Team:ITB Indonesia/Safety

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<p><strong>Do the biological materials used in your lab work pose any of the following risks? Please describe.</strong><br /><br />
+
<p><strong>Do the biological materials used in your lab work pose any of the following risks? Please describe.</strong><br />
-
  <strong>a. Risks to the safety and health of team members or others working in the lab?</strong><br />
+
  <br />
-
  Our team works with <em>Escherichia coli</em> DH5α and BL21(DE3) that prefer to Material Safety Data Sheet (MSDS) mentioned that wild type strain <em>E. coli</em> can irritate to the skin, eyes, inhalation duct, blood circulation, and kidney. Then we modify it to know the sample target that we want by insert genes code, promotor, and reporter genes. The insertion are not expected to increase pathogenicity in any way. In addition to work with <em>E. coli</em>, our team work with aflatoxin that potentially very high hazard and carcinogenically to human. To minimize the risk, our team and the researchers in lab always keep working safe in the lab by using gloves, laboratory coats, mask, and goggles if necessary.<br />
+
  <strong>a. Risks to the safety and health of team members or others working in the lab?</strong><br />
-
Vector used in this project is standard, widely used, and resistent to some antibiotics such as pSB1C3 (Registry of Standard Biological Parts). This is not expected to pose any risk to human health, nor should such resistance determinants be passed to other bacteria.</p>
+
  Our team works with&nbsp;<em>Escherichia coli</em>&nbsp;DH5α  and BL21(DE3). According to Material Safety Data Sheet (MSDS), the wild-type strain&nbsp;of <em>E. coli</em>&nbsp;may irritate the skin, eyes, respiratory tract, blood circulation, and kidney. We modified the strain it so we know the desired target sample by inserting the coding sequences, promoters, and reporter genes. The insertion are not expected to increase bacterial pathogenicity in any way. In addition to our work with&nbsp;<em>E. coli</em>, our team also  works with aflatoxin which, a carcinogenic and harmful chemical. To minimize the risk, our team and the researchers in our lab always working safely by using gloves, lab coats, mask, and goggles (if necessary). <br />
-
<p><strong>b. Risks to the safety and health of the general public, if released by design or by accident?</strong><br />
+
  The vector used in this project is standarized, widely used, and resistent to some antibiotics such as pSB1C3 (Registry of Standard Biological Parts). It is not expected to pose any risk to human health, nor should such resistance determinants be passed to other bacteria.<br />
-
  Our project is not easily give negative impact to environment. This can be seen not only in the use of device but is also seen in practice in the lab, all of waste bacteria, medium, and disposable goods according to the procedure. For waste bacteria and the medium, before discarded, it must pass through stages of destruction by autoclaving to ensure all bacteria die before actually dumped into disposal.<br />
+
  <strong>b. Risks to the safety and health of the general public, if released by design or by accident?</strong><br />
-
Additionally, in our whole cell biosensors are <em>E. coli</em> that has been modified. To maintain the safety and health of the public, our device is equipped with membrane that doesn't provide space for <em>E. coli</em> to be able to exit so that the device we ensured safety for the user. Final device will use freeze dried <em>E. coli</em> are susceptible to moisture (hygroscopic) so that if we have a leak in the device so freeze dried <em>E. coli</em> contained inside will be damaged and no longer work, it would reduce the risk to the public and environment.</p>
+
  Our project would not impact the environment in a harmful way. This can be seen not only in the use of device but is also in the lab practice, all of waste bacteria, medium, and disposable goods are discarded according to the procedure. For waste bacteria and the medium, it must pass through destruction stages by autoclaving to ensure all bacteria die before actually dumped into disposal.<br />
-
<p><strong>c. Risk to the environment, if released by design or by accident?</strong><br />
+
  Additionally, we designed our whole-cell biosensor from modified <em>E. coli</em>&nbsp;strain. To maintain the pblic health safety and health, our device is equipped with membrane that doesn't allow <em>E. coli</em>&nbsp;to exit the device so we ensured the safety of the user. The final device will use freeze-dried&nbsp;<em>E. coli</em>&nbsp;which is susceptible to moisture (hygroscopic) so that if there is any leakage in the device the freeze-dried&nbsp;<em>E. coli</em>&nbsp; inside will be damaged and no longer works.  This system would reduce the risk to the public and environment.<br />
-
  As detailed above we have thought carefully about how to prevent our modified strains from getting into the environment. Inserted genes are not expected to increase the ability of the organisms to survive in the external environment or to cause harm to the environment or any other organisms.</p>
+
  <strong>c. Risk to the environment, if released by design or by accident?</strong><br />
-
<p><strong>d. Risk to security through malicious misuse by individuals, groups, or countries?</strong><br />
+
  As detailed above we have thought carefully about how to prevent our modified strains from entering the environment. Inserted genes are not expected to increase the ability of the organisms to survive in the external environment and  cause harm to any other organisms.<br />
-
  In addition to the hazards posed by the lab workers, as well as design in our devices, the potential danger is also determined by the abuse committed by people who are not responsible. Modified strains could be used as a biological weapon to cause new diseases and mess up a country. Actually it is most likely not going to happen on our device, because the device we use freeze dried <em>E. coli</em> that can only survive in the device, not resistant to humidity changes, and changes in oxygen levels. So if someone wants to steal malicious modified strains in our device can be ascertained that the modified strains defunct when it will be reused by the thieves.</p>
+
  <strong>d. Risk to security through malicious misuse by individuals, groups, or countries?</strong><br />
-
<p><strong>If your project moved from a small-scale lab study to become widely used as a commercial/industrial product, what new risk might arise? (Consider the different categories of risks that are listed in parts a-d of the previous question.) also, what risk might arise if the knowledge you generate or the methods you develop became widely available ? (Note: this is meant to be a somewhat open-ended discussion question.)</strong><br />
+
  In addition to the hazards posed by the lab workers, as well as the design in our devices, the potential danger is also determined by abuse committed by careless  people. Modified strains could be used as a biological weapon to cause new diseases and potentially mess up a country. This is most likely not going to happen to our device, because we use freeze-dried&nbsp;<em>E. coli</em>&nbsp;that can only survive inside the device and are not resistant to changes in humidity and oxygen levels. So if malicious  people try to steal the modified strains in our device, it can be ascertained that the modified strains will defunct when the thieves want to use it.<br />
-
  Our primary motive to design our project is public beneficence, to improve global public health by monitoring the safety of food. We have alo foresee the public and environment implication above. Actually, to make our device can be used commercially by the industry is a long way because it must pass through stages of validation with a series of tests, such as allergicity test, toxicity test, immunity test, and other test support. Although it has been ascertained that the modified strains in our device will not work when there is a change of oxygen and humidity levels it still testing validation should be implemented for the safety, health, and safety of the user and the environment.</p>
+
  <strong>If your project moved from a small-scale lab study to become widely used as a commercial/industrial product, what new risk might arise? (Consider the different categories of risks that are listed in parts a-d of the previous question.) also, what risk might arise if the knowledge you generate or the methods you develop became widely available ? (Note: this is meant to be a somewhat open-ended discussion question.)</strong><br />
-
<p><strong>Does your project include any design features to address safety risks? (For example: kill switches, auxotrophic chassis, etc.) Note that including such features is not mandatory to participate in iGEM, but many groups choose to include them.</strong><br />
+
  Our primary motive to design our project is public well-being, to improve global health by monitoring the food safety. We have also foresee the public and environmental implication as stated above. Actually, making our device can be used commercially by the industry is a long way because it must pass through stages of validation with a series of tests, such as allergicity test, toxicity test, immunity test, and other test support. Although it has been ascertained that the modified strains in our device will not work when there is a change of oxygen and humidity levels the tests and validations still have to be implemented for the health and safety of the user and the environment.<br />
-
  Yes, it does. We would engineer our strains to be kill switches. It is associated with the use of our device are just disposable. To ensure the safety and health of users or the environment then we apply the principle of kill switches so that after the detection of aflatoxin were detected and finish, modified strains can die in the time you've set, and can be safely disposed to disposal.</p>
+
  <strong>Does your project include any design features to address safety risks? (For example: kill switches, auxotrophic chassis, etc.) Note that including such features is not mandatory to participate in iGEM, but many groups choose to include them.</strong><br />
-
<p><strong>What safety training have you received (or plan to receive in the future) ? Provide a brief description, and a link to your institution&rsquo;s safety training requirements, if available.</strong><br />
+
  Yes, it does. We would engineer our strains to contain kill-switches. It is associated with the disposable nature of our device. To ensure the safety and health of the users and the environment, we want to apply the principle of kill-switches so that after the aflatoxin detection process is finished, modified strains can die in the time set, and can be safely disposed.<br />
-
  Specific safety training is not done by our campus, but the material on health and safety has become compulsory each semester credit  in several courses at ITB. The name of the course varies for each program of study, such as the Health and Safety Work in Bioindustrial, Biosafety, Security Process Factory, etc.. The next article we'll have a meeting and discussion with a number of faculty staff who are experts in this field to discuss a peace biosafety our device. Besides writing scholarly articles about health and safety Genetically Modified microorganisms will also team did.</p>
+
  <strong>What safety training have you received (or plan to receive in the future) ? Provide a brief description, and a link to your institution&rsquo;s safety training requirements, if available.</strong><br />
-
<p><strong>Under what biosafety provisions will/do you work?</strong><br />
+
  Specific safety training is not done by our campus, but the materials on health and has become compulsory for credits in several courses at ITB. The name of the course varies for each study program, such as the Health and Safety in Bioindustry Workplace, Biosafety, Security in Process Factory, etc.. We'll have a meeting and discussion with a number of faculty staff who are experts in this field to discuss the biosafety our device, besides writing scholarly articles about health and safety of using Genetically Modified Microorganisms.<br />
-
  <strong>a. Please provide a link to your institution biosafety guidelines</strong><br />
+
  <strong>Under what biosafety provisions will/do you work?</strong><br />
-
  -</p>
+
  <strong>a. Please provide a link to your institution biosafety guidelines</strong><br />
-
<p><strong>b. Does your institution have an Institutional Biosafety Committee, or an equivalent group? If yes, have you discussed your project with them? Describe any concerns they raised with your project, and any changes you made to your project plan based on their review.</strong><br />
+
  <br />
-
  Our institution has a committee in deal of security, health, safety, and environment (K3L). But, they didn&rsquo;t concern in biosafety of modified organism. Our biosafety committe (K3L) deal on laboratory safety and environment security.</p>
+
  <a href="http://www.che.itb.ac.id/safety">http://www.che.itb.ac.id/safety</a></p>
-
<p><strong>c. Does your country have national biosafety regulations or guidelines? If so, please provide the link to these regulations or guidelines if possible.</strong><br />
+
<p><a href="http://www.tf.itb.ac.id/files/2011/11/SOP-K3-Laboratorium-Teknik-Fisika.pdf">http://www.tf.itb.ac.id/files/2011/11/SOP-K3-Laboratorium-Teknik-Fisika.pdf</a></p>
-
  Yes, our country have, that is <a href="http://indonesiabch.or.id/tentang-bkkhi/">http://indonesiabch.or.id/tentang-bkkhi/</a></p>
+
<p><a href="http://www.tf.itb.ac.id/files/2011/11/KEPUTUSAN-sop-kedaruratan.pdf">http://www.tf.itb.ac.id/files/2011/11/KEPUTUSAN-sop-kedaruratan.pdf</a></p>
-
<p><strong>d. According to the WHO Biosafety Manual, what is the BioSafety Level rating of your lab? </strong><br />
+
<p><strong>b. Does your institution have an Institutional Biosafety Committee, or an equivalent group? If yes, have you discussed your project with them? Describe any concerns they raised with your project, and any changes you made to your project plan based on their review.</strong><br />
-
  BioSafety Level 1</p>
+
  Our institution has a committee dealing with environmental security, health, safety, and (K3L). But they didn&rsquo;t concerned in biosafety of modified organisms. In addition, our biosafety committe (K3L) deals only in laboratory safety and environment security.<br />
-
<p><strong>e. What is the Risk Group of your chasis organism(s), as you stated in question 1 ? if it does not match the BSL rating of your laboratory, please explain what additional safety measures you are taking.</strong><br />
+
  <strong>c. Does your country have national biosafety regulations or guidelines? If so, please provide the link to these regulations or guidelines if possible.</strong><br />
-
  Risk Group 1</p>
+
  Yes, our country does. It can be accessed in <a href="http://indonesiabch.or.id/tentang-bkkhi/">http://indonesiabch.or.id/tentang-bkkhi/</a> <br />
 +
  <strong>d. According to the WHO Biosafety Manual, what is the BioSafety Level rating of your lab?&nbsp;</strong><br />
 +
  BioSafety Level 1<br />
 +
  <strong>e. What is the Risk Group of your chasis organism(s), as you stated in question 1 ? if it does not match the BSL rating of your laboratory, please explain what additional safety measures you are taking.</strong><br />
 +
  Risk Group 1</p>
 +
<b>References</b>
 +
<p>[1]http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Appendix_C-II-A._Exceptions</p>
 +
<p>[2] World Health Organization. 2004. Laboratory Biosafety Manual, third edition. Geneva. WHO Library.</p>
 +
<p>[3] Acros Organics. Aflatoxin B1 Material Safety Data Sheet. Accesed from http://www.chemdb-portal.cn/fisher_msds_pdf/1162-65-8_EN.pdf on 9 Junie 2013 at 10.05 am.</p>
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Latest revision as of 03:09, 28 September 2013

Project Safety

Do the biological materials used in your lab work pose any of the following risks? Please describe.

a. Risks to the safety and health of team members or others working in the lab?
Our team works with Escherichia coli DH5α and BL21(DE3). According to Material Safety Data Sheet (MSDS), the wild-type strain of E. coli may irritate the skin, eyes, respiratory tract, blood circulation, and kidney. We modified the strain it so we know the desired target sample by inserting the coding sequences, promoters, and reporter genes. The insertion are not expected to increase bacterial pathogenicity in any way. In addition to our work with E. coli, our team also works with aflatoxin which, a carcinogenic and harmful chemical. To minimize the risk, our team and the researchers in our lab always working safely by using gloves, lab coats, mask, and goggles (if necessary).
The vector used in this project is standarized, widely used, and resistent to some antibiotics such as pSB1C3 (Registry of Standard Biological Parts). It is not expected to pose any risk to human health, nor should such resistance determinants be passed to other bacteria.
b. Risks to the safety and health of the general public, if released by design or by accident?
Our project would not impact the environment in a harmful way. This can be seen not only in the use of device but is also in the lab practice, all of waste bacteria, medium, and disposable goods are discarded according to the procedure. For waste bacteria and the medium, it must pass through destruction stages by autoclaving to ensure all bacteria die before actually dumped into disposal.
Additionally, we designed our whole-cell biosensor from modified E. coli strain. To maintain the pblic health safety and health, our device is equipped with membrane that doesn't allow E. coli to exit the device so we ensured the safety of the user. The final device will use freeze-dried E. coli which is susceptible to moisture (hygroscopic) so that if there is any leakage in the device the freeze-dried E. coli  inside will be damaged and no longer works. This system would reduce the risk to the public and environment.
c. Risk to the environment, if released by design or by accident?
As detailed above we have thought carefully about how to prevent our modified strains from entering the environment. Inserted genes are not expected to increase the ability of the organisms to survive in the external environment and cause harm to any other organisms.
d. Risk to security through malicious misuse by individuals, groups, or countries?
In addition to the hazards posed by the lab workers, as well as the design in our devices, the potential danger is also determined by abuse committed by careless people. Modified strains could be used as a biological weapon to cause new diseases and potentially mess up a country. This is most likely not going to happen to our device, because we use freeze-dried E. coli that can only survive inside the device and are not resistant to changes in humidity and oxygen levels. So if malicious people try to steal the modified strains in our device, it can be ascertained that the modified strains will defunct when the thieves want to use it.
If your project moved from a small-scale lab study to become widely used as a commercial/industrial product, what new risk might arise? (Consider the different categories of risks that are listed in parts a-d of the previous question.) also, what risk might arise if the knowledge you generate or the methods you develop became widely available ? (Note: this is meant to be a somewhat open-ended discussion question.)
Our primary motive to design our project is public well-being, to improve global health by monitoring the food safety. We have also foresee the public and environmental implication as stated above. Actually, making our device can be used commercially by the industry is a long way because it must pass through stages of validation with a series of tests, such as allergicity test, toxicity test, immunity test, and other test support. Although it has been ascertained that the modified strains in our device will not work when there is a change of oxygen and humidity levels the tests and validations still have to be implemented for the health and safety of the user and the environment.
Does your project include any design features to address safety risks? (For example: kill switches, auxotrophic chassis, etc.) Note that including such features is not mandatory to participate in iGEM, but many groups choose to include them.
Yes, it does. We would engineer our strains to contain kill-switches. It is associated with the disposable nature of our device. To ensure the safety and health of the users and the environment, we want to apply the principle of kill-switches so that after the aflatoxin detection process is finished, modified strains can die in the time set, and can be safely disposed.
What safety training have you received (or plan to receive in the future) ? Provide a brief description, and a link to your institution’s safety training requirements, if available.
Specific safety training is not done by our campus, but the materials on health and has become compulsory for credits in several courses at ITB. The name of the course varies for each study program, such as the Health and Safety in Bioindustry Workplace, Biosafety, Security in Process Factory, etc.. We'll have a meeting and discussion with a number of faculty staff who are experts in this field to discuss the biosafety our device, besides writing scholarly articles about health and safety of using Genetically Modified Microorganisms.
Under what biosafety provisions will/do you work?
a. Please provide a link to your institution biosafety guidelines

http://www.che.itb.ac.id/safety

http://www.tf.itb.ac.id/files/2011/11/SOP-K3-Laboratorium-Teknik-Fisika.pdf

http://www.tf.itb.ac.id/files/2011/11/KEPUTUSAN-sop-kedaruratan.pdf

b. Does your institution have an Institutional Biosafety Committee, or an equivalent group? If yes, have you discussed your project with them? Describe any concerns they raised with your project, and any changes you made to your project plan based on their review.
Our institution has a committee dealing with environmental security, health, safety, and (K3L). But they didn’t concerned in biosafety of modified organisms. In addition, our biosafety committe (K3L) deals only in laboratory safety and environment security.
c. Does your country have national biosafety regulations or guidelines? If so, please provide the link to these regulations or guidelines if possible.
Yes, our country does. It can be accessed in http://indonesiabch.or.id/tentang-bkkhi/
d. According to the WHO Biosafety Manual, what is the BioSafety Level rating of your lab? 
BioSafety Level 1
e. What is the Risk Group of your chasis organism(s), as you stated in question 1 ? if it does not match the BSL rating of your laboratory, please explain what additional safety measures you are taking.
Risk Group 1

References

[1]http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Appendix_C-II-A._Exceptions

[2] World Health Organization. 2004. Laboratory Biosafety Manual, third edition. Geneva. WHO Library.

[3] Acros Organics. Aflatoxin B1 Material Safety Data Sheet. Accesed from http://www.chemdb-portal.cn/fisher_msds_pdf/1162-65-8_EN.pdf on 9 Junie 2013 at 10.05 am.