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We collaborated with the Dutch National Institute for Public Health and the Environment (RIVM) about safety in synthetic biology. We, and all other Dutch iGEM teams, were given the assignment to define the term safe by design and to explain how safe by design is related to our own project. On September the 20^th the RIVM gave us the opportunity to present our project by means of a poster and a pitch about the outcome of their assignment at their annual meetup called “Safe step forward with synthetic biology” (“Veilig verder met synthetische biologie”). The outcome of the assignment can be found in the next paragraph. Besides the presentations of the iGEM teams, there were interesting talks about the possibilities and limits of synthetic biology. Also, a brainstorm was organized in which small groups discussed specific innovations in synthetic biology (some of the subjects were iGEM projects from previous years). So besides showing our project we also broadened our view on synthetic biology.

But how did our team define safe by design? In our opinion, it is not possible to define a true meaning of safe by design. A general meaning of the words safe by design is: designing a product that is inherently safe. This immediately raises the questions: How is it possible to declare something ‘safe by design’? Is it not the case that something can always be more ‘safe by design’?

After our research we concluded that the concept of safe by design is to make sure the health and safety risks of the product are addressed from the beginning of the design process. This way, risks can be prevented instead of considered afterwards. Especially in synthetic biology, safe by design is very important, because genetic modification could have irreversible effects. More information about safe by design can be found on our Project Safety page. We have used our definition of safe by design to determine whether safe by design is already applied in the field of synthetic biology. To determine this for our own country, The Netherlands, a stakeholder identification was conducted on GMO policy in The Netherlands.

Organizations or scientists who want to work on GMO-related projects in the Netherlands have to send a request for permission to Bureau GGO, this institution assesses the risk of each request. Before Bureau GGO grants request, they provide the applicant with advise on how to improve the request if necessary. Bureau GGO works with the precautionary principle. For your request to be granted, it has to be proved that the risk is minimal. Advisory institutes are also involved in this process to ensure the decisions made by Bureau GGO are the right choices. The stakeholders in this process are described below.

RIVM
RIVM is the National Institute for Public Health and the Environment. This institute performs independent research and provides policy related advice. The main challenge of the RIVM is: how can we keep ourselves and the environment healthy and safe. To fulfil this challenge, research is done on a wide range of research areas, which are divided in three division.
The first division is Environment and Safety. In this division research is done on the relation between environment and health. Air pollution and radiation are common research area within this division. The second division is Public Health and Health Services. This division investigates safety of pharmaceuticals and the effect of nutrition and lifestyle on health. The third division is Infectious Diseases and Vaccinology. Surveillance, preparedness and response of infectious diseases is one of the main tasks of this division.
The RIVM performs this research to advise and support various Dutch ministries, for example the Ministry of Health, Wellbeing and Sport, the Ministry of Infrastructure and Environment and the Ministry of Economic Affairs. However the advising role of the RIVM stretches further than the national level. The European Union, United Nations and the World Health Organization are also advised by the RIVM. The RIVM is and independent institute. This way the RIVM stays impartial and they can insure their research is executed in a reliable way. All research that is done by the RIVM is placed on their website and accessible for everyone.

Bureau GGO
Bureau GGO is part of RIVM and performs a number of statutory duties within the framework of national and European legislation in the field of genetically modified organisms. Bureau GGO is commissioned by the Ministry of Infrastructure and the Environment. Bureau GGO decides which GMO researches can have permission, and under what conditions, and provide authorization for activities involving GMOs. For the introduction into the environment and market applications, Bureau GGO handles all preparations concerning risk assessment. Bureau GGO is supported by COGEM.
When scientist request a GMO permit, a risk analysis needs to be included in from which the containment level can be deduced. There are five different containment levels: I II-k, II-v, III and IV. When the containment level is higher, more safety measures have to be met to get a permit to work with experiments within that containment level

COGEM
The Commission of Genetic Modification (COGEM) is a commission consisting of scientists. This commission has two key tasks: Advising and signalling. COGEM advises on pending requests for GMO permit. COGEM advises Bureau GGO under what conditions they think the GMO permit request should be granted these analysis’s are based on scientific literature and the ‘expert judgement’ of the members.
The other role of COGEM is a signalling role. COGEM provides consult on possible risks of working with GMOs for humans and the environment. COGEM also informs the government on ethical and social issues concerning GMOs by collecting the statements from other stakeholders. An important aspect of this consult is COGEM does not express an opinion or advice about. The government can what their actions are based on the consult. This is different from the advice COGEM provides regarding the GMO permits, where COGEM is opinionated.

Rathenau Institute
The Rathenau Institute is an organization that deals with issues, concerning science, technology and society, and informs policymakers and society about them. They stimulate society and politics to form an opinion on science and technology. One of their areas of research is GMO, thus this institute is a stakeholder in the GMO process. The institute is part of the Royal Netherlands Academy of Arts and Sciences (Dutch abbreviation KNAW).

Scientists
Scientists who want to do experiments with GMOs for their research need to have permission to do GMO related work. This permission for GMO related work has to be granted via Bureau GGO. Scientist have to send a request for working with GMOs including a risk analysis and the safety measures they are going to take. Based on this risk analysis it can be determined for which containment level the GMO request is sent. Bureau GGO will review the request and with advice of COGEM they decide whether they will grant the request and if extra safety measures have to be taken in order to for the scientist to get GMO permission.

Society
One of the most important stakeholders is society. It is also the stakeholder that cannot be defined with the same precision as the previous stakeholders. Society is every individual who might endure effects from the GMOs. This is a large group of people, which are not necessarily limited to the population of the Netherlands.
Harmful effects of GMOs can spread all over the world very quickly. An example that is not GMO related is the Ebola epidemic. This disease spread through different countries and international collaboration was needed to contain this disease. The Ebola epidemic might have parallels with situations in which GMOs Small mistakes in GMO research may have the potential to have a butterfly effect-like behaviour, this illustrates how citizens in the Netherlands can endure negative effects from GMO policy in Brazil and in reverse for example.
So because of globalization international consensus on GMO policy is necessary. This is the reason national advisory institutes like the RIVM from different countries collaborate with each other. It also explains the existence of international advisory organisations like the world health organisation (WHO).
Society is also the stakeholder with the least knowledge about GMO and the possible effects. To ensure society that the policy that is executed is the right policy, communication is very important.

The conclusion of this stakeholder identification was that safe by design is already applied in the Dutch legislation. Before GMO permission is granted, the researcher has to perform a detailed risk analysis. This ensures safety is taken into account from the beginning of the design process.

Another important conclusion from the stakeholder analysis is that it is extremely important to involve society in the debate about synthetic biology, because the effects of the choices that are made about synthetic biology will have an effect on society. Currently, there is not much knowledge about the safety aspects in synthetic biology. So our goal was to try to make a start in this process in The Netherlands. We did this by creating an animation about the basics of synthetic biology It gives a short explanation about safe by design, a link with our project and in the end the application of safe by design in the Dutch legislation. In this animation it was tried to simplify difficult subjects like safe engineering, without the loss of the most important content. This way the general public is able to understand the subject and learn something new about synthetic biology and safety. The animation can be found below in English and in Dutch.