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Opening of the discussion on "Final improvements to the alignment for submission to the AHTEG" [#5559]
POSTED ON BEHALF OF LUCETTE FLANDROY (MODERATOR)

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Dear Participants of the Online Forum,

As indicated at the end of the last round of discussions, together with the Secretariat and the Chair of the AHTEG, the Manual was revised on the basis of your input. In our attempt to be as inclusive as possible, we reflected concrete proposals for changes that improved the alignment with the Guidance and consistency with the Protocol, corrected or clarified some concepts, and provided “real-life” examples. As in the previous round of discussions, the Manual is being circulated as a “clean” version, which is the basis of our discussion, and as a “track-changes” version for reference only.

I invite you to one last round of discussion before submitting the revised Manual to the AHTEG. In this discussion, you are invited to provide comments, if any, regarding the last revisions in the Manual. If you have any suggestion for improving the last revisions, I kindly ask you to be concise and provide concrete text proposals.

The changes in this revised version are not very extensive and, since many of you will be away for the holiday season, I would like to start this round of discussion right away. The discussion is now open and will close on 23 December at 1:00am GMT (please be aware that this will be Sunday night in many places).   

As for the way forward with regard to the alignment, the Secretariat indicated that they will prepare a draft online package aligning the Guidance and Manual on the basis of earlier inputs from the Online Forum on how this could be done. In March 2014, the Online Forum will discuss and provide input to the draft online package. 

Last, but certainly not least, I would like to already wish all of you a wonderful holiday season with your families and a very Happy New Year!

But, before this deserved break, let us still have a look together at the alignment, improved with your help, between the Manual and the Guidance.  

Best regards,
Lucette
posted on 2013-12-12 16:46 UTC by Ms. Manoela Miranda, UNEP/SCBD
RA Forum: Final improvements to the alignment for submission to theAHTEG - A new message has been posted to the forum [#5565]
Dear Members of the Open-ended online forum,

I realize that we probably all are waiting for the happy days and festivities of the end of the year, and are already a bit dreaming on these while finalizing various professional duties before this yearly break.

But I am sure also that we all want to bring to a success the task that was confided to us in this part of the online forum for the alignment of the Guidance and the Manual.

We are very close to completion !

The last revisions done by me, together with Helmut (as AHTEG Chair) and the Secretariat, include new examples and specific changes aimed at improving the alignment and correcting or clarifying some concepts on the basis of comments posted in preceding sessions of the forum.

It does not take a long time to find and read the amendments if you look just some minutes at the last "track-changes" version. I invite you to do so to facilitate your participation in this last round and please provide comments, if you have any, regarding the last revisions in the Manual. If you have any suggestion for improving the last revisions, please be concise and provide concrete text proposals.

It would also be very nice if you did not wait too long to participate in this last session, mainly to give the opportunity to other members to eventually react to some of your remarks.

I wish you the best, hearing already some Christmas bells in the back-ground.......

Lucette Flandroy




Disclaimer : http://www.health.belgium.be/eportal/disclaimer/
posted on 2013-12-18 22:00 UTC by Ms. Lucette Flandroy, Belgium
RE: RA Forum: Final improvements to the alignment for submission to theAHTEG - A new message has been posted to the forum [#5568]
dear Lucette, dear Members of the online Forum, dear Members os the Secreteriat
I like to take this opportunity to express my thanks and my agreement with this last fine-tuning of the alignment.
I think we achieved a good result.
And in addition I like to send my best wishes to all of you and wish a Happy New Year.
Best regards
Beatrix
posted on 2013-12-19 12:51 UTC by Beatrix Tappeser, Federal Agency for Nature Conservation
RE: RA Forum: Final improvements to the alignment for submission to theAHTEG - A new message has been posted to the forum [#5583]
Dear All,


My thanks to all those involved in again producing a new version of the manual and to Lucette for accepting to moderate again.

As Lucette reminded us, this part of the online forum focuses on alignment of the Manual with the CPB and the Guidance. As per her request, I limit myself in these comments to the changes made.

With that in mind, I believe that overall the Manual has been brought more in line with the CPB and the Guidance, be it that we should keep in mind the very important point that Isao Tojo made, i.e. that the Guidance is still being tested

Quite a number of the suggestions for alignment made were taken on board, sometimes exactly as the suggestions were made and sometimes with some modifications.

While some of those modifications are fine, other amendments needs some further discussion, which I do below (NB: The line numbers I use in my comments below are the line numbers of the document RA_Training_Manual_rev11DEC2013_clean).

Line 213: to properly reflect article 16 of the CBD, the quote should need to read: “The CBD addresses that both access to and transfer of technology, including biotechnology, are essential elements for the attainment of the objectives of this Convention”.

Line 1321: The important term in the original suggestion was the word “only”. The sentence should read:" The golden rule during the risk assessment of an LMO is to ONLY request additional information that is relevant to the evaluation of risk and will facilitate the decision making”

Line 1416: An important qualifier for this suggestion was left out. To be concistent with the CPB and the Guidance, the sentence should read: ” To identify genotypic and phenotypic changes, the ideal comparator is the closest non-modified genotype to the LMO, i.e. (near-)isogenic lines. “

Line 1439:  This sentence is inconsistent with the Protocol, because although the CPB does not make procedural differences in the AIA procedure between field trials and placing on the market, the CPB does explicitly recognise the two categories of releases in article 11 para 1, and for good reasons.

I therefore propose to rewrite this paragraph as follows: “The nature and level of detail of the information needed to conduct the risk assessment will vary depending on the intended use of the LMO (e.g. type of release), the LMO itself and the likely potential receiving environment. As for the ‘intended use’, the Protocol recognises in article 11 different categories of releases, such as field trials and placing on the market. “  I will come back to this paragraph below.

Line 1473: “Potential risks” is a confusing tautology.

Line 1566: the text still incorrectly suggests that gene transfer only happens with GM plants.


Finally, as far as the changes in the text are concerned, others and I also made additional comments aimed at bringing the manual more in line with the Protocol and the Guidance, which were not taken on Board. I refer to suggestions made such as:

• Explaining that the CPB AIA procedure only applies “in cases where there is no applicable domestic regulatory framework”.
• Clearly separating systems to implement the CPB and domestic regulatory systems.
• Reminding the readers that addressing uncertainty is not end in itself, but rather than a means to strengthen the reliability of data, (that is what the RA is essentially doing, i.e. addressing uncertainty.)
• Not presenting outcrossing as a risk per se ;
• Not including agronomic effects (e.g. resistance development) as environmental risks per se;
• Underlining that differences in themselves do not mean risk; in order to pose a risk, changes need to be significant and biologically relevant

The above comments were made in the context of Lucette’s reminder that this part of the online forum focuses on alignment of the Manual with the CPB and the Guidance.

While recognising that the text has been brought more in line with the Protocol and the Guidance, if we take a step back and look at the manual with the question whether it is of practical use for novice risk assessors, than I believe the answer is still “no”. The document is still very general and academic, and lacks clear concrete examples that are of practical use.

That is regrettable and indeed unnecessary, because with some effort, the practical usefulnes of the manual could be greatly increased.

As an example I refer to the paragraph above: “The nature and level of detail of the information needed to conduct the risk assessment will vary depending on the intended use of the LMO (e.g. type of release), the LMO itself and the likely potential receiving environment. As for the ‘intended use’, the Protocol recognises in article 11 different categories of releases, such as field trials and placing on the market. “

The manual would gain great practical use if it included a simple matrix illustrating how the information requirements for placing on the market are typically more detailed than for -  for example – in the case of confined field trials. This could be illustrated with various information categories , such as the molecular characterization.

I hope that this suggestion starts the discussion Lucette hoped for

Wishing you all a splendid holiday season!


Piet
posted on 2013-12-20 22:14 UTC by Mr. Piet van der Meer, Ghent University, Belgium
RE: RA Forum: Final improvements to the alignment for submission to theAHTEG - A new message has been posted to the forum [#5584]
Dear Lucette, Dear All Dear members of the Secretariat,

I would like to thank Lucette for the last updated version of the alignments. You have my full support for this document. I consider it in a good quality.

With the reference to the some comments to make additional explanations "that the CPB AIA procedure only applies “in cases where there is no applicable domestic regulatory framework”, or
"Clearly separating systems to implement the CPB and domestic regulatory systems", I do not consider that AIA under CPB and the domestic regulation should have different understanding or procedures. As the Art. 7,8,10 imply the AIA procedures based on the precautionary principles, it refers that Parties follow this procedures, and there is no space that parties can have different readings or understandings of this in their domestic regulations. The domestic regulation of non-Parties may have different procedures or provisions, at the same time the Protocol invite and recommend them to follow the AIA principles and procedures.

My best wishes of good health and great success in the New Year to All of you! Happy Winter Season Holiday!

Best regards,
Angela Lozan
posted on 2013-12-22 10:02 UTC by Angela Lozan
RE: RA Forum: Final improvements to the alignment for submission to theAHTEG - A new message has been posted to the forum [#5585]
Dear All,

I am pleased that Angela made this posting, because it clarifies that within the AHTEG we have had fundamentally different views on the regulatory context of our discussions, which may explain why the resulting Guidance document reads as a negotiation document with lots of compromises, rather than practical guidance.

I refer to Angela’s comment: “I do not consider that AIA under CPB and the domestic regulation should have different understanding or procedures.  As the Art. 7,8,10 imply the AIA procedures based on the precautionary principles, it refers that Parties follow this procedures, and there is no space that parties can have different readings or understandings of this in their domestic regulations.”

I believe this to be an incorrect interpretation of the functioning of the Cartagena Protocol on Biosafety.

The CPB contains specific procedures for the transboundary movement of LMOs from one Party (the ‘Party of Export’) for subsequent intentional introduction into the environment of another Party (the ‘Party of import’.).

Article 7 of the CPB states that the Advance Informed Agreement (AIA) procedure applies prior to the first transboundary movement of living modified organisms for intentional introduction into the environment of the Party of import. The starting point of the CPB procedures is that an intended transboundary movement must be notified to the competent authority of the Party of Import. (article 8).

In response to such a notification, the CPB requires in article 9 that the Party of Import shall acknowledge receipt of the notification and indicate whether to proceed according to the domestic regulatory framework of the Party of import or according to the procedure specified in article 10 of the CPB.

This is a pivotal provision of the CPB.

• When the Party of import has a domestic regulatory framework for biosafety in place that is consistent with the CPB (see article 9.3), then the Party of import will inform exporters that the domestic regulatory framework applies. Parties must inform the BCH of existing laws, regulations and guidelines (see article 20). 

• When a Party of Import does not have such national biosafety regulations in place, then the AIA procedures of the CPB will apply for import of LMOs for introduction into the environment.

Key question therefore is what is meant by “consistent with the Protocol”. The term “consistent with the Protocol” can address several aspects, e.g. consistent with the objective of the protocol, consistent with the procedures of the protocol, consistent with the internationally agreed principles and method of risk assessment, et cetera.

As for is “consistent with the procedures”, we note that article 9.3 does not – as Angela suggested - refer specifically to articles 7,8 and 10. Moreover, article 9.3 does not refer to procedures at all.

In fact, it would be very illogical for article 9.3 to refer to articles 7,8 and 10, because within the Protocol itself, there are many diversions of those procedures, ranging from simplified procedures to full exemptions (article 7.4). 

In short, Angela’s suggestion that “the Art. 7,8,10 imply the AIA procedures based on the precautionary principles, it refers that Parties follow this procedures, and there is no space that parties can have different readings or understandings of this in their domestic regulations.” Is inconsistent with the Protocol itself.

Lastly, I note an interesting evolution in several submissions from the internationally agreed precautionary approach (Principle 15 of the Rio declaration), to the “precautionary principle”, to “precautionary principles” (plural). I wonder which principles those are.

Looking forward to a continuation of this discussion, and with Holiday Greetings to all

Piet
posted on 2013-12-22 12:36 UTC by Mr. Piet van der Meer, Ghent University, Belgium
RE: RA Forum: Final improvements to the alignment for submission to theAHTEG - A new message has been posted to the forum [#5587]
Dear all:

I read with quite interest on the present interventions. Sorry that I come almost at the end this time due to heavy international travel loads.

With the same participants, some has pretty changes from the original discussion since the Protocol negotiation and the history of RA AHTEG?
Particularly, I feel that Angela’s suggestion is overstatement that “the A. 7,8, and 10 imply the AIA procedures based on the precautionary principles, it refers that Parties follow this procedures, and there is no space that parties can have different readings or understandings of this in their domestic regulations.” Each nation has liberty to set and implement own domestic rules, and the way taken could be an infringement of national sovereignty right.
As for Mr. Tojo’s statement, I appreciate his rigid and practical suggestions based on the abundant national experiences of the corresponding domestic laws in our government also with relevant international law implementation on the risk assessments in general. Those are very experience based and is scientific sounds to provide practicality and help the novice users.
Piet as the PRRI representative to provide relevant experiences of many nations, and also he has the decades history of experiences on the Protocol negotiation and implementation, again I support his straight forward comments on the elaboration of the document contents which are amalgamation of many fair and scientific-sound thoughts by his members.
kind regards,

Kazuo Watanabe
Univ. of Tsukuba, Japan
posted on 2013-12-22 14:20 UTC by Dr. Kazuo Watanabe, University of Tsukuba
RE: RA Forum: Final improvements to the alignment for submission to theAHTEG - A new message has been posted to the forum [#5588]
Dear all,

I am taking this opportunity to support a few of the statements that have already been posted.

First, as others have observed, I agree that the incorporation of many specific changes through this series of online exercises has brought the Manual more in line with the CPB and the Guidance.

Isao Tajo and Piet van der Meer have pointed out in the current discussion some specific areas that should still be considered for improvements, and I agree with their suggestions.

I also agree that the Manual can not be considered final because the Guidance itself is still being tested. In its current state, I still do not consider the Guidance, or the Manual, to be useful to novice risk assessors. 

I think Piet van der Meer has described in his most recent post, something that has not been described so well before, which is that the Guidance and hence the Manual, read more like a negotiation document with lots of compromises rather than a practical guidance.  This is, to me, at the heart of the problems with this entire exercise.

I wish to note that my understanding has always been the same as Piet’s interpretation of the procedures under the protocol for a country to follow their domestic regulatory framework.  The key question is what is meant by ‘consistent’ with the protocol.  If this is still a point of negotiation among the parties, then as it relates to risk assessment, it is reflected as such in this Guidance Document.

Having said that, I agree that there are still areas of improvement in the Guidance Document and the Manual that would make them more useful documents for novice risk assessors:
1) While some better examples have been added to the manual, the manual still lacks the kind of ‘real life’ examples taken from actual cases of risk assessment.  A dedicated effort to add these kind of examples should still greatly improve the Manual.
2) From the very beginning of this effort to develop a Guidance Document, I have begged for a better distinction between risk assessment for field trials and risk assessment for general release, and yet this point is still weak in the Guidance Document. As noted also by Piet, more clear guidance, and examples, to support this distinction would greatly improve the usefulness of the documents to novice risk assessors.

Thanks to everyone for your time and effort.
Happy Holidays to all of you!
Karen
posted on 2013-12-22 14:46 UTC by Ms. Karen Hokanson, University of Minnesota
RE: RA Forum: Final improvements to the alignment for submission to theAHTEG - A new message has been posted to the forum [#5589]
Dear Lucette, dear members of the Secretariat, dear colleagues,

Thank you very much for this new version of the manual.
I have gone through the proposed changes, and I find them generally OK.
There remains a general problem that some of the texts, also some of the new texts, are not very helpful, as they do not explain things, or introduce new unexplained stuff.

I have a few specific text proposals, that I present here in overview. For explanations of my comments please also refer to attached document, where I have added my comments in tracked changes.

Overview of my comments:

198: change ‘allow’ into ‘suggests’ or similar.
566-568: delete text, text is confusing.
1289-90: "The golden rule during the risk assessment of an LMO is to only request additional information that is relevant to the overall evaluation of risk …" (the proposal is to add the word 'only', as has been proposed elsewhere on the online forum).
1320: delete ‘most often’
1407 – 1411: delete; I would agree with replacing the deleted text with new text that was proposed in the discussion forum: “The nature and level of detail of the information needed to conduct the risk assessment will vary depending on the intended use of the LMO (e.g. type of release), the LMO itself and the likely potential receiving environment. As for the ‘intended use’, the Protocol recognises in article 11 different categories of releases, such as field trials and placing on the market."
1589-1594: I think the statement made here is dubious, but I would like to check the arguments that it is based on. However, the reference provided cannot be accessed (the link renders ‘forbidden’!). The statement should only be made on basis of information that is generally available.
2213: is a major improvement.

I’m afraid that this will be my last contribution to the Online Forum as a representative of the Netherlands, as I will be retiring from my position in the Netherlands Natl. Inst. For Public Health and the Environment by 1 January 2014.
I want to thank all the colleagues for their cooperation and friendship over the many years of my involvement with the CPB, and the development of the Guidance.
In particular, I would like to thank the Secretariat for their countless efforts forthe good cause.

Till we meet again, and best wishes for the Holidays,

Hans Bergmans
posted on 2013-12-22 16:18 UTC by Mr. Hans Bergmans, PRRI
RE: Opening of the discussion on "Final improvements to the alignment for submission to the AHTEG" [#5573]
First of all, it would be highly respected that the moderator and the secretariat are tackling such a tough task.  I understand the current discussion is based on “the clear understanding that the Guidance is still being tested” (UNEP/CBD/BS/COP-MOP/6/18, 9(b)).  As the Guidance is still under discussion, I am not sure whether the current discussion on the alignment of the Manual is a right way.  Even though, in order to be consistent with the Guidance and Annex III of the Protocol, the following amendment should at least be reflected in the Manual (see attached file).
i) Establishing the baseline (line 1392)
I understand “establishing the baseline” is not a necessary element of RA in the Roadmap.  In addition there is no standardized method for “establishing the baseline” among Parties.  Thus “Establishing the baseline” is not practical.  Therefore lines from 1392 to 1405 should be deleted.
ii) Gene flow (line 1551)
The term of “gene flow” is not used in step 1 of the Roadmap.  Instead the term of “gene transfer” is used. The term of “gene transfer” would better be used in lines from 1551 to 1569.
The Figure 6 should be deleted or replaced to another figure to explain “gene transfer”, as there is no description on “genetic bridge” in the Manual.
iii) Resistance development (line 1631)
It seems the term of “resistance development” is not included in the Guidance.  Therefore lines from 1631 to 1638 should be deleted.  The herbicide “resistance development” is not caused by the LMO.  I understand the risk assessment of herbicides is not included in the risk assessment of the LMO based on Annex III of the Protocol.
iv) General surveillance (line 2027)
“General surveillance” (line 2027), which has no relation to uncertainty regarding the level of risk in the previous risk assessment, is not included in the monitoring of LMOs under the Protocol.  Therefore lines from 2027 to 2032 related to “general surveillance” should be deleted. 
v) Cumulative effects (line 2046)
I understand there is no scientific paper reviewed on the “cumulative effects” of LMOs.   Such words should not be used in the Manual.  Therefore lines from 2046 to 2048 and foot note 33 on “cumulative effects” should be deleted.

Followings are not the track change comments but general comments.
i) Risk scenarios (line 1528)
In lines from 1528 to 1531, an example of risk scenario is shown in “Example 20”.  Considering the importance of a well-defined risk scenario, it would be helpful for readers to show some more examples of risk scenarios in the actual risk assessment.  Not only good examples but also bad examples would help understanding.
ii) The concept of “familiarity”
It is very strange that there is no explanation on “familiarity”, which is widely recognized as a key concept of the risk assessment of LM crops.  The concept of “familiarity” and its use in the risk assessment should be explained in the Manual, also in the Guidance.

Best wishes and a happy new year!

Isao Tojo
Ministry of Agriculture , Forestry and Fisheries
Japan
posted on 2013-12-20 05:48 UTC by ISAO TOJO, Ministry of Agriculture, Forestry and Fisheries
RE: Opening of the discussion on "Final improvements to the alignment for submission to the AHTEG" [#5580]
dear All
reading the provided proposals for deletions by our respected Japanese collegue I like to provide a slightly different view.
I agree that there is no standardized procedure to establish a baseline and I also would prefer to do a risk assessment as such - looking into the impact/change and then the risk manager decides what impacts are acceptable or which mitigation measures are needed. But as long as we have a comparative approach there is somehow a need to define the comparator and or baseline.

regarding resistence development: at a number of places there is reference to resistence development also to resistence development of weeds: see under Step 1, points to consider
"(j) Potential adverse effects concerning target organisms such as pests developing resistance to the target trait and weeds developing resistance to the herbicide."
therefore I would propose to keep the lines
regarding point iv) In the guidance  the term general monitoring was chosen. We could use this term in addition to be consistent.
to look into cumulative effects is a legal recommendation in Europe. I would prefer to keep the lines to give a full picture.
best regards
Beatrix
posted on 2013-12-20 14:49 UTC by Beatrix Tappeser, Federal Agency for Nature Conservation
RE: Opening of the discussion on "Final improvements to the alignment for submission to the AHTEG" [#5590]
Dear colleagues, I would like to express my gratitude to Lucette, Dr. Helmut Gaugitsch, the Secretariat and the participants of the Forum for the last version of the Manual and supporting it. At the same time it would be not bad to make the links to the relevant scientific papers, for example for the Lines 1581-1588 (Toxicity to non-target organisms) and for the other issues pointed in the Lines 1548-1551 to illustrate this material.
And, of course, I wish you a Happy New Year!!!
Sincerely yours, Galina.
posted on 2013-12-22 16:53 UTC by Dr. Galina Mozgova, Belarus
RE: Opening of the discussion on "Final improvements to the alignment for submission to the AHTEG" [#5591]
Dear all,

I appreciate the opportunity to comment once again on the Manual.  Overall, it appears to be improving somewhat, but it still seems to be falling short of the stated objective as a training manual for novices in the area of environmental risk assessment in the context of the Cartagena Protocol on Biosafety.  The text still is very general and academic, with a shortage of practical information that draws on decades of experience in countries around the world. 

For the sake of brevity, let me just state my support for the insightful and constructive comments posted by Isao Tojo, Hans Bergmans, Karen Hokansen, and Piet van der Meer in which they called for further improvements to make the Manual practical for novice risk assessors and for the Manual to be consistent with the task, namely for environmental risk assessment in the context of the Protocol.  I support their general and specific text proposals, so I will not repeat them in my comments.

I will reiterate my agreement with the comment made online earlier today that the content and process used to develop the  guidance and training documents gives the impression that they are more like negotiation documents rather than practical guidance based upon real-life experiences. 
 
I recognize that the time is short to provide extensive additional comments and text, but I will offer enough to give the AHTEG members something to consider in their work in the coming months – noting  Lucette’s admonition to be concise and offer concrete text proposals here (my comments below refer to the line designations in the file RA_Training_Manual_rev11DEC2013_clean).

It is good to see that the title now reflects that it intends to address environmental risk assessment “in the context of the Cartagena Protocol on Biosafety”. This is an important distinction to make, since the charge for Manual is to be consistent with the Protocol. The consistency with the Protocol’s language is important, too, but I will not reiterate here my comments from previous rounds of online discussions to use the Protocol terminology consistently to avoid confusion for both novices and experts.  

The section entitled “History of the Protocol” still has unnecessary redundancies in lines 186 – 237 in the the description of Agenda 21, CBD Articles 8(g) and 19(3), and the precautionary approach in which the paraphrases in the body of the text leave out significant, meaningful words for each of these.  My concrete text proposal then is to remove the paraphrase text in the body and use the verbatim text of these Articles in the body of the text (thereby avoiding confusion and redundancy).

The content of Module 2 is still confusing, outdated, and out of context for the needs of the risk assessor.  Repeatedly in this module it is suggested that the risk assessor “may need” to be knowledgeable about all of these aspects before conducting the risk assessment.  The context of the Guidance and Training Manual is the CPB, not the national systems that Module 2 quotes indirectly at great length by citing a UNEP publication from 2005.  The examples cited in Module 2 are taken out of context or developed for a purpose other than the environmental risk assessment of LMOs in the context of the CPB (e.g., Example 5 on line 771 cites a US-EPA document that was developed for chemical risk assessments, not LMOs).  I have raised this point in previous rounds of online comments, so I will not belabor the point here again.

Related to the issue of obligations under national, international, and CPB obligations let me urge the authors to use the comments that Piet van der Meer posted earlier today in response to a comment from Angela Lozan.  The Manual does not make it nearly as clear as Piet’s explanation, and that explanation will clarify my point about the relevance of the current content of Module 2, also.

As other commenters have noted previously the Manual still provides little practical information about the similarities and differences between various types of introductions into the environment, such as the small-scale, confined releases of LM plants typical of experimental research versus large-scale, unconfined releases that would be used in commercial production with LM plants.  Line 1439 introduces this concept, but the Manual needs more information if novices are to use this statement in a practical manner.  I have attached a short document to my comments that can serve as a starting point for the members of the AHTEG to illustrate this point more fully (see RA_Training_Manual_rev11DEC2013_AdditionTextReSmallScale_dh_12-21-2013.docx).  There are numerous examples that the AHTEG can add to cite the experience that countries have in conducting risk assessments for both small- and large-scale releases. .  My suggested text includes a few paragraphs to set the stage, then suggests a very simple matrix that the AHTEG members might use as a starting point for further elaboration of these ideas with specific examples.  There is a lot of information available from regulatory agencies around the world (Canada, Australia, US, EU, Philippines, etc.) that can be used to make this point more clearly in the guidance and manual documents, but it will take more time to provide a more complete picture – something the members of the AHTEG might be able to do. 

As it has been throughout the drafting of the Guidance and Manual documents to date, it is still quite unclear what process the Secretariat and the Chair (is this still Helmut?) have used in accepting or rejecting previous online submissions of comments and concrete text proposals.  I recognize that this issue is one of process rather than content, but in my view the process has profoundly influenced the content of both the Guidance and Manual documents. 

I hope the members of the AHTEG are able to use the input from these online discussions to help this Manual reach its stated purpose.

Best wishes to all for the New Year,

David Heron
United States Department of Agriculture, APHIS, Biotechnology Regulatory Services
Attachment:  RA_Training_Manual_rev11DEC2013_AdditionTextReSmallScale_dh_12-21-2013.docx
posted on 2013-12-22 21:20 UTC by David Heron, United States of America
contribution to the discussion [SEC=UNCLASSIFIED] [#5592]
Dear all,
I would like to support many of the valuable comments made earlier. In
particular, those that relate to lines 1439-1443.
Lines 1439-1440 are incorrect as the Protocol does make the distinction
about types of applications in several places. For example, for use as
food or feed, or processing, see Article 7 (3) and Article 11 (1), (4),
(6), (7), (8), (9); for contained use, see Article 6 (2); field trials,
see Article 11 (1); and placing on the market, see Article 11 (1). This
remains a significant oversight of both the Manual and Guidance to ignore
these important considerations that are raised in the Protocol (and affect
the nature of the risk assessment), and which stands in stark contrast to
extensively developed areas of the Guidance that the Protocol is silent
on, namely types of LMOs (eg mosquitoes), types of traits (eg abiotic
stress), and combinations of introduced traits (eg ‘stacking’).
I would suggest replacing lines 1439-1443 using terms directly from the
Protocol, namely, ‘use as food or feed, or for processing’, ‘contained
use’, ‘field trials’ and ‘placing on the market’ with the following
sentences.
The Protocol makes a distinction between the various types of applications
of LMOs, including use as food or feed, or for processing, contained use,
field trials and placing on the market. Accordingly, the nature and level
of detail of the information needed to conduct the risk assessment
depending on the intended use of the LMO (e.g. type of release), the LMO
itself and the likely potential receiving environment. For example, grain
imported for use as food or feed may require information only on controls
to limit spread and persistence during safe handling, storage, transport,
storage and use. In the case of experimental field trials, information
about the molecular and phenotypic properties of the GMO is often limited;
therefore, the risk assessment will focus on the effectiveness of limits
and controls that restrict dispersal of the GMO or the introduced genes.
In contrast, applications for placing a GMO on the market will usually
require complete information about the GMO and the receiving environment
for the risk assessment, including information about the presence of
sexually compatible organisms and management practices.
This would allow the novice evaluator a small insight into these important
distinctions that are often reinforced by national laws and regulations.
Further examples and a matrix as suggested by Dave Heron would be useful
additions in this area.
Wishing you all the very best for a safe, productive and happy New Year.
Paul Keese

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posted on 2013-12-22 23:05 UTC by Paul Keese, Australia
RE: Opening of the discussion on "Final improvements to the alignment for submission to the AHTEG" [#5593]
POSTED ON BEHALF OF KOK GAN CHAN

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Dear Lucette, dear Members of the online Forum, dear Members of the Secreteriat, dear colleagues,

As this online forum focuses on the alignment of the Manual with the CPB and the Guidance. In the light of this, the following is my comments for some changes to be made:

For overview, I agree with Piet that in the spirit of Art. 16 (CBD), I agree that line 213 should be changed as suggested.

The illustrated example of flu and cancer drugs side effects to me is very midleading which I doubt readers can draw any analogy to adverse effects in risk assessment, I suggest to strike this out (as in lines 1476-1478 namely: “For example, a cold medication may be considered harmful if it causes severe side-effects. However, if a cancer drug causes the same type of side-effects, it may not be considered harmful.”).

As to the comment made by Angela ie “I do not consider that AIA under CPB and the domestic regulation should have different understanding or procedures. As the Art. 7,8,10 imply the AIA procedures based on the precautionary principles, it refers that Parties follow this procedures, and there is no space that parties can have different readings or understandings of this in their domestic regulations.”… For this, I think the comment is rather overstated and it really does not reflect the stand made in CPB. Kindly be reminded that in subsection (1) of the Art. 7 CPB which stipulates “Subject to Articles 5 and 6, the advance informed agreement procedure in Articles 8 to 10 and 12 shall apply prior to the first intentional transboundary movement of living modified organisms for intentional introduction into the environment of the Party of import.”. For that matter, Piet has replied more detail and I also agree with the national sovereignty point raised by Kazuo.

Other than this overview comments, I have the following suggestion which is editorial in nature: 

In lines 607-608, delete identify or select cells or organisms

Kindly standardize the abbreviation, eg for living modified organism abbreviated as LMO which was first appeared in line 222-223, so it should be appeared as LMO in subsequent paragraphs, inconsistency is seen in lines 230, 290, 297, 864, 866, 868, 1211, 1015, 1214, 1313, 2063, 2168, 2170, 2273,

Also, Competent National Authorities (CNA) has been appeared for the first time in line  , but it was introduced again in lines 830-831, 1351, lines 2175-2176 and footnote 14 again. Please consider revising National Authority in lines 2193-2194 to CNA

May I also suggest, for the purpose of this manual, standardise the use of genetic modified as LM instead of GM, (for example the use of term “GM crop” in example 17, line 2131 in example 18) , just to minimise too any terms referring to the same item such as this.

Lastly, I wish all of you a Merry Christmas and Happy New Year 2014, and happy holiday to all!

Best regards,

Dr Kok Gan Chan
University of Malaya
Malaysia
posted on 2013-12-23 20:30 UTC by Ms. Manoela Miranda, UNEP/SCBD
RE: Opening of the discussion on "Final improvements to the alignment for submission to the AHTEG" [#5595]
POSTED ON BEHALF OF WEI WEI (message sent before the closing of the discussion but not posted due to technical problems)

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Dear Colleagues,

I agree that RA process may be different regading of different uses of LMOs. For example, there is confined use vs. environmentally release and there is food vs. feed application. Different purpose would need different information when conducting RA. RA at a stage of use would provide useful information for another, but can not define the result of another stage. During the process from lab to field, RA at each stage should be conducted and should be not absent.

Safety certificate in country would not necessarily mean safe for people in another country with different circumstance. It is sometime especially obvious when talking safety of food derived from LMOs. Public may request evidences of safety before acceptance. For the public, importation of grains for food or feed has the same meaning of commercialization with marketing a LMOs. They would like to know the entire information of the imported products. In addition, due to the weaker capability of regulation in developing country like China, sometimes misuse migh happen. People like to have a full consideration and strict regulation of biosafety.

Precautionary principle and approach is the soul of risk assessment thus need to be emphasized in both the Guidance and  the Manual.

Wei Wei
Institute of Botany
Chinese Academy of Sciences
posted on 2013-12-24 15:57 UTC by Ms. Manoela Miranda, UNEP/SCBD