Team:Bielefeld-Germany/Safety

From 2010.igem.org

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(Referenzen / References)
(Biosafety and Biosecurity (English))
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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 and lab use. Biosecurity comprised the safety of the lab. The term Biosafety deals with the biological risks of the samples for the user, the enviroment and the lab. In this article, we are summarizing mostly 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 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 lists 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 Forschung Gesellschaft)].
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It is important to discriminate between Biosafety and Biosecurity in the context of working with genetically modified organisms and lab use. Biosecurity comprises the safety of the lab. 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 lists 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 modulation 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.
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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 modulation 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.
== Biosecurity ==
== Biosecurity ==
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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 they defined 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 (see, what we do to protect).
The WHO defines "security assesments" has the highest priority for the work with organisms. This includes a proper theoretically background of the organism. Further they defined 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 (see, what we do to protect).
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= Transportation of GMOs =
= Transportation of GMOs =

Revision as of 14:39, 27 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 and lab use. Biosecurity comprises the safety of the lab. 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 lists 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 modulation 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.

Biosecurity

clean bench in our lab.

In the context of "genetically engineered" it is quite important to keep unqualified and trespasser 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. The picture 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 extinguisher, emergency showers and a heart defibrillator.

Biosafety

Picture 1: Security entrance to the lab. Every Member of the Team needs a key-token in order to get acces to the lab

The term "biological safety" defines the effort to reduce or elimnate any potential risks caused by biotechnolgy or genetical engineering. The laboratories are scaled into four differnt saftey stages. The stage "S1" defines working with organsims and methods, which do no prooved harm neither to the enviroment or mankind. The stages rises up to Biosafety stage four, which defines working with prooved 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 reviewd and verified all commercial, research or privat laboraties about their safety issues. The iGEM TEAM Bielefeld is currently working with the organisms Agrobacterium tumefaciens and a derivate of E. 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):

1.

- are no proved human-,phyto or animalpathogen
- do not contain or release organism containing to a higher risk stage
- are prooved 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 the $6 of the act of genetics (GenTSV):

a) as biological safe organisms
b) organims or strains, which are contaminated by organisms or strains of a higher security level
c) organisms definied by the risk level S1 (list of organisms used for genetically engineering research)


The list of organisms categorize the strains E. coli K12 and Agrobacterium tumefaciens as biological safety risk 1 (S1). The strain 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.

The WHO defines "security assesments" has the highest priority for the work with organisms. This includes a proper theoretically background of the organism. Further they defined 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 neccessary for organism of risk stage 1. Although we play by the rules and work as carefully as possible (see, what we do to protect).

Transportation of GMOs

The transportation and shipping of genetically modified organisms (GMOs) has to be done under specific safety conditions in order to lower the risk GMOs released into the enviroment. Moreover it is important that no GMOs is sent to unqualified personel or is used by unqualified personell during the shipment.

As a part of the european community, the german law for export of GMOs are similar to the rules of the eurpean community law. Before you send a GMOs, you must ensure that the recipient is allowed to work with the GMO. Moreover every release of the GMOs into the enviroment must be checked by gouvermental law in the recipients country and the country of the dispatcher.

The package must be signed as "shipped GMOs". Otherwise it will not be cross any boarder in the european community.


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 got 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 disinfection, autoclavation and using of protecting clothes
  • In case of emergency there are telephones, fire extinguisher, defibrillator and alarm buttons around the lab
  • We only used organism of the risk stage 1, which do not harm neither mankind nor the environment
  • We modify a unharzadous organism with soecific, 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 after work of all working places (everyday)
  • Autoclavation of waste (solid/liquid)
  • No pipetting with the mouth


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

Der Biosecurity wird Sorge getragen, in dem 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 unterqualifizierte Person in ein höheres Sicherheitslevel eindringen kann. In dem vom iGEM genutzten Labor handelt es sich um die Sicherheitstufe S1. Die WHO definiert die gleichen Sicherheitsstufen, hier "risk group" genannt. Manual of Biosecurity, WHO, page 1.

Biosafety

[[Image:|200px|thumb|left| 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.]]

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 des E. 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 AnhangI Nummer 1 GenTSV der Risikogruppe 1 zu zuordnen (Stand 15.06.2010). Das beinhaltet, dass die Organismen (Auszug):

1.

- 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 biologische Sicherheitsmaßnahme 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 hineingelangen können. Zudem wird der anfallende Organismen-Müll in spezillen Säcken gesammelt, autoklaviert und entsorgt. Die Organismen werden abgetötet. Zudem werden benutzen Flächen vor und nach der Arbeit desinfiziert.

Transport von GVO

Der Transport von genetisch veränderten Organismen (GVOs) unterliegt innerhalb der Europäischen Union und außerhalb davon speziellen Sicherheitsbedingungen. Die deutschen Bestimmung sind denen der Europäischen Union ähnlich.

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
  • We rreduzieren das Kontaminationsrisiko für Arbeiter und Umwelt durch Autoklavieren, Desinfizierren und das Nutzen von protektiver Arbeitskleidung auf ein Minimum
  • Im Falle eines Notfalls gibt es ein Telefon zum Hilferuf, Feuerlöscherr, Defibrilatoren und Feueralarmschalter in Reichweite
  • Wir benutzen ausschließlich Organismen der Sicherheitsstufe 1


Short Summary

1. Would any of your project ideas raise safety issues ?
The bacteria we are currently working with are defined as bio security stage 1 (S1). Our produced GMOs (genetically modified organisms) are therefor no proofed harm neither to mankind nor to the environment. Thus they are GRAS - generally regarded as safe.
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.
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. There is no risk of hazard or biological safety issues to mankind.
3. Is there a local biosafety group, committee, or review board at your institution?
Yes. There is a safety officer at our institution.
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 would be usefull. Some kind of a checklist.

Certainly, it has to be said that the safety of the project must be reviewed by the team performing the experiments.

Referenzen / References

ZKBS, 2010

Kategorisierte Organismenliste (Deutsch) der ZKBS / List of categorized organisms (German) of the ZKBS

Stellungnahme der ZKBS zur Einstufung von Agrobacterium tumefaciens (Deutsch) / Statement of the ZKBS concerning the classification of Agrobacterium tumefaciens (German)]

Comment on synthetic biology of the DFG (German Research Association)/pdf, German

COmments on Safety UNOG Genova, 2008 / pdf, English

WHO; Laboratory Biosafety Manual (English)

WHO; Laboratory biosecurity guidance (English, 2008)