2018-2020 Intersessional Period

---Message posted on behalf of the forum moderator---

Dear participants of the Online Forum on Risk Assessment and Risk Management,

Welcome to the first week of the forum discussions. My name is Marja Ruohonen-Lehto, my educational background is on genetics, microbiology and virology, and I have more than 20 years of experience in Biosafety and Risk Assessment.

I have the honor to serve as the moderator of this forum and as such, I will provide support and guidance to the discussions.

Decision CP-9/13 established a process for identification and prioritization of specific issues regarding risk assessment of living modified organisms for consideration of the COP-MOP. It also entails the commissioning of studies to inform the application of annex I to (i) living modified organisms containing engineered gene drives and (ii) living modified fish. The studies are to be presented to the open-ended online forum and later to the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management.

The discussions in the online forum are organized in two topics – one for each study.
This topic will be dedicated to discussing the draft study on Living Modified Fish.
The draft study is available on the web page for the online forum: https://bch.cbd.int/onlineconferences/forum_ra/discussion.shtml.

For the discussions, I would like to suggest that your comments are always as specific as possible to facilitate the analysis of the information and understanding among other forum participants. In addition, I would like to encourage you to focus your comments on the substance of the studies rather than on editorial suggestions, and to share information that:

• Could complement the study, which may include: further development of concepts, explanatory comments, relevant resources, bibliographic references, among others;
• Could identify any information gaps or factual errors;
• Is relevant to one or more of the aspects of annex I of decision CP-9/13

The consultants who developed the studies will be following the discussions of the forum, and I will be acting as the main focal point to facilitate the exchange of information between them and the forum as needed.

Having said this, I now invite the participants to the Online Forum to comment on the draft study on Living Modified Fish  (topic 2) for the next 2 weeks, and kindly request that you post in reply to this message only, such that all the comments are kept in one single forum thread under this topic.

I wish you all a very productive discussion

Marja

Dear Marja and dear CBD Secretariat:
First of all I must say that it is very important that this discussion is occurring.....very much needed!
The study is very thorough and useful, relating and analysing the main issues related to the development and use of GM Fish vs environmental releases and their potential impacts already described by the "Guidance on Risk Assessment" developed by the previous AHTEG on RA&RM.
In my personal view, it makes it very clear that this issue "GM Fish" fulfills every criteria mentioned in annex I of CP-9/13, and should be therefore recommended as a specific issue of risk assessment for consideration of SBSTTA and then to the CoP.
Delaying this longer is not to the benefit of the environment nor to the biodiversity that could be affected.
Kind regards,
Francisca Acevedo

Posted on behalf of Dr. Carolina Alduvin, Honduras:
*****************************************
Hello Marja and everyone else in the forum.
I must say that having a Guidance in Risk Assesment is an advance, since many countries have not developed procedures of their own to undertake this important regulatory process. My concern with that one is that is not very clear or easy to use, specially by novel regulators with little or no experience, it could be a nightmare and drive to unnecessary excessive regulatory measures in order to go through it and give an urgent response to a request. I would not agree if this particular guidance should be mandatory for all countries. Some parties have developed their guidances tailored to their needs and particular circumstances, so let them use their own and please simplify the above mentioned guide.

Dr. Carolina Alduvin

My name is Werner Schenkel, my educational background is in plant breeding, molecular and population genetics, and, I have more than 15 years of experience in Biosafety and Risk Assessment as scientific officer at the German Federal Office of Consumer Protection and Food Safety.

Firstly, I wish to thank for the opportunity to contribute to the discussions in this online forum. Further I would like to thank J. Sweet and JT Environmental Consultants LtD for conducting the extensive study, including comprehensive literature search, developing and evaluation of questionnaire, and thus for analysing and dissemination of available information on living modified fish (LMF).
My special thanks also to Marja for moderating this forum, and all colleagues sharing fruitful insights.

In my opinion, for further discussions on the necessity of new guidance it is important to consider the following outcomes of the study:
- LMF is one of the most popular model organisms for research under contained use conditions, however the reported commercialization of LMF is intended for confined use in most cases and there are no indications that other commercial fish species are being developed for environmental release.
- Regulations and risk assessment (RA) procedures and several guidance documents for LMF are produced by different countries and entities. They attempt to incorporate considerations on complexity of parameters affecting the potential environmental interactions between fish and different receiving environments. These documents are well represented in the draft study provided.
- RA of an LMF is always case-specific and a guidance document cannot provide protocols for individual events or situations.
- In general, there are experiences in performing RA on LMF by some parties, thus the resources and capacities for RA on LMF exist and should be shared with other Parties. Parties facing challenges in the RA of specific LMF may take advantage of these experiences and should be encouraged to directly interact with Parties already having performed such RA to develop solutions that are in line with the CP.

However, the demand for more assistance cannot be dismissed as irrelevant. Rather, the demand should be examined in any particular case. Individual solutions taking into account existing experience in RA of LMF should be considered. The BCH provides a platform where guidance, trainings and experiences should be shared. Therefore, capacity-building activities, access to the existing relevant guidances, training and other assistance from experienced authorities or organizations should be promoted.

Dear colleagues: thanks you for this opportunity, the issue of transgenic fish needed to be presented to the open-ended online forum and to the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management.
I agree with Dr. Werner Schenkel, the existing guidelines for LMO risk assessments, explain in general how to proceed and they can be used for LMF, but they should be adapted according to each case.
In my opinion, capacity building programs are neccesary to know how to use the guidelines and take into account the hazards and estimate the risks of LMF from experimental phases, releases and commercialization of these organisms with their specific characteristics.
For me the main challenges and limitations for risks assessment of LMF is the lack of training of specialists in risk assessment, the non-formation of multidisciplinary groups with the intervention of biotechnologists, specialists in fish farming, regulators, etc. For example, one of the most important aspects is to avoid releases to the environment. The study speaks about confined conditions for LMF and identifies the levels of containment and isolation required. We can use geographic information systems to locate the aquaculture facilities in appropriate places taking into account, telluric areas, flooding, proximity to the sea, or lakes or rivers, among others. Is important too the appropriate design to make them resistant to adverse weather conditions, containment measures, which include from the protection of the installation against intruders, biological barriers in the organism and compliance with established practices and procedures.
All these points could be included in training programs even with practical exercises based on the experiences of some countries.
Kind regards
MSc. Marvis Suárez Romero, Senior Specialist in Regulation, Control and Safety.
Biodiversity and Biosafety Department (Office of Regulation and Environmental Safety, Environmental Control Directorate)
Cuba

Dear Colleagues!
Well said, Marvis! Capacity building in using guidelines and advice as well as having the knowledge to look at other factors not covered by the guideline is indeed a very important aspect of risk assessments for LMO fish. I have found the Cartagena Protocol's guidance on risk assessment very helpful in helping frame questions about what other considerations should be taken up in a risk assessment.

Melanie Josefsson
Swedish Environmental Protection Agency

Thank you for this discussion [comment #10121], Werner Schenkel.

I am currently a Senior Research Scholar in the Genetic Engineering and Society Center at North Carolina State University (North Carolina, USA). I specialize in risk governance, including risk assessment and stakeholder engagement, related to new and emerging technologies and other emerging environmental risk issues.

I wanted to express particular support of your concluding sentence, to develop "capacity-building activities, access to the existing relevant guidances, training and other assistance from experienced authorities or organizations should be promoted." This is extremely important to provide stakeholders, including local decision-makers and even industry, with the proper tools to help guide informed decisions moving-forward in an evolving context related to LMOs including LM fish. Well stated.

Dear All,

My name is Blessing Aligwekwe, an Assistant Chief Scientific Officer from the National Biosafety Management Agency, Nigeria. My background is Botany; with an M.Sc in Managing the Environment(Pathway: GM Crop Risk Assessment) and 11 years of Biosafety experience.
The discussion on risk assessment as it relates to Living Modified Fish is worthwhile. The study falls within the scope of the Cartagena Protocol on Biosafety and annex 1 of Decision CP 9/13 can actually be applied.

Reports have shown LMF are mostly sterile females, which means some percentage of the fish population are not sterile and are capable of reproducing on escape into sea water although biosecurity and confinement measures may be in place. Besides, reports have shown easy migration of LMF and consequent genetic changes, direct competition and predation effects in wild populations. This is indicative that LMF are capable of disseminating across national borders.

Risk assessment of LMF has been identified by Nigeria as a priority. As such, the country is about to develop risk assessment procedure for LMF. However, certain challenges have been identified in risk assessing LMF as Nigeria’s current Risk Analysis Framework does not cover specific issues relating to fish complex life cycle, the interactions with different species and environments and environmental factors capable of influencing fish reproduction, development and behavior which are issues of consideration in risk assessment.

A discussion on this topic will really be helpful especially in the establishment of comparator base lines for risk assessment of LMF. The development of further guidance is necessary considering the potential harm to the environment.
Marja, thanks to you for moderating this forum. We hope to have a very fruitful discussion.

---Message posted on behalf of Moderator---

Dear Participants of the forum,

thank you very much for opening the discussion in a lively and comprehensive way. This is very productive! I hope that within the coming days more people will join.
Please keep in mind our focus of the discussions and provide comments that are as specific as possible – this is very important for the revision process of the document.

I have compiled, assisted by the Secretariat, a list of issues that have been raised:
- Comments on the usefulness of the study towards the assessment of the need for further guidance;
- Mention to the fact that existing guidance documents are well presented in the study;
- Complexities associated to the fish life cycle in relation to conducting risk assessment were pointed out; and
- The importance of establishment of comparators baseline for risk assessment of fish was also mentioned.

We have still more than a week to go! I look forward to more discussions and want to thank you for taking time from your busy schedules to participate into this important discussion.

Please, keep in mind that to interventions at the last minute you will not receive any important feedback :)

All the best,

Marja from Helsinki, Finland

Dear All

Let me introduce myself: my name is Christoph Then, I was nominated by ENSSER ((European Network of Scientists for Social and Environmental Responsibility) to participate in the debate. My main affiliation is with Testbiotech (http://www.testbiotech.org).

First of all, I would like to say that Testbiotech and ENSSER have just released a number of studies from the RAGES project (http://www.testbiotech.org/en/content/research-project-rages) on the risk assessment of GE (genetically engineered) organisms in the EU. One of the reports is on the issue of GE plants that can persist and propagate in the environment (http://www.testbiotech.org/en/content/rages-subreport-risk-assessment-next-generation-effects). The report comes to the conclusion that next generation effects are an important issue for risk assessment if geneflow and escape to wild populations cannot be prevented. According to the draft report published by the CBD, this is also an issue in regard to GE fish. I propose that these aspects should be discussed further.

Since experience with GE organisms able to spread and propagate in aquatic systems is somewhat limited, I would like to invite the group to discuss the marbled crayfish case for the purpose of comparison. The marbled crayfish is regarded as an invasive new species (Lyko, F. (2017) The marbled crayfish (Decapoda: Cambaridae) represents an independent new species. Zootaxa, 4363(4): 544-552. https://www.mapress.com/j/zt/article/view/zootaxa.4363.4.6). Remarkably, changes in epigenetics, morphology, behaviour and reproductivity seem to be caused by single chromsomal misarrangement, which is likely to have occurred spontaneously. This finding makes this species in some ways unique and different to other invasive species, but also interesting as a potential comparator for GE risk assessment.

The story of the marbled crayfish started in an aquarium in Germany in 1995. It has meanwhile become a threat to biodiversity in Madagascar (Gutekunst, J., Andriantsoa, R., Falckenhayn, C., Hanna, K., Stein, W., Rasamy, J., Lyko, F. (2018). Clonal genome evolution and rapid invasive spread of the marbled crayfish. Nat Ecol Evol, 2(3): 567-573. https://www.nature.com/articles/s41559-018-0467-9). I suggest the group may help to identify similarities and differences by comparing the marbled crayfish to risk scenarios that can be applied to GE fish.

GE organisms that may intentionally or unintendly spread and propagate within wild populations are becoming an increasingly serious issue, which the group should be aware of (http://www.testbiotech.org/content/testbiotech-comment-iucn-report-conservation-synthetic-biology).

With kind regards,

Christoph Then

Dear colleagues,
several interesting interventions since last Thursday. Very many thanks for those! Especially valuable are your concrete suggestions on missing information and issues that you suggest to add to the study. I will reflect these together with the Secretariat and see how they assist in analyzing the issue against the criteria in annex I. The consultants of the study are following the discussions, and they are also taking note of the comments for further analysis.

Please keep in mind the decision 9/13, what it says about the focus of the study, and the criteria in annex I. The study is supposed to inform the RARM AHTEG in the application of annex I.

While a discussion on RARM of LM fish in general is very interesting, and I see your enthusiasm on the subject itself, including the suggestion of information that would be useful for this purpose in the future, our discussion at the moment should be aimed to assist in providing information under the criteria listed in annex I.

I think that it is of utmost importance to follow the process we agreed upon at COP-MOP 9. The decision on whether new guidance is needed or not will be done in COP-MOP 10. And the studies and our discussions are needed for that very process.

Once more, many thanks for your interest, time and comments!

Still 5 more days to go!

Marja from rainy Helsinki (we should have snow!)

Dear participants,

thank you, once more very much for your important and informative comments!

You have shared information by providing citations and publications. Moreover, you have made suggestions in order to fill information gaps, and to provide more details on concepts and ideas. All this is very helpful and will assist the consultants in generating the next version of the study.

I encourage you to provide more input during the remaining time we have left!

As a moderator of this important discussion, I want once more to point out the following: the main objective of the study was not to be a desktop study on LM fish, nor to collect baseline information for an eventual risk assessment, but to inform the application of annex I to this topic.

Still some time left for your last interventions!

All the best, Marja

Dear All,

My name is Piet van der Meer, my scientific educational background is in ecology and microbe-plant interactions, and I have been for over 30 years involved in risk assessment in the context of decision-making on GMOs.

My thanks to Marja for moderating this debate too and for her insistence on keeping the debate focused on the task set by MOP.

As regards the study by JT Environmental consultants, I agree with those who stated that it offers a good basis for this discussion.

In response to Marja’s request for more input during the remaining days and – in doing so - to focus on the application of annex I to the MOP decision, I share the following observations:
Annex I to the MOP decision deals with “Identification and prioritization of specific issues of risk assessment of living modified organisms that may warrant consideration” and asks, inter alia, for an analysis whether the identified issues pose challenges to existing risk assessment frameworks and methodology.

I agree with those colleagues who have concluded that neither the study nor the submissions in this forum have indicated challenges to the existing risk assessment framework and methodology (i.c. Annex III to the CPB), and that a large collection of guidance on aspects of risk assessment of LM fish has been developed over the years.

However, it is also clear that there are challenges in terms of collecting the necessary scientific information to be used in this risk assessment methodology, and the question is how to best address those challenges.

I am inclined to agree with Romero [#10123], Schenkel [#10158] and others who have concluded that those challenges are best addressed by training risks assessors (on the basis of concrete cases, I would add). 

Wishing everyone a splendid weekend!

Piet

Dear Marja, dear all,

My name is Boet Glandorf, I am a senior risk assessor with more than 20 year experience in environmental risk assessment of LMOs.
We were asked by the moderator for comments on the report of JT Consultants.
For me, the report gives an good overview of developments in LM fish, of existing experience in environmental risk assessment (ERA) of LM fish and of existing guidance for LM fish. It becomes clear that there is already quite some guidance for LM fish available and more important, experience with ERA of LM fish. It is also clear that ERA is always case-by-case and experience in LMO risk assessment helps to adequately assess risks of LM fish  Exchange of experience is very important for all LMOs, including LM fish.

A couple of remarks on the report:
- The report could benefit from indicating what criteria were used to select the countries and stakeholders that were contacted with the specific questions in the questionnaire.
- It would be helpful to include more data on environmental effects resulting from current aquaculture with non-LM fish, that can serve as baseline for the ERA of LM fish. Seen the worldwide importance of aquaculture of fish there may be more information available than included in the report.
- Large scale aquaculture can lead to environmental pollution due to the use of antibiotics, feed or other factors. This may be solved or diminished by the modification, e.g. disease resistance, thereby creating benefits for the environment. The report would therefore benefit from taking effects due to a change in the cultivation and management system of LM fish into account.

Kind regards,
Boet Glandorf, the Netherlands

Dear Martja and colleagues,

My name is Mark Walton and I am the Chief Technology Officer (CTO) at AquaBounty Technologies, the company that developed and is commercializing the LM salmon known colloquially as AquAdvantage Salmon. As CTO I am responsible for research and regulatory activities. Before moving into executive management, I was the Global Director of Regulatory Affairs for AquaBounty. In addition to my work with LM salmon, I have experience with the LM fluorescent fish (GloFish®) that are sold commercially in the United States and Canada and prepared the Risk Assessments for all GloFish lines currently available in Canada.

Outside of my work in LM salmon and GloFish, I have been actively engaged with regulators on the topic of LM animals for 15 years, including organizing or co-organizing two international workshops for LM animal regulators. I am currently working with a global group of regulators, academicians and government officials to organize the next international workshop on the regulation of animal biotechnology which will take place in September of this year. These workshops are a forum for regulators to connect, communicate, and exchange ideas and information regarding risk assessments of LM animals.

My comments/observations are regarding the environmental impact of escaped ornamental fish and non-LM salmon.

The state of Florida is the home to most production of tropical aquarium fish sold in the United States and the Tampa Bay region is the primary location, where approximately 800 species and varieties of ornamental fish have been grown since the 1940s. All species and lines of GloFish LM ornamental fish are produced in this region. The Department of Fisheries and Aquatic Sciences at the University of Florida (http://sfrc.ufl.edu/fish/) has conducted numerous studies on the environmental impact of the ornamental aquaculture industry. In 2014, scientists from the University conducted a large scale survey of non-native fishes near ornamental aquaculture facilities in the Tampa Bay area. They determined that most fish escape through discharge of farm effluent and escapes could be minimized by discharging farm effluent into a holding pond before discharge to the environment. Most of the escaped ornamental fish collected during the study were found within 500 m of a farm's discharge point, and they found no evidence that escaped ornamental fish were able to become established in the environment (Tuckett, Q. M., Ritch, J. L., Lawson, K. M., & Hill, J. E. (2017). Landscape-scale survey of non-native fishes near ornamental aquaculture facilities in Florida, USA. Biological Invasions, 19(1), 223-237). 
This work provides evidence that introduction to an environment is not by itself sufficient to result in harm to the environment. It is also an example of the need identified by Dr. Glandorf to conduct environmental risk assessments of LM organisms on a case-by-case basis. The risk posed by the organism to the environment will depend upon multiple factors and those factors will have different weights in every case.

With respect to the desire for more information on the environmental impact of escaped non-LM food fish from aquaculture facilities to the wild, that is an issue of significant concern to the Atlantic salmon (Salmo salar) aquaculture industry and there is an extensive body of literature available on the subject. A 2017 review of the subject: Glover, K. A., Solberg, M. F., McGinnity, P., Hindar, K., Verspoor, E., Coulson, M. W., ... & Svåsand, T. (2017). Half a century of genetic interaction between farmed and wild Atlantic salmon: Status of knowledge and unanswered questions. Fish and Fisheries, 18(5), 890-927, would provide a good starting point for further investigation of the subject.

Mr. Tzvertkov and Dr. Glandorf both expressed their opinion that sufficient guidance is available to assess the environmental risks posed by LM fish. Having worked on the risk assessment of LM fish with regulators from several countries, I concur with that position. I also support the observations made by several participants that additional capacity building in the regulatory sector is a critical need. Based on my experience working with regulators from around the globe, the need to add capacity far exceeds the need for additional guidance on assessing the risk of LM fish.

Dear Colleagues,
My name is Nikolay Tzvetkov and I work at the Bulgarian Ministry of Environment and Water where my responsibilities include the regulation of GMOs and biotechnology in general.
First I would like to congratulate and thank Marja for moderating the forum.
Regarding the study presented by JT Environmental Consultants provides a good overview of current status of the developments in the area of LM fish, incl. the environmental risk assessment. As already mentioned by Werner Schenkel (# 10121) the developments fall within two main groups: ornamental LM fish and LM fish for food production (salmon) that are raised in closed systems.
There have been many cases of non-authorised marketing of LM ornamental fishes and I presume also accidental releases into the environment, but I am not aware any of those to have led to establishment into the environment or to adverse effects. Regarding the LM salmon, there is a great deal of experience with conventional salmon and other species aquaculture. That includes accidental or deliberate releases into the environment. So in agreement with Boet Glandorf (# 10138), I think it will be useful if the authors of the study provide brief overview of environmental releases of the non-LM fish, the effects of it and how such experience can inform the ERA of LM fish.

Regarding the analysis of LM fish vs the criteria set in Annex I of decision CP-9/13 my view the study clearly shows that there is relevant experience in ERA, incl. appropriate guidance documents that can be used directly or after being adapted. Thus I see no need for development of a further guidance documents at that point. More relevant might be capacity building activities in conducting ERA of LM fish for those countries that need it.

Best Regards,
Nikolay

POSTED ON BEHALF OF Dra. Viana Victoria Barceló, Cuba:
*****
Dear colleagues:
It is an honor for me to participate in this online forum and I thank all those involved in creating this space for exchange and discussion, especially the Secretariat and Marja.
My name is Viana Barceló, I am a Veterinary Doctor with a Master in Biosafety and almost 15 years of experience in this field, working in the Cuban Regulatory Authority for the Cartagena Protocol.
From my point of view, the main challenge of the LMF for a regulatory authority goes beyond the characteristics of the species (which is already enough) and includes the competence of our authorities. For 30 years, our institutions have been evaluating the use of modified crops and this has led to the selection and specialization of the staff seeking skills related to plant biology. Now we are faced with the challenge of assuming the evaluation of totally different species from all points of view and most of us are not prepared for it.
The Cuban regulatory authority has the particularity that it assume a broad approach to biosafety, since it not only regulates the use of LMOs, but also assesses the risks arising from the introduction and release of alien species. This aspect promotes a very particular multi-profile staff that facilitates the evaluation of LMF. It is an experience that although it is not necessary to generalize in other small regulatory authorities, it can guide where to look for the necessary competence for the ERA of LMF, in regulatory authorities for alien species.
On the other hand, although it is true that there is a large number of guide documents for the risk assessment for LMF, I think it would be positive to develop a general document that would guide, with general elements that fit different cases. This document should also include proposals for risk management and monitoring measures that can be applied. This guide, developed and promoted by the Secretariat, within the framework of the Protocol, would have the advantage of being available in several languages, making it more accessible and familiar to authorities and specialists around the world.
Dra. Viana Victoria Barceló, Cuba

Dear all,
My sincere apologies for joining the forum late, i have had a handful of work lately. I'm very well grateful for the opportunity to contribute to the discussions in this online forum. I would like to thank Marja for moderating this forum, J. T. Environmental Consultants and all colleagues for sharing their fruitful insights.

This discussion on risk assessment as it relates to Living Modified Fish is expedient. Personally, i think that this study is thorough and has followed a very holistic research approach which has shown the experiences on carrying out Environmental Risk Assessment on LM fish. I would however like to reiterate the observation made by Boet Glandorf, it will be great to state in the study, the criteria JTEC used to select the range of countries and other stakeholders to fill out the questionnaire as well as providing a summary of the effects of non-LM fish to the environment, this can aid in better ERA of LM fish.

Joy Onwude, Senior Scientific Officer, National Biosafety Management Agency, Nigeria.

My name is Abdallah Ramadhani Mkindi from Tanzania. thanks for opening this discussion.
We also need to consider what are socioeconomic of introducing risks living modified fish into our environment.
Also precautionary principals need to be considered as we are carrying out risks assessment
Again, in developing countries they may have limited capacity of carrying out the risks assessment and the costs for carrying out such assessment might be a stumbling block.
What if they accidentally or intentionally escape into the environment, what will happen to the indigenous non modified fish populations? Will they under go extinct? Will they crossbreed and result into a new species? What are the cultural values related to LMF.

Many thanks to Marja for summarizing the recent contributions and for pushing forward the discussion. In addition to the points compiled by Marja, I would once more like to highlight  an issue that has been addressed by many participants (#10124, #10123, #10126, #10138, #10140, #10150) regarding capacity building activities and the exchange of experience. I think it is very important to identify what the specific needs of those Parties who have identified LMF as a priority topic, are, in order to decide on the best way forward to meet these needs. In my opinion, the real challenges identified by the study and raised in the actual discussion are particularly associated with needs to support capacity on risk assessment and risk management and to broaden and exchange experience and expertise in risk assessment and in use of available guidance. Other challenges identified are associated with limited information available on marine and aquatic environments including baseline information on fish biology and ecology in different environments.
These challenges cannot be addressed so much by a new guidance on a given specific topic, but rather by intensification of capacity-building activities (see very valuable comment by Marvis Suárez Romero [#10123]). Therefore, I appeal to the Members of the AHATEG for RA/RM to make a recommendation to include respective programs according to the “Implementation plan for the Cartagena Protocol and Capacity-Building Action Plan (points A.1.4., A.2., A.5) instead of developing a new guidance on LMF fish. Addressing the suggestion of Viana Barceló (#10143) to “develop a general document” I wish to point out that the development of a guidance takes years and consumes a lot of human and finacial resources. It would be very regrettable to spend resources on general guidance that might not address the concrete questions of risk assessors. These resources should rather be allocated to effective training programs and information exchange in order to address the needs of concerned Parties. 
Further, I would like to thank Mark Walton for providing additional information on the environmental impact of escaped non-LM food fish from aquaculture facilities. Collecting and sharing of all available information which can support risk assessors worldwide is the key step to sound risk assessments of LMF. In this regard I would like to emphasize again that the BCH should provide a platform where guidance, trainings and experiences should be shared.

Werner

Dear All

After having read some further comments, I suggest the LMO fish study should be used as a starting point to broaden the debate, as well as to introduce some more general issues on the environmental risk assessment (ERA) of genetically engineered (GE) organisms with the potential for gene flow to natural populations.

If gene flow from GE organisms results in viable offspring, including hybrids and persistent (potentially self-sustaining) GE populations, environmental risk assessment (ERA) faces new challenges. The methodology of ERA as developed and applied is not yet adequate to assess next generation effects, and is likely to lead to results that are not sufficiently robust. This can be concluded from the draft LMO fish report which discusses survival, migration, spawning, hybridisation and introgression under natural conditions and in different environments. It can also be inferred from the recent RAGES report on GE plants that can persist and propagate in the environment (http://www.testbiotech.org/en/content/rages-subreport-risk-assessment-next-generation-effects).

Given the recent debate on the introduction of GE organisms into natural populations of plants (trees) insects, corals, mammals (http://www.testbiotech.org/content/testbiotech-comment-iucn-report-conservation-synthetic-biology), the issue of next generation effects is becoming highly relevant. The expert group should be aware of this development. It is important to understand that the issue of next generation effects not only concerns the application of gene drives, but is also relevant for the potential spread of other GE organisms in natural populations.

We should also be aware that current experience with invasive species is not sufficient to deal with this matter, since LMOs enable the spread of genetic information within populations that are already very well adapted to their environment. Their impact in regard to potential disturbance or disruption of the ecosystem can be very different.

Thank you very much for your interest and comments,

Christoph Then

Dear collegues,
First, I want to thank Dr. Marja Ruohonen-Lehto for moderating this forum and second I would like to present myself; my name is Dr. Lorenzo Guevara Olvera, I have more than 22 years of experience working with plant-pathogen interaction analyzing differential gene expression and actually determining gene function in plants using V-VIGS and gene function in fungal pathogen using DJ-PCR at Tecnológico de Celaya México. Additionally I contribute with CIBIOGEM (Inter-secretarial Commission of Biosafety of Genetically Modified Organisms) as part of the scientific advisory board in Mexico.

After a careful reading of the manuscripts, Study on Risk Assessment Application of annex I of decision CP 9/13 to living modified organisms containing engineered gene drives and Draft study on risk assessment: application of annex I of decision CP 3 9/13 to living modified fish. I would like to share my opinion with you all.

It is obvious that the climate change is occurring, and because of that, the environment as well as all living organisms including us, are facing new challenges in order to adapt.
The new biotechnology approaches represent an outstanding way to study, to understand and generate efficient tools to face them.

In agreement with some of my colleagues that participate in the forum and in the Perseus report itself. I consider necessary that all the legislations and work done, must be focused on the benefit of our countries. In order to achieve that, the regulatory authorities have to set the correct regulations that respect the environment, the biodiversity and the safety of people.
An approach of case-by-case scientific analysis, I consider is the best way.
Here in Mexico, as in other countries, the legislations related to LMO´s, are been analyzed with caution since it is extremely difficult to assure and convince people that gene driving technologies would not impact negatively. 

Best regards, Lorenzo

My name is Todd Kuiken and I am a senior research scholar at the Genetic Engineering & Society Center at North Carolina State University.  Trained as an environmental scientist, I have been working at the intersection of environmental policy and emerging technologies for the past 12 years; focusing on synthetic biology and other emerging genetic technologies. First let me thank our moderator, Marja for leading and probing our discussions so far.  And thank J. Sweet and JT Environmental Consultants LtD for providing a thorough overview of LMF.

Building on Dr. Schenkel’s comment (#10121) and sections 5.3.7 and 5.3.8 of the report, I’d like to stress the importance of LMF as model research organisms (i.e. zebrafish) and their potential use to gather the data which may be required in a risk assessment of other LMF.  This should be considered as we discuss any new regulations around LMF and how to properly conduct risk assessments. Cautious as to not impact the very research systems which may provide valuable data points in evaluating the release of a LMF.

I support the previous comments that current guidance documents available on LMF have provided valuable insights, provide technical expertise on how to conduct a RA on LMF, and are a good source for capacity building. However, many of the parameters used within these studies are tailored to specific geographic locations and environmental conditions. These RA’s should be viewed as a starting point for a particular country/region or application, taking into account the differing geographic and environmental conditions that will impact the RA of LMF. Strengthening the arguments made by many in this forum for a case by case RA.

Capacity building around RAs of LMF should also be expanded to “new actors” who are increasingly accessing the tools of biotechnology and often operate outside the realms of universities and governments. Broadly I am speaking of the DIYbio movement. A map of DIYbio activity can be viewed here: https://sphere.diybio.org/

Various kits are currently available which enable citizens to learn and utilize the tools of biotechnology. Including a kit which enables users to genetically engineer frogs (See: https://www.the-odin.com/frog-ge-kit/). While not LMF, we should assume that kits involving LMF may be coming in the future.  Other groups have begun research projects on cuttlefish with no plans for environmental release (See: https://opensourcecuttlefish.com/). 

While the DIYbio community has developed codes of ethics and other biosafety norms, they should be included in capacity building around RA as they tend to operate outside the realms of governments and may need additional guidance on how to properly contain their research. 

Kindest regards,

Todd Kuiken, Ph.D.

Dear colleagues,
thank you for the interesting discussion and special thanks to Marja for pointing our focus back to annex I of CP-9/13. For this reason, I would like to address some of the criteria laid out in Annex I based on the information provided in the study and their applicability regarding the identification and prioritization of specific issues with the view to developing further guidance.
I agree that the draft study indicates that the issue LMF fulfils the criteria mentioned in Annex I of Dec CP 9/13. However, a closer analysis of the criteria themselves reveals that they are quite universal and therefore, cover almost every kind of LMO. Therefore, it should rather be discussed whether these broadly set criteria ought be improved to better perform the task to identify and prioritize specific issues with an actual need for further guidance.
To my understanding this notion is very well reflected in the responses to the questionnaire (Annex 6 of the study), which weren´t unanimously regarding the need for a guidance: “Nine respondents from national biosafety authorities and institutions considered the need for the development of guidance to be a priority, whereas 13 other respondents from national biosafety authorities and institutions considered that sufficient guidance is available and that it should be harmonized and made more widely available to regions with limited experience with risk assessment and LMF.”
However, the specific needs of these Parties who identified LMF as a priority ought to be considered in order to decide if a guidance is the best way forward to meet these needs.
When reading the study, it is noticeable that the identified challenges fall into two categories:
1) Most challenges are generally associated with the environmental release of non-domesticated species but hardly specific to LMF (e. g. complexities of assessing the interactions of LMF with wild populations and with other components of the environments in which they could move and survive, or the complexities of fish ecology).
The topics addressed here are a fundamental part of each environmental RA and are covered by existing RA frameworks and guidance documents. A case-specific evaluation of interactions with the environment, long-term-effects etc. is a fixed component of a scientifically sound RA. In this regard I would like to refer to the respective chapters of the EFSA Guidance on ERA of GM animals and to Directive 2001/18/EC of the European Union.
2) Other challenges identified are problems to obtain information required to inform the risk assessment (e.g. high levels of uncertainty for some fish species, difficulty of providing data, establishing of comparator base lines or testing interacting factors under controlled experimental conditions). These, however, are not challenges to the methodology of the risk assessment itself.
Here again, the uncertainty based on limited scientific information due to difficulties in providing data is not specific to LMF. A proper uncertainty analysis is an integral part of each ERA for the release of any LMO into the environment, which can principally only be executed on a case by case basis. Methodological frameworks and guidance on these kinds of analyses are available. The draft study has identified a number of relevant guidance documents in its stock tacking section, e. g. the EFSA Guidance on ERA of genetically modified animals (DOI: 10.2903/j.efsa.2013.3200).
Therefore, I come to the conclusion that the study did not identify any specific challenges that cannot be approached within the frameworks, methodologies and guidances available.
However, I explicitly wish to acknowledge, that the risk assessment of an environmental release of LMF will pose significant challenges to regulators having to perform such a RA. The most effective activities to meet these challenges are ongoing research, exchange of information and experience, and other capacity building measures.

Posted on behalf of Ms. Ejebay Kokanova, Turkmenistan:
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Dear colleagues, greetings from Turkmenistan

    My name is Ejebay Kokanova, I am scientist at the National Institute of Deserts, Flora and Fauna of the Ministry of Agriculture and Environment Protection of Turkmenistan. Themain areas of my interests are insect’s biology (particularly Orthoptera, Acridoidea)in arid region; invasive alien species of insects; insect’s population dynamics; integrated pest management (IPM); climate change and insects ecology. Also, I am National Focal Point for Cartagena Protocol on Biosafety for my country.
      Firstly, I would like to thank the Secretariat of CBD for providing the opportunity to participate at this very important, useful and timely forum. I would like to thank Ms. Marja for moderating the forum and all colleagues for their informative discussions. The Draft Study on Risk Assessment Application on Annex 1 of Decision CP 9/13 to Living Modified Fish provided by JT Environmental Consultant Jeremy B Sweet allows  to  review and understand the current status of this specific issue, the developments on the field of LMF, current experience in environmental RA and existing guidance documents.Many thanks!
       Turkmenistan has no experience in undertaking risk assessment of living modified organisms, including LM fish and engineered gene drive. Main challenges in our country at the last decades are locust’sreproduction in natural ecosystems (especially Moroccon locust DociostaurusmaroccanusThunb.in Kopetdag and Koytendag mountain areas and saxaul treehopper Dericorysalbidula Serv. in Karakum desert area). For effective management of insect’s population dynamics we have been developed integrated pest management systems with using preventive, agrotechnical, chemical and biological control methods. Only right and correct scientific information on the biology and ecology of pests,  such as main habitats, duration of life cycle, host plants, migration capabilities, fecundity, natural enemies, ecological flexibility, etc.  to  form the basis for providing effective IPM and reduce adverse environmental impacts of insects reproduction.
       In condition of climate change, for Turkmenistan take place the aridization, we have revealed that such biological and ecological parameters of locusts as hatching time, life cycle duration,fecundity, trophic relations, distribution features was altered. The changes in species biomass ratio of plant composition in natural ecosystems lead to change on insect-plant interactions. All of these new scientific information very important for development of appropriate pest management strategy. 
       On the assumption of foresaids and taking into account the «Guidance on Risk assessment of Living Modified Organisms» which underlined “The novel combination of genetic material in an LMO and its use may lead to environmental effects which may vary depending on the LMO itself,
the environment exposed to the LMO and how the LMO is used ” I would like to agree with all  colleagues  stressed  “…that  any environmental risk assessment can only be performed on case-by-case basis and not a general way”.
        It is important to have scientific dates on if LM fish, for example LM Atlantic salmon with growth enhancement if it’s possess some more ecological flexibility than native salmon species and what place the LM fish will take in food chain of marine ecosystem  in case of intentional or unintentional release?! It is important to identify and evaluate potential adverse effects of the LMF, that may be direct and indirect, immediate or delayed to the environment. It required carefully consideration of possible scenarios of the LMF’s adverse effect.
        At the same time, I agree with suggestions,  pointed out by several colleagues (YannDevos, BoetGlandorf, Ann Kingiri) “It may be helpful to limit the scope of the draft report to the most likely cases of LMF mowing to practical application/.… that may be expected to be environmentally released in the coming 10 years…”  For example, in “Pest risk analysis for quarantine pests including analysis of environmental risks and living modified organisms”. International standards for phytosanitary measures. ISPM. № 11. FAO, 2017. (Page 8) considered that only LMOs that have some specific features as of potential harmful organisms and  are required to be provided with further risk assessment. 

With regards,

Ejebay  Kokanova

Dear all,

My name is Luciana Ambrozevicius and I´ve being working in the biotech field since 2000, including GMO risk assessment and monitoring.

In my opinion the report showed no challenges to existing RA frameworks and nicely summarize the experience with RA of LMF performed by Canada and USA and the guidance documents available (EFSA, ILSI, OECD, CBD). So we do have risk assessors with experience that can share information and we have a mechanism where this information can be shared (BCH) to be used by any interested Party.

I also want to agree with some points already mentioned by other participants that may warrant consideration in the RA:

- the intended use: "LMF is one of the most popular model organisms for research under contained use conditions, however the reported commercialization of LMF is intended for confined use in most cases and there are no indications that other commercial fish species are being developed for environmental release" (#10121)

- the importance of a solid baseline: "to include more data on environmental effects resulting from current aquaculture with non-LM fish, that can serve as baseline for the ERA of LM fish" (#10138)

- the case-by-case nature: "the risk posed by the organism to the environment will depend upon multiple factors and those factors will have different weights in every case" (#10150)

In conclusion I agree with #10158 and #10173 that the resources allocated to research, information collection and RA training programs will be more useful than a new guidance.

Thank you.

Best regards,

Luciana Ambrozevicius
Ministry of Agriculture - Brasil

We thank Marja for moderating this forum, as well as the Secretariat for their support of both threads of this forum.

We also wish to thank the JT Environmental consultants for their work on this report, and we think it is a good summary of the work that has been undertaken and applied in the development and use of LM fish. What is clear is that a number of LM fish species and modifications have been risk assessed, and in some cases, released (both legally and illegally).

We have little to add to the discussion that has already taken place in this forum, other than to echo the comments we made regarding Topic 1 (Gene drive organisms; GDOs). As with any risk assessment, the assessment of the release (or to use in containment) must be done on a case-by-case basis, taking into account the specific characteristics of the LMO among other factors such as the receiving environment, etc.). For this reason, we think the development of general guidance is not consistent with criterion (d) of Annex I.

As with GDOs, LMOs, and other potential environmental stressors such as hazardous substances, the general principles and methods of environmental risk assessment (ERA) apply to LM fish, and thus training of risk assessors in the principles and methods of ERA in general, as well as the sharing of experiences is a better use of resources than the development of additional guidance.

Thanks to all participants for the information and discussion!

Dear all,
Please may I extend my thanks to Marja for acting as a moderator on this forum. I would also like to thank Jeremy Sweet for producing a thorough report.
My name is Heidi Mitchell and I have worked since 2006 in GMO risk assessments.
I agree with many others (Werner #10121, Grieger#10124, Glandorf #10138, Tzvetkov #10140, Walton #10150, Ambrozevicius #10188, Strabala #10194) that the report does not indicate that there would be challenges assessing LM fish according to existing frameworks. In our experience of risk assessment of GM fish it was a lack of information about the GMO rather than the inadequacy of our risk assessment framework that posed challenges.
I agree that it is more important to devote resources to helping risk assessors use existing guidance than developing new guidance on LM fish.
Kind regards
Heidi Mitchell

Dear all,

My name is Motoshige Yasuike, a senior researcher, from Research Center for Bioinformatics and Biosciences, National Research Institute of Fisheries Science, Japan Fisheries Research and Education Agency.

First of all, I am so grateful to the authors of the draft study for providing available information regarding the development status of LMF and the risk assessments (RA) on LMF from the experienced countries and organizations.
My understanding is that the purpose of this online forum is contribute to the discussion about the development of guidance on RA/RM of LMF, according to annex I of CP-9/13.

As described in section 8.1 (c) and (d) on pages 28-30 in the draft report, there are many difficulties in the development of a guidance for LMF, due to limited scientific information available on most fish species.
In particular, it will take considerable time and effort to establish the baseline for wild fish to compare LMF. Unlike GE plants, most aquaculture fish species are almost wild type, and they have genetic diversity within species.

Therefore, if the development of the guidance for LMF is to be considered, I suggest the fluorescent zebrafish as a good candidate for a starting point of the discussion (I agree with the comment by Dr. Todd Kuiken [#10165]). The fluorescent zebrafish has a large history with accumulation of experimental data. A large number of genetically defined lines of zebrafish have been established and high-quality genome sequence information is available. In addition, “fluorescent” zebrafish is easy to visually identify (i.e. easy to distinguish wild type), compare to LMF of aquaculture species.

Finally, as mentioned in the draft report, several countries have experience with risk assessment and regulatory processes for LMF that will be useful for discussion.

Best regards,
Motoshige Yasuike

Dear Marja, dear all,

My name is Kine Rautio Øverland, and I work with GMO impact assessments and GMO management at the Norwegian Environment Agency. My scientific background is in molecular biology and biotechnology, as well as environmental management.

I would like to thank Marja for moderating this forum and the CBD secretariat for facilitating it, it is much appreciated.

Firstly, to the study. I think the study is useful in informing an assessment of the criteria laid down in annex I of CP-9/13.  The study sheds light on the diversity of introduced traits, fish species modified and mentions some unintended effects of the modification. The classification into ornamental fish and food fish is useful. To aid the further assessment, it would be helpful if the study could include more data, if available, on pleiotrophic effects, data gaps and uncertainties.

I would like to echo others that have stressed the importance of capacity building in risk assessment of LM-Fish. As such, guidance on the risk assessment of LM-fish can serve as  capacity building under the Cartagena Protocol. Such a guidance document, would as we know be voluntary to follow, but for us would be helpful when performing risk assessment of LM-fish.
Also, in the context of risk assessment of LMOs, such as LM-fish, it is crucial that we have biology documents for the species modified, to aid the risk assessment. The OECD (2017) Consensus document on the biology of atlantic salmon (Salmo Salar), has already been mentioned in the report and by others in the forum, in this regard.

I would also like to draw your attention to a recent risk assessment by the Norwegian Scientific Committee on the "Assessment of the risk to Norwegian biodiversity and aquaculture from pink salmon (Oncorhyncus gorbuscha)", VKM Report 2020:01. The pink salmon, is an invasive, alien species in Norway. It has not been genetically modified, however, the report provides a useful insight into the risk assessment of an introduced fish species with a new geno- and fenotype, and it's effects on the aquatic ecosystems and on wild and farmed salmon.


Kind regards,
Kine

Dear Marja, dear colleagues.

My name is Christoph Lüthi, I work as a biosafety expert at the Swiss Federal Office for the Environment.

We have provided input for the study as well. The study provides a good overview of the area of LF fish. In Switzerland, genetically modified vertebrates may only be produced and put into circulation for purposes of research, therapy, or diagnostics in human or veterinary medicine (article 9 of the Swiss Gene Technology Act). Because of  this, and because there is no potential for accidental dissemination of currently existing LM fish, this specific example is of limited value for Switzerland. However, we strongly rely on a functioning labelling system for LM fish and the derived products for the enforcement of the Swiss law.

Good day from Canada.  I am posting here some general comments on the need for specific guidance on LM fish and then some detailed editorial comments on the study itself on behalf of my Government of Canada colleagues in the Department of Fisheries and Oceans. 

Canada has been conducting regulatory risk assessments of LM fish since 2013 including Atlantic salmon, danios, and tetras.  Risk assessment summaries can be seen on our website (https://www.canada.ca/en/environment-climate-change/services/managing-pollution/evaluating-new-substances/biotechnology-living-organisms/risk-assessment-decisions.html). Canada did not rely on any specific risk assessment guidance for these fish risk assessments, but were informed by the literature that already existed (including Annex 3 of the Cartagena Protocol) when establishing our framework. Once established in 2013, Canada continued to use the same framework for the rest of the LM fish risk assessments until the current time. There is now more information available to inform risk assessors on what steps to take in performing a risk assessment on LM fish. That being said, developing the framework was a lot of work and may have benefited from additional guidance specific to LM fish if it had existed.

Canada did at one point consider writing our own guidance document for LM fish, but after so many peer reviewed risk assessments, where the framework is described in the problem formulation, we decided that further guidance was unnecessary. However, if such guidance were to be developed by an international body, Canada would like to participate and would find such a document to be helpful especially as that relates to capacity building for Parties and non-Parties alike that have not yet conducted such assessments.

In relation to the study, Canada offers the following specific comments in the attachment (word document). 

Thank you

Dear colleagues,
My name is Anastasiya Astrouskaya and I am researcher of the National Coordination Biosafety Centre of the Institute of Genetics and Cytology, NAS of Belarus. I would like to thank the Secretariat of the CBD for providing the opportunity to participate at this very useful forum. I would like to thank Marja for moderating the forum and all colleagues for their informative input.
In my opinion, Draft study on living modified fish corresponds every criteria mentioned in annex I of CP-9/13/. I generally support the study done as well as development of a new guidance for not only fish but also aquatic organisms.
At the same time we have an observation about very important aspects that might not be primarily a subject of the RA guidance. At the same time as LM fish impact in the complex aquatic systems could be hardly predictible in case of intended and unintended release we beleive capacity building in the area of regulation and monitoring of LM organisms for relevant structures involved in each step starting from creating, release to the environment and post release monitoring is of high importance.
One of the way to do that is to complement another additional source of information that was developed in parallel with RA Guidance-Training Manual on Risk Assessment of LMOs with information and countries examples on the abovementioned aspects (regulations and monotoring).

Dear Marja, dear colleagues,

Having followed this discussion, I would like to share a few thoughts. First of all though I would like to thank Jeremy Sweet and JT Environmental Consultants LtD for producing the draft report and all the effort that went into it.

I find the information provided helpful and relevant to all the aspects of annex I of decision CP-9/13. There are a few points where I would like to have some additional information or a change in tone.

General point: There is an overlapping aspect with the issue of GDOs, namely that the LMO will not stay put unless physically and strictly contained and the potential capability for it to spread widely and beyond national borders, hence with an impact that goes further than the jurisdiction of the country of initial release (including accidental release).  This means there are challenges for generating experimental data under natural conditions, for carrying out ERAs as well as for decision making – i.e., who can make the decision? And who would obtain/provide the data and who would undertake the risk assessment(s) for the different environments and locations and the spectrum of circumstances?

With regards to LMFish, the additional challenge is that impacts may occur in international waters – who then should decide or be party to the risk assessments and the decision making? This may be perhaps a CBD issue than a CPB issue, it will need discussing though.  It involves Articles 3 and 14 of the CBD on transboundary impacts and those beyond national jurisdiction.

The draft report gives evidence that for a reliable ERA there is a it is necessary to understand the characteristics and the behaviour of the LMFish, as well as its interactions with non-LM fish and other species not just under experimental conditions, but for the different natural environments it may escape into. Such knowledge is lacking and will likely remain lacking, as an actual release of the LMF into these environments would be a prerequisite for obtaining any such information, which in itself would run counter to the precautionary principle and the undertaking of an ERA in the first place. This is clearly posing a challenge.  Whilst this should be required for any LMFish, it is particularly highlighted in the draft report for the AquAdvantage Salmon (AAS), where it is concluded that there is “significant uncertainty in final predictions of harm to wild populations from AAS.” (page 24, line 6).

It is my opinion that –unless there is strict, 100% reliable and effective containment (including under adverse natural impacts such as hurricanes, torrential floods, tidal waves, earthquakes etc) -  a full ERA or EIS has to be undertaken (page 24, line 24), which would need to cover the whole spectrum of potential receiving environments and the full range of potential hazards. Whilst the concept/approach of “pathway to harm” (page 23, line 28) is very helpful, it needs further examples or pathways than are given in the current draft. For example, incidents and accidental release during transport; someone taking some hatched fingerlings away with them from facilities or during transport; etc. It is important to underline the need to take all possibilities -however likely or unlikely they may seem- into account, investigate what might go wrong and make sure none of this can happen.

It would be helpful and I think necessary to add these above steps and requirements also to the section on ‘ornamental’ LM fish of the current draft. This would also include the need to take into account and fully assess the impacts should the LMFish ‘return’ to its own natural environment / place of origin. There would need to be clarity under which strict containment conditions such ERA would not be required – possibly in agreement with the regulators in the countries where this fish naturally occurs, in line with environmental protection goals.  These are challenges so far not fully discussed in the draft.

Some briefer additional points.

(a) The draft does not mention precaution, precautionary approach or precautionary principle once in its text – despite it being central to risk assessment and to the Cartagena Protocol on Biosafety. It is important to remedy this, as also pointed out by Abdallah Mkindi [#10151].

(b) Whilst the draft underlines the importance and gives examples for also considering pleiotropic effects, which I appreciate, it fails to also refer to process induced changes, i.e. due to the insertion site, possible gene or gene regulation disruption, small mutations or alterations arisen as part of the genetic engineering procedures. It would also be helpful to include some data on the occurrence and frequency of such (transformation induced) changes and how reliable these data are – and if there have been any systematic assessments.

(c) I would appreciate and urge a change in the use of language where it implies a positive, but would only be seen as such from one specific view point, e.g. from a business point of view or human use perspective view. I regard “improve” as such a word. It is more appropriate to say enhance. I am sure that from an ecological and ecosystem point of view such “improvements” (as referred to in the draft) would mostly not be perceived or judged as improvements. A purely descriptive word like alter, enhance, upregulate, reduce, enlarge are much more helpful.

(d) An additional challenge to risk assessment are also the increasing changes and unpredictabilities due to climate change / global warming, both on land, in rivers and lakes as well as in oceans (for example change of water currents (strength, direction, temperature, salinity, acidity, oxygen level); altered striation of water, altered biodiversity and ecology) – as well as the resulting pressures to adapt.

I agree with Viana Victoria Barceló [#10142], in that any guidance document developed should also cover risk management and monitoring measures that can be applied. This could include how for example to achieve strict containment? With regards to monitoring, this also relates to Nikolay’s point [#10140] of assuming there may have been accidental releases but not being aware of any of these have led to establishment into the environment or to adverse effects. So what would be the time scale where one would expect effects? Or establishment? And where? There is a guidance on monitoring undertaken by a previous AHTEG that could be a resource here, though there would need to be more LMF specific points elaborated for an LMF guidance document.

Thank you all for this interesting forum and thank you Marja for guiding us through it.

With kind regards, Ricarda

Dear Marja and colleagues,

First, thank you Marja and all of the contributors for your thoughts on this topic. It has been interesting and enlightening to follow the discussion. I had not anticipated offering any additional comments as the Forum comes to a close. However, I would like to address two points made by Ms. Steinbrecher [#10214].

First, in my opinion, an EIS of the scope suggested by Ms. Steinbrecher, i.e.  “…which would need to cover the whole spectrum of potential receiving environments and the full range of potential hazards” would be an exercise in conjecture. As is discussed in the Draft Report and referred to by Ms. Steinbrecher and several other contributors, the data needed to conduct such a broadly targeted ERA do not exist and are not likely to exist. The guidance’s identified in the Draft Report are adequate for conducting targeted, meaningful environmental assessments, including assessing the potential hazard arising from the release or escape of a LM fish in or near its native environment. Mandating a full EIS and scoped to take into account all possible receiving environments would not mitigate the environmental risk of a LM fish in any way.

Secondly, several contributors, including Ms. Steinbrucher, commented on the need to assess and account for risks of inadequate containment. I agree with this statement and assert that it is addressed in several of the guidance documents identified in the Draft Report. The approvals for AquAdvantage salmon in the United States and Canada are predicated on the ability to contain the fish and prevent it from entering the environment. This includes considering the effects of natural disaster and malicious release and having adequate measures in place for all circumstances.

In 2018, AquaBounty received approval to produce transgenic salmon at its facility in the State of Indiana. The ERA included details regarding containment measures, evaluation of risks posed by natural disasters, and security measures in place to prevent a malicious release of the salmon. The EA is publicly available and can be downloaded from the U.S. Food & Drug Administration website with this link: https://www.fda.gov/media/112655/download. I have also attached the EA as a reference.

Thank you again for the opportunity to participate in the Forum and best regards to all, Mark

Dear participants,

The forum will close in less than two hours and I would like to take this opportunity to share some additional reflections of the discussions since my posting of this morning.

First of all, I would like to say that your comments and the information shared has been very interesting and will be certainly useful for the next steps, which are the preparation of the final version of the report, as well as the meeting of the AHTEG.

The following are some points (amongst others) that have been raised during the forum:
- The study presents a good overview of the LM fish and the existing guidance documents are well described;
- The importance of capacity-building and information sharing were highlighted as authorities may not have experience with assessing LM fish;
- The case-by-case approach was stressed, and there were different views regarding whether LM fish pose challenges to existing frameworks, guidance and methodologies;
- Challenges and uncertainties may exist for the complexities related to aquatic environments, fish biology, mobility and establishment of comparators; and
- The authors could also consider including the criteria used to select respondents to the survey.

As I said, these are only some of the issues that were discussed, and therefore this is not meant to be an exhaustive list.  I will work with the Secretariat to compile your comments into a report.

I would also like to thank you for your active participation. Your perspectives and input will assist the work of the AHTEG and forthcoming discussions under the Cartagena Protocol.

Many thanks, all the best,

Marja