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Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5631]
POSTED ON BEHALF OF FRANCISCA ACEVEDO (MODERATOR)

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Dear participants of the “Open-ended Online Forum and the AHTEG on Risk Assessment and Risk Management”, and Dear Secretariat.:


First of all, I would like to thank the Secretariat for having invited me to moderate this new two week session and having prepared a very clear and concise concept note on our duties for the next two weeks!

I ask you all to bear with me during these two weeks, and to positively contribute towards our goal.


>>> We need to come up with a proposal regarding “the what, the how and the when” of a relevant, accessible, easy and usable mechanism of developing further guidance on a “prioritized set of topics” (see the consolidate list of topics under the background documents for the discussion at https://bch.cbd.int/onlineconferences/forum_ra/discussion.shtml).

Just for ease on following your contributions, I would like to suggest you separate and classify them under:

I. the mechanism proposed with respect to developing further guidance,

II. the selection of up to three topics (your preferred 3!) including the reasons you have on why these seem to be the most relevant/urgent to you,

III. comments on other proposals/contributions made by your peers during this two week session.


I will start out this discussion with some of my own contributions on these issues, as an example of the type of contributions we are aiming at:


** I. I suggest that the following mechanism could be analyzed as a viable way forward on how to deal with “further guidance development”:

a) The identification of clearly defined components and specific activities necessary for any further guidance development on any topic.

b) The conformation of an open online forum (with a specific time frame for each activity) of experts on X or Y topic (including the “Open-ended Online Forum and the AHTEG on Risk Assessment and Risk Management”, the roster of experts, other national experts on the X or Y topic, etc) whose goal would be to “follow the roadmap through its different segments or steps” with the guide of a moderator or chair and the Secretariat and identify what specific issues need to be recognized/taken into account when doing risk assessment and risk management (RA&RM) on each topic being discussed.


** II. My own prioritization:

“Risk assessment of living modified organisms introduced in centers of origin and genetic diversity”

Why: a) There is a higher probability of gene flow occurring between the LMO released into the environment and the native cultivars and/or the wild relatives when this is done in areas which include centers of origin and genetic diversity,

b) these areas must be preserved and protected because the genetic diversity present has a high potential of being a key provider of solutions to unknown and unprecedented problems (abiotic and biotic),

c) gene flow in these circumstances, and possible introgression of the genetic constructs has unknown consequences.


** III. I´ll bring up some of my own opinions once others start giving their own.



I hope this initial input is clear enough and helps igniting the engines towards our discussions for the next two weeks!

Un abrazo,
Fran
posted on 2014-02-24 14:33 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5633]
Due to the importance for our countries I would like to propose two theme for discution. "Co-existence" between LMOs and non-LMOs in the context of small scale farming as the first item for discussion. Also consider very important to start the discussion about Risk assessment of living modified organisms produced through synthetic biology;
posted on 2014-02-24 17:27 UTC by Prof. Jorge Madriz, Costa Rica
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5635]
Dear Francisca,

Thanks for opening this new discussion and  for your willingness to moderate it. I hope these discussions are as interesting as the previous ones.

I am also interested in discussing the use of OVMs in centers of origin and diversification. As you know,  the Honduran Government approved  commercial production of GM maize in 2003 and so far we have seen several benefits that will be published shortly. The project looks at the adoption of GM corn in Honduras and its socio-economic implications over a decade. This is a collaboration between Zamorano University, IFPRI (Jose Falck naturally) and the University of California Davis. The project is sponsored by the Templeton Foundation.

Having said that, the group may also consider that the topic of introducing OVMs in a center of origin is not relevant to  many countries and does not warrant too much discussion. Furthermore, the issues we consider for the risk assessment already  apply for different environments,  including centers of origin. From personal experience in Central  America, some of these  discussions  often lead to some kind of validation of a desired  prohibition to use GM in centers of origin on ideological grounds.  Much of Mesoamerica has been stuck in this debate for over a decade now, without moving forward, and it seems, without considering plenty of  the new evidence published in the literature.

Please note the following:

“The Nuffield Council on Bioethics has suggested that possible
introgression of foreign genetic material into related species
in centres of crop biodiversity is insufficient justification
for barring GM crop deployment in the developing world. The
Council considers that applying the precautionary approach
and forgoing possible benefits invokes the fallacy of thinking
that doing nothing in itself precludes any risk to the poor”

The reference is on page 34 of a very comprehensive  document from the  EU research on GMOs on “A decade of EU-funded GMO research”.  I have the pdf file to share for anyone interested or you can find it on
http://ec.europa.eu/research/research-eu

Here are some highlights from the introduction of this important report,  which should help us all with our work.  One of the most interesting facts for me is that the EU has spent more than EUR 200 million since 2001 in several fields  of biosafety research, including developing methods for risk assessment of GMOs.  There are no conclusions of harm to the environment or  to human health caused by GMOs.  How much more  effort, time  and money do we need to spend to confirm this?

I look forward to a fruitful but  coherent discussion on how to best  spend taxpayers money on continuing with these revolving questions of biosafety.

Best regards to all from Honduras.

Maria Mercedes Roca
On behalf of the Honduran Biosafety Commission
posted on 2014-02-25 03:46 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5635 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5636]
Here are some important highlightf from the EU report I mentioned in my earlier post:


A DECADE OF EU-FUNDED GMO RESEARCH (2001 – 2010)

Highlights from the Introduction and Foreword

As with all new technologies, the potential risks and benefits
must be identified and quantified. On the basis of the precautionary
principle, the EU has developed research programmes
and practices to evaluate the risks and benefits to animal or
public health and the environment of GMOs. Other international
organisations like the OECD follow the same principles, not only
to ensure consumer safety, but also to harmonise risk assessment
approaches and facilitate the international trade of agricultural
commodities and industrial products.

This is the second volume of results studying different aspects
of genetically modified organisms. It is part of an initiative of
research programmes and activities initiated 25 years ago in
response to policymakers’ and public concerns regarding the
safety of the technology. The reader will note that recent projects
dealing with the development of new products and processes
based on GMO technology fully integrate safety assessments
in their conception, experimentation and development.

This publication reviews the last ten years of research projects
launched under the Framework Programmes for research,
technological development and demonstration activities,
focusing on safety aspects of GMOs but also taking account
of developments in the field over time.

More than EUR 200 million has been invested through the Framework
Programmes since the year 2001, developing agricultural
management techniques for co-existence, tools for detection
in and analysis of food and feed, and methods for risk assessment
of GMOs, thus responding to the need of farmers, consumers,
industry and policymakers.

Sound policy, while needing to take account of a wide range
of views, must be based on sound science. Accordingly, we
will continue to support science on Biotechnologies, including
GMOs, in order to ensure that evidence is available for
a constructive debate in our societies.
posted on 2014-02-25 03:50 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5636 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5638]
Dear colleagues,

Here is another important message I think we should all consider before we embark on our discussions this week. Forgive me if it seems I am  de-focousing our task. The reason I am doing so, is because I am teaching a Critical Thinking class to my  agricultural and environmental students this week.  All come from developing countries in Latin America. The first point I make to my students  is to deconstruct fallacies deeply ingrained in humans,  such as “the world is flat”, “men are superior to women”, “homosexuals are deviant and aberrant”, “GMOs are not natural and cause harm”.

I invite you to read the foreword  of the Nuffield Council for Bioethics published in 2003. A decade later, and after having spent more than 300 million Euros (in the EU alone) we are still stuck on the very same arguments. We cannot afford to keep the status quo regarding a prohibition to GM crops in most developing countries. We must move on. At least in Honduras, we have. 

Please forgive me. You may,  if you read the scientific and bioethics  literature.

Maria


The use of Genetically Modified crops in developing countries:
a follow-up discussion paper

Foreword

In its 1999 Report Genetically modified crops: ethical and social issues the Council concluded that there is a moral imperative to make GM crops readily and economically available to people in
developing countries who want them.

The Council conducts regular follow-ups of all its publications. There was a particular need to do so in the case of the Report on GM crops because of the many developments in science and policy which have taken place over the past four years. We undertook this task in time to contribute to the national debate on the use of GM crops which was sponsored by the UK Government in 2003. We published a draft Discussion Paper in June 2003 and invited comments from interested individuals, organisations and the wider public in developed and developing countries. Eighty-three responses were received. The valuable points they made are reflected in this final version of the Paper.

I have been struck by the extent to which the public debate on GM crops continues to be highly polarised in a partisan way. Instead of a sober estimate of the risks and benefits of GM crops on a case by case basis, there is a view that any attempt to even consider their potential is unconscionable.

This cannot be right. All forms of agriculture affect human health and the environment, including organic agriculture.

GM technology needs to be considered not in the abstract, but by means of comparing its short and long term impact with the impacts of alternative technologies. In this Discussion Paper we provide examples with current and potential benefits to resource-poor farmers and communities. There may well be situations in which such benefits are outweighed by associated risks of GM technology. Intelligent public policy will seek to discriminate between the cases and find ways of developing regulation so as to help those in most need.

This is particularly important in developing countries, where issues of food security and
agricultural development press hard. All too often, the situation of agricultural communities
threatens to become worse, not better. The status quo is not an option unless we are prepared
to see increased suffering and destitution. A precautionary approach may mean going ahead
with novel technologies rather than stalling, as is conventionally assumed when the approach is
applied to agricultural practice in wealthy societies. It cannot be responsible to render a technology unavailable to those whose needs are urgent. Nor can it be responsible to be partisan in a debate where empirical evidence should be decisive in settling the question.

I hope that the Paper will help to clarify these complex issues and encourage constructive
discussion. I also hope that the conclusions and recommendations will provide guidance for policy
makers and others who have to make difficult judgments about the use of GM crops.

Finally, on behalf of the Council I should like to express our appreciation to the members of the
Working Group: Professor Derek Burke, Professor Mike Gale, Professor Michael Lipton and
Professor Albert Weale, who devoted enormous amounts of their time to this review, to those
listed in the Acknowledgments who assisted their work, and to the individuals and organisations
who commented on the draft Discussion Paper.
.
Professor Bob Hepple QC FBA
Chairman
posted on 2014-02-25 17:23 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5640]
Dear Francesca, dear All,

First I would like to thank Francesca for willingness to moderate the RA session.

My choose for the three priority topics from the list is the following:
• Risk assessment for living modified organisms created through use of dsRNA techniques.
• Guidance on integrating human health into the environmental risk assessment;
• Risk assessment of living modified microorganisms and viruses.

The human health and related dsRNA technics and also microorganisms and viruses as part of risk assessment procedures in my opinion should be pointed in the next period. A special guidelines that reflect these topics would be very helpful to assist countries with the RA procedures and to ensure the informed decision making. These three topics are related to all kind of LMOs, as plants, animals or microorganisms. At the same time, ensuring public participatory and consultation, we know that the human health issues are the focus questions and concerns usually requested by public, media, NGOs civil society etc. The health related issues involved in the RA procedures would be very helpful to compliment with the socio-economic assessment procedures as the possible component part of decision making if the countries will consider them valuable and requested at domestic level.

As the following possible procedure for developing the special guidelines for the three selected topics, I would suggest to mandate the AHTEG on RA with the following drafting of the specific guidelines that can be discussed and improved under the on-line forum discussions and the following testing of the usefulness and practicability by the countries.

In the on-line forums the guides might be updated and improved by large participation of the experts, countries and organizations that have practical experience in this field. The reference materials and international experience would be valuable to be used for the developing of the selected topics of the further special guidelines. The guidelines also should be in conceptual line with the Roadmap on RA and reflect the principles and provisions of the Cartagena Protocol on Biosafety.

Best,
Angela
posted on 2014-02-25 18:17 UTC by Angela Lozan
This is a reply to 5640 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5641]
Thank you Francisca for moderating this forum

I think there is a need to develop guidelines for several new guilines on RA. I would like to point out some of then:

1. Health impacts of GMOs and pesticides that are part of the technology package that accompanies them, such as herbicides. LMOs which are engineered to be resistant to herbicides are meaningless without the use of this agrochemicals

2. Since weeds has become e resistant to the herbicide glyphosate , they are about to be adopted new herbicides with stacked genes. Although there is a guide that stacking genes, I think it is important to have guidelines that take into account the synergistic impacts of different herbicides and those with their transgenes

3. I agree with Angela on the need to develop guidelines for new technology LMOs using the dsRNA , the sisgénesis and synthetic biology

4. I also agree with Jorge Madriz to development guides tha assess the impacts of transgenic crops on small producers, and Francisca on the importance of good guides on centers of origin. While the European Union considers that this is not a major issue for them (as I undertood from   Mercedes Roca message), it is in Latin American region, with the largest number of wild relatives of crops and landraces of important crops, some of then have being already object of genetic manipulation (like corn and potatoes, both of vital importance for the local communities)

5. Because so far all have been released transgenic massively have been used as feed, it is necessary to have guides on new transgenic crops that are to be used as a direct human food (such as GM banana, wheat, etc.), since these LMOs need to be assesed with greater scrutiny than previous.

Thank you

Elizabeth Bravo
RALLT
posted on 2014-02-25 22:22 UTC by Dr. Elizabeth Bravo, Acción Ecológica, Ecuador
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5642]
Dear Francisca, dear All

Thank you Francisca for taking the time to again moderate this important forum. Colleagues, thank you for taking the time to participate.

I. the mechanism proposed with respect to developing further guidance
I would like to endorse the continued use of the online forum format for some of the work. I believe it has been a useful way to improve the text and set objectives. However, it is not an adequate alternative to face-to-face meetings for some tasks.
Consideration should be given to making participation in face-to-face meetings more accessible to the different legitimate stakeholders in the process. As far as I can recall, all AHTEG meetings since 2008 have been in the Northern Hemisphere and most in Canada or Europe. As the AHTEG is work relevant to governments and industry, perhaps it could be expected that cases for financial support from a participant’s organisation to represent them would be easier to make than it is for participants considered qualified but from academia and to some extent civil society as well.
Before we recommend further work on the existing guidance, I would like to see the results of the current round of testing. If substantial work is required following the next round, then I agree that it is important to undertake this work. Otherwise, I suggest that the emphasis be on developing guidance on specialist topics such as those nominated by Angela Lozan and Elizabeth Bravo.

II-III. the selection of up to three topics (your preferred 3!) including the reasons you have on why these seem to be the most relevant/urgent to you and comments on other contributions

I endorse Angela Lozan’s list of 3 in its entirety. Guidance on:
• integrating human health into the environmental risk assessment;
• the risk assessment for living modified organisms created through use of dsRNA techniques, engineered to produce dsRNA or exposed to dsRNA;
• Risk assessment of living modified microorganisms and viruses.

I look forward to other contributions and may be persuaded to alter my list as a result!

Best wishes
Jack
posted on 2014-02-26 00:22 UTC by Mr. Jack Heinemann, University of Canterbury
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5643]
Dear Francisca,
Thank you for moderating the forum, and for providing some structure for people to use in providing their comments.  As always, it is difficult to figure out the best place to post your response in the long thread of replies, so I will do my best.

I would like to make comments on points I. and III. 

Regarding the mechanism for developing further guidance, I continue to be aware that participants in this forum and the AHTEG have vastly different notions of the purpose for generating such guidance, and what that guidance is expected to accomplish.  This has ramifications for how the document should be constructed and organized, and I think the lack of common understanding on what a guidance document actually is, will continue to hamper the productivity of this forum.  While the opportunity for discussion and exchange provided by these online forums is always welcome, I think there has been something lost when these discussions are translated into written guidance documents.  I am afraid that, because of this, I can't recommend topics for further development in this forum (point II.)

I will briefly comment on some of the suggestions that have already been proposed (point III).  While all of the suggestions have identified important topics, many of them are outside the scope of what we are expected to deal with in this forum.  It's important to remember that the Protocol deals with the need for assessing risks to the conservation and sustainable use of biodiversity from the transboundary movement of LMOs, and this is a forum on risk assessment under the Protocol.  So, while we may all agree that impacts of herbicides, and considerations of co-existence are important, these are better addressed elsewhere.  We also need to consider that the guidance cannot be a substitute for the setting of national protection goals by individual countries, and cannot replace the application of case by case risk assessments.

Again, I appreciate the opportunity to comment, and I look forward to reading the thoughts of others as the forum continues.

Best,
Andrew
(edited on 2014-02-26 01:39 UTC by Andrew Roberts)
posted on 2014-02-26 01:36 UTC by Mr. Andrew Roberts, International Life Sciences Institute Research Foundation
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5644]
Dear colleagues
I think extending the mandate of the AHTEG together with gathering inputs using online fora would provide the best cost effective combination to further produce guidance documents on risk assessment/risk management. The AHTEG should as much as possible depend on online tools for discussing and elaborating on the documents however, this should not be an alternative to face to face meetings.

With regards to a list of 3 preferred topics for the development of further guidance document. I would suggest the following:
• “Co-existence” between LMOs and non-LMOs in the context of small-scale farming
• Risk assessment and risk management of transgenic microorganisms and viruses
• Guidance on integrating human health into the environmental risk assessment
I also believe that the issue of “Risk assessment and risk management of transgenic fish” is highly important

Warm regards,
O.A.ElKawy
posted on 2014-02-26 04:20 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5647]
Dear participants!
Good morning!!!!!! First of all, let me thank all of you who have already given input to our two week discussion session!!!! Very motivating indeed!
I would like to encourage the rest of you to make an effort now and include comments on the issues that are on the table for discussion.
I would also like to invite you all to please try, as much as possible, to follow the structure proposed (some of you have up to now and others haven´t) for ease of following your inputs.
Again, I thank you all for your contributions...they surely will be extremely useful to advance in our task.
Un abrazo para todos desde México!
Francisca
posted on 2014-02-26 15:18 UTC by Ms. Francisca Acevedo, Mexico
This is a reply to 5635 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5648]
Dear María Mereceds:
I was unable to find the pdf file. Could you inlcude it here for all of us?
Gracias de antemano por tu ayuda!
Francisca
posted on 2014-02-26 15:20 UTC by Ms. Francisca Acevedo, Mexico
This is a reply to 5648 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5649]
Dear Francisca,

Apologies for not including the  attachment for the report for the Nuffiled Council on Bioethics. Here it is.  I also attached the findings of a decade of EU-funded research on GMOs (EUR 200 million spent).

Before we embark on further guidelines, rules and regulations that will demand much of our time, and effort and money (time costs money),  I also include an important recent  letter from the Chairman of  PRRI   (Public Research Regulatory Initiative)  and other associations in Europe,   addressed to the highest level of the European Commission, Council and Parliament.  The signatories   express their deep concern about the effects  EU GMO policies and regulations have on modern biotechnology’s potential to strengthen sustainable food production.

The work of our group also has important consequences - good and bad.  We are not just “the public” expressing our personal views.  We have a huge responsibility and a moral duty to follow strict scientific guidelines and not to create our own rules that many countries will follow – especially poor ones. These new rules may continue to lead to more inacction and prohibitions.

We cannot continue to intensify regulatory requirements without proper justification and I feel as a group, we are ignoring the evidence.  Furthermore, I feel the direction some members of the AHTEG want to follow in our task ahead lacks (quoting the letter) :

“  a scientifically sound scenario of risk, but just with reference to undefined ‘uncertainties’. The fact that some authorities keep asking for more and more scientific data without scientific justification seems to be  based on what is commonly known as the ‘genomic misconception’, i.e. the idea that genetic transformation causes more unintended changes in the genomes than natural crossing.  Solid scientific data shows that this is a misconception”

This misconception, like religious beliefs, seems deeply ingrained in the human psyche and is difficult to shake.  But as a group of experts charged with a very delicate task, it is our duty to read the appropriate literature, continually educate ourselves,  think critically and justly and act accordingly, putting our ideologies or political inclinations aside.

As  a representative from a small developing country,  where resources are very  limited  and challenges are huge, I make no apologies for continually reminding our group of these facts.

I hope you will forgive my insistence.

Maria Mercedes
posted on 2014-02-26 19:22 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5641 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5650]
Dear Elizabeth,

It may give you some peace of mind to read the follwing review:

Review of biosafety  GM food and GM Crops, 1,780 articles reviewed http://www.ncbi.nlm.nih.gov/pubmed/24041244

I include a summary of the review, in Spanish, that you may find useful to circulate among your Spanish speaking colleagues. I invite all of us not ignore the evidence.

Respectfuly yours,

Maria Mercedes

---------------------------------------------------------------------------------------
Más de 1780 publicaciones científicas confirman la inocuidad de los cultivos transgénicos disponibles en la actualidad


La tecnología para mejorar las características de las plantas por ingeniería genética está celebrando su aniversario número 30 y uno de los mayores logros ha sido el desarrollo de los cultivos transgénicos.

La seguridad e inocuidad de estos cultivos ha sido crucial para su adopción y a su vez ha sido objeto de un intenso trabajo de investigación, a menudo ignorado por la mayor parte de la ciudadanía en el debate público.

En septiembre de 2013 científicos italianos llevaron a cabo y publicaron en la revista científica “Critical Reviews in Biotechnology” una revisión y análisis de la literatura científica sobre la inocuidad de los cultivos transgénicos desarrollada durante los últimos 10 años, generando un listado de más de 1.780 publicaciones.

Los trabajos científicos recopilados analizan la interacción de los cultivos transgénicos con el medio ambiente (biodivesidad, flujo génico), alcanzando los 847 reportes; con la salud humana y animal (consumo, equivalencia sustancial, trazabilidad), con 770 reportes; y revisiones y comentarios críticos agrupados como literatura general con 166 publicaciones.

La revisión científica concluye que hasta el momento no se han detectado riesgos significativos directamente relacionados con el uso de cultivos transgénicos, sin embargo, y a pesar de esta información, la discusión sobre los cultivos transgénicos sigue siendo intensa.

Los autores concluyen que es necesario mejorar la eficacia de la comunicación científica hacia el público en general, resaltando la inocuidad de los cultivos transgénicos disponibles, con el fin de generar un impacto positivo significativo en el futuro de la biotecnología agrícola. El listado total de publicaciones científicas está a disposición de los investigadores, comunicadores y profesores de todos los niveles para ayudar a crear una opinión pública informada y equilibrada sobre el uso de los cultivos transgénicos en la agricultura.
posted on 2014-02-26 19:36 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5643 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5651]
See post after Francisca's below.
(edited on 2014-02-26 20:02 UTC by Thomas Nickson)
posted on 2014-02-26 20:00 UTC by Mr. Thomas Nickson, Consultant
This is a reply to 5647 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5652]
Dear Francisca,

Thank you once again for taking on the challenge of moderating this forum.  Your dedication and commitment are truly appreciated.

Dear all,

With regards to the topic at hand, I continue to hold the position that additional guidance is premature until we have successfully completed good, basic guidance.  A good roadmap that describes risk assessment under the Protocol and integrates well-established principles and processes will meet the needs of Parties.  It will also provide needed insights into how to approach risk assessment of products like GM microbes, technologies like dsRNA and issues like centers of origin.

With regard to the best path forward, I would like to see us complete an acceptable roadmap that meets the needs of Parties and reflects the best practices and experiences to date.  More forums or other discussion formats create unnecessary costs and a strain on the stretched resources like those at the Secretariat's office.

Unfortunately, we seen to be held hostage to a process that seems to have a life of its own.  This process is getting more cumbersome and complex by suggesting that topics like coexistence and human health risk assessment may be within scope.  It would be most welcome if boundaries would be placed on the topics based on relevance to Articles 15/16 and especially Annex III. 

So, in summary, the Parties in Hyderabad recognized that additional guidance was the lowest priority work in the biennium.  Let's focus our energy to complete a roadmap that meets the needs of the Parties, especially those that have little to no experience with risk assessment of LMOs. 

Thanks and best regards,
Tom
posted on 2014-02-26 20:01 UTC by Mr. Thomas Nickson, Consultant
This is a reply to 5647 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5653]
Hi Dear Francisca, thank you very much for all your efforts!

Most of us agree in the importance of rigorous safety assessment and at the same time making available the technological advances for sustainable production for small farmers, especially in developing countries. Colombia planted 102000 Ha of GM crops in 2013, including corn, cotton and flowers, and there is increasing interest in growers due to some advantages they perceive and the experience acquired with these crops during the years.
The social and economic costs of implementing more and more regulations are very high and in many cases can delay developments in sustainable agricultural production, mainly in countries with limited resources. Therefore, what is needed as several messages point out is to move forward and try to simplify the assessment.  I agree that a good, basic guidance is what is needed in the first place. I also agree with Maria Mercedes Roca (Honduras) in our responsibility with society in relation to follow strict scientific guidelines, not to increase regulatory requirements. 

Due to the increasing adoption of GM crops, the main topics to consider are
• Socio-economic considerations in the context of environmental risk assessment.
• Risk assessment of living modified organisms introduced in centers of origin and genetic diversity
• Co-existence between LMOs and non-LMOs in the context of small scale farming.

Un gran abrazo,
Elizabeth
posted on 2014-02-26 22:01 UTC by Professor Elizabeth Hodson, Colombia
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5654]
Dear All,

First of all thank you very much to Francisca for moderating this discussion forum.

I would like to take this opportunity to express some considerations that reflect my views and those of my colleagues following this issue. At this time I will react only on the first issue delineated by Fransisca, i.e. the mechanism proposed with respect to developing further guidance.

First, as already pointed out by some participants, we should keep in mind that the Roadmap and the four specific guidance that were developed so far (stacked genes, LM plants tolerant to abiotic stress, LM trees and LM mosquitoes) are still subject to practical testing. Therefore at this point of time their adequacy in terms of structure, content, usefulness, expectation for the users and relevance to the objectives of the Protocol is still a matter of discussion.
Starting developing new guidance on specific issues without exactly knowing if the tools developed previously (and the process for developping them) are really effective does not seem very pragmatic and realistic.

Second, we are of the opinion that developing guidance on specific issues make sense only if the Roadmap (that already describes in detail the principles and methodology of the risk assessment) has been considered insufficient to support the risk assessment of these specific issues. This implies that any possible topic identified for the development of further guidance should be first assessed using the current Roadmap to identify possible weaknesses or missing elements that would trigger the need for additional guidance. This exercise could be done using relevant (eventually theoretical) case-studies. This seems the most appropriate way to provide scientifically-sound arguments why new guidance should be developed.

Third, we share the views expressed by others that time and budget constraints should also be considered. There are many processes currently running in parallel in the frame of the implementation of the Cartagena Protocol and contributing actively and efficiently to these processes becomes very challenging. We should ask ourselves whether developing new guidance, in particular on these “prioritized set of topics”, is really a priority to meet the objectives of the Protocol. This is clearly an issue to be clarified at COP-MOP-7.

Thank you very much again for this opportunity to comment on this important topic.

Looking forward to other contributions.

Kind regards,

Didier
posted on 2014-02-27 09:01 UTC by Didier Breyer
This is a reply to 5654 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5655]
Dear All,
While I agree with others who proposed perfecting the Road map, I am of the opinion that guidance be developed in the areas of:
i) Co-existence between LMOs and non-LMOs and Channel of LMOs Distribution,
ii) Socio-economic considerations in the context of decision making process

Its important to always have it in mind that the essence of modern biotechnology is to solve problems and enhance economic benefit among others benefits, while ensure that potential adverse impacts are prevented or eliminated. It would therefore be reasonable to commit funds in developing  sustainable documents  that would enhance particularly developing countries in embracing the technology and tapping on the benefits with confidence and safety.
Thank you All.

Rufus Ebegba,
National Biosafety Office,
Federal Ministry of Environment,
Abuja-Nigeria
posted on 2014-02-27 10:04 UTC by Dr. Rufus Eseoghene Ebegba, Nigeria
This is a reply to 5655 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5656]
Dear Francisca, thanks for moderating this discussion.

Dear all, I will not rephrase the posted messages that presented concerns about developing new guidance without exactly knowing if the one(s) that were already developed were usefull and or complete. 
Also, I agree with the posted messages informing their opinion that, developing guidance on specifc issues could be needed – if needed – after testing the Roadmap  and considering if this Roadmap is (in)sufficient to support ERA.

So, on Topic I. (Francisca´s message) I agree with the points presented/ explained by Andrew (#5643), and I will not consider any priority in topic II. since I think that additional guidance is premature.

Best

Deise
posted on 2014-02-27 12:13 UTC by Dr. Deise Maria Fontana Capalbo, Brazil
This is a reply to 5643 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5657]
I also extend my thanks to Francisca and to other colleagues who have already posted to this list.

Since I am not directly involved in testing the guidance documents, I will comment on the request to suggest 3 areas for further work.  I agree with some prior postings that we should look at:

• integrating human health (and socioeconomic impacts) into the environmental risk assessment;
• the risk assessment for living modified organisms created through use of dsRNA techniques, engineered to produce dsRNA or
exposed to dsRNA;
• Risk assessment of living modified microorganisms and viruses.

Please note that I have expanded the first point to include SEC.  I have participated in on-line expert forums such as this one dealing with incorporating Art. 26 (on SEC) and I know from professional experience that failure to include impacts in these realms when doing an assessment can easily lead to political strife when the assessment is made public.  People are concerned about the impacts LMOs may have on their health and economic well-being and social stability, and government regulators must take these arenas into account if their work is to be meaningful and useful.
posted on 2014-02-27 18:21 UTC by Dr. Philip L. Bereano, University of Washington
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5658]
We would like to thank Francisca Acevedo for taking the responsibility of moderating this discussion.
In this contribution we will focus on the first question that she raises in her posting: the mechanism proposed with respect to developing further guidance. The question is: "What process and timeframe could be put in place for the development of such guidance?"

We propose the following considerations for the process:

1) COP-MOP 7 will take the decision whether further guidance will be developed, and for which topics, and it will also decide on the process.

2) COP-MOP has already decided that further guidance should take care of the needs of the Parties; these can be deduced from their responses to the testing of the guidance. A careful synthesis should be made of these results, that leads to conclusions about strong and weak points of the guidance documents that have been drafted until now. These conclusions first have to be taken into account when new guidance will be drafted.
For instance, we have pointed out in our test results that the present guidance lacks consistency in structure. The presented information does not follow the structure of the respective steps in the risk assessment. It also leaves ambiguity how to mutually use Parts I and II for the specific types of LMOs and traits discussed in Part II. The guidance could gain a lot of usefulness if relevant examples would be given to underpin various points to consider. These examples could address experiences gained with LMOs in risk assessment and history of use; these topics are now omitted.
We agree with previous participants of this online forum that at this moment it would be wise to first evaluate the present guidance and then address new  topics  for further guidance.

3) Of the potential topics collated in the list provided for this discussion, we would favor 'Risk assessment of living modified microorganisms and viruses'. The reason for this is that we consider   the task of our guidance documents is to lay the fundaments for science based environmental risk assessment, so that users of these documents get a solid basis for their risk assessment discussions. Basic topics are more suited for that purpose than new and sometimes controversial topics where discussions are in full swing, such as the use of LMOs for production of pharmaceutical and industrial
products, the use of synthetic biology and the use of dsRNA techniques.

Regards,

Boet
posted on 2014-02-28 10:24 UTC by Ms. Boet Glandorf, Netherlands
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5659]
POSTED ON BEHALF OF HIROSHI YOSHIKURA

-----

In this round of discussion, I found many opinions, which this group should pay serious attention to: a) concern on developing new guidance under the situation that the existing guidance is under testing (Dr. J. Heinemann, Dr. Breyer); b) lack of common understanding on what a guidance document is (Dr. A. Roberts); and c) incompletion of guidance acceptable to members (T. Nickson, Dr. Denise Maria Fontana Capalbo).

I really appreciate Dr. Maria Mercedes Roca’ comment expressing her doubt on validity of “center of origin”, which was, if my memory is correct, coined by Nikolai Vavilov during his investigation of crop plant origin. To my knowledge, he never meant that the term is for living organisms in general. I also appreciate her citing of message from Nuffiled Council on Bioethics.

In the past 14 years since 2000 when Cartagena protocol was agreed in Montreal, epidemiology of living organisms has advanced to the extent that could not be anticipated (at least to me) at that time. The advance owes lot to advancement of genomic technology (gene-wide sequencing, in particular) and new thinking on evolution and diversity of living organisms (the advancement on microbial ecology is tremendous). The message from these studies appears 1) continuing process of evolution of organisms adapting to new environment, i.e., organisms’ genes are in continuous flux, 2) complex interacting networks of living organisms of unimaginable range, 3) continuing horizontal gene transfer among different organisms, and 4) changing ecology of organisms (which are mutually interacting) under influence of human activity, climate change, etc. (JT Thompson: Relentless Evolution, 2013; D. Simberloff: Invasive Species,2013;O. Ogunseitan: Microbial Diversity, 2005; A. Arnold: Evolution through Genetic Exchange; Koonin: The Logic of Chance, 2011).

As proposed by Dr. E. Hodson, the guidelines should be simple, and they should be usable. To these ends, as I suggested before, the scope of the guidelines could be limited to LMOs derived from organisms with history of safe use, at least, for foreseeable future. This approach will allow the comparative safety assessment (delineated in Annex III) simpler and effective as it benefits the knowledge and experience accumulated during the whole history of humans. The experience can never be replaced by abstract thinking. For organisms without history, one may suggest that application of modern biotechnology to organisms without history of safe should wait until accumulation of knowledge and experience sufficient for the comparative safety assessment.
posted on 2014-02-28 13:20 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5660]
POSTED ON BEHALF OF CAROLINA VILLAFANE PALAU

-----

Dear all,

I would like to thank to Francisca, for his labor like moderator of the forum.

Considering the existence of a Risk assessment guide and that, it is a “living document”, I think it´s better to complement it with topics relating to different types of risk assessment according to specific cases.

On the other hand, for the new guide, would be better if it´s constructed with topics relative to the biosafety, but not involving risk assessment methodologies. That is, aspects like Interface between risk assessment and risk management; “Co-existence” between LMOs and non-LMOs in the context of small-scale farming; Socio-economic considerations in the context of environmental risk assessment. In the moment one of this topics becomes a concrete methodology, should be part of the Risk assessment guide.

About the three topics of main interest, I suggest for complementing the existing guide:

1. Risk assessment of living modified microorganisms and viruses;
2. Risk assessment and management of LMOs intended for introduction into unmanaged ecosystems;
3. Risk assessment of living modified organisms introduced in centers of origin and genetic diversity;

On the topics of the new guide, I consider interesting to board: the Socioeconomic considerations in the context of environmental risk assessment and I propose new topic on "the Intellectual property rights in the context of the living modified organisms and gene flow to non-modified counterparts and wild relatives.

Thanks
posted on 2014-02-28 14:19 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 5660 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5661]
Dear Francisca, dear participants, many thanks for the interesting discussion and your valuable input.
Now to the questions proposed.

I. The mechanism proposed with respect to developing further guidance.

I am fully agree with the mechanism proposed by Francisca, and see that this approach is the most effective for further guidance development.

II. The selection of up to three topics (your preferred 3!) including the reasons you have on why these seem to be the most relevant/urgent to you,

Of jointly completed list of topics I prefer the next three:

• Guidance on integrating human health into the environmental risk assessment;
Because: a) risk assessment of LMOs to human health is the integral part of the Overall risk assessment process (and this position is pointed in Cartagena Protocol); b) society primarily concerned with this issue; c) RA to human health is discussed by public as actively as environmental RA (often even more vexed point) ; c) Methodical approaches and standards on the RA for human health within the countries were developed (and improving). But we have no Guidance that will reveal the important questions that should be asked and considered during the process of  RA and particularly will help in the initial stage of problem formulation - the crucial stage of which would depend further theoretical reasoning and correctness of the laboratory experiments on RA.
• Risk assessment of living modified microorganisms and viruses.
Because: (in spite of the benefits that such organisms brings for different branches of science, medicine and industry): a) there is a high probability of environmental and human health impact; b) this organisms could cause unknown and unpredicted impacts; c) it is rather hard to the experts conducting RA but which are not microbiologist to focus on those issues that should be asked, imagine as comprehensive as possible schemes of interactions and impacts. So I see that the development of such Guidance with involvement of the scientists engaged in scientific research on this topic is very important.
• Socio-economic considerations in the context of environmental risk assessment.
Because: a) again, it is rather hard for the developers, experts and bodies responsible for LMO release, that have no economical and sociological education to capture all mechanisms which may result in LMO disclaimer (even if full tests will be done and the risks of such LMO will not be revealed); b) guidance developed with involvement of the specialists in the fields relevant to this topic will not only help at the planning stage of every RA, but even will help to the developers at the early planning developmental stage  to understand the payback of such invention and to understand is it any use trying?
III. Allow me to provide my reasoning on the item a bit later.
Sincerely, Galina.
posted on 2014-02-28 17:10 UTC by Dr. Galina Mozgova, Belarus
This is a reply to 5661 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5662]
Dear Colleagues.

I appreciate all the topics that our colleagues proposed. They are all very important. Let’s encourage the forum and the AHTEG to develop guidance on these topics. Don’t be afraid of developing guidance and risk assessment, it is an opportunity for us to look at ‘good or bad’ effect of modern technology. This process will not block the progress of our science studies but help to secure a safe world.

Of course, I have own priority of topics but that won’t block my support for other topics proposed by our colleagues. Among all the topics we had discussed, the topic on origin center is much more important for China. I think we had discussed a lot on this issue in previous discussions. I wont repeat that again.

The main topics proposed for priority are 1) Risk assessment of living modified organisms introduced in centers of origin and genetic diversity; 2) Co-existence between LMOs and non-LMOs and Channel of LMOs Distribution, and 3) integrating human health (and socioeconomic impacts) into the environmental risk assessment.

All best wishes to you!


Wei
posted on 2014-02-28 17:32 UTC by Mr. Wei Wei, China
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5663]
Dear all,
First of all, I thank Francisca Acevedo who has kindly agreed to be our moderator for this forum.
Below is my feedback on “recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment””:


I. the mechanism proposed with respect to developing further guidance:
I think Jack has proposed [in thread #5642] and I agree with him the use of the online forum for this work but it is never an adequate alternative to face-to-face meetings AHTEG tasks.

II. the selection of up to three topics:

• Socio Risk assessment of living modified microorganisms and viruses;
• Social-economic considerations in the context of environmental risk assessment.
• Risk assessment of living modified organisms introduced in centers of origin and genetic diversity;
Thank you.

Regards,

Kok Gan CHAN
University of Malaya
Malaysia
posted on 2014-03-01 00:17 UTC by Dr Kok Gan Chan, Malaysia
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5664]
Dear All,

Thanks to Francisca for accepting to moderate this round.

I very much appreciate that Francisca started with the wording of the request of the COP-MOP, i.e. a “recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment”.

Francisca proposed to address this by addressing: 

I. the mechanism with respect to developing further guidance,
II. the selection of up to three topics for further guidance,
III. comments on other contributions

Taking Francisca’s proposed step I first, I propose that we follow the mechanism that is typically followed for developing guidance in any field, i.e. by answering the following tiered questions:

1. Which new types of GMOs or applications of GMOs have emerged?

2. Are the available guidelines sufficient to assist the risk assessment outlined in Annex III for those new types of GMOs or applications? 
NB: in this context it is important to remember the following:
o The mandate of the MOP refers to risk assessment, i.e. matters of decision making such as socio-economic considerations, and matters such as co-existence, which is not a  safety issue, should not be brought into this, however interesting and important they are in themselves; 
o with “available guidelines” we refer to guidelines developed by MOP as well as other relevant international organizations (see point 3 of the general principles of risk assessment in Annex III). The OECD is a good example of such a relevant international organisation. 

3. In assessing whether the available guidance developed under the auspices of the MOP is sufficient to conduct risk assessment for the identified new types of GMOs or new applicantions, we need to ask ourselves the following questions:
 Is the approach of the guidance developed thus far adequate to guide risk assessors in conducting the risk assessment outlined in Annex III? It is in this context that MOP6 explicitly asked the existing guidance to be tested, which is currently ongoing.
 Once the MOP has concluded that the approach of the guidance developed thusfar is adequate as such, then we should ask ourselves the current roadmap suffices for risk assessment for the identified new types of GMOs and applications.

4. In case the available guidelines developed under auspices of MOP and by other relevant international organisations is deemed insufficient, then it needs to be assessed which of the relevant international organisations is best positioned to develop further guidance. 

5. Once it is concluded that the process under MOP is best positioned to develop such further guidance, then the MOP will need to decide whether and for which topics it is worthwhile to redirect resources to developing such further guidance, taking into account the potential of other organisations. The socio-economic impacts of developing guidance can be quiet significant.

Having said this, I am concerned that some interventions seem to skip the questions above, and jump to the conclusion that further guidance for a number of topics is necessary and that this needs to be developed through the process of on line conferences and AHTEG.  With this perspective I fully support the comments by Didier Breyer, Andrew Roberts, Deise Capalbo, and others in this exchange, that any listing of topics is premature.

The rush to listing topics may well be caused by the guiding questions, because instead of focusing on the mandate of the MOP (i’e. “recommendation on how to proceed”), which is well reflected in  guiding question nr I, question number II already moves to suggesting topics for which additional guidance is needed, irrespective of the outcome of question I.

I therefore propose that we bring this discussion back to the mandate of the MOP, by focusing on a proposal to MOP how to proceed, and that that proposal in fact consists of answering the tiered questions above.

Key in all this is indeed the testing of the current draft Guidance. As Jack Heinemann said, we need to see the results of the current round of testing.

Looking forward to the rest of the exchange, and wishing you all a good weekend

Piet
posted on 2014-03-01 08:36 UTC by Mr. Piet van der Meer, Ghent University, Belgium
This is a reply to 5664 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5665]
In reply to Piet van der Meer, the question of "how to proceed" is addressed by the suggestion that we make sure to fold socio-economic considerations into an assessment.  Not because they are "interesting" etc, but because Art 26 of the Protocol urges us to do so. And in the real world, the politics of GE is driven by the perceived economic and social gains and/or losses of different affected parties.

After all, every LMO which the Protocol procedures address is in front of us because of ECONOMIC considerations--some company thinks it can make money by producing and selling it. So the economic concerns of other affected parties are just as integral to assesing the overall risks (and benefits, which would also be assessed of course--and presumably have been already by one party, the company).

Assessors are responsible to society (at least in democracies) as agents of the government.  They need to assure that ALL of society's interests are reflected in their work, not just the interests of some (the more powerful).

Phil Bereano
University of Washington
Washington Biotechnology Action Council
(edited on 2014-03-01 18:41 UTC by Philip L. Bereano)
posted on 2014-03-01 18:39 UTC by Dr. Philip L. Bereano, University of Washington
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5666]
Good afternoon!!!!!
I have been reading your postings through the week and just this morning revised them all.
I am quite happy with the participation, but would like more of you starting to add new ideas into the discussion.
Only 22 participants have expressed their views, and if we have a quick review to the "list of participants" of this online forum we will see that we are not exceeding 10% participation.
Please participate in this very important issue so that the AHTEG, the Secretariat, and above all, the COP MOP have a broad enough input on the issue of the development of further guidance.
I truly believe this type of open forums should be the way forward to help all interested stakeholders engage in rich discussions in these very relevant issues. Lets prove it right!
Kind regards to all!
Francisca
posted on 2014-03-01 20:05 UTC by Ms. Francisca Acevedo, Mexico
This is a reply to 5666 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5667]
Dear All,


I warmly support Francisca’s call to participate in these online debates, as they are indeed an important tool to allow interested stakeholders to enrich the discussions.

Following Francisca’s good example of starting with the actual text of the MOP mandate, I also urge everyone to regularly go back to the actual text of the Cartagena Protocol. It is too often that  interventions seem to be based on (wishful) memory of what the CPB says, rather than on the actual wording of the CPB.

Phil Bereano’s latest intervention is an example of that, where he claims that socio-economic considerations should be folded into risk assessment, because “Art 26 of the Protocol urges us to do so”.

This is an incorrect assumption, as this is not what Article 26 urges - or even suggests.

Article 26 says that in reaching a decision on import, Parties may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of LMOS on the conservation and sustainable use of biological diversity (, especially with ...etc). 

In short, article 26 is about decision making, not about risk assessment. Moreover, article 26 confirms the logical sequence that decision making is based on the outcome of the risk assessment.  In the case the risk assessment shows an impact of LMOS on the conservation and sustainable use of biological diversity, then socio-economic considerations arising from that impact can be taken into account (consistent with...etc).

Bereano’s intervention shows more traces of poor preparation, for example where he says “After all, every LMO which the Protocol procedures address is in front of us because of ECONOMIC considerations -- some company thinks it can make money by producing and selling it”. Apart from the fact that even if this suggestion were true, it is still no reason to confuse risk assessment with socio-economic considerations, his statement shows a poor understanding of the actual situation.

The actual situation is that the players in this field are not only private sector companies, as he suggests, but also include many public research institutes that are trying to help find solutions for the severe challenges we face in agriculture, health care and the environment. These public sector scientists are not involved because they “can make money by producing and selling it”, but because they believe that their research will benefit the environment, farmers and consumers.

I do not raise this here to suggest that we should start a discussion in this forum on socio-economic considerations, because for that we have a separate on line forum and AHTEG (which in itself underlines that socio-economic considerations are separate form risk assessment).

I raise this here to urge everyone to come well prepared to this on line discussions and to regularly go back to the actual text of the Protocol.

Wishing you all a great remainder of the weekend!

Piet
posted on 2014-03-02 08:52 UTC by Mr. Piet van der Meer, Ghent University, Belgium
This is a reply to 5666 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5668]
Dear Colleagues,

I appreciate intervention of Philip L. Bereano, University of Washington [#5665] bringing considerations for socio-economic as part in risk assessment. I also consider this important keeping in mind the Art.26 and the concerns of large public, farmers and decision maker to have clearity in this aspect in the context of sustainable development.

I support interventions of Dr.Galina Mozgova, Dr.Wei Wei, Dr.Ossama El-Kawy, Dr Jack Heinemann and others in providing views and opinions on the topics related human health and socio-economics.

I understand the importance of SEC assessment in the close context with human health considerations. Here I would like to bring some arguments for needs to guiding the RA on human health considerations and as part of it the considerations related the risk assessment for living modified organisms created through use of dsRNA techniques.

Human health:

The possible penetration and residual concentration of dsRNA in animal  and human blood due to their stability in gastric circumstances may provide effects on animal and human health that may have medical treatment costs (see references).

The dsRNA also may be determined via trophic chain as GM-plant – worms – insects- mammals in ecosystems.
dsRNAs are remarkably stable in the environment; a property perhaps overlooked based on the relative instability of single stranded species of RNA (Parrott et al., 2010). Insects and worms that feed on plants that make dsRNA can take in the dsRNA through their digestive system, where it remains intact (Gordon and Waterhouse, 2007 and Mao et al., 2007). RNAi has been induced through oral exposure in several insect pests (Chen et al., 2010 and Whyard et al., 2009) and oral exposure to dsRNA has been shown to reduce the lethal effects of the Israeli Acute Paralysis Virus on honey bees (Maori et al., 2009). Worms can absorb dsRNA through their skin when dsRNA is suspended in liquid (Cogoni and Macino, 2000 and Tabara et al., 1998). Once taken up, the dsRNA can circulate throughout the body and alter gene expression in the animal (Mello and Conte, 2004). In some cases, the dsRNA taken up is further amplified or causes a secondary reaction that leads to more and different dsRNAs (“secondary” dsRNAs) with unpredictable targets (Baum et al., 2007 and Gordon and Waterhouse, 2007). They also readily transfer to mammals through food where they can circulate in blood and alter gene expression in organs (Hirschi, 2012 and Zhang et al., 2012a).
The stability and transmissibility of dsRNAs suggest the potential for existence of exposure routes that are relevant to human and environmental risk assessments of genetically engineered/modified (GM) organisms. As the great majority of existing GMOs in the environment or human food have been modified to introduce one or more additional proteins, there has been no formal international guidance on the risks specific to GMOs that introduce a new dsRNA, much less the development and testing of validated safety assurance procedures specific to dsRNA.

Some microRNAs of plant origin have been detected in the blood of Chinese people, demonstrating that dsRNAs can survive digestion and be taken up via the gastrointestinal tract (Zhang et al., 2012a). These plant-derived dsRNA molecules silenced an endogenous gene in human tissue culture cells, and in mouse liver, small intestine, and lung (Zhang et al., 2012a).
A survey of existing transcriptomic data of small RNA molecules from human blood and tissue sources, farm animals and insects confirmed that regulatory RNAs from plants can be found in animals, including humans (Zhang et al., 2012b).

References:
1. Jack A. Heinemann, Sarah Zanon Agapito-Tenfen, Judy A. Carman. A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments. Environment International. Volume 55, May 2013, Pages 43–55
2. L. Zhang, D. Hou, X. Chen, D. Li, L. Zhu, Y. Zhang et al.
Exogenous plant MIR168a specifically targets mammalian LDLRAP1: evidence of cross-kingdom regulation by microRNA Cell Res, 22 (2012), pp. 107–126
3. Y. Zhang, E. Wiggins, C. Lawrence, J. Petrick, S. Ivashuta, G. Heck
Analysis of plant-derived miRNAs in animal small RNA datasets BMC Genomics, 13 (2012) 

Best regards,

Angela
posted on 2014-03-02 09:44 UTC by Angela Lozan
This is a reply to 5668 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5669]
Dear colleagues,

We seem to be divided in our discussion on how to move forward. I support the many members  who feel that until the parties  have  tested the “usefulness, utility and practicality”  of the previous work produced by the AHTEG, it is premature to embark on new work that may not be useful or practical  later.

Engaging on these discussions is very time-consuming, especially for those who don´t have full time jobs to work on this. Many regulators and risk analyst  in developing countries don’t have the luxury to devote their time exclusively to biosafety regulations.  Poor governments cannot create new  biosafety positions, when there are so many other areas in great need of personnel.  Somehow, these very basic facts seem to be lost by some in this group, who want to further  increase the stringency of biosafety regulation without scientific justification.

To support this point, allow me to invoke Principle 11 of the Rio Declaration.

    “States shall enact effective environmental legislation.  Environmental standards, management objectives and priorities should reflect the environmental and developmental context to which they apply.  Standards applied by some countries may be inappropriate and of unwarranted economic and social cost to other countries, in particular developing countries”

Despite this, I  want to share the information that Honduras, Costa Rica, El Salvador and other Central American countries will conduct a virtual workshop (webinar) on March 3, 2014 to test the guidance.  The CTBio (Comités Tecnicos de Bioseguridad) will assemble in their respective countries, having previously studied the pertinent documents, which are unfortunately still in English.  We understand it is now the responsibility of each country to get the latest documents translated and bear the cost?   Ordinary translators, without risk analysis knowledge cannot properly translate these documents.  We have engaged an experienced, professional,  bilingual risk analyst  to guide the testing process  and the group (ICABB) will share information and  conclusions. Organizing this has taken a lot of our limited resources and time,  but we will do it.
I want to finish with a conciliatory and not divisive tone, by reminding everyone that we are all “on the same boat”. We all want a better world for our children, we want to fix the many ills of industrial agriculture and other threats to biodiversity.  We want to protect our small farmers and our indigenous communities.   I don´t think that creating more and more onerous regulation  and hampering the development,  adaptation, transfer and diffusion of the technologies  that science can bring,  is the right path.

I hope you enjoy the rest of the weekend.

Maria Mercedes Roca
posted on 2014-03-02 16:55 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5669 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5670]
Dear Maria Mercedes,

Your intervention raises a need for clarification. All documents to be used in the testing are available in the six UN official languages, i.e. Arabic, Chinese, English, French, Russian and Spanish, at http://bch.cbd.int/protocol/testing_guidance_RA.shtml. They include the latest version of the Guidance, i.e. the one which the COP-MOP decided to test, an offline questionnaire for gathering the results of the testing and an online questionnaire for submitting the results.

Best regards,
The Secretariat
posted on 2014-03-02 18:19 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 5670 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5671]
Many thanks Manoela.  I apologize for my confusion and thank the Secretariat for providing us with  translations done by bilingual professional risk analysts in many languages.

I was not aware of this  after reading the guidlines on the Notification with instructions for testing of the guidance,  where I quote:

" Further, with regard to the testing of the Guidance, the COP-MOP:

(a) Encourages Parties, other Governments and relevant organizations, as
appropriate, to translate the Guidance into national languages and to make such translated
versions available through the Biosafety Clearing-House for wide dissemination, in order
to facilitate the testing of the Guidance at national, regional and subregional levels"

Without a group of  paid professionals by governements,  dedicated to keeping up with these responsabilities, it is very hard to keep up with the many demands of the  biosafety requirements. 

Again, many thanks for your clarification.

Maria
posted on 2014-03-02 18:41 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5672]
Dear Colleagues
With regards to the ongoing discussion concerning socioeconomic considerations and risk assessment. I would like to highlight the following:

i. Nothing in the Cartagena Protocol or the parent Convention says that socioeconomic consideration can’t not be a part of risk assessment and it should be only restricted to decision making.  In fact it is actually the opposite.
Going back to the mother convention, Articles 7 to 10 of the CBD establish clear and mandatory biosafety and socio-economic provisions for Parties:
• Article 7 establishes the mandate, in particular for the purposes of Articles 8 - 10, to establish a system for identification and monitoring of components of biological diversity that are important for its conservation and sustainable use. In addition, to identify and monitor the effect of processes and categories of activities, (which includes modern biotechnology), which have or are likely to have significant adverse effects on the conservation and sustainable use of biological diversity. An indicative list, clearly including socio-economic aspects, of categories of components of biological diversity to be considered is set out in Annex I (see below).

“Annex I.
1. Ecosystems and habitats: containing high diversity, large numbers of endemic or threatened species, or wilderness; required by migratory species; of social, economic, cultural or scientific importance; or, which are representative, unique or associated with key evolutionary or other biological processes;

2. Species and communities which are: threatened; wild relatives of domesticated or cultivated species; of medicinal, agricultural or other economic value; or social, scientific or cultural importance; or importance for research into the conservation and sustainable use of biological diversity, such as indicator species”

• Article 8(g), together with Articles 19(3) and 19(4), relate to living modified organisms (LMOs), and gave origin to the Cartagena Protocol on Biosafety. It implies that Parties should establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology and are likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account the risks to human health.

• Article 10 specifically provides for the sustainable use of the components of biological diversity. Both “sustainable” and “use” are intrinsically socio-economic issues in themselves, captured by specific elements - such as protection and encouragement of customary use, consistency with traditional cultural practices – spelt out in the CBD´s Article 10.

Thus, in the planning phase of risk assessment, identification of protection goals, assessment ends points and risk thresholds may be guided by socioeconomic considerations, And in this regards, if a party decides that a given species is of a cultural or social importance and want to make sure that it won’t be harmed by the introduction of a given GMO this may be taken on board in the problem formulation step of the risk assessment.

ii. From African point of view: The African Model Law on Biosafety defines risk assessment as the identification  and  evaluation  of  the  direct and  indirect  potential  impacts  of  a  GMO  or  a  product  of  a  GMO  on  the biological diversity, human and animal health, socio-economic consideration and ethical values of the country which may be posed by the making, import, transit,  contained  use,  release  or  placing  on  the  market  of  a  genetically modified organism or a product of a genetically modified organism. This may include the evaluation of secondary and long-term effects.

warm regards,
O.A.Elkawy
posted on 2014-03-02 19:56 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
This is a reply to 5642 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5673]
Dear Francisca and Colleagues

I appreciate the frank and lively discussion evolving on this forum.

I first want to express my empathy for Dr. Maria Mercedes Roca’s seeming frustration (#5669) with the demands of participating in these exercises especially for those, as she notes, who do not work for institutions that consider this activity within their normal activities. Unlike governments, industry and specialist NGOs that see the Protocol and any activity around modern biotechnology as largely within their scope of works, those of us that bring in other civil society perspectives and can contribute diversity of input must struggle to find time to participate and/or funding and this is on top of the cost of time for participating. This should be part of the consideration for future modalities (if that is the right word).

Second I would like to correct some misinterpretations of my clumsy language in my first intervention (#5642). I was responding to an impression that others in the forum were asking for no further work on specialist guidance while the Roadmap was part of ongoing testing and I should have said Roadmap, or Part I, instead of guidance. I said “Before we recommend further work on the existing guidance, I would like to see the results of the current round of testing. If substantial work is required following the next round, then I agree that it is important to undertake this work. Otherwise, I suggest that the emphasis be on developing guidance on specialist topics” meaning that the Roadmap should have priority if further testing suggested that some remedial work was necessary, but that this should not preclude the development of specialist guidance on an ongoing basis. I apologise for creeping late night ambiguity.

Various elements of the existing Guidance package consisting of Parts 1-3 of the Guidance have already benefited from a round of testing (ie, Roadmap and topics in Part 2) and that testing did not find fundamental flaws. I have no reason therefore to anticipate that the most recent testing will require that our overall work agenda be halted. Instead, if the recent testing uncovers areas needing improvement then these will be given priority in our future work agenda but will not be so consuming as to prevent more work on the overall package.

all the best
Jack
posted on 2014-03-02 21:01 UTC by Mr. Jack Heinemann, University of Canterbury
This is a reply to 5669 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5674]
There seems to be an impression among some that Guidance is ‘regulation’ or contributes to a greater regulatory burden. I don't understand this impression. Regulation is a product of legislation; so if a country has more or less regulation on a product that is an issue separate from the Guidance. The Guidance is not a legally binding document and thus adds nothing to regulation. If a regulator finds it of use in meeting their legislative obligations, then it is a benefit. If they do not feel that they need this or any other form of guidance, then they will regulate without using it.


With best regards,
Jack
posted on 2014-03-02 21:57 UTC by Mr. Jack Heinemann, University of Canterbury
This is a reply to 5668 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5675]
Dear Francisca and Colleagues

Angela Lozan has posted further rationale for supporting the suggestion that dsRNA used in modern biotechnology form a focus for further guidance in Part 2 of the package. The use of dsRNA as a nucleic acid in products designed to enter cells, or expression of DNA constructs designed to produce dsRNAs of novel sequence for the organism, or expressed at quantities or times unique to the LMO, are topics of intense discussion among regulators and the scientific community. Research papers that are special to the risk assessment of dsRNA are only just appearing in the peer-reviewed literature [e.g. Auer and Frederick (2009), Heinemann et al (2013), Lemgo et al (2013), Lundgren and Duan (2013), Parrott et al (2010) and Ramesh (2013)]. There are many opinions, but little data special to risk.

I therefore see this topic as worthy of attention by the AHTEG. Contrary to what I understand to be Dr. Glandorf’s position (#5658), the Guidance is very much for issues of relevance and dsRNA-based products are relevant. There are products already on the market or soon to be on the market and guidance is needed by regulators now.

Certainly the science on risk assessment in this area is evolving and what falls into the realm of pertinent to a risk assessment is contested. All the more reason, in my view, to develop guidance. Some of the countries where dsRNA-based products are the most common are convening specialist workshops right now. The US EPA white paper (http://www.epa.gov/oppfead1/cb/csb_page/updates/2014/rnai-whitepaper.html) published just in January states that: “RNAi gene silencing is a relatively recent discovery, and there are general uncertainties with the current state of knowledge about dsRNAs and their potential environmental fate, as well as the importance of effects observed in laboratory studies to actual nontarget hazard. The current approach as used for Bt-derived PIPs may be sufficient; however, information in the literature suggests the need to consider additional effects beyond those typically investigated for Bt-derived PIPs.”… “the screening level assessments currently used for traditional chemical pesticides may not be applicable due to the unique modes of action of dsRNA active ingredients.”

In my view, the special features justify specialist guidance beyond the general cases of the Roadmap.

With best regards,
Jack

Auer, C., and Frederick, R. (2009). Crop improvement using small RNAs: applications and predictive ecological risk assessments. Trends Biotechnol 27, 644-651.

Heinemann, J.A., Agapito-Tenfen, S.Z., and Carman, J.A. (2013). A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments. Environ Int 55, 43-55.

Lemgo, G.N.Y., Sabbadini, S., Pandolfini, T., and Mezzetti, B. (2013). Biosafety considerations of RNAi-mediated virus resistance in fruit-tree cultivars and in rootstock. Transgenic Res 22, 1073-1088.

Lundgren, J.G., and Duan, J.J. (2013). RNAi-based insecticidal crops: potential effects on nontarget species. Biosci 63, 657-665.

Parrott, W., Chassy, B., Lignon, J., Meyer, L., Petrick, J., Zhou, J., Herman, R., Delaney, B., and Levine, M. (2010). Application of food and feed safety assessment principles to evaluate transgenic approaches to gene modulation in crops. Food Chem Toxicol 48, 1773-1790.

Ramesh, S.V. (2013). Non-coding RNAs in crop genetic modification: considerations and predictable environmental risk assessments (ERA). Mol Biotechnol 55, 87-100.
posted on 2014-03-02 22:05 UTC by Mr. Jack Heinemann, University of Canterbury
This is a reply to 5674 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5676]
Dear Jack,

Thanks for your empathy regarding the time and effort it takes to engage  in these biosafety discussions, prepare documents test documents, evaluated testing documents, attend  face-to-face meetings, etc.   So  I do appreciate your comment.

Regarding you point about “regulation”,   think of this danger:  many development countries, especially the least development countries in  sub-Saharan Africa, South Asia and even Central America and the Caribbean,  don´t have the personnel, the expertise  or experience in biosafety regulation  to develop their own systems.

These are the countries  that are likely to adopt a complex system  developed and suggested by others (such as the guidance   we are preparing) because they don´t  know any better, or don´t  have a better system.  I am putting myself in the shoes of the regulators of  these countries,  because this is the context I know and understand (and because I am one of them!).  How many representatives of  the least developed countries of the world are participating in this discussion? I think I am on of the few representatives.

This is my big concern: that countries will adopt onerous and expensive  guidelines  and the inaction will continue to adopt useful technologies, if they don´t understand what it is   they are meant to be doing.   Or  poor countries trying to export the agricultural porducts to say the EU, are faced with impossibly strict and onerous regulation. You know this is already happening.

As an example, we in Honduras and  in Ecuador  could be using GM banana resitant to black Sigatoka (a fungus), but our markets in Europe  reject it,  because EU consumers don´t like to eat GMOs.  It may be bad for their health. So, we keep spending 30% of the production costs of banana to apply very toxic pesticides, often by airplane, over villages where childeren are. Is this  status  quo a better a better alternative? We of course have all kinds of research going on for producing organic  banana, but try to manage a pest like Black Sigatoka in the tropics. It is not easy.

So inaction from adopting onerous guidelines developed by others, because you don´t know any better is a real danger for us.


Maria

P.S. By the way, the GM banana in Ecuador is being developed by a local public university in Guayaquil. The gene comes from another musa (banana) species. They will have to face the bill of conducting a risk analysis (it will be in the millions).  let´s make their job as  simple and practical as possible.
posted on 2014-03-02 22:46 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5672 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5677]
Dear All,

Like the others, I would like to thank Francisca for moderating this round. 

She has provided some suggestions for structuring our discussion and suggestions, but I find that these suggestions make the assumption that additional guidance should be developed and that it should be developed through the mechanisms of online conferences and the AHTEG. I don't share that assumption. 

I have read the interventions with interest, and I will keep my comments here brief and refer readers to the comments already posted by others.  I share the concern voiced by others that some interventions make the assumption that additional guidance for a number of topics is necessary, and that this needs to be developed through the process of online conferences and AHTEG.  In my view, this is an erroneous assumption, and I support the comments by Didier Breyer, Andrew Roberts, Deise Capalbo, Piet van der Meer and others in their conclusions that any listing of potential additional guidance topics is premature. 

Best regards,

David Heron
posted on 2014-03-02 22:48 UTC by David Heron, United States of America
This is a reply to 5677 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5678]
Dear all

Thank you for the interesting discussions with respect to this topic.

While the testing of the Guidance is ongoing, I do not see this to be a stumbling block to the development of further guidance, as the two processes are not mutually exclusive. The Guidance has undergone several rounds of review and testing to further improve it and it is likely that the fundamentals will remain the same. The development of further guidance will therefore build on this process.

Furthermore if we look at the Strategic Plan adopted by Parties, operational objectives 1.3 and 1.4 and their outcomes foresee, inter alia, “guidance on risk assessment and risk management including guidance on new developments in modern biotechnology” and “guidance in identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health”. This puts the onus on us to help elaborate what is most useful for Parties (bearing in mind that any guidance is meant to be that and not an obligation).

My three topics of choice:

1) Risks to human health of living modified organisms and their products, including health-related issues such as the use of agrochemicals with LM crops.

The Protocol clearly states that its objective is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health. In addition, the scope of the Protocol shall apply to the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health. Article 15 of the Protocol obliges Parties to undertake risk assessment, based, at a minimum, on information provided in accordance with Article 8 and other available scientific evidence in order to identify and evaluate the possible adverse effects of living modified organisms on the conservation and sustainable use of biological diversity, taking also into account risks to
human health. Several other provisions of the Protocol, as well as Annex III, also refer to the need to take into account risks to human health. There is therefore strong justification for the development of guidance that includes risks to human health in order to enable and assist Parties to meet their obligations under the Protocol. 

2) Risk assessment for living modified organisms created through use of dsRNA techniques, engineered to produce dsRNA or exposed to dsRNA.

I agree with others who have identified these novel applications as worthy of specialist risk assessment attention, given that the risk assessment experience for these LMOs is rather new and requires elaboration above and beyond current practice. 

3) Risk assessment of living modified microorganisms and viruses.

LM microorganisms and viruses are already in use and released into the environment, but their particularities, including uncertainties, warrant specialist risk assessment attention. 

On the mechanism, I believe it would be most cost-effective and efficient to continue the current process of gathering inputs via the online forum, for deliberation by an extended AHTEG. The AHTEG should as far as possible use online means for discussion and work, but we should not preclude face-to-face meetings.

Kind regards,
Lim Li Ching
Third World Network
posted on 2014-03-03 06:36 UTC by Ms. Li Ching Lim, Third World Network
This is a reply to 5667 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5680]
I am not going to respond to Piet van der Meer's rather ad hominem posting other than to say how profoundly I disagree with his arguments which would enable LMO producers to escape responsibility for the social and economic consequences of their actions.  In this regard I appreciate the comments of Dr Ossama Abdelkawy of Egypt (#5672) and Dr. Angela Lozan of the Republic of Moldavia (#5668) expressing support for the inclusion of SEC in risk assessments of LMOs.

Phil Bereano
Professor, University of Washington
posted on 2014-03-03 19:37 UTC by Dr. Philip L. Bereano, University of Washington
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5681]
Dear “open-ended online forum and AHTEG on Risk Assessment and Risk Management”:
I would like to intervene once more and call on your attention regarding the discussions that have taken place during the past week.
I again thank all the participants for exchanging views and brainstorming but, at this point I would like to ask you, for the remaining time, to focus on the mandate and the expected outcome, i.e.
“A recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment, selected on the basis of the priorities and needs indicated by the Parties with the view of moving toward the operational objectives 1.3. and 1.4 of the Strategic Plan and its outcomes” (decision BS-VI/12, annex paragraph 3(c)).
I would like to invite you all to provide one or two sentences (maximum), in your view and in line with the mandate, of a concrete recommendation for the COP-MOP. This would be most useful at this time!

Un abrazo a todos!
Fran
posted on 2014-03-03 22:15 UTC by Ms. Francisca Acevedo, Mexico
This is a reply to 5681 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5682]
Dear all

I would also like to thank you for the interesting discussions with respect to the development of further guidance on specific topics of risk assessment.

I would like to point out the three topics from the suggested list that I, as representative of Brazil, believe are priorities for our country and neighboring Latin American countries:

• Risk assessment for living modified organisms created through use of dsRNA techniques - Brazil has approved a RNAi-based crop (GM pinto bean). My rational regarding this need has already been expressed by Angela Lozan (#5668) and Jack Heinemann (#5675), including scientific literature on this issue.

• “Co-existence” between LMOs and non-LMOs in the context of small scale farming - Our current national "co-existence" regulation on corn, Normative Resolution No. 04 of August 16th 2007, "disposes of minimal distance between the commercial cultivation of genetically modified and non genetically modified corn, aiming at the coexistence between the production systems." in its article 2, it states: "Art. 2. To allow coexistence, the distance between one commercial crop of genetically modified corn and another one of non-genetically modified corn, located at neighboring area, should be equals or over 100 (one hundred) meters, or alternatively, 20 (twenty) meters, as long as added of border with at least, 10 (ten) rows of conventional corn plants of similar size and vegetative cycle to the genetically modified corn."
We are aware that this ruling is inefficient and further guidance would help us in developing more robust regulation and monitoring.

• Risks to human health of living modified organisms and their products, including health-related issues such as the use of agrochemicals with LM crops - I believe that Ching (#5678) and Galina Mozgova (#5661) have already addressed my concerns regarding this topic.

I also support interventions of Dr.Wei Wei, Dr.Ossama El-Kawy, Dr Jack Heinemann and in providing views and opinions on the topics related human health and socio-economics.

Best regards,

Sarah Agapito
posted on 2014-03-03 23:00 UTC by Dr. Sarah Agapito-Tenfen, GenØk Centre for Biosafety
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5683]
Dear all,

I would like to thank Francisca Acevedo for giving a chance to make comments.

(I) the mechanism proposed with respect to developing further guidance

I think it is important to build process and timeframe to select topics “on the basis of the Parties’ needs and their experiences and knowledge concerning risk assessment” as shown in Annex 1. (c) of BS-VI/12.
I think the Parties’ needs for guidance would typically appear when the Party, which could not perform risk assessment due to lack of experiences, would like to introduce LMOs into its environment in order to, for example, improve agricultural production.  Also, the accumulation of the experiences and knowledge concerning risk assessment would be measured by the number of such LMO events which have been assessed by the Parties, as those classified in the topics.
Anyway, criteria to select topics should be transparent.

(II) the selection of up to three topics (your preferred 3!) including the reasons you have on why these seem to be the most relevant/urgent to you

I understand the topics on the list are based on the discussion of AHTEG and the open-ended forum during the previous inter-sessional period or in the last year.  I wonder these topics are really selected on the basis of both the Parties’ needs and their experiences/knowledge concerning risk assessment.  As I think it would not be appropriate to select topics from the proposed list, I cannot indicate three topics.
Needless to say, the task requested to the AHTEG and open-ended forum is described in BS-VI/12 and its annex, which is relevant to the ANNEX III of the Protocol.  Topics which may be suspected to exceed the scope of the task would be less prioritized.

(III) comments on other proposals/contributions made by your peers during this two week session

If any, I will make comments later.

Best regards,


Isao Tojo
Ministry of Agriculture, Forestry and Fisheries, Japan
posted on 2014-03-04 03:00 UTC by ISAO TOJO, Ministry of Agriculture, Forestry and Fisheries
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5684]
First of all, I’d like to thank Francisca for moderating the discussion, as well as, to thank for the opportunity of sharing ideas and views in this forum.
Reading the comments, I believe that while concentrating on possible risks that any technology/activity poses it is easy to lose focus and sight on the real world problem-solving approaches. We should be careful not to hamper the introduction of activities/technologies that pose a lower risk than that of current practice (a failure to consider the compared benefits/improvements to current situation). An interesting example was posted by Dr. Maria Mercedes Roca (Honduras) that GM banana resistant to black Sigatoka risks are likely to be lower than the current heavy use of fungicides sprayed by airplanes.
I support all those that are concerned about giving priority to quality rather on quantity of guidances (comments from Didier Breyer, Deise Capalbo, David Heron, Andrew Roberts, Piet van der Meer, etc.). First, we have to make sure that the guidances drafted over the last years for RA&M are indeed meeting its objectives before dispersing the limited resources to a number of additional efforts/guidances that might be of little or no value because they couldn’t be developed with the needed care. In addition we should limit duplicative efforts.
A well done general guidance makes possible the understanding of the rationale on the steps taken on the risk assessment and ways to manage the risks (the underlying principles; problem formulation: hazard/risk identification and characterization, exposure characterization, likelihood and severity of potential consequences, ways to manage or mitigate risks….; planning the assessment including defining relevant protection goals and assessment endpoints,…). The understanding of the rationale should give a good basis for assessing any kind of LMO. It’s possible that some companion documents to complement specific cases are useful or even needed. But there are already some relevant information/resources to risk assessment: consensus documents, guidances, scientific literature, etc.  from relevant bodies such as: joint FAO/WHO expert consultations, OECD Guidances and Consensus documents, etc. that should be taken into consideration before starting developing additional resource documents. In this sense, the already proposed careful testing as well building from the results obtained is needed before we can identify relevant specific needed guidance and support their development.
It’s probably easier to make sure that the experience and relevant documents to risk assessment and management are known, shared, easy of finding the needed information/searchable, etc. It’s expected the BCH to share much of the relevant to LMO RA&M and decision taking resources. But searching through the BCH can be frustrating by different reasons: not yet shared, if shared the way to find the information might not be that intuitive or straightforward….. etc. To give an example, you can go under the LMO virtual library   https://bch.cbd.int/database/library.shtml , Search the Biosafety Information Resource Centre (BIRC), select on a dropdown list “risk assessment” (if you wanted to have risk assessment and management together it’s not an option), and also select from a dropdown list “Manual/Tutorial/FAQ/dictionary”. It will give 66 records, if you add the word “guidelines” to keyword search field you’ll have 47 records, but if you add guideline (the same word just in the singular) to the keyword field you’ll have 18 records (that means that small meaningless differences in the word searched will make the assessor miss information that might be important). If you type the word “dictionary” (that you see in the group dropdown list mentioned above) in the keywords field you’ll have all the 66 records listed, though these do not represent a dictionary or glossary of terms or definitions for modern biotech/risk assessment terms by international/standard setting organizations such as OECD, Codex Alimentarius, SPS, FAO/WHO… If you’re not tempted to type “dictionary” as in the dropdown list, but to  type glossary instead, in the keyword field, you’re in a better way….
If you go to BCH, then “Finding Information”, then “Advanced Search” https://bch.cbd.int/database/advanced/ and from the dropdown list you select: “type of record”, “related”, “risk assessment” you’ll have 916 records which can be easily grouped by country but not in an obvious way about the LMO in question or other characteristics which could be of importance when considering doing a risk assessment that was already previously done by other countries. I also missed among the over 900 records of RA, inputs from countries that although are non-parties they have valuable experience in the risk assessments, e.g. USA, Australia…. If you do not use advanced search but you go directly to risk assessments tab you’ll still be limited on the options to search, but you do have better options of grouping into information to match what you’re looking for. It’s easier to find “Biosafety Guidelines: Environmental Risk Assessment of Genetically Modified Plants in Malaysia” through google than searching on the BCH, although it’s also available there. Only with a short search on the BCH, it’s clear that the quantity, quality and the easiness of finding the information are not yet very helpful for assessors and do not reflect the already available experience on the topic. Concerning the existing guidances & relevant biosafety documents, scientific literature,.... there’re more available than most new/unexperienced assessors notice and can be found in the BCH....
posted on 2014-03-04 12:48 UTC by Ph.D. Lúcia de Souza, PRRI - Public Research and Regulation Initiative/ANBio (Associação Nacional de Biossegurança - Brazilian Biosafety Association)
This is a reply to 5684 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5686]
Dear all,

Francisca has asked us to comment on (I) “the mechanism proposed with respect to developing further guidance”.

I support the comments by many commentators on this forum, who have indicated how useful it would be  for the AHTEG to understand if the previous work by this group, is useful to parties. I especially support the comment made by Lucia de Souza [#5684] and  Isao Tojo from Japan [#5683] that parties would need guidance on specific technologies they would like to introduce in order, for example, to improve agricultural production or decrease pesticide use.

Today (March 4,  2014),  15 regulators from 4 Central American countries (Honduras, Costa Rica, Guatemala and El Salvador) participated in a webinar organized by the  ICABB (Iniciativa  Centroamericana de Biotecnología y Bioseguridad). The discussion centered around the  “usefulness, utility and practicality”  of the risk assessment guidance prepared by this group.  Many interesting comments emerged, that I will summarize for the benefit of the group, in 3 main points, before we embark on further work.

Although parties will give their individual comments regarding the testing, we (members of the ICABB) agreed on the following:

1. LANGUAGE MATTERS. Interpretation of language matters greatly in risk assessment.  Translations of documents need to take into consideration the technical language used in the established international discipline of  risk analysis and a glossary of terms and concepts should be developed in English, Spanish and Portuguese (for Latin America), to avoid ambiguity.

To illustrate, many regulators in our group did not understand the meaning/difference o of  the terms “usefulness” and “utility”. The word usefulness was translated as “conveniencia”  in Spanish (convenience – is usefulness and convenience the same?) and the word “practicality” as “practicidad”. The word “practicidad” does not exist in Spanish (not registered in the Diccionario de la Real Academia de la Lengua – the closest is “facticidad”. The ambiguity in language  for the technical terms in risk assessment will result in many different interpretations of how to conduct a process. To illustrate, are there differences between the terms “harm, hazard, risk or danger”?  To a novice risk assessor, all these words may mean the same.  This is not a trivial matter.

2. PRESENT GUIDE IS TOO LONG, COMPLEX AND PRESCRIPTIVE. Although parties will continue to test the guidance in detail and send their specific comments, most observed this morning, that testing the guide (with the ambiguity of the Spanish translation) is a big task that requires time, effort and resources, all in short supply in our countries.  Doing this will distract regulators/advisors from many other duties. Still, they have started. When compared to other published guides and approaches, also available to parties, regulators commented that the AHTEG’s guide is too long and  complex. This length and complexity, coupled to the ambiguity in the language,  makes it difficult to understand, interpret and thus, use.

3. PEDAGOGICAL EXPERTS SHOULD BE HIRED TO MAKE THE GUIDE STUDENT FRIENDY. The guide is not “student friendly” for novice risk assessors, even if it is good for experienced ones.  This  excellent point was made by an ICABB colleague, who pointed out  that accurate  technical content alone,  is not enough in any training guide or teaching material. The  AHTEG guide lacks clear  “learning objectives” (the term we teachers use when developing a class syllabus),  does not specify who the “learners”  are or should be (a good teacher knows and understands his/her students)  and does not present a clear understanding of the context (developed vs. developing country with high or scant resources)  in which the guide will be used. 

There is a growing understanding at universities that technical experts also need to be trained in pedagogy to be effective educators or trainers.  Technical  information  about risk assessment of LMOs is readily available  to anyone on the web. We  (the AHTEG) need to make an effort to guide the novice risk assessor through the complex process of risk assessment,  with the skill of experienced educators and trainers,  and not just experts in risk assessment.

We trust that the effort we have put in Central America, to give objective feedback to the AHTEG, will be considered when developing training material.

Best regards,

Maria Mercedes Roca
On behalf of the Biosafety Commission of Honduras
posted on 2014-03-04 22:48 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5686 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5687]
Dear Francisca, dear All,

First I would like to thank Francisca for willingness to moderate the RA session and for her impetus to encourage participation. I would also like to thank all of you for the interesting discussions.
Many of the things I want to say have been said already so I want to support María Mercedes comments, I also agree with Didier (5654), Deise (5656), Boet (5658), Piet Van Der Meer (5664), David Heron ([5677), as well as recent comments from Isao Tojo (5683) and Lúcia de Souza (5684).
Now on question number I, on the mechanism proposed with respect to developing further guidance, I think that the mechanism should consider several issues before embarking on efforts to develop more guidance.
a) To integrate and analyze the results of the testing of the guidance,
b) To have the guidance aligned with the manual,
c) To have a very clear notion on how the Parties (other governments and organizations) are actually using the produced guidance. I do not see the point to develop more guidance that is not being used (despite if it is useful and practical or not).
d) From the experience gained by the users of the guidance, identify what parts of the guidance are not useful for, and why. Fix those first.
Once we account for these previous steps and information, I recommend the following:
e) List of criteria to select topics
The mechanism proposed should include clear and transparent criteria on how are we going to choose among proposed topics. COP-MOP has already decided that if further guidance is developed, it should take care of the needs of the Parties and their experiences and knowledge concerning risk assessment. If these needs can be deduced from their responses to the testing of the guidance, we need to finish that. Once we identify needs, how to choose?  For example is it going to be a majority voting within the AHTEG? In relation to the experience, how are we going to clearly account for the amount of experience available?. Which other criteria are important to take into consideration? Certainly  guidance already available from other sources or in development may be an important one. Dr HIROSHI YOSHIKURA in his comment (5659) considers other criteria: “the scope of the guidelines could be limited to LMOs derived from organisms with history of safe use, at least, for foreseeable future”. These are just examples, and other criteria are relevant, too.  It is important to clarify those criteria in the mechanism for developing any further guidance. Then, the usal approaches (online fora or face to face meetings) could work.

About question II. The selection of up to three topics (your preferred 3!) including the reasons you have on why these seem to be the most relevant/urgent to you.
I can't recommend topics for further development in this forum; it is not the time yet becuase it is not clear if the new guidance is needed (maybe the testing of the guidance that we have, indicates that it is enough for now) or if it is going to be used (we do not know if the guidance that has been produced is being used), or if there is enough knowledge to develop it… This is according to my previous point on the mechanism.

On III.  Comments on other proposals/contributions made by your peers during this two week session.
On other proposals I will comment that it is important to stay on the mandate of the COP-MOP for this AHTEG, on Risk assessment. So I agree with comment by Andrew Roberts (5643).
Under risk for human health there are several efforts and documents developed in other organizations, for example the Codex Alimentarious and the Task Force at the OECD; and we do not need to replicated efforts and consume more resources.
Coexistence is more related to markets and socioeconomic issues and not directly to risk assessment, or potential adverse effects to biodiversity. There is not an obligation to include this, nor socioeconomic considerations on risk assessment, but if Parties decide on considering socioeconomic issues they may consider these issues as part of the decision making process. Hopefully after a systematic scientific analysis.
I hope this contributes to our deliberations.
posted on 2014-03-05 00:52 UTC by Ms. Sol Ortiz García, Mexico
This is a reply to 5687 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5688]
Dear All,

I appreciate the many comments people have offered, and there is an emerging theme that I would like to highlight regarding the nature of any guidance. 

Guidance is based upon experience that certain approaches are most likely to be successful.  When we choose a guide, we choose the person(s) who have done the activity many times before and been successful.  We don't choose a guide who brings us to the edge of the forest and says that you might take any one of the following paths, and that some paths will take you to your goal, while other paths will be a waste of time.  We choose the guide who gives directions based upon past successes and practical experience in reaching the desired goal or destination.  The guide has gained this knowledge through personal, practical experience and the experiences of others. 

This highlights what I see as the fundamental flaw with the process by which the AHTEG and online discussions have operated to develop guidance in showing someone how to apply the methodology described in Annex III of the Protocol to specific cases of LMOs.  There is no shared consensus that the AHTEG and online experts on how to guide the novice risk assessor, so the guidance document says essentially that the novice might take any one of several paths, yet none are more likely than others to be successful and relevant to the task of evaluating whether the environmental release of the LMO is likely to result in an adverse effect on biological diversity.

This problem with the guidance has beset the AHTEG on risk assessment since it started on the guidance in 2009, and it is still a problem that continues.  Yet this group has been asked to propose how to develop additional guidance.  How can we propose meaningful ways forward when we do not have a successful track record or even a shared view gained from past experience in conducting environmental risk assessments?

Thanks to all for sharing your perspectives.  They have helped me to better understand some of the underlying obstacles to the process of providing good guidance that is truly relevant to the novice risk assessor.

- David Heron
posted on 2014-03-05 15:29 UTC by David Heron, United States of America
This is a reply to 5681 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5689]
Dear Francisca,

I admire your energy and persistence in getting people to participate more in the online conferences.

I understand that it is tempting to ask people to give their views in just one or two sentences.

However, I don’t think that contributions of one or two sentences will help us at this stage, because we clearly have very different views among the contributors in this on line conference about the role and modus operandi of this process of online conferences and AHTEG.

One group argued that before listing new topics for guidance to be developed in this process, we should:
- finalise the testing to assess whether the approach of the current guidance is useful
- assess whether existing guidelines offer sufficient guidance for risk assessment of those new topics
- assess whether for those new topics the on line conferences and AHTEG are the most appropriate way to develop new guidance, or whether other organisations would be more appropriate. 

Another group argued that the Guidance has already undergone several rounds of review and will probably not change much, and that the ongoing testing should not exclude working at the same time at new guidance. Further, those contributions suggest that the existing guidance is not sufficient and that therefore new guidance is needed.

Much of the debate has focused on the above first two questions, i.e. whether the guidance is tested adequately and whether the available guidance is sufficient. This debate has been confounded by discussions whether topics such as socio-economic considerations are part of the risk assessment as outlined in the Protocol. The discussion on socio-economic issues is a separate one that is not under consideration  in this online forum; it is ongoing in another forum, in preparation  of discussion of the issue at COP-MOP 7.

Building on the contributions by Isao Tojo, Boet Glandorf and David Heron, I would suggest that we also discuss the third question in some depth, i.e. once we have established that certain new topics deserve additional guidance, are the on line conferences and AHTEG are the most appropriate way to develop new guidance? Needless to say that that question is directly relevant to the request of the MOP.

With regard to this question there are also clear differences in the contributions, and I expect that those differences find their origin in a diverging views on the modus operandi of the process we are in.

My impression is that some contributors are of the view that the online conferences and AHTEG could address topics for which there is substantial experience while others favour to, also, include very new topics, with which experience is limited.

I believe that the  aim of the on line conferences and AHTEG has been and is to look at areas with which substantial experience has been accumulated and see whether we can provide guidance on the basis of that experience, to help novel risk assessors avoid having to start from scratch. Yet, I do not believe that the on line conferences and AHTEG are the best way to address emerging areas. There we need specialised experts in those particular fields coming together to bounce ideas around. The composition of the AHTEG and the online discussions are not, or certainly not all of them, equipped for that process. They do have as added value that they can ‘take a step back’, look at the available experience collated by the specific experts and extract commonalities out of that experience, for the benefit of novel risk assessors.

A good example is the topic of dsRNA / RNAi,. Unlike the suggested topics of SEC and Co-existence, I agree that the topic dsRNA / RNAi is a topic that has relevance to risk assessment. Yet, I also believe that the discussion on this topic is still in such early stages of discussion (e.g. at an EFSA meeting in June this year), and that there is very little commonality that the online conferences and AHTEG could extract from that. I therefore believe that this type of topic is best first digested for a while by specialised experts.

My conclusion is that for the process of drafting guidance on new topics, such as dsRNA, an additional step of discussions, preferably face-to-face, by specialised experts, would be necessary, before an online forum and an AHTEG can start its work.

I am aware that this exceeds the two sentences Francisca wanted, I do hope that these thoughts are useful.

Piet
posted on 2014-03-05 21:49 UTC by Mr. Piet van der Meer, Ghent University, Belgium
This is a reply to 5689 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5690]
Dear Francesca

Thank you for the opportunity to contribute to this lively discussion.

I feel that Sol Ortiz Garcia [#5687] has made some important points that deserve reiteration. For example, how much of this guidance material will be used in practice by competent authorities? The discrepancy between self-reported behaviour (eg shoppers reported preference of items in a supermarket) and actual behaviour (eg items actually in the basket at checkout) is well established. Therefore, it might be prudent to pause on the production of guidance material until there is a clearer indication of actual use.

Sol also points out there are no criteria for selecting the topics of choice. It seems that some may not be appropriate. For example, as pointed out by others, socio-economic considerations are already the subject of another AHTEG. Also, there has been strong interest expressed for dsRNA; yet an independent review by a competent authority finds no issues that need special attention, see http://www.foodstandards.gov.au/consumer/gmfood/Documents/Heinemann%20Response%20210513.pdf

Part of the difficulty is that different competent authorities are likely to have different things, even for an application of the same LMO. In addition, there is already plenty of guidance material available to competent authorities, including their own, that may be preferred despite the value attributed to the Roadmap and its sister documents.

Furthermore, Annex III states that risk assessment should be carried out in a scientifically sound and transparent manner. However, the Guidance material itself has not been subjected to scientific validation (eg in a manner used to validate other risk assessment methodologies, see Caley P, Kuhnert PM (2006) Austral Ecology 31:647-655; Stone LM, Byrne M (2011) Plant Protection Quarterly 26:29-35; or Virtue JG, Spencer JE, Weiss JE, Reichard SE (2008) Protection Quarterly 23:166-178).

Therefore, I would like to suggest that although we should wait to see if the Roadmap at the very least is used, we should roll up our sleeves and be prepared for some heavy lifting mentally to:
1. Address issues arising from the current round of Roadtesting.
2. Scientifically validate the Roadmap.
3. Offer the services of this group to address any specific risk assessment issues as requested by competent authorities when faced with real applications.

Finally, in remaining mindful of Maria Mercedes Roca’s concerns [#5676] we should seek appropriate activities with considerable care. My estimate of the costs for one face-to-face meeting of the AHTEG equate to the costs of all government regulatory staff that process LMO applications from all sub-Saharan African countries (except South Africa) for about 2-5 years. Our activities can be expensive from some perspectives.

Paul Keese
posted on 2014-03-06 12:55 UTC by Paul Keese, Australia
This is a reply to 5690 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5691]
Dear All,

I truly appreciate the honest and frank discussion that has taken place in this forum. What is becoming clear to me is that the process has undergone an inversion.  At the start, Parties requested the Secretariat to bring together experts to develop guidance and propose new guidance.  While it is widely accepted that the first step is incomplete as evidenced by the testing underway, the second step has given rise to an inversion.  It seems that some of the experts in the forum may be interpeting the second request to honestly acknowledge their lack of expertise (experience) by requesting new guidance.  This to me is not what the Parties requested in essence because it is illogical to ask experts assert their expertise in one manner and declare their lack of expertise in another.  A complicating aspect is that the Parties are still awaiting for the Roadmap, which would provide an appropriate context for next steps and future guidance.

Putting aside the topics that are clearly out of scope like socio-economic analysis and human health risk assessment (beyond its narrowly defined role in environmental risk assessment). many of the topics suggested are scientifically interesting, but need to be evaluated in the context of a completed roadmap. 

I am deeply concerned that putting forward underdeveloped ideas as expert opinion will only confuse and complicate the development and implementation of legitimate expert guidance.  The final roadmap must, in the end, enhance one's ability to complete a task - ERA for LMOs in the context of a law or in this case an international agreement - or understand how someone else has completed this task. 

Best regards,
Tom
posted on 2014-03-06 16:55 UTC by Mr. Thomas Nickson, Consultant
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5692]
POSTED ON BEHALF OF DETLEF BARTSCH

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Dear All,

I also like to thank Francisca for moderating this discussion forum.

I can not add much to the arguments exchanged so far. I fully support Didier Breyer’s contribution. In addition, I also recommend that the [environmental] risk assessment task under the protocol should not be mixed with socio-economic considerations like co-existence of approved GMO cultivation with non-GM technology using systems.

Best wishes

Detlef
posted on 2014-03-06 20:28 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 5690 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5693]
Dear Francesca and Dear All

Paul’s post is for me quite illustrative of why guidance on certain topics nominated by Parties, mainly from developing economies, is both desirable and justified. Paul posts a response to a peer-reviewed article on risk assessment of dsRNA for both human health and the environment from a food safety regulator, confusing the difference between one particular technical argument of exposure in humans through food on the one hand with environmental risk assessment on the other. Such clarity between topics is something that obviously might be needed.

When it comes to dsRNA, many Environmental regulators are interested and concerned. I posted many such references earlier (#5675). Researchers at the USDA also published a peer-reviewed article with a focus only on environmental risk assessment. The US EPA is working on the topic and recently published a white paper that outlines areas of uncertainty that are special to dsRNA. EFSA is convening a specialist workshop on the topic too. They haven’t left the topic to anonymous rebuttals on the internet by a single food safety regulator to decide what is the appropriate course of action for the environment.

Others in the forum seem to me to be suggesting that where issues are relevant but ‘new’, the good regulators of developing countries might be better off leaving it to the OECD countries to work out the problems for them. I am all for making use of work that has gone before regardless of where that work comes from, but I don’t subscribe to the view that the selection process for ‘experts’ for participation in these other forums is demonstrably superior to the process established by the Parties to the Protocol, or that the AHTEG and online forum is incapable of identifying for itself what is important guidance on how that might be of use to other Parties. I trust the Parties to this international agreement to choose what is important to them and when it is relevant to them.

Here I see a difference of opinion between Parties, with some arguing for additional guidance and some arguing for no additional guidance, at least at this time and for various reasons. As Lim Li Ching (#5678) and Fran (#5681) posted, however, the Parties have asked for topics of further guidance “A recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment, selected on the basis of the priorities and needs indicated by the Parties with the view of moving toward the operational objectives 1.3. and 1.4 of the Strategic Plan and its outcomes” (decision BS-VI/12, annex paragraph 3(c)).” Some Parties believe that these topics are of priority and that there is a need for guidance. Listing these topics is not an expensive exercise and the Parties can determine for themselves whether future work on these topics is financially worthwhile.

Best regards,
Jack
posted on 2014-03-06 21:44 UTC by Mr. Jack Heinemann, University of Canterbury
This is a reply to 5689 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5694]
I would like to reiterate my support for the need of developing guidelines for risk assessment for the new GM technologies such as RNAi, dsRNA and cisgenesis.

Although some of the forum participants considered that these are not GM technologies, thet do fall within the definition of a LMO of the Cartagena Protocol.

Another participant believes that this new technology  are incipients because the EFSA will discuss this topic in June, but I would like to remember the forum members, that the world does not begin and end in Europe. In Brazil there is already field test of the beans 5.0 that uses this technology and could be marketed in the coming years. These seeds could be marketed in other countries in Latin America or Africa which are not prepared to do risk assessment.

Same  happen with the so-called cisgenics crops (which also would be covered in the definition of the Cartagena Protocol ). They are already used this technology in Uganda with bananas, as well as in Ecuador.

The issue of coexistence goes beyond socio- economic considerations , because we are talking about gene flow, contamination due to technological package among others issues.
posted on 2014-03-06 22:23 UTC by Dr. Elizabeth Bravo, Acción Ecológica, Ecuador
This is a reply to 5694 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5695]
Dear friends:

I would like to make an additional comment on the GM banana resistant to black sigatoka, with particular reference to Ecuador. Not only the rsik assessment is very expensive.

Is  also very expensive to develop the GMbanana (which probably will not work in the long term given the large capacity of adaptability of fungus). And after all that effort the buyers do not want to eat it.

The alternative of course is not spraying with fungicides, but  to diversify genetically the bananas (remember that whole international trade of banano is based on a clone) and to cultivate with agrocological techniques. The choice: GM or pesticides is a fallacy.

Elizabeth Bravo
posted on 2014-03-06 23:00 UTC by Dr. Elizabeth Bravo, Acción Ecológica, Ecuador
This is a reply to 5695 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5696]
Dear Elizabeth,

I do appreciate your irreverent but accurate comment that the world does not begin and end with Europe and that European policy on GMOs  (shaped by a few) should not influence ours.  Nor should food choices of wealthy Europeans dictate agricultural policies in countries that export their produce to Europe. I guess that will change when Asia, local economies  and other emerging economies become bigger and compete for food with Europe. Having said that, I have the greatest regard and admiration for the many Europeans that want to reverse this Eurocentric trend, including members of this group. 

Regarding your suggestion about genetically diversifying the banana stock, let me share with you that Honduras has one of the most famous banana breeding programs in the world. Banana plant breeding is technically very hard because bananas don´t produce true seed and to this day, no plant breeding program anywhere in the world has been able to  manage Black Sigatoka and other banana diseases without pesticides. Your suggestion is not as easy and inexpensive as you suggest. Pesticides sprayed by planes continue (terribly) to be the best alternative.

But we must not digress from what Francisca has asked as to do:

I support Paul Keese statement that it is premature to produce more guidance before knowing that the AHTEG´s work is useful and is being used by parties.  Maybe, if the guidance was more didactic and student friendly, more novice regulators  would understand and use them. Finally, I also share Paul´s concern  on the cost of producing more guidance.  Let´s use the resources prudently and wisely.

Maria
posted on 2014-03-06 23:39 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5696 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5697]
Thank you to Francisca for chairing this session and thank you everyone for an interesting and robust discussion. I am glad that work pressures have relented enough for me to again participate in this important forum. 

For the mechanism proposed for developing further guidance, I agree with various participants that a continuation of the online forum is a useful format for most of the work, with face-to-face meetings for some of the work. I would like to echo Dr Jack Heinemann [#5642] when he requests that the place for face-to-face meetings be more accessible to participants outside of Europe and Canada.

Regarding which of the topics on the list for further further guidance, I would need to opt for Guidance on integrating human health into the environmental risk assessment as my highest priority because it impacts on many of the other topics on the list. For example, some of the LMOs on the list may be intended for direct human consumption, such as LM fish and nutritionally altered LMOs, while others on the list such as pharmaplants and micro-organisms may inadvertently enter the human food supply.  Moreover, many people may receive occupational exposure via farming practices, transportation and processing of many of the LMOs on the list, such as animals, fish, algae, pharmaplants and biofuel plants.   Ms Li Ching Lim [#5678] gives further reasons as to why this topic is important.

My next most important topic for discussion would be a risk assessment for living modified organisms created through use of dsRNA techniques because there are products already on the market or soon to be on the market that have been created using this technology [Jack Heinemann, #5675, Elizabeth Bravo #5694], and these organisms may have a different risk profile to most of the LMOs that have already been released into the environment.  Consequently, there is a need for guidance now.

After those two topics, in my view, risk assessments for micro-organisms and viruses, animals including fish, pharmaceutical and industrial products, and nutritionally altered plants all have equal merit.

I would also like to take the opportunity to agree with Dr Elizabeth Bravo [#5641] that a risk assessment of an LM crop that is designed to be tolerant to a herbicide needs to be a risk assessment of the crop as it will be used in reality.  That is, the risk assessment needs to include the use of the herbicide on the crop as per the technology user agreement associated with the crop.  And if a crop is designed to be resistant to several herbicides at once, all of those herbicides should be likewise assessed.  Furthermore, if a LMO contains several stacked genes, it would be wise for any synergistic effect of those genes and their gene products to also be assessed.

Best wishes to all.

Judy Carman
posted on 2014-03-07 00:07 UTC by Dr Judy Carman, Institute of Health and Environmental Research
This is a reply to 5696 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5698]
I have been thinking a lot about Francisca´s first question: how to proceed … It is hard to know and opinion is greatly divided.

I have a question for anyone with experience in Monitoring and Evaluation (M&E), as I guess the exercise of “testing the utility, usefulness and practicality” of the guidance is an exercise in M&E.

How would the AHTEG  and the Secretariat know if the guidance has utility, is useful and is practical? What are the INDICATORS used and how do we know if those indicators are reliable?

1. Are the only indicators a compilation of answers in the questionnaires? Is it a question of numbers ( how many say good/bad/don’t know)?  How are “absentees” (parties not giving their opinion) assessed? Are they excluded/ignored because they did/could not give their opinion? Of course, it is only human to ignore those who never speak.

2. Let’s assume the majority of participants say they found the guidance very useful and practical and will  use it to assess applications in their country.  Later we must then assess if using the guidance allowed them to “move forward” and they want more guidance on other topics such as dsRNA.

How would this “moving forward”, as opposed to more inaction,  be assessed?  Continuing prohibition to introduce GMOs would be considered a success? I fear some in this group would count inaction as success and proof that the guidance was useful. Others in this group would feel the opposite.  The first group wants more guidance, the second group wants to wait and perfect the first work, so it is used more objectively.

On interpreting silence by parties, I know from experience that if countries in our region were not pushed (a lot or persuasion was required) to engage on the testing and someone organized the complex logistics required, many would not have participated.  The least engaged countries are normally the ones who need the most help. My guess is they don’t participate, mainly because they don’t know how. 

My humble opinion as a teacher is that before we proceed with more guidance, we need to objectively assess the feedback  of our prevoius  work adn make sure it is student friendly, or we risk investing more time and resources into something few will find useful or will ever use.
posted on 2014-03-07 00:59 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5699]
POSTED ON BEHALF OF PATRICIA GADALETA

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Dear colleagues,

I found, as other participants have been commented, that the list includes topics that are out of the scope of the environmental risk assessment of the Annex III. It will be usefulness to distinguish between the items that are related with, and need of guidance, of those that are related with political decisions to be addressed in each country or region, such as the topics co-existence or socio economic considerations. I believe that it is important to have good and useful guidance about environmental risk assessment of GM animals, microbes and plants, therefore, the improvement and alignment of the Roadmap, the Guidance and the Manual is critical and I think it is a priority to reach the goals of to give support to the Parties in developing the basis of their environmental risk assessment and management in an appropriated way to cover their national and/or regional expectations on the use of the technology taking into account the conservation and sustainable use of the biodiversity according the Protocol. I agree with other participants that without a clear assessment if the Guidance developed to date is acceptably useful, it is precipitate to embark on new guidance because it is time and resources consuming. In this regard, I also would like to take this opportunity to grateful the Secretariat for invite to participate in these interesting and important discussions and to be part of this AHTEG, but personally I find difficult for on line participants and the AHTEG work on the new topics without a clear and effective support of the Secretariat on what is needed to do first and without a distinction of topics in regard of their significance with different areas of the current knowledge, expertise of the countries and regulatory status or their constraints. I agree with other that the online forums are a great tool to discuss thoughts, ideas and also share references and information, but I consider that is not enough for reach an operative outcome, neither one face to face meeting, could give good results without a good orientation and the attendance of professionals with truly expertise in the topics to discuss.

Thanks for this opportunity to comment.

I look forward to reading other contributions.

Best regards,
Patricia Gadaleta
Biotechnology Directorate
Ministry of Agriculture, Livestock and Fisheries
Argentina.
posted on 2014-03-07 02:01 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 5699 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5700]
Thank you Francesca for focusing our discussion on the recommendation on how to proceed with respect to the development of further guidance on specific topics.

As it is clear stated in the Strategic Plan, Parties agreed to develop Guidance on risk assessment and risk management including guidance on new developments in modern biotechnology as well as a common approaches to risk assessment and risk management (1.3 Risk assessment and risk management). It is requested also to develop a Guidance on living modified organisms or specific traits that may have adverse effects on biological diversity and human health (1.4 LMOs or traits that may have adverse effects).
Since the Strategic plan is being agreed and adopted it guiding us to proceed with further development of the guidance on specific topics.

A combination of face-to-face AHTEG meetings as well as on-line forums, webinar, regionals/subregional meetings, all these modalities would be appropriate to drafting, discuss and testing of the new documents on specific topics.

I appreciate efforts of Maria (Honduras)  to organize the webinar testing in the region. Just to share with you our experience in testing of the Roadmap at the Eastern European Regional face-to face meeting recently organized in Moldova. The 45 participants from 13 countries of Eastern Europe and Central Asian region, that representing the decision makers, academia, universities, NGOs, exercised the testing of Roadmap based on the real dossier on RA. The overall conclusion of the participants is that the Roadmap is a very helpful document, is scientific based, is written in an understandable language and may be easy used to develop the domestic regulation and procedures for risk assessment. The practicability, usefulness and utility of the Guidance were appreciated as very positive.  There were no difficulties in understand and practically use of the Guidance. The participants also remarked that the human health aspects are missing in the Guidance and should be developed accordingly.

In response to Paul’s comments. The reference materials as the component part of the Guidance and bring the scientific knowledge and the world experience in RA made it scientific based. In my view there is no necessary to scientific validation of the roadmap, as soon as this is a not-prescriptive or standard document.

Best,
Angela
posted on 2014-03-07 05:00 UTC by Angela Lozan
This is a reply to 5700 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5701]
Dear Francisca,

As you have asked for two ‘sentences’ to summarize the most pressing recommendations, I would like to give it a try.
Having read the many interesting contributions, some of which were very insightful from my point of view as an LMO risk assessor, I think that:

A reasonable consensus should be reached what the main audience of the guidance, i.e. less experienced risk assessors, expect to find in this guidance, in terms of a guidance on environmental risk assessment, before we can start drafting new guidance on whatever topic.

We should consider to apply a two-step approach for the writing of new guidance:
1) A first step, in which specific experts in the topic of the guidance present their views; this step will probably not lead to consensus – to the contrary: it is important that points of disagreement are clearly laid out and discussed;
2) A second step, in which experts in environmental risk assessment of LMO digest the information produced in the first discussion into guidance for risk assessors, with proposals and examples how the problems raised in the first discussion could be approached in environmental risk assessment.

I hope this ccomment is useful for the discussion

Boet Glandorf
posted on 2014-03-07 07:28 UTC by Ms. Boet Glandorf, Netherlands
This is a reply to 5701 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5702]
Dear Francisca and participants, thanks for the discussion and all interesting inputs.

I´d like to summarize my opinion - that we don´t need any additional guidance in this moment - with three main arguments:
• Any Guidance should be elaborated based upon experience and with expertise in that area 
• Additional Guidance should be elaborated based on the feedback if the AHTEG elaborated documents are useful to parties (RoadMap testing)
• Additional Guidance or any specific assessment issues should be addressed as requested by competent authorities when face real applications  [#5690]

Those arguments were already presented and well addressed by many other participants like Didier, Deise, Andrew, Piet, Maria, David, Isao, Lucia, Paul, Tom etc

Regarding Sarah Agapito´s comment [#5682] I believe she, like all other participants in this forum, are not acting in this forum as ´representative´ of their countries. We were indicated to be part of an ´OnLine Expert Group´ and to express our personal scientific opinion and not to express any country position, which is beyond our competency. That being said I totally disagree with Sarah priorities for our country, as following:

- dsRNA techniques: we do have a GM common bean approved in Brazil expressing resistance to golden bean mosaic develop by a public institution – EMBRAPA (bean is a staple product for Brazil and small farm spend tons of pesticides to control virus vector with losses of millions of dollars in productivity). The GM bean was evaluated and approved using our regulatory framework and no new issue regarding risk expressed by dsRNA technique was identified concluding that existing guidance/regulations as much as available scientific literature can be used in the RA of dsRNA. The same rationality can be applied testing the RoadMap, if is considered useful, this Guidance could also be enough for RA of dsRNA techniques and we do not need any further document. Some references for common bean RA are available at:
http://www.ctnbio.gov.br/index.php/content/view/17813.html
http://www.ctnbio.gov.br/upd_blob/0001/1750.pdf (dossier in portuguese)
Aragão, F. et al. Journal of Biotechnology v. 166, p. 42– 50. 2013.
Faria, J. et al. Plant Breeding (accepted manuscript)

- Coexistence: First of all there is no common understanding among countries on what is coexistence and its scope of application as well as there is no disposal in the text of the Cartagena Protocol on this matter. In Brazil there is a normative and field inspections in place for commercial maize production and there is no point of creating an additional guidance in the scope of Cartagena Protocol´ to help us in developing more robust regulation and monitoring´ as described in the post [#5682]. The normative resolution 04 from CTNBio(http://www.ctnbio.gov.br/index.php/content/view/12858.html) is based on scientific literature  (http://www.ctnbio.gov.br/index.php/content/view/17987.html in portuguese but the references are available in the document). Coexistence in Brazil is not a biosafety issue since it is applied to GMOs already evaluated as safety and released for commercial production. It is part of the internal decision making process and implemented as one of the risk management measures. The coexistence is therefore beyond the scope of the discussion in this forum.

Let spend our effort to fix the RoadMap in the way it can be useful for countries that do not have a biosafety framework in place instead of developing complexities in new documents.

Best,
Luciana

Luciana P. Ambrozevicius
Ministry of Agriculture, Livestock and Food Supply / Brasil
posted on 2014-03-07 12:18 UTC by Ms. Luciana Ambrozevicius, Brazil
This is a reply to 5701 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5703]
It’s been an interesting discussion to follow and I appreciate the various points of view.
I agree with respondents who highlight that the Roadmap is crucial in that it should provide a framework that can be used to assess systematically the environmental risks posed by any LMO. My view is that in order for specific topics to warrant additional attention – a clear understanding of what is needed and how best to provide it is required.

In some cases, regulators may wish to understand the science/ technology better (e.g. use of dsRNA). This is not the same as needing further guidance on environmental risk assessment (ERA). Recent discussions on ‘new techniques used in plant breeding’ in the EU and OECD have demonstrated this. (Noting that some of these techniques may not produce organisms that are captured by LMO legislation). In other cases, the issue appears to be associated with what constitutes environmental harm, rather than how to carry out an ERA (e.g. organisms introduced in centers of origin and genetic diversity).

In cases where further ERA guidance may be necessary, I agree with others who propose that utilising existing experience is the most effective approach. Otherwise, there is a tendency for the guidance to become a shopping list for items that may or may not be needed.
I would also suggest that some of the topics suggested are outside of the scope of the risk assessment/ risk assessment working group.

We should not dismiss requests from the Parties for additional guidance but we do need a process that considers what information is required and how best to provide it. Central to this is whether the Roadmap is fit for purpose. I think Boet’s suggestion is helpful but may benefit from a first step that considers the nature of the request and what information is already available. It is very likely that further guidance developed by the AHTEG is not the best approach. We should also be mindful about the cost of any project as most Parties will not be in a position to contribute further funding.

Regards to you all,
Louise
posted on 2014-03-07 12:25 UTC by Ms. Louise Ball, United Kingdom of Great Britain and Northern Ireland
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5704]
Dear Francisca,

I agree with other participants that it would be helpful to analyse the result of the testing of the Guidance before starting a new development. I absolutely agree with Sol Ortiz: we also need to know who is really intending to apply the Guidance, and listen to their needs. Nevertheless, as other participants pointed out, I find out of the scope two topics of the list, socio-economic considerations and co-existence. Coexistence is a problem of market choice and socioeconomic considerations are not health or environmental issues. In fact, it is already being discussed in another on line forum and AHTEG.

I think the appropriate mechanism to follow up with our task also depends on the result of the testing.

Kind regards,

Victoria
posted on 2014-03-07 12:50 UTC by Dra Victoria Colombo Rodríguez, Spain
This is a reply to 5704 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5705]
Dear colleagues,

It is really interesting to read all the comments on this online forum. Obviously, the views were divided into two different groups. It is also interesting to share my view on this point. I recently read the reports on global GM crops by ISAAA and found out the area of GM crops in developing countries increased and have become higher than the developed countries, although the products from developed countries are planted. Highly extension of GM crops was observed in certain developing countries. I assumed it is a victory of developed countries.

I can see the difference in opinions to the guidance came from parties’ own needs. Some countries like to have a safe manner in management may like to see more good guidance documents, others may not. Thus it is hardly here to reach a consensus with such a division in their actual needs. I am wondering if it is much appropriate to have the guidance developed only for those who actually in a need of the documents. The parties who do not need the guidance may help in this issue but choose not to use them. Not sure if it is a good idea, and I like to hear comments from colleagues. Anyway, there is no way to delay the progress of the works and the development of guidance docs.

Best wishes

Wei
posted on 2014-03-07 14:06 UTC by Mr. Wei Wei, China
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5706]
POSTED ON BEHALF OF LETICIA PASTOR CHIRINO

-----

Dear colleagues,


First of all I send my apologies for my delay on this, but serious problems with internet connection have prevented me from participating  actively. I would like to thanks to the secretariat for providing us for this space for the exchange of information and experiences  among all the experts on a such complex  subject and particulary, thanks to Francisca for serving as a very good moderator .

I agree with my colleagues in the point that caution is needed concerning the work on new documents and guidelines, I would rather also focus on the ones we are discussing now in order to turn them into a more understandable and applicable guide for all the stakeholders, tacking into account that we are dealing with a very technical problem .   The succes of the process of elaboration and comprehension of the future documents, according to the priorities of biotechnology, will depend on the quality of the ones we are working today which means that all requirements made by the possible users have to be beared in mind.

macking an analysis of all comments posted up to date, I think that the test results will be critical in the decision to be made regarding the continuity of this  work aimed at improving the existing documents or the begining of the new ones tacking as a reference the documents already drafted by organizations as FAO, WHO, and CODEX, in order to avoid duplicities of efforts.

I emphasyze that a close link between thecnical assessors and educators or teachers is strongly needed in order to facilitate the comprehension of the guide. In addition, this would give the possibility of spreading its use by a greater number of countries.

Best wishes

Leticia
posted on 2014-03-07 18:47 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5707]
Dear Francisca and participants in the online discussion,

This has been a very interesting forum indeed, and I have finally had a chance to catch up on the conversation.  I would like to lend my voice to the previous contributors who have recommended that the first step in a mechanism of developing further guidance is to assess the effectiveness of the guidance already written.  As I read the task before us, we are to come up with a mechanism for developing further guidance on a prioritized set of topics, not on the set of topics themselves.  I do not mean to say that the topics proposed are not relevant or not important to those who have proposed them.  However, I believe our focus is on the guidance.  It seems to make little sense to forge ahead with further guidance without first concluding that the guidance so far has been useful.  The opinion of developing country regulators, who I believe were the intended primary beneficiaries of the guidance should be weighed appropriately here.  In this regard, I am concerned that we are not hearing much from our African colleagues, particularly from sub-Saharan Africa.  I cannot see how we can come up with a mechanism for developing further guidance unless we hear from them about the usefulness of the guidance so far.

Best wishes to all,

Hector
posted on 2014-03-07 20:11 UTC by Mr. Hector Quemada, Western Michigan University
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5708]
I would like to thank everyone for a lively and enriching discussion.
There is little that I can add to the views already expressed.  I would like to support the comment made several times that before entertaining thoughts of more guidance it would be useful to finish the testing process on the guidance that has already started and identify the relevant issues with the document.  The Parties in Hyderabad recognized that additional guidance was the lowest priority work for the AHTEG and it was generally felt that completing the Roadmap was the highest priority    This is especially true for those that have little to no experience with risk assessment of LMOs.   If the Roadmap is robust enough to guide the ERA of any LMO surely it should suffice for most cases.     As Didier accurately pointed out, if the Roadmap is not robust enough to cover specific areas, then the specific areas where it may fall short with regard to specific examples should be identified.  Again, before that process starts, the testing of the Roadmap should be completed and the results analyzed.

I agree with Louise Ball and Andrew Roberts that there seems to be confusion between looking to explore an interesting topic like dsRNA  and addressing the need for specific guidance on environmental  risk assessments within the scope of the Protocol.  For example, I am struggling to see where an ERA of crops using dsRNA  would require special guidance when so many have made it to the market already without any issues.    The EPA white paper cited by Jack Heineman quite correctly identifies that the use of plant expressed micro RNA  to target specific pests is not as well understood with regard to non-target effects as Bt proteins with which we have very long experience but it does not suggest that current risk assessment procedures are not already adequate.    Others agree that current risk assessment approaches are quite sufficient.   For example Petrick et al. 2013 in a review of the safety assessment of food and feeds derived from crops using RNA mediated gene regulation have concluded that the crops derived utilizing RNA based mechanisms are as safe as those derived from conventional plant breeding, agreeing with the experience of those who have already approved these products for the market place.  In this environment, it seems contradictory to me to try and offer to provide guidance to the inexperienced on a topic where there is controversy and uncertainty.
As others have said, topics like, socio-economics, pesticide use, human health and co-existence are outside of the groups mandate and in the case of socio-economics, duplicates the work of another AHTEG. 

I am looking forward to further discussion and views.

Dickinson, Brent, Zhang, Yuanji, Petrick, Jay S, Heck, Gregory, Ivashuta, Sergey, Marshall, William S
Nat Biotech 31(11)965-967

Petrick JS, Brower-Toland B, Jackson AL, Kier LD. Regul Toxicol Pharmacol. 2013 Apr 2;66(2):167-176
posted on 2014-03-07 20:48 UTC by Mr. Phil Macdonald, Canada
This is a reply to 5631 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5709]
Dear Francisca,

Thanks for your willingness to moderate this forum. I apologize for my delay to get in this very important Open-ended Online Forum.
1. Like everyone else I also could register some kind of polarity in terms of how it is understood the development of further guidance on specific topics of risk assessment. Interestingly, I have also notice that even experts from the same region/country share different opinions.
2. Following the suggestions of the moderation of this forum, I share the same position stressed by other colleagues that do prioritize the topics listed below:
• integrating human health into the environment risk assessment;
• the risk assessment for living modified organisms created through use of dsRNA techniques, engineered to produce dsRNA or exposed to dsRNA;
• “co-existence” between LMOs and non-LMOs in the context of small scale farming.
I would also like to emphasize that to my understanding other topics should be included into further guidance.


3. I would like to take the opportunity to agree with Dr Elizabeth Bravo [#5641] and Judy Carman [#5697] that risk assessment of a LM crop designed to be tolerant to herbicide needs to be a risk assessment of the crop as it will be used in reality. As a risk assessor and by performing evaluation of such dossiers, I found we lack specific guidance on that.

I hope we can get the best from this forum.
Best Regards
Paulo Ramos
posted on 2014-03-08 01:23 UTC by Paulo Ramos, Brazil
This is a reply to 5709 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5710]
Dear All-

I would like to thank Francisca for hosting this online discussion.

I have followed the discussion with interest thus far, and as it is very late in the discussion, my comments here are mainly in response to the comments of others, and I will try to keep them brief.

In terms of how to proceed with respect to development of further guidance, I have seen some very useful and important suggestions of questions or steps to consider either before we proceed or as part of the process, including in particular those listed by Boet [5701], Sol Ortiz [5687], and Piet van der Meer [5664].

Like a number of other commenters, I wish to agree with those who have said that is premature to choose additional topics or develop additional guidance until the work of testing the roadmap is finished.  

I agree with those who have suggested that some topics that have been suggested in this discussion for additional guidance should be addressed under the existing roadmap already, eg. assessing risks in centers of diversity, dsRNA, or microorganisms and viruses. The roadmap should be tested to determine whether it can be used for these cases.  If the roadmap is not sufficient to assess these cases, then it could be that the roadmap must be revised.

As for topics such as socioeconomic considerations, coexistence, impacts on human health, I also agree with those who have suggested that these topics do not fit under the mandate of this AHTEG, whose task is to develop guidance consistent with risk assessment in Annex III.  This does not necessarily mean that guidance on these topics is not needed, but that it would not be appropriate for this AHTEG to do so. 

I also agree with others who have commented that it will be important to consider for all of the topics proposed, what existing guidance there is already and evaluate this guidance before developing something new.

I am not in favor of choosing additional topics at this time for these reasons and those mentioned by a number of other commenters; However, if we were to choose one topic for further guidance, the one that I could justify might be for LMOs intended for confined field trials (limited and controlled introductions). Or, likewise, to determine whether there is existing guidance for this purpose that is already better suited than the roadmap.

I wish to point out that, while it is true that guidelines are not meant to be the same as regulations, novice risk assessors who see the need for this guidance will be likely to confuse this issue, and will interpret these guidelines as strictly as a regulation. Developers of fledgling biosafety systems may even go so far as to cut and paste parts of this guidance, even in draft form, into their regulations.  This has always been a concern for me with the output of this AHTEG’s efforts, and in my line of work, I have already seen it happening.  So our work here should never be taken lightly. 

And finally, I must take this opportunity to agree that there are and will continue to be LMOs developed by public research institutions for the public good, and to develop overly restrictive regulation, or guidance, for these products, does not recognize ‘the great potential of modern-biotechnology for human well-being, if used with adequate safety measures for the environment and human health’, to which the parties of the Protocol have agreed.

Thanks to everyone for the time and energy you invest.
Karen
posted on 2014-03-08 13:11 UTC by Ms. Karen Hokanson, University of Minnesota
This is a reply to 5710 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5711]
Thanks to all the participants in this interesting discussion that soon will be closed.
Thanks to those who mentioned or attached references, there is always something important out there that we have missed. I hope all these are available at the Biosafety Information Resource Centre. Thank you Dr. Lúcia de Souza, for sharing with all of us, the enlightening exercise on results from retrieving information from the BIRC using different searches. I will keep your points in mind for my next searches there.
I also want to express my agreement with recent postings in particular from Luciana P. Ambrozevicius, (#5702), Victoria Colombo Rodríguez (#5704), Leticia Pastor (#5706) and Karen Hokanson (#5710). Happy International Women´s Day.
Kind regards
Sol
posted on 2014-03-08 17:54 UTC by Ms. Sol Ortiz García, Mexico
This is a reply to 5711 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5712]
Dear participants, like many others colleagues I would like to thank you for very interesting discussion, your opinions and valuable links to the sources of information.
I also join to the colleagues, who have expressed that firstly it is very important to see the results of the Guidance testing, and Parties opinions and suggestions. I also participated in the workshop held in Moldova and would like to join to the words of Dr. Angela Lozan [5699]. Brief discussions of those workshop on Guidance testing (English and Russian versions), joining many people from different countries, professions and experience in RA, lead to the overall opinion that the Road map is very useful guidance for RA, with understandable structure, that allows to focus on the really important issues that should be considered in the risk assessment process. And I see completely different results of the Webinar, that were held in Honduras. So it is quite important that as many representatives of the Parties, to find time and submit the results of their testing, and to provide their valuable suggestions why, on their opinion, it could be improved, where it could be improved and how to do it, rather than just declaration that it is not useful and complex.
And I also would like to express my agreement with the two-step approach for the writing of new guidance proposed by Dr. Boet Glandorf. Just would like to add that, if it is decided to develop the additional guidances on specific issues, every step of discussion (on-line, face to face) should include as many as possible researches experienced in this specific field.
With best wishes,
Galina.
posted on 2014-03-09 11:10 UTC by Dr. Galina Mozgova, Belarus
This is a reply to 5712 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5713]
Dear All,
Its has been a lively debate .
The Guidance materials are to guide and assist particularly developing countries to carry out appropriate Risk Assessment.
Very few  countries  in Africa have approved regulatory frameworks as such they  have not started modern biotechnology activities. Quite a large   number are still developing thier regulatory frmework or thier implenting regulationa and guidelines as such the guidance materials are timely as it would be an opportunity to use some of the guidance materials to develop thier regulatory frameworks.
Because of low capacity  of developing countries, the guidance materials  are quite handing at this time in point.  The more guidance materials developed the better it is for the developing countries.
  How ever to test the usefulness or the acceptability of the existince guidance materials and to determine the need for new ones there is the need to devlop  a set of questions  for National Focal Points either those of CPB or BCH  to answer and respose received by  the SCBD before the next face to face meeting of AHTEG.
Inview  of the above I wish to propose  the  following questions in addition to others after introducing the topic for the national focal points:
i) Are you aware of the AHTEG
ii) Are you aware of the on line forum
iii) Are you aware of the Road and Guidance materials,
iii) Will your Country Use the Road Map and the Guidance Materials,
iv) Have you tested the Road Map and the Guidance Materials in your Country,
v) Are the Road Map and the Guidance Materials Useful to your Country,
vi) Has your country adopted any of the Guidance materials solely or partially in the development of national guidelines
vii) Which need guidance would you propose
and so on and so on.
The more guidance the better for developing countries that need them. 
Rufus Ebegba,
National Biosafety Office,
Federal Ministry of Environment,
Abuja -Nigeria
posted on 2014-03-09 14:21 UTC by Dr. Rufus Eseoghene Ebegba, Nigeria
This is a reply to 5650 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5714]
Dear friends:

Reviewing the material sent by Mercedes Roca some days ago (a long compilation of scientific papers showing tha GM crops are safe) , ir make me to wonder from which scientific paradigm those research were made, as there are an equal number of scientific papers that accounts the serious impacts of GM crops on health, biodiversity, economic society welfare of communities.

It is not possible to say , with all the advances of epistemology, that science is neutral. Facing the same problem two researchers will get different results, depending on what they want to find, the methodology applied, etc.

This is relevant to address the issue of risk assement, which claims to be objective and based on science. The question is, from which scientific paradim are choosen the evidences in the decision making process. 

Science and its applications are traversed by relations of power, as is the risk assessment. And these are issues that need to be taken into account in these discussions.

I'm sorry for this digression

Elizabeth Bravo
(edited on 2014-03-09 15:41 UTC by Elizabeth Bravo)
posted on 2014-03-09 15:33 UTC by Dr. Elizabeth Bravo, Acción Ecológica, Ecuador
This is a reply to 5714 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5715]
Dear all,

As this lively and productive discussion draws to a close, it will be most interesting and enlightening to see how the conclusions of the forum are drafted by whoever is responsible of this task (Francisca our kind and brave  moderator? other officers in the Secretariat?). As Elizabeth has rightly pointed out in her last posting  [#5714], there are many ways of interpreting data, results and even conclusions.

The interpretation of this forum will be no exception.  We are all humans and mostly incapable of totally escaping personal bias which is based on our personal experience, our cultural believes,  information we are exposed to, identification of “the problem”, concepts and theories we are familiar with (or not), suppositions, points of view, ideologies and other factors.  I teach this in a Critical Thinking class to my students.  This is why it is key to  have appropriate  representation  for different stakeholders,  and I think the Secretariat does a good job with this, for it promotes fairness and transparency.

To illustrate the point further, the regulators from Central America are mainly apathetic about doing the testing of the guidance and one has to ask why. There may be many reasons that I have already discussed in earlier postings. Still, at the webinar last week, we did not do the testing, but just went  through   what is required and expected to test the guidance:  what approach could be taken, who should do it and why,  how long should it take, what resources are needed (mainly time and a clear understanding of the task ahead!) and what documents are necessary to study. Some countries will actually undergo the testing. Others will not and won’t say why not, but I think I know the reasons, at least for my region.  I hope most post their conclusions.   

By contrast, our colleagues in Eastern Europe report that regulators there did  the testing and found the guidance helpful, useful, practical and with much utility. What are these contrasting levels of engagement, enthusiasm and vastly diverging results show us? I would not dare to give an answer to this complex question, except that it appears that “one size does not fit all”, so doing the same guidance for all countries  regardless of context and regions, does not seem to be working.

It also illustrates that who guides the process of the testing, has a huge effect on the outcome, especially on novice regultors. Non-experts in any subject cannot judge how good or bad any text, idea or guidance is, and even less so, how to improve it. Non-experts, or people who don't understand an issue, mainly stay silent and may agree with the majority,  if pushed for an answer. That is my experience as a teacher.

The question still remains, that ALL countries need to develop biosafety systems  if they are to benefit from, or stop the advancement of agricultural biotechnology and beyond. It is up to each country. Sadly,  the outcome will be y a reflection of the opinions/diligence/bias of their  regulators and governments,  and will not so much reflect what the people in the country  need or want, especially farmers in need of  better technologies (for the first generation of biotech products).  In this respect, the comment made by Karen [#5664]  is very accurate, which I feel is important enough to cite again:

“I wish to point out that, while it is true that guidelines are not meant to be the same as regulations, novice risk assessors who see the need for this guidance will be likely to confuse this issue, and will interpret these guidelines as strictly as a regulation. Developers of fledgling biosafety systems may even go so far as to cut and paste parts of this guidance, even in draft form, into their regulations.  This has always been a concern for me with the output of this AHTEG’s efforts, and in my line of work, I have already seen it happening.  So our work here should never be taken lightly”.

I deeply share Karen’s concern.  Many parties may adopt the AHTEG´s guidance by default,  not able to critically assess what they are doing and if it really addresses their country´s needs. 

Since we need to move on and not get stuck in circular arguments on  how to move forward, I also want to support the statement from Rufus from Nigeria [#5713], who suggest the questionnaire for testing the guidance  asks further questions from the regulators, so the Secretariat can get a better sense of  why parties are answering the questionnaires and why so many, especially in the least developed countries where there is the greatest need,  are abstaining from the testing. 

Regards to all,

Maria
posted on 2014-03-09 17:07 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5711 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5716]
I wish to voice my strong support for the proposal described by Boet. By breaking this problem into steps that engage appropriate experts, the overall process would benefit and could progress.

Thanks,
Tom
posted on 2014-03-09 21:39 UTC by Mr. Thomas Nickson, Consultant
This is a reply to 5715 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5717]
My gratitude to you, Fran, and the Secretariat for taking on the difficult job of extracting the essence of this frank and enjoyable exchange.

Maybe I’m an optimist, but I don’t share the view expressed here by some that regulators from either developing or developed countries are in any doubt of their obligations under their own legislation, nor are they likely to confuse a legally binding obligation with the Guidance produced by the AHTEG at the request of the Parties. I’ve so far not met any regulator that seemed prone to this kind of confusion.

I have met regulators that are more and less secure in their knowledge about particular technical questions. Given that they are responsible to their government for the advice that they give, where they are uncertain in their knowledge they may find useful guidance as to how to resolve, as much as can be done, such uncertainty before issuing advice. Where regulators have achieved satisfaction with their risk assessments they may not draw upon the Guidance at all and where regulators may have questions of specific interest for their receiving environment they may benefit from reference to the Guidance.

To imply that some regulators may use the guidance ‘incorrectly’ is to impart judgment on the judgment of those who are specialist in their legislation and uniquely responsible for their sovereign environments. They may reach conclusions that some of us would disagree with, but most regulators will have experienced that they make recommendations that not everyone agrees with!

If, as Maria suggests (#5715), regulators of some countries are so biased as to be unable to exercise competent judgment, then this would be true regardless of the existence of the non-binding Guidance and probably no amount of guidance of any kind would have an effect on such regulators. Indeed, the bias may not just be against e.g., “farmers in need of better technologies”, but just as possibly in approving products that could do harm. Attempting to write guidance to foil what are effectively political actions would in any case be impossible.

The Parties have asked for guidance. The existing Guidance may not be of equal use and value to all Parties, but it clearly is to some users including among them Parties. By agreement in the next MOP, the Parties may feel that starting work on new topics is worthwhile, or they may not feel that it is. In the meantime, they have asked for suggestions for additional topics “selected on the basis of the priorities and needs indicated by the Parties with the view of moving toward the operational objectives 1.3. and 1.4 of the Strategic Plan and its outcomes” where those objectives state: “on new developments in modern biotechnology” and “guidance in identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health”. We are not ‘choosing’ (#5710) but suggesting topics for consideration by the Parties.

The focus on the cost of developing new guidance rather than on topics that might be useful to some Parties is in my view a distraction from our task because it is the Parties who will decide if the investment is worth it, and they will be very aware of what both the direct and indirect costs are so far.

With best wishes,
Jack
posted on 2014-03-09 22:27 UTC by Mr. Jack Heinemann, University of Canterbury
This is a reply to 5717 RE: Opening of the discussion on how to proceed with respect to the development of further guidance on specific topics of risk assessment [#5718]
Dear All,

Thanks for the open exchange of views during this online discussion.

Several of the comments have emphasized the need to base guidance on a history of real, practical experience in risk assessment of LMOs, and I agree completely.

A number of other comments have suggested that there is a need for guidance in newer areas of genetically modifying organisms, and several commenters have suggested the modifications now known as RNAi.  The mechanism which we now are calling RNAi is likely the same or similar mechanism which we have previously referred to as "antisense constructs" (slow-ripening tomatoes, altered oil profiles of soybean) as well as the constructs which have conferred resistance of plants to certain plant viruses (potator leafroll and papaya ringspot virus resistant potatoes and papayas, respectively, come to mind).

These are very useful examples to reflect upon, because they reinforce one of the key concepts that practitioners of risk assessments for LM plants have found over the past twenty years, namely that the phenotype or characteristics of the LMO are of greater predictive value to the risk assessor than the precise genetic construct or the mechanism by which the construct results in the changed characteristic(s) of the organism.

If future topics for risk assessment guidance are taken up by the Parties, the lessons from past experience may guide them in pointing novice risk assessors toward evaluations of the characteristics of the LMOs moreso than the types of genetic constructs. Nevertheless, it may be useful for the Parties to consider ways to better disseminate existing scientific knowledge.  In addition, it may be useful for the AHTEG on risk assessment to make clearer the types of guidance that is already in the public domain or under development by other international collaborative bodies, such as the OECD.  This can help the international community to avoid unnecessary duplication of efforst to share our experiences and knowledge related to the environmental assessment of LMOs.

Best regards,

David Heron
posted on 2014-03-09 23:26 UTC by David Heron, United States of America