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

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Opening of the discussion [#8844]
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 2 (Information on needs and priorities for further guidance on specific topics of risk assessment of living modified organisms) please reply to this message.
posted on 2018-01-29 01:01 UTC by Mr. Tim Strabala, New Zealand
RE: Opening of the discussion [#8848]
Issues of consideration in risk assessment should include:
Likelihood of gene transfer to other organisms
Impacts on human and animal health
Likelihood of realizing  potential adverse effects
Estimation of overall risk
Possible consequences

Blessing Aligwekwe
posted on 2018-01-31 15:17 UTC by Ms. Melissa Willey, UNEP/SCBD/Biosafety
RE: Opening of the discussion [#8852]
I recommend visiting and reading the risk assessment  guidance produced by the AHTEG with input from the online forum. Much work went into it and some very useful information was included.
Kind regards to all!

can be read at:
also related to the decision:
posted on 2018-02-01 15:19 UTC by Ms. Francisca Acevedo, Mexico
RE: Opening of the discussion [#8857]
Phytosanitary risks that may be associated with a LMO are within the scope of the International Plant Protection Convention (IPPC) and should be considered using pest risk analysis (PRA) to make decisions regarding pest risk management. To protect the environment and biological diversity without creating disguised barriers to trade, environmental risks and risks to biological diversity should be analyzed in a PRA.
The IPPC Commission on Phytosanitary Measures (CPM) adopted a CPM Recommendation on “LMOs, biosecurity and alien invasive species” and this recommendation can be found at: https://www.ippc.int/en/publications/84228/

The IPPC Secretariat has putted together in 2016 an “Overview on International Standards for Phytosanitary Measures (ISPMs) and their application to living modified organisms (LMOs)”. This material can be found at: https://www.ippc.int/static/media/uploads/ippc_ispmsforlmos_2016-02-24.pdf. We hope that this material will be updated for a more friendly explanatory on its information, for example to include FAQs or case studies related to LMOs in the implementation of the IPPC and ISPMs. 

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 [#8862]
(Following from my submission under Topic 1)
Greetings again

In my opinion, existing guidance (specifically that produced by the RARM AHTEG up to 2016) provides an adequate general basis for RA. This is also the conclusion of years of testing and surveys.

Understandably, it is heavily plant-oriented. If an assessor has good knowledge of the biology of other kinds of organisms that can be made into LMOs, he or she may be able to adapt the guidance. However, if specific biological experience is lacking, then she will need more support such as from Part II of the guidance. It is worthwhile then to expand this section.

The existing guidance produced by the AHTEG is true to the literal wording of Annex III of the Protocol, but mainly limited to paragraphs 8 and 9. In my view, risk assessors might benefit from more development of what is called for in paragraph 3:

Risk assessment should be carried out in a scientifically sound and
transparent manner, and can take into account expert advice of, and guidelines
developed by, relevant international organizations.

What are indicators of ‘soundness’ and ‘transparency’ that can be used by law makers, policy makers and risk assessors to evaluate their processes? How should expert advice and other guidelines, which might conflict, be taken into account? What could constitute expertise? There is some text on this in the introduction, but it is far lower in detail than is the material supporting paragraphs 8 and 9.

With best wishes
posted on 2018-02-02 21:09 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Opening of the discussion [#8865]
From my experiences on the risk assessment of living modified organisms, the risks of LMOs we considered include food safety, resistance to target pests, effects on non-target organism, effects of gene flow and some other unintended effects. With the development of omics, such as Genomics, Transcriptomics, Proteinomics, Metabolomics and so on, the unintended effects would be easily to assess. Meanwhile, a long time and comprehensive assessment should be conducted before making decisions.
There were some similarities between the risks of LMOs and Phytosanitary, some international standards should be propounded to guide further risk assessments. With these standards, risk assessments would be more scientific and reasonable.

Best regards,
Gongyin Ye
posted on 2018-02-06 04:11 UTC by Gongyin Ye, China
RE: Opening of the discussion [#8869]
I agree with Jack Heinemann (#8862) that specific guidance on how to achieve a high quality scientific risk assessment would be beneficial to the international community. Developing this guidance (in the context of the use and release of synthetic biology products) would also provide an opportunity to align CBD recommendations with those of the US National Academies of Sciences Engineering and Medicine (refer to my post on Topic 3).
posted on 2018-02-06 23:29 UTC by Dr Keith Hayes, Data 61, CSIRO
RE: Opening of the discussion [#8871]
Dear all,
  It is my honor to have the opportunity to attend this forum. I am an associate professor from Chinese academy of Inspection and Quarantine. I mainly engaged in detecting techniques for vector-borne diseases and identification of animal resources. Recently, we conducted some risk assessment for imported animal feed such as fish meal and fish oil. I had read through the guidelines on the risk assessment of LMOs and found that this guides focused on Living modified plants and vectors (mosquitoes) rather than Living modified animals. Though there is no genetically modified animal available on the market until now, I believe the possibility of addition of genetically modified animal components in fish meal or fish oil could not be ignored. As we know, the FDA is evaluating the biosafety of gene modified salmons and perhaps in the near future we could buy these modified salmons from market. If possible, we should consider addition of one part about the risk assessment of living modified animals. 
  Besides, the uncertainty of LM mosquitoes is great and we should consider the possibility of transmitting new pathogens by these modified vectors and the influence of them to the ecosystem and environment.
  Best wishes,
                      Jizhou Lv 
                      Chinese academy of Inspection and quarantine
posted on 2018-02-07 05:17 UTC by Jizhou Lv, China
RE: Opening of the discussion [#8873]
Dear Tim,
Thank you for also moderating topic 2, which is on information and views on existing guidance materials on risk assessment. In my opinion there are many guidance materials on risk assessment available worldwide which are in accordance with Annex III of the Cartagena Protocol, among them the voluntary guidance developed under this Protocol. Many of these guidance materials have been mentioned in earlier online fora and can be found in the BCH or via websites of Parties to the Protocol. For example in the EU, guidance documents have been developed by the EFA GMO Panel on LMOs such as plants (for food or non-food purposes), microorganisms, mammals, fish and mosquitoes. These can be found through the following link: https://www.efsa.europa.eu/en/applications/gmo/regulationsandguidance.
Based on the existing guidance material I do not see any need for further guidance on specific topcis of risk assessment at this moment.

Kind regards,
Boet Glandorf, GMO Office, The Netherlands
posted on 2018-02-07 12:19 UTC by Ms. Boet Glandorf, Netherlands
RE: Opening of the discussion [#8876]
Dear Tim, dear colleagues,

thank you Tim for moderating also this discussion under Topic 2. Here are my contributions:

The Guidance on Risk Assessment as developed by a couple of AHTEG meetings with input from online forum discussions is a useful tool to assist conducting risk assessment in accordance with the Cartagena Protocol. It has been tested and reviewed and has undergone many rounds of revisions.

In addition regional guidance documents, such as relevant OECD documents, Guidance Documents by the European Food Safety Authority (EFSA), as well as numerous national Guidance Documents may provide very useful additional information. In Austria the basis for LMO risk assessments can be found in the national legislation (ordinance on deliberate release and placing on the market).

Kind regards
Helmut Gaugitsch
Environment Agency Austria
posted on 2018-02-07 13:38 UTC by Mr. Helmut Gaugitsch, Austria
RE: Opening of the discussion [#8882]
Dear Tim,
Thank you for Topic 2 moderation.  Greetings to all participants.
On my opinion Road map of the existing Guidance on risk assessment is useful tool that can be applied to all LMOs which fall under the Provisions of the Cartagena Protocol, that means that the main focus of this Guidance is environmental risk assessment (RA) starting from field trials to commercial release of Living Modified Organisms. The Road Map covers methodology of the RA starting from problem formulation  to overall risk estimation. On-line forum and AHTEG experts tried to cover all "points to consider" which could be relevant to RA process and helpful for risks` estimation and evaluation, and Parties to the Protocol  contributed on this "points" during the Guidance`s revision. Guidance contains direct examples of RA and references to scientific papers, regulations and Guidances developed by other international organisations.
The objective of risk assessment, under the Cartagena Protocol, is to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health. That`s why it was decided to include risk assessment to human health  in the context of the environmental RA.
At the same time it was established mechanism of references approval  and existing Guidance contains a lot of cross links to relevant Guidances (including applicable to  medical and biological RA  of GMO and GM-products  developed by FAO and other relevant organizations).
Best wishes,
(edited on 2018-02-07 20:31 UTC by Dr. Galina Mozgova)
posted on 2018-02-07 20:28 UTC by Dr. Galina Mozgova, Belarus
RE: Opening of the discussion [#8884]
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
RE: Opening of the discussion [#8901]
Dear Colleagues,

There are certainly some guidance documents for risk assessment of GMOs or LMOs. We shall recognize that each document may root in their specific view and have their own applicable scope. The guidance that were developed and those are going to be developed that were identified by parties have taken or will take all the consideration of current risk assessment methods, approaches and views and focused on developing countries that have the need and are willing to employ. As I understand, they are not designed for developed countries that have already strong national legislation. Those documents are not mandatory and parties can use them at their own willing. I do not see any reason for blocking this process. Those documents are actually step by step manual for people to follow and focus on specific issues that may not be covered by a general guideline. From my point of view, the focused subjects of those guidance documents are different compared to others. Obviously, GMO is not equal to a LMO. I would certainly believe that those developed documents are very useful and have great maneuverability in practice. A risk assessment officer with bachelor knowledge in basic biology will be easily to follow each step of procedure. All in all I believe that those guidance documents developed including those that are going to be developed would complement other existing guidance materials and will contribute to a society of sustainability and diversity.

Best wishes

posted on 2018-02-09 02:27 UTC by Mr. Wei Wei, China
RA&RM FORUM - Topic 2: Information and views on existing guidance materials on risk assessment [#8888]
Dear Tim,

Thank you for the opportunity to contribute to this discussion.

As Boet Glandorf (#8873) already mentioned, there are several guidance documents available for LMOs. At EU level, such guidance documents have been developed by the European Food Safety Authority and can be found at the following link:

Kind regards,
Maria Kammenou
posted on 2018-02-08 13:14 UTC by Maria Kammenou, European Union
RE: RA&RM FORUM - Topic 2: Information and views on existing guidance materials on risk assessment [#8899]
Dear Tim and colleagues
I believe that there are many useful guidance materials on risk assessment already available. As stated by others  there is publically available guidance materials developed by organisations such as EFSA and the OECD. The OECD WGHROB is currently working on a document on Environmental Considerations for Risk Assessment of GM plants which will also add to the guidance available in this area. As mentioned by Boet (#8873) and others many countries have also produced publically available guidance. The OGTR has a Risk Analysis Framework (http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/risk-analysis-framework) which guides how we do risk assessments which also has been adopted for use in other countries. We have also recently developed new application forms with guidance and example answers which explain how the information we collect is relevant to risk assessment.

There is also much practical material available outside of the GMO space on risk assessment, which can be adapted for use with GMOs. For example, we have adapted weed risk assessment methodology to include in GMO risk assessment (see Keese et al 2014 Transgenic Res. 2014; 23(6): 957–969, and the weed risk assessments that we incorporate into our baseline biology documents and RARMPs).

There are also scientific papers published by academics which address these topics, although this methodology often needs modifying to incorporate into regulatory science where there are statutory considerations and timeframes to meet.

With the wealth of guidance material already available and the willingness of countries to share material it would seem unnecessary for the AHTEG to develop further guidance at this time.  

Kind regards,
OGTR, Australia
posted on 2018-02-08 21:43 UTC by Ms. Heidi Mitchell, Australia
RE: Opening of the discussion [#8904]
Dear Tim and colleagues,

There are various existing guidance materials on environmental risk assessment.
Some Parties established guidance documents for risk assessment based on ANNEXⅢ of Cartagena Protocol and posted them on the Biosafety Clearing House and/or their national websites. Other international organizations such as the OECD Working Group on Harmonization of Regulatory Oversight in Biotechnology also provide guidance materials. 
Furthermore, environmental risk assessment reports of individual LMOs available through the websites could be valuable reference materials.

OECD website: http://www.oecd.org/science/biotrack/

Kind regards,

Misuzu Watanabe
posted on 2018-02-09 08:07 UTC by Misuzu Watanabe, Japan
RE: Opening of the discussion [#8908]
Dear colleagues,
I think Boet Glandorf [#8873] made a good point to mention the abundance of guidance materials on risk assessment which are in accordance with Annex III of the Cartagena Protocol and can be found in the BCH (http://bch.cbd.int/database/laws/). Another important source of information with respect to questions on how to implement existing guidance to complicated cases could be the Roster of Experts (Link: http://bch.cbd.int/database/experts/).

Werner Schenkel
Federal Office of Consumer Protection and Food Safety (BVL), Germany
posted on 2018-02-09 15:11 UTC by Dr. Werner Schenkel, Germany
RE: Opening of the discussion [#8913]
Thank you for the moderator and for the participants for an interesting discussion under this topic.

Annex III of Cartagena Protocol, CODEX Principles for the Risk Analysis of Foods Derived from Modern Biotechnology together with OECD Consensus Documents (http://www.oecd.org/science/biotrack/consensus-documents-safety-of-novel-foods-and-feeds.htm; http://www.oecd.org/science/biotrack/consensusdocumentsfortheworkonharmonisationofregulatoryoversightinbiotechnology.htm)  forms an excellent basis for any country to develop their regulations and procedures for risk assessment of LMOs.

Together with those sources are various scientific papers, national guidances, manual from International bodies (ISPM11 from IPPC; Biosafety Resource Book from FAO, among others), BCH virtual library, previous discussions at RA on line forum etc.

Best regards,

Luciana P. Ambrozevicius
Ministry of Agriculture / Brasil
posted on 2018-02-09 15:46 UTC by Ms. Luciana Ambrozevicius, Brazil
RE: Opening of the discussion [#8916]
Related to this Topic 2,  I concur here with Boet Glandorf [#8873],  Heidi Mitchell [#8899] and Misuzu Watanabe[#8905], among others,   who well summarized and informed about sources already available.
There is no need for an extra big effort from AHTEG to develop any extra items or guidance.
posted on 2018-02-09 16:58 UTC by Dr. Deise Maria Fontana Capalbo, Brazil
RE: Opening of the discussion [#8920]
Dear Tim,

In response to this topic 2 (Information and views on existing guidance):

“Information on existing guidance”: I support the post by Boet Glandorf that there are many guidance materials on risk assessment available worldwide that are consistent with Annex III of the Cartagena Protocol, and that there is at this moment no need for additional guidance on specific topics of risk assessment to be developed through this forum.

“views on existing guidance”: there are many documents out there that can be used as guidance, ranging from actual guidance documents, to specific decision documents, to background documents on crops and traits. Given the number of documents out there, it is not feasible to provide views on all of them, so I limit myself to a general observation in relation to all those documents:  Risk assessment is an interdisciplinary process, involving different scientific disciplines ranging from molecular biology to ecology. Guidance documents can help understand the overall flow of the entire process, or provide specific guidance on a specific topic, such as molecular characterization. The trick is to find the right document that is best helpful to the specific case at hand. I for one have always found the background documents on crops and traits very useful.

Further, since there are several posts that provide views on one particular piece of guidance, i.e. the draft guidance produced through the process of online fora and AHTEGs, let me add my views on that document. One post suggested that the draft guidance produced by the RARM AHTEG up to 2016 provides an adequate general basis for RA, and that this is also the conclusion of years of testing and surveys. This is incorrect on several levels. First, the basis for risk assessment under the CPB lies in Annex III, and not in any guidance. Second, the testing of that draft guidance did not result in a general conclusion that it provided an adequate general basis for RA. I think that the one general observation that we can make about the draft guidance was well put by Francisca Acevedo, i.e. that much work went into that guidance and that it contains some useful information. As Helmut Gaugitsch posted, the draft guidance has been tested, reviewed and has undergone many rounds of revisions. Yet, despite all that, MOP8 did not endorse or welcome the draft guidance, but it ‘took note’ of it, which in the sphere of COPs and MOPs is quite significant. (NB: the not endorsed draft guidance still features on the CBD site under the Biosafety Technical Series). In short, the views on that draft guidance are mixed, and we should refrain from statements suggesting general satisfaction or dissatisfaction with it. In my view the draft guidance contains useful elements, but it also has many confusing elements and it lacks coherence, and is therefore not helpful.

On to topic 3.

Regards and good weekend to all!

posted on 2018-02-09 20:43 UTC by Mr. Piet van der Meer, Ghent University, Free University of Brussels, Belgium, PRRI
RE: Opening of the discussion [#8925]
Dear all,

As Jane Morris [#8879] and Karen Hokanson [#8881] mentioned in their opinions, I agreed that the risk assessment process of LMO should be complemented with the consideration of benefits: This far there is a gap about how to consider information related to the potential benefits for the introduction of this kind of organisms. I also think that the consideration of this information could help with the risk communication and to a better understanding of the decision-making process that leads to the decisions the Parties governments are making.

I also agree with the opinion of Josphat Muchiri [#8890] and Piet van der Meer [#8920], because from my point of view the current voluntary guidelines developed under this Protocol is full of information that could help the risk assessment process, but at the same time is too long, confusing and difficult to follow. Hence, the current Guide not really contribute into the establishment of regular standards for the guidance of the many different Parties governments in the generation of their own regulatory systems based on their own interests, conditions and specifics characteristics.

In this sense, I think that the voluntary guidance should be shortened in order to keep only a basic document that does not imply the imposition of a full battery of characteristics and factors that may or may not apply to the diverse conditions of the Parties participant. Therefore, my proposal is to work with the available guidance material, including Annex III of the Protocol and the different guidance documents referred by several colleagues (FAO, OECD, papers from ICGEB), and not to produce any further guidance.

Finally, I consider important if a Party wishes to take into account the basic elements of all the guidance that are already on the BCH. But it is also important that they could also have the chance to generate their own guidance documents and regulations, according to their own experience considering the characteristics that are of their interest in relation with their sovereignty (e.g. protection goals, final assessment endpoints, ecosystem services, centers of origin and genetic diversity, use of herbicides and so on), following the provisions of the Cartagena Protocol.

Kind regards,

Rafael Romero
Mexican Service of Agro-Alimentary Health, Safety, and Quality (SENASICA)
posted on 2018-02-10 00:40 UTC by Mr. Rafael Romero, Mexico
RE: Opening of the discussion [#8935]
Dear participants to the forum,

In my contribution to topic 2 of the discussion ‘Information and views on existing guidance materials on risk assessment’,  I think that existing guidance materials on risk assessment and risk management of LMOs are well in alignment with the principles and methodology of risk assessment and risk management in Annex III, and are appropriate for current and realistically foreseeable LMOs globally. 
I concur here with Deise Maria Fontana Capalbo [#8916], Boet Glandorf [#8873], Werner Schenkel [#8908],  Heidi Mitchell [#8899], Misuzu Watanabe[#8905], and others that note guidance materials, as well as examples of risk assessment and risk management applied to LMOs are readily available through the BCH and other websites.  The accumulated practical experience of conducting risk assessments at national level, the existing guidance materials, and the established risk management practices from countries with experience with environmental releases of LMOs can be used to guide and assist Parties that request additional guidance in conducting LMO risk assessments. 
Along these lines, the voluntary Guidance developed by the former risk assessment AHTEG may be a helpful reference when considering risk assessment of LMOs.  As the Parties themselves, in decision VIII/12 noted, countries and organizations are invited to “take the Guidance into account as a voluntary tool to assist in conducting risk assessment in accordance with the Cartagena Protocol while acknowledging that other guidance documents and national approaches can also assist in conducting risk assessment in accordance with the Protocol.”

However, if a comparison is to be made on the utility of existing guidance materials, some general points could be underlined. Although all guidance materials are aligned with the principles of Annex III, they differ, sometimes substantially, in the way the information is organized and presented, and  how clearly and comprehensibly topics are addressed.  We have witnessed diverse views about the utility of the voluntary Guidance developed by the former AHTEG on RA and RM.

In comparison, other documents have been presented as examples of more comprehensive and generally more useful materials, and such include guidance on risk assessment produced by some international bodies such as the OECD or Codex Alimentarius or some countries, as for example:
Australia, Department of Health and Aging, Office of the Gene Technology Regulator.  Risk Analysis Framework. May 2013. 139 pages. Available through:  http://www.ogtr.gov.au
Guidelines for certification of containment conditions: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/guidelines-1
Risk analysis framework:  http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/risk-analysis-framework
Risk assessment reference documents: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/riskassessments-1
Canada, Canadian Food Inspection Agency (CFIA) has been evaluating Plants with Novel Traits since 1996, http://www.inspection.gc.ca/plants/plants-with-novel-traits/eng/1300137887237/1300137939635
Guidelines for Assessment of Novel Feeds: Plant Sources, http://www.inspection.gc.ca/animals/feeds/regulatory-guidance/rg-1/chapter-2/eng/1329298059609/1329298179464?chap=6, and Directive 94-08 revised (2004). Assessment criteria for determining environmental safety of plants with novel traits at: http://www.inspection.gc.ca/plants/plants-with-novel-traits/applicants/directive-94-08/eng/1304475469806/1304475550733
The CFIA – Plant BioSafety Office just released this update to Directive 94-08 last week, and it won’t be in effect until June of 2018: http://inspection.gc.ca/plants/plants-with-novel-traits/applicants/directive-94-08-revised-/eng/1512588596097/1512588596818
A link to the guidance document for Health Canada who also is part of the Canadian approval system can be found at: https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/guidelines-safety-assessment-novel-foods-derived-plants-microorganisms/guidelines-safety-assessment-novel-foods-2006.html

I have also attached a document referencing a number guidance materials that are actively used by countries conducting risk assessment for releases into the environment or for import of GMOs.

While the methodology of performing risk assessment is founded on sound scientific principles, and is unlikely to change over time, specific considerations as part of the case-by-case risk assessment evolve over time reflecting on new scientific knowledge and technological progress that are readily addressed with the developments in the filed of regulatory sciences.

By following the discussions of this forum for the last four years, I am also left with the impression that there is a general misunderstanding amongst us on what constitutes risk assessment methodology, and what  is meant under “gaps” in existing guidance materials. 
A well-established risk assessment methodology, such as the one described in Annex III remains valid for all cases of risk assessment. This methodology is flexible and recognizes that “the process of risk assessment may on the one hand give raise to a need for further information about specific subjects, which may be identified and requested during the assessment process, while on the other hand information on other subjects may not be relevant in some instances”.

Thank you all for the interesting exchange of views and information under the three topics of the forum,

Ana Atanassova
(edited on 2018-02-11 15:13 UTC by Ms. Ana Atanassova)
posted on 2018-02-11 11:37 UTC by Ms. Ana Atanassova, Bayer CropScience
RE: Opening of the discussion [#8939]
Dear Tim,
Thank you very much for taking on the responsibility to moderate this forum.

Dear colleagues,

It is encouraging to read those contributions that have shared references to existing guidance.  These interventions and other evidence demonstrates that much national and regional guidance on risk assessment exists and is readily available.  These materials, and more importantly the national experts that develop and use this existing guidance, should be a valuable resource to those regulators who need support and resources for capacity building under their individual biosafety framework. 

Attached is an example list of available guidance that I and some colleagues collected for your consideration. 

Thank you for allowing me this opportunity to contribute.
Tom Nickson
posted on 2018-02-11 15:54 UTC by Mr. Thomas Nickson, Consultant
RE: Opening of the discussion [#8941]
Dear all,

Please excuse my providing the virtually identical attachment which Ana provided earlier.

Tom Nickson
posted on 2018-02-11 16:41 UTC by Mr. Thomas Nickson, Consultant
RE: Opening of the discussion [#8946]
Dear Tim and  Colleagues

On Topic 2 related to “Information and views on existing guidance”,  I agree with the observations made by  Boet Glandorf [#8873],  Heidi Mitchell [#8899],  Misuzu Watanabe[#8905], Piet van der Meer [#8920], that there are a number of guidance materials available globally which are consistent with Annex III of the biosafety Protocol. At this point there is no need for additional documents on specific topics to be developed.  The robustness of a regulatory process comes with real time experience and therefore use of available documents as a starting point seems more practical.  However, based on experience, countries may choose to develop their own guidance which is aligned with the CPB obligations.
The Risk Analysis Framework (RAF), ERA Guidelines of GE Plants and ‘User’s Guide to ERA’ developed by India may be viewed at http://geacindia.gov.in/guidelines-and-protocols.aspx
posted on 2018-02-11 19:30 UTC by Dr. Ranjini Warrier, India
RE: Opening of the discussion [#8956]
Dear Tim,

On Topic 2 related to “Information and views on existing guidance”,  I agree with the observations already made by  Boet Glandorf [#8873],  Heidi Mitchell [#8899],  Misuzu Watanabe[#8905], Piet van der Meer [#8920], Ranjini Warrier [#8946], and others that there are already many of guidance materials and specific cases (dossiers, notifications, etc.) available globally which are consistent with Annex III of the Cartagena Protocol.

I agree also that at this point there is no need for additional documents on specific topics to be developed. 

I also agree that risk assessors need access to real cases with which to test their skills, the usefulness of guidance documents and the risk assessments of others, all in the context of their own national regulatory framework and national needs.  Guidance is useful only if it is actually used in real cases to see if is adequate, workable, and practical in doing the assessments and communicating the information to  decision-makers in a way that they can understand the rationale for making their decisions (and communicating that rationale to the general public).


posted on 2018-02-11 22:27 UTC by David Heron, United States of America
RE: Opening of the discussion [#8960]
As we have said in Topic 1, New Zealand’s Environmental Protection Authority is guided in its risk assessments by its legislation (the Hazardous Substances and New Organisms Act) and its associated regulations. However, The Australian OGTR’s Risk Analysis Framework (please refer to post #8899) is a very useful guide which we would recommend, among others.
posted on 2018-02-12 00:47 UTC by Stephen Cobb, New Zealand
RE: Opening of the discussion [#8968]
POSTED ON BEHALF OF RICARDA STEINBRECHER (This message reached the Secretariat before the 12 February 1:00 a.m. GMT closure of the forum):
Dear Tim, dear colleagues,

Concurring with others (eg Francisca Acevedo, Jack Heinemann, Helmut Gaugitsch, Galina Mozgova), I also find that the guidance preparared by the AHTEG on RA&RM (including part I, II and III) is a very useful and adequate basis for risk assessment of LMOs in general and of those specific types of LMOs and traits covered in part II.

The guidance so far, however, does not cover risk assessment for socio-economic impacts nor impacts on traditional knowledge and customs of indigenous peoples and local communities.

Guidance thus far has been for such LMOs where the intention had been to limit and minimise their spread into the wider environment and into wild populations of the respective species and their close releatives. Attention was given to minimise or prevent gene flow into the wider gene pool of a species.

Some of the new techniques and applications of genetic modification under development though are specifically designed and intended for the capacity to spread widely into the environment, into wild populations, to alter species, to alter ecosystems, potentially with global reach, especailly when designed to overcome the Mendelian rules of inheritence. There are multiple aspects present that have thus far not been part of LMO risk assements or the guidance under the CPB, or even regulations – and I will come back to this under topic 3.

I find Jack Heinemann’s note [8862] concerning paragraph 3 of Annex 3 helpful and think further clarification of and guidance on these terms in this context (‘soundness’ and ‘transparency’) would be beneficial, as they touch key issues for conducting risk assessment and the related regulatory and procedural framework.

It seems that the issue of benefits is being discussed also under topic 2, though mostly under 3, so I will post my thoughts and comments on this in the other thread.

With kind regards,

Ricarda Steinbrecher, Federation of German Scientists
posted on 2018-02-12 13:44 UTC by Ms. Melissa Willey, UNEP/SCBD/Biosafety
RE: Opening of the discussion [#8972]
POSTED ON BEHALF OF DR. FLERIDA A. CARINO (This message was received by the Secretariat before the 12 February 2018 1:00am GMT closure of the forum):

Thank you so much, Ana for providing the Risk Assessment Guidance Listing!  We have been trying to make our own compilation and the document is a great help.  There indeed are so many guidance documents that one really has a diverse menu from where to choose.
posted on 2018-02-12 15:37 UTC by Ms. Melissa Willey, UNEP/SCBD/Biosafety