| | english | español | français |
  Home|RARM Portal|Past Activities|2012-2014   Printer-friendly version

Return to the list of threads...
Forum closed. No more comments will be accepted on this forum.
Opening of the discussion - analysis of the results of the testing and possible improvements [#5772]
POSTED ON BEHALF OF ANGELA LOZAN (MODERATOR)

-----

Dear Participants of the Online Forum,

Greetings from Chisinau!

I am very happy for the chance to moderate this discussion on the analysis of the results of the testing. Many of us, including myself, have been part of the exercise to test the Guidance and I am sure you share my excitement in seeing the results.

First of all I would like to thank the Secretariat for its excellent work of providing us with the Analysis of the Results of the Testing of the Guidance on Risk Assessment of Living Modified Organisms and other background information and documents useful for actual discussion.

I highly appreciate the Parties, other governments and organizations in making their efforts to organize the testing of Guidance and submitting the total number of  55 of reports of testing, expressing  their valuable views and suggestions of how to improve the Guidance.

As you are surely aware, with regard to the testing, the COP-MOP requested the Executive Secretary of the CBD to:

“(a) Develop appropriate tools to structure and focus the testing of the Guidance;

“(b) Gather and analyse, in a transparent manner, feedback provided as a result of testing on the practicality, usefulness and utility of the Guidance, (i) with respect to consistency with the Cartagena Protocol on Biosafety; and (ii) taking into account past and present experiences with living modified organisms; and

“(c) Provide a report on possible improvements to the Guidance for consideration by the Conference of the Parties serving as the meeting of the Parties to the Protocol at its seventh meeting;”

I wish to remind you that our role in the testing of the Guidance is mandated by the COP-MOP and is to “provide input, inter alia, to assist the Executive Secretary in his task to structure and focus the process of testing the guidance, and in the analysis of the results gathered from the testing”.

As such, our role in the testing of the Guidance is to assist the Secretariat, who, in turn, will submit a report to the COP-MOP containing an analysis of the results of the testing and possible improvements.

In line with the message sent by the Secretariat on 15 April, I would like to invite you to actively participate in this discussion by sharing your views on the results of the testing, in particular focusing on:

i) General views and feedback about the results of the testing;

ii) Your comments on the improvements to the Guidance as per submissions received during the testing;

iii) Your suggestions of possible mechanisms through which the Guidance could be improved.

To help in our discussions, please refer to the background materials made available by the Secretariat at http://bch.cbd.int/onlineconferences/forum_ra/discussion.shtml

The discussion will take place for the next two weeks but, to the extent possible, I encourage you to post your views as soon as possible in order to foster a lively debate.

I am looking forward to your views and feedback on the results of the testing. Wish you an interesting and constructive discussion.

All the best,
Angela Lozan
posted on 2014-04-21 00:50 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 5772 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5795]
Dear Participants to the Forum,

Many of us had spent happy time visiting our parents and children during the Easter holidays and enjoying from the family atmosphere and wonderful spring. Wish you Happy Easter to those of you who share this tradition.

Now we are slowly back to our day-to-day activities and I hope you may find time in your busy schedules to work on the proposed topic of the Forum.

I would like to invite you to share your personal opinions and views on the quality of the Guidance having your great experience in testing of the document, vile it has been done on individual base or on the group discussion during the meetings, at organization, national or regional levels.
Your suggestions and comments could be very important to improving the Guidance!

I am waiting very much to see your comments in the remaining time of the Forum!
If you consider that we can propose some additional questions for discussion within the topic, you are welcome to address them.

Looking forward for a lively and interesting discussion.

Sincerely,

Angela
posted on 2014-04-25 07:23 UTC by Angela Lozan
This is a reply to 5795 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5796]
Dear Angela,

Thanks for your works as a moderator of this discussion. Also appreciate the Secretariat for drafting an analysis of the testing reports.

It is a shame that China did not submit a report, I am sorry for that. I originally heard that they will do a test but there might be some reasons that delayed the process. Anyway, we have 55 submissions. That is good and I appreciate the submissions very much.

First of all, we need see if the submission can be a good sample of parties. I can guess what the response is when I just see the name of the country; I hardly miss in anyone. Secondly, I agree it is reasonable to divide the parties into developed and developing ones as it could make the analysis easier. However, I deeply feel that we can easily see the different attitude in the testing between countries who commercialized the LMOs and others who do not yet, although there are always exceptions.

As I always insisted that it is not a very good idea to have those important guidance docs only tested by governments who have diverse views and benefits. The testing should also follow a scientific approach and be peer-reviewed by scientists who actively work on this field in biosafety. Although the views of scientists might be also diverse, they may give their reasons properly to improve the language and the science.

Not sure if I have missed something, please forgive me if my message is risking a distraction from the main discussion. I am just trying to throw a sprat to catch a whale and it might be a good start to obtain more advices from our experienced colleagues.

Thank you!

With my best wishes

Wei
posted on 2014-04-25 14:57 UTC by Mr. Wei Wei, China
This is a reply to 5796 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5799]
Dear Wei, Dear All,

thank you very much Wei for your intervention that is a premier one in this round of the Forum.

In my view you have raised a very important issue. In fact it would be very welcomed to have the testing experience not only form regulators/Parties, but also the reflection and suggestions from the academic institutions and researchers, as far as the risk assessment should be based on scientific evidence and statistics. Scientists who work actively on RA, as well as peer-reviews may be extremely beneficial to improve the language and scientific essence of the document.

I want to suggest to participants to express their view on this topic.

I wish just to point out that the number of 55 of submissions were from the Parties and non-parties, and also from organizations, among them research institutions, universities, academy of sciences and NGOs. The actual On-line forum offer large possibilities to be joined by academia/research people to share their experience and give their useful recommendations. They can proceed to registering to the forum as "observers".

In this context I would like to invite the participants of the Forum to try to contact the scientists/academia from your countries, who are experienced in this field of activity, making possible their large participation in the discussion.

At the same time I will be glad to see the comments and suggestion referring to the three questions proposed for this round!

Thank you!

Best wishes,

Angela
posted on 2014-04-25 19:32 UTC by Angela Lozan
This is a reply to 5799 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5811]
Dear all,

We want to thank Angela for moderating this discussion and the Secretariat for all their work on the integration and analysis of this high number of  testing results!

The Analysis of the results of the testing of the guidance on risk assessment of living modified organisms that has been provided by the Secretariat presents sample lists of the suggestions that have been made for improvements of the Guidance, to make it more accurate and useful. It seems, however, that these samples are only a part of the suggestions that have been made, and that have been, very usefully indeed, compiled by the Secretariat.

We also think that the Concluding Remarks, in section D of the Analysis, do not do justice to the multitude of suggestions. The concluding remarks seem to focus on the over-all level of agreement that appears to exist among Parties that the different sections of the Guidance are practical, useful and consistent with the Protocol taking into account past and present experience with LMOs.
It would be better if the concluding remarks would also focus on the vast amount of general as well as detailed suggestions for improvement that have been made by the respondents. These suggestions were explicitly asked for in the questionnaire, and it is clear that a vast amount of time and effort has been invested by the respondents to perform a detailed testing of the Guidance.
It seems that the concluding remarks should therefore reflect this, and a proposal should be made how to use these suggestions to amend and improve the Guidance.

We propose that COP-MOP 7 adopts a mechanism to perform these improvements, in which the Secretariat takes the lead in drafting a new version of the Guidance, that shows how each suggestion for improvement has been dealt with, and that this version is discussed in several, closely moderated, rounds of discussion on the online forum. This mechanism has proved its value in the past rounds of discussion on the Guidance. The amendment of the Guidance could be commenced asap after COP-MOP 7. As the content and style of further guidance for section II depends on the agreed outcome of the amendment of the Guidance, it seems likely that drafting of further guidance can only be initiated after consensus has been reached on the amendment of the Guidance.

We want to indicate that the Analysis provides samples of the comments that are mostly interpretations. Consequently, we have problems to recognize our original comments, and in particular the flavor of our comments, in these sample lists. We therefore suggest  that  the Analysis document includes a procedural paragraph, that states how the analysis was made, and that states that the sample lists are the personal choice of the Secretariat, and are based on personal interpretations of the suggestions.
 
To illustrate our point we attach a full list of our suggestions, including a summary.

Kind regards,
Boet
posted on 2014-04-29 13:04 UTC by Ms. Boet Glandorf, Netherlands
This is a reply to 5811 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5818]
Dear all, sorry for this late participation.

Thanks to Angela for accepting to Coordinate this round of the Open Forum, and to the Secretariat for all the support.

I was preparing my comments when Dr. Boet Glandorf posted his comments [#5811].
His comments go in the same direction of my thoughts and I will try not to repeat all the comments he posted so clearly and which I would like to support.

I will add just a few more considerations:

i) General feedback about the results of the testing:
Despite the overall numbers indicating a high approval, in average, of the Guidance, the separation between "developed" and "developing" countries in the graphics certainly did not help the vision of the usefulness of the Guidance and the Roadmap. Probably a group of "countries that already produce and market GMO" (ie the ones that exercise the Risk Analysis in daily basis) and another one that "does not have such experience" (or have little experience) in RA would be more useful to conclusions.
It was difficult to me to do a quick analysis of so many country and responses, but for comparison purposes, I took a look at USA, Canada and Brazil positions (countries that produce and market GMO) and realized that all of them gave a score between 1-2  if not neutral (3) to the usefulness and other aspects of the questionnaire. This certainly shows a trend: countries that are practicing the process of RA do not see much aid regarding the Guidance and the Roadmap.

ii) Comments on the improvements to the Guidance as per submissions received during the testing:
Since I am unaware of the criteria that were used to include / mention the comments or even to summarized them in the report, I will not present any consideration on this point which seemed a little "nebulous”.
Dr Boet suggested, and I agree with him, that the concluding remarks should reflect the suggestions of the whole questionnaires and a proposal should be made how to use these suggestions to amend and improve the Guidance.

iii) Suggestions of possible mechanisms through which the Guidance could be improved:
The suggestion presented by Dr. Wei that other experts, not only government or regulators, analyze the documents seems interesting but not necessary to this point since the Guidance and Roadmap are proposed mainly for regulators…or maybe I am wrong, and in this case, sorry for the misunderstanding.

Finally I would like to support the proposal of Dr Boet to include a procedural paragraph, that states how the analysis was made, and that states that the sample lists are the personal choice of the Secretariat, and are based on personal interpretations of the suggestions.

Thanks for your attention

Deise
posted on 2014-04-29 18:32 UTC by Dr. Deise Maria Fontana Capalbo, Brazil
This is a reply to 5818 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5819]
Dear colleagues,

I thank very much Wei, Boet and Deise for your interventions to the forum and useful comments.

I am a little worried of the low participation in the discussion.  Just to remind to all of you that the forum will be open till 5 May. I encourage the registered participants to submit your comments and opinions taking in mind the guiding questions proposed for this round.

Looking forward for your active participation!

Best wishes,

Angela
posted on 2014-04-29 18:58 UTC by Angela Lozan
This is a reply to 5819 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5821]
Dear colleagues

I would like to begin by thanking the Secretariat for providing the results of the testing process of the Guidance and for compiling all suggestions in one single document.

Although Argentina as a non-Party government had intentions to perform the testing of the Guidance, this have resulted difficult to do formally, not only because of time that this task involved but also because of the difficulty of identifying a publicly available material (e.g a dossier or report with all the information) that would be suitable for testing, and preferably in Spanish.

Regarding the information that emerges from the analysis and in relation to the number of suggestions and comments received in the testing, there seems to be a proportion of participants that have not made any comments or suggestions, other that agree with the practicability, usefulness and consistence with the Protocol taking into account the experience with LMOs, but also they gave relevant suggestions and comments that, I think, should be taken into account as also those of other that not agree with the practicability, usefulness and consistence with the Protocol taking into account the experience with LMOs (between them some countries with a lot experience in environmental risk assessment).  Reviewing comments and suggestions, it is clear that both the Guidance and the Roadmap show some complexity in wording; the ¨use of terms¨ is not clearly defined and some translation problems arise in languages other than English. I agree with the comments about the importance of focusing on the different steps of the environmental risk assessment in terms of depth, inclusion of examples, and the differentiation of the information required for the different types of applications (confinement trials, liberation into the agroecosystem, LMO other than plants), and I think that this implies that more work still needed to make for improve this document.

For other part, I believe that the Guidance - in its current version - could be misinterpreted by novel assessors in matters such as risk identification where these do not exist (e.g. gene flow) since the wording and in particular the Points to Consider as present in the Guidance seem to remark the concept that LMOs pose new risks or are riskier than non-LMOs almost in all cases.

Finally, I believe it is important that the Guidance be consistent with the spirit of the Protocol, as it is exposed in last paragraph of the Preamble -¨ The Protocol thus creates an enabling environment for the environmentally sound application of biotechnology, making it possible to derive maximum benefit from the potential that biotechnology has to offer, while minimizing the possible risks to the environment and to human health¨- . Therefore, future corrections and improvements of the Guidance and the Roadmap should capture this positive idea to enable the Parties to benefit from the safe use of modern biotechnology products.

Thank for the opportunity to comment.
Best regards,

Patricia
(edited on 2014-04-29 22:47 UTC by Patricia Gadaleta)
posted on 2014-04-29 22:46 UTC by Dr. Patricia Gadaleta, Argentina
This is a reply to 5821 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5823]
I would like to thank Angela Lozan for your time in moderating this discussion and the Secretariat for compiling these useful documents.

Overall, the response from the testing was clearly positive. While any survey will return a variety of opinions, the mean and the median scores for the survey shows that the guidance was well received by our intended audience.  From the concluding remarks, (2) ‘there was a high level of agreement that the Guidance is practical, useful, and consistent with the Protocol, and that it takes into account past and present experience with LMOs.’  I was pleased to note that the level of agreement was highest among developing countries.

The testing appears to have been successful in surveying numerous stakeholders, and eliciting a good diversity of responses.  Though not all in agreement, this diversity of perspectives will be useful for the upcoming AHTEG, where recommendations for improving the Guidance can be made."

As Deise Maria Fontana Capalbo notes, three exporting countries have given the guidance low scores [5818].  I agree that the AHTEG should carefully consider the comments of this group because of their seemingly uniform response and because of their experience. Two of these are non-Party countries, however, and their view of how to appropriately conduct a Risk Assessment may not be entirely compatible with the protocol.  This should also be taken into account.

It is also not clear that the apparent uniformity of the response from Brazil, Canada and the USA is uniform.  While all three commented on the roadmap, they did not all comment on the other sections.  The USA completed an evaluation of Part III, monitoring, and some but not all of Part II, omitting mosquitoes. In contrast, Brazil commented on Part III as well, but not abiotic stress in Part II.  Canada did not comment on PartIII, but not on stacked plants in Part II. Thus, out of these three countries, there are a maximum of only two responses on PartIII and individual sections of PartII.  This is a very small sample size, and as I understand it, neither the US nor Canada have formal monitoring programs from which to claim greater experience than that of other countries even if they have been conducting some form of risk assessment for longer than many in the target audience. 

In summary, I do think that the responses from all submitters is valuable and what is unique about these three countries should be taken into account when considering how, where and if the guidance can be improved.  However, I do not think that we should let the opinion of a small number of countries, that disagree with the vast majority of respondents, dictate our impressions of the testing as a whole.
posted on 2014-04-30 06:42 UTC by Dr Dorien Coray, University of Canterbury
This is a reply to 5772 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5824]
Dear Angela,

First of all, thank you very much for having taken the lead to moderate this discussion. As you rightly pointed out, finding time in our busy schedules to provide feedback is challenging, particularly given the number and frequency of on-line discussions taking place in the context of the Cartagena Protocol (not only on risk assessment, but also on other issues). This plethora of online activities might be a point for discussion at the next COP-MOP.

I would like also to thank the Secretariat for providing a first draft analysis of the results of the testing.
Looking at the graphs presented in the document, one could indeed consider that there is a relatively high level of recognition that the Guidance is practical, useful, consistent with Protocol and takes into account past and present experience with LMOs.
However, the impressive amount of comments that have been provided clearly shows that there is still a large room for improvement. In that respect, I fully agree with Boet that the current analysis is over-simplistic and does not reflect the nuances of the multitude of suggestions.
The challenge is now to find the most efficient and transparent way to take these 70 pages of comments on board to make the Guidance even more practical, useful, consistent with Protocol and relevant.

Since we were asked to suggest possible mechanisms through which the Guidance could be improved, let me share the following general ideas with you.

1. The analysis of all the comments would be facilitated if they are grouped by categories, e.g.
- editorial comments or comments related to translation issues,
- comments applicable to all sections of the Guidance vs. comments on a specific section,
- general vs. specific comments,
- comments on the risk assessment process/methodology (e.g. problem formulation).
- …
This work could probably be done by the Secretariat. In this process, all comments would be kept in their integrality.

2. Based on this revised and structured version of the comments, a second step could be to streamline and condense the comments into more concrete proposals for improvement of the Guidance. At this stage, it would be very important to clearly justify how each initial comment has been considered (or not considered) in the proposals.
I do not think it is realistic to make this exercise in a large group of people. One could have groups of 2-3 people per section of the Guidance, chosen e.g. based on the comments that were provided during the testing.

3. The more concrete proposals made in the previous step could then be discussed in several on-line discussions to try to reach a consensus on new wordings.

4. It would be very useful to include into the next national reports on the implementation of the Cartagena Protocol some questions dedicated to the practical use of the Guidance and suggestions for possible improvement.

5. I fully agree with Boet that improving the current Guidance should be considered as first priority and that drafting further guidance on specific topics should be kept on hold during this process.

Last but not least, with regards to Angela’s suggestion to invite scientists/academia who are experienced in the field to share their experience and give recommendations, I am wondering whether this is a good idea at this point of time to engage in a new round of suggestions and recommendations about the content of the Guidance. Although I agree that the testing of the Guidance should be an ongoing activity, the most urgent task now is to decide how to take into account the suggestions made during the last testing, keeping in mind that Decision BS-VI/12 asks the Executive Secretary to provide a report on possible improvements to the Guidance for consideration by COP-MOP-7.

Kind regards,

Didier
posted on 2014-04-30 07:48 UTC by Didier Breyer
This is a reply to 5823 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5825]
It is always difficult to know where to enter the conversation on these threads, but I would like to offer a few responses to Ms. Dorien Coray's post, so this seems as good a place as any.  As always, thanks to the Secretariat for facilitating the online forum and to Angela for serving as the moderator.

In response to Ms. Coray, I think your overall assertion that the responses are all useful and should be taken into account in the proper context is a very good one.  I will point out, for the sake of my colleagues in the U.S., that the U.S. does have a longstanding monitoring program in place for monitoring insect resistance.  There is also ample experience within the U.S. government at monitoring all sorts of things in the environment and related to agriculture, so I would not be quite so quick to suggest that there is no particular expertise on this subject. 

The other point I would like to make, is that I would not necessarily agree with the statement that the response from the testing was "clearly positive."  As has been our unfortunate habit during this whole process, we embarked on sending out a survey to test the guidance without making any attempt to make sure that the testing tool would return useful results, and to set clear boundaries on what the testing was expected to accomplish and how the results would be used.  Surveys are an art and a science in and of themselves, and while I can't pretend to be an expert, I do have a lot of experience looking at the results of similar 5 point scale surveys related to conference speakers.  I can tell you definitively that I have never seen anyone score lower than an average rating of 3 on any of these surveys, no matter how dismal their presentation, and that if you're not averaging above a 4 you are not likely to be invited for a command performance.  This just has to do with the psychology of taking a survey.  It may or may not be applicable to these results.

Certainly I wouldn't argue that the results were clearly negative.  I would just like to suggest that the survey results, to my mind, are not a particularly useful way of assessing the utility of the guidance.  This is doubly so, since we don't have any real understanding of how each country's test was conducted, and if the results are therefore even comparable - let alone appropriate to "average" into an overall rating.

I would very much echo the comments of Boet Glandorf that there is likely to be much more value in the specific comments submitted together with the survey.  These contain a wealth of suggestions and if the goal is truly to improve the guidance then this would be far more useful information to sort through than simply knowing that the Roadmap rated a 3.7 average.
posted on 2014-04-30 07:58 UTC by Mr. Andrew Roberts, International Life Sciences Institute Research Foundation
This is a reply to 5772 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5826]
Dear all,

Firstly, I want to thank the secretary for their work preparing the documents for the discussion, and Angela for moderating it.

I agree with other colleagues that we should not focus on the numbers, but take advantage of the comments. In the previous debate, it came out that in all this process sometimes it is not easy to know if some comments have been taken into consideration. I supported Piet´s proposal to introduce, on the table comparing the Guidance and the Manual, an explanation about those comments that have been incorporated or not. Now a similar mechanism of analyses is proposed by Boet (#5811). I support any mechanism that helps to show in a document all the suggestion that have been made during this process (both in the testing of the Guidance and in the on line debates) and take a decision about them.

Regarding the advisability of incorporating scientists on the debate, I think that they are already in it, but even if their opinion has to be taken into account, I think that the testing of the Guidance had to be done by risk assessor and risk managers, as potential users.

I have also suggested in other debates the need of identify these potential users. I am glad to see in the report distributed by the secretary a list of countries that have been using the Guidance for the purpose of conducting risk assessment or for evaluating risk assessment reports submitted by notifiers. Some of these countries have submitted their opinion, and they do not share the agreement about practicality, concerning specially the Roadmap.

There are also, more in the on line debates than on the survey, comments regarding some problems in the translation. We conducted the testing using the Spanish version. Even if we found some odd wording, we think that mostly the document is properly translated. We suggest progress in the work document in English before concentrate our efforts in the translation, to be sure that the different versions share the same information. But we agree with other no-english speakers that at some time we will have to improve the translation if we want to make a document friendly and usable.

Kind regards,

Victoria
posted on 2014-04-30 13:01 UTC by Dra Victoria Colombo Rodríguez, Spain
This is a reply to 5825 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5828]
Dear all,

First I would like to thanks the Secretariat for facilitating the forum and Angela for being a moderator.

The COP-MOP decision requested to the ES to: ´Gather and analyse, in a transparent manner, feedback provided as a result of testing on the practicality, usefulness and utility of the Guidance…´  having the ´transparency´ as an essential component in the process is necessary to know the criteria to accept/reject the suggestions.

At this stage I really want to stress out the necessity of the transparency component in the process of creating documents in such way that we have now a different feedback than the previous foruns/testing. To illustrate the situation I´ll take few examples of the result of testing conducted in November/2011 where the suggestions from different parties were not accepted and neither have a justification and some of them are actually back in the current testing. For example – JAPAN:  - ´As the cumulative effects of LMO would not be the common understanding of the Parties, a) line365:The words of “Cumulative effects with any other LMO present in the environment” should be deleted´ (LINE 495 in the current Guidance); – MEXICO: - “…Also the section of Related Issues, for someone with little experience could be confused as those issues are not related to risk asssessment but are still in the guidance document. In addition to the last section of RELATED ISSUES it is not part of the analysis of risk, but policies and it can be confusing for someone with little experience.” (LINES 713-723 in the current Guidance); GERMANY: - ´It contains parts that are too speculative and do not contain guidance, e.g. application of ´omics´-techniques for risk assessment or future possibilities of PCR-discrimination between single events and stacks.´ (LINES 939-942 and LINES 1040-1043 in the current Guidance); BRAZIL: - ´…for a risk assessor with limited experience it will be difficult to select which information will be essential for a RA of a small scale release, considering that not all the information in the guide is required in this case (LINES 324-328 in the current Guidance).
´
Regarding Ms. Dorian Gray comment I totally agree with the fact that the ´diversity of perspectives will be useful for the upcoming AHTEG, where recommendations for improving the Guidance can be made´ but I agree with Deise that there are ´two package´ of answers from those that have experience in risk assessment (not only Brazil, USA, Canada, but also Australia, New Zealand, India, Japan etc) and those that have less experience because they do not cultivate GMO or do not have a regulatory system in place. That do not diminish the contribution of each country but they do show that experience can change the way usefulness; practicability and consistency of the Guidance are evaluated.

Is not a question of letting ´the opinion of a small number of countries, that disagree with the vast majority of respondents´ as Ms. Gray said, is more complex than that. Is a question of not let an over-simplistic analysis of scores to overlap the richness of 70 pages of comments and suggestions where countries spend time and effort hoping to contribute for a better guidance.
  
And finally I fully support Boet´s suggestion that ´COP-MOP 7 adopts a mechanism to perform these improvements, in which the Secretariat takes the lead in drafting a new version of the Guidance´ and Didier´suggestion of how to reflect the multitude of suggestions in a efficient and transparent process.

Kind Regards,

Luciana
Ministry of Agriculture, Livestock and Food Supply / Brasil
posted on 2014-04-30 15:29 UTC by Ms. Luciana Ambrozevicius, Brazil
This is a reply to 5828 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5829]
Dear colleagues,


While I am pleased with the engagement and suggestions made, I believe that some comments posted need clarification. In particular, that everybody is most welcome to read and analyse all the comments made in detail by the Parties, non-Parties and organizations in the response to their testing initiatives. The full results of the testing are publicly available at http://bch.cbd.int/protocol/testing_guidance_RA.shtml in a transparent manner.

As indicated in paragraphs 11, 17, 24, 27, 30, 33, and 36 of the draft analysis prepared by the Secretariat, what is shown in the analysis is „a sample from the list of comments and suggestions that emerged from the testing exercise“. By definition, a sample cannot contain all the elements of the detailed responses.

Therefore, in this discussion, participants are encouraged to analyze the detailed responses individual responses, which will also be part of the package for subsequent consideration by the AHTEG and COP-MOP7, as well as any follow-up process established by the Parties, as appropriate.

My best,

Angela Lozan
posted on 2014-04-30 17:05 UTC by Angela Lozan
This is a reply to 5829 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5832]
Dear participants,
first of all I would like to say many thanks to the Secretariat for the compilation of the testing results and to Dr. Angela Lozan for coordination of this round of discussion.
Now I would like to give some comments on the topics proposed.
Looking through the section-by-section analysis, I didn`t find the Parties, other Governments and Organizations that gives the grade 1 (exception – «Monitoring into the environment», where one Other government, tested this Part of Guidance, gave rate 1). The lowest ratings were given by Other governments, and the number of this Governments didn`t exceed 3 from 54 reports submitted for every part of the Guidance. At the same time the Parties, Other Governments and Organizations find the time and gave many valuable suggestions on how to improve the Guidance. Thus the testing results indicating for me that the Guidance is not refusing by the Testers and about the possibility of constructive dialogue. For me the suggestions are more important and valuable than ratings and I also share the view expressed above that all of them are valuable and should be taken into consideration and discussed. I appreciate the proposal of Dr. Didier Breyer about grouping the comments by categories (#5824]) to capture as much information as possible to discuss and make the Guidance improvements (especially in light of foregoing #5828). I am also supporting that the mechanisms of the information inclusion into the Guidance could be improved and hope that the COP-MOP7 will consider this issue.
Reading the countries suggestions on improvement, in many of them I have found the reflection of our own thoughts, and I shared this thoughts in previous on-line forums. The illustrative material (flowcharts, matrices, etc) of real procedures of risk assessments that explaining how to conduct the different steps of RA and corroborating well described, in my opinion, «Steps of the Road Map» and «Points to consider» should be incorporated in Guidance. I consider that if it wouldn`t be done many of the inexperienced risk assessors would write again and again that the Guidance is very complex and not friendly. The examples could be done directly in text or in the forms of links, which refers to the background documents. And I also would like to share my disagreement with those who writing that the Guidance is too Academic. Steps are written in clear for biologists language (I think that people, who directly conducting RA – scientists in present or in past), all the possible risks in Points to consider were covered and only the examples on how to conduct this steps are valuable for the inexperienced risk assessors.
The other important issue, have been written by the Testers, necessity of interpretation of terms clearer. Many proposals on this topic were given. I think that many of uncertainties for newel risk assessors rising from bad formulated and unclear terms and this topic should be considered as very important and stressed again in AHTEG and Cop-Mop discussions.
With best wishes, Galina.
(edited on 2014-05-01 22:23 UTC by Galina Mozgova)
posted on 2014-05-01 22:17 UTC by Dr. Galina Mozgova, Belarus
This is a reply to 5832 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5834]
Thank you to the Secretariat for preparing the analysis of the results of the testing of the Guidance, and to Angela for moderating this round of discussions.

While I agree that we need not be fixated with numbers, I think that the testing results, overall show that the Guidance is welcomed, and there is strong agreement that the Guidance is practical, useful, consistent with the Protocol and takes into account past and present experiences with LMOs. I am particularly encouraged by the fact that of the Parties that responded, over half were developing countries, and that for this category of countries, the level of agreement is even higher. 

It is also encouraging to note that research institutions, academia, NGOs, industry etc. contributed to the testing, which contributes to the robustness of the results.

The testing has not challenged the substance of the Guidance, but has suggested improvements in order to be even more practical and useful for Parties in meeting their risk assessment obligations under the Protocol. The results of the testing can and should already lead to improvement of the Guidance, and there needs to be a mechanism by which the rich comments emanating from the testing can be meaningfully integrated and taken into account. I believe that the AHTEG, when it meets in June, will be well placed to begin this process.

I agree with an earlier comment that it would be useful to integrate some questions on the implementation of the Guidance for the next cycle of national reports. Especially as one of the indicators in the Strategic Plan in relation to risk assessment and risk management is the percentage of Parties adopting and using guidance documents on risk assessment and risk management.

Kind regards,
Lim Li Ching
Third World Network
posted on 2014-05-02 09:04 UTC by Ms. Li Ching Lim, Third World Network
This is a reply to 5824 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5839]
Thanks to Angela for agreeing to moderate this forum.  I am sure we can look forward to thoughtful input as the forum draws to a close.

I would like to support both Boet and Didier for their suggestions on how to incorporate the outcomes of the testing.  Considering the extensive effort that has gone into the testing process, a very thorough analysis that captures the depth of detail is warranted.  I think the mechanisms for that analysis that have been suggested are an excellent start.  I would encourage the Secretariat to take these suggestions into consideration as we advance the work.

I noted with some interest Wei Wei's suggestion that scientists should now be asked to embark on the testing of the guidance.  This comment is interesting because I think it underlies where some of the key differences of opinion on the guidance arise.  Regulators who conduct risk assessments of products for commercial release are typically reminded that they need to make the paradigm shift from research scientists to regulators.  The usual term of the art is "need to know vs. nice to know".  This is at odds with a research project where the acquisition of as much knowledge as possible is the goal.  Scientists are well equipped to embark on the acquisition of knowledge and create hypothetical constructs but not always the best equipped to decide what is necessary and sufficient to determine the safety of an LMO.   The current guidance seems to have the same failing in that it often looks more like a scientific exercise in data generation and less like a process to guide a regulator through what is necessary and sufficient to conduct the risk assessment. 

I look forward to the rest of the comments and I hope we will see a clear path forward that captures the useful input form the testing.
Phil
posted on 2014-05-02 21:51 UTC by Mr. Phil Macdonald, Canada
This is a reply to 5772 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5846]
Thank you Angela for moderating this forum. And a big thanks to the Secretariat for the hard work in preparing the analysis documents.

In many ways I see this forum as the most challenging of the series.

Having been the recipient of probably over 10,000 survey points from undergraduate students over the last 20 years using a similar format as used in the testing, I have some observations to offer.

1. I initially made the error of prioritizing strongly expressed minority views. I assumed that if someone went to the trouble to write something down, then that was an indication that they were more engaged than someone who didn’t. That is far from reliably true.
2. Those who like something may not say so. But if you change something that they like, you’ll hear about it. Taking an action that altered some aspect of my courses that were not commented on by the vast majority but were negatively criticized by a minority more often than not lead to a much larger number of negative criticisms the next year. The ‘silent majority’ may be happy and engaged and competent to judge.
3. I am guilty of having a personal empathy for some (even negative) criticisms and am more likely to want to act on them. This ‘radar’ does not seem to be any better at predicting success.

In saying this I don’t think we should either ignore or dismiss the negative criticisms, and constructive criticisms, of the minority. Like Dorien [#5823] and others, I think that they should be carefully collated and considered, as Ching [#5834] has said, by the AHTEG. To the suggestion that each needs to have a separate formal and written response is to me beyond our resources and obligations to our mandate, which I understand to be to revise the Guidance through a process where we have taken into consideration the results of the testing.

Another thing in common between my undergraduate students and those in the regulatory community, as Phil points out [#5839], is that both are fixated on the ‘need to know’ (e.g. for the exam or the RA) and the ‘nice to know’ line. And I think Phil is right to suggest that research scientists and academics such as myself probably innately resist such a demarcation, even if we practice it ourselves precisely because we recognize that there are limits in time, energy and attention for all activities, including among students and Guidance users.

Nevertheless, that demarcation is a normative judgment, not a result of a scientific experiment. It will likely and indeed frequently be contested by those who reach different conclusions by their normative processes. Therefore different people will tend to have different reactions to a Guidance document that attempts to minimize imposing a particular demarcation. Some will welcome that the Guidance assists them in identifying ‘need to know’ issues and others will be annoyed at the Guidance because they consider those very same issues to be ‘nice to know’.

As a general principal, I don’t find the ‘need to know’ and ‘nice to know’ border helpful. I attach a picture I frequently use when discussing this very notion. The divide will vary by person, country, receiving environment, and time. Its usefulness I think is in post hoc risk communication or justification, where the assessor can carefully point out their reasons for including or excluding the need for some kinds of testing.

So how do we use the combination of quantitative and qualitative feedback from the testing? I concur with Dorien [#5823] that we should look for the constructive in all criticisms but not undervalue the comments from those who only returned a number. As to the observation that the lowest score returns were from those with the most ‘experience’, this group may be unhappy for various reasons including if or when the Guidance does not directly vindicate choices they have made. That does not make their past choices incorrect for their receiving environments in any case, but likewise it does not make them right for others. For example, Andrew [#5825] points out that the US does monitor in a case-specific way for some potential adverse effects. However, it does not use ‘general surveillance’ or surveillance that takes into account human health as far as I’m aware. This choice may be true to their legislative framework, but that framework is not required to be harmonized to the Protocol. The Guidance, in contrast, allows other risk assessors to decide for themselves whether such monitoring is ‘nice to know’ or a ‘need to know’ consistent with the provisions of the Protocol.

I appreciate the many views that have appeared in this forum and look forward to the work of improving the Guidance as a result of the testing.

Best wishes
Jack
posted on 2014-05-03 23:27 UTC by Mr. Jack Heinemann, University of Canterbury
Attachement need 2 know.pdf - 257 KB
This is a reply to 5772 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5847]
Dear Angela, Secretariat and members of the open online forum of the AHTEG....

I am sorry to not have been able to make some comments beforehand during the two week discussion period, I apologize.

I have read the comments in the forum as well as most of the documents put forward by the Secretariat in relation to the testing results, including several of the testing reports made by Parties, Non Parties and Organizations.

The analysis made by the Secretariat is useful and provides a general overview of the testing results, the AHTEG must use this document during its work in the face to face meeting. I agree with Didier on the suggestions made to obtain more information on the testing reports, this effort could be made by the Secretariat prior to the AHTEG meeting as further input into its meeting.

It is clear that there are strong contrasting views on the Guidance as a whole, specially on the roadmap......this has to do in part on the different approaches made by different actors to risk assessment as a whole....not only on their level of "experience" related to risk assessment. It is also important to note that not only developed countries have experience in risk assessment, several of the developing countries participating in the testing process do too....

Kind regards to all.

Francisca
posted on 2014-05-04 01:32 UTC by Ms. Francisca Acevedo, Mexico
This is a reply to 5772 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5848]
Dear all,
First, I’d also like to thank: Angela for moderating the discussion, the secretariat for drafting the testing results report and the sharing of views in this forum.
Taking that the testing is meant for “further improvement in actual cases of risk assessment and in the context of the Cartagena Protocol on Biosafety” (as stated on the 1st paragraph, “b” of the report and similar in other paragraphs). There are at least two obvious points to be careful about:
a) if you aim to improve it, suggestions and criticisms are highly important and for instance the “sample” in the report should be meaningful and representative; 
b) that actual experience is taken into consideration.
At this stage some thoughtful comments in this direction were already made, such as from Boet  Glandorf [#5811] , Deise Capalbo [#5818], Didier Breyer (#5824]; Dr. Galina Mozgova; Luciana Ambrozevicius; Phil Macdonald, etc (sorry for not naming everybody). These comments have in common that the many suggestions and criticisms should be taken on board and/or question that experience is not well reflected yet.
About 25% (41 of the 167 parties) parties have engaged in giving feedback on the testing of the guidance. This is relatively high percentage for such a time demanding work but many (majority actually, not visible in the graphs as they do not show the number of non-respondents within the total of parties) still did not participate. When one goes down to the different parts of the testing form the number of responses will decrease even further for each subpart. Even with only a minority of respondents, we have some 70 pages of suggestions, which is already a great work to deal with, as well as a strong indication that there is a lot to consider for improving the roadmap.  I also very much welcome the suggestion from Didier and Boet to group the suggestions for clearer view on the major points for improvement.
Considering making use of available experience, in addition to the given comments in this forum, it also seems to be a common suggestion among the respondents.  Though the protocol cares to assist developing country parties special needs to be able to make own decisions/implement the protocol, the division into developing countries tells little on level of experience (as pointed out by Deise). According to ISAAA, of the 27 countries which planted biotech crops in 2013, 19 were developing (on 54% of cultivated area) and 8 were industrial countries. There are ways to consider level of experience on RA&M without meaning that a country prefers or not to cultivate GM crops.  For instance, several countries have a different number of successful field trials conducted. I mean by successful as being able to conduct a trial with appropriate risk management to gather data for a scientific evaluation. In that sense, no matter weather the decision at some point was commercial adoption or not, indeed sometimes RA has considered a LMO “as safe as the conventional” but nevertheless it was not followed by cultivation/adoption.
I wish you all a nice rest of weekend. Best regards, Lúcia
posted on 2014-05-04 04:13 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 5848 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5849]
Dear All,

thank you Jack for the funny pictures! I consider it is valuable observations made over the multi years exercises on risk assessment made by the undergraduate students.

In my view it is very interesting suggestion made by Lucie to discuss the existent practices of field trials to see how the management strategies can be applied for accepted risks. 

I just want to bring to your attention the opinion expressed during the testing session in Chisinau,  where participants mostly proposed to including  in the roadmap of aspects related to human health, that is not a critical reflection of the document, but is a suggestion to further development in accordance with countries needs.

Hope in the remaining two days of the forum we will see more interventions and constructive comments on the proposed topic.

Wish you successful discussion and nice weekend.

Best wishes,

Angela
posted on 2014-05-04 07:44 UTC by Angela Lozan
This is a reply to 5849 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5855]
Thank you to the Secretariat for doing analyses and getting these documents together, and to Angela Lorenz for moderating this forum.

I agree with the Concluding Remarks of the Analysis of Results document and would like to add the following comments to them.

There are 54 responses, which is a very nice sample size and certainly sufficient to determine how useful the Guidance is.

I've analysed numerous questionnaires and I'm impressed by how much agreement there is between 96% of the recipient categories.  These categories constitute the Parties, the Developing Country Parties and Organisations.  And these group agree to a high extent that both the Guidance and the Roadmap are practical, useful, consistent with the protocol, and take into account past and present experiences with LMOs. It is impressive to see this much agreement between classes of recipients.  It is also clear that the only category of recipients that clearly disagree with the consensus are the three respondents that constitute the “other government” category, being a small minority of only 6% of the respondents. This category groups together the governments of the US, Australia and Canada, which are developed countries for whom the Guidance is not designed. I agree with the assessment of Dorien Coray [#5823], who stated that “I do not think that we should let the opinion of a small number of countries, that disagree with the vast majority of respondents, dictate our impressions of the testing as a whole.” I also agree with Li Ching Lim [#5834] that “testing results, overall show that the Guidance is welcomed”.

For each section-by section analysis of the results, I am particularly struck by the very close agreement between the results for the Parties and the Developing Country Parties and how both groups obviously consider not only the Roadmap, but also the Guidance, to be practical, useful, consistent with the Protocol and to take into account past and present experiences with LMOs for all the categories tested for, being all of: stacked genes or traits, LM crops with tolerance to abiotic stress, LM mosquitoes, LM trees, monitoring of LMOs released into the environment, and the background documents.  Moreover, there are sufficient sample sizes for each of these categories of Parties for each of these sections of the results to ensure that the findings are robust and would be unlikely to change if the Guidance and Roadmap underwent further testing.  While there is less liking of the Guidance and Roadmap from the few respondents from the categories of Other Governments and Organisations, these latter groups were also less likely to respond to questions about these areas. Their participation dropped off considerably for these questions and some chose not to respond at all to some sections for eg questions on the background documents. 

These results also make it clear that comments in the Analysis of Results documents that criticise the Guidance and/or Roadmap, such as: the text should be revised to be simpler and less prescriptive, the background documents need to be re-examined for relevance, etc are not held by the majority of respondents who tested the Guidance. 

The strength of the positive results of the Guidance as shown in the Analysis of Results document also clearly contradict the views of Patricia Gadaleta [#5821] that “the Guidance - in its current version - could be misinterpreted by novel assessors”, Didier Breyer [#5824] that “there is still a large room for improvement”, and Francisca Acevedo  [#5847], that “strong contrasting views on the Guidance as a whole, specially on the roadmap”.

Of the comments in the Analysis of Results document, I agree with:
19(f): “There could be a stronger focus, in the Roadmap, on issues of human health in the context of risk assessment of LMOs” and the similar 21(d): “The Roadmap should address the potential adverse effects to human health in more detail”, because this is a key concern for governments and people exposed to the LMO.  I further agree with the elaboration of this point in 37(a): “Although it is clearly stated that monitoring for human health is within the scope of this section of the guidance, there is little information that would allow practical human health monitoring. Therefore, to improve this section’s consistency with the Protocol more elements could be provided on how to account for issues of human health in the context of environmental monitoring”.

Of the comments in the Analysis of Results document, I disagree with:
  20(c): “Placing much of the information, such as examples, options or alternatives, in appendices/explanatory notes to simplify the main document” as this will make the document cumbersome and less user friendly.  I disagree because readers will need to flip constantly between the main document and the appendices.
  21(e): “Removing issues that are focused on policy elements that are not within the scope of a risk assessment (e.g., the section on “related issues”, data quality, consultation with stakeholders, selection of experts) or outside the scope of the Protocol (e.g., co-existence, ethical issues)”, because issues such as data quality and co-existance are important aspects of a risk assessment.
  21(g): “Including the notions that access to and transfer of biotechnology are essential elements ..... Parties agree to promote and advance priority access to the ...  benefits arising from biotechnologies ..... and that modern biotechnology has great potential for human well-being” as they are not statements that could be considered to be neutral or balanced.
  22(d): “Removing speculative risks such as those arising from indirect effects, synergistic and combinatorial effects, horizontal gene transfer among plants, and persistence of the gene product in the environment as they ignore the long history of experience with LM crops where these risks have not been realized.”, because there is debate for each of these individual risks as to whether it is a speculative risk or a real risk.  Furthermore, what may constitute a speculative risk for one LMO may constitute a real risk for a different LMO.
  31(i): “The relationship between considerations of the environmental risks of LM mosquitoes and human health benefits should be mentioned more explicitly”.  If human health benefits are mentioned more explicitly, so should the risks to human health be more explicitly mentioned to ensure a balanced approach.

Paragraph 44 of the Analysis of Results document contains this statement: “For most sections of the Guidance, the criteria of usefulness and consistency with the Protocol were rated higher than the criteria of practicality and taking into account past and present experiences with LMOs. Therefore, improving the practicality and the extent to which the Guidance takes into account available experience with LMOs could be the primary focus of further improvements, as appropriate, including, as recommended by several respondents, simplifying the language of the Guidance and adding examples of real cases throughout the text.”  I wonder if this is actually correct.  As a quick analysis, I took each section-by-section analysis of the results and considered only those responses from the Parties (whether Developing Country Parties or other Parties), because they constituted by far the largest groups that replied.  The average rating for practicality was 4.0, usefulness was 4.1, consistency with the protocol was 4.2 and taking into account past and present experiences with LMOs was 3.9.  It could therefore be considered that there was essentially no difference between these categories of responses.  I recommend a full weighted average be calculated (where the averages are weighted to the number of respondents) to determine if these findings hold with for the full data set.

It is important to note that, as described in paragraph 43 of the Analysis of Results document, seven Parties are already using the Guidance for  the purpose of conducting risk assessments, of which six are developing countries.  Consequently, the Guidance could be considered to have passed the most crucial test of usefulness – countries are “voting with their feet” to use the Guidance.  They would only do this if they considered the Guidance to be a useful tool. Of additional importance, not only are there are 54 responses to the testing, which is a good sample size, but the high level of agreement between 96% of the recipient categories provides strong indication that any repeat of the testing would just provide a repeat of the current findings.  Therefore, speaking as a biostatistician, in my view, any further testing of the guidance would be essentially pointless. 

Finally, as Jack Heinemann has stated [#5846], the results of the testing contain both quantitative and qualitative responses.  In this sort of testing, the quantitative responses constitute the core results while the much more optional written comments constitute a means of clarifying issues and understanding some aspects of the quantitative results.  I am therefore concerned that several commentators have suggested elevating the qualitative results to be more important than the quantitative results, particularly as (as Jack Heinemann has said), such comments can often only contain “strongly expressed minority views”.
posted on 2014-05-04 14:41 UTC by Dr Judy Carman, Institute of Health and Environmental Research
This is a reply to 5855 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5857]
Angela, please accept my apology for mis-spelling your surname.  My excuse is that it is after midnight here......!
posted on 2014-05-04 14:48 UTC by Dr Judy Carman, Institute of Health and Environmental Research
This is a reply to 5857 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5858]
Dear Judi, no problems. Thank you very much for your detailed intervention in the discussion.

Best wishes,
Angela
posted on 2014-05-04 15:46 UTC by Angela Lozan
This is a reply to 5855 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5859]
Hello everyone,

Thanks to Angela for moderating this online discussion.  I apologize for only finding time to make a brief comment at the end of the discussion.   The 70 pages of comments and suggestions in the report from the testing are surely overwhelming, and yet should be very useful indeed for improving the guidance, and as noted by others, suggest ample room for improvement still.

I agree with many others in this discussion so far who have expressed concern that the analysis provided is an over-simplification, and the results of the testing will only be truly useful to improve the guidance when each of the many suggestions have been considered and dealt with in a transparent process.

I did not want to miss this opportunity to strongly agree with the suggestions from Boet [#5811] and Didier [#5824] on possible mechanisms through which the results of the testing could be used to improve the guidance, in a way that is transparent.   I found their two posts to be quite constructive, and note that a number of other responders in this discussion also agree with them.

Thanks,
Karen
posted on 2014-05-04 21:05 UTC by Ms. Karen Hokanson, University of Minnesota
This is a reply to 5772 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5860]
Dear friends and colleagues

I will start by a big thanks to the Secretariat for the hard work in preparing the analysis documents.

The careful reading of the analysis shows that there is a high level of recognition concerning the Guidance practicability, usefulness, consistency with Protocol and taking into account past and present experience with LMOs. I wanted also to highlight that when it comes to any document there will always be a room for improvements. So bearing in mind the lengthy discussions on the guidance documents, the process that lead to what we have in hands now and the urgent need of developing countries to have some sort of guidance on the issue, I believe that the adoption of those documents should not be further delayed. The possibilities for improvement should not be used, any more, as an excuse for not acknowledging those guidance documents which have already gone through several rounds of testing and discussions otherwise we will get stuck in a never ending circle.

Regards,
O.A.El-Kawy
(edited on 2014-05-04 21:49 UTC by Ossama Abdelkawy)
posted on 2014-05-04 21:32 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
This is a reply to 5860 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5861]
Dear All,

Let me express my thanks to Angela for moderating this session, the Secretariat for their work in preparing the materials, the many people who made contributions in testing the Guidance, and those who are providing reflections now online regarding the analysis of the testing of the Guidance. 

Angela, you reminded us at the outset of this forum that our role is to provide input to assist the Secretariat will submit a report to the Parties on the testing of the Guidance and possible improvements that are needed to the Guidance.  Whereas some of the online responses have merely sung the praises of the Guidance in its current format and content, it is clear from numerous comments in testing and the online forum discussions that the Guidance still needs substantial revision if it is to meet the stated goal of being practical, useful, and consistent with the Cartagena Protocol on Biosafety -- all the while taking into account past and present experiences with living modified organisms.
 
I have found the detailed comments from Boet Glandorf and her Dutch colleagues to be especially constructive and insightful (comment #5811).  I will not reiterate all the points here, but I urge everyone to carefully review her comments in the forum and the especially detailed analysis and recommendations in the attached file she and her colleagues provided along with her comments.  I would like to echo the comment that Boet made regarding the need to reach consensus on the main Guidance (Roadmap) before trying to reconcile the topic-specific portions (e.g. mosquitoes, trees, etc.) and certainly before embarking on developing additional guidance documents.

Regarding the procedure used by the Secretariat to summarize the testing, I believe that Boet’s comments include an excellent suggestion to increase the transparency of the procedure by having the Analysis document prepared by the Secretariat document includes a procedural paragraph that states how the Secretariat’s analysis was made, clarifies that the sample lists are the personal choice of the Secretariat, and that these sample lists are based on personal interpretations by the Secretariat of the suggestions received in the testing.

I find that Didier Breyer (comment #5824) has provided many very constructive suggestions toward improving the analysis of the testing and thereby serve to guide any revisions of the Guidance itself.

I think that Victoria Colombo Rodríguez (comment #5826 ) has made a very good suggestion for the Secretariat’s analysis to incorporate the relevant, constructive ideas that have put forward in the online forum discussions.

There is one final observation that I would like to share, and that is regarding the lack of context in responses from the Parties as to whether their evaluation was “in the context of the Cartagena Protocol on Biosafety” or their national legal framework (for those Parties which are using national laws rather than the Protocol).  I think this may be instructive in reviewing the responses from Parties, and it may also be useful in clarifying the distinction that arises frequently about the way an academic views risk assessment versus the way that a government views risk assessment as part of its legal framework and obligations.  Such an analysis may not be possible at this stage, but I am reminded of this issue because the instructions from the Secretariat invariably use this phrase, “in the context of the CPB”, when asking for input.

This has been quite a long process over more than 5 years of work, and there is still considerable work that lies ahead for the AHTEG and the Secretariat to prepare materials for the upcoming Meeting of the Parties.  I wish the best for all in this endeavor.

Regards,

David Heron
posted on 2014-05-04 21:51 UTC by David Heron, United States of America
This is a reply to 5772 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5862]
Dear All,

I join others in thanking Angela for agreeing to moderate this session and the Secretariat for preparing the documentation.

Up to this round I have been able to submit my interventions in an earlier stage  of the online conference, but like Dider and others, I am bit overwhelmed with monitoring and seeking input from PRRI members on two parallel on-line conferences that are currently held in preparation of MOP7. Yet, we believe that it is important to follow the various online discussions on the different topics, to ensure consistency.

Returning to the assignment at hand: as Angela reminded us, in this round we have to focus on
1) the request of the MOP to gather and analyse, in a transparent manner, feedback provided as a result of testing, and
2) on possible mechanisms through which the Guidance could be improved.

As to the first point:  I agree with Boet and others that the Secretariat did a good job in gathering and compiling the test results, but that the analysis presented was an over-simplification that did not do justice - nor made good use of -  the many suggestions for improvements made. PRRI too had problems to recognize the specific comments that PRRI made. 

I fully appreciate Angela’s observation that the suggested improvements listed in the analysis of the Secretariat were just a sample, and I can understand that it is very difficult in the current setting to collectively produce an analysis in a transparent manner.

I therefore fully support  Boet’s proposal that this process results in a recommendation that COP-MOP 7 adopts a transparent mechanism to address and where appropriate incorporate the suggested improvements.

The suggestions made by Didier, Deise, Patricia, Lucia, and Luciana would be excellent elements of such a process.

Best regards

Piet
posted on 2014-05-04 23:08 UTC by Mr. Piet van der Meer, Ghent University, Belgium
This is a reply to 5862 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5864]
Dear all,

Thank you Angela for moderating this session.

Only about 1/3 of Parties responded to the request to test the Guidance document, we don't know what the other 2/3 of Parties think about it, so these results should be put in that context.

In looking at the results of the testing, I find that the scores alone (in multiple raphs) do not reflect well the views of the testers and cannot be used alone without considering the comments provided by the testers.

Taking into consideration the request from MOP-6
1. to gather and analyse, in a transparent manner, feedback provided as a result of testing, and
2. on possible mechanisms through which the Guidance could be improved
Many comments for improvement were provided. I agree with Boet [#5811] and Didier [#5824] that the Secretariat should list all comments grouped in categories as suggested by Didier to be analyzed.  The AHTEG should then decide how to review them and incorporate the comments that seem appropriate in a transparent manner.

Best regards,
Esmeralda
posted on 2014-05-05 00:21 UTC by Ms. Esmeralda Prat, CLI representation
This is a reply to 5772 RE: Opening of the discussion - analysis of the results of the testing and possible improvements [#5879]
POSTED ON BEHALF OF VILASINI PILLAI
(Note: this message was received before the closing of the discussion)

-----

I would like to take this opportunity to thank the Secretariat for analyzing the testing results and drafting the report- it is a mammoth task and also to Angela Lozan for moderating this discussion.

I apologise for this late response but I did not want to loose this opportunity to voice my support for the many suggestions and recommendations put forward  especially by Boet and Didier. I did not have time to complete reading the full report prepared by the Secretariat which contained many relevant suggestions. however,  I read the Malaysian report where the Malaysian regulators carried out the testing of the Guidance together with the scientists that serve in the advisory committee on RARM. Many issues were raised by them on the Guidance documents especially on the practicality of the document from various aspects. Based on this I would like to fully support the comments of many that suggestions, criticisms, shortfalls of the present Roadmap and Guidance documents should be incorporated in the report to indicate that there are still parties that would like changes made to the Roadmap so that it can be a document that is practical and user friendly.

Didier suggested that the Secretariat should list all comments grouped in categories  after which AHTEG can decide on how to review them and incorporate the comments that seem appropriate in a transparent manner. I totally agree on this good suggestion and would also support what others have said that a proposal should be made on how to use these suggestions to amend and improve the Guidance. This is also the request of MOP-6 to come up with possible mechanisms through which the Guidance could be improved.

I also concur on what Boet and others have suggested that a consensus should be reached on the Guidance (Roadmap) before embarking on developing additional guidance documents as well as the other topic specific parts of the Guidance. We need to rectify and improve the existing documents first before limited resources are wasted on developing new ones.

I wish the AHTEG and the Secretariat the very best in their arduous task ahead of them in preparing all the necessary material for the upcoming COP-MOP.

Best wishes
Vila
Ministry of Science, Technology and innovation
Malaysia
posted on 2014-05-05 14:40 UTC by Ms. Manoela Miranda, UNEP/SCBD