Biosafety
Would any of our project ideas raise safety issues
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Do any of the new BioBrick parts (or devices) that was made this year raise any safety issues?
Is there a local biosafety group, committee, or review board at our institution?
Which laws and guidelines we have to consider in Denmark
Which laws and guidelines we have to consider in Denmark
The scope of this part of the paper is to draw attention to some of the laws and guidelines, which we have to consider in Denmark, when we are dealing with genetically modified microorganisms (GMM's). Our project is defined as an 'contained use' project, which means that the organisms we are handling are contained from the environment at large. The following laws are based on the ”Bekendtgørelsen om Genteknologi og Arbejdsmiljø” (litt. The order on gene-technology and working environment) of 2008, which follows the rules laid down by the European Union in 1990 in the ”directive on the contained use of genetically modified micro-organisms”.
Risk-assessment
One of the first, and indeed one of the weightiest points in the directive on GMM safety, is to ensure the public health and the preservation of the environment. And...
T''o that end [to avoid adverse effects on human health and the environment which might arise from the contained use of GMM’s], the user shall carry out an assessment of the contained uses as regards the risks to human health and the environment that those contained uses may pose, using as a minimum the elements of assessment and the procedure set out in Annex III, Sections A and B.
Article 4.2''
It is required of us to make an throughout risk-assessment, so that we may judge if our use of GMM's poses a threat towards the well being or safety of human beings, animals, plants, or the environment. To help perform this assessment, the UN has laid down a minimum standard of elements required to make an adequate assessment of the potential harm of an accident resulting in the release of the GMM's into the environment. The following is an list of the minimum required elements:
-Assessment of potential harmful effects, defined as:
-disease in human beings animals or plants
-harmful effects resulting from inability to cure disease
- harmful effects resulting from organisms establishing itself in nature
-harmful effects resulting from the organism, through natural processes confers part of it's genome, such as heightened resistance, to other organisms in nature
-resulting from:
-the host-organism to be modified
-the parts inserted into or otherwise used to alter the organism
-the vector
-the donor-organism
-the resulting modified organism
-characteristics for the organism's activity
-How potent the potential harmful effects are
-The likelihood of harmful effects being realised
Based on this risk-assessment it is possible to rank the project according to the risk, ranking from level 1 to 4, in accordance to the procedure giving by the UN.
Personal safety
To be allowed to work in a level 1 laboratory, it is required that there at all times is a suitable instructed person present. At level 2, all personnel in the laboratory is required to have been suitable instructed in lab safety and procedure. Al access to the lab by non-members of this group or the lab-staff is to be restricted.
All members of our team has in the time prior to the work in the laboratory received a lab-safety-course, thus fulfilling the requirement. See appendix x for the actual safety guidelines laid down by our local work-safety group.
Substitution
Further, it is not allowed to work with any host, donor or vector-system, should another, safer, system, containing the same basic features, be available. If it is possible to find a suitable system, compatible with the intended work, that is safer for humans, animals and plants, or the environment at large, it must always substitute the other, more dangerous system. It is in other words prohibited to take unnecessary risks, or use unnecessarily risky setups. Should a possible substitute system be unreasonably difficult or expensive to acquire, then the risks and benefits must be weighted out against each other, favouring safety above economical issues.
As we're working with an relatively harmless strains of E.coli (mg16 and TOP10), it has not been necessary to locate a safer, compatible host, donor or system, but we have nonetheless attempted to locate such systems for wholesomeness, although without luck.
Assessment by local bio-safety group
Assessment by local bio-safety group
Arbejdsmiljøgruppen is the local bio-safety group associated with the University of Southern Denmark. During an interview with a representative from this group we explained the project, it's scope, parts and procedure. The following is a number of questions concerning the safety and security issues relating to our project, and the essence of their replies
If they perceived an increased risk due to work being performed by relatively inexperienced students
The project is not considered any more dangerous due to the fact that most of the work in the lab is performed by relative inexperienced students. As long as the lab's safety protocol is followed, and the fact that the risk-assessment of the work safety group put our project firmly on level 1, they believe that there should be little to no risk to lab personnel or the outside environment. As all students participating in the lab has successfully completed the lab safety course provided by the arbejdsmiljøgruppe, they perceived no increased risk.
If they perceived any danger should the bacteria get out of the lab
They perceived no danger to the environment or the well being of animals, plants or human being should the bacteria be released into the environment. This is due to the extremely fragile nature of the E. coli strain that we are using in our project. Should it somehow find its way outside of the lab, it would die within a very short time.
If there exists an emergency safety protocol in case of accident (i.e. unintentional release of GMM's into environment)
The emergency protocol is still a work in progress, but although it is unfinished it should not pose a breach in safety, as we're only working with an level 1 GMM, which due to it's extremely fragile nature cannot survive outside of laboratory environment. This coupled with adherence to the standard laboratory safety protocol, should at all times ensure the safety of the environment.
Overall assessment
The work safety group [ufærdig]
They see no apparent way of weaponizing or in any other way using our project for malign purposes. None of the modifications made to the bacteria has in any way made it more pathogenic. Further the bacteria we work with are unable to survive and reproduce outside of laboratory conditions. Thus they perceived no security issues with our project.
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Our ideas on 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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