Team:Paris Bettencourt/ReviewBoard

Summary :

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.

This was a very interesting experience both for the team and for the people that participated, and gave us valuable input for our project design. The methodology and transcripts of the discussion can be taken as an example of further experiences in other synbio groups.

Methodology :

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.

The board was composed by 5 members outside of the team and one facilitator from iGEM Paris Bettencourt team:
-JUANMA (22), iGEM Paris Bettencourt member, facilitator.
-SIMON (22), MD student, participant.
-NIKOLA (20), 1st year undergrad in Biology, participant.
-LARA (18), 1st year undergrad in Biology, participant.
-ALEXEY (30), Software developer and Biologist, participant.
-URSZULA (25), PhD student in Biology, participant.

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.

Figure 2: Wordmap of the transcripts of the discussion made by the review board on risk assessment. Font size is proportional to the frequency of a given word.

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.

Synthetic selection markers or viral vectors should be avoided in the final GMM. Additional containment strategies such as auxotrophy or xenobiology should be explored. Giving the cooked idli as final product with no living GMM should be considered.

Figure 3: Wordmap of the transcripts of the discussion made by the review board on implementation and bioethics. Font size is proportional to the frequency of a given word.

"

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.

ANNEX I:

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"

ANNEX II:

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