Activities of the Open-Ended Online Forum (2014-2016)

Dear participants of the Open-ended Online Expert Forum and AHTEG,

During the past two months, the AHTEG sub-Group held online discussions where it was asked to: (i) review the grouping done by the Secretariat of comments provided through the testing of the Guidance and revise the grouping as needed; (ii) identify which general issues raised during testing may be incorporated into the Guidance or improved upon; and (iii) identify which additional risk assessment topics may be incorporated into the Guidance and further developed.

In response to part (i) of the task, the grouping of comments from the testing of the Guidance was revised and is available as one of the “information documents” for this discussion.

In response to part (ii) of the task, the AHTEG sub-Group considered the general issues emerging from the comments of the testing on the Roadmap and other sections of the Guidance, and identified which issues could be prioritized during the revision of the Guidance. Issues identified by the sub-Group include the need to:

• Define audience
• Define scope of application (i.e. for field trial and/or full release of LMO)
• Clarify when the ‘points to be considered’ are relevant and why
• Link the five risk assessment steps
• Clarify that risk assessors can draw on knowledge and experience gained from non-LMO risk assessments
• Describe mechanisms of communication between risk assessors and risk managers
• Clarify consistency with the Protocol if needed
• Provide “real-life” examples of LMO risk assessment and/or effects (including, inter alia, human health related issues)

In response to part (iii) of the task, the AHTEG sub-Group identified the need to incorporate into the Roadmap further risk assessment guidance for the following:

• Living modified fish
• LMOs that produce pharmaceutical and industrial products
• Nutritionally altered living modified plants
• LMOs introduced in centres of origin and genetic diversity
• LMOs intended for introduction into unmanaged ecosystems
• LMOs created through use of dsRNA techniques, engineered to produce dsRNA or exposed to dsRNA
• LMOs containing RNAi 
• LMOs produced through cisgenetics
• LMOs produced through synthetic biology
• Integrating human health into the environmental risk assessment
• Synergistic impacts of different herbicides that are part of the technology package that accompanies certain LMOs

With completion of this work, the next task – as indicated in the agreed calendar of activities (please see https://bch.cbd.int/onlineconferences/calendar_ra/) – is to provide “Feedback on the general issues identified by the AHTEG sub-Group that may be incorporated or improved in Guidance”.

The Secretariat has prepared and circulated two background documents summarizing the outputs of the Sub-group to provide a basis for the discussion. Forum participants are invited to consider the following questions when providing feedback:

**General considerations**

• Do the general issues identified by the AHTEG sub-Group properly reflect the main issues that were raised during the testing of the Guidance?
• Are there other issues from among those raised in the testing of the Guidance that could be included as priorities for the revision and improvement of the Guidance?

**Specific considerations**

• How could the five risk assessment steps be linked (e.g. graphically or through text)?
• When may ‘points to consider’ be considered relevant, and on what basis? “Real-life” examples that support comments would be helpful, as well as an indication as to how such examples might be most effectively included in the Guidance (e.g. by using text boxes; introduced directly into the text; or through links).
• Are there non-LMO risk assessments that could inform LMO risk assessors? “Real-life” examples that support comments and suggests would be helpful.
• What mechanisms of communication could be used between risk assessors and risk managers? “Real-life” examples that support comments and suggests would be helpful.

This discussion will take place from 27 April to 11 May 2015.

I look forward to your reading your contributions to this discussion.

Thank you Stacy for chairing this forum. I also want to thank the members of the AHTEG sub-Group for their careful analysis of the feedback. And of course I should mention my ongoing appreciation for the work of the Secretariat and Chair of the AHTEG.

(i) The outcome of the grouping of comments appears reasonable and helpful. (ii) The list of general issues for further discussion and possible revision of the guidance will be challenging but achievable and I have no objection to the order.

I seek clarification on (iii). Here the “sub-Group identified the need to incorporate into the Roadmap further risk assessment guidance” for the listed topics. In the Background document, the sub-Group indicates that these topics “could be incorporated or further elaborated upon, as appropriate, into the relevant sections of the Roadmap.” These two statements are compatible, but slightly different, and different from the opening line of the Background document which reads “The AHTEG Sub-group took into account the topics prioritized by the AHTEG for the development of further guidance.”

Am I correct in my interpretation that the sub-Group has made two recommendations and they are 1. that revision is recommended for only Part 1 of the Guidance; and 2. that some sort of revision of only Part 1, and not other parts of the Guidance, are sufficient to fully address the needs of our audience on each of the listed topics?

Best wishes
Jack

I thank the Secretariat and the sub-Group for their extensive and diligent work, and also thank Stacy for chairing the forum.

May I please have a little more information about the columns in the Excel file that was kindly sent out to us? Specifically:
• For the “Sub-category(ies)” column, please may I have a list of all the subcategories available, rather than just the subcategory the item was placed into?
• For the “Priority” column, please may I ask for some information as to how something gets into a  high compared to a medium, compared to a low category? 
• For the “Notes” columns, I can see that there are several such columns for each ID# rather than just one.  It therefore seems that there is a difference between the different types of notes, but I don’t have any information as to what the difference may be or why they were put this way. Please may I have this information so that I can properly interpret this section? 

Please may I ask for clarification on these matters?  I’ve looked on the website for the information but cannot find it.  I apologise if I have missed it. 

Kind regards

Judy Carman

Dear Judy,

Thanks for your very pertinent questions. Indeed the columns in the background document require additional explanation and I apologize for the oversight.

Let me please try to answer your questions one by one as follows:

• For the “Sub-category(ies)” column, please may I have a list of all the subcategories available, rather than just the subcategory the item was placed into?

In the first round of online discussion, the AHTEG suggested that the Secretariat would make an attempt to further group the comments in categories B and D into sub-categories in accordance with their subject matter. So far, we have only done this for the general comments in category B and the result is what you see in the “Sub-category(ies)” columns of the background document. When put together, the items in the “Sub-category(ies)” columns of the seven spreadsheets (i.e. roadmap, stacked, abiotic, etc) make up for all the sub-categories.

• For the “Priority” column, please may I ask for some information as to how something gets into a  high compared to a medium, compared to a low category? 

In an attempt to focus the exercise and make best use of resources, when evaluating the general comments provided through the testing of the Guidance, the Sub-group agreed that each of its members would look at and label each comment as being “high priority” or not. After that, the Secretariat compiled the results by the members of the Sub-group by averaging their responses. This was done by changing “yes” (high priority) to 1 and “no” (not high priority) to 0 and taking an average of the responses. The resulting average was rated as follows: 0-0.33 = low priority; 0.34-0.66 = medium priority; 0.67-1 = high priority). It is important to note that this rating simply provides a rough indication of the views expressed by members of the Sub-group but the sample size is too small. I recommend that participants also look at the original posts by the members of the Sub-group to get a more accurate picture (https://bch.cbd.int/onlineconferences/RA_ahteg_subgroup/).   

• For the “Notes” columns, I can see that there are several such columns for each ID# rather than just one.  It therefore seems that there is a difference between the different types of notes, but I don’t have any information as to what the difference may be or why they were put this way. Please may I have this information so that I can properly interpret this section? 

Each column contains the notes from a different member of the Sub-group. For example, if you see that there are 3 columns with notes, it means that 3 members of the Sub-group added notes when evaluating the general comments. 

I hope these much needed explanation helps you and the other participants understand better what the Sub-group has done and how the background document came about. Please do not hesitate to write again if you have additional questions.

Thank you and best wishes,
Manoela

Thank you, Manoela for such a thorough explanation. 

I can now see what you have done. And I can also see that the process you have followed is pertinent, useful and thorough. 

Kind regards

Judy Carman

Dear Jack,

Thank you for your comments and questions. Let me please jump in and try to clarify. The opening line of the background document would be more accurate if the word “previous” was added, i.e. “The AHTEG Sub-group took into account the topics prioritized by the previous AHTEG for the development of further guidance.”

I will try to explain better. The previous AHTEG prioritized a number of topics of risk assessment for the development of further guidance (this list can be found in the report of the previous AHTEG at http://www.cbd.int/doc/meetings/bs/bsrarm-05/official/bsrarm-05-06-en.doc). At the last meeting of the COP-MOP, there was a long discussion between Parties who wanted new guidance on specific topics to be developed and those that were of the opinion that the AHTEG should focus exclusively on the revision/improvement of the existing Guidance. As a compromise solution, the Parties added the following to the TOR of the AHTEG (annex to decision BS-VII/12):

“2.While revising and improving the Guidance, an attempt should be made to take into account the topics prioritized by the AHTEG, on the basis of the needs indicated by the Parties with a view to moving towards operational objectives 1.3 and 1.4 of the Strategic Plan and its outcomes, for the development of further guidance.”

In practice, if the AHTEG so decides, this will mean drafting new text in order to incorporate the new topics into the existing Guidance or to further elaborate on issues that are already mentioned in the Guidance, e.g. centres of origin.

I hope this helps. Please do not hesitate to ask if you have questions as I am sure others may have the same doubts and it is important to clarify them.

Best wishes,
Manoela

Dear Stacy and all,

Since the prioritized topics seem to be generic, may I post my comments on the Guidance itself?

Lines 351-352. I believe that location should ideally be the native habitat of the comparator used where information on the comparator’s ecological function would be more readily available. Otherwise changes in the non-native receiving environment, in my opinion, should first be characterized in the presence of the comparator before introducing the LMO. Also, there is a possibility of interaction between the LMO and the comparator when found in the same location. Does the word “locations” here refer to open field trial or controlled simulated environment? In my opinion, open field trial should only be done when the best perceived control or containment measures are available should there be adverse effects observed in the environment.



Lines 501-504. In my opinion, the evaluation of likelihood should always be undertaken together with evaluation of consequence at the same time since risk is a function of both likelihood and consequence. If consequence is evaluated at some other time, conditions may have already changed which may also affect the likelihood of occurrence of an adverse event. Thus, the calculated risk in this situation may deviate farther from the actual risk. It is also my opinion that the step in risk assessment described herein as “exposure assessment” is the step for risk characterization. Exposure assessment as described that follows the step on risk identification, may refer to determination of factors, conditions, or activities that can make the identified hazard pose a potential risk. The deciding point in my opinion, will be the step after risk characterization, which is risk evaluation, at which point a Party decides whether the risk level is acceptable or not.

Lines 519-522. Will it not follow that when there is a very high uncertainty in the determination of likelihood of an adverse event to occur, that the hazard has not been fully identified? Or that factors, conditions, or activities that may cause the identified hazard to pose potential risk have not been adequately characterized? In my opinion, that in this case, it is not only the likelihood that may be assigned 100% but the calculated risk itself. Therefore, efforts should first be done to adequately identify and characterize the hazard or the factors, conditions or activities that may cause the hazard to pose potential risk before going to the next steps.

Lines 523-525/580-582. Likelihood and consequence which together are a function of risk may be expressed in such a way that a semi-quantitative risk assessment is obtained by assigning numerical ranks. When the ranked likelihood and consequence are multiplied as they appear in a risk matrix for likelihood and consequence, a product is obtained which is a semi-quantitative risk expression.  This can be done both for the comparator and the LMO. The comparison of values can indicate whether the risk level would be the same or higher for an LMO compared to that of the comparator.

Dear Stacy, thank you for Forum chairing and issues raised. And I would like to say many thanks to Manoela for clarifications.
Now we see two groupings together and the mechanism of the second grouping is clear. From my point of view the grouping made by the Secretariate on category B is rather useful, appropriate for further work and transparent. And once again it would be very good if this two Exel documents will be provided together, because it will help new participants of the Forums to work with the text and track the mechanisms on which the creation of the documents are based as well as see the transparency of incorporation of countries` feedback.
In regard to the notes in the document «General issues_ AHTEG-SG». May be it will be good if the other members of AHTEG and on-line Forum will provide their feedback in the Notes on the categories that are grouped now and the categories that will be grouped and then to make some rounds of on-line discussions on this feedback.
To questions.
**General considerations**
After watching the documents, in my opinion the general issues identified by the AHTEG sub-Group in category B reflect the main issues that were raised during the testing of the Guidance.
**Specific considerations**

• How could the five risk assessment steps be linked (e.g. graphically or through text)?
The five steps could be linked graphically (and we already have it in Guidance in the «FLOWCHART FOR THE RISK ASSESSMENT PROCESS») and through the text by working on the text and coordination of steps. It seems to me that not bad way to connect the steps and to present an examples of continuous risk assessment process is to create textual references in relevant «points to consider» in each of 5 steps directly to examples of the real risk assessments (to relevant pages that describe this «points to consider» in the documents that are already inserted in the Bibliographic references to the Guidance` chapters) and to make crossing between relevant «points to consider» from step 1 to step 5.
Allow me to provide feedback on the last two questions later.
With best wishes, Galina.

It will be better to describe the steps in a flow chart for easy follow up. Giving enough details of the procedure to be followed.

Thanks,

HC Sharma

Dear Jack,

Thank you for your comments and request for clarification on (iii). Apologies for my tardiness in replying to you in regards to the latter, but I trust the Secretariat’s excellent explanation has provided the clarification you were after. To supplement this explanation, I offer a brief sequence of events summary below;
- Firstly, a “List of topics identified by participants who support the development of further guidance” was prepared by the previous AHTEG for COP-MOP7 in 2014 (please see UNEP/CBD/BS/COP-MOP/7/10/Add.1)
-  Between 30 March – 13 April 2015, the AHTEG sub-Group was asked to identify which topics may be incorporated into the Guidance (please see https://bch.cbd.int/onlineconferences/calendar_ra/)
- The AHTEG sub-Group identified the need to incorporate some of the topics into the Roadmap (please see http://bch.cbd.int/onlineconferences/ra_ahteg_subgroup).

Regards,
Stacy

Thank you to both Stacy and the Secretariat for providing clarification on my question on topics prioritized by the previous AHTEG for the development of further guidance. I really apologise but I need to ask one more question.
As Stacy said, "The AHTEG sub-Group identified the need to incorporate some of the topics into the Roadmap". Did the sub-Group intend this list to be inclusive of topics for which only the Roadmap was relevant, or has the sub-Group identified the need to incorporate these topics into the Guidance, wherever they might be appropriate?

Best wishes
Jack

Dear Jack,

I recommend looking at the original posts by the members of the Sub-group. The post that is relevant to your specific question can be found at https://bch.cbd.int/onlineconferences/RA_ahteg_subgroup/ under the thread titled 'Opening of the discussion: Identifying general issues and new topics to be improved or incorporated in the revision of the Guidance' and within the .docx file titled ‘prioritized_topics_Fran plus Marja’

Kind regards
Stacy

Here are my some considerations to the specific comments section:

• How could the five risk assessment steps be linked (e.g. graphically or through text)?
- I consider this is a reasonable suggestion of the participants to the testing of Roadmap. In my view the linkage between the 5 risk assessment steps may be done as through the texts and also graphically. The Flowchart of the Roadmap make a general attempt to provide this graphical view and interrelations between the steps. It would be useful to provide a more detailed graphical expression of the steps and bring more specific elements to show linkages and consequences.

Best wishes,
Angela

Dear Stacy, the Secretariat and fellow members of the forum

Thank you to both Stacy [#6861] and the Secretariat [#6852] for providing clarification on my question on topics prioritized by the previous AHTEG for the development of further guidance. And I again want to thank the sub-Group and Secretariat for doing so much toward our work agenda for the period.

My next comment is about “the topics prioritized by the AHTEG, on the basis of the needs indicated by the Parties with a view to moving towards operational objectives 1.3 and 1.4 of the Strategic Plan and its outcomes, for the development of further guidance.”

When it comes to these two issues:
(a) Risk assessment of living modified organisms created through use of dsRNA techniques, engineered to produce dsRNA or exposed to dsRNA;
(b) Risk assessment of living modified organisms containing RNAi;

1. I see no particular reason for grouping (b) outside of the scope of (a). RNAi is a manifestation of the effects caused by dsRNA. However, what is generally understood as RNAi is not always called RNAi in all kinds of organisms or historically. Thus to me (a) is the more general terminology. I wonder if these two items can just be combined under one title, eg Risk assessment of living modified organisms created through use of dsRNA techniques, engineered to produce dsRNA or exposed to dsRNA (including living modified organisms containing RNAi)”?

2. As Stacy indicated, the AHTEG sub-Group identified the need to incorporate (a) and (b) into Part I (the “Roadmap”).

I agree with the sub-Group recommendation. I would like to discuss the possibility that modification of Parts II and III of the Guidance also be considered to address the needs of our audience on dsRNA. There is uncertainty among experienced risk assessment agencies about the adequacy of RA frameworks for some LMOs based on dsRNA. For example, the US Environmental Protection Agency (EPA) considers that its risk assessment framework is not in present form adequate to evaluate the risks of LMOs that express insecticidal dsRNA.
[FIFRA. RNAi Technology: Program Formulation for Human Health and Ecological Risk Assessment. (Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP), 2014).] Given the uncertainties in RA, I think that it is possible that we may could do more than modify Part I alone.

Moreover, (a) includes a new development in modern biotechnology and may benefit from a treatment more in line with the specialist coverage of Parts II and III of the Guidance. For example, spray on pesticides that use dsRNA active ingredients applied to crops to kill pests or weeds are under development (http://agadvance.com/issues/mar-2014/running-interference.aspx). New dsRNA delivery techniques might be considered to be in-field transformation technologies under the literal wording of the Protocol: “the application of: a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles”. Thus arguably both exposed target and non-target (including the crop itself) organisms might be part of the risk assessment. Risk management might include, inter alia, elimination of the pest from the product, or loss of the dsRNA (and any effects) from non-target organisms.

However, the use of exogenous dsRNA may not be limited to pesticides. It could be used to effect other kinds of traits, for example: male sterility, colouration, changes to the rate of ripening, changes in nutrients, or changes in susceptibility to pesticides or pests. In these types of cases, the exposed organism may be considered to be an LMO. In plants, these exposures may result in modified nucleic acid passing to offspring and epigentically inherited through cell division, transport to other cells and between plants by grafting. In perennial plants, the effect could conceivably persist for long periods of time.

To my recollection, we have not considered what kind of advice might be needed to conduct a risk assessment wherein the field is the place of creation, as opposed to the field being a place into which the pure final product is released. In short, I can anticipate that this scenario would fit into the outcomes of the Strategic Plan Operational Objective 1.3.

I concur with the sub-Group that this topic could be incorporated into Part I alone and provide substantial benefit to our audience. If time permits, I also suggest that dsRNA would be worth considering as a new entry in Part II of the Guidance as well as modification of Part III.

Best regards
Jack

Dear Stacy, Dear all
First I would like to thank the Secretariat and the sub-Group for their extensive and diligent work.
Also, thanks to Manoela for the additional explanation provided

I just have one comment concerning the columns with notes. I believe that they need some sort of revision. Some of them are not readily understood and require further explanation. I also think that some notes like “Spanish which I unfortunately do not speak" need be deleted

Warm regards,
O.A.El-Kawy

POSTED ON BEHALF OF HARI SHARMA
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Dear Stacy,

As in the earlier discussion, I find that several comments are being made on generic issues, but to make tangible progress, it will be good if the comments are linked to the document indicating topic, page, and line numbers. My thoughts may be at variance with other members, but I feel that this will be the right way to improve the document. And I will provide my inputs during the weekend.

With kind regards,

Hari Sharma

POSTED ON BEHALF OF VERONICA SINOHIN

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Dear Stacy'

I commend the observation of Hari Sharma. The discussion should be toward the improvement of the guidelines. I have two  concerns: First is on Part III, Monitoring of LMO Released into the Environment. How are you going to gather baseline data for monitoring purposes to its impact to biodiversity if a certain Living Modified crops were already introduced under commercial scale?  Second, there should also be RA guidance for Living Modified Organisms for bioremediation.

Thank you very much with kind regards.

VERONICA O. SINOHIN
Department of Environment and Natural Resources, PHILIPPINES

Dear participants of the Online Forum and AHTEG,

Thank you for your contributions to the discussion so far.

Comments related to topics for further risk assessment guidance have been posted - i.e. to combine guidance on LMOs created using dsRNA, LMOs that produce or are exposed to dsRNA, and LMOs that contain RNAi into one topic (from Jack Heinmann); and to develop guidance on LMOs for bioremediation (from Veronica O. Sinohin).

To briefly summarise the comments on the task at hand - to provide “Feedback on the general issues identified by the AHTEG sub-Group that may be incorporated or improved in Guidance” – it is beginning to emerge that participants believe the general issues identified by the sub-Group (see opening message) reflect the general issues raised by the testing of the Guidance.

Some participants have provided more detailed feedback on these general issues, including Franco Teves who commented that a) the LMO’s comparator(s) be evaluated in the non-native receiving environment before the LMO, b) the evaluation of likelihood and consequence should be always be undertaken together, in perhaps a semi-quantitative way, when considering risk (semi-quantitative risk expression can indicate whether LMO risk is the same or higher than its comparator), and c) rather than assigning a likelihood of 100% when there is a high level of uncertainty, efforts should be focussed on adequately identifying and characterizing the hazard/cause of hazard. Further, Angela Lozan, Hari Sharma and Galina Mozgova have commented that the five risk assessment steps could be linked using text and graphics (i.e. use a flowchart). Galina also commented that the ‘points to be considered’ sections could in-text reference real-life examples.

In the remaining few days I encourage you to post your feedback on the general issues identified by the sub-Group to assist the sub-Group in its task moving forward, and I'd like to reiterate that forum participants are invited to consider the **general considerations** and **specific considerations** questions (see opening message) when providing feedback.

Dear all,
I like to thank the secretariat and the AHTEG subgroup for their extensive work and Stacy Scott for chairing this discussion. Here my answer to the questions raised in this part of the online forum:

• Do the general issues identified by the AHTEG sub-Group properly reflect the main issues that were raised during the testing of the Guidance?
Answer: In my opinion most of the issues identified by the sub-group are the main issues raised during the testing.
Some remarks:
- In the grouped comments it was mentioned that risk assessors can draw on knowledge and experience gained from non-LMO risk assessments. However, some parties also adviced to include knowledge and experience gained with LMOs (e.g. earlier performed risk assessments and experienced gained with cultivation and monitoring of these LMOs). This information is also quite relevant to take into account in the risk assessment, since we have gained already quite some experience with a number of LMOs (familiarity) 
- It is not clear what is meant with the priority identified by the sub-group titled ‘Describe mechanisms of communication between risk assessors and risk managers’. Reading the grouped comments does not clarify this priority. Can the secretariat or the chair clarify this issue?

• Are there other issues from among those raised in the testing of the Guidance that could be included as priorities for the revision and improvement of the Guidance?
Answer:
In order to obtain a comprehensive and clear structured guidance, a strong linkage between part I to part II is a prerequisite. Therefore the same structure used in part I of the guidance (5 steps of risk assessment), should be used in part II. Based on this same structure, elements that are new, different or need more attention in the risk assessment for these specific LMOs could be highlighted. In this way part I of the guidance can function as the general basis for the guidance, applicable for all LMOs, whereafter in part II specifics of certain can be mentioned without losing the general context of risk assessment and the steps to be taken.

**Specific considerations**

• How could the five risk assessment steps be linked (e.g. graphically or through text)?
Answer: Both graphic as well as textual would be the best. There is already a figure in the present version of the Guidance, which could be used to create flowchart. The textual version could be linked to the description of a  ‘real life’ example, to clarify what these steps really mean in practice, by actually perfoming a risk assessment.

• When may ‘points to consider’ be considered relevant, and on what basis? “Real-life” examples that support comments would be helpful, as well as an indication as to how such examples might be most effectively included in the Guidance (e.g. by using text boxes; introduced directly into the text; or through links).
Answer: The only way to explain that a specific point to consider is actually relevant for the risk assessment, is by using real life examples (for example herbicide tolerant plants or Bt plants). I myself would prefer to use text boxes for these real life examples, since my experience is that retrieving information through a link takes time and links not always work that well. Readers do not always want to take the time to click on a link.

• Are there non-LMO risk assessments that could inform LMO risk assessors? “Real-life” examples that support comments and suggests would be helpful.
Answer: Non-LMO risk assessments that could inform LMO risk assessors can be considered as the familiarity that we have obtained with the non-LMO crop after decades of cultivation. Information on characteristics relevant for risk assessment for several crops be found in the OECD consensus documents. Some risk assessments relevant for LMOs may also be obtained through assessments made for potential invasive species. From the viewpoint of risk assessment As mentioned before, I myself would be more interested in risk assessments that have already been performed for LMOs and the scientific argumentation to approve these LMOs or not. 

• What mechanisms of communication could be used between risk assessors and risk managers? “Real-life” examples that support comments and suggests would be helpful.
Answer: As indicated earlier I do not understand exactly what is meant here.


Considering the incorporation into the guidance of the topics mentioned in the starting mail of this discussion, I understood that these examples were only used to ‘keep in mind’ when improving the guidance. In other words, part I of the guidance should be applicable to all LMOs. The list of examples provided is only to help to improve part I and assure that this part I is  generally applicable to all these examples. I hope I understood well.
In that respect I would have the same remark as Jack Heinmann made earlier, in  that ‘LMOs continaing RNAi’ could better be integrated with ‘LMOs created through use of dsRNA techniques, engineered to produce dsRNA or exposed to dsRNA ‘. Another remark: since the guidance has to be applicable to all LMOs, it  should be applicable to plants, microorganism, fish, insects and  animals. In this respect I miss examples of LM animals and insects.

POSTED ON BEHALF OF COLIN McGOWAN

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Hello to all and thank you all very much for the clarifications.

Here are some comments regarding three of the points on the list.

• Define audience

The guidance is written at the working level of an operational risk assessment team, with enough detailed information to guide the completion of the five risk assessment steps, and provide a comprehensive report of its scientific findings to decision makers. I believe the scope and level of the current guidance is good and describes a well-framed risk assessment.

Most risk assessment teams will include experts with experience in risk assessment and experts on subject matter. In such cases, the guidance is perfectly set. However, I believe the guidance will be adequate for teams that may only have subject matter expertise. Consequently, it may be important to briefly stress the difference between the scientific risk assessment process and the decision making process, and how the frameworks for each might differ. 

I agree with the comments in the table that the guidance is not prescriptive in character. This is good for flexibility when evaluating projects under a case-specific scenario or under unique circumstances; however, there should be some mention of how standards for data quality can be established, which is directly related to uncertainty in the risk assessment conclusions.

• Define scope of application (i.e. for field trial and/or full release of LMO)

There might also be consideration for ‘no release’. For example, with fish, the application or scenario may involve containment in land based facilities, with no intension of release. This can have a dramatic effect on the risk assessment outcome since exposure will depend heavily on the likelihood of entry.

I think the document is good in that it provides broad scope and flexibility at the working level; however, the risk assessment team must clearly define the scenario. Each scenario will require its own refinements to scope for each risk assessment, though some groupings of scenarios, such as fish, or mammals, or contained, or full release, might benefit from more detailed guidance, as has been done in Part II of the guidance document.

• Link the five risk assessment steps

I think the five steps are adequately linked through chronological order, and I think the text is well ordered and well organised. Figure 1 is an excellent complement to the text and will be very useful for communication between risk assessment teams, managers and decision makers. Both text and Figure 1 should stay.

The links to online references are also good.


Best regards,
Colin

I agree with Dr Colin McGowan, and would like to add:
The document while being very comprehensive is not that easy for a "newcomer" to risk assessment to understand.  This is partly because of the language: very technical and sometimes long and winding.
I do appreciate the hard work put in by the various people in producing this document, but it must be user-friendly as well.  Perhaps, as a compromise, a simpler version can be made while the main document will then serve as a source of reference for more in-depth reading and understanding of the topic and process at hand.
I hope my comments will not be construed as being negative.  I have nothing but great respect for the authors of the document, but they must also appreciate that not everyone who wishes to use the guidelines are experts in this field.  Indeed, some may well be novices and need to be helped along the steep learning curve.

Best wishes,
Tan Swee Lian

Dear Forum Participants,
I`m also supporting the point of view that real examples (especially from relevant and representative risk assessments) is very important to explain specific `points to consider` - both text, boxes, graphical schemas and it is very important to working in this direction to make the text stronger. I`m working at the National Biosafety Coordination Center, reading lectures, including this topic, to different people (students, LMO developers, officials etc.), so I supporting Boet Glandorf when she saying `` Readers do not always want to take the time to click on a link``. From the other hand when I proposed one of the variants [#6968] I am thinking not about how to strengthen `point to consider`, but more how to connect relevant `points to consider` through the different steps of the Guidance (1 to 5 in the Road Map) in one bundle to show the reader the continuity of the risk assessment process. From my point of view on-line formats become more accessible to people and so I would not be discounted my proposal, especially since we already have in our hands scientific papers and other documents in the references to each chapter of the Guidance.
And we need to think about the other thing – how not to overload the text making it user friendly. In this context I`m thinking on Tan Swee Lian post. Of course we need to account that not only risk assessors will use the Guidance, but it will be very good if it will help those people who involved in the decision-making process. But I would like to remind that for this purposes we also have Training Manual (http://bch.cbd.int/cpb_art15/training.shtml) and during the past 2014 we tried to bind this two documents, and thinking about what illustrative material to  include into the Training Manual, how to include, with examples (please, see past on-line activities). In this context I would like to propose to renew (after this main work will be done or if possible in parallel) the work on binding of Guidance and Traning Manual and also to suggest to place basic illustrations in the Training Manual.
To the questions proposed:
Are there non-LMO risk assessments that could inform LMO risk assessors?
I`m in one line with what Boet Glandorf said.
Also I supporting Jack`s considerations to combine under one title:
Risk assessment of living modified organisms created through use of dsRNA techniques,
engineered to produce dsRNA or exposed to dsRNA;
Risk assessment of living modified organisms containing RNAi.
• What mechanisms of communication could be used between risk assessors and risk managers?
One idea – through consultations, e.g. knowledge of the risk managers could be quite useful in Planning Phase of the Risk assessment to identify protection goals, assessment endpoints and risk thresholds relevant to the assessment and help to set the direction of the risk assessment.
With my best wishes, Galina.

Dear all,

I would like to thank the secretariat and the ATHEG sub-group for carrying out these difficult tasks. Please find below my comments on some of the questions raised:

**General considerations**

• Do the general issues identified by the AHTEG sub-Group properly reflect the main issues that were raised during the testing of the Guidance?
The majority of the general issues identified indeed reflect the main issues raised  during the testing of the Guidance and I would like to congratulate the sub-group for the great work.
Like Boet (post 7008), I also had trouble identifying the relevance of the issue on communication between risk assessors and risk managers to the comments made.

• Are there other issues from among those raised in the testing of the Guidance that could be included as priorities for the revision and improvement of the Guidance?
I would agree with Boet that previous experience with LMOs should also be taken into account.
I also agree with her suggestion to follow the same structure in Part I and Part II. Indeed this way the link between Part I (general principles of RA)and Part II will be even more evident and it would be easier to highlight the specific requirements to each case of LMO developed in the guidance.

**Specific considerations**

• How could the five risk assessment steps be linked (e.g. graphically or through text)?
A combination of the two would be a good approach. The link between the five steps which would be visible by the use of the graph already existing in the guidance, should be demonstrated through the text as well.

• When may ‘points to consider’ be considered relevant, and on what basis? “Real-life” examples that support comments would be helpful, as well as an indication as to how such examples might be most effectively included in the Guidance (e.g. by using text boxes; introduced directly into the text; or through links).
The use of text boxes is a good solution. This way the examples will remain as part of the guidance document, yet they will be separated from the body of the tex,t therefore examples would be easy to find. I agree with Boet that links are the least useful, plus they restrict the use of the guidance in electronic format only.

On the priority topics (task iii), I would like to thank Stacy and Manoela  for the clarifications provided with regard to Jack's questions (posts 6852, 6854 and 6861). Unfortunately, it is still not clear to me what the intension of the AHTEG subgroup is with regard to the priority topics,  therefore I would appreciate clarification on the following:
Is the AHTEG planning to include in the roadmap just a statement about the need for further guidance on the topics that have been identified or is the AHTEG planning to already draft new text on these topics (Manoela's answer – post 6852 -  leaves the issue open), or is it what Boet understood (post 7008) or something different?

Furthermore, I would appreciate clarification on the topic related to synthetic biology. The AHTEG is aware that with regard to synthetic biology there is an online forum ongoing and an AHTEG will be convened in the coming months under the CBD which will also deal with RA. Could you please clarify how will the AHTEG deal with this so that there is no duplication of work.

Thank you very much.

Kind regards,
Maria

Dear participants of the Open-ended Online Expert Forum and AHTEG,
I thank the secretariat and the AHTEG subgroup for their hard work and Stacy Scott for chairing this discussion.

I agree that the issues identified by the AHTEG sub-Group properly reflect the main issues. I agree with Boet via thread#7008. See also #7012. While “link” in the document only works in e-format, hence text box may provide solution to this, but it should be kept concise to ensure the document is readble.  For the excel file given, there are various worksheet that contains varying number of “Notes” (for eg. 4 Notes for Road map worksheet; 2 Notes for LM mosquitoes but no content for these 2 Notes), may be this can be improved further. 
On the priority topics (task iii), I am fine with the list given.

Thank you.

Regards,
Dr Kok-Gan Chan
University of Malaya

Dear Stacy, the Secretariat and fellow members of the forum,

In response to part  “(iii) identify which additional risk assessment topics may be incorporated into the Guidance and further developed”
I agree with Dr Jack Heinemann [#6891] that the two issues:
(a) Risk assessment of living modified organisms created through use of dsRNA techniques, engineered to produce dsRNA or exposed to dsRNA;

(b) Risk assessment of living modified organisms containing RNAi;

can just be combined under one title.

However, I would suggest not to include in the new combined title the words “or exposed to dsRNA”. In my opinion the definition of LMO “…possesses a novel combination of genetic material obtained through the use of modern biotechnology….” does not include the epigenetic modifications.

Thank you.
Best regards
Vincenza Ilardi

Dear all,

First, I would like to thank the AHTEG for all the work done in categorising the comments received during the testing. It must have been an enormous task. I believe that they have done a good job. I have gone through the comments in detail and noticed that, due to the nature of the testing process, some comments may seem vague (particularly in category B). On close inspection, in my opinion, these comments reveal consistent trends and key messages that are worth considering when revising the guidance. The general comments selected by the AHTEG appear to reflect the main issues, but the prioritization may need to be re-visited. In particular for comments that refer to the roadmap, for example:
• There are many comments that highlight that the structure of the guidance is not in line with real cases of risk assessment and how ERAs are conducted in practice (470, 166, 272, 295, 381, 434, 458, 478, 387). These comments have been placed in the “low” category and the notes suggest that this is not considered relevant as the risk assessments posted in the BCH referred to are only summaries of ERAs conducted by regulatory authorities. However, these comments suggest a consistent message from countries that have a regulatory system, with a proven record of conducting ERAs that allow them to make decisions regarding LMOs,  that the Guidance does not reflect how ERAs are conducted in practice. The comments provided by developers, who routinely prepare ERAs to support regulatory submissions in many countries, also appear to support this view. Hence, this is worth taking into account during the revision of the roadmap and giving it a higher priority. Revising the structure and content of the guidance in a way that reflects how ERAs are conducted in practice in countries where functional regulatory systems exist, would result in a document that will be more acceptable to these countries and will be a practical and useful tool for countries with less experience. A more simplified document reflecting standard ERA methods commonly used, could provide a good base that all countries could easily comply with. Then those countries that, given their internal policies and protection goals, consider that additional considerations need to be added, can do so. 
• There are many comments that suggest the need to clarify “the context” in which the ERA will be performed (75, 158, 193, 470, 166, 167, 330, 389). My understanding is that what these comments are suggesting is the need for a “problem formulation” step, where the type of LMO, scope, receiving environment, protection goals and assessment endpoints are clearly outlined at the beginning of the risk assessment. Although a small reference is made to problem formulation in the guidance, there is no clear description on how to do this. Including a good problem formulation section may resolve the issues highlighted regarding linking the steps, the relevance of the points to consider for each LMO and the distinction between the scope of the ERA between field trials and cultivation.  Again, these comments have received a “low” priority ranking, when this could be a key improvement.
• Some comments refer to the need to keep the text of the guidance and its recommendations strictly scientific and remove all references to elements that are policy related (166, 331, 434, 296, 298, 357). Removal of policy statements may facilitate the acceptance of the guidance document, especially from those countries that have a  process in place that works and is practical. This will provide all countries with a practical and useful guidance document that allows national implementation according to local policies.

Comments on other sections
• There are several comments on the stacks, abiotic and LM trees sections that express the view that the guidance provided on these sections does not add anything new to that provided by the roadmap (9, 10, 15, 16, 18, 23, 27, 32, 34, 44, 41, 67).  Hence, it is a good idea to keep special topics in mind when revising the guidance to make it applicable to a range of LMOs. As the discussions at the last COP-MOP meeting pointed out, the limited availability of resources should focus the work on improving the roadmap first. Once this is done, the need for further guidance can be re-evaluated.


Regarding the question on mechanisms of communication between risk assessors and risk managers, I believe that this is key, especially considering that the guidance aims at covering ERA methods for all types of LMOs. The main aim of the guidance is to provide ERA methods that can be used to prepare ERAs that will be used to facilitate decision-making. Therefore good communication between those gathering data for ERAs and those who will need the data for making decisions is essential. Consultations before the regulatory package for ERA is put together can ensure that the data gathered will meet the local regulatory needs. Consultations before submissions are made could also help as often some LMO products present specific challenges that require unconventional approaches in data gathering. A good dialogue during the review could also streamline the process, as often those preparing an ERA and those reviewing it may have different interpretations of what the results mean or there may be questions easily addressed in face to face discussions rather than long written correspondence.  I believe there are a number of countries that follow this approach, examples are Canada, USA and Australia. Good communication during the whole process is likely to result in fit for purpose ERAs that facilitate making decisions.

I hope these comments are useful
Best regards
Monica

Dear participants,

I´d like to thank the AHTEG for their work on grouping the suggestions and present some comments and questions regarding the topics being discussed:

i) Revising the document

I totally agree with Dr. Monica suggestions about the comments that worth considering when revising the guidance, some of them classified as ´low priority´. Those are important to improve the Guidance in terms of :

- Guidance structure aligned with real cases of RA
- Necessity to clarify the context´ or the ´problem formulation step´
- Keeping the text of the guidance and its recommendations strictly scientific
- Link the steps described in the Guidance in a logical way
- User-friendly and to facilitate implementation under local conditions
- Distinction between field trials and cultivation RA scope
- Revision of the Use of Terms

ii) Further guidance

The secretariat explained under the current on line forum that: ´In practice, if the AHTEG so decides, this will mean drafting new text in order to incorporate the new topics into the existing Guidance or to further elaborate on issues that are already mentioned in the Guidance, e.g. centres of origin.´

As some other participants I didn´t understand such afirmative, also looking the doc mentioned by the moderator (prioritized_topics_Fran plus Marja). That means the Guidance will be  ´improved´ adding new text or further elaboration of existing text in the Guidance for all the prioritized AHTEG topics and the justification is the item 2 of the annex to decision BS-VII/12?

If this is the case I would like to remember three very important points in the spirit of compromise assumed by the Parties in the COP-MOP 7:

- discussions at COP-MOP 7 pointed out that the AHTEG work should focus on the roadmap revision based on the outcomes from the testing phase 

- in the current on line forum is being proposed for the Guidance to be improved incorporating all new topics prioritized by the AHTEG were the prioritization of those same topics was not accepted in the COP MOP-7

- according to Decision BS-VII/12 Item 5, Parties are invited to submit information on their needs and priorities for further guidance

I appreciate some clarification on this subject.

Best regards,
Luciana / Ministry of Agriculture - Brazil

Dear all,

I too wish to add my thanks to the Stacy for chairing this session and to the sub-working group for their hard work in organizing the comments.  I completely support the comments made by Monica [#7053], and have nothing to add with regard to the request for input on general and specific considerations. 

With regard the topic of additional risk assessment guidance that seems to have come up in other comments [most recently #7073] and a clarification [#6852], it is my continued understanding such a list is merely exploratory.  Comments on this list are not necessarily the subject of this forum.  On the subject of additional guidance in general, Decision BS VI/12 called for, in priority order, better testing, aligning the guidance with other capacity building materials on ERA, and (3rd) “consider the development of guidance on new topics”.  This mandate did not change in Korea and Decision BS VII/12 paragraphs 5-7, very clearly asks for input on this question and agrees to take up the matter at MOP8.  As such, at this time the discussion on additional guidance is preliminary and will need to be taken up by Parties after higher priority matters are addressed.  A decision by Parties to draft additional guidance at MOP8 will be made easier if they have a good guidance document in hand. 

Thanks for this opportunity to comment.

Best Regards,
Tom Nickson

Dear colleagues,

My thanks to the Secretariat and the sub-working group for their work in organizing the comments, and to Stacy for having agreed to moderate this session.

In response to the points that Stacy put before us:

General considerations

I believe that the Secretariat and sub working group have done a good job in grouping the comments, but I endorse the comments by Monica Garcia and Luciana Ambrozevicius about prioritisation.

Key in effectively working towards MOP8 and COP13 is securing consistency and avoiding duplication with what is being discussed under the other topics. I very much support the point made by Maria Kammenou with regard to the on line debate on synthetic biology.  More in general, we should remain aware that are a number of simultaneous online discussions, e.g. SECs, Synthetic Biology, RA, databases, where ERA every now and then pops up.

As regards the list with suggested topics for further guidance, I support the observations made by Luciana Ambrozevicius and Tom Nickson. Discussing at this point in time topics for further guidance seems inconsistent with the MOP7 discussions and decisions (e.g. Decision BSVII/12 Invites Parties to submit information on their needs and priorities for further guidance, whereby submissions are due 31 May 2016). As was clear from the MOP discussions, we are well advised to first improve the existing guidance before discussing additional topics. The excel file produced by the subworking group shows that still much needs to be improved. Moreover, when discussing countries’ needs and priorities for further guidance, a first step should always be to identify whether other organisations have developed or are developing such guidance (see article 29 CPB).

Specific considerations

Overall, I support Boet Glandorf’s suggestions on linking the steps, points to consider, use of examples, non-LMO risk assessments and following the same structure in Part I and Part II. I urge to differentiate between confined and unconfined situations (see also Colin McGowan’s point). Swee Lian Tan’s and Galina Mozgova’s point that the text is not easy to read is very pertinent and that improving user friendliness should be a priority.

Best regards

Dear All,
first of all I wish to thank Stacy, the Secretariat and the sub-working group for their work.
About the points of the discussions.
**General considerations**
I agree with Boet (post 7008) and Maria (post 7012) that most of the general issues identified indeed reflect the main issues raised  during the testing of the Guidance.
I consider the Guidance a practical tool for a step-by-step procedure of a risk assessment. In some comments it is defined to prescriptive but I think that it is structured in a way that reflects the precautionary approach requested in the Protocol.
I feel comfortable on the fact that the guidelines are not too rigid, they will help to go through the different steps of a risk assessment and to collect information and data in systematic way; this at the same time would help communication between risk assessors and risk managers. Furthermore I think that Communication of risk should be taken into account too, thus suggestion on mechanism of communication between these three figures: Risk assessor – risk manager – risk communicator shall be given.
What mechanisms of communication could be used between risk assessors and risk managers? “Real-life” examples that support comments and suggests would be helpful.
The risk assessment process described in the Guidance allows the collection of information and conclusion referring to each step of the RA process. This would improve and facilitated communication between stakeholders, including risk assessor, manager and communicator. The results of the RA should be summarized in reports containing and describing  the followed “Road” together with the conclusions and identified effects. To facilitate communication between stakeholders each identified effect should be referred to the identified hazards (step1),  the likelihood and exposure (step2) and consequences (step3).

In response to part (iii): identify which additional risk assessment topics may be incorporated into the Guidance and further developed”.
I agree with comments done by Piet van der Meer (#7082). The Conference of the Parties, in decision XII/24,  established an  Ad Hoc Technical
Expert Group (AHTEG) on Synthetic Biology that, it  will also deal to find an
operational definition of synthetic  biology, comprising inclusion and exclusion
criteria. I, further, agree with Maria's comment [#7012] we should avoid a duplication  of work and it would be better to await  the results of the on line forum and the ATHEG
on Synbio, before to take any  decision on this issue.
My best regards
Valeria Giovannelli

My dear colleagues,

the disadvantage when joining the discussion at a late stage is that everything important has already been posted. Therefore in short: I am happy with the latest suggestions of Piet van der Meer, Boet Glandorf and Valeria Giovannelli.  The initiatives of Stacy Scott (chairing, clarifications and summaries) were indeed very helpfull. To all others: Thanks for shaping the discussion. I must admit that I did not fully understand the example of "New dsRNA delivery techniques might be considered to be in-field transformation technologies under the literal wording of the Protocol" by Jack, but this could be clarified at a later stage.

Kind regards

Detlef

To reply [#7082] posted by Mr. Piet van der Meer.
I didn`t say, that the «text is not easy to read and that improving user friendliness should be a priority». Like Ms. Valeria Giovannelli I consider, that the Guidance is a practical tool for step-by-step procedure of RA and useful tool. And I am using this Guidance in my practice as a risk assessor. I have just said in my post  [#7048] that inclusion of real life examples into the Guidance could be very useful to explain specific `points to consider (in addition to all scientific papers that have been included previously in the Guidance (and will be included) and already give this examples). Also I reasoned how to include examples to connect the different steps of RA and reminded to participants about the second important tool – Training Manual, about its connection with Guidance, what was done to make the Training manual user friendly for the whole people, who involved in the process of RA (newel risk assessors, officials, other interested) and that the real examples can be distributed between the two very helpful, in my point of view, tools – Guidance and Training Manual.
With my best wishes, Galina.

Hi Galina,

my apologies - I had actually meant to support your comment about the real life example, but hit the sent button too quickly -

Cheers

Piet

Dear Luciana,

Thank you for your message. I will attempt to clarify the points you raised in your last intervention (#7073).

In particular, I will try to answer your question “That means the Guidance will be ´improved´ adding new text or further elaboration of existing text in the Guidance for all the prioritized AHTEG topics and the justification is the item 2 of the annex to decision BS-VII/12?”

I will also try to shed some light on the relationship between the processes set out in paragraphs 5-7 of the decision and paragraph 2 in the annex to the decision.

In paragraphs 5-7 of decision BS-VII/12, the COP-MOP invited Parties to submit (a) information on the needs and priorities for further guidance on specific topics of risk assessment of living modified organisms, and (b) existing guidance on specific topics of risk assessment of living modified organisms (para 5), requested the Executive Secretary to compile the information received (para 6), and agreed to consider the need for further guidance at the eighth meeting (para 7).

In decision BS-VII/12, the COP-MOP also set out another process, i.e. the Online Forum and AHTEG, which is guided by the terms of reference in the annex to the decision setting out the following work methodology as paraphrased below:

----------
(Online Forum and AHTEG)

1. Taking into account the results of the testing process, established in decision BS-VI/12, the Guidance on Risk Assessment of LMOs shall be revised and improved in accordance with the mechanism detailed in the TOR;

2. While revising and improving the Guidance, an attempt should be made to take into account the topics prioritized by the AHTEG, on the basis of the needs indicated by the Parties with a view to moving towards operational objectives 1.3 and 1.4 of the Strategic Plan and its outcomes, for the development of further guidance.

(AHTEG alone)

3. The AHTEG shall continue to operate the mechanism for regularly updating the list of background documents to the Guidance as established in decision BS-VI/12, paragraph 6, and improved as per paragraph 10 of this decision.

4. Subject to the availability of funds, the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management shall meet face-to-face, at least once, prior to the eighth meeting of the Conference of the Parties serving as the meeting of the Parties to the Protocol.
---------


It is important to note that paragraphs 5-7 of the decision and paragraph 2 of the annex refer to two parallel processes. In practice, what this means is that the Online Forum and AHTEG will revise and improve the Guidance on Risk Assessment of LMOs on the basis of the results of the testing while making an attempt to take into account the list of topics prioritized by the AHTEG. In a parallel track, Parties will indicate their needs and priorities for the development of further guidance on risk assessment, and share existing guidance.   

As such, it is not accurate to characterize the prioritization of topics done by the previous AHTEG as “not accepted in the COP MOP-7” (#7073) or that it is inconsistent with the COP-MOP decision. Quite on the contrary, as per the COP-MOP decision, the Online Forum and AHTEG are mandated to “make an attempt” to take those topics into account when revising and improving the Guidance. Thus, the Online Forum and AHTEG, in making such an attempt, will decide whether and how the topics will be taken into account during the revision of the Guidance.

Moreover, it is worth mentioning that some of the topics identified by the previous AHTEG were also mentioned in the comments provided through the testing, including comments that called for more emphasis to be placed on issues related to human health, LM animals, centres of origin and centres of genetic diversity, etc.

The current discussion is only the beginning of the consideration on which comments and topics will be taken onboard. Based on the outcomes of this discussion, in its next task as per the calendar of activities, the AHTEG sub-group will streamline which suggestions will be taken onboard during the revision of the Guidance, and provide a justification for each of the suggestions that will not be taken on board.

I hope this explanation helps.

Thank you and best regards,
Manoela

My thanks again go to the Sub-group and Secretariat for all their hard work, to Stacy Scott for moderating and to all participants for an interesting discussion.

With regards to: “(i) review the grouping done by the Secretariat of comments provided through the testing of the Guidance and revise the grouping as needed”, I consider the work that the Secretariat has done to be very good. I support Jack Heinemann [#6827] and Galina Mozgova [#6968] in their statements that that the general issues identified by the AHTEG sub-Group in category B reflect the main issues that were raised during the testing of the Guidance, the grouping of comments is reasonable, useful, helpful, appropriate for further work and transparent, and I also have no objection to the priority order suggested. 

With regards to: “(ii) identify which general issues raised during testing may be incorporated into the Guidance or improved upon”, I refer to the document, dated 20 May 2014, that was produced by the Secretariat and discussed at the previous face-to-face meeting of the AHTEG, titled: “Analysis of the results of the testing of the Guidance on risk assessment of living modified organisms” (UNEP/CBD/BS/AHTEG-RA&RM/5/2).  This provided a summary of the results of the testing of the Guidance, including by countries with “functional regulatory systems” [#7053].  The Guidance was found to rate very highly and was found to be highly practical, useful, be consistent with the Protocol, and to take into account past and present experience with LMOs.   I am in agreement with that overwhelming majority view, and while just about any document could be improved, I consider that the existing Guidance is adequate for all the dot points listed in Stacy Scott’s email [#6758], ranging from “define audience” to “provide real-life examples”.  I therefore do not have much to add under **General considerations** or **Specific considerations**, except that:
(1) I consider that the general issues identified by the AHTEG sub-Group properly reflect the main issues that were raised during the testing of the Guidance; 
(2) I agree with Boet Glandorf [#7008] and others that if more clarification of the Guidance is wanted, then more real-life examples could be incorporated into the text as in my view, examples help to clarify any text and to “bring it alive”, so I would support the inclusion of examples where it would be useful to do so; and  
(3) with regards to the comment made in the Excel file, Roadmap section, ID#158, I consider that it may be best to make it even clearer (if possible) that the Roadmap is voluntary and countries may choose to follow it or not.

With regards to: (iii) identify which additional risk assessment topics may be incorporated into the Guidance and further developed, I agree that if the Guidance were to be improved, it could be expanded to include the topics listed as dot points in Stacy Scott’s email [#6758].  I also support Jack Heinemann [#6891] when he stated that “RNAi is a manifestation of the effects caused by dsRNA” and that therefore these two categories of LMOs:
(a) Risk assessment of living modified organisms created through use of dsRNA techniques, engineered to produce dsRNA or exposed to dsRNA;
(b) Risk assessment of living modified organisms containing RNAi;
could be combined into one group.  I also support the suggested name of that combined group, being: “Risk assessment of living modified organisms created through use of dsRNA techniques, engineered to produce dsRNA or exposed to dsRNA (including living modified organisms containing RNAi)”.  I further support Jack’s suggestion that given the complexity of the issue, the number of different ways that dsRNA technology can be used, and the difficulties that experienced risk assessment agencies (eg the US EPA) have with regulating the technology, that, “this topic could be incorporated into Part I alone and provide substantial benefit to our audience. If time permits, I also suggest that dsRNA would be worth considering as a new entry in Part II of the Guidance as well as modification of Part III.”

Some specific comments on the Excel spreadsheet include:
• Stacked LMOs.  There were some comments given in the general issues Excel spreadsheet (eg ID# 23 and 44) suggesting that it was not scientifically sound to do a risk assessment on stacked LMOs and hence a suggestion that the Guidance should not be changed to include these.  I agree with the member of the Sub-group (column I) that it is scientifically sound to look specifically at stacked LMOs and with the reasons given – that while a single trait may have low risk, by the time several have been stacked together, the accumulated low risks may have joined together into a higher risk.  There is ample evidence of this occurring in the scientific literature on e.g. the effects of pharmaceutical drugs on animals and humans.  I also agree with further comments by this member of the Sub-group that you first need to have done a risk assessment on each of the single events in the LMO before you can determine how they may act together.  And I therefore consider that these matters should be included in a section on stacked LMOs in any improved Guidance.
• LM trees.  I agree with the Sub-group member in column I – there is a need for specific guidance on LM trees as they have different uses and exposures than e.g. LM crops.  E.g. LM trees are planted to grow in the environment for years rather than just a season like LM crops, they are generally not eaten, they are often used for construction and hence their products are designed to stay in the environment for decades, and they are often burnt, including as fuel inside houses. 
• Monitoring.  I agree with the comments in Column I that the Guidance should stress the need for long-term monitoring.

Best wishes to all

Judy Carman

My thanks again go to the Sub-group and Secretariat for all their hard work, to Stacy Scott for moderating and to all participants for an interesting discussion.

I believe that there is no need for a specific section on stacked LMOs in an improved Guidance, as there are not scientific bases for it. When there are identified interactions with two or more pharmaceuticals it is not just because they are there, but because there is an understood way in which these may interact, mostly through identified biochemical or physiological interactions. In the case of stacked LMOs, the current methodology should be enough, as it will only require that the possibility of interactions among the different transgene-derived products be assessed through a testable risk hypothesis followed by the corresponding analysis of the pathway to harm. The proposition that stacked LMOs require a specific section is based on the false assumption that the risk associated with the single events will add up to a higher risk in the stacked LMOs. Only when interaction between two or more transgene products are identified there is a cause for a new analysis, and this will not mean adding the risks of the independent events but evaluating the new phenotype altogether.

With respect to LM Trees the fact that these will be interacting with the environment for years rather than months is a matter to be consider in the exposure side of the risk equation, without having to change anything else, and the fact that these are often burnt means that the product of the transgene, a protein or RNA, will become CO2 and water.

As with long term monitoring, it should be clearly stated that case-specific monitoring is the only way to obtain information directly relevant to the RA process.

Best Regards

Reynaldo Ariel Alvarez-Morales

Dear Manoela and participants,

Thank you for your clear explanation, I understand your answer but I do not agree with your interpretation of paragraphs 5-7 of decision BS-VII/12 and the terms of reference in the annex to the decision based on what I´ve heard in the COP-MOP 7 and it´s written in the cited documents:

- Parties are being invited to submit information on the needs and priorities for further guidance on specific topics: I do think it´s accurate to characterize the prioritization of topics done by the previous AHTEG as “not accepted in the COP MOP-7” (#7073) as it´s not usual to ask twice for the same things.

- In your explanation about TOR you missed a very important part in the statement ´While revising and improving the Guidance, an attempt should be made to take into account the topics prioritized by the AHTEG, ON THE BASIS OF THE NEEDS INDICATED BY THE PARTIES´. So the attempt to take into account the list of topics prioritized by the AHTEG has to be based on Partie´s needs and not decided by the AHTEG meaning that are not two parallel processes. This is a very important point as not many countries are represented in the AHTEG.

My opinion is that a usefull RoadMap can cover all the LMOs without being necessary to elaborate a Guidance or new sections in the current Guidance each time a new organism or an informative element for RA is considered to be important.

Hopefully AHTEG will consider different interpretations as this on line forum is the only mechanism to express the opinion in the process.

Best regards,
Luciana Ambrozevicius / Ministry of Agriculture - Brasil

With regards to Reynaldo’s [#7116] desire not to have a separate section on stacked LMOs, please understand, Reynaldo, that it has already been identified as an area of need. 

Such a section is not “based on the false assumption that the risk associated with the single events will add up to a higher risk in the stacked LMOs” [#7116].  A properly-conducted risk assessment process does not assume a higher or lower risk.  It should simply ask the question: is there a higher risk? And then should consider the evidence for and against.  Raynaldo then suggests that a risk assessment into stacked traits should not occur unless it has been proven that the traits do interact.  In my opinion, a reasonable question to ask in a risk assessment of an LMO with stacked traits is this: is there an interaction between these stacked traits or their products?  And the answer would be one of : “yes”, “no” or “don’t know”.  If the answer is “don’t know”, the regulator may then choose to seek more information from eg the developer of the LMO to determine if some interaction is possible and to consider whether any interaction may be harmful.  Yet Raynaldo is suggesting that only a “yes” should require a risk assessment and that a “don’t know” should not require any more information.  Hence, he is suggesting that if a regulator does not know for sure that stacked traits or their products interact, then the regulator should not investigate to determine if there is an interaction.

With regards to Reynaldo’s statement that when an LM tree is burnt, “the product of the transgene, a protein or RNA, will become CO2 and water” – on the contrary, it is well known that wood (including the proteins, DNA and RNA of that wood), when burnt, do not combust cleanly to CO2 and water. Rather, hundreds of complex combustion products are formed, the nature of which depend on the temperature of the fire and the amount of oxygen present.  These complex molecules get emitted as smoke and ash, and deposited as ash.  In Australia, many people burn wood for fuel in urban settings and that smoke can cover hundreds of square km.  Australia also has regular large bushfires/wildfires in wooded areas that can burn for weeks, and the smoke can travel for hundreds of km.  Bushfires are so pervasive that various species of Australian native plants have even evolved to require the presence of some of their combustion products in the soil before their seeds can germinate.

Dear Luciana, dear colleagues,

thank you for the many and interesting contributions so far, which will be very important inputs for the further discussion. I would like to briefly provide some reflections on the discussion concerning paras 5 to 7 of Decision BS-VII /12 (information on the needs concerning the development of further guidance and consideration at COPMOP8) vis-a-vis para 2 of the terms of reference of the online forum and the AHTEG (take account the topics prioritized by the AHTEG, based on the priorities identified by the AHTEG).

Having chaired the discussions in the Contact Group at COPMOP-7 which led to the fine-balanced compromise between those Parties who wanted to see the development of further Guidance right away and those who did not see a need for that, I want to remind you that this is indeed a very fine-balanced compromise where both parts of the Decision BS-VII/12 have to be read together. COPMOP did not reject each of the agreed ways forward nor „not accept“ the so far elaborated results (such as the list of topics identified by the Parties) but decided that a two-track approach should be followed, mutually sopportive rather than exclusive.

Para 2 of the Terms of reference has to be read as taking into account the topics already prioritized by the AHTEG. But this priority setting exercise was not a sole exercise of the AHTEG, the topics were selected based on the needs and priorities identified by the Parties BEFORE. The concrete task by the way will not be to develop new Guidance at this stage or draft new chapters in the extisting Guidance, on the contrary. The task will be to explore possibilities to incorporate in the existing Guidance relevant aspects with respect to LMO risk assessment of the identified priorities. In addition, and supporting this approach, the text in paras 5 to 7 foresees that the Parties further reflect on the need and priorities for further Guidance, provide information in this context and allow the COPMOP8 to consider the development of further Guidance on that basis, and having considered to which extent the AHTEG was able to incorporate the previously prioritized topics into the existing Guidance..

I kindly ask all of you to take this fine-tuned compromise into account in our further deliberations so that we can achieve a good result accomodating the compromise view adopted at COPMOP7.

Thank you and best wishes
Helmut Gaugitsch
AHTEG Chair

Dear all,

I have appreciated reading the comments during this round, and I regret that my schedule has not permitted me the time to be more fully engaged in the many thoughtful questions that Stacy has raised for our consideration. 

Let me offer just a few reflections before this discussion closes.

I note Helmut’s clear statement, “The concrete task by the way will not be to develop new Guidance at this stage or draft new chapters in the existing Guidance, on the contrary.”  
I appreciate the differing views regarding the existing Guidance, especially the supplementary chapters on trees, stacked traits in plants, mosquitoes, etc.  Luciana makes a good point that if the main Guidance is properly done, there should not be the need for these additional chapters.  This was precisely the view that I and other members of the AHTEG raised when these additional chapters were selected by a majority of the Party members of the AHTEG – all of which followed only a brief discussion of less than an hour on the topics under consideration.  These topics were not chosen by the Parties, but rather by some of the members of the AHTEG.  It seems that it would be worthwhile for the AHTEG to consider whether to recommend that these chapters be continued or deleted from future drafts of the Guidance.  As just one example, Ariel has made some good points about the lack of scientific basis for having the chapter on stacked traits in plants.

Stacy raised a specific consideration with the question, “Are there non-LMO risk assessments that could inform LMO risk assessors?”  In fact, there are numerous examples that can be drawn from environmental risk assessments of non-LMOs.  For example, weed risk assessments are done to evaluate whether a plant is likely to have adverse impacts on environments.  Such assessments can be used in evaluating LM-plants.  This point also reinforces the need for relevant expertise among the reviewers; in the case of LM-plants the expertise would be in the area of plant breeding.

I hope these comments are useful in the ongoing work.

Best regards,

Dave Heron

Dear Secretariat, participants of the Online Forum and AHTEG members,

Thank you for all your contributions to this discussion.

In this forum, feedback on the general issues identified by the sub-Group has been provided, including specific suggestions on how to address these issues.

Additionally, comments related to the list of topics for further risk assessment guidance have been posted, and in some instances, have sparked debate.

Taken together, your efforts in this forum will assist the sub-Group in its next task, “Streamlining which suggestions for changes provided through the testing of the Guidance will be taken onboard during the revision of the Guidance, and providing a justification for each of the suggestions that will not be taken on board” (please seehttps://bch.cbd.int/onlineconferences/calendar_ra/), and will ultimately inform how the general issues with the Guidance will be addressed.

Dear All, I really appreciate the work done by the AHTEG –sub group.
I think that, in general, the Guidance can be considered a practical tool for a step-by-step procedure of a risk assessment.
In accordance with Valeria Giovannelli (#7083), I think that the Guidance is structured in a way that reflects the precautionary approach requested in the Protocol.
I agree with those comments that ask for a better definition of the audience of the Guidance.
I think that Guidance is developed to be used by professional personnel or  by those that are approaching to Risk Assessment, in both cases risk assessors should work together with specific expertise, e.g. in ecology, molecular biology, etc.  When there is no consolidated experience on risk assessment procedures or on LMOs, specific issue training will be required both using the training manual developed by the Secretariat and ad hoc courses.
In response to question “Are there other issues from among those raised in the testing of the Guidance that could be included as priorities for the revision and improvement of the Guidance?” , I agree with Boet  (#7008) that “linkage between part I to part II is a prerequisite” and that “the same structure used in part I of the guidance (5 steps of risk assessment), should be used in part II”.
In response to question “How could the five risk assessment steps be linked (e.g. graphically or through text)?”, I agree with Boet (#7008) suggestion that it is would be better to use both a flowchart as well as text. The flowchart could be organized as a Decision Tree, the text should describe step by step the Decision Tree and key points could be linked to the description of  ‘real life’ examples. The real life examples could be inserted in separate boxes.

Laura Mancini
Istituto Superiore di Sanità, Italy

POSTED ON BEHALF OF COLIN MCGOWAN
Note: this message arrived at the Secretariat BEFORE the closing of the discussion.

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Hello All,

Here are a few more comments on the Guidance Document with reference to the issues listed.
Thanks to all for your hard work on an important document.

Best regards,
Colin

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• Clarify when the ‘points to be considered’ are relevant and why

**Step 1 regarding characterization of the LMO**

Under point (a), it might also consider the differences between wild and domesticated organisms, comparators, and recipient organisms. Assessors may have to justify the choice for a comparator.

A lot of this is covered under choice of comparators.

Under point (d), ‘stability’, could be further defined to include stability over multiple generations.

Under point (e), it might also consider the effect changes to the target trait on other traits. For example, in fish, if the target is growth rate, increased growth hormone levels may lead to changes in time to reach sexual maturation, aggressive behaviour, or motivation to eat (pleiotropic interactions). Again, it is important here to define if the ‘non-modified recipient’ is domesticated or wild.

Under (h), it might include biological, physical or mechanical and geographical confinement. This is vaguely mentioned under Step 2 (d) as rearing or cultivation practices. Consequently, you might want to considered moving point (h) from Step 1, over to Step 2 (d), as it is more relevant to exposure. 

Under (q), it might be good to define cumulative effects over time and over multiple generations.

One should also consider how the LMO’s phenotype changes under different environmental conditions (environment x genotype interactions).

**Step 2 regarding likelihood of adverse effects**

Further consideration should be given to the differences between qualitative and quantitative data, and the dangers of slipping into a ‘pseudo-quantitative’ analysis when mixing terms such as 100% and likelihood, or when attempting to describe the rankings for likelihood, and the associated ranking for uncertainty.  When communicating to decision makers, it is important that qualitative data is not unintentionally presented as quantitative data, when no statistical data is available. 

Under point (e), examples could be used that broaden the scope of the guidance, such as examples for fish and animals, though many will be similar to those for plants.

**Step 3 regarding the consequences if adverse effects are realized **

Under (d), results from laboratory experiments could include those examining the ecological effects of the transgenic organism on the environment. With transgenic animals, and particularly with transgenic fish, dispersal patterns can be rapid and difficult to predict. Consequently, all data on the organism will be derived from experimental research conducted under conditions of physical containment, and in some cases, may only involve surrogate organisms or comparator species. This information is critical since there will often be no field data or historical data available to conduct the risk assessment.

**Step 4 regarding estimation of overall risk**

An additional point that should be considered is how exposure and hazard are combined to estimate risk (likelihood of hazardous effects being realized) and how uncertainty is reported.

This is not really addressed in the section covering Uncertainty, earlier in the document.

**Step 5 regarding recommendations and risk management**

This should include consideration of communications between risk assessors and managers, how risk is concluded on, and how conclusions are presented to decision makers.

This might also be a good place to consider mechanisms of communication between risk assessors and risk managers.

The difference between risk assessment conclusions and regulatory decisions should be stressed here.

Under (f), as mentioned earlier, there needs to be greater guidance on how protection goals and assessment endpoints are determined, presumably in the section on Planning Phase of the Risk Assessment. 

• Clarify that risk assessors can draw on knowledge and experience gained from non-LMO risk assessments

Something to this effect should be included in the guidance, somewhere up front in the document, and with links to appropriate examples. Though the links to references that are placed throughout steps one though five, all links lead back to the same document, with the same list of references. This link should be provided once at the start in reference to the value of other risk assessments, and to the value of risk assessment research on related or surrogate species.  

• Describe mechanisms of communication between risk assessors and risk managers

As mentioned above, this is an important consideration, and should be a part of Step Five of the risk assessment, or better yet, the Planning Phase, to ensure that there is no miscommunication down the line. 

• Provide “real-life” examples of LMO risk assessment and/or effects (including, inter alia, human health related issues)

Examples in the form of case studies would be useful to help explain concepts and the rational for completing each step. The examples should be kept short and to address a particular element of the risk assessment process. Examples should also touch on a variety of scenarios and different types of scenarios and organisms to accommodate a broader scope.

Greater focus in the type of scenarios and organisms that are given as examples should be used in Part II of the guidance document on Specific Types of LMOs and Traits. 

• Living modified fish

Applications for the commercial production and sale of Living modified fish is likely to increase in coming years, as countries struggle to meet an increasing demand for protein, in the face of collapsing fisheries. There are a number of special issues associated with the assessment of aquatic organisms that are not typically considered for terrestrial vertebrates or plants. Most notable is the potential for rapid and distant dispersal of aquatic organisms following entry into the environment, and the special circumstances of physical and biological containment to mitigate exposure. In addition, aquatic organisms are often transboundary; especially in the marine environment where international mixed stock fisheries can intersect. Consequently, I believe Living Modified Fish should be considered under Part II as a specific type of LMO.    

• LMOs introduced in centres of origin and genetic diversity

Both of these are important considerations and should be part of “Establishing the context and scope”, and in Step 1 of ‘Conducting the Risk Assessment’

• LMOs intended for introduction into unmanaged ecosystems

This should be part of ‘context and scope’.

• LMOs created through use of dsRNA techniques, engineered to produce dsRNA or exposed to dsRNA

• LMOs containing RNAi 

• LMOs produced through cisgenetics

• LMOs produced through synthetic biology

Though the technology used to create the LMO should be considered in Step 1 of the risk assessment (when characterizing the LMO), the risk assessment should be conducted on the LMO itself, or the “product” of biotechnology. 

• Integrating human health into the environmental risk assessment

These should be kept separate, carried out by risk assessors with knowledge and experience in relevant fields. ‘Indirect’ human health (casual contact with humans in the environment) could be integrated by using a common likelihood of exposure assessment (Step 2), however food or feed safety issues should be considered in a separate risk assessment that is written by experts in human and animal health, not the environment.