Risk assessment and risk management of transgenic fish

1. I think to apply appenx III of the Protocol, Parties should develop their own risk assessment guideline to adjust to their domestic or regional legal framework. Then the risk assessment framework should address the issue of non-safety, international agreements, stakeholder input, public opinion, national policies and the risk assessment of itself. The risk assessment of transgenic fish should include harzadous to ecosystem before the release, toxicity to non-target organisms, allerginicity to humans, gene transfer within fish, level of inviasiveness etc.

2. We don't have experiences in assessing risks from transgenic fish because there is no transgenic fish import yet into the country.

3. Prior required information on the transgeic fish is important from the applicants.  Any assessed result on the fish should be requested from to the applicants or the country of export (party of export) including receiving environment, environmental interaction, parental organisms and recipient.

4. Recommendations for preparing risk assessment report:
- introduction,
- regulation of LMOs fish
- application
- application evaluation process
- hazard identification
- risk assessment
- risk evaluation
- conclusion of risk assessment
- summary of risk assessment
- reference.

Pisey Oum
Cambodia's Ministry of Environment

My name is Eliana Fontes and I was indicated by the Brazilian government to participate in this forum. I am not a fish specialist, so I am going to ask a general question to the forum participants to bring to the discussion some issues that are relevant to the risk assessment of GM fish. They are simple question that might seem irrelevant, but in my view they are basic background to follow the debates on the points for discussion suggested by the secretariat.

The risk assessment of GM crops currently in the market took in great part into consideration the concept of familiarity with the crop species in which the new genes have been inserted, and in the fact that most or all of the transformed crop varieties are the result of decades of conventional breeding and usually highly dependent on human intervention to survive and reproduce. It is thus expected that such varieties would have lower chance to compete and survive in the wild, in case of escape. My question to the fish specialists is: what is the degree of familiarity that we have with the fish species that are being subject of genetically engineering research? How much do we know about their genetics, have they been conventionally bread and further released into the environment? If so, has the impact of improved individuals in the introduced environment been measured? Has non-transgenic individuals of these species been introduced into new environments and if so, what has been the impact of such introduction, particularly to the local food chain?

Dear Dr. Fontes and other forum participants,

I am a Ph.D. Candidate studying gene flow from genetically engineered fish to unmodified (wild-type) conspecifics. I'm using growth-enhanced Japanese medaka (Oryzias latipes) as a model species for the gene flow experiments that I'm doing in a confined laboratory environment.

Dr. Fontes asked some excellent questions - I'll answer them to the best of my knowledge, and encourage others to reply to this post with more information where available.

"- what is the degree of familiarity that we have with the fish species that are being subject of genetically engineering research?"
Some of the fish species nearest to commercialization as transgenic varieties include Common carp, tilapia, Atlantic salmon, and mud loach (Table 3.1 in the book, Environmental Risk Assessment of Genetically Modified Organisms. Volume 3: Methodologies for Transgenic Fish, 2007, by A. R. Kapuscinski et al. (editors) - see the list of Selected Readings for this discussion group). The degree of familiarity with these fish depends on the species: for mud loach and tilapia there are gaps in our knowledge even about basic biology and physiology, and for most fish species we don't know much about their ecology. In almost all cases, these fish species are less well-known to us than the crop plants that have been genetically modified.

"How much do we know about their genetics, have they been conventionally bread and further released into the environment? If so, has the impact of improved individuals in the introduced environment been measured?"
Compared to the highly domesticated crop plants Dr. Fontes referred to, we know relatively little about the genetics of most commercially important fish species - in fact, there may be no example of a truly "domesticated" fish line. Many farmed fish species have been subject to selective breeding to maximize particular traits (catfish, salmon, rainbow trout); one of the few tropical fish that has been part of a formal breeding program is the GIFT tilapia. Other farmed fish are not part of an intentional breeding program but may be under different selection pressures because they are reared in a farm environment, resulting in a genotype different from that of wild conspecifics. Very little is known about the impacts of escaped farmed fish - except that escaped/introduced fish exist outside their natural ranges. Tilapia, for example, have been intentionally introduced and have escaped from farms throughout the tropics. However, *measurements* of the environmental impacts of these fish in the wild are lacking.

"Has non-transgenic individuals of these species been introduced into new environments and if so, what has been the impact of such introduction, particularly to the local food chain?"
Much of the work on escaped farmed fish has been with Atlantic salmon, and a lot of that research has focused on impacts mediated by reproduction and interactions with wild populations (i.e., McGinnity, P. et al. "Fitness reduction and potential extinction of wild populations of Atlantic salmon, Salmo salar, as a result of interactions with escaped farm salmon" Proc. R. Soc. Lond. B (2003) 270, 2443–2450; Fleming, I. et al. "Lifetime success and interactions of farm salmon invading a native population" Proc. R. Soc. Land. B (2000) 267, 1517-1523). Measurement of a specific environmental impact like the effect on the local food chain is very challenging. If other forum participants are familiar with research investigating local food chain impacts of introduced/escaped fish, please reply to this post.

Overall, Dr. Fontes's questions seem to bring us back to discussion points #3 ("Difficulties in accessing or reviewing baseline information related to the recipient and parental organisms, receiving environment, environmental interaction, etc.") and #4 ("Elements necessary to conduct risk assessments of transgenic fish"). In many cases we are hampered by a lack of baseline data that could help us assess the ecological impacts of transgenic fish. Figure 6.1 in Devlin et al. (2007), "Assessing Ecological Effects Prior to Entry into Nature" (Chapter 6 of the book Environmental Risk Assessment of Genetically Modified Organisms. Volume 3: Methodologies for Transgenic Fish), presents one series of questions to ask to guide the process of assessing ecological effects of transgenic fish:
1. What are the relevant ecosystem components and processes?
2. What are the relevant phenotypic characteristics of the transgenic fish?
3. What are the most important interactions between the ecosystem components and the transgenic fish's phenotype?
4. What is the likelihood that genotype-environment interactions will affect the transgenic fish's phenotype in the environment of interest?
5. What unexpected environmental responses might result?
6. What are the consequences of the identified ecological effects, and how likely are they?

These questions could also be applied to better understanding the ecological impacts of selectively bred lines of fish.
While the answers to these questions are still not simple, they do provide a framework for collecting some of the data needed to understand potential ecological effects of a given transgenic fish.