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

POSTED ON BEHALF OF JANNE ØVREBØ (MODERATOR)
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Dear participants of the Online Forum,

It is an honour to me to also moderate this discussion on "risk assessment of living modified fish" (11 - 25 April) and I thank the Secretariat for the invitation.

Based on suggestions and feedback during the previos online discussion, the group of volunteers drafted an outline for guidance on risk assessment of LM fish based on the structure of the roadmap (many thanks to Ossama, Hrvoje and Wadzi for their help drafting the outline). The proposed draft is based primarily on the structure of LM trees and LM mosquitoes and complement the roadmap when it comes to reflect the missing aspects that are unique to GM fish.

The suggested draft include a short introduction explaning the background for the document. We decided that this guidance will include all freshwater, marine and anadromous fish and shellfish, including aquarium species. The introduction part gives an overview of LM fish under development and list issues of particular relevance to risk assessment of LM fish, as well as uncertainties. Under the chapter dealing with risk assessment, we have listed 12 different issues linked to the roadmap.

Members of the Online Forum are invited to provide feedback on the draft outline with a view to helping the AHTEG improve the outline before submitting it to the COP-MOP. The discussion may focus on the structure of the outline but, most importantly, feedback is sought on issues that are unique or particularly relevant to the risk assessment of LM fish are whether these issues are adequately covered in the draft outline.

The Online Forum is asked to comment on issues included in the draft – if they are relevant, if there are overlapping issues, and if there are additional issues that should be included. It would also be of great advantage for the next step if relevant information and suggestions to the text could be provided. Also additional references are welcomed. 

We would also like to draw the attention to risk management strategies and containment strategies decribed. Are the methods adequately decribed and up to date?

I look very much forward to the discussion and your valuable input that will help us improving the draft.

Best regards, Janne

Dear Janne, thank you to moderate this Online forum and to have further clarified the goals of this discussion.
I've tried to focus my comments on the structure of the draft outline, but I found difficult to make general comments. For this reason I'm attaching a file where my comments are written in red in the related paragraphs of the draft_outline.
Just one general suggestion is that the outline shall follow more likely the structure of the guidelines developed for LM mosquitoes and/or LM trees.
Please let me know if this  way of submitting input is ok for you.

Valeria

Dear Janne, dear participants,

I am also wish to say many thanks to you and the subgroup team for preparing the draft fish document. I find the proposed guidance on GM fish as a comprehensive and consistent paper in line with the roadmap and bringing also specific elements related to the GM fish biology, ecology, physiology etc.

I would suggest to including some additional aspects of GM fish assessment that can have importance in assessing the overall risks, as ex.:
- a study of ecosystem components, fish-environment interactions 
- behavioral, phenotypic, physiological and reproductive characteristics of GM fish
- unexpected environmental interrelations might occur with the abiotic and biotic components?
- toxicological aspects (capacity for accumulation of toxins etc.)
- ecological effects and consequences.

It would be interesting to discuss available information and experience on the mentioned topics.

Best regards,
Angela Lozan
Moldova

Thanks Janne for Forum moderating, many thanks volunteers from the Sub-group for capturing the main points to consider for risk assessment and thanks for Valeria Giovannelli for additional information especially for Williamsburg Resolution.
My comment is the same –  the text structure should be similar to the structure of Guidance PartII, as well as the Road Map, e.g. it will be good to give short rationale for sections, where it is possible, and name the issues revealed for every section (named in the text as elements to consider, unnamed - just marked as well as named `Monitoring methods` in section `Risk management strategies`) as points to consider.
As the reference material I propose FAO website http://www.fao.org/fishery/resources/en (or http://www.fao.org/fishery/species/search/en) , which contains information on morphology, habitat and biological characteristics, behavior, migrations, geographical distribution and other relevant information for different species as well as lot of references, that could help in risk assessment.
Best wishes, Galina.

Dear Janne,

We would also like to thank you to moderate this forum and the team for preparing the draft document we are working on. We consider that this document goes through the most important aspects on the LM fish RA and we find it really interesting.

We also appreciate and agree on the comments made by Valeria Giovannelli. As her, we find it easier to attach a file where our suggestions are written in green and some comments are on the right side of the page. We hope this is OK.

As Valeria and Galina mentioned, we consider that the outline of this guide should resemble more to other previous developed guidelines.

Thank you again for your hard work.
Best regards,

Patricia Gadaleta and Yanina Petracca
Directorate of Biotechnology.
Ministry of Agroindustry of Argentina.

Dear Janne and dear participants,
First of all, I am honored to be a part of this discussion group. Thanks to you for moderating the forum and to the group that took the time to draft the fish RA outline. I´ve added some comments to the draft outline and, as other participants have done, I am enclosing a file in which you can read my comments. I also agree with the fact that short rationales should be added for sections.
Best regards
Roberto

POSTED ON BEHALF OF IDUN M. GRØNSBERG

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Thanks to Janne for moderating this forum and the team preparing the draft outline attached to this discussion.

We support the form of the document and its structure and content. The comments made by the other members of the forum are well formulated and make a good input to the further development of the document.  We look forward to the further discussions on this theme.

Regards

Idun M Grønsberg

Dear Janne, Dear all
Many thanks for your commitment and dedication to improving the primary draft of the GM fish guidance document.

I propose we add the following useful manuscripts as a part of the reference materials:

- Andrew C. Wong, Alison L. Van Eenennaam (2008); Transgenic approaches for the reproductive containment of genetically engineered fish. Aquaculture 275:1–12

- Rex A. Dunham (2009); Transgenic fish resistant to infectious diseases, their risk and prevention of escape into the environment and future candidate genes for disease transgene manipulation. Comparative Immunology, Microbiology and Infectious Diseases 32:139–161

- Robert H. Devlin, L. Fredrik Sundstro, William M. Muir (2005); Interface of biotechnology and ecology for environmental risk assessments of transgenic fish. TRENDS in Biotechnology 24(2):89-97

- Hallerman E (2008); Application of risk analysis to genetic issues in aquaculture. In M.G. Bondad-Reantaso, J.R. Arthur and R.P. Subasinghe (eds). Understanding and applying risk analysis in aquaculture. FAO Fisheries and Aquaculture Technical Paper. No. 519. Rome, FAO. pp. 47–66.

Best regards,
O.A.El-Kawy

Dear All,

I join the others in thanking Janne for taking up the role of moderator.

Turning to the draft outline for further guidance on risk assessment of LM fish: It is good to start with the section “Background/Objective And Scope”, in which it is explained that this outline will be submitted to the COP-MOP at its meeting in December 2016, and the Parties will decide whether or not this guidance is needed and, if so, how it could be developed.

I was interested to read that “in its current form, this draft guidance is meant to be complemented by the Roadmap”.  This would mean a break with the previous documents which were intended to build on/complement the roadmap, rather than the other way around. Also the outline itself diverts from the stepwise methodology of Annex III and the Roadmap, by lumping the various steps of Annex III and the Roadmap in different groups under the various headings.

Like others before me, I would recommend that this outline follows closer the structure of Annex III and the Roadmap, to facilitate a comparison by MOP.

Annex 1 is quite helpful in getting an idea of the kind of applications out there.

Best regards

Piet