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Activities of the Open-Ended Online Forum (2016-2018)

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Opening of the discussion [#8845]
Welcome to the Open-Ended Forum on Risk Assessment and Risk Management. In its decision BS-VIII/12, the COP-MOP decided to “extend the Online Forum on Risk Assessment and Risk Management to exchange experiences on risk assessment, provide information and views on, and perceived gaps in existing guidance materials, and proposals to address any gaps identified".
To give effect to the COP-MOP’s decision the following three discussions topics are being organized under the Online Forum:
- Topic 1: Sharing experiences in conducting risk assessment of living modified organisms
- Topic 2: Information and views on existing guidance materials on risk assessment
- Topic 3: Perceived gaps in existing guidance materials on risk assessment, and proposals to address any gaps identified
We now request participants to the Online Forum to provide submissions on these three topics for the next two weeks in this forum, which will close at 1 am GMT on Monday, 12 February.
Our hope is that this will provide for a more comprehensive discussion of risk assessment and risk management to increase awareness amongst Parties as to the availability of resources. I suggest that submissions under the first heading can either be of a general nature, with more specific views or examples in the discussion on the other two topics.
Because these topics are interrelated and somewhat overlapping, we are requesting submissions on all three topics concurrently for the duration of the forum. To facilitate the discussion, we have established three submission headings for the three forum topics. Again, while acknowledging the somewhat overlapping nature of these topics, we would request and appreciate that if Parties wish to provide submissions on more than one topic, to keep them separate as best they can within each of the three submission headings.
I thank you for your participation in this forum, and I look forward to an interesting fortnight of discussion.
Tim Strabala

Note: To post on topic 3 (Views on perceived gaps in existing guidance materials) please reply to this message.
posted on 2018-01-29 01:02 UTC by Mr. Tim Strabala, New Zealand
RE: Opening of the discussion [#8850]
1. No Risk management strategies were stated for Living Modified plants with stacked genes or traits and Living Modified plants with tolerance to abiotic stress which should come under Part 11 and assigned as sub-section 2.3.6, and Part 11, assigned sub-section 3.3.5 respectively.
2. Sensitivity and reliability of the mitigation strategies need to be included
3. Guidance material did not include sensitivity and reliability of the monitoring techniques which should come under Part 111 of the material, and assigned as sub-section 6.4.5.
4. An inclusion – “Mitigation strategies, Sensitivity and Reliability of mitigation and Monitoring techniques” under Part 1 is missing. This inclusion should be assigned as 1.4.4 and 1.4.5.
5. Page numbers on the Table of Contents do not correspond with the page numbers of some sub-topics in the main body of the document. For example, Quality and relevance of information is tagged page 14 on the Table of Contents whereas its actual page number in the main body is 16

Blessing Aligwekwe
posted on 2018-02-01 13:55 UTC by Ms. Melissa Willey, UNEP/SCBD/Biosafety
RE: Opening of the discussion [#8853]
I percieve two possible gaps:

I.- Going further into risk assessment under complex settings (see my contribution under topic 1), although the AHTEG on risk assessment and risk management did include a box on centers of origin and genetic diversity in the guidance produced (see my contribution to topic 2 for a link to the guidance), thinking and developing further on the topic might be useful for several Parties.
2.- Thinking on how risk assessment might need adequacies in relation to synthetic biology products might be very useful.

Kind regards,
posted on 2018-02-01 15:23 UTC by Ms. Francisca Acevedo, Mexico
RE: Opening of the discussion [#8858]
Possible gaps, as outlined in the CPM Recommendation on “LMOs, biosecurity and alien invasive species” (this recommendation can be found at: https://www.ippc.int/en/publications/84228/) are:

- New topics for standards to ensure that they adequately address environmental risks of plant pests.
- Identification by countries of their phytosanitary capacity-building needs and recognize the special needs of developing countries regarding LMOs and products of modern biotechnology, and IAS.

Best regards,
Adriana G. Moreira (IPPC Secretariat)
posted on 2018-02-02 14:05 UTC by Ms Adriana Moreira, Food and Agriculture Organization of the United Nations (FAO/UN)
RE: Opening of the discussion [#8863]
(Following from my submission under Topic 2)
Greetings fellow participants

The existing guidance was written to accommodate a diversity of input not all of which was easily reconciled. All international documents have this challenge. As a result, some topics can be left out or left underdeveloped for the time being. I understand this to be what is meant by ‘gaps’ in coverage.

(1) As I mentioned in my intervention under Topic 1, I believe that the guidance could be improved through the inclusion of more specific topics. In addition to those that are based on type of organism (eg microbes), I suggest that there is scope to include those based on type of technology. By this I mean among other things topics such as suggested by Mauritania on open-field transfer of nucleic acids (either RNA or DNA) to plants and animals, eg, as biological pesticides (bch.cbd.int/database/attachment/?id=16832). This could be seen as complimentary to the topic suggestions in intervention [#8853] by Francisca.

(2) I think that ‘scientific risk assessment’ is a term very often too narrowly defined, and operationally inconsistent with what is or needs to be done. I prefer the term research-based risk assessment as being inclusive of both the biotic and abiotic ecology being described, but also the human conditions that influence how the former is incorporated into the risk assessment. In other words, research on how to govern risk assessment is as critical to the desired outcome of providing guidance as can be the discussion of any particular biological issue.

Along these lines, there has been a large body or credible research that indicates the need to thoroughly separate risk assessment from risk mitigation. In the existing guidance, risk mitigation, other than monitoring (Part III), is an underdeveloped issue.

In addition, there is research on how to best organize the regulatory framework to minimize conflicts of interest. For example, whether the assessor should be under the same roof as ‘agriculture’ or other combinations, or whether the foundation legislation should include an obligation to promote trade. I’m suggesting that these topics could be considered for future guidance on research-based (scientific) risk assessment.

With best wishes
posted on 2018-02-02 21:14 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Opening of the discussion [#8866]
Thanks for the opportunity to participate in this discussion.

Parties to the Cartagena Protocol on Biosafety have over several years and through various processes, identified their needs and priorities for further guidance on risk assessment, including, most recently, in response to Decision VIII/12. This is presumably because there is a perceived gap in existing guidance materials on risk assessment.

There are several broad groups of LMOs that have been consistently identified as priorities, and I think these could benefit from further guidance on risk assessment. The following is a non-exhaustive list:

1) LMOs that are obtained through synthetic biology, including those with gene drives, and those obtained through genome editing or new plant breeding techniques

2) LM animals; particularly LM fish and aquatic organisms, and LM insects

3) LMOs obtained using RNA interference

4) LM microorganisms and viruses, including those used in paratransgenesis

The above groups of LMOs are either already in commercial use or close to commercial use. Furthermore, the rapid pace of development in synthetic biology means that existing risk assessment methodologies would need to be updated and adapted; this has been recognised by COP 13 in Decisions VIII/17 and the Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology.

In addition, as identified by post #8853, there may also be specific situations, e.g. in centres of origin and centres of genetic diversity, that require further special considerations.

While the Guidance on Risk Assessment of Living Modified Organisms produced by the previous AHTEG on Risk Assessment and Risk Management is a tool to assist in conducting risk assessment in accordance with the Cartagena Protocol, it could be complemented by further guidance on specific topics, such as those identificed above.

kind regards,
Lim Li Ching
Third World Network
posted on 2018-02-06 11:11 UTC by Ms. Li Ching Lim, Third World Network
RE: Opening of the discussion [#8867]
As Jack Heinemann (post #8863) points out international guidance documents such as the AHTEG guidance on risk assessment for Living Modified Organisms are written under various constraints that inevitably leads to generic guidance written at a high level with little or no specific detail on how to achieve the document's aspirations (such as conduct a "scientific risk assessment"). Nonetheless, in the context of synthetic biology and gene drives in particular, a gap is immediately apparent between the recent recommendations of the US National Academy of Science Engineering and Medicine (which are also echoed by the Australian Academy of Sciences) and those of the AHTEG. The Academy advocates the need for modelling and quantitative approaches to risk assessment, using probability theory to address uncertainty, whereas AHTEG are much more circumspect in their guidance, and allow for qualitative assertions of likelihood and consequence. Qualitative risk assessments are easier to conduct but they are inherently unscientific unless the terms that they use - such as "highly unlikely" - are numerically defined. Without numeric definition it is impossible (even theoretically) to invalidate risk predictions with experiments or observations. If likelihood and consequence are numerically defined then the risk assessment is de facto quantitative and the main issue that remains is how well the risk assessment was conducted. So in the first instance I would recommend that the CBD consider how its guidance in this context aligns with the more recent recommendations of the Academy.

I also concur with Lim Li Ching (post #8866); there are notable groups of LMOs including arthropods (mosquitoes) and vertebrates (fish) that are in commercial use or close to uncontrolled release where additional specific guidance on important experiments and observations would be helpful to assist agencies conduct scientific risk assessments. Having recently completed two quantitative risk assessments for genetically modified mosquitoes, it is appears that there is an emerging consensus on (at least some of) the important risk endpoints. This emerging consensus could provide the focus for a more structured discussion and agreement on a set of essential experiments. In the context of genetically modified mosquitoes, for example, endpoints such as toxicity/allergenicity, the potential for enhanced insecticide resistance, enhanced vectorial capacity and enhanced female fitness are amenable to experimentation and analysis under agreed protocols. I believe risk-endpoint specific experiment and analysis standards, targeted at specific LMO groups, would encourage scientific approaches to risk assessment, help streamline the risk assessment process and provide a platform for consistency between assessments.
posted on 2018-02-06 22:52 UTC by Dr Keith Hayes, Data 61, CSIRO
RE: Opening of the discussion [#8870]
Dear Tim,

Many thanks for agreeing to moderate this important discussion and thanks to the Secretariat for the opportunity to participate.

As Dr Keith Hayes (#8867), from  CSIRO reminds us very appropriately, qualitative risk assessment is only a first step towards assessing risk and the one used where a safe history of previous use of the LMO is available. In many instances, it may be enough, but not in all cases.

Dr. Hayes rightly points out, that more “scientific approaches” require quantitative risk assessment that uses mathematical modeling and thus, sophistic dedicated modeling software. This in turn, requires highly trained and specialist professionals that have a background in biology, mathematics and statistics – not easy to find, or to train in the kind of workshops we normally use to train government officials in risk assessment of LMOs. This training approach can be too simplistic and costly if not done appropriately.  Furthermore, to expect inexperienced regulators from resource-poor biosafety agencies in developing countries, to have these highly trained professionals is unrealistic and maybe unnecessary.  

A history of safe use and data transportability are two key - yet often neglected   -aspects of conducting a risk assessment.

To illustrate this point, let’s consider the geography, ecological context and borders of Mesoamerica (Mexico and  7 small Central American countries). Each country has a specific – and different – biosafety policy framework. However, country borders were mainly drawn for geopolitical reasons and often don’t reflect marked differences in ecosystems. An Environmental Risk Assessment should be conducted using ecosystem and not geopolitical criteria.  For example, Mexico obeys one single national jurisdiction and spans most of Mesoamerica with vastly different ecosystems and “biomes” (the total component of live species). The rest of Central American countries are very small in territory, with similar ecosystems, yet each country has a different biosafety policy.  For example, Honduras biosafety policy is vastly different to Nicaragua's policy or Panama's policy is very different from neighbouring Costa Rica with a thriving Eco-tourism industry.  This makes political but not biological sense when biological criteria is key to conduct a sound risk assessment, qualitative or quantitative.  The all-important geopolitical and socio-economic consideration should be part of the Risk Management process, but not part of the  Environmental Risk Assessment  (ERA) process. Yet often, the political scenario is what drives how an ERA should be conducted in a given jurisdiction. 

To summarize, I strongly support Dr. Hayes statements and urge members of this forum to consider not pushing for even more onerous biosafety regulation that will need to be adopted by countries that are already  burden with a myriad of  urgent problems (like narcotraffic and crime) and already overwhelmed with inefficient  biosafety frameworks that continue to block useful and already proven technologies.

Many thanks and best regards to all,

posted on 2018-02-07 04:09 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
RE: Opening of the discussion [#8879]
Dear Tim

Thank you for moderating this discussion.

I was interested to read the posts of Dr Keith Hayes (#8863 and #8867) and the response from Ms Maria Mercedes Roca (#8870). In the context of the advocacy for more quantitative risk assessment, I would like to draw attention to a paper I published in 2011 "A semi-quantitative approach to GMO Risk-Benefit Analysis. Transgenic Research 20,1055-1071. A copy is attached to this post.

The methodology in the paper is intended to be easily used by risk assessors in developing countries, without requiring sophisticated software or a background in mathematics and statistics.

I have for some time bemoaned the fact that there is no clear agreement as to whether, or how, benefit should be considered as well as risk - either in the Protocol itself, or in the AHTEG guidance. This is further discussed in Chapter 4 of the recently published book "Genetically Modified Organisms in Developing Countries: Regulation and Governance", eds. AA Adenle, EJ Morris and DJ Murphy (Cambridge University Press, 2017).

In the absence of any consideration of benefit, there is no clear end point to determine how much risk (if any) is acceptable. But if the two are considered together, it is much easier to decide whether the benefits outweigh the risks.

I know that this goes against the accepted approach in many countries, but perhaps it is time to move beyond a pure consideration of the precautionary principle to also take into account the so-called "venture principle" that I describe in the 2011 paper.

Meanwhile an article that came out in Nature Biotechnology yesterday may also be of interest to the participants of this forum. It is entitled "Rationalizing Governance of Genetically Modified Organisms in Developing Countries", Nature Biotechnology 36(2), 137-139.
posted on 2018-02-07 16:58 UTC by Dr Jane Morris
RE: Opening of the discussion [#8881]
Greetings everyone, and thank you to Tim for hosting this forum discussion.

I am posting this thought under Topic 3 on  'perceived gaps' in response to the post from Jane Morris  [#8879].  I think that Jane has raised an excellent point!  If ever there is a gap in existing guidance on risk assessment that is particularly critical for developing countries, it is the lack of guidance on how to incorporate 'benefit assessment' along with risk assessment into the decision-making process.  As Jane notes, this is not the accepted approach in many countries, and some people following this forum might also note that benefit assessment could be considered outside the scope of AnnexIII.  However, benefits certainly should be considered within the scope of the Protocol.  The dual purpose of the protocol, as stated in its introduction, is 'an enabling environment for the environmentally sound application of biotechnology, making it possible to derive maximum benefit from the potential that biotechnology has to offer, while minimizing the possible risks to the environment and human health.'  I agree with Jane that guidance on risk assessment under the Protocol should go beyond a strictly precautionary consideration of the risks to include some means by which to consider benefits in the decision-making process.  If it does not, this represents a significant gap.

posted on 2018-02-07 18:56 UTC by Ms. Karen Hokanson, University of Minnesota
RE: Opening of the discussion [#8910]
Dear All
I  think that Jane Morris [#8879] and Karen Hokanson [#8881] raised an important subject by pointing out the lack of information on how to consider benefits along with the risk assessments under the Protocol. While it will certainly not be necessary to carry out an elaborate benefit analysis for any activity with LMOs, there should be a place for the consideration of benefits in the decision-making process, in particular in cases where it is necessary to decide how much risk (if any) is acceptable.

Werner Schenkel
Federal Office of Consumer Protection and Food Safety (BVL), Germany
posted on 2018-02-09 15:16 UTC by Dr. Werner Schenkel, Germany
RE: Opening of the discussion [#8874]
Topic 3
Dear all, dear Tim,
It is a pleasure to also participate in this forum with respect to topic 3, which is on
perceived gaps in existing guidance materials on risk assessment, and proposals to address any gaps identified. Given my reaction on topic 2 (existing guidance materials on risk assessment) it may be evident that in my opinion there are –at the moment- no gaps in existing guidance materials. Although developments go fast, such as in synthetic biology, the current environmental risk assessment framework for LMOs is still valid for organisms that are in the current state of development. Close monitoring of scientific developments is essential to see whether risk assessment considerations or methodologies need to be adapted. Such monitoring of new developments during the last years has resulted for example in discussions and/or recommendations with respect to LMOs with traits based on RNAi or on LMOs with synthetic gene drives. 
The second part of topic 3 is about proposals to address any gaps, when they are identified.
For me it would be important that a clear process is established in order to decide if and how an identified gap needs to be addressed. This process can then be used to assess each gap that is identified and lead to prioritization of topics to be addressed. Key criteria for the selection of topics that need to be addressed can be the following (1) the topic is not too broad, but well defined, (2) topic is identified by a Party of the Protocol (3) topic falls within the scope of the Protocol and may adversely affect biodiversity, (4) topic is not covered by other existing guidance, and  (5) topic is close to commercial application. If all criteria are fulfilled, it can be considered whether additional guidance is necessary or that other methods of addressing the gap may be a better approach. If it is decided that further guidance on the specific guidance is deemed the best approach, it could then be decided who should write this guidance as to include the best expertise on the specific topic.

Kind regards,
Boet Glandorf, GMO Office, The Netherlands
posted on 2018-02-07 12:24 UTC by Ms. Boet Glandorf, Netherlands
RE: Opening of the discussion [#8877]
Dear Tim, dear colleagues,

thank you Tim for moderating also this discussion under Topic 3, perceived gaps and proposals to address any gaps identified:

While the Guidance on Risk Assessment developed by the AHTEG and online forum as well as additional regional and national guidance documents, as mentioned in my previous posting under topic 2 above, provide a good basis, remaining open and specific questions on certain types of organisms and traits as well as recent scientific developments lead to gaps and therefore require additional guidance to be developed under the Cartagena Protocol in the following areas:

- LMOs developed through new molecular techniques including gene drive and synthetic biology techniques: major developments in new molecular (breeding) techniques provide challenges for risk assessment and appropriate guidance. Existing guidance documents for current LMOs are an appropriate basis but may need further specifications taking into account the characteristics of the new molecular techniques and the resulting products. Synthetic biology techniques may even provide further challenges: even if most LMOs produced today with synthetic biology can be assessed with existing guidance, the development of techniques is very rapid and it can be difficult or impossible to find suitable comparators. Also gene drives may and can be used in synthetic biology applications. This technique can alter very rapidly whole populations. Gaps in existing guidance for addressing these challenges need to be taken care of by developing further Guidance. In this context it may be necessary to differentiate between new molecular techniques and synthetic biology.

- LM fish
- LM algae
- LMOs involving the technique paratransgenesis
- Guidance on how to perform a “per se” risk assessment (e.g. where a comparator is not available)
- Guidance on how to implement the concept of “limits of concern” in LMO risk assessment

A clear three-step process should be established to address any gaps:

1. Possible criteria that may facilitate the section of topics for the development of further guidance on specific topics of risk assessment of LMOs could be the following:
- Topics fall within the scope and objectives of the Protocol
- There are potential adverse effects on biodiversity, taking also into account human health
- Existing guidance is not sufficient for performing risk assessments
- The topic involves a high pace of scientific and technological development and there is a likelihood of application, including placing on the market
- Emerging new challenges concerning risk assessment frameworks and methodologies, as well as concerning conservation and sustainable use of biological diversity, including new ways of exposure

2. A clear process for selection based on the criteria above
3. A clear process for developing additional Guidance in an efficient and inclusive manner

Thank you and Kind regards

Helmut Gaugitsch
Environment Agency Austria
posted on 2018-02-07 13:44 UTC by Mr. Helmut Gaugitsch, Austria
RE: Opening of the discussion [#8878]
Dear Colleagues,
The discussion on |Topic 3 on perceived gaps in existing guidance on RA leads me to a question on adopting an LMO developed in environment A to environment B based on RA in environment A. I am not aware of adequate consideration of genotype x environment interaction. This is important for us as we look to adopting GM cotton(inserted genes) with RA done in the US.
Happy New Year.
David A. Mbah, Yaounde, Cameroon
posted on 2018-02-07 15:32 UTC by Ms. Melissa Willey, UNEP/SCBD/Biosafety
RE: Opening of the discussion [#8880]
With regard to the submission in response to paragraph 10 of decision XIII/17 made by several parties, it seems to be a general agreement that:
- methodologies to conduct risk assessment of LMO exist
- they need adaptation due to the increasing complexity of LMO as a result of the advances in modern biotechnology

Although there are examples of organisms developed through techniques of synthetic biology that are in a grey area (not fully compliant to the definition of LMO), many actual development of synthetic biology organisms that are LMO are available. Such examples include microorganisms developed by gene editing into which a synthetic genome had been inserted (e.g., Craig Venter Institute research on Mycoplasma laboratorium), or in which the chromosomes had been redesigned or contain an expanded genetic alphabet developed through the use of “unconventional” synthetic nucleic acids.

In order to achieve an international harmonization, we strongly support the development of guidelines and methodologies on how to conduct environmental risk assessment in situations where risk scenarios drafted on the basis of data on exiting biological processes or based on scientifically sound knowledge are unavailable.

Furthermore, in the context of LMO containing a gene drive mechanisms and particularly where the goal of the release of such LMO is the extinction of populations or species, respectively, many relevant issues, ranging from risks to the environment to authorisation criteria, need to be discussed and properly assessed to safeguard the CBD and Cartagena protection goals.

Such gene drive systems are actually in development in many areas (e.g., public health, agriculture) to control vector or pest populations, or host competence. An example is the use of CRISPR–Cas9 to engineer a gene drive mechanism to insert a specific deleterious mutation, which is copied from one chromosome to the other and, thus, spread in non-mendelian inheritance in sexually reproducing species. For gene drive LMO, international guidelines (e.g., regarding justifiable reasons for a release or mandatory integration of safety mechanisms) are of particular importance because such LMO might easily spread across boarders into areas where a control of the target is not desirable or acceptable, respectively.
posted on 2018-02-07 17:24 UTC by Mr. Christoph Lüthi, Switzerland
RE: Opening of the discussion [#8885]
Thank you all for your kind words regarding my moderation of this forum, and for your excellent contributions to our three topics so far. I think it’s fair to say that we’ve read a range of views, as well as useful information regarding publicly available resources for risk assessment. As we approach the end of the forum, I would like to see that continue.

As a reminder, the official closing time for the forum is 1 am GMT on Monday, 12 February.

Based on past experience, I know that the rate of submissions to these forums increases as we approach the deadline. Ours is now a bit less than four days away. I would like to encourage those participants who haven’t posted their views yet to do so as early as possible to facilitate further thought and discussion on these topics, as well as to get the fullest range of views on experiences and challenges, information on existing risk assessment resources, and perceived gaps as well as ways to address them as possible.

I apologise in advance that you may receive this message three times, but I'm posting it under all three topic headings in case anyone is only monitoring one of them. I'm looking forward to everyone’s input over these last four days.

Kind regards, Tim
posted on 2018-02-08 04:29 UTC by Mr. Tim Strabala, New Zealand
Topic 3:Perceived gaps in existing guidance materials on risk assessment, and proposals to address any gaps identified [#8889]
Thank you very much for the opportunity to contribute to this online forum.

I share to a great extent the views of Boet Glandorf (#8874).

Regarding the perceived gaps, at this stage, no identification of specific topics in need of further guidance has taken place at the EU level.

Regarding proposals to address any gaps, when they are identified, I also agree that a clear set of criteria needs to be agreed among the Parties of the Protocol before starting evaluating how the identified gaps should be addressed.

The criteria proposed by the EU and its Member States in response to the CBD Notification 2017-035 (Risk Assessment and Risk Management) form a good basis for discussion among the Parties of the Protocol. In summary those criteria are:
1. Risk assessment with regard to the topics in question is within the scope and objectives of the Protocol.
2. Risk assessment with regard to the topics in question cannot be performed by using existing guidance documents.
3. Specific topics with a high pace of scientific and technological advancement.
4. Specific topics with potential adverse effects on biodiversity and/or human health.
5. Specific topics might be prioritised if the LMOs in question are already, or are likely to be, commercialised and marketed somewhere in the world.

Kind regards,
Maria Kammenou
posted on 2018-02-08 13:17 UTC by Maria Kammenou
RE: Topic 3:Perceived gaps in existing guidance materials on risk assessment, and proposals to address any gaps identified [#8896]
Hello again,

I wish to support the posts by Boet Glandorf [#8874] and Maria Kammenou [#8889] under this TOPIC #3 on perceived gaps in existing guidance and proposals to address any gaps identified. 

First, I find it helpful to note that gaps in existing guidance or identified specific topics that require further guidance have not been identified at the EU level – at the moment.  I think Boet explained very well how close monitoring of scientific developments is necessary to prompt a discussion about needs for additional guidance.  Second, both Boet and Maria proposed good ‘criteria’ (also reflected somewhat in the post by Helmut Guagitsch #8877) for identifying gaps worth considering.  Third, I think Boet in her post identified two critical points to consider for the ‘process’ needed to address those gaps.  I’ll repeat these here, in case they get lost in the discussion:
-“If all criteria are fulfilled, it can be considered whether additional guidance is necessary or that other methods of addressing the gap may be a better approach.” 
-“If it is decided that further guidance is deemed the best approach, it could then be decided who should write this guidance as to include the best expertise on the topic.”

posted on 2018-02-08 19:26 UTC by Ms. Karen Hokanson, University of Minnesota
RE: Opening of the discussion [#8890]
Dear Tim

Thanks for accepting to moderate this very demanding topic on risk assessmet.

Views on perceived Gaps on the Guidance Document.

1. The Guidance document is too long, Part II on specific types of LMOs and traits seemingly confusing to new users of the document. The best scenario would be to have a general guidance document for all LMOs. That would mean retaining only Part 1 and III of the document as the general road map for risk assessment, risk management and monitoring. Part II can be designed as case studies for specific LMOs/traits but in separate document from the main guidance document.

2. Real case studies on actual risk assessment has not been provided. For new risk assessors, it would make a lot of sense if a real risk assessment case study, from start to end, is given. Of course not in the Guidance document but as a reference record. I would propose that real case studies for the most common traits be developed ie risk assessment for Bt technology products, risk assessment for herbicide tolerance trait, risk assessment for RNAi based trait for disease resistance, risk assessment for nutritional enhancement trait and others on need basis.

3. The Guidance document should be clear and precise on how risk assessors can navigate through unforeseen long term effects and uncertainties that may be caused by LMOs. The text in the current document is not prescriptive and many risk assessors would find difficulties navigating through this critical aspect.

4. Estimation of risk (1.5.4). Its not helpful to leave it to individual Parties or risk assessors to decide on their own the range of risk ie from negligible to high. Experts can use existing experience to clearly define the estimates of risk so that it is somehow standardized. As it is currently, different Parties or risk assessors will most likely have different conclusions on risk estimate for the same product/process.
posted on 2018-02-08 13:49 UTC by Mr. Josphat N. Muchiri, Kenya
RE: Opening of the discussion, topic 3 [#8891]
Dear Colleagues,
Many thanks to the moderator, to those that have contributed to this very interesting discussion and especially to the members of the AHTEG who produced the excellent and useful Guidance on Risk Assessment of Living Modified Organisms!

The gaps that my colleagues and I have identified in the Guidance on Risk Assessment of Living Modified Organisms (LMO) are similar to those that others have already identified;
• Living Modified Organisms developed through Synthetic Biology,
Risk assessments of these organisms present new challenges when using the key factors that the guidance use as the basis for risk assessment of LMO which include; the lack of relevant and suitable comparators, development of an increasing number of traits in an organism developed through synthetic biology, the potential to use a number of novel techniques in development or modification of an organism with synthetic biology, and the difficulties in detecting the methods of modification that have been used.

• Living Modified Fish,
LM fish are highly mobile and consequences of their contact or interbreeding with wild fish or conventional farmed fish and interactions in the habitat can be far reaching. Consequences could  include out-competition of wild and conventional farmed fish of the same species and resulting trophic changes in the habitat as well as unexpected genetic changes in both the LMO and wild/farmed conventional relatives. We are especially concerned about this in Sweden as native salmon races endemic to certain water systems are already under threat from escaped cultivated conventional salmon. We know from experience how difficult it is to prevent escape from “secure” facilities.

• Guidance on long-term effects of LMO,
In our experience of reviewing risk assessments of living modified organisms, we have seen a tendency that long-term effects, especially long-term indirect environmental effects and effects on non-target populations and abiotic factors are very superficial and often lack fundamental information.

Other topics mentioned in this discussion, such as gene drives, and living modified microorganisms are also worth considering.

I agree with Maria Kommenous comment that we need to consider the process and criteria for considering the gaps in guidance and how they can be addressed as a first step in working with the perceived gaps. The criteria that she presents are thought-provoking and could be used as a basis for further consideration in this discussion.
posted on 2018-02-08 14:33 UTC by Ms. Melanie Josefsson, Sweden
Assessing potential LMO effect on geneflows within Crop Genepools [#8895]
Dear Tim
Allow me to take you away from biotechnology matters and introduce you to evolutionary matters! We all know that crops have relatives with which they exchange genetic material; they constitute "Genepools" that relate to each domesticated crop!
My concern is about the potential effect of LMOs on "geneflows" within genepools and how we can assess it.
I had and still have the intime conviction that whatever hazards might occur from LMOs, these can be overcome on the short-term, and can't reach the scale of disaster! but if LMOs have potential effects on geneflows inside our genepools, this will jeopardize the existence of species itself! and that is really of great concern to the future of our crops.
I remember that in the early days of transgenic experiments in the 90s some simulation experiments have been done on this topic at the ENEA- Casaccia (Rome, Italy), but frankly I don't have any record of that. If someone could help!
Mohamed Elyes Kchouk
NCB - Tunisia
posted on 2018-02-08 18:25 UTC by Prof. Mohamed Elyes Kchouk, Tunisia
RE: Assessing potential LMO effect on geneflows within Crop Genepools [#8902]
Dear Tim, dear participants,

I think Guidance for specific types of LMOs and traits, whose risk assessment may differ from the general principles which could be applied to all LMOs, highlight all important points that risk assessor should take into account and concentrate on points which are more applicable to specific types of LMOs and which are not common for all LMOs. Examples of actual RA and relevant guidelines from different organizations are given in references to corresponding chapters. And mechanism and criteria on how to add this references have been developed. From my point of view it is better to have methodical guidelines for specific types of LMOs rather than to have simple collection of risk assessments as it was proposed in one of the posts, because they could apply different approaches even for one group of LMOs and if we provide only 1 of them we can miss important point to consider as well as all process of assessment.
Probably one of the challenges that can be resolved is to add direct links to concrete risk assessments or appropriate scientific articles directly in the text, e.g. after elements for consideration or after appropriate sentences in Guidance. At the same time I would like to remind that we already have after each chapter in the Road map or Chapters for specific LMOs links to reference materials (Guidelines of international organizations, articles in peer-reviewed publications and other relevant illustrative information) and we can give the link to this materials after relevant points to consider/ appropriate sentences directly in the appropriate text.
I also support scientific (research based, evidence based) approach, including methods of statistical analysis, as well as methods developed by academia, which are supported statistically / approved by relevant organizations / published in per reviewed articles, etc. As this Guidance is not static document all relevant and articles/ other kind of appropriate documents can be added to reference materials and mechanism is developed. Author just send document and members of AHTEG considers should it be added based on developed criteria. Also general sentences to quantitative methods could be added in appropriate part of text and illustrative links could be given for this important documents from academia.
As to the new chapters for specific types of LMOs our center support development of them. The subject selection criteria: the new LMO is fundamentally different in its properties from the previously developed ones and it cannot be assessed using the Roadmap or particular Guidelines to it. When we submitted information Declared In Decision Viii/12 On Risk Assessment And Risk Management we identified two areas which actual now for us: risk assessment of LMO fish and aquatic ecosystems’ LMOs and LMOs developed on the basis of new technologies including synbio organisms. Reasons for development of this kind of guidance echo previous posts of the forum participants.
Also we believe that it is necessary to thoroughly refine the Section “Monitoring”, to introduce the examples of various monitoring types including development of ecological experiments for confined and large scale field trials. When assessing the risks of LMOs destined for field testing, we faced with the fact that often an expert conducting a risk assessment should not only assess all risks and give conclusion and recommendations on monitoring, but also develop a field experiment for assessing an environmental risk. Therefore it would be good to add appropriate sentences in the text and links to proper examples.

Best wishes,
posted on 2018-02-09 07:28 UTC by Dr. Galina Mozgova, Belarus
RE: Assessing potential LMO effect on geneflows within Crop Genepools [#8906]
Reply to #8895:
Dear Colleagues

extensive knowledge has been gathered on the potential gene flow and effects on wild relatives in the past twenty years (e.g. the links below). I agree that geneflow from crop to wild relative may be of concern with respect to evolutionary matters. However, this concern does not differ between conventional crops and gm-crops as long as the transferred trait does not influence the rate of gene flow. In addition, the assessment of the consequences of potential gene flow within genepools and beyond has always been part of the risk assessment on a case-by-case basis.

1) https://vdf.ch/synthesis-and-overview-studies-to-evaluate-existing-research-and-knowledge-on-biological-issues-on-gm-plants-of-relevance-to-swiss-environments-1480741353.html?author_id=3362
2) https://ec.europa.eu/research/biosociety/pdf/a_decade_of_eu-funded_gmo_research.pdf
3) Ellstrand et al 2013 http://www.annualreviews.org/doi/full/10.1146/annurev-ecolsys-110512-135840
4) Ellstrand and Rieseberg 2016 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947145/

Overall, an exiting excercise!

Detlef Bartsch, BVL, Berlin
posted on 2018-02-09 14:49 UTC by Prof. Dr. Detlef Bartsch, Germany
RE: Opening of the discussion [#8905]
Dear Tim and other colleagues,

At this time, I think there is no gaps in existing guidance materials on risk assessment. Some existing guidance materials including the guidance produced by AHTEG instruct fundamental methodology of conducting an environmental risk assessment; firstly envision a scenario of how the LMO in question may cause adverse effects to the environment, with taking into account the characters of the LMO, and then prove the certainty of the scenario with scientific data. Even if a LMO in question has a high heritability of its modified genes (such as gene drive LMO) or an ability of moving broad area (such as LM fishes), this fundamental methodology of assessment itself has no need to be changed – though the scenario may become more complicated and necessary data for assessment may increase on a case by case basis.

And, I also would like to echo the previous comments of [ #8874] pointing out the importance of establishing clear process in order to decide if and how an identified gap needs to be addressed.
Kind regards,

posted on 2018-02-09 08:08 UTC by Misuzu Watanabe, Japan
RE: Opening of the discussion [#8909]
Dear All
Thank you for your great contributions and the opportunity to attend the forum.
I strongly support the suggestions made by Boet Glandorf [#8874] to establish a process following a row  of criteria if and how identified gaps needs to be addressed. Criteria suggested by Miss Glandorf and by Miss Kammenou/EU and its Member States [#8889; submission of EU to notification ntf-2017-035] might build a good basis for further considerations.
In my opinion so far, all LMOs developed, including organisms developed through recent technological advancements in synthetic biology, or organisms containing gene drive systems, can be comprehensively assessed based on available guidelines. Please refer to the BCH to find guidelines (http://bch.cbd.int/database/laws/).
Therefore, I think at this time there is no gap in existing guidance material on risk assessment. These guidelines have always been applied specifically to the case in question and this can and will be done for newly emerging cases. I concur here with Misuzu Watanabe [#8905] who has well summarized this point.
In reply to Jack Heinemann [#8863] the term “research-based risk assessment” is misleading since ‘research’ is a different scientific discipline than ‘risk assessment’. We should not mix these terms.
Additionally, in agreement with Josphat Muchiri [#8890] I support the idea that we should consider well the benefits of additional guidance documents to fill perceived gaps before developing those.
It might be a good idea to establish more generic guidance under the Cartagena Protocol on the principles of risk assessment, risk management and monitoring and guidance on how to implement these principles to address specific cases. Many of the perceived gaps mentioned in the posts relate to the latter.
Since the Cartagena Protocol as well as all national regulations I know of are based on protection goals it can be justified to adapt the information required for risk assessment and management measures as required to meet those protection goals.
A strong reason to argue against developing too specific guidance on how to implement these principles to specific cases on a level of international treaties like the Cartagena Protocol is the timeframe necessary to develop such guidance documents. As we all realize, new techniques are emerging at a fast rate in the area of biotechnology. I don´t think internationally agreed  specific guidelines can be developed at an equally fast pace. Therefore, it seems reasonable to cover new species groups and techniques within the existing framework and provide assistance on implementation of this framework to specific cases via other faster routes [#8907],[#8908].

Werner Schenkel
Federal Office of Consumer Protection and Food Safety (BVL), Germany
posted on 2018-02-09 15:15 UTC by Dr. Werner Schenkel, Germany
RE: Opening of the discussion [#8911]
Dear colleagues, dear Tim,
Thank you very much for the interesting discussions and the opportunity to share my view on perceived gaps in the existing guidance materials.

I would like to comment on the perceived gap in risk assessment of organisms produced through synthetic biology. I think that the operational definition established by the AHTEG on Synthetic Biology is not suitable to define such a gap. The definition is very broad and includes most applications and techniques generally considered modern biotechnology, including LMOs as defined in the Cartagena Protocol. As these can be risk assessed with the methodologies implied under the Protocol, we haven´t identified any gaps so far.
However, I agree that technical progress in the field of synthetic biology but also in modern biotechnology may produce organisms for which risk assessors may need more or a different kind of information. To identify those applications that cannot be classified as LMOs under the scope of the Cartagena Protocol, a close monitoring of scientific developments as stated by Boet Glandorf [#8874] is essential.

Best regards,
Swantje Strassheim
Federal Office of Cosumer Protection and Food Safety (BVL), Germany
posted on 2018-02-09 15:44 UTC by Ms. Swantje Strassheim, Germany
RE: Opening of the discussion [#8914]
Thank you for the moderator and for the participants for an interesting discussion under this topic.

Having in mind that Cartagena does not regulate all aspects of LMOs but only those that are relevant to biodiversity issues, account risks to human health, and specifically focusing on transboundary movements, there are no perceived gaps at this moment. It´s important to highlight that any guidance material should only be written by experts and based on practical experience. This would produce a real and useful document rather than an academic document.

For some topics already suggested as synthetic biology, for example, the expert group on SynBio under CBD concludes from their last report (CBD/SYNBIO/AHTE/2017/1/3) that “the general principles and methodologies for risk assessment under the Cartagena Protocol and existing national biosafety frameworks, as well as voluntary guidance, could provide a good basis for risk assessment of organisms developed through synthetic biology”. Also for gene drive it was noted in the synbio AHTEG report “that additional research and guidance were needed…” but the AHTEG also concluded that “most living organisms already developed or currently under research and development through techniques of synthetic biology, including organisms containing engineered gene drives, fell under the definition of LMOs as per the Cartagena Protocol”.  Therefore, I do not agree with the inclusion of synthetic biology and gene drive as further topics for guidance development under RA AHTEG at this moment.    

In my opinion, we should concentrate the efforts and resources in training to help people to establish their biosafety framework based on the experience we already have with LMOs instead of creating additional documents for hypothetical hazards already covered by existing regulations.

Best regards,

Luciana P. Ambrozevicius
Ministry of Agriculture / Brasil
posted on 2018-02-09 15:48 UTC by Ms. Luciana Ambrozevicius, Brazil
RE: Opening of the discussion [#8917]
I share to a great extent the views of  Boet Glandorf [#8874], Jane Morris [#8879], . Karen Hokanson [#8881] that guidance on risk should go beyond and  include some benefits in the decision-making process.  If it isnot consider under a specific country framework, this represents a significant gap.
Thanks again for the moderator and for the participants.
Under this Topic 3, I would like to echo the previous comments of Maria Kammenou [#8889] and others, that raised the point regarding proposals to address any gaps:  when and if they are identified,  a clear set of criteria needs to be agreed among the Parties of the Protocol before starting evaluating how the identified gaps should be addressed.
Finally I concur here with  Luciana Ambrozevicius [#8914] who has well summarized the need for “…a  real and useful document rather than an academic document.”  And also  reinforce the need to concentrate resources in helping  building a workable legal framework based on the experience already in place instead of creating guidance for  hazards already covered by existing regulations.
posted on 2018-02-09 17:04 UTC by Dr. Deise Maria Fontana Capalbo, Brazil
RE: Opening of the discussion [#8918]
Dear Tim and colleagues,

I am also of the opinion that the guidance document developed by the AHTEG and online forum have provide a good basis over these years for the comprehensive and holistic safety analysis of LMOs. And it should be possible to continue to be an open document as new develops and techniques evolve and arise. Therefore, I echo the voices of other colleagues on the following topics to address perceived gaps:

• Detection and identification of transgenes in landraces and wild relatives (We have recently published a paper where we discuss the gaps in detection methodologies and how to address the issue https://link.springer.com/article/10.1007%2Fs10531-017-1471-0). The existing detection network could follow on this topic.
• Open-field transfer of nucleic acids (either RNA or DNA) to plants and animals, eg, as biological pesticides
• LM fish (other aquatic organisms)
• LMOs involving the technique paratransgenesis
• Guidance on how to implement the concept of “limits of concern” in LMO risk assessment
• Living Modified Organisms developed through Synthetic Biology, which includes organisms developed by new techniques such as genome-editing techniques (eg. CRISPR/Cas) and RNA interference.

In addition, I would also like to highlight the use of “omics” techniques as useful tools to address new and potential gaps in RA such as the need to perform a “per se” risk assessment (e.g. where a comparator is not available) as mentioned previously. This topic is gaining more attention as new and complex GMOs are being developed. EFSA is currently organizing a colloquium on the topic (https://www.efsa.europa.eu/en/events/event/180424-0).

Thank you

posted on 2018-02-09 17:13 UTC by Dr. Sarah Agapito-Tenfen, GenØk Centre for Biosafety
RE: Opening of the discussion [#8923]
Dear Tim, Secretariat and fellow forum participants

Several times in this forum appears the suggestion that there is a gap in guidance on benefit assessment. In my view, there are good reasons for not mixing a ‘benefit assessment’ with a ‘risk assessment’ in the Guidance.

1. Annex III of the Protocol provides support for decision makers who are obligated to take into account the outcome of a scientifically sound (which I understand to mean at least research informed) risk assessment, but are not limited to the risk assessment in coming to a decision. The risk assessment is described in Article 15 which refers to Annex III for further detail. Annex III neither includes instruction on how to conduct a benefit analysis nor suggests that one is required for a scientifically sound risk assessment. While actual or potential benefits of an LMO in the receiving environment could be taken into account by a decision maker, a benefit analysis is not part of the risk assessment recipe of Annex III. The inclusion of a ‘benefit assessment’ in the RARM potentially would conflate the role of risk assessor and decision maker.
2. A benefit analysis is fundamentally different from a risk assessment. Hypotheses of risk can be tested, at least at some scale, and observations or evidence of harm can be used to refuse an application to release an LMO. In contrast, benefit is based on a series of intangible and uncontrolled variables that are out of the realm of the risk assessor. For example, if a product promises to reduce pesticide use, how long must it do this for to have delivered on the promise? Who is obligated to monitor the delivery of the benefit?

Whereas a biosafety regulator can theoretically determine a low probability of harm or a high probability of harm mitigation in a pre-market risk assessment backed by legislation that protects human health and the environment, she or he cannot similarly establish a high confidence for benefit realization because there is no equivalent legislation to compel delivery of benefits. There is no provision for post hoc reassessment for released LMOs that do not deliver promised benefits, thus undermining the comparative nature of risk of harm with a risk of benefit. (Having said this, I’d be interested to know if there are any countries with biosafety legislation that either imposes a legally binding requirement to monitor benefits and/or has provision to enforce delivery of benefits.)

Thanks to everyone for the very interesting contributions to the forum.
posted on 2018-02-09 23:28 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Opening of the discussion [#8930]
Dear Tim, dear colleagues,

Many thanks to all  the commentators for the enlightening discussion that indeed helps us to see our field of risk assessment of LMOs more clearly. Of special interest are comments regarding the need to assess risk against benefit made by many commentators including  Boet Glandorf [#8874], Jane Morris [#8879],  Karen Hokanson [#8881] and Deise Capalbho from Brazil (# 8917) that “guidance on risk should go beyond and include benefits in the decision-making process. Not including benefit represents a significant gap”. I strongly support these obvious and common sense views.

Like all laws and all rules,  the Cartagena Protocol, including Anex III was drafted by designated people that are not free from using wrong or flawed paradigms, even with the best intentions. Stating “it is the law” or invoking the text of a specific protocol or convention,  does not mean it is well or justly crafted. Examples of these abound:  Nazi Germany and Jewish people, segregation law against black citizens in the US,  Apartheid in South Africa, anti-gay laws...  the list is endless. Flawed laws only change when enough people state they are flawed or rebel (often sadly with violence).

In my experience, two obvious flawed paradigms of the Cartagena Protocol that cause a lot of discord and problems in implementations by parties, are the Precautionary Principle and not using a benefit vs. risk analysis.

It is only when we assess the benefit of adopting a new technology, that we can truly assess what risk we are prepared, as a society,  to accept in the right context.  By society, I mean that all segments of society are considered, yet not all segments of society are qualified to express their views on assessing the risks vs. the benefits of adopting or using a technology.

This delicate assessment is a highly specialized job for trained professionals and should not be discussed in very general and open fora, like it is normally done in many countries for LMOs. Imagine if airlines asked all stakeholders waiting on a boarding gate to travel if a plane should go ahead or cancel the trip because of mechanical or weather situations. Only those highly trained in plane mechanics or weather fields are qualified to assess the risks vs. the benefits. The passengers ( and the airline the main stakeholders affected by a decision not to fly) simply follow instructions of those who are trained to make those decisions for everybody.

Until we change this very important flawed paradigm in risk assessment of LMOs, where we only assess the risk  - without considering the benefit of adoption or the risk of inaction -  I fear we are going to continue to go round in circles, like we have done for the last two decades.

To illustrate this point, I bring to light the situation in most  Andean and Central American countries in Latin America that are stuck in a situation of inaction because of flawed risk  paradigms adopted more than a decade ago,  that are now difficult to change politically and legally and are causing confusion and heated internal debates. Ecuador and Perú are classic examples, as they have explicit prohibitions in their national constitution and biosafety laws respectively.
The more developed countries like Brazil. Argentina, Colombia and Mexico have successfully adopted GM crops and the predicted biological risks inherent to genetic engineering, warned by outside observers, have not materialized to date. Sure, there are heated internal debates in these countries too, but they are more of a political and ideological, nature related to agricultural systems and politics than to  do with a biological hazard regarding the risks of genetic engineering and LMOs in general.

Thanks to everyone for this lively discussion that challenges us all. It helps me learn.

Best regards,

Maria  Mercedes Roca
posted on 2018-02-10 23:14 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
RE: Opening of the discussion [#8924]
We shall look at the progress of biotechnology and the current guidance material to see the gaps. I remember that several topics were identified by Parties as priorities for the development of new guidance and two were recommended by the AHTEG to MOP8. Those topics are still valid as they aim to take care the need of risk assessment by modern biotechnology, which can not be met by other existing documents.


posted on 2018-02-10 00:19 UTC by Mr. Wei Wei, China
RE: Consideration of benefits [#8928]
Dear Tim and fellow participants
Further to my original comments regarding consideration of benefits (#8879) there have been several responses supporting this, including those of Karen Hokanson (#8881), Werner Schenkel (#8910) and Dr Deise Maria Fontana Capalbo (#8917). However Jack Heinemann disagrees (#8923) and I feel I must respond to his arguments which I find somewhat specious.
It is perhaps noteworthy that the 2012 draft of the guidance stated that "the recommendation on the acceptability of risk(s) should take into account any available scientific analysis of potential benefits for the environment, biodiversity and human health" but by the 2015 draft the word "should" had been diluted to "may" so there is obviously some dissent on this matter. Nevertheless, a number of countries do specifically refer to benefits in their biosafety legislation even if this is not a feature of the CPB.
To specifically address Jack Heinemann's points:
While I agree that Annex III does not include information on a benefit analysis this does not mean that it has to be excluded. Dr Heinemann suggests that benefit is based on a series of intangible and uncontrolled variables that are out of the realm of a risk assessor. Here I beg to differ, and suggest that the potential benefits, their magnitude and probability can be assessed in the same way as risks. There are in any case ongoing studies that look at socio-economic and environmental benefits already achieved, such as the Brookes and Barfoot studies, and this information may be used to inform some future-based assessments. I understand that IFPRI also has an ongoing project to answer the question "Is there clear use and benefit to agricultural biotechnology in developing countries?"
Dr Heinemann asks the question: if a product promises to reduce pesticide use, how long must it do this for it to have delivered on the promise? Certainly a time line in terms of reduced pesticide use can be monitored, and the Brookes & Barfoot studies again provide data over such a timeline. However conversely, I am not aware that any risk assessment includes consideration of the length of time that the risk will exist so he is to an extent putting an expectation on the assessment of benefits that he is not including in the assessment of risks.
He points out that assessment of risk is backed up by legislation to ensure that risks are mitigated and monitored, there is no equivalent legislative provision to compel delivery of benefits. This is perhaps the fault of the legislation rather than an argument not to consider benefits. Nevertheless, some countries do require applicants for permits under their legislation to provide information on benefits, such as the Philippines, which asks applicants to provide a "summary of potential benefits (describe how the new trait will benefit farming, the farmer, the environment and society as a whole". Whether this is subsequently monitored is another matter.

I am grateful to the forum for providing the opportunity for some robust debate on this matter.
posted on 2018-02-10 11:35 UTC by Dr Jane Morris
RE: Consideration of benefits [#8929]
Dear Tim, dear all,

In response to Topic 3 “Perceived gaps in existing guidance materials on risk assessment, and proposals to address any gaps identified”: the various posts show that there are many perceived gaps, and to go from “perceived” to actual “identified” gaps, we need adequate criteria.

In this respect it is useful to look at the MOP8 decision, which refers to “needs”, “priorities” and “gaps”. It is important that we keep in mind the distinction between “needs” and “gaps”, because not every need constitutes a gap. Moreover, not all needs are the same, some will have more priority than others.

I support the observation by others in earlier posts that the methodology as laid down in Annex III allows experts to conduct environmental risk assessments of all LMOs that are currently under development,  including LMOs under development through the various approaches such as genome editing, synthetic biology, gene drives, etc.

Having said that, fact is also that guidelines, decision documents and background documents on crops and traits can be very helpful in reducing the resources and time needed for risk assessments. The key beneficiaries of that will be authorities, applicants and, indeed, society as a whole.  With regard to the latter: it would for example be very regrettable if decisions potential solutions for important challenges such as Vitamin A-deficiency, malaria or the zika virus would be significantly delayed because an authority has difficulty in applying the methodology of Annex III without specific guidance.

In summary, while there is no need for additional guidance in the sense that otherwise a risk assessment in accordance to Annex III could not be conducted, there is certainly benefit in having guidance documents available.

Since this on-line forum is expected to provide input to the SBSTTA, I would recommend that the SBSTTA be advised to make a list of the topics that have been suggested for additional guidance and compare that list with the list of available guidance resources. Next, if there are topics that are not adequately covered by existing guidance or guidance that is under development, the SBSTTA should propose criteria for prioritisation of those remaining topics. For me the key criteria would be a) applications of potentially significant societal benefit that b) are in advanced stage.

Once important topics have been established for which there is not yet guidance available, then the next question is which body or organisation is best equipped to provide such guidance. This is a matter of efficiency and synergy, which is also reflected in article 29 of the CPB stating that the MOP will “seek and utilize, where appropriate, the services and cooperation of, and information provided by, competent international organizations and intergovernmental and non-governmental bodies”. As I illustrated under Topic 1, there is a whole range of relevant organisations out there with specialised expertise, such as the OECD, IPPC, OIE, etc.

Finally, some observations on comments made in earlier posts.
a) I support Werner Schenkel’s observation that the suggestion to use the term “research-based risk assessment” is misleading. More in general, as we are talking about risk assessment in the context of decision making we should constantly remind ourselves of the important distinction between ‘nice to know’ (e.g. interesting research questions’) and what is ‘need to know’ with regard to decision making on a specific case.
b)  I support Jane Morris and others in the suggestion that there is a need to provide guidance as to how to deal with benefits. That need is clearly illustrated by Jack Heinemann’s reaction to that suggestion. In such guidance, it should first be explained that benefits can play a role in the scientific risk assessment under the CPB as well as in the final decision making. That benefits can play a role in ERA under the CPB is clear from, for example, Annex III which refers under the Methodology of ERA in point e) to “A recommendation as to whether or not the risks are acceptable”. This is linked to the general principle in Annex III that ERA is comparative, i.e. any identified risks should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment. As an example: during an ERA it may have been established that a maize plant with a Bt gene may have an effect on certain butterflies through the consumption of maize pollen by those butterflies. The comparative aspect of the ERA then requires comparing that scenario with the effect of cultivating the non-modified plant, which may include the use of pesticides to combat the pest insect, which can also impact butterflies. I.e., in that case we take in the ERA into account the potential benefit of reducing the use of pesticides. Such comparisons may in some cases be straightforward, but may in other cases also require more elaborate quantitative assessments as suggested by Keith Hayes in earlier posts.

Good remainder of the weekend to all!

posted on 2018-02-10 20:57 UTC by Mr. Piet van der Meer, Ghent University, Belgium
RE: Consideration of benefits [#8937]
Dear Tim and all
I write this to follow up on the interesting interventions by Piet van der Meer (#8929) and Maria Mercedes Roca (#8930).
Of course I understand that the role of this forum is not to challenge the CPB itself, yet perhaps it is time for those who have some influence in these matters to consider whether there is a need for change in the light of lessons learned since the introduction of the Protocol. This is also a point that we make in our recent book on "Genetically Modified Organisms in Developing Countries: Regulation and Governance" that I mentioned in my original post (#8879).
Piet indicates that Annex III does indeed make provision for benefits to be taken into account. Unfortunately the consideration of benefits is not explicitly mentioned, and his solution seems to be a bit of a work-around. The majority of real-life risk assessments do not seem to explicitly consider benefits and I suggest that the lack of clarity on this matter has severely hampered the introduction of LMOs in many countries. This is reinforced by Jack Heinemann's statement that "Annex III neither includes instruction on how to conduct a benefit analysis nor suggests that one is required for a scientifically sound risk assessment".
Indeed the only reference to benefits of LMOs in the CPB is in the Preamble which states "Recognizing that modern biotechnologies have great potential for human well-being...." . Interesting also that this does not indicate potential for environmental well-being! The introduction to the Explanatory Guide does detail some potential benefits but how (or if) these are to be taken into account is never explained.
Maria Mercedes Roca also states that the focus on Precaution and the lack of a benefit vs risk analysis represent flaws in the CPB.
One could argue that it is only the less experienced regulators in developing countries who will take a narrow perspective on a risk assessment leading to non-adoption or prohibition of the technology, as indicated by Maria. However this attitude is also reflected in the European position. European feedback on the 2012 Guidance draft stated that "The EU does not support an approach to risk assessment that balances risk acceptability with benefits". Since many developing countries follow the EU's position, this does nothing to move things forward.

I do hope therefore that this discussion may prompt some soul-searching that will influence not only the guidance but the whole approach to risk (and benefit) assessment in the international community.

Food for thought for the rest of the weekend!
posted on 2018-02-11 12:04 UTC by Dr Jane Morris
RE: Opening of the discussion [#8931]
Dear Tim, Dear all—

Many thanks to all participants for an interesting and informative discussion.  The topics of synthetic biology and gene drives have been raised about 10 times each throughout this thread. As these are the topics I know best, I would like to add a few comments.  In addition, given that we are nearing the end of the discussion, I will also attempt to tie together some other themes that have been raised throughout the discussion.

First, I note postings from 5 participants (including myself) at the recently held Synthetic Biology AHTEG meeting.  Luciana’s posting [#8914] quotes the AHTEG’s key conclusions relevant to this online discussion, which I will briefly repeat: current “principles and methodologies… provide a good basis for risk assessment of organisms developed through synthetic biology” and that virtually all examples of such organisms “fell under the definition of LMO’s as per the Cartagena Protocol”.  I agree with Luciana and Boet [#8874] that no new guidance is necessary.  But as the AHTEG also stated, “updates and adaptations might be needed”.

Potential applications of LMO’s that include gene drives, in my view, is a good example of the latter.  In a recent Correspondence in Nature Biotechnology, 32 coauthors and I reviewed existing guidance documents for research on, and testing of, genetically engineered insects (including guidance by regional and international institutions, such as the CBD and World Health Organization).  Most of these documents addressed earlier generations of the technology; several directly addressed gene drives.  http://www.nature.com/nbt/journal/v35/n8/full/nbt.3926.html . We identify what we believe are the most important areas where current guidance needs to be updated and adapted.  Fortunately, much of this work is already underway and will be appearing soon. 

Boet [#8874] also most helpfully, in my view, broadened the discussion from identifying gaps to identifying priorities for revised or additional guidance.  Others (including Maria [#8889], Karen [#8886], Piet [#8929], and more) stressed the importance of setting priorities.  As technical experts, we can all too easily be distracted by interesting gaps in knowledge about LMOs unlikely to make it to market or lead to adverse effects on biodiversity.

Several participants pointed out that other organizations (such as IPPC, as represented by Adrianna [#8858], OIE, OECD, and others) are also engaged in these activities and may be better choices for providing additional guidance on some LMOs.  Relevant to the topic of genetically modified mosquitoes, including those with gene drives, I would like to add one other organization that is crucial:  WHO, which has been actively engaged in providing guidance on insects that transmit human disease for years.

Finally, the topic of benefits was mentioned dozens of times throughout the discussion.  One clear need, in my view, and recommended by many participants of this online forum, is guidance on evaluating potential benefits in addition to risks.  Though not strictly the topic of this thread, I do hope that this perceived need and its importance is communicated to SBSTTA and ultimately to COP-MOP.

Regards to all,
Bob Friedman
posted on 2018-02-11 02:10 UTC by Mr. Robert Friedman, J. Craig Venter Institute
Topic 2 [#8932]
Dear all,

As we near the end of this online forum, I would like to again express my gratitude to Tim for moderating this discussion and my thanks to the Secretariat for inviting us to share our views.

Regarding topic 2, I support the many views that there is already plenty of good methodologies available for assessing the risk of LMOs. 

As in previous online fora, I beg your indulgence in allowing me to wear my teacher/educator’s hat to share my views on the need to develop further guidance.  I trust I am not mistaken by thinking that at the core of developing ERA guidance, we are mainly discussing training material for inexperienced risk assessors from developing countries?  Many commentators with experience in Environmental Risk Assessment (ERA) have pointed out repeatedly that there are sufficient ERA guides of high quality already published, and which are freely available to regulators wishing to learn how to conduct a risk assessment.

These excellent guides come from different representative sectors ranging from international,  regional and government agencies. Examples include guides published by FAO, OECD,  EFSA, OGTR,  and from countries like Cuba, Argentina and India,  to name only a few.

To add to this robust list, there is a new ERA guide published in English in its second edition, developed to help students and young researchers in biotechnology/ synthetic biology from developing countries, as well as regulators needing to conduct  ERAs for new and emerging technologies.  The first edition of this guide was developed in Portuguese and Spanish by experienced risk assessors from several regions, but mainly from Latin America (many have served in the RA AHTEG). This first edition included real case examples from risk assessments dossiers from  Brazil, Argentina, Colombia,  Mexico and Honduras and has been used by regulators of several Latin American countries such as Paraguay and Central American countries.

The second revised edition of the Latin American ERA guide is in English  (still in its final draft) so it can be used by a wider audience in developing countries.  This second edition has expanded the scope to include  GM agricultural crops, GM trees,  GM mosquitoes,  and  GM yeast for confined use. Understanding the important contribution of genome editing, gene drives and other emerging technologies, the second edition also has a comprehensive glossary in English, Spanish and Portuguese and includes terms and concepts used in synthetic biology (still without a formally accepted definition).

Prior to final publication in 2018 before the next COP-MOP, the authors and editors want to consider advances in both the fields of risk analysis and in synthetic biology. Furthermore, they have plans to translate the second English edition into a third edition in Spanish for the benefit of Latin American developers of new technologies (students and researchers from local universities and research institutions ) and for risk assessors and regulators from government agencies. 

Finally, it would be a great addition to our discussion if somebody could share a comprehensive list of all the available ERA guides already available and if an experienced researcher in risk assessment did a comparative review of the different approaches and contents of the many guides already available.  With so many training texts for regulators and trainers of risk assessment, it is difficult to decide which resources to use. Thus, I support other commentators in stating that we do not need further guidance at this point. Furthermore, I feel  that adding  one more general  resource (“one-size-fits-all”),  that has not reached consensus among AHTEG members since its inception almost a decade ago, had mixed reviews when “tested” by 34  parties  with experience in commercial releases of LMOs, and was further  not endorsed or welcomed  by parties  at the last MOP in Cancun, would add confusion to an already confused field.

Many thanks for the opportunity to share my views and best wishes to all,

posted on 2018-02-11 06:51 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
RE: Opening of the discussion [#8933]
Thanks Tim for moderating this forum. Thanks all colleagues for sharing their views.

I agree with many that there is an abundance of guidance for Risk Assessment and Management consistent with the CPB. As already pointed out, several available good resources including from OECD, EFSA, OGTR, etc. At this stage, there is no need to develop additional guidance (#8873-Boet Glandorf, #8888-Maria Kammenou, #8899-Heidi, #8904-Misuzu Watanabe, #8913-Luciana Ambrozevicius, #8916 Deise Capalbo, and others).

Perhaps one of the reasons for the perceived gap comes from the not so user-friendly search option at the BCH, that some resources are missing, and some additional work is needed to make this important tool more useful to parties and non-parties.

I share the opinion that the voluntary Guidance developed by the AHTEG has information that can help risk assessors but it is also confusing ([#8925]-Rafael Romero, [#8920]-Piet van der Meer, [#8890]- Josphat Muchiri). For instance, [#8926]-Chalinee Kongsawat sharing their experience, mention requesting information difficult to differentiate between "nice to know" and "needed to know".

Before much effort and resources are spent on developing new guidance that may take too long to be clear and easy to follow and that may be unnecessary, well-thought criteria are needed including reviewing the available information and ease of access at the BCH.

I also would like to echo the importance of weighing the potential benefits versus the potential risks in decision making, as the newer product can have risks less serious than existing alternatives.
posted on 2018-02-11 08:30 UTC by Ph.D. Lúcia de Souza, PRRI - Public Research and Regulation Initiative/ANBio (Associação Nacional de Biossegurança - Brazilian Biosafety Association)
RE: Opening of the discussion [#8936]
Dear participants to the forum,

In addressing topic 3 of our discussion, ‘Perceived gaps in existing guidance materials on risk assessment, and proposals to address any gaps identified’, I am of the opinion – in concurrence with others [#8874] [#8889], [#8896], [#8905], [#8909] and [#8914]-  that currently and for the foreseeable future, there are no gaps in existing guidance and thus it is not necessary to  initiate work for developing further guidance on specific topics. Countries or individual risk assessors that perceive gaps in exiting guidance materials should present their specific examples where challenges were encountered (and not solely anticipated). 

Some posts to topic 3 point to specific “technology” (for example, the umbrella term of synthetic biology, or RNA interference, etc.) as a trigger for development of specific additional guidance. Such an approach is however erroneous as it is displacing the focus of risk assessment  from the characteristics of the living modified organism to the technology or processes used in its development.  Furthermore, exiting guidance and the principles and methodology of Annex III would be sufficient to address such perceived new cases.

As pointed out in comment [#8914] above, the synthetic biology AHTEG (CBD/SYNBIO/AHTE/2017/1/3) concluded “the general principles and methodologies for risk assessment under the Cartagena Protocol and existing national biosafety frameworks, as well as voluntary guidance, could provide a good basis for risk assessment of organisms developed through synthetic biology”.  This was similarly the conclusion of the moderator in the Online Forum on Synthetic Biology held July-October 2017, who stated, “in light of the frameworks that are already in place in the context of the Cartagena Protocol there is probably no need for new or unique regulations or provisions, and that if new regulations are put in place they have to be evidence-based and proportionate to risk.”

Finally, perceived “gaps” seem to be attributed to a myriad of realistic and hypothetical scenarios. I agree with previous commenters that it is therefore very important that agreement is reached on the criteria for identifying gaps and for development of new guidance.

Amongst the considerations for development of new guidance, I propose the following:

-          Empirical and evidence-based demonstration by a Party and supporting consensus in the risk assessment community with proven experience in the field, that existing risk assessment and risk management measures would fail to provide adequate protection level of humans and the environment;
-        Evidence based on scientific studies that demonstrate that Annex III is not fully adequate for addressing identified risks, including to appropriately assess environmental risk;
-        When identified as needed, additional guidance is developed by risk assessors with proven scientific and technical expertise and is further validated in a real-world, scientifically robust manner.
posted on 2018-02-11 11:43 UTC by Dr. Ana Atanassova, EuropaBio
RE: Opening of the discussion [#8940]
Dear Tim,

Thank you very much for taking on the responsibility to moderate this forum.

Dear colleagues,

I have carefully reviewed the many interventions made to this point.  It is my conclusion that Topic 3 is the most complicated because terms like “gap” and “guidance” have been undefined and left to personal interpretation.  Importantly, this forum was not asked to consider criteria for determining “gaps”.  Several commenters (#8874, #8879, #8889, and #8896) identified this issue as important to provide necessary structure and context. 

With regard to the question of what is a “gap”, I perceived (at least) three distinct threads.  First, as in past years, there has been reference to topics which some participants to the forum perceive as novel and/or they believe there is a deficiency of basic scientific information need to conduct a risk assessment.  I address this from a historical perspective under Topic 1 where I have found references in CBD reports to about 65 different topics in need of “guidance”.  Not surprisingly, perceived and actual “gaps” differ depending on who is making the evaluation.
Second, we had an interesting exchange of ideas on benefits assessments (#8879, #8923, and #8928) and whether or not this is a “gap” to address.  Whether there will or ever could be international agreement explicitly standardizing and providing guidance on benefits information in risk assessments under the Protocol will be a long negotiation.  Nevertheless, I personally found the exchange thought provoking. 

Third, I was struck by #8867 and other references to the use of more sophisticated statistical methods in an attempt to better quantify information used in risk assessments.  In my experience with risk assessment, I have seen many methodological improvements to the experimental approach to collecting and analyzing data.  I fully expect this to continue regardless of this forum since scientific improvements are in the best interest of regulators and registrants.  But, as a question for this forum, I do not see a workable path to creating guidance on making methodological improvements, which are frequently ad hoc and result from scientific advances (not guidance). 

In conclusion, I am concerned that material improvements to risk assessments and capacity building cannot be made using a process that has failed to deliver widely acceptable guidance after 12+ years.  The exchange of views has been enlightening and useful for me personally.  However, the continued lack of definitions and criteria applied to this discussion will only result in more years of disagreement at an international level.   

Thank you for allowing me this opportunity to contribute.
Tom Nickson
posted on 2018-02-11 15:58 UTC by Mr. Thomas Nickson, Consultant
RE: Opening of the discussion [#8942]
Dear Tim, dear colleagues,

A couple of days ago during the online Forum discussions, I have already provided my suggestions concerning gaps in risk assessment guidance and how to address them. Reflecting on this thought-provoking debate over the last few days, allow me to share a few further observations:

Firstly I think it is important to differentiate in the discussion between the question if benefits assessment on LMO products should be done and the question if there is a gap in risk assessment guidance which should be addressed by complementing guidance on benefits assessment.

On the first point: benefits assessment as part of decision making is probably done by many if not all decision makers, either implicitely or explicitely. So there is no question if this should play a role, it is already done and implemented in practice. However, for good reason it is not and should not be part of a risk assessment , but definitely is part of decision-making. Risk assessment should be based on scientific principles and on data, inter alia resulting from research.

However, if in the area of risk assessment, guidance on benefits-assessment needs to be done, is less clear or even highly questionable based on the observation above that it is part of decision-making.

That is why I think that it is probably worth-wile to consider both - complementing existing guidance on risk assessment, by developing additional guidance in those areas where many experts - in the past and also during this online Forum - have identified gaps, e.g. LMOs resulting from gene-drives, certain areas of synthetic biology, or new molecular biological techniques, LM organisms such as fish, certain micro-organisms etc etc. And then, provided that there is a decision by Parties to do so, also developing guidance on how to implement benefits assessment as part of decision-making, but also strictly based on scientific principles and socio-economic data.

However, these are two completely different subjects, concept-wise, with respect to the necessary scientific expertise for developing such guidance, the relevant models etc.

Unfortunately experts have mixed these two items here together in an unsuitable and flawed manner.

Let me also remind all of us that there is a very important complementing process already ongoing under the Cartagena Protocol which is already fully taking into account the concept on benefits assessment, and that is the existing AHTEG and online Forum on socio-economic considerations. If we have relevant thoughts on benefits assessment and related areas let us address them there and not under the risk assessment discussions.

I hope that the subsequent process (Report from the online Forum, peer-Review, SBSTTA, COPMOP) will be addressing these important concepts in a structured and scientifically valid manner, so that we can make real progress in this area.

I am sorry for sharing these observations so late, but many of the the pervious comments on benefits assessment have been posted very late in the debate.

Thank you and best wishes to all

Helmut Gaugitsch
posted on 2018-02-11 17:05 UTC by Mr. Helmut Gaugitsch, Austria
RE: Opening of the discussion [#8943]
Dear Tim and colleagues,

I tend to agree with Jack (#8923) and Helmut (#8942) on the difference between a 'risk assessment' and its potential gaps and a 'benefit assessment'. Therefore, in the case of a demand from Parties, the latter should be discussed separately.

Thank you

posted on 2018-02-11 18:58 UTC by Dr. Sarah Agapito-Tenfen, GenØk Centre for Biosafety
RE: Opening of the discussion [#8944]
Dear Tim and all

I thought I had said enough about benefit assessment but in the light of the post by Helmut Gaugitsch I feel obligated to respond.
He, as well as Jack Heinemann, feels that a benefit assessment, where it is carried out, forms part of the decision making process. I beg to differ from this viewpoint.
A risk assessment is carried out as a separate process that then feeds in to the decision making process. I fail to understand why a benefit assessment should not also be carried out as a separate process to feed into the subsequent decision making. Decision makers surely cannot be in a position to take potential benefits into consideration without a prior assessment of those benefits.
I would also like to stress that benefits do not only fall in the socio-economic category and therefore discussion cannot be confined under that heading. For instance, I doubt if possible increases in biodiversity as a result of reduced pesticide use would be considered in that forum. Benefits can be multi-dimensional in the same way that risks are multi-dimensional, encompassing many aspects of environment, agriculture, health etc.

After this post I shall endeavour to keep quiet!
posted on 2018-02-11 19:00 UTC by Dr Jane Morris
RE: Opening of the discussion [#8950]
Dear Jane, Jack and Helmut, dear all,

Many thanks for your insightful comments on the “correct” methodology to include, or not include benefits in an environmental risk assessment.  As a group, we may agree to disagree on this topic, yet whether we include benefits, or not in the  ERA  or in Socio-Economic Considerations,  as some commentators suggest, is a key issue, especially for training purposes.  Having clarity on this issue may help us advance in the right direction.

I offer the suggestion that to define “a risk vs. benefit analysis” or a “comparative risk analysis” that includes benefits would indeed be very helpful for future training purposes.

Dear Helmut, if you maintain that benefit belongs outside an ERA, where would you put the risk of inaction? Action may bring a benefit and by definition, inaction may bring a risk. Who assesses that risk? The socio-economics evaluators?  Indeed, there is a risk of not adopting a technology when one is available (eg. vaccinating babies in endemic areas vs. no vaccination). Who measures if maintaining the status quo with the “conventional technology”(eg use of pesticides vs. Bt crops) is less risky? I believe we have a case for risk assessment here.

Here is my humble opinion: both risks and benefits are very subjective to the context in which the technology is applied. As an example, let’s consider if the same ERA methodology was used to train European and Latin American regulators.  Because of winter cycles and other agro-ecological conditions,  farmers in Europe are more protected (or less vulnerable - both sides of the same coin) from insect pests to crops like corn than  say Peruvian,  Bolivian  or Central American farmers, who have very high rates of lepidopteran and coleopteran  insect damage and other pathogen pressures like viruses and fungi. Not taking action in Austria does not constitute a risk (or indeed a benefit). However, for farmers in tropical countries, not addressing pests problems appropriately is akin to financial ruin and environmental and health decline,  if the only alternative is not applying pesticides at all, or applying pesticides that are more harmful than the Bt technology. Another good example to consider is gene drives for mosquitoes to address deadly diseases like malaria, dengue or Zika that exist in tropical countries and not in Europe.

A lot of GM technology was developed to address agricultural constraints and now to address health issues outside Europe. However, we all know that the EU is the main driver of international biotechnology or GM policy that permeates policy in developing countries that have very different contexts.  As " trusted older brothers" (I mean this with the greatest respect), many in developing countries watch what Europeans do and then follow. I know this because I  hear students often state the following: "if Europeans think GM technology (or now gene drives or synthetic biology) is dangerous, it must be true".  "They know better... they have more experience and are more educated than us" ...

I won't even address issues of European development agencies and activist groups working in developing countries that greatly influence policy, maybe with the best intentions.

Thus, a careful definition of what constitutes risk vs. benefit is indeed required in training workshops for both developers of new technologies and for regulators.

This is of course my personal view. I would be most interested in your views to, to consider adding an explicit section on this topic  in the second edition of then ERA guide for Latin America.

Many thanks for sharing your thoughts,

posted on 2018-02-11 21:08 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
RE: Opening of the discussion [#8947]
Dear Tim and Colleagues

On Topic 3 related to “Perceived Gaps”, I am of the view that limited experience in conducting risk assessment of LMOs is the biggest gap. Developing additional guidance documents would not resolve this issue.  Real time experience is required by Parties to come up with identified gaps based on their national priorities, needs and identified protection goals.

I support the observation by Maria (#8870) regarding the importance of “history of safe use” and “data transportability” in the risk assessment process.  One other limitation is the availability of baseline information.

I also support Boet’s (#8874) proposal for developing criteria to decide on the need for developing additional documents with due considerations to alternatives available to address the identified gaps.  


Ranjini Warrier
posted on 2018-02-11 19:34 UTC by Dr. Ranjini Warrier, India
RE: Opening of the discussion [#8952]
Dear Tim,

I guess that you wish that you had had this kind of active debate in the early phases of this on-line forum…

Although it is Sunday evening, I am indeed tempted to respond to some posts about benefits, as they have been an eye opener in some respects.

In response to post #8937 of Jane Morris:

True, despite that the legal basis of the Cartagena Protocol is article 19 of the Convention, which deals with “handling of biotechnology and distribution of its benefits”, it often seems that there is more focus on hypothetical risks than on likely benefits.

Yet, the cause of this does not lie in the CPB, but in the way in which some authorities implement regulations. As said, the CPB suggests in Annex III to take certain environmental benefits into account in the risk assessment, as part of the comparative element of the assessment. For example, if we look at the potential impact of a certain LMO on a specific component of biodiversity, such as non-target organisms, then we take – in a holistic fashion - the potential adverse impact as well as the potential beneficial impact on that non-target organism into account. Leaving the potential benefits out of the equation would not be in the interest of the non-target organism and of biodiversity as a whole.

Heinemann's argument that "Annex III neither includes instruction on how to conduct a benefit analysis nor suggests that one is required for a scientifically sound risk assessment" is – as you put it so aptly before – specious. If we were to follow that logic, then we could not consider potential impacts on non-target organisms in the environmental risk assessment, because non-target organisms are not mentioned in the Annex III nor in the rest of the CPB.

About your concern that the statement in the Preamble "Recognizing that modern biotechnologies have great potential for human well-being...." might not refer to environmental benefits: since the Stockholm Conference in 1972 it has been recognized that environmental quality is a key component of human well-being. And for a more explicit reference in relation to biodiversity: article 16 of the CBD states explicitly that both access to and transfer of technology, with biotechnologies explicitly included, are essential elements for the attainment of the objectives of the CBD.

Finally, thanks for drawing the attention to the EU feedback on the draft guidance which stated that “The EU does not support an approach to risk assessment that balances risk acceptability with benefits". This prose is so convoluted that I must have read over it. Risk acceptability means weighing risks and benefits. But “balancing risk acceptability with benefits” makes little sense. Perhaps the EU meant that they did not want to weigh the benefits twice, which I could understand. If, however, this phrase intends to suggest that in an ERA in the EU potential beneficial impact should not be included in the assessment of the potential impact of a GMO on non-target organisms, then I advise to look into the history and text of Annex II of the GMO Directive on with the principle and methodology for environmental risk assessment. Part D of that Annex II is titled “Conclusions on the potential environmental impact from the release or the placing on the market of GMOs”, and states in the opening paragraph: On the basis of an e.r.a. carried out in accordance with the principles and methodology outlined in sections B and C, information on the points listed in sections D1 or D2 should be included, as appropriate, in notifications with a view to assisting in drawing conclusions on the potential environmental impact from the release or the placing on the market of GMOs. Where sections B and C talk about ‘potential adverse effects’ and ‘risks’, section D talks about ‘Impacts’.

In response to post #8942 of Helmut Gaugitsch:

As I posted before: benefits can be part of the risk assessment and of decision making, and above I have illustrated with the example of non-target organisms how certain environmental benefits can be part of the environmental risk assessment.

I fully agree with Helmut where he said “benefits assessment as part of decision making is probably done by many if not all decision makers, either implicitly or explicitly”. Also in the EU we have done this, for example in the early years of the GMO Directive with the release of the rDNA vaccine against the Aujeszky disease.

However, I am troubled by Helmut’s next statement “However, for good reason it [benefit assessment] is not and should not be part of a risk assessment”.  The wording “is not and should not” were an eye opener for me vis a vis the process we have gone through over the years.

The post continuous with “Risk assessment should be based on scientific principles and on data, inter alia resulting from research.”. This is very true, and can indeed be applied to assessing both the potential adverse effects and the potential beneficial effects on, to stay with the example, non-target organisms.

This part of the post ends with “Unfortunately experts have mixed these two items here together in an unsuitable and flawed manner”. I believe that that comment is uncalled for, because it fails to recognise the difference between environmental benefits which can be taken into account in risk assessment and other benefits, such as socio-economic benefits, which can be taken into account in the decision making.

In response to the post of #8947 of Ranjini Warrier:

I believe that Ranjini hits the nail on the head where she says: ”I am of the view that limited experience in conducting risk assessment of LMOs is the biggest gap. Developing additional guidance documents would not resolve this issue.  Real time experience is required by Parties to come up with identified gaps based on their national priorities, needs and identified protection goals. “.

I fully agree with that sentiment. While it is very convenient to have guidance documents available, it is crucially important to “learn by doing:” i.e. going through the process of handling a real notification, with real deadlines, etc etc. Such an exercise would be extremely valuable for both authorities and applicants.

Perhaps there would be mileage in public research institutes obtaining funding from the CBD budget to prepare and submit a request for a field trial with a GM crop in the country where they are based.

Finally, in response to post #8936 by Ana Atanassova:

I fully endorse the comment  that “Some posts point to specific a “technology” as a trigger for development of specific additional guidance, and that such an approach is however erroneous as it is displacing the focus of risk assessment  from the characteristics of the living modified organism to the technology or processes used in its development”. 

Regards to all!

posted on 2018-02-11 21:42 UTC by Mr. Piet van der Meer, Ghent University, Belgium
RE: Opening of the discussion [#8948]
Dear Tim thank you for moderating, dear colleagues,
Many thanks to the Secretariat for initiating this fora and apology for late arrival. Detlef [#8906] from BVL, Berlin sent me recently a very nice document published by the European Food Safety Authority (EFSA). The document “Guidance on Uncertainty Analysis in Scientific Assessments” has been published in EFSA Journal doi: 10.2903/j.efsa.2018.5123 and in my opinion should be considered when we discuss Topic 3.
Although, I do agree with some of the colleagues who have pointed out that RA and SA differ to some extent.

Best Wishes,
Hrvoje Fulgosi
posted on 2018-02-11 19:44 UTC by Hrvoje Fulgosi, Croatia
RE: Opening of the discussion [#8949]
Greetings everyone and thank you very much or the opportunity to contribute to this discussion, and to the moderators for a great job in promoting discussion.

As raised by several contributors here, I believe that the Risk Assessment Guidance produced by the previous AHTEG on Risk Assessment and Risk Management is a useful tool and provides thorough guidance for certain types of LMOs such as those with stacked traits. It would be very useful to include such specific guidance on LMOs developed with emerging synbio technologies such as dsRNA, gene editing, gene drives, and other new GM techniques that modify the epigenome. Most of these techniques raise unique issues in relation to off-target effects, lack of suitable detection methods, identification of assessment endpoints, and suitable comparators. Section 1.5.1 on RNA interference provides a starting point on the background of RNAi and possible additional considerations that could be expanded.

As mentioned by other contributors, some specific guidance on LM soil microorganisms, fish and insects could also be useful. For LM fish, adverse effects on wild salmon population numbers are already a problem with unintended escapes of farmed non-LM salmon and may be exacerbated by the escape of LM salmon, depending in each case on the intended and unintended effects of the genetic modification. Risk assessment guidance could therefore include specific considerations on effects on genetic diversity, behaviour, mating success and survival success of their non-modified counterparts.  LM insects such as mosquitoes, raise specific considerations surrounding the potential adverse effects of unexpected releases of biting females, the potential rise of other disease vectors following suppression of the target species, wider effects on food webs and ecosystems in cases where there are drastic reductions in target populations, and survivability of LM insects with tet-inducible systems in relation to potential environmental presence of tetracycline, amongst other issues.

I also concur with Dr Agapito-Tenfen’s contribution (#8918) and the use of “omics” technologies as useful tools in addressing potential gaps, especially in light of emerging technologies such as gene editing and RNAi organisms, where it could be particularly appropriate in detecting off-target effects.
posted on 2018-02-11 19:47 UTC by Dr. Eva Sirinathsinghji, Third World Network
RE: Opening of the discussion [#8951]
My dear colleagues,

a number of technical methods were mentioned within the 'gap' discussion round (latest #8949). I don't think many of the techniques, especially 'omics' are yet mature enough to contribute substantially to the risk assessment framework. Some of these technologies produce a huge number of 'differences' between test treatments independent of plausible/specific risk hypothesis. I have high respect to developers of these technologies in research activities. But unless a clear and guided hazard identification is established such detection methodologies would generate more problems than solutions.

Kind regrds

Detlef Bartsch, BVL, Berlin
posted on 2018-02-11 21:14 UTC by Prof. Dr. Detlef Bartsch, Germany
RE: Opening of the discussion [#8953]
Dear forum participants,

I would like to address references made in our discussion on risk assessment gaps to  specific “synthetic biology techniques” and note that after several years of discussion under CBD, no one has identified exactly what is included under the  term of “synthetic biology techniques”.

The AHETG’s definition of synthetic biology was considered by COP/MOP13 useful as a starting point (i.e. not a final definition) for the purpose of facilitating scientific and technical deliberations under the Convention and its Protocols.

While there was a lot of debate as to whether the AHTEG definition brings any distinction between  “synthetic biology” and the terms “modern biotechnology”  as defined under the Cartagena Protocol and “biotechnology” as defined under the Convention,  it is very clear that no discussion has taken place to agree on what “techniques” belong to the category “synthetic biology”. From my point of view, methods like RNA interference and  gene editing do not belong to the category of “synthetic biology”.

In addition, I would like to  share with these of you that may be interested in the relevance of ‘omics techniques in the context of regulatory risk assessment of chemicals a recent publication by Sauer et al., 2017 presenting a comprehensive evaluation of the challenges for use of ‘omics technologies. The same considerations will be equally applicable to the use of ‘omics data in the context of LMO risk assessment.

Kind regards,

Ana Atanassova
posted on 2018-02-11 21:44 UTC by Dr. Ana Atanassova, EuropaBio
RE: Opening of the discussion [#8955]
Dear all,

Thank you Detlef for posting your concerns regarding the use of omics techniques in RA. I take the opportunity to express into more detail my arguments for the utility of such profiling techniques.

Profiling techniques such as proteomics or transcriptomics are not new techniques, some of these have been used for decades now and they certainly have evolved. In fact, there are several specifically dedicated journals that have been publishing studies on omics also for decades (eg. Proteomics Journal has been running since 2001).

In addition, omics techniques are a reality in most molecular biology labs and they are part of most studies on gene function. They are in the pipeline for drug discovery experiments, disease diagnosis and also plant breeding platforms. In fact, they are routinely used for the discovery of new genes in the development of GMOs.

They can be used to screen non-target molecules that have biological relevance, such as proteins. Imuno proteomics, or the search for proteins with immune activity are actually recommended in the allegernicity assessment by EFSA. It can be also used to screen for unintended side-effects at early stages od the RA, such as the molecular characterisation. They will be very useful too for the RA of complex organisms in which a suitable comparator will not be available, but also to track off-target activity of gene-edited organisms.

Therefore, I must disagree that these techniques arent 'enough mature', or at least not less mature then its use for the pipelines I have mentioned before. Many efforts have been also put into omics validation and standardisation and these is why their use just increases. I would also like to share a paper which discusses how biological background assumptions influence scientific risk evaluation of GMOs because it also brings the discussion on the utility of omics (open access https://lsspjournal.springeropen.com/articles/10.1186/s40504-017-0057-7).

Unfortunately, we are running out of time and this is a much broader discussion. Hopefully, we will have more space to discuss the topic.


posted on 2018-02-11 22:27 UTC by Dr. Sarah Agapito-Tenfen, GenØk Centre for Biosafety
RE: Opening of the discussion [#8957]
Dear Tim,

On Topic 3 related to perceived gaps in existing guidance materials on risk assessment, and proposals to address any gaps identified, I do not believe there are any gaps. 

I would like to support the post earlier today by Detlef Bartsch [#8951] regarding the suitability of certain techniques that were proposed by others in the forum.  I agree that the 'omics' techniques are not useful at this time.  These techniques may be able to identify some differences, but these differences are not predictive as to any associated phenotypic characteristics, nor whether these differences indicate likely adverse effects on the sustainable use of biological diversity.  I agree that urging risk assessors to ask for and rely on 'omics' data is an approach that is likely to cause more confusion in the risk assessment rather than clarity.

As risk assessors we are not just looking for differences or changes in genes or phenotypic traits, but rather for phenotypic traits in that LMO that are likely to result in adverse effects on the sustainable use of biological diversity, namely a scientifically plausible risk hypothesis. 


posted on 2018-02-11 22:51 UTC by David Heron, United States of America
RE: Opening of the discussion [#8958]
Since this is my first chance to participate, I’d like to thank the moderator for chairing this fascinating discussion, and to sincerely thank all the participants for their thoughtful comments.  I very much regret that I have not had more time to spend engaging in the discussion.  I will try to keep my comments brief.

First, I’d like to offer yet another vote of support for the comments by Boet Glandorf in #8874.  Looking at the landscape, I don’t see any gaps in risk assessment guidance.  I think any disagreement on this forum about this point is caused by different understandings of what is meant by “guidance.”  I’m inclined to strongly support Tom Nickson in #8940 on this point.  “Guidance” is not the solution to every conceivable challenge in risk assessment, and frankly, most of what I see being identified as “gaps” in the discussion are simply risk assessments for organisms or applications that have not yet been done, but are not fundamentally different than risk assessments that have been done for similar organisms in the past.  I think Ranjini Warrier says this very eloquently in her post #8947, and I would like to strongly echo this view.  I also have to say that new guidance doesn’t need to be developed every time we invent a new term.  “Synthetic biology” means different things to different people, but I’m not aware of any organism being developed using synthetic biology that has no relation to existing organisms and is intended to be used in a way for which there is no prior human experience.  Yes, specific applications may require thoughtful application of guidance and prior experience – and potentially the collection of new information, to ensure that risk assessment is adequate to the task.  But this will always be true, and there is no guidance document that will save us from the hard work of case by case risk assessment.

I have read with great interest the discussion of benefits as a component of risk assessment.  I am firmly of the opinion that a risk assessment should focus on the task at hand, and not attempt to incorporate every facet or potential interaction that might be of interest to decision-makers.  That means that, in the context of the Protocol, risk assessments are focused on the conservation and sustainable use of biodiversity, not on other things.  While I don’t think a holistic “benefits assessment” makes sense as a component of the risk assessment, I am very inclined to agree with Piet van der Meer in post #8952.  When looking at the likelihood of harm (i.e. risk) from an activity, you simply cannot ignore potential benefits to protection endpoints and claim to be providing an accurate assessment of risk.  This forms part of the context of the assessment.  So if there are benefits to the conservation and sustainable use of biodiversity they must, of course, be part of the assessment.  As far as whether guidance on the incorporation of benefits into risk assessment is needed, I would still suggest that this is not a gap, and that there is no realistic opportunity for a group convened at the international level to develop something more useful than what is already in existence.
(edited on 2018-02-11 23:16 UTC by Andrew Roberts)
posted on 2018-02-11 23:16 UTC by Mr. Andrew Roberts, Agriculture & Food Systems Institute
RE: Opening of the discussion [#8961]
There has been some discussion already of the benefits of qualitative, semi-quantitative, or quantitative methodologies.

A qualitative approach is suitable for most risk assessments although in some situations (where there is sufficient data) it may be useful to adopt a quantitative methodology as an adjunct to a qualitative risk assessment. For example, to gain further insights, to investigate the impact of uncertainty or to examine the benefits of risk management strategies.

A quantitative approach is not necessarily any more objective or precise than a qualitative approach, and invariably there are challenges regarding initial assumptions, describing the quantitative model, and communicating the results.

Objectivity in risk assessment is not achieved through the choice of methodology but rather through ensuring the assessment is transparent with all inputs, assumptions, methods and results clearly described.

Rather than explore in detail any perceived gaps in existing guidance materials on risk assessment (and several contributors including Boet Glandorf (#8873),  Heidi Mitchell (#8899), Misuzu Watanabe (#8905), and Deise Maria Fontana Capalbo (#8916) have already stressed that there is a lot of guidance already publically available), we wish to reiterate the point from our national submission on this topic last year, that the most useful guidance will take not only risk into account, but also potential benefit, as well as risk mitigation strategies. The need to consider benefits in an assessment has already been highlighted in submissions from Jane Morris (#8879), Karen Hokanson (#8881), Werner Schenkel (#8910), Deise Maria Fontana Capalbo (#8917), Rafael Romero (#8925), and Maria Mercedes Roca (#8930) amongst others.

We agree with the submissions from Boet Glandorf (#8874), Maria Kammenou (#8889), Karen Hokanson (#8896), and Misuzu Watanabe (#8905) that there are currently no gaps in the existing guidance material and there is a need to establish criteria for identifying gaps and a process for addressing these once they are identified.
posted on 2018-02-12 00:47 UTC by Stephen Cobb, New Zealand
RE: Opening of the discussion [#8969]
POSTED ON BEHALF OF MARJA RUOHONEN-LEHTO (This message reached the Secretariat before the 12 February 2018 1:00 a.m. GMT closure of the forum)
Dear Tim, dear colleagues,

thank you for an interesting discussion and many interesting views. Special thanks to Tim for moderating the discussions.

As we are soon closing the discussions I would like to make this short intervention.
I strongly support those colleagues who point out that analysis of benefits is not part of the risk assessment process.
In addition, I would like to share the views of my colleagues and myself on gaps identified where additional Guidance is needed:

LM fish
The guidance could consider e.g. the specific life cycle characteristics of fish species, different uses of fish, different modification techniques and breeding strategies, data and research needs, and possible cumulative long-term effects (this list is not exhaustive).

LMOs produced through synthetic biology
The guidance could consider e.g. technical development in synthetic biology, gene drives in synthetic biology applications, specific cases of LMOs produced through synthetic biology and how to carry out risk assessment when it may be difficult or impossible to find a suitable comparator (this list is not exhaustive).

LM soil dwelling organisms
The guidance could consider e.g.  soil biodiversity, soil fertility and plant health. In addition, new approaches are probably needed for assessing possible effects in ecosystems which are highly variable both spatially and temporally due to several abiotic factors (this list is not exhaustive).

LM birds
The guidance could consider e.g. specific life cycle characteristics of birds, modification methods that are used for preserving birds and possible adverse effects to the ecosystem from such approaches, zoonosis issues, especially in relation to migratory bird species (this list is not exhaustive).

In addition to this, the following gaps were identified:

How to perform a "per se" risk assessment? This refers to a situation where a comparator is not available.
How to implement the concept of "limits of concern" in risk assessment?

There has been many good posts on what type of possible criteria could be used when selecting topics for new guidance. They will be very useful in our further work.
We would like to highlight the following: Gaps identified in the risk assessment methodology/framework and urgent need to protect specific aspects of biodiversity.

Thanks once more for an interesting discussion. Sorry for being able to join only at this late stage.

All the best,

Marja Ruohonen-Lehto
posted on 2018-02-12 13:48 UTC by Ms. Melissa Willey, UNEP/SCBD/Biosafety
RE: Opening of the discussion [#8970]
POSTED ON BEHALF OF RICARDA STEINBRECHER (This message reached the Secretariat before the 12 February 2018 1:00 a.m. GMT closure of the forum):
Dear Tim, dear all,

Further to my thoughts on topic 2, here a few points on topic 3.

Thank you to the input provided by Adriana Moreira (IPPC) [8858]: Unfortunately I have not been able as yet to look at the linked document  – but was wondering if ‘adequately addressing environmental risks of plant pests’ would include the emergence of secondary pests that in turn may become a major devastating pest to particular crops, as has happened in the past? This indeed would be an important aspect to cover.

As outlined under topic 2, and as pointed to by for example Francisca Acevedo [8853] and Jack Heineman [8863] the general guidance (part I) would need to be expanded by specific guidance to cover organisms and specifically products produced through synthetic biology; further, specific techniques, such as open field transfer of nucleic acids (including dsRNA sprays) and LM fish (pointed out by Jizhou Lv [8871] and Lim li Ching [8866]) have new dimension or elements of risk, risk assessment and risk management, which are also not covered in previous guidance and cosnstituting a gap. Different parties had previously highlighted the need of guidance also for LM microorganisms and LM algae, also menitoned in this forum, which again constitute a gap in existing guidance.

Further to my intervention on topic 2, it deems necessary to develop guidance and mechanisms of oversight for (synthetic / genetically engineered) gene drives, whether intended for use in agriculture, conservation, disease vectors, or alien invasive species.
It has been pointed out by others in this Forum that guidance is lacking for LM animals which I agree with and which in the case of gene drives for example could range from insects, to fish, to mammals.

Lim Li Ching has pointed out not only various categories that are lacking guidance, but further stated, that this was an open list. This in mind, it would be helpful to study the list of “New Techniques” (current topic of debate in Europe) and check them individually to see which additional guidance would be needed to help risk assessors for cases of genome editing, RdDM, reverse breeding, grafting on GM rootstock etc.  

Whilst different parties will have different procedures for decision making re granting release or marketing of LMOs or SMOs or produts derived by synthetic biology, it would be beneficial to elucidate further the various requirements and methodologies and problems that accompany such processes and that need adressing in decision making. This would in my opinion also address further issues, like quantitative and qualitative risk asessment, as raised by Keith Hayes [8867], which in my experience cannot be an either or. The suggestion to call the latter unscientific is defining “scientific” much too narrowly, indicating that we need to enter into a broader discussion and understanding, also bearing in mind different science and knowledge systems. Regarding uncertainty, there had however been a good and intensive debate on uncertainty analysis and its need and use in risk assessment in the early rounds of the AHTEG. Some of this is reflected in the roadmap. It would be beneficial though to have this very important tool and approach further debated and made available in an expanded form to risk assessors and decision makers.

Concerning the issue of benefit analysis, raised in this forum, I concurre with the opinion of Jack Heinemann, eg as outlined [8923]. Risk assessment and benefit assessment are very different from each other, serving different purposes, requiring different tools, data and approaches. Benefit assessment cannot be seen as part of risk assessment.

Finally, as with other topics and in other bodies, it would be important to cover the issue of conflict of interest and to give guidance on the need and the means to minimise and prevent it.

With kind regards, Ricarda.
posted on 2018-02-12 13:50 UTC by Ms. Melissa Willey, UNEP/SCBD/Biosafety
RE: Opening of the discussion [#8973]
POSTED ON BEHALF OF DR. FLERIDA A. CARINO (This message reached the Secretariat before the 12 February 2018 1:00am GMT closure of the forum):

I support the Misuzu Watanabe’s statement that there are no gaps in the existing guidance materials on risk assessment. Case in point, AHTEG has produced a guidance material on the fundamental methodology of conducting an environmental risk assessment which takes into consideration the need for scientific data in proving the certainty of the adverse effect(s) a LMO in question may bring. Additionally, the fundamental methodology of assessment in place is applicable even for LMO with high heritability of its modified gene or has an ability to move in broad area.
Also, I concur to Boet Glandorf’s response that it is vital to establish a clear process in determining whether a gap existing and needs to be addressed.
posted on 2018-02-12 15:43 UTC by Ms. Melissa Willey, UNEP/SCBD/Biosafety