Activities of the Open-Ended Online Forum (2014-2016)

Dear participants of the online forum for guidance on risk assessment of LM fish.

Thank you for the comments and suggestions that have been posted so far, they are all important to give the AHTEG the best background to develop an outline for standalone guidance on risk assessment of LM fish.

In addition to expressing your views on the main sections of the outline, in which I encourage you to continue doing, it would be of great advantage to have some more details on particular issues related to risk assessment of LM fish.

It would also be of great help if you could recommend sources of information for example on development of LM fish, reports on LM fish risk assessment or literature that are of relevance to perform risk assessment of LM fish.

The online discussion will continue until March 7th, and in advance thank you for taking some time to post your view and/or links to relevant information.

Good luck, regards Janne

Dear colleagues,

in the very first place I wish to thank Janne for the hard work in moderating this forum and the Secretariat for the opportunity to contribute.

My name is Werner Schenkel. I am from the Federal Office of Consumer Protection and Food Safety (BVL) which is the leading federal authority with regard to genetic engineering in Germany and as such responsible e.g. for the authorization of experimental releases of LMO.

With regard to genetically modified fish our experience in Germany is so far restricted to cases of non-authorized distribution of LM aquarium fish. One example has been the so called GloFish, a genetically modified zebrafish (Danio rerio). We are so far of the opinion that it is generally difficult to forecast the environmental impact of an escape or the deliberate release of genetically modified fish and assume that it will essentially depend on the species, the genetic modification and the receiving environment.

As a comprehensive piece of information we would like to refer to a scientific/technical report that has been prepared by Cowx and others in 2009:
Cowx I.G., Bolland J.D., Nunn D., Kerins G., Stein J., Blackburn J., Hart A., Henry C., Britton J.R., Copp G., Peeler E. (2010) Defining environmental risk assessment criteria for genetically modified fishes to be placed on the EU market. Scientific/technical report submitted to EFSA, CT/EFSA/GMO/2009/01, 1-264 - http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/69e.pdf
The report not only addresses potential adverse effects and consequences from the release of genetically modified fish into the wild, it also identifies assessment endpoints and methodologies and defines environmental risk assessment criteria. Empirical data concerning the fate of genetically modified fish that escaped into the environment are so far missing. Therefore the risk assessment will have to be based on assumptions that rely on knowledge from conventional species that have escaped from e.g. commercial fish breeding units. Due to the variety of aquatic ecosystems and the multiplicity of possible combinations of fish species and genetic modifications a multiplicity of possible environmental impacts has to be considered.

Thank you very much again.

Kind regards,
Werner

Dear all,
Thanks for all the interesting contributions so far and for Janne for the difficult job to keep everybody on track!

The question right now is about particular issues related to risk assessment of LM fish and relevant background material, like risk assessment guidances for LM fish. My colleague Werner (7729) already referred to the report on LM fish of Cowx et al, 2010. Based on this report, EFSA developed a guidance for the environmental risk assessment of GM animals, including fish, to be found through the following link  http://www.efsa.europa.eu/en/efsajournal/pub/3200.

I have no experience with the environmental risk assessment so far, so I have nothing useful to add there. However, would like support earlier reactions (Didier (7701), Esmeralda (7710), Piet (771) and Ayako (7727) in that it will be the COP-MOP who will decide on additional guidance. In this respect it should be made very clear to the COP-MOP why this guidance is needed. In my opinion additional guidance is only valuable if it builds further on the guidance (‘Roadmap’) that is improved as we speak and should indicate to specific issues that only relate to LM fish, and not to LMOs in general.  So far I have not seen much reactions in which these specific issues for the environmental risk assessment of LM fish are highlighted.

Best wishes,
Boet Glandorf, The Netherlands

Thank you Janne for moderating

Having read Helmut's post, I support those before me who believe the decision on whether a separate guidance is necessary ought to be taken at COP-MOP, particularly as the basic principles of risk assessment outlined in the road map should in essence be applicable to any organism.

Regards

Kelebohile Lekoape

POSTED ON BEHALF OF BIRGIT WINKEL

Note: This post was submitted before the closing of the discussion.

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Dear Janne, dear colleagues,

Thank you Janne for moderating this and thanks to all of you for the opportunity to be part of this really encouraging discussion.

I´m of the same opinion as Maria Andrea that we on one hand should follow the outline of the other guidelines as long as it is also appropriate for the guideline for LM fish and on the other hand add the special points which need to be considered for such organisms.

I would just shortly  like to point out the most outstanding differences:

Fishes live in a total different environment/ecosystem

Dissemination follows other rules in the water than it does on land

Escapes are common

Protection goals differ from those on land

Monitoring is much harder

I can therefore absolutely go with Maria Andrea that monitoring strategies and traceability need to be addressed with focus on LM Fish.

I would also propose to add the following aspects:

Invasiveness into natural habitats
effects on the food web (algae, plankton, higher organisms)
Suppression or extrusion of other species or the wild type

If the guidance would focus on the points that Didier proposed we would just have an analysis of what already exists, but would not have a stand alone guidance that would help people to do a thorough risk assessment on LM fish. Therefore I think, this analysis is also useful, but does not fulfil the needs of the structure for the guideline.

I would like to thank Colin for the insight he gave on his experience. One point he said was that field trials with LM fish are unlikely. We need to keep this in mind and understand that uncertainty in the risk assessment on LM fish is much bigger than it is with plants.  

Regards Birgit

POSTED ON BEHALF OF VERONICA SINOHIN
Note: This post was submitted before the closing of the discussion.

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Dear colleagues,

     Thank you Janne for your hard work in chairing this session.

      I concur with the opinion of Werner Schenkel [#7729] on the difficulty of determining the environmental impact of an escape LM acquarium fish. I believe that each country has different or unique receiving environment so the parameters to be considered in the conduct of RA and RM for these should be included in the meeting.

VERONICA SINOHIN, Philippines