Risk assessment boards are used to give advice to stakeholders about the dangers of a certain technology or proposal. Several organisms keep this function. For instance, the FSSAI (food safety and standards authority of India) or the EFSA (European Food and Safety Authority). Having access to an university and to a wide public thanks to our events, we decided to make a demo of a review board according to the EFSA. We took as references 4 documents that describe its policy and procedures and well as two case studies.

Figure 1: The European Food and Safety Agency building. EFSA provides independent scientific advice to member national authorities on existing and emerging risks in food safety. Source: EFSA website.

All of them had a basic knowledge in biology, allowing discussion about risk assessment and safety at a basic level. The project was explained in a 20 minute presentation with a special focus on the techniques and genetic modifications introduced in the natural strains and the new phenotypical characteristics that can arise in the Genetically Modified Microorganisms.

Participants were guided through the different considerations of the European Food and Safety Authority Guide for Genetically Modified Microorganisms. Transcripts were recorded and filmed with informed consent of the participants. The risk assessment was complemented with a discussion about the bioethics and implementation of the project.

In the risk assessment, several points were discussed by the reviewers, such as: i) the ability of the recombinant DNA to be transferred to the environment and its consequences, ii) the ability of the GMMs to survive in the environment, iii) the risk for biogeochemical processes, iv) the risk for toxicity, or v) human allergens, for example. The main points that came out of the discussion were:

The possibility of the recombinant DNA to be transferred to the environment is very little but still possible. In case the recombinant DNA is transferred to natural species, the impact would be very limited as ORF for vitamins are already present in this environment.

In the implementation and bioethics assessment, the reviewers discussed: i) the acceptance of GMM food by the population, ii) the difficulties for this product to penetrate the developing world or, iii) strong and weak points of the implementation. The main points that came out of the discussion were: It is very difficult to implement such a product to a population that is not educated about bacteria Special consideration should be taken into account for regulation about GMM, because giving living GMM might be considered as a major risk Studies in rodents showing that the GMM idli probiotics are not going to colonize animal’s flora are essential for further development of the project.

1/ Guidances from the European Food and Safety Agency panel on Nutrition.

2/ "Scientific Opinion on the substantiation of a health claim related to glycaemic carbohydrates and contribution to normal cognitive function pursuant to Article 13(5) of Regulation (EC) No 1924/2006"

3/ Guidances from the European Food and Safety Agency panel on GENETICALLY MODIFIED MICROORGANISMS.

4/ "Scientific Opinion on application (EFSA-GMO-NL-2012-108) for the placing on the market of the herbicide-tolerant genetically modified soybean MON 87708 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto"

Extracts from the transcripts of the review board. If you want to see the entire transcript please click Here.

URSZULA: Could the DNA of the dead bacteria and yeast [in idli] be ingested by other bacteria [present in the environment]?

JUANMA: the DNA would not in principle go to environmental bacteria and in any case the genes that we are introducing to the bacteria do not increase the ability of the bacteria to transfer genes [to other bacteria already present in the environment]. That would be the main argument [...]

URSZULA: Yes, but in the rice DNA is not denaturated. Bacteria can be dead but DNA is maybe not denaturated [...] it should be actually with the cooking.

JUANMA: I think it goes more than 100 C for sure and DNA denaturates around 100 [...] do you have any insight on this?

[talking to ALEXEY]

ALEXEY: 100 sounds right but I think there is still a small but existing probability that some bacteria get this DNA inside of them.

JUANMA: But how? No more than a natural strain in a natural environment.

ALEXEY: Not, definitely not.

JUANMA:[...] the genes that we are introducing are vitamins and they are already present in some natural strains so the genes by themselves do not constitute any harm.

URSZULA: [...] it is not about the harm but about the modification.

JUANMA: O.K.

URSZULA: What if a natural strain ingest this new [...] and survive the cooking and can transfer this gene to a natural strain and make them producing the vitamin [...] it is just a hypothetical situation. It is not about the risk itself of this DNA of these vitamins but [...] environmental risk. That you would modify natural existing bacteria.

Implementation and bioethics

LARA: I specially like the fact that people can have this powdered yeast and bacteria in their home and have the independence [...] to get the product.

JUANMA: But then, as we discussed before, now you have a problem of release [...] how would prevent people from throwing the bacteria to the sink [...]. We have two cases [...].

NIKOLA: Maybe you can add some color to make the rice coloured and see that there is something in it apart from rice [...].

ALEXEY: [...] I think the project is not very feasible in the implementation [...]. These people are isolated in the village and probable the word “bacteria” sounds magic to them. It would be very hard to educate them about what are bacteria starting from 0 [...].

JUANMA: How would you best frame the project?

ALEXEY: I think it could be an interesting project for a more developed world, [...] as a novelty food [...] but the regulations are hard.