POSTED ON BEHALF OF FRANCISCA ACEVEDO
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Dear members of the Online Forum,
I am very satisfied with our past discussion on gathering views, information and sources of reference on four topics and for that I would like to thank all who have actively participated.
We have a rich and diverse community of very capable experts in our Forum which helped me learn a great deal about the four topics during the two weeks of discussion. It is quite obvious that there are different points of view among us on how to proceed but, in my personal opinion, it is this very diversity that adds value to this type of discussion and that is precisely the greatest strength of such online platforms.
We had much participation in all four topics for which information was solicited and for each of them we have read different viewpoints. In the following lines I will attempt to provide a “flavor” of some of the views shared, without any intention of providing an exhaustive list of the issues that were raised during the discussion.
-> Under the topic “LMOs introduced in centres of origin and genetic diversity” and “LMOs intended for introduction into unmanaged ecosystems” (the two topics will be addressed together), among other issues, we read about how outcrossing and introgression of the transgene into sexually compatible plants could have an impact on wild genetic resources and/or in situ germplasm collections; about the potential impact of LMOs on the domestication processes of wild relatives; the importance of monitoring activities in centres of origin and genetic diversity; and how the introduction of LMOs in centres of origin and genetic diversity would be closely inter-linked with socio-economic considerations, particularly the contribution of farmers and indigenous peoples in such centres of origin and centres of genetic diversity.
On the other hand, we also read that these are issues considered in any ERA process of LM crops for cultivation via protection goals and problem formulation. The particularities of a receiving environment are an intrinsic part of the risk assessment and are already captured by many Elements for Consideration presented in the Roadmap and the inclusion of specific consideration on centres of origin would be redundant.
-> On the topic of integrating “Integrating human health into the environmental risk assessment” taking into account the topics “Nutritionally altered living modified plants” and “LMOs that produce pharmaceutical products”, as appropriate, we read that when considering human health as the protection goal, the safety assessment of foods derived from LM plants improved for nutritional or health benefits can be conducted according to the Guideline elaborated by the Codex Task Force on Foods derived from Biotechnology. Furthermore, it was noted that it is quite unlikely that nutritionally altered LM plants would pose special considerations for the environment since they are specifically developed for nutritional or health benefits. It was also noted that many pharmaceutical compounds are derived from plants that are not LMOs, and that the potential for a pharmaceutical compound to cause harm in the environment is not related to its use as a pharmaceutical.
On the other hand, we also read that a useful and practical addition to the Guidance would be to focus on the 'how' aspect of integrating human health into the environmental risk assessment. The intention with the inclusion of human health considerations in a more appropriate manner would not be to duplicate a health risk assessment or a safety assessment carried out in accordance with the Codex Principles and Guidelines, but to provide further information that is relevant to the assessment of the LMO and to fill the gaps of the food safety assessment. For example, the effects on human health related to the environmental risk assessment of an LM plant relates to possible immediate and/or delayed effects on human health resulting from potential direct and indirect exposure to the LM plant. Exposure pathways to be assessed would include those arising from the environmental release, such as alterations that may affect pollen in plants, leading to inhalation and contact exposures. In case of detection of potential chimerical ORFs a bioinformatics analysis should be done to establish possible similarity with known toxins or allergens. Moreover, it was noted that in the case of nutritionally altered LM plants and LMOs that produce pharmaceutical substances, potential challenges for traditional comparative risk assessment approaches could be created. Another aspect was the risk that LMOs producing pharmaceuticals may accidentally enter the food supply.
-> Concerning the topic “LMOs created through use of dsRNA techniques, engineered to produce dsRNA or dsRNA” and “LMOs containing RNAi”, we read that it would be important to note in the Guidance that the risk assessment of RNAi LMOs may require the use of different risk hypothesis or scenarios, taking into account the resilience of the RNA molecule in the environment, the potential of dsRNA to produce heritable silencing effects (through epigenetic transmission), and the ability of dsRNA to be taken up and further amplified, and potential toxicity which may need to be investigated through genome-wide microRNA screening. It was also suggested that the title of this topic should be changed to “LMO possessing a transgene(s) capable to induce an RNA silencing response”. The need to define relevant terms was also noted.
On the other hand, we also read some views that risk assessments of these types of LMOs follow the same paradigm as other LM plants and, therefore, no additional guidance on this topic is needed.
-> And, finally, on “Synergistic impacts of different herbicides that are part of the technology package that accompanies certain LMOs”, on the one hand, we heard that this topic is outside of the scope of the environmental risk assessment of an LMO crop under Annex III of the Cartagena Protocol and covered by other regulatory frameworks, which also assess the safety of herbicides as applied to LMOs.
On the other hand, we also heard that the focus of this topic is on LMO risk assessment and some of the specific considerations would include the choice of comparators, synergistic effects, potential of multi-herbicide resistant LM plants to establish as weeds, changes in the management related to the use of herbicides which is induced by the characteristics of the LMO: amount of herbicides, the time of the application and the combination of different herbicides if applied combined at the same time or on the same field at different times, as well as potential “joint action” of two or more herbicides being used in connection to an LM crop.
With regard to the format, the suggestions include adding text boxes, additional sentences in line with the existing text and/or examples. Also, a number of relevant references were proposed. There were also views that the addition of more examples focusing on specific LMOs in “boxes” or with additional sentences would not improve the flexibility of the Guidance but rather create confusion for novel risk assessors.
Furthermore, some participants were of the view that some of the topics warrant the development of entire separate sections of the Guidance (i.e. under Part II), while others called for efforts to focus on improving the existing Roadmap and argued that boxes or additional text on the four topics are unnecessary and would add complexity to the Guidance.
It is important at this point to remember why we have been discussing on these matters, and I therefore will permit myself as the moderator to add the following reference text extracted from the COP-MOP 7 decision BS-VII/12:
“Annex TERMS OF REFERENCE FOR THE OPEN-ENDED ONLINE FORUM AND AD HOC TECHNICAL EXPERT GROUP ON RISK ASSESSMENT AND RISK MANAGEMENT”
“Methodology […] 2.While revising and improving the Guidance, an attempt should be made to take into account the topics prioritized by the AHTEG, on the basis of the needs indicated by the Parties with a view to moving towards operational objectives 1.3 and 1.4 of the Strategic Plan and its outcomes, for the development of further guidance.” “Expected outcome […] 5. An improved version of the Guidance on Risk Assessment of Living Modified Organisms”.
I also include the link to the page were operational objectives 1.3 and 1.4 of the Strategic Plan and its outcomes can be directly visited:
http://bch.cbd.int/protocol/issues/cpb_stplan_txt.shtml#oo1_3
We in this online forum had the objective of gathering views, relevant guidance and sources of information on the four topics shown above so as to be incorporated into the existing Guidance, by creating text boxes or adding text, as appropriate, in the "Roadmap for Risk Assessment of LMOs" (Part I of the Guidance). Discussing if the topics should be taken on board at all, or if they had to be further developed into complete documents (Part II of the Guidance) was out-of-scope of this exercise.
At the last COP-MOP meeting, the Parties agreed that, in parallel to revising the Guidance in response to the comments from the testing, an attempt would be made to take into account the topics prioritized by the previous AHTEG. Adding some sentences or boxes on the specific topics in the existing Roadmap and/or other parts of the Guidance is already a compromise solution, which was reached at the last COP-MOP, between Parties who wanted full guidance to be developed on those topics and Parties who did not want any additional guidance to be developed. Therefore, discussing whether the new topics should be developed as an entire section of the Guidance or not be developed at all not only is a step back, but it also goes against what was already decided by the Parties.
I would also like to recall that the topics prioritized by the previous AHTEG are not their own input but rather the result of several requests and inputs from Parties over the years, which were streamlined by the previous AHTEG as the list that was sent to the last COP-MOP meeting. Interestingly, but by no means a coincidence, the call to add more information into the Guidance on two of the topics prioritized by the AHTEG (centres of origin and human health) were also made by different Parties during the testing of the Guidance, further emphasizing the importance of those topics. The most important in this debate is not how the list came to be, but rather the fact that Parties mandated us to take into account that particular list of topics as prioritized by the previous AHTEG. Therefore we should turn back to the discussion on “how” to integrate these topics in the current version of the Draft Guidance rather than discussing if this should be done or not.
The main challenge now is to reconcile the different views; we should go beyond weighing one view against the other, but instead should distill and make sense of them all into something that helps the users of the Guidance. With this thought in mind, the Sub-group will make its best attempt to reconcile the views and the result will be discussed at a later stage by the entire AHTEG and Online Forum.
I recognize that other suggestions were made, which are not being included in this summary, and that is because they were not directly related to the topic of discussion and I will leave them for consideration by the AHTEG and/or Secretariat, as appropriate.
Finally, I would like to again thank the Secretariat on having selected me as moderator in such a process to help out in what I believe a very important instrument for the implementation of the Cartagena Protocol. I would like to thank you all as well for participating in the Online Forum.
Francisca Acevedo Gasman
