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Does your country have national biosafety regulations or guidelines?
In the Netherlands, any person or institution intending to perform genetic modifications is required to obtain licenses under the Royal Order on Genetic Modified Organisms (which is called ‘Besluit GGO’ in Dutch), Regulation Genetic Modified Organisms (‘Regeling GGO’) and environmental legislation as the Law on Environmental Management (‘Wet Milieubeheer’). The Dutch governmental page on [http://www.rijksoverheid.nl/onderwerpen/biotechnologie/wetten-en-regels-biotechnologie Biotechnology laws] directs to these laws. Food related genetic modifications and border crossing transport of genetically modified (micro-)organisms are also regulated by European legislation. While neither one of these is valid for our project this will not be expanded upon further on this page, but more information could be found on the site of the European [http://bch.cbd.int/ Biosafety Clearing-House].
The Royal Order on Genetic Modified Organisms is for the greater part about the classification of the organisms, in which consideration is taken regarding possible modifications of their genomes. Our team has applied this information by rejecting any project idea that required a cell chassis of BSL 2 and higher from the list with brainstorm ideas we made.
According to the Regulation Genetic Modified Organisms, Wageningen UR employs a number of (biological) safety workers. Every lab has one or more laboratory manager(s). The Law on Environmental Management notes especially the actions that should be taken in case the environment gets into contact with genetically modified organisms. These actions are stated generally. If this occasion would appear, we are responsible to do everything in our ability to solve the problem. This means we should inform the Biosafety officer, which then will inform the license holder, that again informs our Minister and environmental agencies for thoroughly sterilization. To provide directly available information to the Minister, furthermore, there’s a document with information about the micro-organism that is used and a safety assessment of the project.
Although our team did not choose to design constructs in order to help and to be present in the environment, we would like to notify that such a genetic modified organism might be approved under European legislation. The presence of a genetically modified organism in the environment can be allowed under several conditions. According to Eur-Lex Home states that an environmental impact assessment would have to be made and safety and emergency measures have to be documented well (2001). Eur-Lex Home moreover indicates that an accredited Dutch institution would have to approve the introduction (2001). Finally, Eur-Lex Home stresses that each case would have to be treated separately (2001). Thus, introducing a potentially beneficial BioBrick system or device that should be beneficial to the environment is not restricted by all means, but to apply for this laborious.
Finally, when microorganisms (or plants) are genetically modified ethics and societal issues are not looked at by the Dutch government. Therefore only the, above mentioned, regulations have to be applied in the Netherlands.
