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Validation by the authorities, a step by step to go in the field
As we want to use it in the field, our prototype should be approved by the authorities as we’re using GMOs. This is a delicate social issue and it’s important to consider the media pressure that it could generate. Having an official agreement from the authorities is a very strong argument against any trouble that may come our way.
The following step by step is one way to do that:
Step 1: Get in touch with a biosafety expert
We first met Dr. Sabrina Leuenberger who explained us the legal aspect of our project. She gave us the important law texts we had to consider. For our kind of prototype, we had to refer to the Ordinance on Handling Organisms in Contained Systems» 814.912
Also, she explained us how one can interpret the law and helped us to prepare for all eventualities.
Step 2: Be informed
We had to read some law texts such as the Ordinance on Handling Organisms in Contained Systems. It is important that you come across as someone that knows what you’re talking about. Background reading on all subjects of your project (bioreporter functioning etc…) is an important part of the preparation leading to the meeting with the authorities.
Step 3: Contact the authorities
We sent an email to Basil Gerber from the Federal Office for the Environment (FOEN); he is a deputy head of section and is responsible for the implementation of the Biodiversity Convention in the area of genetic resources. Thus, we organized a meeting with him in Bern to talk about our project. This first contact was required because of the novelty of our project and the problem concerning the use of GMO.
Step 4: Make a powerpoint presentation
During three weeks, we prepared our presentation. This presentation contained some explanation about how our prototype works and targeted the problem of confinement and GMO. We also added some slides about the legal aspects of our prototype. An important fact, is that we compared our prototype to ARSOlux. ARSOlux has a kit called AQUA-CHECK3 that detects the concentration of Arsenic in a water sample by bioluminescence which also needs GMO bioreporters. So the idea was to show them that our prototype was not so different from this already approved kit. Indeed, as we said, we use the same vial. Also, we use a similar strain of bacteria that also can’t do conjugation. With this comparison, one of our strong arguments to show that our prototype is safe, was to give them the ARSOlux risk assessment done by the ZKBS in Germany.
At the end of this presentation, we managed to get a verbal agreement by Basil Gerber. He gave us his point of view about our project and talked about the possible issues concerning our prototype. The main issue was to prevent that the user hurts himself with the syringe and advised us to use of a safe syringe.
Here's the powerpoint presentation we did in Bern with all the main keypoints you should think of: http://filopodia.files.wordpress.com/2014/05/presentation-final1-pdf.pdf
Step 5: Send a notification to the authorities to have a written agreement
In order to have a written agreement, we sent them several files: We filled in the official notification form, added a document where we explained our project and added the powerpoint presentation that we showed to Basil Gerber.