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Opening of the discussion "Alignment of the Guidance and Training Manual – Further improvements to the alignment (all modules)" [#5509]


Dear Members of the Open-ended Online Forum,

Welcome again to all of you to this session of our forum aimed at developing a package that aligns the Training Manual “Risk Assessment of LMOs” with the Guidance on Risk Assessment (e.g. the Roadmap).

In a view of continuity, I have accepted with pleasure to moderate this new session, launched today to last till November 18 at 1:00a.m..

As explained by the Secretariat in its message sent last Wednesday, in this new session, participants are invited to provide feedback on the revised Manual (all modules) and to **make concrete text proposals**, if any, that **further improve the alignment with the Guidance**.

A new version of the complete manual has been presented last Wednesday, where previous comments of participants on the alignment of the Manual with that of the Guidance, including some clarification of specific concepts, have been taken into account.

We can thus consider that we have now accomplished the steps i, ii, and partly already iii, of the alignment that were proposed during the forum session of last July, and that we now proceed further through step iii : “ Adding new text to the Manual if and where necessary to better explain some sections and concepts contained in the Guidance in a coherent manner.”

You are thus invited in this session to provide further comments on the “product thus far” on the alignment the Training Manual “Risk Assessment of LMOs” with the Guidance on Risk Assessment (e.g. the Roadmap), and to suggest concrete additional text in the Manual, a. o. for examples to illustrate some concepts/ideas of the Guidance for the improvement of the Manual. 

I am looking forwards for your feed-back and proposals in this colourful and inspirational fall season.

With best regards.

Lucette Flandroy
posted on 2013-11-04 01:21 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 5509 RE: Opening of the discussion "Alignment of the Guidance and Training Manual – Further improvements to the alignment (all modules)" [#5513]
Dear Lucette, dear All.
To start our discussion round I like to congratulate and thank you for your renewed moderator  role.
And I like to thank you, the chair and the secreteriat for a thorough and very good revision of the Training Manual in line with comments made. As far as I could see the use of terms and concepts is now in good agreement between the two documents.

Best regards
posted on 2013-11-06 14:17 UTC by Beatrix Tappeser, Federal Agency for Nature Conservation
This is a reply to 5509 RE: Opening of the discussion "Alignment of the Guidance and Training Manual – Further improvements to the alignment (all modules)" [#5517]
Dear Lucette, Dear All,

First i would like to thank Lucette and the Secretariat for the revised Manual that is very good and takes into consideration the comments and suggestions made by the participants.
Congratulations to Lucette for being invited to chair the next forum.

I would suggest to complete the Manual in the lines 207-249 with the reference to the AICHI Biodiversity targets.   A text in a box related the Aichi strategic goals would be helpful to provide the link between biosafety and biodiversity strategic approach:

AICHI Biodiversity Targets:
    Strategic Goal A: Address the underlying causes of biodiversity loss by mainstreaming biodiversity across government and society
    Strategic Goal B: Reduce the direct pressures on biodiversity and promote sustainable use
    Strategic Goal C: To improve the status of biodiversity by safeguarding ecosystems, species and genetic diversity
    Strategic Goal D: Enhance the benefits to all from biodiversity and ecosystem services
    Strategic Goal E: Enhance implementation through participatory planning, knowledge management and capacity building

Best regards,
Angela Lozan
posted on 2013-11-07 08:53 UTC by Angela Lozan
This is a reply to 5509 RE: Opening of the discussion "Alignment of the Guidance and Training Manual – Further improvements to the alignment (all modules)" [#5518]


Dear Lucette, dear colleagues:

First of all, as other colleagues have done, I would like to congratulate Lucette as she has been invited to participate as moderator of this new round of discussion. I would like to congratulate the chair and the secretary for the excellent work developed in the revision of both documents on line with the comments and suggestions carried out in the last discussion forum. There is now a relation between the Manual of training and the Guide of risk assessment, mainly concerning the concepts it refers to.

Warm regards,
posted on 2013-11-07 21:10 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 5518 RA Forum: Further improvements to the alignment of the Guidance andTraining Manual - A new message has been posed to the forum [#5519]
Dear Members of the Forum,

I appreciate the encouraging first messages that came on the forum this week and that confirm that we have all made with the Secretariat a useful work in the right direction for  the alignment of the Training Manual and the Guidance.

We are hoping for still more feedback opinion from you on the present alignment between the two documents, realized till now.

But I remind you also that, as started already by Angela, you are kindly invited to suggest additional  ** concrete text proposals **  in the Manual, that would  ** further improve the alignment with the Guidance ** , such as explanatory notes or examples to better explain concepts/ideas already included in the Guidance.

With best regards to all of you.

Lucette Flandroy

Disclaimer : http://www.health.belgium.be/eportal/disclaimer/
posted on 2013-11-08 17:10 UTC by Ms. Lucette Flandroy, Belgium
This is a reply to 5519 RA Forum: Further improvements to the alignment of the Guidance andTraining Manual - A new message has been posted to the forum [#5521]
Dear Members of the Open ended Online Forum,

I am optimistic that your silence this week means that you are satisfied with the present state of alignment realized between the Manual and the Guidance. We indeed have made together our best to align the language of both documents, in parallel to the mapping of corresponding sessions in the two documents.

Nevertheless, now is the chance ( following the steps proposed in the July session ) to propose additional text to the Manual to better explain some sections and concepts existing in the Guidance.

In the September session of discussions, some participants had proposed to add examples in some sections of the Manual to facilitate the understanding of some complex concepts.

Participants are welcome to provide, through this discussion, such concrete examples and/or to make concrete text proposals that could be included in the Manual.

With best regards, reminding you that now is the time to get inspired ...........

Lucette Flandroy
(edited on 2013-11-13 23:19 UTC by Manoela Miranda)
posted on 2013-11-13 22:35 UTC by Ms. Lucette Flandroy, Belgium
This is a reply to 5509 RE: Opening of the discussion "Alignment of the Guidance and Training Manual – Further improvements to the alignment (all modules)" [#5523]


I have been silent for quite a long time in this forum. This is partly because I still am wondering the present formulation of the risk assessment guideline is really usable or not. In my personal view, the guidelines, or this manual, should be primarily for risk assessment of LMOs having a conventional counterpart, with which there is a long history of safe use.

It is imprudent to give guidance on what we don’t know much actually. The guidance should admit that for LMOs without conventional counterpart the method should be further explored through experience. Therefore, I propose to replace the last paragraph of “The choice of comparator”, whose content is too speculative and needs further consideration, with a short paragraph, ”For foreseeable future, the present guidelines are not intended to be applied for environmental use of LMOs, which have no appropriate conventional counterpart(s) with history of safe use”.
posted on 2013-11-14 14:15 UTC by Ms. Manoela Miranda, UNEP/SCBD
This is a reply to 5523 RE: Opening of the discussion "Alignment of the Guidance and Training Manual – Further improvements to the alignment (all modules)" [#5525]
Dear Lucette, dear colleagues.
I would like to join the previous words of gratitude to the Secretariat and participants for the hard and well done work made in the course of previous forum.
I share the opinion of those participants who believe that two discussing documents are useful and allow to train newel risk assessors and help in the risk assessment process. But, when I began to study the risk assessment process, I have read many different guides and instructions. So happens that one of the first documents was the Guidance on Risk assessment of GMOs (not Training manual). And I tell you that I had to read it more than once. It seems everything was good with the guidance and key issues that need to be taken into account were identified, but something was missed for me to understand the risk assessment process thoroughly. Then I read our native book on this issues and it all came together. The fact is that book, in addition to the theoretical content, includes examples of decision-making process (in the form of text, but what's even better, in the form of schemes) – this is the thing that is missing in both Guidance and Training Manual. As it seems to me it is very important to show the statements on real examples. Of course you can say that such examples are in the references, and of course I agree with all those who say, that you should read many scientific works and everyday practice, practice and practice…, but I believe that the visual material directly in the text or in the appendices is very, very important for the newel experts.
Now about the proposals. As for me I have found such important visual material in the modified schemes of «Experimental evaluation of weed potential of transgenic plants and the likelihood of transgene migration and the changes in characteristics of natural populations due to its introgression» by [Rissler J. and Mellon M. Perils amids the promise. Ecological risk assessment of transgenic crops in a global market, 1993 – modified in our native book http://biosafety.org.by/sites/default/files/downloads/Publications/Bio(Tech-Saf-Eth).pdf - p. 180, 196 – unfortunately in Russian), Risk assessment of transgenic crops`invasiveness by [Hancock J.F. A framework for assessing the risk of transgenic crops / BioScience. - 2003. – Vol. 53. – P. 512-519.] and structured ecological risk assessments of LMOs carrying Bt-genes. I believe that the participants of our on-line forum from countries experienced in RA have the other good examples of their own structured decision-making process or good links in their opinion they could share.
With best wishes, Galina.
(edited on 2013-11-15 08:02 UTC by Galina Mozgova)
posted on 2013-11-15 08:00 UTC by Dr. Galina Mozgova, Belarus
This is a reply to 5521 RE: RA Forum: Further improvements to the alignment of the Guidance andTraining Manual - A new message has been posted to the forum [#5527]
Dear All,

My thanks to the Secretariat and the AHTEG Chair for producing a new version of the manual and to Lucette for accepting to moderate again.

I admire Lucette’s cheerful optimism that the silence last week possibly meant that every body is satisfied with the present state of alignment.

One would wish that this is the case, but I think that the reality is that many people – like I – do not find it easy to find time to go through a 75 page document (I assume that this time the idea was to look at all modules), comparing it with another long document. If you want to do this seriously in the interest of novel risk assessors, then that takes time. As I said in the previous round, if you want to have a real on line discussion, then the topics and questions should be very focused.

With that, I hereby share my comments on the text.


To align the Manual with the Guidance (and given that the manual is produced by the Secretariat in the context of the CPB) the title of the manual should make clear that this is a manual for ERA in the context of the CPB.


It is always good if a manual on risk assessment provides the broader context, to help risk assessors to understand the broader context. This context is indeed the context of Agenda 21and of the CBD.

Yet, the way in which that broader context presented in Module 1 is in part incomplete and in part inaccurate.

Line 188 – 192: the text states that Chapter 16 of Agenda addresses the need for international agreement on principles to be applied to risk assessment and management. This is true, but that is only part of Chapter 16 of Agenda 21. 

Chapter 16 starts with recognising that modern biotechnology can make a significant contribution to strengthening the sustainable production of food, feed and fibre, to addressing water shortage, to improving health care and to environmental protection. It is also recognises that there is a need for further development and implementation of internationally agreed principles on risk assessment and management.

Based on these considerations, Chapter 16 gives a detailed blueprint for international action and collaboration for development of biotechnology aimed at:
• Program area A: Improving sustainable production of food, feed and renewable raw materials
• Program Area B: Improving human health
• Program Area C: Enhancing protection of the environment
• Program Area D: Further development and implementation of internationally agreed principles on risk assessment and management, etc.

For the usefulness of any Guide and Manual on risk assessment, it is essential that this broader context is well understood, because it makes little sense to talk about biosafety without taking into account the broader context in which modern biotechnology is applied.

I therefore propose that the above text be included in Module 1.

Line 200 – 202:  the text paraphrases principle 15 of the Rio declaration as “Principle 15 addresses the possibility of harm from actions or decisions when extensive scientific knowledge on the matter is lacking”. As a comparison with the actual text of Principle 15 shows, this is an inaccurate and therefore confusing paraphrase. I propose to delete this sentence and stick to the actual text of Principle 15.

Line 201 – 214: In explaining the broader context of biosafety as addressed in the CBD, it is crucial to include article 16 of the CBD, which starts with

“Each Contracting Party, recognizing that technology includes biotechnology, and that both access to and transfer of technology among Contracting Parties are essential elements for the attainment of the objectives of this Convention, undertakes subject to the provisions of this Article to provide and/or facilitate access for and transfer to other Contracting Parties of technologies that are relevant to the conservation and sustainable use of biological diversity or make use of genetic resources and do not cause significant damage to the environment.”.

Likewise, reference to article 19 CBD should not be limited to article 19.3, but should  start with the basis of that article, as laid down in 19.1 and 19.2:
• 19.1:  Each Contracting Party shall take legislative, administrative or policy measures, as appropriate, to provide for the effective participation in biotechnological research activities by those Contracting Parties, especially developing countries, which provide the genetic resources for such research, and where feasible in such Contracting Parties.
• 19.2: Each Contracting Party shall take all practicable measures to promote and advance priority access on a fair and equitable basis by Contracting Parties, especially developing countries, to the results and benefits arising from biotechnologies based upon genetic resources provided by those Contracting Parties. Such access shall be on mutually agreed terms.

I propose that the text of Articles 16.1, 19.1 and 19.2 be included in boxes, and referenced in the text.

Line 289 – 291: this quote from UNEP 2006 is not exactly the same as the actual objective text of the Protocol (quoted later) says. Propose to delete.

Line 294 – 301: this quote from the IUCN document is not helpful, because the quote from article 4 is incomplete and incorrect. Article 4 refers also to “transboundary movement”. Further, article 4 does not refer to “ LMOs which may have ...”, but “LMOs that may have...”. There is a crucial difference between which and that. 

More in general, it will be very important that the Secretariat, as the custodian of the CBD and CPB, checks the entire text for accuracy of the quotes from the CBD and CPB.

Further, the quote from the IUCN guide is also not helpful, because under exlcusions it only mentions article 5 (pharmaceuticals), while there are moire articles that result or may result in exemptions from the procedures, e.g. article 6, article 7.4, article 13 and article 14.

Line 304 – 305:  To ensure consistency with the CPB and the Guidance, it is important to explain at this point that:

• “introduction into the environment” covers various types of handling, e.g. field trials, placing on the market, disposal etc.
• The AIA procedure only applies in cases where there is no applicable domestic regulatory framework. In case there is such a domestic framework, the the procedures of that framework apply (which may also mean that no procedures apply, in case certain introductions are exempted from regulation). I propose to add at the end of the firstsentence “in cases where there is no applicable domestic regulatory framework (see also article 9.2.c).”

Line 317: Add at the end, “unless article 10.2.b applies”.

Line 320, text box: Add here too “in cases where there is no applicable domestic regulatory framework”.

Lines 322 – 326: See earlier comment about exemptions.

Line 444: for a more accurate quote, make reference to the ‘consistent with its international obligations” 

Annex - Techniques used in modern biotechnology

It is good to start this part with an introduction to the technical aspects of modern biotechnology.  Links to websites in various languegs would be helpful.

Lines 564 – 566: this text is inconsistent with the CPB, because in its current form it suggests that processed products are living things. This is not what the CPB says. This text mixes the notion of ‘living” and information that can be included in the BCH. 

Lines 620 – 633:  use more up to date references to the ISAAA reports.


General: It will be good to explain the difference between module 1 and module 2: module 1 addresses the broader context of biosafety in general, while module 2 addresses the context of specific risks assessments.

This module duplicates in part what is also addressed under “problem formulation” in Module 3. I advise that the Secretariat removes the duplication.

The remainder of the text of Module 2 suffers from mixing two concepts: systems to implement the CPB and domestic regulatory systems. These may be the same but do not have to be. This mixing leads to all kinds of confusing text.

For example, in line 833 – 837 it is stated: “ Under the Cartagena Protocol two specific cases require mandatory risk assessments prior to making a decision: a) the first intentional transboundary movement of a living modified organism for intentional introduction into the environment of the Party of import, and b) a final decision regarding the domestic use of a living modified organism, including its placement on the market, that may be subject to transboundary movement for direct use as food or feed, or for processing.”.

While point b is indeed something that always aplies to Parties to teh CPB, point a does not have to apply in all cases, for example in cases when a country has exempted a category of LMOs.

This comes back to the importance of highlighting the fact that the AIA procedures of article 9 and further only apply to cases where there is no domestic regulatory system. (see article 9.2.b.).

I propose that Module 2 be the topic of a separate on line conference.


While I believe that the text has improved, several of the general concerns I expressed in the previous round are still there:

• Insufficient distinction between ERA for confined field trials and market releases
• Elevation of addressing uncertainty to an end in itself, rather than a means to strengthen the reliability of data, forgetting that that is what the RA is doing addresisng uncertainty.
• Many examples are out of date or inappropriate
• Presenting outcrossing as a risk per se ; freak text such as : (‘genetic pollution’)
• Including agronomic effects as risks (e.g. resistance development)
• Suggesting that differences in themselves do not mean risk; in order to pose a risk they need to be significant and biologically relevant

I note that this time specific text examples are requested, and to avoid a very lenghty submission, I refer to the specific text proposals I have given last time.

Wishing all a good remainder of the weekend

Piet van der Meer
posted on 2013-11-17 14:36 UTC by Mr. Piet van der Meer, Ghent University, Belgium
This is a reply to 5509 RE: Opening of the discussion "Alignment of the Guidance and Training Manual – Further improvements to the alignment (all modules)" [#5528]

Dear Forum Participants,

Like others before, I too wish to express my thanks to those who have spent long hours to prepare text for us to review, and to our moderator for encouraging participation.  The task before us was challenging from the start approximately 5 years ago.  I believe the Protocol and Annex III reflect a necessary flexibility on the subject of risk assessment and risk management.  The final text needed to account for the fact that Parties maintain sovereign rights over any final decision as to the nature and significance of harms to their biodiversity and interpreting what it means to be “precautionary”.  Our on-line forum and the two AHTEGs also embrace this diversity of views.  Consequently, the process of developing guidance as mandated by several MOPs has struggled to produce anything other than draft text that seems to be moving no closer to becoming a consensus among experts.  Again, we are faced with a timeline to “provide concrete text proposals” on text that many of us believe is flawed in its tone, degree of prescriptiveness and presentation of key principles.  Once again we are challenged by the request to find the corner in a round room. 

I think that Module 3 is looking a lot more like the Roadmap.  This is as welcomed outcome, because as has been stated by many others in earlier forums we can (and should) focus on completing the roadmap first.  No progress can be made toward producing useful, expert-based guidance on the use of Annex III until the job of finalizing the roadmap is done.  But again, this will be no simple task since the current confused text on risk assessment, in my opinion, reflects the fundamental bias of the experts regarding the inherent risk/safety of LMOs.  Nevertheless several interesting postings have been made that merit comment.
First, it is interesting to contemplate suggestions like Angela’s (#5517) to incorporate several of the Aichi Targets into the Manual.  In what context should these be included?  I would presume the proposal is to present these as examples of environmental goals.  I believe that some members of the on-line forum believe that there should be universal environmental goals and standards for risk assessment.  However, is this reflected in Annex III or even the objective of the Protocol?  We, the on-line forum and AHTEG, will continue to tackle this tough problem that, despite the decision of the MOP that this guidance is not legally binding, some experts would like to see us be a standards setting body.

Second, I thank Galina for his contribution (#5525) because it highlights several challenges that we have in producing guidance.  The first is language.  Galina honestly admits that it took several readings of the guidance to develop an understanding.  However, the concepts came together upon reading some other materials in his native language.  This problem will unfortunately persist and there is probably no solution.  Second, it seems that Galina used his native text and some pre-existing guidance to interpret “our” guidance.  This fact for me begs the question: is our guidance useful if understanding it requires existing guidance?  Finally, Galina points out that the guidance needs something more to be useful.  He highlights the need for visual aids to help interpret the text.  I agree that visual aids help me understand difficult concepts.  However, should our forum gather, develop and use such aids?  And, will they help us progress toward a greater consensus among experts? 

Third, we carefully consider the wisdom within Yoshikura-san’s intervention (#5523).  It is practical and reasonable simplifications like this that I believe have been dismissed in the past.  Yoshikura-san points out, again, that the guidance should be based on experience (which is largely on GM crops) and should not stray into theoretical speculation.  The latter creates confusion.

I recognize that this note does not meet the very precise request of the moderator, a request that we have heard repeatedly in this forum.  However, it is a request that can only be made if the solution to the immediate problem can be fixed with concrete text proposals.  I am please to see that efforts are being made to make Module 3 more roadmap-like.  Now we can focus on the challenging task of getting the roadmap “right”.
posted on 2013-11-17 18:54 UTC by Dina Abdelhakim, SCBD
This is a reply to 5527 RE: RA Forum: Further improvements to the alignment of the Guidance andTraining Manual - A new message has been posted to the forum [#5529]
Dear all,

I join many of my colleagues in congratulating Lucette  for taking on the task of moderating this forum and thank  those who have spent long hours preparing and reviewing the text.  Piet Van der Meer´s posting early this morning (still Sunday in Honduras) jolted me into the realization that time is running out to give our last comments and that  “silence”  does not translate in agreement or satisfaction with the text of  aligning the manual and the guidance.

I will share some of the concerns I still have, and those  of other biosafety regulators in Central America.  We had an important two hour, on-line virtual meeting this week, where we discussed testing the guidance and other related topics.  In this first posting, I will give comments on some general issues that are causing problems for the countries in my region (Central America) and some Andean countries, and later, if time allows and I manage to speak to my colleagues from the ICABB (Central American Initiative on Biosafety and Biotechnology), I will make final comments on specific lines of the text.

The general comment is that the manual and the guidance, in their current form, are still very complex and difficult to understand for many inexperienced regulators in our region. More specific points of why this is so,  include:

1. Time needed to review the documents and to test the manual and guidance.  Most countries in Central America (as is the case for Caribbean and Andean countries) do not have the resources and the luxury to employ a group of trained  and dedicated professionals to deal with biosafety regulation and comply with the demands and expectations of tasks requested  by the Secretariat and it´s various task forces.

2. Language of the documents.  Most of my colleagues from the ICABB and other countries do not speak English to a level of proficiency, to undertake testing the guidance in English. Unless the documents are presented in their native language and are translated by professional translators and risk analysts, it is impossible to assess the utility and accuracy of any document.  This point was discussed particularly strongly on our last meeting. Some countries suggested that they themselves take on the task of translating the English version, but it was pointed out that many different versions would results in different non-official translations, where technical language matters a great deal.  This would only add to the confusion and the complexity of the task.

3. Definition of terms such as Biosafety and Environmental Risk Assessment (vs. all the components of Risk Analysis, including risk management and risk communication).  We have discussed the exclusion of legal and socio-economic considerations from a risk assessment,  but would consider them under risk management. Thus, an ERA guide that includes socio-economic considerations would cause confusion. We  as a region (Latin America) have spent considerable time, money  and effort in developing  our biosafety systems. The smaller, less developed countries in the Americas (the Caribbean, Central America  and Andean countries)  have learned much from  our “older bothers”   in Brazil, Argentina, Mexico, etc, and have received considerable training from them (in Spanish!).  Furthermore, we are all interested in developing sustainable agricultural systems and may have different definitions of the “ precautionary approach” and what “ genetic pollution”  means. When the ERA  texts are translated, we would ask to delete terms like “genetic pollution or contamination” as these sound more ideological than biological problems.

4. Make a clear distinction between assessing the biological risks of LMO´s as the products of modern biotechnology, and not confuse this with an evaluation of  the ills or virtues of industrialized-unsustainable agriculture, globalization, market dominance, capitalism, etc. Discussing the latter  issues are very pertinent and necessary to all countries, but must not be mixed and confused with biosafety  issues, as we run the risk of  confusing inexperienced regulators and demonizing a technology that can actually bring benefits for our developing countries. 

I also deeply appreciate that this posting is not strictly sticking to the points of commenting on the specific text of the documents, but as someone pointed out recently, we have been asked to “ find corners in a round room”. 

I hope I will be able to make more specific comments to the text, in a later posting before the deadline, once I consult with other colleagues.

Best regards,

Maria Mercedes Roca
National Biosafety & Biotechnology  Committee
posted on 2013-11-17 19:13 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5529 RE: RA Forum: Further improvements to the alignment of the Guidance andTraining Manual - A new message has been posted to the forum [#5530]
Dear colleagues,

Many thanks again to the secretariat for making available the new version of the manual.
I apologize for being late in entering my comments. This is due to a very busy schedule, but I regret very much that I am not able to spend more time on the manual.

Many of the improvements bring the manual more in line with the guidance, which is a good thing. There is however a drawback: there is a tendency to use the same language of the guidance literally in the manual. A problem with the guidance is just that its language is sometimes hard to grasp. The aim of the manual to explain things in a more straightforward way is a bit lost in this way.

In my comments I have focused on the changes compared to the previous version, in the tracked changes version. I have not been able to go through the entire text in detail, but where I spotted specific deficiencies in the not-changed text I have also mentioned them.

My comments:

Line 746: add “for which they apply”. For example: protection goals related to biodiversity of marine fish would not apply to LM crop plants, but could apply to LM salmon.”

Line 1303: “As such, the case-by-case approach does not allow an existing risk assessment to be applied “as is” to different LMOs, uses or receiving environments. In practice, if faced with a request to conduct or review a risk assessment that does not follow the case-by-case principle, a risk assessor recommends that a new risk assessment be carried out with a scope that is specific to the case under consideration (i.e. the LMO, its specific use and the likely potential receiving environment).” The second sentence does not make sense: the risk assessor is faced with a request, by whom? And then he recommends that a risk assessment is carried out, by whom, if he is the risk assessor? More important, however, is the concept of case-by-case: it implies that each LMO and its use is taken as one case and needs its own risk assessment, but what should also be highlighted in this text: this case-by-case risk assessment may, and even has to, take into account valid, relevant knowledge and experience gained in other risk assessments.

Line 1367: “the choice of appropriate comparators will depend on specific national regulatory requirements.” This is not helpful, and the manual should provide some examples. I would be at a loss to provide examples here where our regulatory requirements would help. The cases where there are problems finding a comparator will be too specific to be covered by regulations. This is clearly shown, as a matter of fact, by the examples given in the remainder of this section, through line 1382. Indeed, “choosing an appropriate comparator(s) can be a challenge “. Therefore I propose to delete the reference to regulatory requirements.

Line 1414: the word “unintended” is awkward here, as we are talking about an intended gene product, only at an unintended place.

Line 1444: “undesired” should be deleted: when establishing a risk scenario one looks at factors in an unbiased way. In this case: the risk scenario looks at what introgression might do, and then one may conclude that its effects are undesirable.

Line 1548: To define “gene transfer” as “genetic pollution” is a bit stiff. Gene transfer is a normal genetic process that occurs anywhere in nature; as a matter of fact biodiversity has gene transfer as a prerequisite.

Line 1591: “For example, the nature and detail of information about the recipient organism that is required may differ between small-scale releases for experimental purposes and large-scale commercial releases.” This is just one of the, more or less haphazard, places where ‘small scale releases for experimental purposes’, ‘field trials’, or similar terms, are discussed. The big picture about how to approach risk assessment for field trials is not presented in the document. This would be a big help for the novice risk assessor, for which this manual should be useful in the first place. This is a serious flaw in both the manual and the guidance, which should be fixed in both.

Line 1718: “As such, during a risk assessment in accordance with the Protocol, in addition to the area where the LMO will be intentionally introduced, the likely potential receiving environment of an LMO should also be thoroughly examined with particular attention given to areas where exposure levels to the LMO will be the highest.” The phrase ‘in accordance with the Protocol’ has no function and should be deleted. More important: the meaning of the sentence is not at all clear, and I cannot think of a relevant example to explain its meaning.

Line 1957: “Where it is appropriate, other potential adverse effects such as delayed, cumulative, combinatorial or indirect effects resulting from the LMO, the trait or the inserted or modified genes may be considered in the post-release monitoring strategies.” This sentence brings together a number of disparate factors, which I think is confusing. Especially the ‘combinatorial’ effects are confusing: these are genetic effects within one LMO and not particularly relevant for monitoring. Cumulative and delayed effects, where you bring several LMOs together, or that take a long time to surface, make more sense to be considered in monitoring. I could also not think of a sensible example that would explain why combinatorial effects should be taken into account here. I propose to delete “combinatorial” here.

I am very grateful to Lucette for moderating this forum, and to all participants for entering comments. In particular I would like to join Tom’s gentlemanly comments, that make me wish I had his command of the English language. Piet has pointed out a number of issues about consistency between relevant official texts that I think require further scrutiny.

Best wishes,

Hans Bergmans
GMO Office, The Netherlands
posted on 2013-11-17 22:32 UTC by Mr. Hans Bergmans, PRRI
This is a reply to 5529 RE: RA Forum: Further improvements to the alignment of the Guidance andTraining Manual - A new message has been posted to the forum [#5531]
Dear all,

Following my earlier posting, here are some specific comments on the text:


Lines 261-263: “Biosafety comprises multidisciplinary scientific fields including, but not limited to biology, ecology, microbiology, molecular biology, animal and plant pathology, entomology, agriculture and medicine as well as legal and socio-economic considerations, and public awareness”.

We suggest deleting “as well as legal and socio-economic considerations, and public awareness”. Modules 2 & 3 give specific guidance on how to conduct a risk assessment, but nowhere on the text is  there guidance on how to approach the latter issues. This may seem very confusing to risk assessors. 

Lines 506-510: “The SPS Agreement concerns the application of sanitary and phytosanitary measures for food safety and animal and plant health regulations and may apply to LMOs. Article 5 of the SPS Agreement is of interest in the context of this training material since it addresses risk assessment and the determination of the appropriate level of sanitary or phytosanitary protection. Article 3 of the SPS Agreement recognizes the standards, guidelines and recommendations set by IPPC, OIE and Codex Alimentarius Commission”.

This section is very relevant to risk assessors, but would contradict what is stated in the SPS Agreement, if socio-economic considerations and public awareness were to be included as part of the risk assessment process.


This section is pertinent to my earlier comments about the need to have documents translated by professional translators and rigorously reviewed by bilingual risk assessors, familiar with the terminology in both languages: English – where the terms for risk assessment originated,  and the language in which the document is being translated.

To illustrate :

Lines 1238 - 1241 “Familiarity with the different terms used in risk assessment enables a more direct comparison between the terminology used in Annex III and different risk assessment frameworks. It will also facilitate the interpretation of results from different risk assessments, for instance, for the same LMO”

Line 1192 “Risk is often assessed through the combined evaluation of hazard and exposure”.

The word “hazard” does not exist in Spanish and has been (wrongly) translated to the word “danger” and it has now “stuck” in the technical literature, for lack of a better term. In English, “hazard” and “danger” have different meanings and evoke different degrees of risk.  The same applies to the word “likelihood” translated in the  Spanish literature as “probability”.

Lines 1606 "The likelihood of transgenes escaping from cultivated GM crops into wild relatives".

This line would be translated in Spanish as “the danger of transgenes escaping”,  where a more appropriate   English phrase should read “the likelihood on transgenes being introgressed, with potentially negative consequences for the fitness of the wild relative”.

I want to avoid more lengthy submissions, so I will stop here.

Again, many thanks to all who have generously given up their time to contribute to this interesting discussion, so that we may truly help those risk assessors that will benefit from this documents.

Best regards,

posted on 2013-11-18 00:49 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 5530 contribution to on-line discussion [SEC=UNCLASSIFIED] [#5532]
Dear colleagues,

Many apologies for the late contribution, but as Piet commented there is
much to consider in these large documents. My comments relate to Module 3,
but I do support Piet’s comments on Modules 1 and 2, which are important
to retain consistency with the wording of the CBD and CPB.

Lines 1203-1207. This is a chemical example that is not that useful or
relevant for biological organisms. Suggest deleting.
Lines 1214-1222. These should be related to the steps in Annex III as was
done in the Roadmap.
Lines 1290-1294. Delete Example 12 as it does not offer any practical
suggestions about how a risk assessor should deal with uncertainty. Annex
III only refers to uncertainty of the overall risk, but the discussion in
the training module goes way beyond this notion. Furthermore, it should be
acknowledge that as uncertainty is an inherent part of risk, then the risk
assessment is already a formal, structured way of dealing with
uncertainty. The other point missing is that the uncertainty is only
relevant if it is likely to significantly affect the decision of overall
Lines 1303-1307. Agree with Hans, suggest deleting.
Line 1367. Agree with Hans.
Line 1380. Mis-spelling of species.
Lines 1380-1382. This goes beyond the requirements of step 1 in Annex III.
Suggest deleting.
Lines 1402-1408. Delete this example or change as suggested. The whole
section in describing step 1 fails to actually describe what an adverse
effect is, including Example 15 (for example, ‘likelihood of ….’ cannot by
definition be an adverse effect). Suggest replace Example 15 with
‘Harm [adverse effects] reflects an undesirable condition involving damage
or injury. This includes change in the morphology, physiology, growth,
development, reproduction or life span of an organism or group of
organisms that results in an impairment of functional capacity, an
impairment of the capacity to compensate for additional stress or an
increase in susceptibility to other influences.
The perception of harm can vary between people. It can also change over
time and differ according to other factors such as variations in the
vulnerability of individuals or type of land use. 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. Similarly, a plant producing large amounts of
biomass in a pasture may be considered desirable whereas the same plant
may be considered harmful (weedy) in a nature conservation area as it may
end up displacing a native species. In addition, one harmful outcome can
sometimes give rise to further downstream harms. For example, increased
harms from weeds, pests or pathogens can lead to loss of biodiversity.’
Risk Analysis Framework 2013, Australia.
Examples of adverse effects from plants can be found in
FAO (2011) Procedures for post-border weed risk management . Plant
Production and Protection Division, Food and Agriculture Organization of
the United Nations, Rome.
1. Could the plant reduce the establishment of desired plants?
2. Could the plant reduce the yield or amount of desired vegetation?
3. Could the plant reduce the quality of products or services, including
biodiversity, obtained from the land use [receiving environment]?
4. Could the plant restrict the physical movement of people, animals,
vehicles, machinery and/or water?
5. Could the plant affect the health of animals and/or people?
6. Could the plant have negative effects on environmental health?
(a)     provides food/shelter to pests or pathogens.
(b)     adversely changes the fire regime.
(c)     adversely changes the nutrient levels.
(d)     increases soil salinity.
(e)     adversely changes soil stability.
(f)     adversely changes soil water table.

Line 1444. Agree with Hans, suggest deleting ‘undesired’.
Line 1510. Demonstrates one of the difficulties when use adverse effects
(instead of something like harm) as the ‘adverse’ gets deleted and one is
then left looking only for ‘effects’, which has very different
connotations that are not in line with Annex III. Suggest delete use of
‘effects’ unless specifically linked to ‘adverse’.
Lines 1536-1555. This example only confuses as it is unclear as to whether
these ‘concern[s]’ are adverse effects or not. Suggest deleting.
Line 1588. Suggest adding significant in front of risk as there is always
risk present with everything that we do.
Line 1616. Dispersal can also occur via vegetative propagules as well as
Line 1710. There should be some text added to say that the intended
purposes of the receiving environment (e.g. agricultural, conservation,
urban etc) is also important as the specific land use affects protection
goals, interpretation of what is an adverse effect in that land use, and
the types of management practices, which may affect exposure.
Line 1773. Suggest replacing ‘are more likely to’ with ‘may’.
Lines 1778-1782. Suggest adding something along these lines to the section
on comparators as it is highly relevant to the baseline considerations.
Lines 1783-1788. Suggest deleting as these refer to likelihood, not
adverse effects.
Line 1812. Suggest deleting ‘undesired’ for the same reason Hans used to
suggest deleting ‘undesired’ in line 1444.
Line 1898. Suggest deleting ‘eliminate’ as there is no such thing as zero
risk, there is always some degree of risk with all activities.
Lines 2035-2044. Consider adding other types of information that are
commonly included, such as the parent organism, management practices that
are intended to be applied that control spread and persistence, and
intended activities and use of the LMO.
Line 2103. Suggest changing ‘conclusions’ to ‘risk’ to stay consistent
with Annex III.
Line 2117. Suggest adding a line to this section that states that
decision-making typically takes into account other factors, described in
national legislation, that are additional to the risk assessment (e.g.
socio-economic factors, contingency plans etc.).

Best wishes

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posted on 2013-11-18 00:55 UTC by Paul Keese, Australia
This is a reply to 5532 RE: contribution to on-line discussion [SEC=UNCLASSIFIED] [#5533]
Dear All,

I want to express my thanks to the Secretariat for providing us this opportunity to comment on the "Alignment of the Guidance and Training Manual – Further improvements to the alignment (all modules)".  I also appreciate that Lucette has again offered her time and guidance to chair this online session. 

I must admit that the process used for the online sessions has been a bit of a mystery to me, especially when looking at which previous comments were taken for revisions and which comments were not accepted. 

I will follow Lucette’s call at the start of this session to heed the directions from the Secretariat to use this online session by “adding new text to the Manual if and where necessary to better explain some sections and concepts contained in the Guidance in a coherent manner.” 

Before I turn to my comments on the alignment of the Guidance and Training Manual, I would like to echo and support a number of important comments that have been sent in just today during the online forum.  In particular, I found the comments and suggestions from Maria Mercedes Roca, Hans Bergmans, Paul Keese and Piet van der Meer to offer very important and constructive points for improving the alignment and content of the texts.  In addition, I think that Tom Nickson has raised some important points about the overall process of revising and aligning the documents over many months. 

Many of these comments popped up on my computer screen today as I was finishing my comments, and I will not reiterate them here, but instead I urge everyone to take a look for yourself.  As both Maria and Piet have noted, the amount of time needed for careful review, analysis and comment is rather daunting.  Many of the comments can be covered only briefly in these online sessions, and it will be a great challenge for the members of the AHTEG to take each of these comments into careful consideration over the coming months.

In addition to my comments below, I think that the text of the Manual needs to be more consistent with the terminology used in the Protocol.  This is especially problematic for novice risk assessors, as well as those who may have forgotten that much of the alternative terminology is derived from risk assessments for evaluating chemicals and radiation in the environment, not organisms. 

My comments below will cover much of the same areas as my comments during the last online forum in September, and they fall into the following categories of concern:

1. Clarify the Manual to make it more useful for training novice risk assessors.

2. Because the manual is a technical training tool, it should - like the Guidance - not contain prescriptive language nor deal with regulatory aspects.

3. The manual should clarify that biological concepts such as “change”, “outcrossing”, “introgression”, “resistance development” are natural phenomena that in themselves do not imply risk.

4. The manual should clarify that uncertainty is a normal element of any biological process and in itself does not imply risk.

5. Examples and figures should be clear, provide added value to the discussion in the text, and be based on up to date actual experiences with releases of LMOs.

6. The manual should clarify the importance of mutual acceptability of data both in the normal course of scientific inquiry and in the risk assessment of LMOs.

7. The manual should more often describe the context of the existing situation with non LMOs.

8. The manual should distinguish more clearly between confined field trials and unconfined releases.

Here are my specific text proposals for each of the headings:
1. Clarify the Manual to make it more useful for training novice risk assessors.
Text proposals :
[lines 1297 – 1300]. These first sentences here are very convoluted and oriented toward specific regulation, rather than keeping the focus on the CPB (something that needs to be done consistently here and throughout the Manual and Guidance). I propose to delete these sentences, and to start the next sentence with the working “In accordance with the Cartagena Protocol the elements of a risks assessment include...”.

[line 1361] Start this paragraph with the sentence “the choice of appropriate comparators will be different depending on the step in the risk assessment”.  The current text in this paragraph gives the mistaken impression that Annex III calls for specific types of comparators,  something that the Annex does not do.

[line 1364] Place after “comparator” the working “to identify novel characteristics of a genetically modified plant”. Then add a sentence next that states " Near-isogenic lines may work for some plant species, but not for turf and forage grass species and alfalfa, which are bulked populations.  Near-isogenic lines are not appropriate or perhaps even possible for animals and many other organisms that may be LMOs.”

[line 1466 – 1482] In the section on toxicity to non-target organisms.  The suggested approach is not typical to evaluate the toxicity of an introduced gene product this way.  Direct toxicity testing needs to be explained here, too.  Only gene products that are likely to be toxic are tested.  Many gene products are widespread in nature and are unlikely to be toxic in ways that could be evaluated in the manner described here.  This section gives the impression that toxicity testing is more the rule, rather than the exception (it fails to take into account the scientific plausibility discussion previously covered).  In addition, it should be noted here in the text that such testing is rarely needed for small, confined field releases in which exposure of the other “non-targets” in the environment is limited in time and geography

[line 1465] What does this mean?  What variants would be produced in an LMO that would not be produced elsewhere?  As with the comment on small-scale, confined field releases mentioned for toxicity testing, there should be a note here, too, in the text that such allergenicity evaluations are not typical prior to small-scale environmental releases.  Also, it should be clarified under which circumstances allergenicity to humans upon ingestion is more appropriately covered under such guidance as found in the Codex Alimentarius guidance for food derived from recombinant DNA plants.

[line 1514] Can the authors provide a relevant example of a biodiversity protection goal sensu CPB or CBD?  The given example is rather weak.

[line 1642-1645] Delete “which of the endogenous genes of the recipient or parental organism(s) may be affected by the genetic modification”. This is inconsistent with the CPB, it is not part of the genetic modification as such and it is unclear how that would be ascertained.

[line 1652-1658] This is unclear. Does this mean the same as the inserted genetic elements?  It is better to start with the actual language of the CPB, and then elaborate.

[line 1672-1686] For clarity, the section on detection is best placed separate from RA (i.e., not in module 3 of the Manual).  Unique Identifiers are only being used for LM-plants, and they are not typically designated during early phases of research and development, such as when field testing may occur.  Likewise, detection methods are not typically part of a risk assessment, nor are they integral to the risk assessment process.    The information on the BCH is not appropriate here. 

2. Because the manual is a technical training tool, it should - like the Guidance - not contain prescriptive language nor deal with regulatory aspects.
Text proposals :
[lines 1534 and 1681 This manual is about the protocol, not about ‘some regulatory frameworks”.  Delete this phrase.

3. The manual should clarify that biological concepts such as “change”, “outcrossing”, “introgression”, “resistance development” are natural phenomena that in themselves do not imply risk.

In general, the text still needs better description and discussion of the distinction between gene flow and introgression (see in particular lines 1443-1461).  The current text seems to equate the two terms, but this is not correct.  The difference between the two concepts should be explained, as well as that these concepts do not only apply to plants.  In addition, I strongly support the points that Hans Bergmans made today on the discussion in this section, including his comment on “undesired” introgression.

4. The manual should clarify that uncertainty is a normal element of any biological process and in itself does not imply risk.

In general, the Manual still has a number of inconsistencies with the CPB regarding the use of the term “uncertainty” and how it pertains to the Protocol.  Notwithstanding the use of the term elsewhere in society, it is important that the reader of the Manual is directed to the way that the Parties used this term in drafting the Protocol.  The entire section starting on line 1268 entitled “identification and consideration of uncertainty” needs to be fundamentally revised to reflect the way that the Protocol uses this term.  A search of the term “uncertainties” throughout the document reveals these inconsistencies with the text of the Protocol, and they need to be revised in the Manual and Guidance if these documents are to reflect the text of the Protocol.  Uncertainty throughout should state “uncertainty regarding the level of risk”.

5. Examples and figures should be clear, provide added value to the discussion in the text, and be based on up to date actual experiences with releases of LMOs.

Text proposals :
[line 1402, Example 15] Apart from the fact that this example cannot be found on the GMAC website, this example should be deleted as it is inconsistent with the CPB and the Guide as it, among other things, incorrectly suggests that outcrossing in itself is a risk. 

[line 1428, Example 16] This example needs to be given a bit more detail to be understandable for novice risk assessors.  The text that follows this example says “A well-defined risk scenario should be scientifically plausible and allow the assessor to identify information that is necessary for the assessment of risks.”  However, the given example does not illustrate this point of providing the assessor with enough information.

[line 1459, Figure 7] It’s good to see that the ant cartoon is gone, but Figure 7 now introduces allergenicity in a food safety evaluation, something that is clearly outside the scope of the Protocol (Codex Alimentarius covers this).  This figure should be omitted.

[line 1548, Example 18] This text contains text that is pejorative (e.g., genetic “pollution”), inaccurate (e.g., the suggestion that persistence of a gene in the environment is a risk  in itself). Delete and replace by more objective and balanced examples than provided in ICGEB’s list.

[line 1572, Example 19] - Here and elsewhere, the examples are not real examples, but rather theoretical digressions from other texts. Replace by real-life examples that illustrate the concepts. Also, see the comments submitted by Hans Bergmans regarding the appropriate description of what case-by-case means and what it does not mean.  He has it right.

[line 2107 , Example 28] This is the wrong quotation of the precautionary approach cited by CPB.  See Rio Declaration text (also included correctly in the Guidance doc) for the actual statement of the precautionary approach.

6. The manual should clarify the importance of mutual acceptability of data both in the normal course of scientific inquiry and in the risk assessment of LMOs.

Let me support here the comments by Hans and others on this topic.  The Manual and Guidance do not give this important point the emphasis it needs.  As Hans mentioned in his online comments today regarding the fact that the necessary information for a risk assessment can often be found in the scientific literature, and that frequently there is no need for additional experimentation to answer the relevant questions.  This is particularly the case when doing a risk assessment for a confined environmental release.  The text of the Manual and Guidance both give the inexperienced practitioner the impression that lots of new data need to be generated for a specific LMO.  This is decidedly not the case, yet the text does not make this clear.

7. The manual should more often describe the context of the existing situation with non LMOs.

Text proposals :
[line 1528-1535] Context is needed for readers who may not know that these phenomena can – depending on their use - occur with conventionally produced crops as well as with LMOs. Proposal to start the paragraph with: ”As with conventionally produced crops, extensive use of ….”   The phrase “as with non-LMOs” may be an even better phrase to use consistently throughout the Manual to emphasize this point.

[line 1530] The sentence on that reads “Several weed species have developed resistance to specific herbicides which are extensively used in combination with herbicide-resistant LM crops” is misleading, because it gives the erroneous impression that the development of weed resistance to herbicides has occurred in herbicide tolerant LM-crops (in fact, resistance to herbicides has developed primarily in other settings).  In general, this section on development of resistance to herbicides, like the development of resistance of pests to pest-resistant plants is not a risk issue with respect to biodiversity, but rather a way for agriculturalists to prolong the useful life of herbicides and pesticides in agricultural production.  These sections of the Manual and Guidance need to be revised to reflect this fact.

8. The manual should distinguish more clearly between confined field trials and unconfined releases.

This is a point that others have made in their comments, and I believe this needs still additional emphasis throughout the Manual.
Text proposals :
[Line 1410 - 1417]  For most field testing, extensive molecular characterization is not necessary, since the interactions of the LMO with the environment are limited in area and time.   Before “molecular analyses” add “ For requests for placing on the market of LMOs”, 
[line 1591] Add after “case” the wording “, whereby for placing on the market typically more detail is needed than for confined field trials”
[line 2037] Add after “environment” the wording “indicating whether this is for confined releases or for placing on the market”

Thanks again to all for a most stimulating online session.

Best regards,

Dave Heron
posted on 2013-11-18 01:23 UTC by David Heron, United States of America
This is a reply to 5509 RE: Opening of the discussion "Alignment of the Guidance and Training Manual – Further improvements to the alignment (all modules)" [#5535]


I would like to thank the team that has worked hard at putting together this extensive work. I would like to contribute to the discussions from a practical perspective informed by own experience as an environmental risk assessor in the South African regulatory system.

As a country with an active rgulatory system undertaking an average of 60 assessments for field use every year there are a number of practical aspects that I feel need to be highlighted if this guidance is to be useful for developing countries like ourselves.

Line 1162 – 1165: using definitions of risk assessment from other areas may confuse.

Risk assessments are conducted in a number of fields and the context is very important. It is therefore best to limit examples from other areas of work as these may result in further

Line 1169: delete the extreme examples (flooding, extreme weather events, etc.)

It is best if extreme examples are avoided as they alter the entire conceptual framework under which a risk assessment for an LMO may be made.

Line 1183: advise to avoid terminology that is not in the CPB, such as ‘hazard’, and advise exmaples form different areas of risk assessment (such as for chemicals), to avoid confusion.

Line 1276: add sentence “the golden rule in this context is to only ask for additional information if one has established how the additional information is relevant to the actual risk assessment and how it will enhance decision making"

Additional information should be requested if it will be in a format that is helpful to the risk assessment itself. often additional information requires additional interpretation and creates further delays in decision making.

Line 1303: delete the sentence: ” As such, the case-by-case approach does not allow an existing risk assessment to be applied “as is” to different LMOs, uses or receiving environments”.

There is no basis for this statement. we have successfully applied a case by case approach and found it to be most expedient in decision making.

Line 1464, text box: replace the drawing by one that shows that conventional and organic crops also outcross with other conventional and organic crops as well as with wild relatives

Line 1720: place before “the likely potential receiving environment” the wording “the relevant characteristics of” 

Line 1889: to be consistent with the CPB, reflect in the title that this step addresses “acceptibility” as well as “managability” of identified risks. As for “acceptability” refer to the section starting with line 2117.

Line 1939:  replace “designed” by “that can make use of existing, broader monitoring programs that may identify..” (one  cannot design to detect for unintended effects, that would be case specific. ).

Line 2127: add after “government policies,” the wording “anticipated environmental or socio-economic benefits”
posted on 2013-11-18 03:14 UTC by Ms. Manoela Miranda, UNEP/SCBD