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Rules & regulations around GMOs in general
For the rules and regulations around GMOs we spoke to Eric van den Akker from the department Bureau GGO of the RIVM, the national institute for public health and environment. He told us a lot of important things we have to know when we want to bring a GMO outside the lab into the environment. To be able to bring a GMO into the environment in the Netherlands an IM(Introduction into the Environment)-license is needed. This license can be requested by means of the a form.
After getting this license, a risk report has to be sent to the COGEM (Commission of Genetic Modifications). The COGEM will then decide if you get a disposal. This approach is also described in Article 4(2) of the European law on the deliberate release into the environment of genetically modified organisms.
Frank van der Wilk, the executive director of COGEM, told us the most important things we have to take into account. The first thing they look at is the type of bacterial strain that is been used. We are already on the right track by using an E.coli K12 strain. This strain is harmless in the environment and will therefore be approved most of the time. He also mentioned that genes expressing resistance to antibiotics are taken into particular consideration. This is one of the reasons we chose ampicillin resistance, because this antibiotic is already common in use and will probably be accepted easily.
Rules & regulations around our application scenarios
Application scenario: the intestinal tract
For the rules and regulations around our application in the intestinal tract we spoke to Claudette de Vries and Robert Geertsma from the department of Product Safety of the centrum of Health Protection of the RIVM. They told us that our application is a diagnostic medicinal product based on advanced therapy. This means it is a new application based on gene therapy, cell therapy and tissue engineering. For this kind of medicinal products special rules apply in Europe.
Projects like ours will have to deal with the rules around the clinical trials first, which can be found in this document. After comply with these rules and consulting the agency, the Commission shall draw up detailed guidelines on good clinical practice. It is an important thing to start with this in time. In this way good advises can be taken in consideration and the definite final report will be accepted easier.
One of the most important things for our application is the fact that the rules around advanced therapies and the use of GMOs are getting adapted at this moment. One of the most radical changes will be that these rules will also apply within the field of microbiology, which is also the field of our application. In the most recent documents nothing about advanced therapies in the field of microbiology is included. Unfortunately this will take a couple of years before the rules are official, because all the countries within the European Union have to come to an agreement.
Application scenario: Q fever
Around the application of Q fever the rules and regulations relating to veterinary medicinal products are applicable, which can be found here.
In the field of veterinary medicinal products nothing is known about the use of GMOs in these products, because this is a really new development. To combine these rules with the general rules around the use of GMOs in the environment we hope to satisfy to the most rules as possible and get the best approach to acceptance of our product.
Application scenario: pesticides
There are no special rules and regulations around the use of pesticides, because the pesticides our sensor could be excreting into the environment are already in use and accepted by the government. Talking about GMOs, the rules for bringing GMOs in the environment are applicable.