Team:Utah State/Safety

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Ethical and safety considerations
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For this project there were several steps that were considered at the design stage. First,  standard laboratory strains of <i>E. coli</i> were chosen as the chassis for production of AMPs (XL1 Blue and BL21). Since standard strains of <i>E. coli</i> were used, standard molecular biology and genetic engineering provisions were followed.
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AMPs that were chosen for this project had no known injurious effects towards humans. This was an important factor to consider as there are AMPs that could potentially be hazardous to humans and these were completely avoided. All AMPs chosen in this study had previous been documented in literature, which was in important first reference to consider safe handling production and downstream processing of AMPs. The promoter chosen for expression of AMPs was a lac inducible system, so that we could regulate production of AMPs in <i>E. coli</i>. All AMP expression systems were on a plasmid backbone with antibiotic resistance, without selection the plasmid would not be maintained in <i>E. coli</i>.
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Additionally, all team members have attended safety training (Biological and Chemical) at Utah State University. Undergraduate student members were also trained by experienced graduate and faculty advisors. Members of the team met with Dr. Marie Walsh, member of the Utah State University Biological Safety Committee member) about the implications of the safety and ethical implications of this project.
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High school outreach was carried out in two separate sessions. The positive outlook on synthetic biology was evident from the surveys that were conducted. Approximately 61% of the students responded 'More favorable' to synthetic biology after our outreach sessions. 
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Official safety form
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Safety forms were approved on 9/20/13 by Julie McNamara and David Lloyd
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                 1. Please describe the chassis organism(s) you will be using for this project. If you will be using more than one chassis organism, provide information on each of them.
                 1. Please describe the chassis organism(s) you will be using for this project. If you will be using more than one chassis organism, provide information on each of them.
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               2. Highest Risk Group Listed=1
               2. Highest Risk Group Listed=1
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               3. List and describe all new or modified coding regions you will be using in your project.
               3. List and describe all new or modified coding regions you will be using in your project.
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               4. Do the biological materials used in your lab work pose any of the following risks? Please describe.
               4. Do the biological materials used in your lab work pose any of the following risks? Please describe.
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                         <b>a. Risks to the safety and health of team members or others working in the lab?</b>
                         <b>a. Risks to the safety and health of team members or others working in the lab?</b>
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                         No we do not think that our work would pose a risk to security.
                         No we do not think that our work would pose a risk to security.
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               5. If your project moved from a small-scale lab study to become widely used as a commercial/industrial product, what new risks might arise? (Consider the different categories of risks that are listed in parts a-d of the previous question.) Also, what risks 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.)
               5. If your project moved from a small-scale lab study to become widely used as a commercial/industrial product, what new risks might arise? (Consider the different categories of risks that are listed in parts a-d of the previous question.) Also, what risks 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.)
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               6. 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.
               6. 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.
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               7. 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.
               7. 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.
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               8. Under what biosafety provisions will / do you work?
               8. Under what biosafety provisions will / do you work?
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                         We are using a risk group 1 organism (E.coli) for our chassis.  
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                         We are using a risk group 1 organism (<i>E.coli</i>) for our chassis.  
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Latest revision as of 04:03, 28 September 2013



Ethical and safety considerations

For this project there were several steps that were considered at the design stage. First, standard laboratory strains of E. coli were chosen as the chassis for production of AMPs (XL1 Blue and BL21). Since standard strains of E. coli were used, standard molecular biology and genetic engineering provisions were followed.

AMPs that were chosen for this project had no known injurious effects towards humans. This was an important factor to consider as there are AMPs that could potentially be hazardous to humans and these were completely avoided. All AMPs chosen in this study had previous been documented in literature, which was in important first reference to consider safe handling production and downstream processing of AMPs. The promoter chosen for expression of AMPs was a lac inducible system, so that we could regulate production of AMPs in E. coli. All AMP expression systems were on a plasmid backbone with antibiotic resistance, without selection the plasmid would not be maintained in E. coli.

Additionally, all team members have attended safety training (Biological and Chemical) at Utah State University. Undergraduate student members were also trained by experienced graduate and faculty advisors. Members of the team met with Dr. Marie Walsh, member of the Utah State University Biological Safety Committee member) about the implications of the safety and ethical implications of this project.

High school outreach was carried out in two separate sessions. The positive outlook on synthetic biology was evident from the surveys that were conducted. Approximately 61% of the students responded 'More favorable' to synthetic biology after our outreach sessions.

Official safety form

Safety forms were approved on 9/20/13 by Julie McNamara and David Lloyd

1. Please describe the chassis organism(s) you will be using for this project. If you will be using more than one chassis organism, provide information on each of them.




2. Highest Risk Group Listed=1


3. List and describe all new or modified coding regions you will be using in your project.




4. 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?

No. All team members have been trained by higher authorizes at our institute. Furthermore experienced graduate student mentors are on hand to assist us with any issues that may arise regarding safety.

b. Risks to the safety and health of the general public, if released by design or by accident?

No. If our E. coli were to be released into the environment they would not maintain the plasmid during replication as there would not be any antibiotic in the environment.

c. Risks to the environment, if released by design or by accident?

No. If our E. coli were to ‘escape’ into the environment then they would not be able to maintain the plasmid without the correct antibiotic. Hence would not be able to produce AMPs outside of the lab. Furthermore our constructs have been codon optimized for expression in E. coli and hence a foreign species would very unlikely be able to uptake the genes and express them.

d. Risks to security through malicious misuse by individuals, groups, or countries?

No we do not think that our work would pose a risk to security.



5. If your project moved from a small-scale lab study to become widely used as a commercial/industrial product, what new risks might arise? (Consider the different categories of risks that are listed in parts a-d of the previous question.) Also, what risks 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.)

With any potential scale-up project there are always risks involved. We do not envision any major risks associated with our project as the AMPs we would produce will be thoroughly tested before going to the large scale.



6. 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.

No.



7. 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.

All iGEM team members take a day long safety training course at Utah State University through the Environmental Health and Safety department (EH&S).



8. Under what biosafety provisions will / do you work?

a. Please provide a link to your institution biosafety guidelines.

USU Biosafety Guidelines

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.

Yes Utah State University has an institutional biosafety committee. We have discussed our project with them.

c. Does your country have national biosafety regulations or guidelines? If so, please provide a link to these regulations or guidelines if possible.

Yes, please see: National institute of health (NIH).

d. According to the WHO Biosafety Manual, what is the BioSafety Level rating of your lab? (Check the summary table on page 3, and the fuller description that starts on page 9.) If your lab does not fit neatly into category 1, 2, 3, or 4, please describe its safety features [see 2013.igem.org/Safety for help].

We operate under BSL 2 safety regulations.

e. What is the Risk Group of your chassis 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.

We are using a risk group 1 organism (E.coli) for our chassis.



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