Laws and Guidelines to be Considered 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” (eng. 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. To 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 a 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 a list of the minimum elements required: 1. Assessment of potential harmful effects, defined as a) Disease in human beings animals or plants b) Harmful effects resulting from inability to cure disease c) Harmful effects resulting from organisms establishing itself in nature d) Harmful effects resulting from the organism, through natural processes confers part of its genome, such as heightened resistance, to other organisms in nature 2. Resulting from a) The host-organism to be modified b) The parts inserted into or otherwise used to alter the organism c) The vector d) The donor-organism e) The resulting modified organism 3. Characteristics for the organism's activity 4. How potent the potential harmful effects are 5. The likelihood of harmful effects being realized 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. See appendix I for the risk-assessment we made for our project. 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 are required to have been suitable instructed in lab safety and procedure. All access to the lab by non-members of this group or the lab-staff is to be restricted. All members of our team have in the time prior to the work in the laboratory received a lab-safety-course, thus fulfilling the requirement. See appendix II for the actual safety guidelines lay 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, favoring safety above economical issues. As we're working with relatively harmless strains of E. coli (MG1655 and TOP10 strains), 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 Laboratory Safety Course Team SDU-Denmark consists of students from various fields such as Biochemistry & Molecular Biology, Chemistry, Physics, Medicine and Philosophy. Not all are used to working in the lab, and so it was necessary to make sure everyone knew about basic safety precautions to be taken when in the lab. Hence our first step in addressing the safety issue, was to have everyone on our team participating in a Laboratory Safety Course (unless already attended) held by Mogens T. Jensen and Marianne Due from the Committee for Students’ Laboratory Safety. This included a small handbook and information on /practice in: good conduct in the lab, use of safety devices, signs used in the lab, emergency cases (fire), elementary first aid, waste, knowledge about the Organisation for Work Environment at SDU and suggestions to further readings. Safety of our Laboratories We are using the labs of Biochemistry and Molecular Biology (BMB) and the Centre for Fundamental Living Technology (FLinT). Both are security level 1 laboratories, which is what we need for this project, and the bacteria we are working with, since they are non-pathogenic.

The Group “Arbejdsmiljøgruppen” (eng. The Working Environment Group) 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, its 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 Working Environment Group, 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 a level 1 GMM, which due to its 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 We have at all times upheld the laws and regulations imposed upon us by UN and by the Working Environment Group. We have performed a risk-assessment of our project as required by the UN, as well as following the laws regarding to personal safety and to substitution of potentially harmful host and donor organisms. The work safety group has assessed our project to be a class 1 project, as they have perceived no risk associated with our work. They see no apparent way of weaponizing or in any other way using our project for malign purposes. Thus our project should not pose any threat to the security of the world at large. Although most of the genes inserted into our bacteria are harmless, hyperflagellation is in fact something that increased pathogenicity. Further the bacteria we work with are unable to survive and reproduce outside of laboratory conditions. Should it accidentally be released into the wild it would lose its plasmids within a very short time span and thus return to a non-GMO state. And as the bacteria we have been working with, namely E. coli MG1655, is a naturally occurring bacteria, it should not pose any threat to the environment at all. As long as the normative work safety protocols were followed they could not perceive any danger due to the work being performed by relatively inexperienced students. Thus they perceived neither security nor safety issues with our project. Sources: [1]: http://www.bmwf.gv.at/fileadmin/user_upload/forschung/gentechnik/2009-41-EC.pdf [2]: https://www.retsinformation.dk/Forms/R0710.aspx?id=121099