User:VolkerMorath/Safety

From 2010.igem.org

References:

Legal regularisation in the Federal Republic of Germany

Which specific biosafety rules or guidelines do you have to consider in your country?


In Germany all working that includes recombinant DNA technologies is regulated by the Gesetz zur Regelung der Gentechnik. This law regulates general aspects arising from the life sciences and refers for more precise interpretations in §4 to the Zentrale Kommission für die Biologische Sicherheit. The ZKBS is a commission composed of 20 technical experts that releases yearly statements to actual issues of biosafety. So far the ZKBS released three stratements affecting the work with Adeno-associated viral systems.

References:

  • Risk assessment of human Adeno-associated viruses
  • Advises for AAV carrying cell cycle regulating genes
  • Risk assessment of human Adeno-associated viruses and AAV derived vectors
  • Is there a local biosafety group, committee, or review board at your institution? If yes, what does your local biosafety group think about your project?


    At the Albert-Ludwigs-University Freiburg for all concerns of security the Stabsstelle Sicherheit is responsible and to contact if questions arise. Especially for questions of biological security Dr. Petra Markmeyer-Pieles is cognizant. We contacted her a first time befor the begin of our project in March when it was clear that the Adeno-associated Virus (AAV-2) was chosen as the topic of our project. At that time she proposed to do the cloning in the AAV-2 that is for sure to handle under biological security level 1 and to prepare everything for work under biological security level 2 to satisfy the precaution principle. The precaution principle was realized and all viral vectors that contained a modified capsid were handled under SII conditions until proven harmless. In August the planing of the project was completed, summarized in an Biosafety application and handed to the department for biological security of the regional board in Tübingen which had to to approve the whole project.

    References:

  • Biosafety application of the iGEM team Freiburg_Bioware 2010 (in German)
  • Official classification as Biological Safety Level 1 by the local biosafety office
  • Do any of the new BioBrick parts (or devices) that you made this year raise any safety issues? If yes, did you document these issues in the Registry? How did you manage to handle the safety issue? How could other teams learn from your experience?


    Warning sign for part descriptions Several composite parts that were assembled by our Team this year are alone capable of producing infectious viral particles when transduced together with a vector plasmid and a helper plasmid into AAV-293 cells. These special cells provide the adenoviral gene E1 stabily integrated in trans. These cells are not provided in the Virus Construction Kit nor availible in the Parts Registry and have to purchased from other laboratories or a commercial supplyer. For this reason we estimate the risk of a accidental transformation of AAV-293 cells with all three plasmids for negligible. Nevertheless we considered it useful to mark every BioBrick or Composite Part in the Registry that contributes to the production or is capable of producing viral vectors when transformed under the previously mentioned conditions.

    References:

  • Description of the AAV-293 cell line
  • Contribute to community discussions on what needs to go into a code against the use of our science for hostile purposes (see A Community Response)


  • Public Perception
  • importance of maintaining public legitimacy and support
  • apllications should demonstrate clear social benefits
  • not overhyped - anxiety and unrealistic hopes
  • psychological research into the concept of "identity-driven decision-making" (Torpman,2004) 19
    Every grout has a set of norms: a code of conduct about what is acceptable beahviour (Jaques, 2004] 19

    References:

  • 01) Synthetic Biology & Biosecurity - Awareness in Europe by Dr. Alexander Kelle in 2007 [http://www.idialog.eu/uploads/file/Synbiosafe-Biosecurity_awareness_in_Europe_Kelle.pdf Kelle ; 2007 1]
    used
  • 02) Synthetic Biology - Social and Ethical Challenges [http://www.bbsrc.ac.uk/nmsruntime/saveasdialog.aspx?lID=2277&sID=4233 2]
    used
  • 03) Synthetic Biology - Applying Engineering to Biology
    used
  • 04) The Impact of the Development of Modern Biology and Medicine on the Evolution of Offensive Biological Warfare Programs in the Twentieth Century [http://www.informaworld.com/smpp/content~content=a713604665&db=all]
  • 05) Chemical Synthesis of Poliovirus cDNA: Generation of Infectious Virus in the Absence of Natural Template [http://www.sciencemag.org/cgi/content/full/297/5583/1016 Cello et al. ; 2002 5 ] used
  • 06) [http://www.nytimes.com/2003/12/03/opinion/03iht-edstein_ed3_.html Dangerous research : When science breeds nightmares]
  • 07) [http://www.jcvi.org/cms/fileadmin/site/research/projects/synthetic-genomics-report/synthetic-genomics-report.pdf Synthetic Genomics - Options for governance]
  • 08) Synthetic biology by [Benner & Sismour 2005] [[Media:Freiburg10_Synthetic_Biology_by_Benner_and_Sismour.pdf | here]]
  • 09) Synthetic biology—putting engineering into biology by [Heinemann & Panke 2006]
  • 10) [http://www.guardian.co.uk/world/2006/jun/14/terrorism.topstories3 10] Revealed: the lax laws that could allow assembly of deadly virus DNA]
  • 11) [http://www.thenewatlantis.com/docLib/TNA12-TuckerZilinskas.pdf The Promise and Perils of Synthetic Biology [Tucker & Zilinskas, 2006]]
  • 12) [http://www.sciencemag.org/cgi/content/short/310/5745/17 1918 Flu and Responsible Science] Reaction to the H1N1 sequence [http://www.sciencemag.org/cgi/reprint/310/5745/17.pdf Sharp ; 2005 12] used
  • 13) [http://www.fas.org/irp/cia/product/bw1103.pdf The Darker Bioweapons Future by the CIA in 2003]
  • 14) [[Media:Primer for Synthetic Biology - Mohr 2007.pdf]]
  • 15) [[Media:Freiburg10_The bugs of war.pdf]]
  • 16) [[Media:Freiburg10_Expression of Mouse Interleukin-4 by a Recombinant Ectromelia Virus Suppresses.pdf]] [http://www.ncbi.nlm.nih.gov/pubmed/11152493 Jackson et al. ; 2001 16 ] used
  • 17) [http://www.ncbi.nlm.nih.gov/pubmed/19784453] [[media:Freiburg10_Governance_of_dual-use_research-_an_ethical_dilemma.pdf]]
  • 18) [http://www.ncbi.nlm.nih.gov/pubmed/18625678 18] [[Media:Freiburg10_Evidence-based_biosafety-_a_review_of_the_principles_and_effectiveness_of_microbiological_containment_measures.pdf]]
  • 19) [http://www.ncbi.nlm.nih.gov/pubmed/16819452 19] [[Media:Freiburg10_A Hippocratic Oath for life scientists.pdf]]
  • 20) [http://www.ncbi.nlm.nih.gov/pubmed/16819443] [[Media:Freiburg10_Empowerment and restraint in scientific communication.pdf]]
  • 21) [http://www.ncbi.nlm.nih.gov/pubmed/16819441] [[Media:Freiburg10_When risk outweighs benefit.pdf]]
  • 22) [http://www.ncbi.nlm.nih.gov/pubmed/12789408 22] [[Media:Freiburg10_Advances in life sciences and bioterrorism - Risks perspectives and responsibilities.pdf]]
  • 23) [http://www.ncbi.nlm.nih.gov/pubmed/12590130] [[Media:Freiburg10_PNAS policy on publication of sensitive material in the life sciences.pdf]]
  • 24 [http://www.sciencemag.org/cgi/reprint/310/5745/77.pdf] [http://www.sciencemag.org/cgi/reprint/310/5745/77.pdf Tumpey et al. ; 2005 24 ]
  • 25 [http://www.nature.com/nature/journal/v438/n7065/pdf/438134a.pdf v. Bubnoff; 2005 25]
  • 26 [[Media:Freiburg10_Risk assessment of human Adeno-associated viruses 2001.pdf|Risk assessment of human Adeno-associated viruses; 2001 26]]
  • 27[[Media:Freiburg10_Advises for AAV carrying cell cycle regulating genes 2004.pdf|Advises for AAV carrying cell cycle regulating genes; 2004 27]]
  • 28[[Media:Freiburg10_Risk assessment of human Adeno-associated viruses and AAV derived vectors 2005.pdf|Risk assessment of human Adeno-associated viruses and AAV derived vectors; 2005 28]]
  • 29[http://www.ncbi.nlm.nih.gov/pubmed/10700178 Kai et al. ; 2000 29] Bioverteilung in Klinischer Studie