Legacy applied to our project

Working in a lab is not the same as going in the field and working with a genetically modified organism complicates even more the problem regarding applicable laws. When working in a lab, some basic legal principles exists and must be applied, but they are obvious because they concern security. When going into the field, principles about the safeguard of th environment applied as much as principles about public health. Furthermore, we work with a GMO, a sensitive subject concerned by even more laws. Hence, we have to carefully take care of the legacy applicable to our project even if we have to find which laws concern our project and interpret them because our case is special.

There are also ethical problems we have to face, mostly because we want to work in the environment with a GMO having a antibiotic resistance gene but with a public health purpose.

We did research about laws in Switzerland. The first goal of this research was to understand what we are allowed to do with a GMO in Switzerland and if we will be allowed to do anything with our prototype. As the problem is more complex than jus a yes-or-no answer, we had to examine the questions, the legal framework (swiss and international) and the solutions we could find for our prototype.

The beginning of the work about laws is to specify the questions related to our project. They act as a framework or guidelines during the research. In our case, we defined:

• What are we allowed to do? Particularly, what are we allowed to take in the environment?
• What do we have to pay attention to? What do we have to protect and to what extent goes the protection?
• Will our research be legally usable?
• We work with two domains: the environment in which we use the biosensor and the public health that is affected by Arsenic presence in water and about which we want to raise awareness. Knowing that, which domain do we have to give the priority to?

Having defined the questions, we also observe what are the problems we are facing with our biosensor. Indeed, the concept of our biosensor is to produce fluorescence proportional to Arsenic concentration in water, but this fluorescence is due to a gene from the jellyfish that has been introduced by genetical engineering techniques into the bacteria; this makes the bacteria a GMO. The problems are related to our questions and the laws we imagined to find.

• The bacteria is a GMO -> as it is a sensitive subject, there are many regulations. There are also many fears and opinions in the society about GMOs and we have to pay attention to them.
• There is a gene inducing a resistance to an antibiotic (kanamycin) that was used for the selection of the modified bacterias -> it is potentially dangerous if the gene is transmitted to other pathogenic bacterias because kanamycin is an antibiotic use in human medicine.
• These two points lead to questions about what we can legally/ethically do.
• We also have to think what to do with the waste because it cannot be left in the environment.

Juridically, the framework has basically been set up in order to answer the problems about alimentary GMOs. We also found some laws that treat research with organisms containing some particular paragraphs about genetically modified microorganisms such as the bacteria we use. But these laws are not exactly corresponding to our example because the laws on alimentary GMOs concern organisms that have not any gene with an antibiotic resistance and laws about research with GMOs treat only research that happens in a laboratory.

At an international level, we find two principles that governs the laws related to alimentary GMOs and GMOs in general:

• Precaution principle, mostly used in the European Union (If there is any risk of serious or irreversible damage, the absence of absolute scientific certainty must not serve as pretext to postpone adoption of effective measures to prevent environment degradation. The idea is that we need to proove absence of potential risks and not their presence. Any project must proove scientifically that there are no risks due to their product. A quite difficult work with GMOs.)
• Substantial equivalence principle, mostly used in the USA (This principle is used to regulate production and commercialization of new food products as those derived from biotechnologies
  (GMOs). It statuates that if an alimentary coumpound is essentially similar to an existing coumpound, it can be treated the same manner concerning security. This principle applied to a GMOs signify that
  if the GMO is substantially equivalent to its conventionnal equivalent, it will be declared as healthy as the conventionnal product. This concept is used among others by the american Food and Drug Administration to appreciate and declare innocuousness of GMOs.)

We then also find protection measures and procedures to get an authorization for a product. In fact, a GMO can be allowed in the environment if it satisfies a range of demands, the procedure to obtain the right to use a GMO in the environment is called an authorization. An authorization procedure involve:

• Security: The product must be securized and not cause damage to human, environment or animals. Tests must be done with the most recent knowledge and technology.
• Free choice: Even if a GMO obtained an authorization, consumers, farmers and factories must have the freedom to choose between a product with or without GMOs.
• Labelling: To maintain free choice, a GMO product must be correctly labelled, so the consumer can take a decision correctly informed.
• Traceability: The consumer must have the information of the route from the producer to the seller.
• But at the same time, the authorization must respect protections measures and can be removed if it has to breach them. The protections measures means:
  • Safeguarding clause: Politicians can forbid a product if they estimate it is dangerous or not enough known.
  • Coexistence, buffer zones, isolation distances: It must exist a «buffer» zone between GMO culture and non-GMO culture. Distance of this zone is regaulated differently in each country. In Europe, it goes from 15m in Sweden to 800m in Luxembourg.
  • Zones sans OGM: A state has the possibility to decide that a zone is to be protected and has to be GMO-free.

In Switzerland, the principal argument is the protection. (The federal office of public health investigate, collaborating with other federal offices, autorisation demands: it gives autorisation only if all risks for health and environment is eliminated.) The confederation also function with a duty to inform, There is a need to communicate to the authorities any research, accident, change...

There are two ordinances and one theme from the Swiss Expert Committee for Biosafety that can be applied to our project. The purpose of these ordinances is to protect humans, animals, the environment and its biologic diversity from threats resulting form the use of organisms, their metabolites and their waste. These ordinance regulate the use of organisms in general but contains also specific paragraphs about genetically modified organisms. We find them here:

• Ordinance 814.911 on the Handling of Organisms in the Environment
• Ordinance 814.912 on Handling Organisms in Contained Systems
• Topic of SECB (Swiss Expert Committee for Biosafety) on transport, import and export of biological substance that contain GMOs

The ordinances have the ability to define and clarify the terms we use in order to define what is concerned by which law. They also emphasize on the necessity to classify the organisms we work with and to make an evaluation of the risks and of the danger. The purpose of the evaluation is the diligence duty, that is: everyone must act with counsciousness and precautions that the situation demands to avoid that ogranisms or their waste put in jeopardy humans, animals and the environment and its sutainable use.

The incidence these ordinances have on our project is that they give restrictions on the way we will build and use our biosensor. Especially:

• Our biosensor bacteria must be confined because of its resistance to kanamycin.
• Confinement = constant existence of a physical or a chemical barrier  between the environment and the organism.
• We must think of the sample-holder to respect this compulsory confinement meaning the sample-holder must guarantees that the bacteries inside are never in contact with air, water or anything that will return to the environment. Thinking of that we also need to considerd how to put water in contact with the bacteries without breaking the confinement of the bacteries.
• We must manage the waste in order that they remain confined and are destroyed accordingly with the law (autoclaved or inactivated with 80% alcohol).
• We have to notify the authorities what we are doing at least at the beginning of the activities, and we will need to ask for an authorization to use the prototype in the environment.
• We have to inform if there is any accident
• We have to name someone responsible of the biologic security

In a nutshell, we were looking what we are allowed to do and we discover that the legal demands forces us to think HOW to continue our research and build our prototype.

Furthermore, we have to think not only of the laws but also of the society and its opinions. Because we are working with a GMO and that many people are afraid of the consequence of the use of biotechnologies in the environment, we have to be aware to avoid a potential scandal. It is important to inform people and guarantee the confinement to forestall fears. It is also important to have the support of the authorities and the security department of our schools.

This chapter is adapted from the researches presented on our blog. There is a complete and detailed presentation we used for a specific presentation about this subject here: Legacy about GMO in Switzerland