegen, ehe er Zugang zu den Laboratorien bekommt. Die Labore sind je nach Sicherheitsgefährdung gekennzeichnet und verschlossen, so dass keine unautorisiert Person in ein höheres Sicherheitslevel eindringen kann. Das vom iGEM Team genutzte Labor ist als Genlaboratorium Sicherheitsstufe S1 ausgewiesen. Die WHO definiert die gleichen Sicherheitsstufen, hier "risk group" genannt. Manual of Biosecurity, WHO, page 1.

Biosafety

Figure 3: The Sign says: No Trespassing, Security stage 1.

Als Biologische Sicherheit (Biosafety) wird der Versuch zur Reduzierung bzw. Eliminierung potentieller Gefahren durch Biotechnologie definiert. In Deutschland werden die unterschiedlichen Organismen in vier Sicherheitsstufen von S1 für keine bekannte Gefährdung, bis S4 für erwiesene humanpathogene Gefährdung eingeteilt. Die zentrale Kommission für Biologische Sicherheit (ZKBS) überprüft alle Laboratorien, ob privat, gewerblich oder für die Forschung, vor Inbetriebnahme auf Sicherheitsmängel und Einhaltung der rechtlichen Grundlagen. Das iGEM Team Bielefeld nutzt die Stämme Agrobacterium tumefaciens und einen Ableger von Escherichia coli K12 in einem ZKBS geprüften Labor der Sicherheitsstufe S1 für gentechnische Arbeiten. Die Stämme sind nach dem Gentechnik Gesetz (GenTSV) § 5 Absatz 1 Satz 1 und Anhang Nummer 1 GenTSV der Risikogruppe 1 zu zuordnen (Stand 15.06.2010).

1. Das beinhaltet, dass die Organismen (Auszug):

- weder ein human-, pflanzen- noch tierpathogen sind
- keine Organismen höhere Risikogruppen abgeben
- sich durch experimentell erwiesene oder langfristig erprobte Anwendung auszeichnen oder eingebaute biologische Schranken […] die Überlebens- bzw. Vermehrungsfähigkeit in der Umwelt begrenzen

2. Organismen, die die Punkte unter 1 erfüllen, sind gemäß §6 Abs. 1 in Verbindung mit Anhang II Teil A des GenTVS

a) Organismen, die als biologisch sicher anerkannt sind (§6 Abs. 3 GenTSV)
b) Zellen oder Zelllinien, die nicht von außen mit Organismen höherer Risikogruppe (2-4) kontaminiert sind
c) Organismen der Risikogruppe 1 nach der Organismenliste (Spender- und Empfängerorganismen für gentechnische Arbeiten zu Forschungszwecken)

Die verwendeten Stämme E. coli K12 und Agrobacterium tumefaciens werden nach dieser Organismenliste als Risikogruppe 1 klassifiziert. Agrobacterium tumefaciens ist zwar als phytopathogen vermerkt, ist jedoch ubiquitär, d.h. weltweit im Boden (ca. 500 Bakterien / 1 g Boden) verbreitet und wurde aus diesem Grund der Risikogruppe 1 zugeordnet.

Zur Sicherheit des Personals und der Umwelt herrscht ein konstanter leichter Unterdruck in den Laboratorien und die Fenster sind geschlossen zu halten, so dass weder Organismen weder hinaus noch hinein gelangen können. Zudem wird der anfallende Organismen-Müll in speziellen Säcken gesammelt, autoklaviert und entsorgt. Die Organismen werden abgetötet. Zudem werden benutzen Flächen vor und nach der Arbeit desinfiziert.


Risk Assessment

What we do to protect

  • Every single person in the lab is trained on their work.
  • Every working person in the lab is trained on safety issues.
  • We have a safety and a disinfection officer at our lab.
  • No unqualified personal has access to the lab.
  • No public access to the lab.
  • We reduced the risk of contamination of the environment or staff members by desinfection, autoclavation and using of protection clothes.
  • In case of emergency there are telephones, fire extinguishers, defibrillators and alarm buttons around the lab.
  • We only used organisms of the risk stage 1, which do not harm neither mankind nor the environment.
  • We modifed an unhazardous organism with specific, identified and characterized BioBricks. So we can appraise the risk causing by the modified organisms.
  • Constantly low pressure, no open windows => no organism can get in or out
  • Desinfection of all working places after work (everyday)
  • Autoclavation of waste (solid/liquid)
  • No pipetting with the mouth


Unsere Schutzmaßnahmen

  • Jede Person, die sich im Labor aufhält und arbeitet ist in ihrer Arbeit ausgebildet und/oder unterwiesen.
  • Jede Person, die sich im Labor aufhält oder arbeitet hat eine Sicherheitsbelehrung unterlaufen.
  • Es gibt einen Sicherheits- und eine Desinfektionsfachkraft in unserem Labor.
  • Kein unqualifiziertes Personal gelangt ins Labor.
  • Kein unqualifiziertes Personal gelangt in eine höhere Sicherheitsstufe, als ihr erlaubt.
  • Kein öffentlicher Zugang zum Labor möglich.
  • Wir reduzieren das Kontaminationsrisiko für Arbeiter und Umwelt durch Autoklavieren, Desinfizieren und das Nutzen von protektiver Arbeitskleidung auf ein Minimum.
  • Im Falle eines Notfalls gibt es ein Telefon zum Hilferuf, Feuerlöscher, Defibrilatoren und Feueralarmschalter in Reichweite.
  • Wir benutzen ausschließlich Organismen der Sicherheitsstufe 1.


Short Summary

1. Would any of your project ideas raise safety issues? Researcher safety, public safety, or environmental safety?
The bacteria we are currently working with are defined as biosecurity stage 1 (S1). Our produced GMOs (genetically modified organisms) are therefore harmless to the user, mankind and the environment. Thus they are GRAS - generally regarded as safe.
Further we are working in a biosecurity laboratory of the stage 1 (S1). There is no possible access for the public. :Every person working in the lab is trained and instructed by the safety rules for laboratories S1.
2. Do any of the new BioBrick parts (or devices) that you made this year raise any safety issues?
No. All GMOs are S1 biosafety level. We did a risk assesement and know what kind of modulation we did on the GMOs. There are no risks of hazard or biological safety issues to mankind. We used phage activators as sensitivities tuners. Hence the user of our sensitivity BioBricks must be aware of the risks concerning working with phage DNA.
3. Is there a local biosafety group, committee, or review board at your institution?
There is no specifical group. There is a safety and a desinfection officer at our institution who support our project.
4.Do you have any other ideas how to deal with safety issues that could be useful for future iGEM competitions? How could parts, devices and systems be made even safer through biosafety engineering?
Every team must be aware of the risk that might be based in the organisms they use and they modify. Maybe a general safety instruction, which can be downlaoded from the igem.org page will be helpful to secure the research done in this competition. Moreover a list of risk organisms, with easy acces on the igem.safety page, would be a great benefit. Additional the safety page could be tidied up to ease the acces to the key facts. Hence a small safety summary, like a checklist would be useful.
Certainly, it has to be said that the safety of the project must be reviewed by the team performing the experiments.


References

  • Comment on synthetic biology of the DFG (German Research Association)/pdf, German
  • WHO; Laboratory Biosafety Manual (English)
  • WHO; Laboratory biosecurity guidance (English, 2008)
  • Stellungnahme der ZKBS zur Einstufung von Agrobacterium tumefaciens (Deutsch) / Statement of the ZKBS concerning the classification of Agrobacterium tumefaciens (German)
  • Kategorisierte Organismenliste (Deutsch) der ZKBS / List of categorized organisms (German) of the ZKBS
  • Merkblatt zum Transportieren von GVOs / ZKBS
  • ZKBS, 2010