Safety

From 2012.igem.org

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==FAQ==
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===Question 1: Why does iGEM ask teams to address safety questions and screen projects? === 
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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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===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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'''iGEM Safety Committee:'''
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*Todd Kuiken, Synthetic Biology Project, Woodrow Wilson Center, Smithsonian Institution; 
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*Piers Millett, UN Biological Weapons Convention, Implementation Support Unit, Geneva; 
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*Kenneth Oye, Engineering Systems and Political Science, Massachusetts Institute of Technology; 
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*Megan Palmer, Deputy Director, Practices, NSF Synthetic Biology ERC, Stanford University;
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*Sam Yu, Biosafety Officer, Hong Kong University of Technology, Clearwater Bay, Hong Kong
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 +
'''Graduate Safety Screeners:'''
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*Shlomiya Bar-Yam, MIT,
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*Julie MacNamara, MIT, 
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*Ralph Donald Turlington, MIT 
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'''External Consultants:'''
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*Rocco Casagrande, Gryphon, former Director UNMOVIC Biological Lab;
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*George Church, Harvard Medical;
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*Chan-Wha Kim, President Asia-Pacific Biosafety Association and Korea University;
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*Michael Imperiale, U Michigan Medical and NSABB; Allen Lin, Cambridge University;
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*Scott Mohr, Chemistry, Boston University;
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*Pamela Silver, Harvard Medical
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 +
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===Question 3: We need clarification on the safety questions. Would you please provide guidance on each iGEM safety question?===
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====1. Would any of your project ideas raise safety issues in terms of:====
====1. Would any of your project ideas raise safety issues in terms of:====
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'''*Researcher safety''' <br>
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*researcher safety,
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Biological sciences are a great tool for innovation and improvement of human society; nevertheless when the biosafety parameters are ignored, this area of research can become quite dangerous. We always have that idea present while working at the laboratory. We follow the rules stated at the Good Laboratory Practice (GLP) and according to the safety guidelines established by the Instituto de Fisiología Celular (IFC), part of the Universidad Nacional Autónoma de México (UNAM). We also have been working under the statutes of the Mexican official law (published in 2005) and guidelines (published in 2008 and reformed in 2009) about biosafety regarding genetically modified organisms, both available in the Mexican Government web site. Furthermore, we work under the guidance of Soledad Funes, PhD, who is always ready to solve any doubts we have regarding the disposal of biological and non-biological wastes.
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*public safety, or
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The materials used throughout the project do not pose any safety or health risk neither to the team members nor to the rest of the members of the lab.  For the development of this project, we have looked for those materials and reagents which would represent the least risk for ourselves, others and the environment.  We understand, however, that when used in the wrong concentrations or without the proper care, some of the solutions, buffers and materials can be potentially harmful.  In order to avoid any possible harm or injury, during every lab work session, all the team members always use gloves and white cotton laboratory coat as basic protection, and each time they start working or finish any experiment, common basic material, like micropipettes, UV transilluminator, analytical balance, used reagents, timers, glass ware and the lab bench, is cleaned superficially with water and/or ethanol 70%, to assure avoidance of any health risks to lab members as well to prevent cross-contamination among other experiments.
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*environmental safety
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'''*Public Safety''' <br>
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=====Guidance:=====
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The materials and reagents used also do not represent any safety or health risk to the general public.  It is important to stress that, like any other institutional research center, the access to the building is restricted and controlled, so general public entrance is not allowed, as well to children and suspect persons. With this measure, the possibility of accidents and malicious misuse of our experimental material by other individuals or groups is reduced.
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There are three recommended steps in addressing this question.
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#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?
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'''*Environmental Safety''' <br>
 
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Furthermore, they also do not pose any risk to the general public or to the environmental quality when released. During the development of our project, it is of outmost importance to consider the management and destination of the dangerous and toxic reagents, genetically modified organisms and other substances that may pose a threat to the environment and/or living beings. In the experiments we are performing, the presence of dangerous reagents is limited and therefore buffers and other non-biological reagents can be easily disposed. As common practice, strong acids and bases are neutralized before disposal, and other reagents are disposed according to the manufacturer recommendations and to local and institutional laws and regulations. All the used plastic material (like pipette tips, eppendorf tubes, etc.) is disposed into a special container and afterwards incinerated.
 
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====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?
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*How did you manage to handle the safety issue?
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*How could other teams learn from your experience?
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=====Guidance:===== 
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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. 
 
----
----
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====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? ====
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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.
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=====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 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 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.

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