Safety

From 2012.igem.org

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==FAQ==
==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.
 +
 +
 +
 +
===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:'''
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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:'''
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*Shlomiya Bar-Yam, MIT,
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*Julie MacNamara, MIT, 
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*Ralph Donald Turlington, MIT 
 +
 +
'''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;
 +
*Pamela Silver, Harvard Medical
 +
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'''2.Do any of the new biobrick part (or device) that you made this year raise any safety issues?'''<br>
 
-
'''*If yes, How did you manage to handle the safety issue?'''<br>
 
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Yes we do. To handle the security issue of our work, we always consult with the team advisor and instructor who handle the laboratory security work in IPB. Our security is guaranteed by following the standard operating procedures which provided in each laboratory. As a mechanism to ensure the safety of our work, first of all we started it by product testing step in the laboratory before applying it in nature, so when the result is guaranteed safely, it can be applied in nature.<br> <br>
 
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'''*How could other teams learn from your experience?''' <br>
 
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Other teams can learn from the procedure that we have used. We use the common procedure that is used by molecular researchers at the laboratory, so its safety has been tested (as long as we follow the standard operation procedure had been given).
 
===Question 3: We need clarification on the safety questions. Would you please provide guidance on each iGEM safety question?===
===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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We have isolated and cultured the bacteria sample from landfill at Galuga, West Java Indonesia. To prevent contamination by some harmfull bacteria, we have followed the instruction of safety procedure, such as using sensigloves, mask, and washing hand after sampling. Hazardous chemicals that we used are aclrilamide and ethidium bromyde. Acrylamide (or acrylic amide) is a simple organic compound with the chemical formula C3H5NO. It’s potentially hazardous to health (cancer or carcinogenic). Acrylamide can form long polymer chains known as polyacrylamide, which is also carcinogenic. Inhalation: irritation, disorientation, burning, convulsions. Contact with skin: irritation, disorientation. Eye contact: irritation, a burning sensation of the eyes, eye damage.
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*public safety, or  
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Ethidium bromide will reduce the rate of migration of linear DNA molecules by 15%. This solution is extremely dangerous and carcinogenic. All solutions which contained ethidium bromide should be decontaminated before disposal. Ethidium Bromide (EtBr) will fluoresce under UV exposure. These dyes can be added to the gel and buffer so there is no staining after electrophoresis process. The advantage is more practical, but the possibility of EtBr contamination is greater. Due to the carcinogenic factor, it must be avoided for direct contact.<br> <br>
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*environmental safety
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'''*Public Safety''' <br>
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=====Guidance:=====
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We have ethics to minimize the danger possibility to public. We usually wear single-used gloves, covered shoes, lab coat, and mask so the accumulation of materials and impurities are not exposed to participant directly. We have a liquid discharge valves which equipped with running water, so it won’t settle. We also have a separated solid waste disposal for potentially hazardous materials. Those ethics are rules in our work on this project. <br> <br>
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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?
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'''*Environmental Safety''' <br>
 
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No harmful effect on our enzyme product. E. coli bacteria which inserted by  Cutinase gene has been set for its life period by sonicator so there’ll no blooming act in nature. Destruction of PET by using our products is done at indoor laboratory so the waste does not impact to the environment directly. The enzyme does not cause further effect especially for chemical / physical danger.No harmful effect on our enzyme product. E. coli bacteria which inserted by  Cutinase gene has been set for its life period by sonicator so there’ll no blooming act in nature. Destruction of PET by using our products is done at indoor laboratory so the waste does not impact to the environment directly. The enzyme does not cause further effect especially for chemical / physical danger.
 
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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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'''*Did you document these issues in the Registry?''' <br>
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*Did you document these issues in the Registry?  
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No, we don’t document the safety issue to the registry, but our procedure was according the Standard Operational Procedure of Molecular Biology Laboratory and Microbiology laboratory in IPB (Bogor Agricultural University). So we think our project hasn’t any safety risk during we follow the procedure carefully.<br> <br>
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*How did you manage to handle the safety issue?  
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'''*How did you manage to handle the safety issue?''' <br>
+
*How could other teams learn from your experience?  
-
Yes we do. To handle the security issue of our work, we always consult with the team advisor and instructor who handle the laboratory security work in IPB. Our security is guaranteed by following the standard operating procedures which provided in each laboratory. As a mechanism to ensure the safety of our work, first of all we started it by product testing step in the laboratory before applying it in nature, so when the result is guaranteed safely, it can be applied in nature.<br> <br>
+
-
'''*How could other teams learn from your experience?'''<br>
+
-
Other teams can learn from the procedure that we have used. We use the common procedure that is used by molecular researchers at the laboratory, so its safety has been tested (as long as we follow the standard operation procedure had been given).<br>
+
 +
=====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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 +
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====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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'''*Which specific biosafety rules or guidelines do you have to consider in your country?'''<br>
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*If yes, what does your local biosafety group think about your project?
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We have no local biosafety committee at our institution but there are Biosafety rules or guidelines in our country. Please see below :<br>
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*If no, which specific biosafety rules or guidelines do you have to consider in your country?
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1. Regulation Law No. 32 of 2009 about Environmental Protection & Management<br>
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2. Law No. 7 of 1996 on Food<br>
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3. Law No. 18 of 2002 on National System Research,Development and Application of Science and Technology<br>
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4. Law No. 18 of 2004 on Plantation<br>
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5. Law No. 23 of 1992 on Health<br>
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6. Law No. 23 of 1992 on Animal, Fish, and Plant Quarantine<br>
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7. Law No. 41 of 1999 on Forestry<br>
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8. Government Regulation No. 21 of 2005 on Biosafety of Genetically Engineered Product<br>
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9. Presidential Decree 39 of 2010 on Biosafety Commision of Genetically Engineered Product.<br>
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10. INSTITUTIONAL ARRANGEMENT Biosafety Commision Established by Presidential Decree No. 39/2010 <br>
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11. Biosafety Technical Team In the establishment process.<br>
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12. Biosafety Clearing House Regarding Article 20 of the Cartagena Protocol, Indonesia has been establish a Biosafety Clearing House to facilitate the exchange of scientific, technical , environmental and legalinformation on LMO. BCH is coordinated by Ministry of Environment in cooperation with Indonesia Institute of Science Secretariat of Biosafety Commission.<br>
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13. Law 32/2009. Every activities may create important risk on environment, biodiversity and human healthand human safety have to carry out Environmental Risk Analysis, Risk Assessment, Risk Management, Risk Communication.<br>
+
 +
=====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? ====
-
To ensure the biosafety, it will be more certified for documents which  related materials provided to the participants. Each institution must have own fire fighters and integrates directly with the center of fire fighters and the local police. iGEM is required to add a safety tool for iGEM participants in the DNA kit.
+
 
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To minimize hazardous chemicals, so far the equipment that is used is fairly easy to control these biosafety. The system is recommended to used, better security, is an safety accordance, such as safety SOP, JSA (Job Safety Analyst).
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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.

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