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

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

First of all, I would like to thank those participants who already have posted their views and provided important information to the draft. This is crucial for our next step to improve the outline before submitting it to the COP-MOP. I encourage participants to continue providing comments, ideas, references, etc,  within the draft or as separate text.

I am looking forward to the last days of discussion and input and will kindly remind you that the discussion will end at 1:00am on 25 April (the night from Sunday to Monday in many countries).

Good luck, Janne

Dear participants,

I think the outline looks great and covers most of the needed RA elements. I do however believe that there should be a bit more emphasis on the problem formulation as the principle document that should come out of the planning phase, setting the stage and the scope for the risk assessment that follows. Indeed, I think the ‘choice of comparator’ section fits under the problem formulation, which should also include an explanation of the legislative and regulatory context, the risk assessment framework, the regulatory decision making framework, and a strategy for dealing with and communicating uncertainty. All of these will help to define the scope.
There is also room in the problem formulation for sections on the history of use or invasiveness of wild strains that can be written and undergo peer review before the start of the risk assessment proper.

Protection goals are fairly easy to state, since they are often defined in the regulations or legislation that triggers the risk assessment in the first place. However, establishing assessment endpoints can be especially difficult and time consuming and they are critical in determining scope. Excellent guidance for the identification of endpoints is provided in chapter six of the volume by Kapuscinski et al. that you’ve referenced on page six, just above the annex. Tables 6.1 and 6.2 of the chapter can be completed for any fish species, providing an excellent method for defining endpoints and scope (I have used it recently for aquarium fish and it worked very well).

Under the 'risk assessment' section there should be a section near the beginning on the molecular and phenotypic characterization of the LMO. Information for this may not be available for the problem formulation, but only after the regulatory process is triggered and the risk assessment is underway.

Under containment strategies for LM fish, Methods of induction of sterility in fish and their efficacy looks a bit out of place and might fit better as part of the reproductive containment section. There should also be some mention of geographical containment, such as the use of tropical fish in a temperate zone, or a temperate fish in the tropics. Under these circumstances it may be impossible for the fish to survive outside of captivity.

I like the annex, but it will require constant updating, and is already out of date. I’m not sure if it will be of any use to risk assessors.

I hope this is useful.

Regarding the earlier side conversation from this session, I think it is more helpful to the discussion overall if all comments are posted, or at least a summary of comments are posted, and not just submitted with a reviewed copy of the document in question. Without knowing what others are thinking, there can be no discourse, no support for ideas, and no red flags.

Otherwise I look forward to the next session of discussions.

Special thanks to Janne for your hard work on this file.

Best regards,
Colin

Dear Janne and participants

Thank you to Janne for moderating the discussion and to the Subgroup and the Secretariat for providing an excellent draft.

My comments are as follows.

On page 2, shouldn’t the passage read (my addition is in capitals):  The current draft for a risk assessment document of LM fish includes all freshwater, marine, CATADROMOUS and anadromous fish and shellfish, including aquarium species.

On page 2, (my suggested change is in capitals): Potential to escape from containment facilities and spread to natural environments, FROM WHERE IT MAY MOVE ACROSS NATIONAL BORDERS” .  Essentially, I am trying to say that an LM fish approved in one country (perhaps because it is not considered a risk to that country’s environment if it does escape) may, if it escapes from containment, swim to another country and cause a problem for the second country’s (different) environment.   Regulators may wish to consider this possibility.

On page 3: The use of the word “DNA” in the following dot points excludes the possibility that the LM fish may be modified via dsRNA technology, so I suggest the following changes (in capitals): Survival of DNA OR RNA from LM fish in water (feces and from decaying dead fish). Survival of DNA OR RNA from LM fish bound to particles in water and to sediments

On Page 4, second paragraph, there is a typo: “triploid fish grows faster” should be “triploid fish grow faster”

On page 4, for the dot point “The net fitness trait data on real transgenic individuals and their non-engineered counterparts. Six fitness components (fecundity, fertility, juvenile viability, age at sexual maturity, mating success, and longevity”, there is no mention of the viability of sperm and eggs from LM fish in the environment. Many fish species reproduce by the female releasing eggs and the male releasing sperm into the environment, so that fertilisation talks place in the water body. Fish may be considered to be “fertile” if they simply produce viable eggs and sperm, but there is no mention of how long those eggs and sperm may remain viable in the water body. LM fish may be different in how long their eggs and sperm remain viable under different environmental conditions.

Warm regards to all

Judy