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Opening of the discussion group on "New specific topics of risk assessment for the development of further guidance" (topic 3) [#2229]
Dear all,

The discussion group on "New specific topics of risk assessment for the development of further guidance" (topic 3) is now open for comments at http://bch.cbd.int/onlineconferences/discussiongroups_ra.shtml .

This discussion will take place from 11 to 18 April 2011 (1:00am GMT) concurrent to the discussion on topic 2.

You may post comments in this discussion group by going to the website above and by either creating a new thread or replying to this posting. Alternatively, when viewing this message through email, you may also reply to it using the address at the end of the email, and your comment will be automatically posted in the discussion group.

Thank you and best regards,
Manoela

----

Introduction to the topic of discussion:

During the previous intersessional period, the Open-ended Online Group and AHTEG identified topics for further development of guidance.

Under this discussion, from the list of identified topics (http://bch.cbd.int/forum/ahteg/bsrarm-02-05-en-annex5.doc?download), participants are invited to indicate, in his/her opinion and taking into account the needs from Parties,

***which are the 5 (five) most important topics in order of priority for the development of additional guidance.***

Suggested format: to facilitate the exchange of views, it is recommended that each message posted in this discussion group shows, at the top, a list of five selected topics (from the 1st to 5th in order of priority) followed by the exact titles as indicated in the list of identified topics. Explanatory comments on why the topics were chosen may be added after the list.
(edited on 2011-04-14 22:08 UTC by Manoela Miranda)
posted on 2011-04-11 01:05 UTC by Manoela Miranda, UNEP/SCBD/Biosafety
 
New specific topics [#2259]
Hello, manoela, we cannot access the thread, so letr's try this avenue.
Please post on my behalf.

We suggest that we come up with a guidance document that does not prescribe
specific information but recommends the type of information that may be
necessary for a comprehensive risk assessment. This type of document should
have enough flexibility to address different situations without having to
come up with a document that applies only for a limited number of taxa and
specific introduced traits.

We need to elaborate on what type of ecological data are necessary for a
rational environmental risk assessment and rationalize why such data are
indeed necessary. Clarifying why such data are needed will lend flexibility
to a guidance document and perhaps negate the need for creating specific
guidance documents for many situations

Having too many specific guidance documents may eventually lead to
confusion. There may be situations where specific documents may start
conflicting with a previously issued guidance document that deals with
situations which are very similar. A particular taxon/trait combination may
also fall under more than one classification and as such fall under
different guidance documents. In this situation, the result of the risk
assessment may differ when more than one guidance document is used.

Especially disconcerting would be a situation where a newly issued guidance
document may lead to reassessments of entries that have already been
categorized as “unlikely to cause adverse effects” by an earlier document.
We may end up in an unforgiving cycle of risk assessments and risk
reassessments every time a new document is created for a specific entry.

For example there are x number of species of insects where y genetic
modifications may be made for one reason or another. It would be very
unwieldy to craft guidance documents for each and every possible
insect/trait combination. When the possibility of stacking events is also
considered, we may end up with a never ending exercise of doing risk
assessments without drawing any conclusions.

Flerida A.Carino
posted on 2011-04-14 16:30 UTC by Flerida Cariño, Philippines
 
RE: Opening of the discussion group on "New specific topics of risk assessment for the development of further guidance" (topic 3) [#2275]
Dear colleagues,

My top 5 topics:
• Risk assessment of living modified microorganisms and viruses;
• Risk assessment of living modified fish
• Risk assessment living modified organisms for production of pharmaceutical and industrial products
• Risk assessment of living modified pharmaplants
• Risk assessment of living modified organisms produced through synthetic biology

Rationale:
• Risk assessment of living modified microorganisms and viruses;
This would be a logical counterpart to the Roadmap that is there now, and that is focusing very much on eukaryotic 'macro'-organisms. I think that risk assessment of micro-organisms, both prokaryotic and eukaryotic is an important issue because quite a number of issue have to be approached in a different way for micro-organisms.
There is a lot of experienxce already available for micro-organisms, although not as much as for crop plants. Still, this topic appears to me to be very urgent, and quite feasible.
• Risk assessment of living modified fish;
Also this topic is urgent, and feasible.
• Risk assessment living modified organisms for production of pharmaceutical and industrial products;
I am not sure what exactly is the dividing line between this topic and the next on my list, pharmaplants.
This topic would appear to include also micro-organisms; it is a topic that would be very timely, for instance also biofuel production by micro-organisms.
• Risk assessment of living modified pharmaplants;
Is important, but define carefully, see previous item.
• Risk assessment of living modified organisms produced through synthetic biology;
This is an area where we would have to be working in proactively; it is considered very important by my office in the Netherlands, as it implies (or may imply) some paradigm shifts.

Hans Bergmans
The Netherlands
posted on 2011-04-15 15:09 UTC by Hans Bergmans, Netherlands
 
RE: Opening of the discussion group on "New specific topics of risk assessment for the development of further guidance" (topic 3) [#2278]
Dear Hans,
I am agree on the importance of Risk assessment of living modified organisms produced through synthetic biology; however I am wonder if it is on the scope of the Protocol of Cartagena.
As I understand the Protocol scope is limitated by the procese to obtain a LMO.
Thank you
Adriana
posted on 2011-04-15 18:40 UTC by Dr. Adriana Otero-Arnaiz, Mexico
 
RE: Opening of the discussion group on "New specific topics of risk assessment for the development of further guidance" (topic 3) [#2288]
Dear Hans, Adriana and all:

The list which Hans indicated follow the ANNEX V of the RA AHTEG Report (FINAL REPORT OF THE AD HOC TECHNICAL EXPERT GROUP ON RISK ASSESSMENT AND RISK MANAGEMENT UNDER THE CARTAGENA PROTOCOL ON BIOSAFETY, UNEP/CBD/BS/COP-MOP/5/INF/15*
3 August 2010) and if additional topics is considered, at first all participants shall consider the listed items. Especially, those who participated as RA AHTEG members shall go back to this document and build up the discussion based on what you have done?

However, some of the items, especially those which related to LMOs FFP have been widely discussed at different scientific and inter-governmental forums over more than decades and I do not see much needs of topics consideration at this on-line forum and RA AHTEG. Even LMOs-FFP related international and scientific conferences have been held extensively, and smaller forums here do not have advantage and strength to proceed.

Also the balance shall be considered over the most important mission at CBD and Cartagena Protocol: environment.  The consideration on human health issue is however, stated over the text of the CBD and Protocol, yet those aspects are more covered at the other forums and if any of related topics to be considered for further discussion, inter-relationships with CODEX, WHO etc and comparative strength of this forum as discussion topics.

Having stated general direction, I would be putting further point on LMO FISH as a consideration.

But synthetic biology issue would not be the scope of the Cartagena Protocol and the focus should be carefully examined if there is need with very limited expert speciality at RA AHTEG and with the present on-line forum members can sustain discussion?


rgds,

Kazuo
posted on 2011-04-16 02:21 UTC by Dr. Kazuo Watanabe, University of Tsukuba
 
RE: Opening of the discussion group on "New specific topics of risk assessment for the development of further guidance" (topic 3) [#2296]
Dear forum participants.

I agree with Kazuo when he says that the most important mission at CBD and Cartagena Protocol is environment. I disagree that new topics should be “tested” in the RA road map, since the first three exercises were (in my opinion) unsatisfactory. Moreover, from the three topics (i.e., GM mosquitoes, stress-tolerant plants and stacks) only the first two brought into discussion really environmentally important issues. For the stacks, the environmental issues were highly hypothetical. I may be worng but before been successful with the first three topics, AHTEG should not try to advance on new topics

However, as mandated, AHTEG should indicate new topics; therefore I will try, as Kazuo, to produce my list, taken from http://bch.cbd.int/forum/ahteg/bsrarm-02-05-en-annex5.doc?download and not repeating “old” topics

• Risk assessment of living modified trees
• Risk assessment of living modified fish


Only two topics?!! Why not some of the remaining topics?

• Post-release monitoring and long-term effects of LMOs released into the environment
This is indeed risk management, not risk assessment. Moreover, after many years of commercial use of GM plants, harms associated to theoretical risks are essentially nil. I do not see how the, taken this unsubstantial experience, the AHTEG would develop a meaningful proposal.

• Risk assessment and risk management in specific receiving environments;
This is indeed part of the risk evaluation process, and not a topic by itself

• Risk assessment of living modified microorganisms and viruses;
Most of their use is in containment or in certain specific environments. It may, however, be interesting to discuss how microorganismos used for food and beverage could impact thje environment, especially those that are sold as living organism and consumed as so by humans and animals.

• Risk assessment of living modified pharmaplants
The environment impact of such crops, which will be most probably kept in greenhouses, is in principle very small.

• Risk assessment of living modified crops;
This was a former AHETG topic, at least partially covered by stacks and stress-tolerant crops

• Risk assessment living modified organisms for production of pharmaceutical and industrial products
Again, in most cases the production is made in full containment of in restricted environment.

• “Co-existence” between LMOs and non-LMOs in the context of small scale farming
This is not risk assessment and perhaps even not risk analysis (as risk management), being solely an economic issue

• Risk assessment of living modified plants for biofuels;
Their risks are essentially the same as those observed for similar crops and different traits.

• Risk assessment of living modified organisms produced through synthetic biology
As stated by Kazuo, “synthetic biology issue would not be the scope of the Cartagena Protocol and the focus should be carefully examined if there is need with very limited expert specialty at RA AHTEG and with the present on-line forum members can sustain discussion”

• Uncertainty analysis
Although important, the topic is not directly related do an environmental issue, but to the RA methodology

• Establishment of criteria for transparency and reproducibility of information
Again, not directly related do an environmental issue, but to the RA methodology

• Interface between risk assessment and risk management
Again, not directly related do an environmental issue, but to the RA methodology

• Environmental risk assessment and monitoring taking into account human health
This is a side issue in ERA

• Unintentional transboundary movements
Out of the scope of the Protocol

• Risk assessment and management of LMOs intended for introduction into unmanaged environments
Always when the introduction of a LMO in a certain environment is analyzed, the impact on wild, unmanaged environments in the reachable neighborhood is assessed, I do not see the point in considering this issue as an independent topic.

Moreover, I again agree with Kazuo that “some of the items, especially those which related to LMOs FFP have been widely discussed at different scientific and inter-governmental forums over more than decades and I do not see much needs of topics consideration at this on-line forum and RA AHTEG. --- smaller forums here do not have advantage and strength to proceed”.

Best regards
Paulo
posted on 2011-04-16 22:17 UTC by Paulo Paes de Andrade, Brazil
 
RE: Opening of the discussion group on "New specific topics of risk assessment for the development of further guidance" (topic 3) [#2295]
Ossama El-Tayeb, Cairo University.
Ths question of synthetic biology is indeed a valid one and perhapse in a strict sense, synthetic genomes are not included in the Protocol, since it was not known in 2000.  However, the techniques used are just as foreign to nature as GMOs technology and hence are covered by the Protocol.  This is a common problem with science-related treaties where future developments are impossible to anticipate without being legally unacceptable.  Some of our legal experts assure us, however, that synthetic biology is legally covered.  If they are not, we need a decision from COP-MOP.  A similar situation arose during negotiation of the ABS Protocol under the CBD which ran againest an old COP decision to exclude human genomes for reasons not anticipating the outcome of the human genome project and the aftermath of patents of human genes based on studies of isolated communities and used for commercial purposes.
posted on 2011-04-16 19:38 UTC by Dr. Ossama El-Tayeb, Egypt
 
RE: Opening of the discussion group on "New specific topics of risk assessment for the development of further guidance" (topic 3) [#2300]
As a member of the AHTEG on Risk Assessment and Risk Management (though we seem to have forgotten the “Risk Management” portion of our given name!), I have been following along with interest and gratitude for the many thoughful inputs on all the topics discussed thus far.

I would like to contribute briefly to the discussion on "New specific topics of risk assessment for the development of further guidance" with three points:

1. The guidance developed to elaborate on RA and RM by the AHTEG must be applicable to ALL LMOs under the stated scope of the Protocol. Specific guidance can help orient to specific challenges or needs that are not easily extrapolated by the language of the protocol, which was written primarily with GM crop plants in mind. There is therefore a clear need to provide guidance on new classes and types of LMOs that were not, or could not of been known or taken into account during the development of the Protocol.

2. I wish to orient participants here to the guiding mandate (that we have been asked to further consider in Decision BS-V/12 ), stated in Decision BS-IV/11 (http://www.cbd.int/decision/mop/?id=11690) from COP-MOP4, and included as an annex “TERMS OF REFERENCE FOR THE AD HOC TECHNICAL EXPERT GROUP ON RISK ASSESSMENT AND RISK MANAGEMENT”,

Within, it is stated:

“The Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management shall: …
(ii) Taking into consideration the identified need for further guidance on specific aspects of risk assessment, including particular types of (i) living modified organisms (for example, fish, invertebrates, trees, pharmaplants and algae); (ii) introduced traits; and (iii) receiving environments, as well as monitoring of the long-term effects of living modified organisms released in the environment, prioritize the need for further guidance on specific aspects of risk assessment and define which such aspects should be addressed first, taking also into account the need for and relevance of such guidance, and availability of scientific information;”


3. With relation to specific additional guidance, I would like to further remind the participants of one of the background documents that our work in the AHTEG-RA/RM is expected to based upon, as outlined in Decision BS-IV/11 referenced above. This document, the “Canada-Norway Workshop on Risk Assessment for Emerging Applications of Living Modified Organisms” (UNEP/CBD/BS/COP-MOP/4/INF/13), gives specific recommendations for further needs in development of risk assessment of LMOs.

Principally, the workshop and report:

”addressed available guidance on risk assessment for emerging applications of modern biotechnology, identification of gaps in information or science that could impact on appropriate risk assessments and appropriateness of current models for risk assessment applied to emerging applications.”

Finding within its recommendations:

“There is insufficient guidance on how to perform risk assessment for GM fish and viruses.”

The report continues with a substantive discussion on the challenges and needs for environmental risk assessment with these classes of LMOs.

Based on this report, LM fish and LM viruses are of considerable importance for the development of further guidance in the AHTEG-RA/RM’s future work.

Kind regards from the Arctic Circle,

David
posted on 2011-04-17 11:41 UTC by David Quist
 
RE: Opening of the discussion group on "New specific topics of risk assessment for the development of further guidance" (topic 3) [#2305]
Ossama El-Tayeb, Cairo University.
I am in full agreement with the views expressed by Dr. Quist.  We should be careful not to focus the discussion on strictly managed commercial agricultural systems to the exclusion of the much broader environment where real biodiversity is in operation and where ecosystem services are indispensible.  I also find the report of the Nor-Canada meeting to be an excellent stating point for key areas of discussion at the Expert group meeting.  Many of the elements of thatreport were eye openers and need further elaboration which the guidance should be sensitive to.
posted on 2011-04-17 21:06 UTC by Dr. Ossama El-Tayeb, Egypt
 
New specific topics [#2308]
Dear participants,

Whereas I find all topics identified as important for desserving some
specific guidance, I agree with some priorities already mentionned, find
it difficult to establish a order of priority,  but would propose the
following order on basis of urgency:

1. Post-release monitoring and long-term effects of LMOs released into
the environment.
Long-term effects of LMOs should be evaluated in the RA, but it is still
more recognized that, because of lack of methodologies to apprehend all
indirect and complex interactions of the evolving ecosystems, it is not
possible to foresee all potential long-term impacts. Moreover monitoring
should early detect the eventual appearance of impacts foreseen in the
RA as being possible, and thus allow to avoid their extension. Despite
the importance of post-release monitoring, no precise guidance exist
presently in the Protocol for monitoring.

2. RA of LM microorganisms and viruses.
These organisms have very different life characteristics than
macro-eukaryotes. Are invisible. Some have been and are in development
for vaccines or other medical and veterinary use, or for biomonitoring
or remediation. Environmental monitoring should also be very necessary.

3. RA of LM trees.
Various LM trees are in field trials since years, and some of them are
already on the market, if I am not wrong ( ? In China, in particular ?
). LM trees need specific RA on the basis of their long life-time
compared to annual plants and of other characteristics ( difficulty of
green-house trials, are part of very complex terrestrial and soil
ecosystems,..... ) .

4. RA of LM plants for production of pharmaceutical, industrial
products, biofuels.
Like other participants, I do not quite understand the difference made
between some topics identified in the presented list. I find in any case
that the risk for LMOs producing such materials is, in the context of
the Protocol,  to consider in priority for plants released into the
environment ( if in confined use, would it be plants, algas,
microorganisms, the risk is different ).
It seems to me that LM plants producing pharmaceuticals, biofuels or
other industrial products could be handled together for a big part of
their RA concerns different from the RA for LM plants aimed as food or
feed.  

5. RA of LM fishes.
Various LM fishes are in development and some are close to
commercilaization. Fishes "escape" more easily than plants in a poorly
visible and complex ecosystem and food chain.  

I find, like other participants, that the "Canada-Norway Workshop on RA
for emerging Applications of LMOs" is a good basis of reflexion for the
AHTEG on some new topics.



I find the following topics also very important presently, but they
should logically be treated in the general roadmap:

Uncertainty analysis. Uncertainty is part of the RAs, has been often
mentionned during the online discussions these last weeks, but is a sort
of " tabou " poorly treated in practice during the RAs of LMOs, whereas
it is closely linked to the precautionary principle application.

Risk assessment ( and risk management ) in specific receiving
environments. I do agree with Beatrix Tappeser comments on this topic. 

Concerning " Coexistence", as reminded several times, this topic does
not per se concern the RA if meant following the EU interpretation ( at
least if uncertainty is not taken into account ), but " contamination "
does well concern the RA; as previously discussed, this could be treated
more deeply, but also in the context of the general roadmap.


I thank already the members of the AHTEG and hope they will be able to
manage with new topics while bringing the wished improvements in the
previous roadmap and guidances !

Best regards.

Lucette Flandroy




Disclaimer : http://www.health.belgium.be/eportal/disclaimer/index.htm
posted on 2011-04-17 23:40 UTC by Ms. Lucette Flandroy, Belgium
 
RE: Opening of the discussion group on "New specific topics of risk assessment for the development of further guidance" (topic 3) [#2323]
THIS MESSAGE WAS SUBMITTED SHORTLY AFTER THE CLOSING OF THIS DISCUSSION AND IS BEING POSTED ON BEHALF OF GEORGINA CATACORA-VARGAS, BOLIVIA

-----

Dear all,

To the Plurinational State of Bolivia, all the proposed topics for developing guidance material are important and we hope that they are addressed at certain point; however, we prioritized the following five:

1. Post-release monitoring and long-term effects of LMOs released into the environment
2. Risk assessment of living modified plants for biofuels
3. Unintentional transboundary movement
4. Establishment of criteria for transparency and reproducibility of information
5. Risk assessment of living modified trees

If our list of most important topics could be expanded, we would additionally suggest:

- Environmental risk assessment and monitoring taking into account human health
- Uncertainty analysis
- Risk assessment and risk management in specific receiving environments

Thanks and kind regards,

Georgina Catacora-Vargas
posted on 2011-04-18 14:32 UTC by Manoela Miranda, UNEP/SCBD/Biosafety
 
RE: Opening of the discussion group on "New specific topics of risk assessment for the development of further guidance" (topic 3) [#2324]
THIS MESSAGE WAS SUBMITTED SHORTLY AFTER THE CLOSING OF THIS DISCUSSION AND IS BEING POSTED ON BEHALF OF RICARDA STEINBRECHER

-----

Dear Manoela,

sorry to be late, but I had horrible internet glitches over the wekend.
If possible, I would appreciate if my comments can still be included.

My list of priorities:
1. Risk assessment of living modified trees;
2. Risk assessment of living modified fish;
3. Post-release monitoring and long-term effects of LMOs released into the environment;
4. Risk assessment of living modified microorganisms and viruses;
5. Risk assessment and risk management in specific receiving environments

1. Risk assessment of living modified trees; - There is an increasing number of field trials around the globe, with the aim for commercial releases. This enhances the need to very soon focus on LM trees in our deliberations. Given the distinct differences to annual crop plants, - including management systems and receiving environments - I regard this to be top priority.

2. Risk assessment of living modified fish; LM fish are so far not properly covered by our guidelines, yet there are many developments on the way as well as a marketing application. The potential impact on biodiversity and ecosystems should make the development of guidance material another priority, next to LM trees.

3. Post-release monitoring and long-term effects of LMOs released into the environment; ..I agree with many of the statements made by others to this topic, and there should be much experience and data for evaluation to enable a good discussion and development of guidance. It may be possible to expand this from annual crops to also include trees, animals and microorganisms in a second stage.

4. Risk assessment of living modified microorganisms and viruses; this is so far not covered by the roadmap and needs addressing, but might require some scoping first.

5. Risk assessment and risk management in specific receiving environments – agree with others on this.

with kind regards,
Ricarda
posted on 2011-04-18 14:32 UTC by Manoela Miranda, UNEP/SCBD/Biosafety
 

   
   
Update on 2011-04-18
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