Past Activities 2017-2018

Dear participants,

For me was a pleasure to have the opportunity to moderate this second topic. I would like to thank everyone who has contributed to this discussion, all your points of view are relevant for me and of course for the next AHTEG's deliberations.

I hope to have a summary of the main outcomes of this discussion within the next few weeks.

Kind regards,

M. Andrea

The market mechanism to manage adverse effects is insurance, which was broached in [#8475][#8554][#8693]. The absence of any reply concerning insurance also invites economic analysis.

Dear Members
Though there were lot of contributions from published research as “evidence” there are few main points left without much consideration. I wish emphasis on
1. Impact of LMOs on food habit or culture – for eg. Introduction of bt cotton prevented Indian farmers from feeding cotton seed to the cattle. Cotton seed was a major component in some traditional food preparations and rituals too. These items are missing nowadays.
2. Economics of GMO crop cultivation and profit earned by the farmers – not much importance is given on this part as what is available in literature is not reflecting the true status. When inputs are selling at very high price, farmers are deprived of higher cost for their products.

Thanks

Dear colleagues,

This is my first contribution to this AHTEG.  I was a member of the 2015 AHTEG, a representative, then and now, of the Canadian Friends (Quakers), who have had a sustained interest in biotechnology, particularly in its social justice, ecological and spiritual dimensions.

I am a retired physician, trained in epidemiology, whose career focused on tobacco addiction at clinical and population levels.  Decision-making under uncertainty has interested me for a long time.

Thank you to Ms. María Andrea Orjuela Restrepo, for taking on the daunting task of moderating this discussion.  And my appreciation to the contributors for the many articulate, informing, and passionate contributions they have made.

I had not expected to write anything for Topic 2, since my framing of risk strays beyond published evidence.  However, the broad discussion leads me to agree with Deborah Scott (#8698) and to also recommend to Ms Orjuela Restrepo that she include in her summary the substance and flavour of the contributions that addressed risks and benefits of LMOs without offering published evidence. 

I agree with Ms. Scott (#8698) about the value of the 2012 Nuffield report Emerging Biotechnologies.

In medicine, the testing of new pharmaceuticals, even in large, well-done, randomized trials, sometimes does not have the statistical power to detect rare but serious adverse effects.  In changing a species’ genetics, the potential for very rare but very serious adverse effects may have consequences much greater than those even rarely seen in drug trials.  So, given the dynamic, changing nature of living organisms, the varying environments they might encounter and the length of time that might precede the appearance of adverse effects, I would think published evidence would not account for all  their potential risk.  Joyce Tait (#8700) has recognized this type of uncertainty and provided an approach.

I look forward to the continuing discussion.

Fred Bass

Dear all,
I have not had the chance to post in the last two weeks, but as posting still seems to be possible, I try to provide some of my thoughts.
I will address organisms that are produced by synthetic biology and there effects on biodiversity.
It is correct at least in Europe as Boet mentioned that all organisms produced by synthetic biology approved until now are LMOs. But we are not of the same opinion concerning the conclusion that the risk assessment guidances are therefore sufficient. First, there has never ever been a consensus between European Member States for the proved safety of LMOs/GMOs. The reason for this was mainly the lack of information about possible adverse effects to the environment and biodiversity. Second, our task here, in my opinion, is to take into account future developments possibly developed through synthetic biology, what they may look like and which effects they may have on the objectives of the protocol. So the question about evidence of adverse or beneficial effects is in my opinion very difficult to answer. We need to transform our experience gained through RA for LMO to new fields. We need to be able to answer to the new developments and therefore in my opinion we need guidance that can be used for the developments in expectation. Our current principle for RA on LMO is based on the idea of substantial equivalence. This in my opinion does not suit organisms produced by synthetic biology if the depth of the change makes them not comparable to any living organisms any more. Evidence for this is that already approved LMOs like stacked GMOs show that in many parameters measured during compositional analysis they are significant different from there conventional parameters (this is confidential information provided in the studies, but all regulators can confirm that).
Hope that my comments will still be taken into account also I posted them late,
Birgit

Dear members

I thank the moderators for the extended time to share the opinion.

I agree with the opinion of Ms.Winkel and Dr. Bass.

#8715 [my opinion we need guidance that can be used for the developments in expectation]- I don’t understand here. Being an expert from whom you expect guidance ?
Earlier we have concluded that
1. “case by case analyses” is required
2. Stringent regulations are needed when release in environment is initiated.
3. As far as the products are in confinement there could be no adverse effect on environment and biodiversity but care should be taken to avoid intentional and unintentional release
4. Care should be taken not to completely destroy any species from their existence
5. “Big no” to sterility genes
6. Definition needs to be changed to accommodate wider techniques and products
Apart from this what you mean by “developments in expectation”

thanks

Dear members,

I have followed with interest much of the discussion on this topic and am encouraged to see it is generating so much active discussion. I am a molecular entomologist trying to develop gene drives as a self-sustaining and long term solution for the control of malaria. At this stage I’d like to address the post of Ms Jeshima Yasin (#8715) and point out that the ‘consensus’ stated does not represent a consensus of the opinions offered on this topic.
I might share some of the opinions stated there, such as need for a case by case analysis, and a robust regulatory process and evaluation of ecological effects. However, I would not pretend that this makes it a consensus. Moreover, there seems to be a fair amount of misunderstanding as to what is meant by ‘sterility’ genes – without going into the specifics here, the idea is not to drive some broad acting ‘sterility’ gene into a population. Rather the gene drive can be designed to interfere with female reproduction by precisely interrupting a gene essential for female fertility, in a very species-specific manner (e.g Burt et al. 2003 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1691325/; Hammond et al. 2016 http://www.nature.com/nbt/journal/v34/n1/full/nbt.3439.html?foxtrotcallback=true).

Dear colleagues, dear Ms. Jeshima k Yasin,
Thank you for your question.
I am sorry that I have not been clear about my intention:
What I propose is that experts on RA should combine their expertise to develop a guidance for future organisms developed through synthetic biology and/or other organisms for which a comparing RA does not work. This should be done also taking into account expertise from risk assessors from other fields like RA of invasive species or pesticides etc.. I think that guidance helps everybody and am sure that exchange between risk assessors is a step forward.
To develop a guidance is in no way contrary to a case by case analyses. It is supposed to help the analysis and to regulate releases.
I used the term “developments in expectation” only to distinguish between already approved SynBio organisms that are LMO and new organisms were changes are much bigger.
Thank you again,
Birgit