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

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 1 (Sharing experiences on Risk Assessment of Living Modified Organisms) please reply to this message.

IPPC Secretariat

Because the scope of the International Plant Protection Convention (IPPC) extends to protecting natural flora, the IPPC as biodiversity-related convention, collaborates with environmental programmes to ensure that its activities take account of intergovernmental environmental agreements and that people working in environmental frameworks understand the role of the IPPC.

Many of the IPPC’s principles and phytosanitary measures apply to the CBD. Cooperation and information exchange between environmental organizations, the Commission on Phytosanitary Measures (CPM) and the IPPC Secretariat strengthen the implementation of their respective mandates. Therefore, in this forum, no particular experience is being shared, however we are looking forward to see the outcomes of this discussion and experiences shared.

Best regards,
Adriana G. Moreira (IPPC Secretariat)

Thank you Tim for moderating the forum and greetings to all colleagues

My experience in risk assessment has been in both official and unofficial capacities. In the former I assess the risks of my own laboratory work environment which includes hazardous chemicals and GMOs for my students, fellow lab workers and myself. In the latter, I voluntarily contribute to consultations on food and feed releases conducted by relevant government agencies, and occasionally to post hoc reviews of those decisions or implementations of those decisions.

While the majority of risk assessments on release of LMOs have been on plants (or GM plants for food derived from plants), some have been on microorganisms and animals at the national level.

I also have been engaged in risk assessment by learning to teach about it. I have done this for professionals that were gaining additional education and within the curriculum of my university.

With best wishes
Jack

Thank you very much Tim for this opportunity to share our experience on the risk assessment regarding GMOs.
In fact i have participated in the frame of the implementation of the National Framework of Biosafety in Tunisia conducted by the Ministry in charge of Environment through the project UNEP/GEF between 2007 and 2015. In this project many training sessions regarding risk assessment have been performed by international experts and many stakeholders have been invited for the purpose from different ministries involved. In addition i have also participated and contributed to the elaboration of Guidance including risk assessment, GMO detection and the strategy of Biosafety in Tunisia. In the other hand since  i am associate professor in Biotechnology i present courses in the University focusing on Biosafety in General and taking as examples the GMOs under containment, containment measures and confined and Limited Field Trials. These information are sometimes not well understood and i can explain that because in my country no GM plants are cultivated and also no regulation regarding GMO containment is adopted (submission is pending). Many laboratories are still waiting for the adoption of the regulation so they can apply the exact measures for the containments and the field trials as well. Finally i have noticed that the facilities available in different research structures are not adapted and should   meet minimum standards set for each category of risk related to lab and green houses experiments (BL-P1 to 4).

With my best wishes,
MAHER CHAOUACHI

Thank you Tim for the opportunity to participate in this Forum. The CSIRO environmental and ecological risk team have recently completed two risk assessments for the accidental release and controlled field release of genetically modified mosquitoes. Although these mosquitoes are not modified with synthetic gene drives, we have completed these risk assessments to the standards recommended by the US National Academies of Sciences, Engineering and Medicine for gene drive modified organisms and synthetic biology more generally, and in doing so have gained valuable insights into some of the challenges that these assessments will likely present to others. In our assessments we advocate the use of probability theory as a coherent calculus for uncertainty, and adopt a Bayesian approach to the risk calculations due to the paucity of data that typically accompanies new technologies. We believe that this approach provides a firm foundation for scientific risk assessment, but note that successful implementation requires careful coordination of experimental/observational studies with the risk calculation and analysis activities (which is related to my response to Topic 3).

Dear all, Dear Tim,
Thank you for moderating this forum on three topics at the same time. Quite a job! Topic 1 is about sharing experiences in conducting risk assessment of living modified organisms. As a risk assessor of LMOs for almost 20 years, I have gained experience with of conducting risk assessments of e.g. bacteria, plants, trees and mosquitoes. There is much more experience among other Parties. All this is documented and can be accessed in the BCH, the platform that is  used to share and exchange information on risk assessments. So with respect to topic 1 of this online forum on sharing experiences in conducting risk assessment of living modified organisms, I would like to refer to the information as can be found in the BCH. 

Kind regards,
Boet Glandorf, GMO Office, The Netherlands

Dear Tim, dear colleagues,

thank you Tim for moderating this online forum discussion. With respect to Topic 1 I would like to priovide the following Input:

Over more than 20 years the Environment Agency Austria has reviewed numerous notifications, in the context of the EU wide approval process of commercial LMO products intended either for food, feed or cultivation. While the quality of the notifications has improved over the years, we have identified a couple of shortcomings in the notifications, limiting the possibilities for a complete risk assessment. These include inconclusive molecular data, lack of data on indirect, long-term and complex environmental interactions with target-, non-target organisms and the abiotic environment. Our comments on the notifications are submitted to the European Food Safety Authority (EFSA) which leads the risk assessment of the EU wide notifications on commercial LMO products.

If requested by the Austrian authorities we have undertaken more detailed risk assessments on a national and regional level, taking into account regional ecological characteristics, which sometimes have led to particular measures including restrictions for placing on the market in Austria.

Kind regards
Helmut Gaugitsch
Environment Agency Austria

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

Hello all, and thanks again to Tim for hosting this forum discussion.

Relevant to TOPIC 1  ‘Sharing experiences in conducting risk assessment of LMOs’, I would like to point the participants to some useful information regarding ‘experiences in conducting risk assessment’ which can be deduced from the 3rd National Reports that were submitted to the CBD Secretariat before MOP8.  All of these national reports can be found in the Biosafety Clearing-House.  I took some time before MOP8 to look closely at the answers to the questions that are concerned with risk assessment (Q. 77-97 - Article 15&16 Risk Assessment and Risk Managment). I looked at the reports that had been submitted by Oct. 28, 2016.  If any were submitted later, I did not include these in my summary.

In so doing, I noted some interesting trends:

Of the 128 Parties that submitted reports, 64 Parties reported having ever conducted a risk assessment of an LMO including any type of risk assessment of LMOs (e.g. for contained use, field trials, commercial purposes, direct use as food, feed, or for processing), and of those, 36 have conducted Risk Assessments for ‘Commercial Production’.

Of those 64 Parties that have conducted Risk Assessment, 57 also reported that they have adopted or used ANY guidance documents for the purpose of conducting or evaluating risk assessments, and 42 of those answered ‘NO’ to the question: ‘Is your country using the “Guidance on Risk Assessment of LMOs” (developed by the online forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment […] or for evaluating risk assessment reports submitted by notifiers?’ (Q. 86 in the 3rd National Report)

If we narrow the focus to those 36 Parties that have conducted Risk Assessments for ‘Commercial Production’, assuming these risk assessments for ‘commercial production’ would include the environmental safety assessment that is most relevant to adverse effects on biological diversity, 34 of these reported having used ANY guidance. Of those 34, 9 answered ‘YES’ and 25 answered ‘NO’ to the question about using the risk assessment guidance developed by the online forum and AHTEG (Q. 86, as above).

Those 34 countries that indicated they are using guidance for risk assessment for commercial production (with * by those that are also using the guidance developed by the AHTEG) are:
Austria, Bangladesh*, Belgium, Brazil, Burkina Faso, China*, Colombia, Costa Rica*, Cuba*, Czech Republic*, European Union, Finland, France, Germany, Honduras, India, Indonesia, Italy, Japan, Mexico, Netherlands, Norway*, Pakistan*, Philippines, Portugal, Republic of Korea, Slovenia, South Africa, Spain*, Sudan*, Sweden, United Kingdom, Uruguay, Vietnam

Interestingly, nearly half (16) of these 34 countries can be considered ‘developing countries’, 10 of which indicated they are using other guidance, but not using the guidance developed by the AHTEG.

(I am attaching my summary of risk assessment and guidance from the 3rd National Reports with this post. And I hope there are no errors; it was a lot of information to wade through.)

The point to take away from this for this discussion is not so much that the guidance developed by the previous online forum and AHTEG is not useful (although one might take away that point).  It is more this: there are 34 Parties that claim to have experience conducting risk assessment for commercial production, that are already using ‘some sort of guidance’ (mostly existing guidance other than that developed by the AHTEG) for the purpose of conducting risk assessment or evaluating risk assessment reports.  It would be best to build upon this experience using guidance and the risk assessments that have been produced or evaluated using it, to develop any additional guidance on this or any other topics or 'new' technologies.

I believe this was the original intention for the guidance that was developed by the previous online forum and AHTEG, but that one strayed too far from ‘what has been done’ into ‘what should be done’, and led to compromise positions that could not ultimately be endorsed by the Parties.  This was clearly not a good way to develop guidance on risk assessment, and should not be repeated to develop any future guidance.

Thanks,
Karen

Dear Karin,
Thank you for a very interesting analysis! It is very interesting that you write in your analysis that many  developed countries use the guidance developed within the Cartagena work on Risk Assessment. YOu also write that of these countries many are EU countries, that have an obligatory EU guidance to follow. One can wonder if this indicates some gaps or unclarities in the EU guidance that are addressed in the Cartegena guidance.

With best regards
Melanie Josefsson

Dear Tim and colleagues,

Thank you for accepting the challenging task of moderating these 3 topics. I have been involved with risk assessment under different contexts. Under the BCH portal, I have been advising the Brazilian government since 2012 on RA&RM, Synthetic Biology and the Detection Network fora and related activities.

I have been also developing risk assessment-based research since 2008 in Brazil. The main focus of my research has been to uncover the roles of transgenes in gene regulation in plant systems and to apply that knowledge to assessing their safe use in food and the environment. Particularly, I have been using omics techniques, such as proteomics and transcriptomics, to profile GM and non-GM systems on the field and in laboratory conditions.

More recently, I have joined GenØk, designated The National Competence Center for Biosafety in Norway and so I have been contributing to technical submissions on the country’s RA demands. Other experiences in conducting RA include teaching on international courses focused on biosafety and RA (http://genok.com/capacity-building/courses/).

With regards to the analysis made by our colleague Karen, I would like to comment that although some countries might have submitted information that they do not apply the AHTEG guidance itself, this does not exclude the possibility that they might have use it as a background document to develop their own official guidance. This is case for countries in which RA rules and procedures are part of their national regulation. Therefore, I believe the original intention of the guidance is still valid.

Thank you,
Sarah

Hello Melanie,

What I wrote in my post is different than what you've written in yours.

I wrote this:
"Interestingly, nearly half (16) of these 34 countries [that have conducted risk assessments for commercial production and indicated they are using any guidance] can be considered ‘developing countries’, 10 of which indicated they are using other guidance, but not using the guidance developed by the AHTEG."

To me, this means 10 out of 16 (ie., more) of these developing countries are using 'other' guidance, but not the AHTEG guidance.

I do not know what 'other' guidance those countries used, but I think it would be worth investigating this and comparing any 'other' guidance used by the 'developed' countries (including the AHTEG guidance, and the EFSA guidance - as you note this will be what the EU countries are using) to see where there are commonalities and differences. 

One could also wonder if this indicates some gaps or unclarities in the 'AHTEG guidance' that are addressed in the 'EFSA guidance' (this is the opposite of what you wrote in your post), or in any other guidance that has been used by many of these countries, both developed and developing. 

To me, this represents 'experiences conducting risk assessments of LMOs' from which we can learn, which is the subject of this TOPIC #1 in this online forum.  That is my point.

Thanks,
Karen

Dear Tim,

Great to see you at the helm of this debate and thanks for the reminder that there are only 4 days left.

As regards topic 1 (experience with risk assessment): I have been conducting risk assessments for GMOs since 1986, when I was assigned with drafting and implementing the Dutch GMO regulations, which continued as of 2000 in my work in providing support to international organisations and governments in biosafety matters.

In response to your specific questions:

a) Share experiences with risk assessment of LMOs:
From over 30 years of experience with risk assessments of very diverse GMO/LMOs, I know that in all of those cases the risk assessment could be conducted adequately by multidisciplinary groups of scientists through the methodology as is laid down in Annex III of the CPB (which in itself is a reflection of experience gained in the decades before the CPB),

b) Point out particular challenges:
One of the challenges in conducting risk assessments with a multidisciplinary group of scientists is to stay focused, because it is not uncommon that while discussing one topic, such as non-target organisms, suddenly aspects of another aspect of ERA, for example weediness, pop up in the discussions and lead to a diversion. In addition, it also happens that discussions stray into scientifically extremely interesting avenues, but which are not always related to the scope of environmental risk assessment. I have always found the use of a simple matrix, first developed by Sir John Beringer, a former chair of UK-ACRE, a great tool in helping the process to stay focused.

c) Point out instruments (e.g. guidelines) that have been used:

Over these years we have always made good use of the following types of documents:
- Existing guidance documents, of which there are very many. As Boet Glandorf said, many of those are already in the BCH, and it would be great if the authors of other guidance documents also include forward their work for inclusion in the BCH. What will also be important is to increase the availability of documents in various languages.
- Risk assessments on comparable cases conducted by other countries or organisations. Decision-documents of other countries are very useful sources for that, and many of those decision documents can be found on the BCH.
- Documents with factual background information, such as the excellent OECD consensus documents on crop plants and traits.

d) Share experience with support received from other countries or organisations:

In my experience, governments are typically quite prepared to provide information that may be helpful for risk assessment.
The same is the case for international organizations, such as OECD, IPPC, and the OIE. It is good to see the participation of the IPPC Secretariat in this forum.  The IPPC and its standards are a good source of guidance documents that address how to evaluate organisms that might pose risks to plant health (e.g., bacteria, viruses, fungi, arthropod pests, weeds). The standards under IPPC are technical documents developed cooperatively and adopted by the members of IPPC, and can be found at https://www.ippc.int/en/core-activities/standards-setting/ispms/. ISPM-11 includes an annex on evaluating LMOs for potential adverse effects to the health of plants in both managed and unmanaged environments. These documents are good examples of guidance documents that are developed and continually revised among member countries. 

Looking forward to the remainder of the forum

Regards

Piet

Dear Tim,
Thank you for moderating this Forum
The Office of the Gene Technology Regulator (OGTR) in Australia has been conducting risk assessments since 2001. The Gene Technology Regulator has issued licences for commercial releases for 20 plants for commercial cultivation, 5 human vaccines, and 1 animal vaccine. We have also conducted risk assessments for over 100 crop or vaccines trials. This has given us a broad experience in GMO risk assessments of cultivation of numerous plant species with different traits, live vaccines and viruses for both trials and commercial scale releases. We also prepare risk managements plans and associated trial licences. The experience obtained from monitoring trials is fed back into future risk assessments and management plans to improve their robustness. These risk assessments and risk management plans are available publically on the OGTR website at http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ir-1 and the commercial scale releases are listed on both the BCH and OECD Biotrack databases. We also publish the supporting information on the biology of the parent organisms and risk assessments references on topics such as methods of genetic modification and use of selectable markers.
We have also been able to share our experiences with visiting delegations and have participating in risk assessments workshops internationally.

Dear Tim and colleagues,

Thank you for giving this opportunity to share my experience. I work at Ministry of Agriculture, Forestry and Fisheries and have responsible for environmental risk management and assessment of LMOs intended to be used for agricultural purposes.

In Japan, according to the Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (Cartagena Act), the environmental release of over 130 LM events have been approved for agricultural purposes after conducting environmental risk assessment. The events include;
・crops: alfalfa, carnation, oilseed rape, soybean, sugar beet, corn, papaya, rose, cotton
・animals: silkworm
・microorganisms: live vaccine for animals

The list of approved LMOs and the assessment reports are available in the national Biosafety Clearing House of Japan (http://www.biodic.go.jp/bch/english/e_index.html).

Kind regards,

Misuzu Watanabe

Dear All
Thank you for your great contributions and the opportunity to attend the forum.
As Boet Glandorf mentioned before [#8872] the Biosafety Clearing-House is a comprehensive source of information on how to conduct risk assessments. This is laid down in Article 20 3. of the Cartagena Protocol that asks Party to“[…] make available to the Biosafety Clearing-House […] Any existing laws, regulations and guidelines for implementation of the Protocol, […]; Summaries of its risk assessments or environmental reviews of living modified organisms […]”. Furthermore, „The Biosafety Clearing-House […] shall provide access to information made available by the Parties relevant to the implementation of the Protocol. […]” (Article 20 1.).

As Karen Hokanson mentioned [#8886] "there are 34 Parties that claim to have experience conducting risk assessment for commercial production, […] It would be best to build upon this experience..."

Further – and also specific – advice on conducting risk assessments can be found in the Roster of Experts (Link: http://bch.cbd.int/database/experts/) that “aims to provide advice and other support, as appropriate and upon request, to developing country Parties and Parties with economies in transition, to conduct risk assessment, […]". Biosafety experts might be contacted and can provide help.
I therefore support the contributions of our dear colleagues mentioned above.

Werner Schenkel
Federal Office of Consumer Protection and Food Safety (BVL), Germany

Thank you for the moderator and for the participants for an interesting discussion under this topic.

Brazil has a biosafety framework in place and based on the existing system 117 events in different organisms (crops, tree, mosquito, microorganism, vaccine) were approved by the National Biosafety Technical Commission. There a specific regulation in place for commercial approval (Normative Resolution 5 - http://ctnbio.mcti.gov.br/resolucoes-normativas) with the requirements for risk assessment. There is also specific requirements for field trials depending on the type of the organism. The risk assessment has three general principles: case-by-case, evidence-based and it´s an iterative process. The methodology used for RA is based on Annex III of CPB and Codex Alimentarius. Any new organism with a new trait is evaluated under the same normative, the difference will be the risk hypothesis created by experts in that area to ensure the assessment is as robust as our current knowledge allows. Training for risk assessors is an important part of the process and ICGEB (https://www.icgeb.org/ts-home.html) is an example to be mentioned.

Best regards,
Luciana P. Ambrozevicius

Ministry of Agriculture / Brasil

Greetings everyone, and thank you to Tim for hosting this forum discussion.

Related to Topic 1 (Sharing experiences), I would like to echo some previous comments pointing the existence of many guidance documents like  international organizations, such as OECD, IPPC, and the OIE, OGTR among others already mentioned. They are a good source of information and many are revised continually which gives then a strong support to and from “real life” exercises.

Dear All,
The Czech Committee for GMOs and Products is an advisory body of the Czech national authority – Ministry of the Environment – for  the GMO handling and release of GMOs in environment in the Czech Republic (CZ).
      In order to obtain country-related data useful for RA&RM, we initiated in CZ since year 1998 a long-term monitoring of field experiments of various GM crops and trees (e.g. maize, winter oil seed rape – OSR, potato, flax, sugar beet, plum). Our effort was focused mainly to the possibility of horizontal gene transfer (OSR), transfer of pollen by honey bees (OSR, plum), persistence of viable seeds (OSR, flax, maize) and vegetative parts (potato) in the soil, ability to establish feral populations, and possible negative effects on flora and fauna (e.g. arthropods, birds). Over a period of 20 years numerous important results and practical findings have been obtained and used for RA, to set up/improve safety measures of trials and commercial cultivation of Bt maize, to give recommendations for coexistence rules, etc. Noteworthy is also the experience of members of control teams and inspectors of the Czech Environmental inspectorate supervising the trials and GMO fields, as well as of national laboratories for GMO detection and DNA fingerprinting.
Best regards,
           Slavomir

Slavomir Rakousky
Czech Committee for GMOs
Czech Republic

Many thanks to Tim for moderating the forum. 

I work for National Science and Technology Development Agency, Ministry of Science and Technology, Thailand. We are responsible for the technical body for risk assessment of LMOs. We would like to share our experience of conducting the risk assessment of LM plants in Thailand.

Thailand has developed the guidelines on an environmental risk assessment that comply with the guidance produced by the RARM AHTEC. Due to the unique biological characteristics of LM plants, the requirements of risk assessment are variety among each plant.

There is information that requires from applicants. We inform the data requirement list which shows definition and explanation. However practically there are comments from stakeholders who are scientists, regulators and applicants on data requirement list that what information are “need to know” or “nice to know” which challenge to distinguish. It seems to be a challenge because in some case this is a reason for failure to find consensus on risk assessment.

This online forum and BCH are the great opportunities to learn and exchange our experience of risk assessment with other countries. We hope that experience we earn from this forum and BCH will lead to better understanding of risk assessment which reduces argument among stakeholders.

Best regards,
Chalinee Kongsawat

Dear Tim, dear colleagues,
I also would like to share experience. I work at the National Coordination Biosafety Centre (NCBC) of the Institute of Genetics and Cytology NAS of Belarus, which established in 1998. Since that time employees of the Center have been involved in development and provision of advisory services to the Ministries and other Republican bodies of State Administration in drafting legislative acts on import (export) and safe use of genetically engineered organisms and the products derived from them, Guidelines on environmental risks’ assessment and prevention, including risks to human health, Safety Guidelines for Genetic Engineering Laboratories, provides trainings on RA and in other fields of LMO safety. Legislative acts and instructions starting from contained use provisions could be found at http://bch.cbd.int/database/results?searchid=698116. All our legislative and administrative acts were developed in accordance with the Cartagena Protocol, as well as all Guidelines include fundamental principles of RA of the Cartagena Protocol.
We were responsible for risk assessment of LMOs developed in our country (contained use) and Scientific Safety Expertise of plant origin LMOs intended for field trials (1 call was in 1999 and then since 2014 we provide assessment on a constant base). Also other Belarusian organizations were responsible for RA of plant and animal origin LMOs (all documents are available on BCH, Belarus profile).
In 2006 developed by Republican Scientific and Practical Center of Hygiene, NCBC and Republican Center for Hygiene, Epidemiology and Public Health "Procedures for Risk Assessment of Possible Harmful Effects of Genetically Engineered Organisms on Human Health. Instructions for use." were approved by the Ministry of Health as the National Guidelines. This Guidelines were developed in accordance with key provisions of the Cartagena Protocol and relied on international Guidelines and documents developed by WHO, FAO, OECD and others. At the same time as we had only 1 call for release to environment for testing till 2014 and it was in 1999 (before the Cartagena Protocol was singned) in 2013 we started developing Guidelines for environmental RA «Risk assessment of LMO exposure for conservation and sustainable use of biological diversity, taking into account risks to human health» which was published at the end of 2014. First part concerning environmental RA have been developed on the base of AHTEG and on-line forum Guidance as we considering Guidance as more comprehensive and useful one, the second part concerning human health risk assessment relies on appropriate international guidelines including developed by organizations mentioned above. So as you see we also in the list of Countries which carry out RA in accordance with Guidance which we discuss here and different organizations carried out RA in our country considering this Guidance as very helpful. As on the moment of providing response for III National Report we only provided RA for field trials in our III National Report we were not in the list of countries which use this Guidance for commercial purposes.
Best wishes,
Galina

Dear forum participants,

Thank you for the opportunity to contribute to the discussions of the on-line forum. In response to the questions of our moderator grouped under topic 1 ‘Sharing experiences on Risk Assessment of Living Modified Organisms’, I would like to share my experience in conducting risk assessment of LMOs, as well as point to what particular challenges that I have noted during the process as well as indicate examples of support that has been useful in this process. My answers are based on my direct experience from risk assessment of LMOs as part of an internal process in my organization, on one hand, and from my interactions and collaboration with regulatory bodies who are responsible for assessment of LMOs, on the other.

My organization is active in research and development activities with plant LMOs and  implements internal processes that ensure safe handling and use of LMOs and adherence to applicable legal and regulatory requirements in all stages of the R&D process. Early on, research LM plant lines undergo screening process in containment (e.g. growth chamber or  green house) to select lines for further testing.  Selected lines would be then brought to research field trials in order to begin the accumulation of observations and data on the plant performance under field conditions. This first release is part of a step-wise approach of releases into the environment, where initial releases are done on very small and restricted area, observing strict confinement measures. LMO release can only happen after the responsible regulatory authority of the country where the activities are taking place has completed their assessment and had granted permit for the release.

In preparation for field trial permit applications, a preliminary risk assessment in performed that is in full alignment with the general principles, methodology and points to consider as laid down in Annex III of the Cartagena Protocol.  Briefly, the assessment evaluates  potential or anticipated impact of the LMO on the receiving environment, human and animal health, taking into consideration the limited and confined scale of the release, and the exiting gaps of knowledge about the LMO at the early stages of research.
This assessment addresses a range of topics, including the potential  or anticipated change in plant characteristics due to the genetic modification and includes consideration on weediness and invasiveness; pollen flow;  organisms and food web; soil function; plant health; non-target species; potential for adverse effects in humans.
The potential hazards, their likelihood, potential impact, and when relevant, specific or additional risk mitigation measures  are identified taking into account the mode of action of the transgene, the expected phenotype of the plant line and the place of the release.

I would like to stress that in the early stages of research, we do not yet have detailed information about the performance of the plant lines in field conditions, but this lack of knowledge and understanding is mitigated by the conditions that regulators impose for the field releases. Such conditions include restrictions on the scale of the experiment, obligations for isolation zones, for monitoring and reporting to ensure that the regulated plant material remains separated from other cross compatible plant species and does not enter the food and feed flows.
 
Because my organization has research and development operations  in different locations globally, I have had the opportunity to learn about  the established procedures of regulatory authorities and their risk assessment procedures in different countries.

In my view, the countries that conduct routinely LMO risk assessments have well-functioning systems that are invariably based on the principles and methods of risk assessment captured in Annex III. 
I believe that major challenges in conducting risk assessment are not linked with availability or use of one or another guidance as such. These are available from different sources and present good base to structure the assessment process.

The issues that challenge risk assessment in practice are often of administrative and organizational nature, and pinpoint individual or institutional challenges in implementing risk assessment in practice.
This can be due to lack of sufficient human and technical resources but also is due to lack of, or insufficient understanding of the general principles of risk assessment. 
For instance, challenges in conducting risk assessment can be linked to lack of, or insufficient understanding of the principle of case-by-case assessment;  inability to apply a tiered approach for data requirements; insufficient understanding of the step-wise approach to release into the environment;  or even misunderstanding or misinterpretation of the concepts of hazard and risk.

I find that risk assessment can be facilitated when conducted in a structured but flexible way that allows adjustments depending on the specific case at hand. In addition, some regulatory authorities provide direct advice to developers that is very helpful for identifying the best strategies for each specific case that is assessed.

If I would make a recommendation to this forum, it would be to work towards raising the level of understanding about the objectives, the use, general principles, and methodology of risk assessment in general.
Specific additional topics should be considered based on actual needs for LMO risk assessment rather than on “perceived” gaps or hypothetical cases.

Kind regards to all,

Ana Atanassova

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

Dear colleagues,

My experience with regard to risk assessment of LMO plants goes back to 1991 when I assumed responsibility to coordinate the environmental dossier for Roundup Ready® Canola.  This data package was submitted to and reviewed by the regulatory authorities in Canada.  Over the next 19 years with Monsanto, I coordinated data collections and prepared other environmental submissions for several other LM crops that were reviewed by numerous national and regional authorities.  Perhaps most significant for this forum was the role I played in enhancing the experimental basis of the risk assessments conducted on many GM Crops.  In that capacity, I had the good fortune to consult with scientists from around the world whose expertise were brought to bear on improving my own environmental data collection and analysis.  I also had the opportunity to dialogue with many national and regional risk assessors from Africa, Latin America, the EU and many of its member states, India, Japan, Philippines, Thailand and Russia to name a few. 

Perhaps more relevant for this forum has been my experience with the development of guidance under the Protocol.  I was a participant of the first AHTEG on risk assessment in 2005 and subsequent AHTEGs over nearly 13 years now.  In the ensuing twelve years, the topic of development of additional guidance has been discussed at eight AHTEGs (2005, 2009, 2010, 2011, 2012, 2014, 2015 and 2016), two sub-working group meetings of the AHTEG (2009 and 2012), five workshops (Canada-Norway, GRULAC, CEE, Africa, Asia Pacific in 2007 and 2008), fifteen online fora and twelve “real time” fora (2008, 2009, 2010 and 2013, 2015 and 2016) and seven meetings of the COP/MOP between 2005-2016.  These extensive and duplicative discussions have resulted in quasi “agreement” to produce additional guidance documents on four specific types of LMOs (LMOs with stacked genes or traits, LMOs with tolerance to abiotic stress, LM trees and LM mosquitos) and overwhelming consensus by the Parties that the existing guidance should apply to all types of LMOs.

To prepare this submission, I researched reports from the previous years and found reference to over 65 separate suggested topics in need of specific guidance.   Nevertheless, since 2009 solicitations of input from Parties, Governments and observers on their needs for new guidance and perceived gaps in existing guidance has continued.  While some commenters have concluded that the voluntary guidance is adequate, and perhaps helpful, many other commenters disagree.  Furthermore, using history as a guide, the future of developing guidance for synthetic biology using this process does not bode well. 

Thank you for allowing me this opportunity to contribute.
Tom Nickson

Greetings to all!  Thank you, Tim, for moderating the online forum and apologies for the late entry.  Since 2002, I have been part of the Indian GMO regulatory which has experience in the review of three GM crops namely Bt cotton, Bt brinjal and GM Mustard. 

I take this opportunity to share India’s experience in the evolution of ERA guidance document for  GM crops

In India, legislative measures to implement biosafety were initiated in 1986, i.e. much before the Convention on Biological Diversity (CBD) came into force in 1992.  Subsequently the Protocol was adopted in 2000 and came into force only in 2003.  While impact of GMOs on the environment is not reflected in the EPA, 1986, the need to regulate products from biotechnology intervention was envisaged by the Policy makers at the time of enacting Environment (Protection) Rules, which led to the enactment of Rules 1989 for GMOs.  The Rules, 1989 also require statutory regulatory committees to review scientific advancements and issue manuals/guidelines for risk assessment and risk management.

The review of Bt Cotton, first GM crop in India was initiated in 1994 and the field trials commenced in 1998 and finally approved for commercial release in April 2002 much before the biosafety protocol came into force. 

Any limitation in Rules, 1989 due to scientific advancements was addressed by the regulators at the time of Bt cotton review process through data requirements and updating of guidelines.  It is evident from the Bt cotton decision documents, that ERA is an integral part of the risk assessment process, though not explicitly defined in the Rules 1989.

Based on the Bt cotton experience and international developments to ERA of LMOs in the context of biosafety Protocol, a more structured documentation and review process was put in place during the review of Bt brinjal (eggplant or aubergine). The element of public consultation was also introduced all through the review process. 

It was also recognized, because of historical precedence, there are opportunities to align the provisions of Rules 1989 with that of the Protocol. To increase conformity with the Protocol, a few different options was considered by GoI and the option to publish new ERA guidelines for GE plants, under the authority of the Rules, 1989 that promote the approach taken under the Protocol was considered as the best option..

MoEF&CC, pending the enactment of Biotechnology Regulatory Authority of India Bill, initiated a process under the UNEP/GEF supported Phase-II Capacity Building Project on Biosafety through which dedicated guidelines for ERA of GE crops has been developed.

The Risk Analysis Framework (RAF), ERA Guidelines of GE Plants and ‘User’s Guide to ERA’ were developed as part of the Phase-II Capacity Building Project with a view to (i) align and harmonise the risk assessment process under Rules 1989 with Annex III of the CPB; (ii) to provide clarity on the information requirement; (iii) lend transparency to the process followed by RCGM and GEAC and (iv) to address some of the contentious issues in the Supreme Court.    These documents may be viewed at http://geacindia.gov.in/guidelines-and-protocols.aspx

While developing this document, it was also recognized that concept of risk assessment is universal but extremely complex and accordingly attempts have been made to integrate the best practices from countries with experience in environmental risk assessment as well as the ‘Road Map’ in the Guidance Document developed under CPB process as a starting point.

Review of GM mustard -DMH-11 (Brassica Juncea) is based on the newly developed guidelines which have been harmonised with the requirements under CPB.

Regards

Ranjini Warrier

Dear Tim.

Thanks for your work moderating this forum and providing the structure in three topics.  I will keep my comments on Topic 1 brief in light of the late hour of the forum.  Let me consider each of the items in turn that you have suggested for this topic.

a) Share experiences with risk assessment of LMOs:
My experience in conducting environmental risk assessments of LMOs has been accrued over the past 27 years with the U.S. Department of Agriculture's Animal and Plant Health Inspection Service, specifically the program responsible for the biotechnology regulations.  I was fortunate to be involved in doing risk assessments, and training others, in environmental risk assessments for biotech plants at the field testing and commercialization phases.  I have also been involved in drafting the amendments made to our APHIS biotech regulations in 1993, 1997, and 2005.  I have been members of RA/RM AHTEGs on the

b) Point out particular challenges:
In my experience, one of the particular challenges is making sure that the risk assessors have a multi-disciplinary approach that includes those plant scientists who can remind others of the vast variability built into species.  In recent years, we now have come to find transposable elements and their role in constantly modifying genomes without human intervention.  This is reinforcing the idea that genetic changes are not inherently undesirable, and it reinforces our need to keep the phenotype of the modified organism as the main focus in risk assessments (with the genetic analysis helping to frame relevant considerations about inheritance of the trait(s) in breeding programs as well as natural populations.

One other particular challenge is communicating the essence of the risk assessment to decision makers in terms that are understandable to a non-technical person. People are still getting the erroneous impression that a change in characteristics of an organism is unique to LMOs and that change in any organism is undesirable.  We have a long way to go as risk assessors to make the concepts and rationale of our analyses understandable to the non-specialist.

c) Point out instruments (e.g. guidelines) that have been used:
For environmental risk assessments, we have built our approach on the approaches used in evaluating the environmental safety of all organisms, regardless of whatever genetic modification techniques that might have been used.  Much of this experience has been gained by organisms that are known to cause problems in the environment, especially those that cause disease (e.g., plant pathogens and arthropod pests) and those problematic plants that are often referred to as "weeds".  In the case of problematic plants, or weeds, there is a wealth of information available worldwide in evaluating potential adverse effects from undesirable plants.  I will not cite individual documents here, but instead refer interested readers to the many standards developed by the International Plant Protection Convention (IPPC).  We have found this to be a very useful forum for technical exchanges and finding shared approaches in environmental risk assessments. 

d) Share experience with support received from other countries or organizations:
As others have already noted in this topic, governments are very willing to share information and experiences that may be helpful for risk assessment. During the early- and mid-1990s, my agency and other U.S. regulatory agencies began bilateral technical exchanges with our regulatory counterparts in Canada and the European Union.  Although the discussions with the EU faded during the late 1990s, the discussions with Canada continued to grow into trilateral technical exchanges that have included Mexico since 2000.  A common thread in these technical exchanges has been focusing on the ways that we evaluate the safety of new biotech plant species.  We have found over the years in these and other technical exchanges that government regulatory agencies use similar approaches for risk assessments, even if the terminology or legal frameworks we use may have differences.

As others have already commented, we have benefited greatly from shared technical exchanges in a variety of settings that have been beneficial to setting shared approaches to the concepts of risk assessment, as well as practical, science-based approaches to use in implementing a domestic framework.  I am glad to see that others have cited the important work in this area done under international standard setting bodies, such as the IPPC.  Many of us engaged in this forum know that the basic elements of the methodology of Annex III of the Cartagena Protocol follow in the footsteps that countries cooperated in developing in the OECD Blue Book and the 1985 UNEP Guidelines.

Best regards,

Dave Heron

Risk assessments for LMOs in New Zealand are conducted by the Environmental Protection Authority. As stated in our national submission on this topic, our legislation and associated regulations dictate much of our approach to risk assessment. However, this approach includes the assessment of potential benefits, and also includes the ability to impose risk-mitigating controls (if necessary) that usefully affect the risk/benefit balance. We wish to stress some key principles that should underpin any risk assessment, regardless of the adopted methodology:

• Transparency is essential
• Uncertainty should be identified and clearly described in the risk assessment
• There should be a dialogue between risk assessors and risk managers
• Risk assessments are case-by-case, and take into account the particular details of the LMO(s) under assessment
• The scope of a risk assessment must be clearly defined
• The risk assessment must follow a clearly described process
• Risk assessments should include benefit assessments as part of the evaluation, and the risk/benefit balance should be an integral part of the decision-making process
• Risk assessments should be subject to internal (and, if required, external) peer review

POSTED ON BEHALF OF Dr. Flerida Cariño (This message reached the Secretariat before the 12 February 2018 1:00am closure of the forum):
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A quick survey of the BCH entries of parties as well as non parties showed at least 44 countries/territories have done risk assessments on various activities involving LMOs, mostly on the direct use of the LMO as food or feed.  Following the links would show that many have likewise done risk assessments on environmental releases, and have had experience with actual implementation of small- and large-scale releases.  To date, no serious adverse effects to health and environment have been directly related to the use or release of LMOs, even in countries that have effected releases for more than 20 years.  We, in the Philippines have done assessments of contained, confined, and large scale cultivation of LMOs, including their direct use as food and feed, and have not had any incident where the introduction of LMOs has harmed our biodiversity.  To us, this indicates that our existing guidance documents and risk assessments done by other countries are sufficiently robust to allow a country to reach a decision on whether or not to adopt this technology. 

The BCH and websites of scientific societies offer a wealth of information useful for even inexperienced regulators.  As a developing country short on resources, we find that the OECD, the ILSI, the ICGEB, and the various WHO and FAO documents provide insights that help us evaluate options in the context of our needs and protection goals.  We regularly survey BCH entries for new uploads of approval documents to update our capability and gain insights on what factors they considered in issuing approvals, or their rationale for declining to use this technology, and suggest that less experienced countries do the same.  We also continuously review the sites of scientific societies and international organizations to update our information and anticipate new LMOs that may require our risk assessment and regulatory approval.

For countries who would like some guidance, we suggest that a survey of the BCH entries can first be made, and depending on the inclination, needs and protection goals of that country, opt for the guidance documents of countries which have successfully deployed LMOs or declined their use.