Safety

From 2012.igem.org

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====1. Would any of your project ideas raise safety issues in terms of:====
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==FAQ==
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'''*researcher safety''' <br>
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===Question 1: Why does iGEM ask teams to address safety questions and screen projects? ===
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The University of Westminster have a full range of safety documents relating to all laboratory safety issues. Protocols range from the appropriate behaviour in the laboratory to the correct procedure for handling spills. In the three floors where the laboratories are located, by policy it is not allowed to consume any food or drinks as a safety measure. All laboratory users are required to use protective equipment when working in the laboratory, such as laboratory coats, eye protection and gloves, and laboratories are subject to on-the spot inspections to ensure that the policies laid out by the University are being adhered to.
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iGEM safety questions and screening procedures are designed:
 +
*To protect team members as they work in their labs, iGEM institutions, the general public and the environment
 +
*To encourage team members to consider safety, health, security, and environmental implications of their projects, both within and beyond the scope of iGEM competition.
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All potentially hazardous materials are documented in COSHH forms (Microbial and Chemical) which the iGEM team are required to complete themselves. These COSHH forms are prominently displayed in the laboratory and are always carried with the researchers. We are using the DH5α strain of E. coli for amplification of our plasmids. This is a well-studied laboratory strain and is classed as Level 1.
 
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All our experimental work is in the mammalian cell lines, MG63 and MCF7. MG63 is an osteosarcoma cell line (Level1) and MCF7 is a well characterised breast cancer cell commonly used as a tumor model system. Any risk due to contamination (bacterial, viral, prion) will be taken care of by following approved disposal protocols. Standard mammalian cell culture techniques are designed to minimise the risks of such contamination affecting users. Furthermore a strict- No White Lab Coats policy is in place when entering the mammalian cell culture laboratory.
 
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All BioBrick parts created and used are non-hazardous as none of them produce toxic levels of substances. The parts we are producing are mammalian promoter sequences. They are amplified from the mammalian cell line, HeLa. Promoters produced are ALDH1A1, ALDH1A3, ALDH2 and ALDH3A1. None of these are harmful. Doxycycline-induced mammalian promoter is amplified from a plasmid and does not produce harmful products.
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===Question 2: How does this work? Does anyone actually read answers to safety questions and review project wikis? ===
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Members of the iGEM Safety Committee and Graduate Safety Screeners review all safety pages and project wikis for consistency, identify potential safety issues and contact iGEM teams and external advisors if additional information is needed.   Teams may be disqualified if they do not demonstrate that their projects are safe.
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'''*Public Safety''' <br>
 
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The study is a proof of concept. Risk to public is minimal. The laboratory is kept locked when not in use. Mammalian cell culture laboratory adjoins our main working laboratory and is also locked. None of our transformants produce products which would be toxic to humans. DH5α is a laboratory strain and not associated with disease in healthy humans. Although bacteria would be transformed to have antibiotic resistance, it is not a strain which is able to thrive outside the laboratory. The mammalian cell lines used pose minimal risk to the public as do the products which they express.
 
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'''*Environmental Safety''' <br>
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'''iGEM Safety Committee:'''  
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DH5α is a genetically engineered lab strain which does not transfer genes and therefore poses minimal risk of transferring antibiotic resistance to other bacteria. The mammalian cells would not survive for extended periods outside the laboratory and therefore is of minimal risk.
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*Todd Kuiken, Synthetic Biology Project, Woodrow Wilson Center, Smithsonian Institution; 
 +
*Piers Millett, UN Biological Weapons Convention, Implementation Support Unit, Geneva; 
 +
*Kenneth Oye, Engineering Systems and Political Science, Massachusetts Institute of Technology; 
 +
*Megan Palmer, Deputy Director, Practices, NSF Synthetic Biology ERC, Stanford University;
 +
*Sam Yu, Biosafety Officer, Hong Kong University of Technology, Clearwater Bay, Hong Kong
 +
'''Graduate Safety Screeners:'''
 +
*Shlomiya Bar-Yam, MIT,
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*Julie MacNamara, MIT, 
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*Ralph Donald Turlington, MIT 
 +
 +
'''External Consultants:'''
 +
*Rocco Casagrande, Gryphon, former Director UNMOVIC Biological Lab;
 +
*George Church, Harvard Medical;
 +
*Chan-Wha Kim, President Asia-Pacific Biosafety Association and Korea University;
 +
*Michael Imperiale, U Michigan Medical and NSABB; Allen Lin, Cambridge University;
 +
*Scott Mohr, Chemistry, Boston University;
 +
*Pamela Silver, Harvard Medical
 +
 +
 +
 +
===Question 3: We need clarification on the safety questions. Would you please provide guidance on each iGEM safety question?===
 +
 +
 +
====1. Would any of your project ideas raise safety issues in terms of:====
 +
*researcher safety,
 +
*public safety, or
 +
*environmental safety
 +
 +
=====Guidance:=====
 +
There are three recommended steps in addressing this question.
 +
#To start, please list organisms you are using and organisms from which your parts are derived, indicating the risk group or biosafety level for each.  For help, see Table 1 and 2 of the [http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf World Health Organization (WHO) Laboratory Biosafety Manual].  You are welcome to use your national standards if you prefer.  If national standards do not use the WHO 1-4 scale, please provide a link to an explanation of your standards. 
 +
#Then consider risks to team members, publics and environment if the project goes according to plan.  Please describe risks posed by lab equipment and chemicals as well as biological parts and organisms.  How are you addressing these issues in project design and lab work?  Have you received biosafety training and other laboratory safety training?  If so, please briefly describe the training.
 +
#Then consider risks to team members, publics and environment if the project does not go according to plan.  What are risks if safety measures such as containment procedures go wrong and organisms or parts are released?  What are risks to security from malicious misuse?    How are you addressing such risks?
 +
 +
 +
 +
----
====2. Do any of the new BioBrick parts (or devices) that you made this year raise safety issues? If yes, ====
====2. Do any of the new BioBrick parts (or devices) that you made this year raise safety issues? If yes, ====
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No. The parts produced by our group have all been promoter BioBrick parts and they do not raise any safety issues.
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*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?
 +
 
 +
=====Guidance:===== 
 +
Please reference the biosafety level of parts.  If you are working with anything other than a BSL1 organism, take extra care with this question. Your nation regulates handling and transfer of pathogens and parts associated with pathogenicity.  For a list of regulated organisms, see the [http://www.australiagroup.net/en/biological_agents.html Australia Group website].
 +
 
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====3. Is there a local biosafety group, committee, or review board at your institution? ====
 
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Yes, University of Westminster has a GM safety officer. The project was cleared as Containment Level 1. An ethics filter form was filled before the start of the project. All the chemicals and other materials used for the project are approved for laboratory use. 
 
----
----
 +
====3. 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?
 +
*If no, which specific biosafety rules or guidelines do you have to consider in your country?
 +
=====Guidance:===== 
 +
The iGEM Safety Committee is not a substitute for national and local university institional biosafety committees 
 +
# Does your university have a Biosafety Committee or equivalent? Please provide a link to regulations and local requirements.
 +
# Is your project in compliance with national regulations and university requirements?
 +
# If you are working with any organisms or parts requiring containment arrangements above BSL 1 or equivalent, have you consulted with your Institutional Biosafety Committee regarding your 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? ====
-
Yes, University of Westminster has a GM safety officer. The project was cleared as Containment Level 1. An ethics filter form was filled before the start of the project. All the chemicals and other materials used for the project are approved for laboratory use.
+
=====Guidance:===== 
 +
This is an open-ended space for you to consider and suggest ways of improving safety or safety awareness at iGEM and beyond.   Some iGEM teams have offered ideas (and sometimes full projects) to limit gene flow, to create software for screening pathogens, and to reduce reliance on antibiotic resistant markers.   Other iGEM projects have discussed concerns that might arise if the project succeeded and became widely used, as commercial product or other means of distribution.  Some iGEM projects have discussed risks that might materialize if the knowledge generated or methods developed were to become more widely available.

Latest revision as of 03:47, 16 December 2012

Safety

Before answering these questions on your team Safety page, be sure to read the Safety in iGEM page. and the FAQ section below.

Key questions

For iGEM 2012, teams are asked to detail how they approached any issues of biological safety associated with their projects. Specifically, teams should consider the following questions:

  1. Would any of your project ideas raise safety issues in terms of:
    • researcher safety,
    • public safety, or
    • environmental safety?
  2. 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?
  3. 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?
    • If no, which specific biosafety rules or guidelines do you have to consider in your country?
  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?

 

Teams, please document any answers to these safety questions on your wiki safety page. Judges will be asked to evaluate your project, in part, on the basis of if and how you considered and addressed issues of biological safety. If any questions arise regarding iGEM and biological safety please send an email to safety AT igem.org.


Contents

FAQ

Question 1: Why does iGEM ask teams to address safety questions and screen projects?

iGEM safety questions and screening procedures are designed:

  • To protect team members as they work in their labs, iGEM institutions, the general public and the environment
  • To encourage team members to consider safety, health, security, and environmental implications of their projects, both within and beyond the scope of iGEM competition.


Question 2: How does this work? Does anyone actually read answers to safety questions and review project wikis?

Members of the iGEM Safety Committee and Graduate Safety Screeners review all safety pages and project wikis for consistency, identify potential safety issues and contact iGEM teams and external advisors if additional information is needed. Teams may be disqualified if they do not demonstrate that their projects are safe.


iGEM Safety Committee:

  • Todd Kuiken, Synthetic Biology Project, Woodrow Wilson Center, Smithsonian Institution;
  • Piers Millett, UN Biological Weapons Convention, Implementation Support Unit, Geneva;
  • Kenneth Oye, Engineering Systems and Political Science, Massachusetts Institute of Technology;
  • Megan Palmer, Deputy Director, Practices, NSF Synthetic Biology ERC, Stanford University;
  • Sam Yu, Biosafety Officer, Hong Kong University of Technology, Clearwater Bay, Hong Kong

Graduate Safety Screeners:

  • Shlomiya Bar-Yam, MIT,
  • Julie MacNamara, MIT,
  • Ralph Donald Turlington, MIT

External Consultants:

  • Rocco Casagrande, Gryphon, former Director UNMOVIC Biological Lab;
  • George Church, Harvard Medical;
  • Chan-Wha Kim, President Asia-Pacific Biosafety Association and Korea University;
  • Michael Imperiale, U Michigan Medical and NSABB; Allen Lin, Cambridge University;
  • Scott Mohr, Chemistry, Boston University;
  • Pamela Silver, Harvard Medical


Question 3: We need clarification on the safety questions. Would you please provide guidance on each iGEM safety question?

1. Would any of your project ideas raise safety issues in terms of:

  • researcher safety,
  • public safety, or
  • environmental safety
Guidance:

There are three recommended steps in addressing this question.

  1. To start, please list organisms you are using and organisms from which your parts are derived, indicating the risk group or biosafety level for each. For help, see Table 1 and 2 of the [http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf World Health Organization (WHO) Laboratory Biosafety Manual]. You are welcome to use your national standards if you prefer. If national standards do not use the WHO 1-4 scale, please provide a link to an explanation of your standards.
  2. Then consider risks to team members, publics and environment if the project goes according to plan. Please describe risks posed by lab equipment and chemicals as well as biological parts and organisms. How are you addressing these issues in project design and lab work? Have you received biosafety training and other laboratory safety training? If so, please briefly describe the training.
  3. Then consider risks to team members, publics and environment if the project does not go according to plan. What are risks if safety measures such as containment procedures go wrong and organisms or parts are released? What are risks to security from malicious misuse? How are you addressing such risks?


2. Do any of the new BioBrick parts (or devices) that you made this year raise 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?
Guidance:

Please reference the biosafety level of parts. If you are working with anything other than a BSL1 organism, take extra care with this question. Your nation regulates handling and transfer of pathogens and parts associated with pathogenicity. For a list of regulated organisms, see the [http://www.australiagroup.net/en/biological_agents.html Australia Group website].


3. 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?
  • If no, which specific biosafety rules or guidelines do you have to consider in your country?
Guidance:

The iGEM Safety Committee is not a substitute for national and local university institional biosafety committees

  1. Does your university have a Biosafety Committee or equivalent? Please provide a link to regulations and local requirements.
  2. Is your project in compliance with national regulations and university requirements?
  3. If you are working with any organisms or parts requiring containment arrangements above BSL 1 or equivalent, have you consulted with your Institutional Biosafety Committee regarding your 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?

Guidance:

This is an open-ended space for you to consider and suggest ways of improving safety or safety awareness at iGEM and beyond. Some iGEM teams have offered ideas (and sometimes full projects) to limit gene flow, to create software for screening pathogens, and to reduce reliance on antibiotic resistant markers. Other iGEM projects have discussed concerns that might arise if the project succeeded and became widely used, as commercial product or other means of distribution. Some iGEM projects have discussed risks that might materialize if the knowledge generated or methods developed were to become more widely available.

Retrieved from "http://2012.igem.org/Safety"