Team:UTP-Panama/Safety

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Biosafety And Biosecurity

Biosafety and biosecurity are related, but not identical, concepts. Biosafety programs reduce or eliminate exposure of individuals and the environment to potentially hazardous biological agents. Biosafety is achieved by implementing various degrees of laboratory control and containment, through laboratory design and access restrictions, personnel expertise and training, use of containment equipment, and safe methods of managing infectious materials in a laboratory setting.

The objective of biosecurity is to prevent loss, theft or misuse of microorganisms, biological materials, and research-related information. This is accomplished by limiting access to facilities, research materials and information. While the objectives are different, biosafety and biosecurity measures are usually complementary. Biosafety and biosecurity programs share common components. Both are based upon risk assessment and management methodology; personnel expertise and responsibility; control and accountability for research materials including microorganisms and culture stocks; access control elements; material transfer documentation; training; emergency planning; and program management.

Biosafety and biosecurity program risk assessments are performed to determine the appropriate levels of controls within each program. Biosafety looks at appropriate laboratory procedures and practices necessary to prevent exposures and occupationally-acquired infections, while biosecurity addresses procedures and practices to ensure that biological materials and relevant sensitive information remain secure.[http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf]

Laboratory Practices Followed By Our Team

The laboratory supervisor must enforce the institutional policies that control access to the laboratory.
Persons must wash their hands after working with potentially hazardous materials and before leaving the laboratory.
Eating, drinking, smoking, handling contact lenses, applying cosmetics, and storing food for human consumption must not be permitted in laboratory areas. Food must be stored outside the laboratory area in cabinets or refrigerators designated and used for this purpose.
Mouth pipetting is prohibited; mechanical pipetting devices must be used.
Policies for the safe handling of sharps, such as needles, scalpels, pipettes, and broken glassware must be developed and implemented. Whenever practical, laboratory supervisors should adopt improved engineering and work practice controls that reduce risk of sharps injuries. Precautions, including those listed below, must always be taken with sharp items. These include:
- Careful management of needles and other sharps are of primary importance. Needles must not be bent, sheared, broken, recapped, removed from disposable syringes, or otherwise manipulated by hand before disposal.
- Used disposable needles and syringes must be carefully placed in conveniently located puncture-resistant containers used for sharps disposal.
- Non-disposable sharps must be placed in a hard walled container for transport to a processing area for decontamination, preferably by autoclaving.
- Broken glassware must not be handled directly. Instead, it must be removed using a brush and dustpan, tongs, or forceps. Plastic ware should be substituted for glassware whenever possible.
Perform all procedures to minimize the creation of splashes and/or aerosols.
Decontaminate work surfaces after completion of work and after any spill or splash of potentially infectious material with appropriate disinfectant.
Decontaminate all cultures, stocks, and other potentially infectious materials before disposal using an effective method. Depending on where the decontamination will be performed, the following methods should be used prior to transport:
- Materials to be decontaminated outside of the immediate laboratory must be placed in a durable, leak proof container and secured for transport.
- Materials to be removed from the facility for decontamination must be packed in accordance with applicable local, state, and federal regulations.
A sign incorporating the universal biohazard symbol must be posted at the entrance to the laboratory when infectious agents are present. Posted information must include: the laboratory’s biosafety level, the supervisor’s name (or other responsible personnel), telephone number, and required procedures for entering and exiting the laboratory. Agent information should be posted in accordance with the institutional policy.
An effective integrated pest management program is required.
The laboratory supervisor must ensure that laboratory personnel receive appropriate training regarding their duties, the necessary precautions to prevent exposures, and exposure evaluation procedures. Personnel must receive annual updates or additional training when procedural or policy changes occur. Personal health status may impact an individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions. Therefore, all laboratory personnel and particularly women of childbearing age should be provided with information regarding immune competence and conditions that may predispose them to infection. Individuals having these conditions should be encouraged to self-identify to the institution’s healthcare provider for appropriate counseling and guidance.

Safety Issues

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?

Some answers and open debates around these issues

1- For Researcher

Since our project is based on using the existent BioBricks for engineering devices, we do not have new safety issues in our project for researchers & students.

For the Environment and Public Safety

The reagents used in the lab do not pose a risk if standards microbiological practices are used. In addition, biological parts used to make our BioBrick are not from pathogenic or toxic sources and therefore pose no risk to the safety of team members, laboratory and general public or for environmental quality.

The potencial risk of liberating a LMO (for example, frost conditions resistance bacteria) into the environment must be observed, since GMO & LMO ecological interactions have not been tested or studied enough. (see about devices)

2- About Devices

About safety on implicated parts in our Project:

AgrColi Project, while Nitrate Biosensor (PyeaR promoter) was developed, was made by trained students following the UoB Safety Committee guidelines and local rules stablished by the laboratories where they performed their work, approved and overseen by the iGEM supervisor Dr. Nigel Savery. Regarding Public and Environmental Safety, the E.coli’s encapsulated within the beads die when there are not appropriate conditions; since the gel they are is biodegradable, there is very little potential danger from the substances or bacteria used to either humans or animals. Finally, it has not raised exceptional safety issues in the past and complies with most bioethics regulations.

On the other hand, in Georgia Tech part (hybB+OmpA+AOX), the alternative oxidase gene (AOX) was taken from a natural plant which does not represent any threat for environmental, public or research safety, but it would cause some adverse effects when this trait is expressed on wild bacterial colonies, due to the heat, energy production and their interesting but not studied improvement of growth under low temperature conditions. Although of this, its components don’t raise any biosafety issues.

In case of LMO (Living Modified Organisms) liberation on soil, thermogenesis is just temporary because these organisms need another conditions to survive, not only an appropriate temperature, and as the faster they grow, the faster they deplete some of their sources. Anyway, to avoid this situation, mixing these traits in a part and following the standard security we shouldn’t have high risks or “bio-issues".

Finally we are planning experiments to meassure the impact of the CspA promoter, in replace of the hybB promoter in the AOX expressión machine, that could lead to a significative improvement of growth and expression capabilities under cold shock situation. This effect should be carefully analyzed due to the possible extension of bacteria survival and action range. This experience will be consultate about how to realize with professional of the National Biosafety Committe (or won't be made).

3- About Biosafety Groups

Our Institution

Our university has neither biosafety rules nor a biosafety committee, because we do not have Biological schools in our University. But with the emergence of Synthetic Biology, the next step should be to develop it in order to fix limitations in experimental projects and make students and professors aware of this. Nevertheless, we have the advise of The Institute for Scientific Research and High Technology Services; their Biosafety section will collaborate with us for lab rules and projects safety observations. We are establishing a conversation with the Nationals professionals in Molecular Biology and Genetics, at this moment to explain what's synthetic biology, then what we are doing.

Has not been easy to get contact with people involve in biosafety and bioseccurity in our country, due there is not a institution exclusively working in this, usually is a comitte or department inside other institutions.

Our country

In Panama, Synthetic Biology does not have its own rules, but it follows the rules of government that dictate the basic instruments of reference to determine procedures, limitations and regulations established to manage LMO, GMO and bioethical issues.

However, in our country there is a commission that determines the biosafety guidelines, was establish in 2002, under the named as: “National Biosafety Committee for Genetically Modified Organisms and Another’s ”[http://faolex.fao.org/docs/pdf/pan41988.pdf].
In this way, the Panamanian Government organized in 2007, the "Development of the National Regulatory Framework on Biosafety for the Republic of Panama" which establish the National Center for Biotechnology Information Exchange (BCH). See the draft of this document here [http://www.unep.org/biosafety/files/Informe%20final_MNB%20Panama%20dic2007.pdf].

Actually the information collection, new frameworks and regulations are discussed in the National Center for Biotechnology Information Exchange (BCH) of the Republic of Panama[http://www.bioseguridad.gob.pa/].

4- Ideas

Our team is composed with students of engineering degrees, without biological background formation in their careers, for this reason, we propose tutorials for lab techniques & safety requirements at the beginning of the competition.
We need a database of information (papers, books, etc) that explains the real implications and issues of using DNA recombinant technology to modify organisms and understand the possible ways to analize their release in the environment. The question is: ¿How do we analize the interactions between new organisms and the environment?

Additional Safety Issues

How we addressed these issues in project design and while conducting laboratory work

We review that the biological parts used in our device, being aware of possible damages on the safety of team members and our environment (the environment, and others). As our project is of very low risk to the safety of our team, using standard security measures avoid any incidents that may arise.

Biosafety Training

We received general instructions on the equipment used in the laboratory, the risks of working in certain areas of it and the precautions we got to have on some materials.

References

[1] National Institutes of Health 2009 Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, U.S. Department of Health and Human Services, Public Health Service Centers for Disease Control and Prevention HHS Publication No. (CDC) 21-1112

[2] Gaceta Oficial, miércoles 14 de agosto de 2002
Ley 48 del 8 de agosto de 2002
Que crea la Comisión Nacional de Bioseguridad para los Organismos Genéticamente Modificados y dicta otras disposiciones

[3] Autoridad Nacional del Ambiente
Proyecto PNUMA/GF: 2716-01-4319/ Sub Proyecto PNUMA/GF: 2716-02-4
Desarrollo del Marco Regulatorio Nacional de Bioseguridad de la Biotecnología para la República de Panamá

[4] Portal Nacional del Centro de Intercambio de Información sobre Seguridad de la Biotecnología (BCH) Panamá

Note: At present, we are consulting and working to establish some comittee to debate about this and other issues that raise from Synthetic Biology inside our University and the whole community.

@@ Line 1: / Line 1: @@
 <!--- The Mission, Experiments --->
 {{Team:UTP-Panama/utptemplate}}
-== Biosafety And Biosecurity ==
+== Biosafety And Biosecurity  ==
+<div align="justify">
 <p>Biosafety and biosecurity are related, but not identical, concepts. Biosafety programs reduce or eliminate exposure of individuals and the environment to potentially hazardous biological agents. Biosafety is achieved by implementing various degrees of laboratory control and containment, through laboratory design and access restrictions, personnel expertise and training, use of containment equipment, and safe methods of managing infectious materials in a laboratory setting.</p>
 <p>The objective of biosecurity is to prevent loss, theft or misuse of microorganisms, biological materials, and research-related information. This is accomplished by limiting access to facilities, research materials and information. While the objectives are different, biosafety and biosecurity measures are usually complementary. Biosafety and biosecurity programs share common components. Both are based upon risk assessment and management methodology; personnel expertise and responsibility; control and accountability for research materials including microorganisms and culture stocks; access control elements; material transfer documentation; training; emergency planning; and program management.</p>
-<p>Biosafety and biosecurity program risk assessments are performed to determine the appropriate levels of controls within each program. Biosafety looks at appropriate laboratory procedures and practices necessary to prevent exposures and occupationally-acquired infections, while biosecurity addresses procedures and practices to ensure that biological materials and relevant sensitive information remain secure.</p>
+<p>Biosafety and biosecurity program risk assessments are performed to determine the appropriate levels of controls within each program. Biosafety looks at appropriate laboratory procedures and practices necessary to prevent exposures and occupationally-acquired infections, while biosecurity addresses procedures and practices to ensure that biological materials and relevant sensitive information remain secure.[http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf]</p></div>
 '''Laboratory Practices Followed By Our Team'''
 <p>
 # The laboratory supervisor must enforce the institutional policies that control access to the laboratory.
@@ Line 25: / Line 25: @@
 # A sign incorporating the universal biohazard symbol must be posted at the entrance to the laboratory when infectious agents are present. Posted information must include: the laboratory’s biosafety level, the supervisor’s name (or other responsible personnel), telephone number, and required procedures for entering and exiting the laboratory. Agent information should be posted in accordance with the institutional policy.
 # An effective integrated pest management program is required.
-# The laboratory supervisor must ensure that laboratory personnel receive appropriate training regarding their duties, the necessary precautions toºprevent exposures, and exposure evaluation procedures. Personnel must receive annual updates or additional training when procedural or policy changes occur. Personal health status may impact an individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions. Therefore, all laboratory personnel and particularly women of childbearing age should be provided with information regarding immune competence and conditions that may predispose them to infection. Individuals having these conditions should be encouraged to self-identify to the institution’s healthcare provider for appropriate counseling and guidance.</p>
+# The laboratory supervisor must ensure that laboratory personnel receive appropriate training regarding their duties, the necessary precautions to prevent exposures, and exposure evaluation procedures. Personnel must receive annual updates or additional training when procedural or policy changes occur. Personal health status may impact an individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions. Therefore, all laboratory personnel and particularly women of childbearing age should be provided with information regarding immune competence and conditions that may predispose them to infection. Individuals having these conditions should be encouraged to self-identify to the institution’s healthcare provider for appropriate counseling and guidance.</p>
 <br>
 == Safety Issues ==
 ; 1- Would any of your project ideas raise safety issues in terms of'''
@@ Line 47: / Line 48: @@
 ====Some answers and open debates around these issues====
 ;1- For Researcher:
-Since our project is based on using the existent BioBricks for engineering devices, we do not have new safety issues in our project for researchers & students.
+Since our project is based on using the existent BioBricks for engineering devices, we do not have new safety issues in our project for researchers & students.<br>
 ; For the Environment and Public Safety:
-The potencial risk of liberating a GMO (for example, nitration sensing and fixation) into the environment must be observed, since GMO ecological interactions have not been tested or studied enough.
+<Div ALIGN=justify>The reagents used in the lab do not pose a risk if standards microbiological practices are used. In addition, biological parts used to make our BioBrick are not from pathogenic or toxic sources and therefore pose no risk to the safety of team members, laboratory and general public or for environmental quality.<br>
-<br>
+The potencial risk of liberating a LMO (for example, frost conditions resistance bacteria) into the environment must be observed, since GMO & LMO ecological interactions have not been tested or studied enough. (see about devices)
+<br></div>
-In case of LMO liberation on soil, thermogenesis is just temporary because these organisms need another conditions to survive, not only an appropriate temperature, and as the faster they grow, the faster they deplete some of their sources. Anyway, to avoid this situation, mixing these traits in a part and following the standard security we shouldn’t have high risks or “bio-issues”.
-The reagents used in the lab do not pose a risk if standards microbiological practices are used. In addition, biological parts used to make our BioBrick are not from pathogenic or toxic sources and therefore pose no risk to the safety of team members, laboratory and general public or for environmental quality.
 ;2- About Devices:
-The devices that we look to improve are non-pathogenic.
-In the project of Biomaterial, the Curli promoter, promote that E.Coli bacterias do biofilms. This is important to know when we are working with this BioBricks (but easy to control with the properly good lab practices).<br>
 ===='''About safety on implicated parts in our Project:'''====
-'''AgrColi Project''', where Nitrate Biosensor was developed, was made by trained students following the UoB Safety Committee guidelines and local rules set out by the laboratories they performed their work, approved and overseen by the iGEM supervisor Dr. Nigel Savery. Regarding Public and Environmental Safety, the E.coli’s encapsulated within the beads die when there are not appropriate conditions; since the gel they are is biodegradable, there is very little potential danger from the substances or bacteria used to either humans or animals. Finally, it has not raised exceptional safety issues in the past and complies with most bioethics regulations.<br>
+<Div ALIGN=justify>'''AgrColi Project''', while Nitrate Biosensor (PyeaR promoter) was developed, was made by trained students following the UoB Safety Committee guidelines and local rules stablished by the laboratories where they performed their work, approved and overseen by the iGEM supervisor Dr. Nigel Savery. Regarding Public and Environmental Safety, the E.coli’s encapsulated within the beads die when there are not appropriate conditions; since the gel they are is biodegradable, there is very little potential danger from the substances or bacteria used to either humans or animals. Finally, it has not raised exceptional safety issues in the past and complies with most bioethics regulations.<br>
-In the other hand, Georgia Tech part was taken from a natural plant which does not represent any threat for environmental, public or research safety, but it would cause some adverse effects when this trait is expressed on wild bacterial colonies, due to the heat and energy production. Although of this, its components don’t raise any biosafety issues.<br>
+On the other hand, in '''Georgia Tech part''' (hybB+OmpA+AOX), the alternative oxidase gene (AOX) was taken from a natural plant which does not represent any threat for environmental, public or research safety, but it would cause some adverse effects when this trait is expressed on wild bacterial colonies, due to the heat, energy production and their interesting but not studied improvement of growth under low temperature conditions. Although of this, its components don’t raise any biosafety issues.<br>
-In case of LMO liberation on soil, thermogenesis is just temporary because these organisms need another conditions to survive, not only an appropriate temperature, and as the faster they grow, the faster they deplete some of their sources. Anyway, to avoid this situation, mixing these traits in a part and following the standard security we shouldn’t have high risks or “bio-issues”.
-AgrColi Project, where Nitrate Biosensor was developed, was made by trained students following the UoB Safety Committee guidelines and local rules set out by the laboratories they performed their work, approved and overseen by the iGEM supervisor Dr. Nigel Savery. Regarding Public and Environmental Safety, the E.coli’s encapsulated within the beads die when there are not appropriate conditions; since the gel they are is biodegradable, there is very little potential danger from the substances or bacteria used to either humans or animals. Finally, it has not raised exceptional safety issues in the past and complies with most bioethics regulations.
+In case of LMO (Living Modified Organisms) liberation on soil, thermogenesis is just temporary because these organisms need another conditions to survive, not only an appropriate temperature, and as the faster they grow, the faster they deplete some of their sources. Anyway, to avoid this situation, mixing these traits in a part and following the standard security we shouldn’t have high risks or “bio-issues".
+Finally we are planning experiments to meassure the impact of the CspA promoter, in replace of the hybB promoter in the AOX expressión machine, that could lead to a significative improvement of growth and expression capabilities under cold shock situation. This effect should be carefully analyzed due to the possible extension of bacteria survival and action range. This experience will be consultate about how to realize with professional of the National Biosafety Committe (or won't be made).  <br></div>
-In the other hand, Georgia Tech part was taken from a natural plant which does not represent any threat for environmental, public or research safety, but it would cause some adverse effects when this trait is expressed on wild bacterial colonies, due to the heat, energy production and interesting capability of growth under low temperature conditions.<br>
-Finally we are planning experiments to meassure the impact of the CspA promoter, in replace of the hybB promoter in the AOX expressión machine (OmpA+AOX), that could lead to a significative improvement of growth and expression capabilities under cold shock situation. This effect should be carefully analyzed due to the possible extension of bacteria survival and action range. <br>
-Although of this, its components don’t raise any biosafety issues.<br<
 ;3- About Biosafety Groups
-'''Our Institution''' <br>
+<Div ALIGN=justify>'''Our Institution''' <br>
 Our university has neither biosafety rules nor a biosafety committee, because we do not have Biological schools in our University.
 But with the emergence of Synthetic Biology, the next step should be to develop it in order to fix limitations in experimental projects and make students and professors aware of this. Nevertheless, we have the advise of The Institute for Scientific Research and High Technology Services; their Biosafety section will collaborate with us for lab rules and projects safety observations.
 We are establishing a conversation with the Nationals professionals in Molecular Biology and Genetics, at this moment to explain what's synthetic biology, then what we are doing.<br>
-Has not been easy to get contact with people involve in biosafety and bioseccurity in our country, due there is not a institution exclusively working in this, usually is a comitte or department inside other institutions.
+Has not been easy to get contact with people involve in biosafety and bioseccurity in our country, due there is not a institution exclusively working in this, usually is a comitte or department inside other institutions.</div>
 <br>
 <br>
 '''Our country''' <br>
-In Panama,  Synthetic Biology does not have its own rules, but it follows the rules of government that dictate the basic instruments of reference to determine procedures, limitations and regulations established to manage LMO, GMO and bioethical issues.
+<Div ALIGN=justify>In Panama,  Synthetic Biology does not have its own rules, but it follows the rules of government that dictate the basic instruments of reference to determine procedures, limitations and regulations established to manage LMO, GMO and bioethical issues.
 However, in our country there is a commission that determines the biosafety guidelines, was establish in 2002, under the named as: “National Biosafety Committee for Genetically Modified Organisms and Another’s ”[http://faolex.fao.org/docs/pdf/pan41988.pdf].<br>
 In this way, the Panamanian Government  organized in 2007,  the "Development of the National Regulatory Framework on Biosafety for the Republic of Panama" which establish the  National Center for Biotechnology Information Exchange (BCH). See the draft of this document here [http://www.unep.org/biosafety/files/Informe%20final_MNB%20Panama%20dic2007.pdf].
-Actually the information collection, new frameworks and regulations are discussed in the National Center for Biotechnology Information Exchange (BCH) of the Republic of Panama[http://www.bioseguridad.gob.pa/].
+Actually the information collection, new frameworks and regulations are discussed in the National Center for Biotechnology Information Exchange (BCH) of the Republic of Panama[http://www.bioseguridad.gob.pa/].</div>
@@ Line 93: / Line 90: @@
 == Additional Safety Issues ==
-'''How we addressed these issues in project design and while conducting laboratory work''' <br>
+<Div ALIGN=justify>'''How we addressed these issues in project design and while conducting laboratory work''' <br>
 We review that the biological parts used in our device,  being aware of possible damages on the safety of team members and our environment (the environment, and others). As our project is of very low risk to the safety of our team, using standard security measures avoid any incidents that may arise.
 '''Biosafety Training''' <br>
-We received general instructions on the equipment used in the laboratory, the risks of working in certain areas of it and the precautions we got to have on some materials.
+We received general instructions on the equipment used in the laboratory, the risks of working in certain areas of it and the precautions we got to have on some materials.</div>
+== References ==
+<font color="blue">[1]</font> National Institutes of Health 2009 Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, U.S. Department of Health and Human Services, Public Health Service Centers for Disease Control and Prevention HHS Publication No. (CDC) 21-1112
+<font color="blue">[2]</font> Gaceta Oficial, miércoles 14 de agosto de 2002 <br>
+Ley 48 del 8 de agosto de 2002 <br>
+Que crea la Comisión Nacional de Bioseguridad para los Organismos Genéticamente Modificados y dicta otras disposiciones
+<font color="blue">[3]</font>  Autoridad Nacional del Ambiente <br>
+Proyecto PNUMA/GF: 2716-01-4319/ Sub Proyecto PNUMA/GF: 2716-02-4 <br>
+Desarrollo del Marco Regulatorio Nacional de Bioseguridad de la Biotecnología para la República de Panamá
+<font color="blue">[4]</font> Portal Nacional del Centro de Intercambio de Información sobre Seguridad de la Biotecnología (BCH) Panamá
 [[Note:]] At present, we are consulting and working to establish some comittee to debate about this and other issues that raise from Synthetic Biology inside our University and the whole community.
-<!--{|align="justify"[[Image:UTP-Panama_logo.png|200px|right|frame]]--->