3. Regulations

National regulations

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 laboratory manager sees to it that genetic modification related research is being executed according to the involved rules. If an accident happens, like aerosol formation, the manager also is the first person who would be notified about this. Because they create safer lab work conditions, the practical tutor’s instruction, supervision and presence are very welcome.

The Law on Environmental Management notes especially the actions that should be taken into account 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. The Eur-Lex Home states that an environmental impact assessment would have to be made and safety and emergency measures have to be documented well. Eur-Lex Home moreover indicates that an accredited Dutch institution would have to approve the introduction. Finally, Eur-Lex Home stresses that each case would have to be treated separately [9]. Thus, introducing a potentially beneficial BioBrick system or device to the environment is not restricted by all means, but it requires a lot of paperwork to get approval.

Institutional regulations

Wageningen UR has its own biosafety rules next to the national biosafety regulations. Its rules can be found on this [http://www.wageningenuniversity.nl/UK/informationfor/Current+students/Student+information/healthsafety/Laboratory+general/?wbc_purpose=basic#basic laboratory safety page].

Specific training

Next to the biosafety rules from Wageningen UR, techniques for working aseptically to perform Good Microbial Practices are generally learned in a Microbiology introductory course. A lab manager, also called a practical tutor, has introduced every team member to the lab by giving them a “safety tour.” Therein, we came across a lot of general rules we should regard at working in the laboratory. The rules dealt with the discardment biological and chemical waste, the disinfection of the lab bench, the clothing to wear inside the lab, the way of acting during an emergency and more.

Institutional Biosafety Committee

Instead of having a Biosafety Board at Wageningen UR, all chair groups of the institution have their own Biosafety officer(s). We have discussed our project with the Biosafety officer for our project. The [http://bggo.rivm.nl/Paginas/bch.htm Biosafety Clearing House] of the Netherlands handles licenses for genetic modifications, which have to be requested. The Biosafety officer has subscribed our project to the Bacterial Genetics license. We could approach him if there would be any questions.

References

9. [http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0018:EN:HTML Directive 200118EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90220EEC - Commission Declaration.]