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Comments on the Roadmap
[#2090]
POSTED ON BEHALF OF HIROSHI YOSHIKURA
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Dear Mme Manoela Miranda, I appreciate AHTEG for developing the present document, Guidance on Risk Assessment of LMOs. My comment is the following. General comment 1. As indicated by Dr. Adriana Otero-Arnaiz supported by Dr. Saturnina Halos, it is important to keep focus on the RISK ASSESSMENT. In this connection, I propose to use, at least the spirit of, the well established risk analysis framework in the Codex Alimentarius, i.e., risk assessment is a scientifically based process, and risk management is the process distinct from risk assessment (See Definitions of Risk Analysis Terms Related to Food Safety in the Codex Procedural Manual for the full text). In this spirit, it may be useful to sort out which description in the present draft belongs to risk assessment and which one to risk management.
2. Though I appreciate the present activity of developing Guidance on Risk Assessment, I note that such an activity sometimes leads us to re-interpretation of the original text. I give just one example. While “points to consider”, paragraph 9 of Annex III starts with statement “Depending of the case”, the corresponding paragraphs in the present draft, “Points to consider regarding the receiving environment” and “Points to consider regarding the characterization of the LMO” in page 6 omit the qualification “depending of the case”. This omission will lead to interpretation that the items are obligatorily considered. Re-interpretation should be strictly avoided in view of the fact that the present document was agreed on after long difficult negotiation.
3. I note that the present Annex III is already sufficiently prescriptive. The rest can be left to the users of Annex III and related texts. What may be required for us is to give guidance on how to use the Annex III in the whole context of Cartagena Protocol and Convention on Biological Diversity while referencing to the pertinent paragraphs and Annexes.
4. The RISK ASSESSMENT described in pages 6 – 13 consists of five steps. I my view, only the Step 1 may belong to the risk assessment in a strict sense. Even some part of the suggested step 1 goes beyond the content of Annex III, for example, bullet points (g) – (n) under heading of “Points to consider regarding the potential adverse effects …..”. Some of them can possibly be addressed by risk managers during the use of LMOs, such as, as tool of monitoring.
5. I think the issue on “co-existence” raised by Dr. Wei Wei merits consideration in this group, as the main issue here is probably not introgression of “trans-genes” into wild varieties but into non-GM cultivated varieties (The former is very rare according to Kuroda et al, Molecular Ecology (2010) 19, 2346-2360, while the latter could be more frequent). The issue here is rather the issue on agricultural biodiversities. Specific comments
1 The third paragraph of page 1, PART I, says “The Roadmap applies to all types of LMOs”. In the spirit of Cartagena Protocol, this statement is understandable. In a literal sense, however, “all types of LMOs” mean “LMOs derived from any organisms on the earth including species poorly known or yet to be discovered” (it is said every year several thousands of new species are discovered). I do not think it realistic that this Guidance covers LMOs derived from such unknown or poorly known living organisms. Practically, when we produce LMOs, we select organisms familiar to us through the history of safe use and long scientific investigation. Therefore, I propose that LMOs to be treated in the Guidance should be restricted, at least for foreseeable future, to LMOs that have “conventional counterpart(s)”(See below). Use of unfamiliar or poorly known organisms as parental organisms for generation of LMOs should be discouraged. Full assessment of the parent non-modified organisms should always precede production of LMOs.
2 “Conventional counterpart” is defined in Codex Alimentarius as “a related organism/variety, its components and/or products for which there is experience of establishing safety based on common use as food”. We can adapt the definition of the Codex Alimentarius to Cartagena Protocol by changing it in such a way, for example, that “a related organism/variety for which there is experience of establishing safety based on common agricultural or other use in the environment”. 3 According to the last sentence of the third paragraph of Background, General Introduction (page 2), “The choice of protection goals by the Party could be informed by Articles 7(a), 7(b) and 8(g) and Annex 1 of the Convention on Biological Diversity.” However, 7(a) and referred Annex 1 are respectively on “identifying components of biological diversity” and “identification and monitoring”; 7(b) is on monitoring of the components of biological diversity; and 8(g) is establishing/maintaining means to regulate manage or the risks associated with the use and release of LMOs. I do not understand why these sentences are appropriate in defining the goal.
4 In my view, the choice of protection goals has to be done in a multidisciplinary way by risk managers before use of LMOs in a manner most suitable to each case. In addition, I believe “the choice of protection goals” should be done by risk managers based on risk assessment done by risk assessors, not by risk assessors themselves. Best regards, Hiroshi Yoshikura
posted on 2011-03-31 14:14 UTC by Ms. Manoela Miranda, UNEP/SCBD
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RE: Comments on the Roadmap
[#2106]
Dear All. I would like to add some general comments on the Road Map. Drs. Hiroshi Yoshikura. Adriana Otero-Arnaiz and Saturnina Halos remarks on risk analysis and on some special issues of it are in almost complete agreement with my personal point of view, which in turn mirrors the predominant opinion of the Brazilian Biosafety Clearing House. As stressed before, we should avoid re-interpretation of the original text in view of the fact that the present document was agreed on after a long and difficult negotiation. Moreover, the road map without its Part II is already sufficiently prescriptive and has a suitable set of guidelines. I believe that more detailed examples, as the present texts of RA for stress-tolerant crops and LM insects form Part II are superfluous. They should be avoided as part of the road map and be left as a set of suggested approaches to the RA of these specific subjects. This would not be a re-interpretation of the proposed road map, but a simplification, leading to a more focused text. Anyway, as far as the specific examples are concerned, I would like to stress that many of the risk hypotheses are highly speculative and should be supported by references. These references should not be listed after the main body of text, but clearly indicated just after the hypothesis formulation. This is the common practice in science and should be respected in these texts. Just as a example, please consider the text below, taken from Part II, item B, Risk assessment of LM crops with tolerance to abiotic stress: “Questions that may be relevant to the risk assessment of LM crops with tolerance to abiotic stress in connection with the intended use and receiving environment include: • Would the tolerance trait have the potential to increase the invasiveness, persistence or weediness of the LM crop that causes adverse effects to other organisms? --- • Would the abiotic stress tolerance trait, for example, via pleitropic effects, have the potential to affect, inter alia, pest and disease resistance mechanisms of the LM crop?” As can be seen, no references are directly indicated. In the linked webpage http://bch.cbd.int/onlineconferences/abioticref_ahteg_ra.shtml there are 16 references (mostly papers or technical texts), but it is difficult to know which of them would support the above hypotheses. I found 8 which could discuss these points, but looking at the closely I was unable to find any supporting evidences. My concern may be unjustified, but the hipotheses contradict what is known of the biology of cultivated plants and of the phenotypic changes expected from the gene modification for abiotic stress tolerance in a GM plant. As far as I know no tolerance trait will be so radical as to allow the GM plant to increase the invasiveness, persistence or weediness. Indeed, tolerance will be very limited and may allow, for example, the GM plant to withstand some water shortage, but never to propagate in a new, dry environment. The same may be true for metal tolerance, i.e., plants may tolerate a little more aluminium, for example, but nor really harsh conditions, as the introduced changes are very limited, usually in one single biochemical pathway, with no morphological or behavioral changes. Just as an example, can anyone imagine how could maize or soybean propagate in semi-arid areas just because they got some genetic modification for drought tolerance? On the other hand, as far as I know, most of our cultivated plants cannot easily propagate without the direct help of us. A single gene, does not matter which, will never be able to change this behavior, not even the introduction of many genes, specially those with do not contribute in any way to change the plant behavior: invasiveness and weediness are complex behaviors that depends on many characteristics and changes are NOT expected to occur just as a side effect of transgeny. Such an hypothesis should be supported by solid references, as it contradicts what is expected by the sheer crop biology. The last hypothesis is completely speculative: the scientific evidences of unintended pleiotropic effects in selected elite events put into the marked are still to be produced and even the same evidences for transformed plants before agronomical selection are very scarce. If a Partner decides to follow this suggestion, it would have to apply much effort and a considerable amount of funds to try to prove something that is possibly very rare, if non-existing. Again, the literature listed in the linked page do not support this hipothesis. Going back to the general issues, I got the impression that speculative hypotheses are also present in the other two specific examples on the use of the road map. In my opinion, this should be discouraged as the final text must be science-driven. Please forget my words and the way, perhaps too blunt, of expressing my ideas, as English is not my mother tongue.
posted on 2011-04-02 16:05 UTC by Mr. Paulo Paes de Andrade, Brazil
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From Ossama El-Tayeb, NFP of Egypt again.
The arguments put forward by Professor de Andrade are quite logical and convincing from a purely agronomic or crop biology perspective. He rightly refers to some proposed elements as "speculative" and deviating from "the common practice in science" which should be respected in our text. Of course the RA should be conducted on a scientific and not an arbitrary basis but this goes only as far as not contradicting universally accepted scientific facts, which in the broad science of ecology and the even broader one of environment, are not too many . He poses as a convincing example, that no one could predict (with certainty?) how maize or soybean would propagate in a semi-arid environment "just because they got some genetic modification for draught tolerance" and that is exactly what a RA should attempt to predict, with painstaking, and often expensive and time consuming, uncertainty. Such cost should, of course, be internalized into the cost of the LMO rather than externalized to the environment, including biodiversity. Certainly we need to conduct RA reproducibly and predictably but also recognize the uncertainty which characterizes performance of biological entities in a holistic ecosystem rather than in a managed one as is the case in agronomic practice. In the final analysis the road map must not be discipline-focused but capable of dealing with a variety of situations across the world. In all cases it should be cognitive of the precautionary approach, the un-denied pillar of the Protocol, and leave sufficient room for country to country approaches dictated by variation in peculiarities of practice in different human environments as influenced by culture, and by physical peculiarities of ecosystems which may not fit a one size fits all approach. This is essential if we are to avoid possible damages, especially in some knowledge-poor developing countries where, say, agriculture does not follow the modern industrialized practices which are common in other developing countries like Brazil and Argentina. The newly adopted Nagoya-Kuala Lumpur Protocol should be taken into consideration to guard provider and user alike. A RA which is not sufficiently broad may be too expensive to both parties in the end.
I wish to conclude with an emphasis on my belief that if we are to design a RA approach which will likely be accepted as a standard by the WTO, we will probably have to dispense with the precautionary principle, which we cannot without re-writing the Protocol and not just Annex III. In many ways this also reflects on the prevailing tendency to exclude co-existence from the roadmap. Sorry for being a bit too candid: many of these concerns were raised during COP-MOP meetings which will eventually consider our roadmap.
posted on 2011-04-02 19:25 UTC by Mr. Ossama El-Tayeb, Egypt
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RE: Comments on the Roadmap
[#2110]
From Ossama El-Tayeb, NFP of Egypt again. The arguments put forward by Professor de Andrade are quite logical and convincing from a purely agronomic or crop biology perspective. He rightly refers to some proposed elements as "speculative" and deviating from "the common practice in science" which should be respected in our text. Of course the RA should be conducted on a scientific and not an arbitrary basis but this goes only as far as not contradicting universally accepted scientific facts, which in the broad science of ecology and the even broader one of environment, are not too many . He poses as a convincing example, that no one could predict (with certainty?) how maize or soybean would propagate in a semi-arid environment "just because they got some genetic modification for draught tolerance" and that is exactly what a RA should attempt to predict, with painstaking, and often expensive and time consuming, uncertainty. Such cost should, of course, be internalized into the cost of the LMO rather than externalized to the environment, including biodiversity. Certainly we need to conduct RA reproducibly and predictably but also recognize the uncertainty which characterizes performance of biological entities in a holistic ecosystem rather than in a managed one as is the case in agronomic practice. In the final analysis the road map must not be discipline-focused but capable of dealing with a variety of situations across the world. In all cases it should be cognitive of the precautionary approach, the un-denied pillar of the Protocol, and leave sufficient room for country to country approaches dictated by variation in peculiarities of practice in different human environments as influenced by culture, and by physical peculiarities of ecosystems which may not fit a one size fits all approach. This is essential if we are to avoid possible damages, especially in some knowledge-poor developing countries where, say, agriculture does not follow the modern industrialized practices which are common in other developing countries like Brazil and Argentina. The newly adopted Nagoya-Kuala Lumpur Protocol should be taken into consideration to guard provider and user alike. A RA which is not sufficiently broad may be too expensive to both parties in the end. I wish to conclude with an emphasis on my belief that if we are to design a RA approach which will likely be accepted as a standard by the WTO, we will probably have to dispense with the precautionary principle, which we cannot without re-writing the Protocol and not just Annex III. In many ways this also reflects on the prevailing tendency to exclude co-existence from the roadmap. Sorry for being a bit too candid: many of these concerns were raised during COP-MOP meetings which will eventually consider our roadmap.
posted on 2011-04-02 19:43 UTC by Mr. Ossama El-Tayeb, Egypt
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RE: Comments on the Roadmap
[#2112]
In environmental sciences, the word "contamination" means imparting an unusual or foreign material to a natural environment previously free from that material, hence it is not really incriminating. In a RA context it is quite neutral. The fact that to the public it may be alarming is unfortunate but quite truthful. When an exotic gene is introduced through lab work into a genome, it contaminates that genome. May be one could put a footnote note that "contamination may be beneficial such as when a human insulin gene is deliberately introduced into bacteria in order to manufacture human insulin in a factory for alleviating certain cases of diabetes".
posted on 2011-04-02 19:49 UTC by Mr. Ossama El-Tayeb, Egypt
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RE: Comments on the Roadmap
[#2124]
In Response to HIROSHI YOSHIKURA
I agree that it is important to focus on the RISK ASSESSMENT. However, I disagree with the suggestion of necessarily using the (spirit of) the CODEX framework where risk assessment and risk management are kept separate. I suggest that we also take into consderation ISO31000 (risk management) where risk assessment is an integral part of risk management. Risk assessment provides information for risk management. To say that "risk assessment is a scientifically based process" is not necessarily helpful. Risk assessment does not follow the scientific method. Strictly, risk assessment is an analysis process that USES information derived from scientific processes, and presents it in a way that focuses on the concept of risk (defined in ISO31000 as the "effect of uncertainty on objectives").
I agree with point 2 that we need to be careful to avoid reinterpretaiaton of the original text. However, there is a problem in that our understaninding of risk and risk assessmetn has moved on since the text was developed. This matetr will need to be consdiered at some stage.
I also agree strongly with point 3 that "the present Annex III is already sufficiently prescriptive." and that "What may be [IS]required for us is to give guidance on how to use the Annex III in the whole context of Cartagena Protocol and Convention on Biological Diversity while referencing to the pertinent paragraphs and Annexes."
posted on 2011-04-03 20:52 UTC by Janet Gough, Environmental Protection Authority
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RE: Comments on the Roadmap
[#2128]
Ossama El-Tayeb, NFP-Egypt
The views expressed by Ms. Janet Gough are very true and need to be considered with great care.
posted on 2011-04-03 22:31 UTC by Mr. Ossama El-Tayeb, Egypt
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RE: Comments on the Roadmap
[#2129]
In terms of revision of the Roadmap I have done a brief analysis of of the responses to questions 6 through 11. From this I have extracted a series of themes that I hope willl get considered in the next review of the Roadmap. (1) The nature of risk is that outcomes are uncertain (2) Risk assessment supports decision making – adopting od a precautionary approach is part of decision making, not part of risk assessment (3) Risk assessment does not need full information (guidance should be provided as to how to decide when more information is needed) (4) Some kinds of uncertainty cannot be resolved by further information (5) Practical risk assessment requires an ability to decide which uncertainties need to be analysed – guidance is needed as to how to decide when you have enough information to proceed with risk assessment (6) No such thing as zero risk and this needs to be highlighted (7) Needs better guidance on context (what it is and how to establish it) so that protection goals can be identified, including guidance for working out what aspects of the consequence matter (ie the ‘so what’)
posted on 2011-04-03 23:47 UTC by Janet Gough, Environmental Protection Authority
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RE: Comments on the Roadmap
[#2132]
There is the need for clear indicators for determining which risks can be addressesed through risk management and those that will warrant out right rejection of risk in the road map. Rufus Ebegba
posted on 2011-04-04 10:31 UTC by Dr. Rufus Eseoghene Ebegba, Nigeria
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RE: Comments on the Roadmap
[#2146]
Dear participants,
We have only a few days left in the discussion of the Roadmap. I would like to thank very much those of you that have already commented on the Roadmap. To the others, I would like to draw your attention to a number of issues that resulted from the scientific discussion on the Guidance on risk assessment, in particular on the Roadmap.
The SCBD has kindly summarized the comments, in their posting ‘Results of the scientific review of the "Guidance on Risk Assessment of LMOs"', on the page ‘List of threads’. You find the text of this summary below, after my name. I would like to commend these issues to your attention, especially the bulleted points. Your comments will be highly appreciated.
Hans Bergmans, chair of the AHTEG Sub-working group on the Roadmap
Results of the scientific review of the Roadmap:
“Seventy-eight percent of respondent Parties agreed that the overall quality of the Roadmap is good. However, only 12.5% of the respondent other Governments and 27.5% among relevant organizations agreed that the overall quality of the Roadmap is good. The level of agreement among all three respondent groups combined was 54%. The majority of respondent Parties indicated that the Roadmap is consistent with the Cartagena Protocol and a useful tool to assist countries in conducting and reviewing risk assessments (i) in a scientifically sound and case-by-case manner, and (ii) of LMOs introduced into various receiving environments. On the other hand, when asked if the Roadmap is applicable to the risk assessment of LMOs of different taxa, many respondent Parties shared the view that although the Roadmap is meant to give guidance on the risk assessment process for all types of LMOs this aim is not entirely met. It was noted that there was a bias towards crop plants in the terminology used and in many aspects of the Roadmap. For example, it was noted that several aspects which are relevant to LM micro-organisms are not included in the Roadmap. To address this issue, it was recommended that there is a need to include examples related to non-crop LMOs in the Roadmap or further develop guidance on other types of LMOs such as fish, trees, insects, microorganisms and viruses. With regard to the completeness of the Roadmap, a number of issues were identified that should either be included or be further elaborated in the Roadmap. These issues included guidance on: • The use of tiered approaches in the risk assessment process; • The use sound statistical tests in the risk assessment process and the importance of describing these tests in the risk assessment report; • How to deal with conflicting scientific data, especially data from publications and how to inform the decision makers of the difficulties encountered during the risk assessment such as high degrees of uncertainties, ambiguities or contradictory information; • How to take into account human and animal health during the risk assessment in addition to environmental issues; • How to take into account the intended scale and duration of the environmental release, in particular of releases whose objective is to generate information for further risk assessments, such as field trials; • How to take into account the intended use of the LMO during the risk assessment (e.g. for cultivation vs. for import and processing); • How to define the various levels of likelihood and consequences; • How to implement monitoring as a means to address assumptions made during the risk assessment or to validate conclusions of the risk assessment on a wider (e.g. commercial) level of application. It was also recommend that a number of terms be included in a glossary; for example terms such as: “protection goals”, “assessment end-points”, “risk thresholds”, “gene product”, “intended and unintented effects”, “cumulative effects”, “combinatorial effects”, “cumulative vs. aggregate effects”, “unmanaged ecosystem", “epistasis”, “gene function”, “gene products”, “co-existence”, “receiving environment”, “EC50”, “LD50”, etc. Examples of concepts that were noted for further clarification are: “acceptable scientific quality”, “methodological and analytical requirements”, “management strategies” “manageability and acceptability of risks”. Some Parties recommended improvements to the flowchart of the Roadmap (Please refer to submissions by Austria, Bolivia, Malaysia and Mexico).”
posted on 2011-04-05 13:30 UTC by Mr. Hans Bergmans, PRRI
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RE: Comments on the Roadmap
[#2188]
Dear colleagues,
Building on all the suggestions that were made to improve the Roadmap and the 3 guidance documents, I would like to stress that an important purpose of the Roadmap is to provide access to useful background materials relevant to risk assessment (stored into the BCH). Possible mechanisms, including criteria, for future updates of the lists of these materials will be subject for further discussion. But we should keep in mind that the Roadmap is an entry point towards useful references and that it should therefore be kept concise, users-friendly and straigthforward, focused on the main principles and objectives of the RA and not entering to much into details. These details should be available from the linked resources.
This brings me to another issue that was mentioned by Hans in one of his previous intervention. RA is supported by scientific data that are, for some aspects, of conflicting nature. The Roadmap should not aim at interpreting or weighting these conflicting scientific data. This should be done during the evaluation of risk assessment reports. Scientific process (and thus also scientific expertise) is by definition not univocal but contradictory. When necessary, scientific ambiguities or contradictions encountered during the risk assessment should be reflected in the information sent to the decision makers.
Kind regards,
Didier Breyer
posted on 2011-04-08 07:41 UTC by Didier Breyer
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RE: Comments on the Roadmap
[#2147]
POSTED ON BEHALF OF MR. HIROSHI YOSHIKURA
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I appreciate Dr. Janet Gough’s comment on my previous one. The following paragraphs copied from the Codex Procedural Manual will further clarify the risk assessment- management relation in the Codex . “9. There should be a functional separation of risk assessment and risk management, in order to ensure the scientific integrity of the risk assessment, to avoid confusion over the functions to be performed by risk assessors and risk managers and to reduce any conflict of interest. However, it is recognized that risk analysis is an iterative process, and interaction between risk managers and risk assessors is essential for practical application. (Paragraph 9 of WORKING PRINCIPLES FOR RISK ANALYSIS FOR APPLICATION IN THE FRAMEWORK OF THE CODEX ALIMENTARIUS, Codex Procedural Manual 19th Edition page 87)”
The definitions of risk assessment and risk management are as follows; Risk Assessment: A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.
Risk Management: The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant [for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options](DEFINITIONS OF RISK ANALYSIS RELATED TO FOOD SAFETY). Underlines are mine. Though the scheme is for the food safety and fair trade, there will be much to learn from the codex scheme, I believe.
I already posted this mail but somehow could not be sent. If you have got the previous one, please delete it.
Hiroshi
posted on 2011-04-05 14:12 UTC by Ms. Manoela Miranda, UNEP/SCBD
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RE: Comments on the Roadmap
[#2148]
Further to the comments posted by Mr. Yoshikura, may I also add that the International Plant Protection Convention (IPPC)has an international standard entitled "PEST RISK ANALYSIS FOR QUARANTINE PESTS INCLUDING ANALYSIS OF ENVIRONMENTAL RISKS AND LIVING MODIFIED ORGANISMS" (ISPM 11) that is avaialble at https://www.ippc.int/index.php?id=ispms&no_cache=1&L=0 This standard describes the processes to be used for risk assessment as well as the selection of risk management options. It also includes guidance on evaluating potential phytosanitary risks to plants and plant products posed by LMOs. The process is defined by 3 main stages with risk assessment and risk management being clearly separated as follows: Stage 1 (initiating the process) involves identifying the pest(s) and pathways that are of quarantine concern and should be considered for risk analysis in relation to the identified PRA area. Stage 2 (risk assessment) begins with the categorization of individual pests to determine whether the criteria for a quarantine pest are satisfied. Risk assessment continues with an evaluation of the probability of pest entry, establishment, and spread, and of their potential economic consequences (including environmental consequences - S1). Stage 3 (risk management) involves identifying management options for reducing the risks identified at stage 2. These are evaluated for efficacy, feasibility and impact in order to select those that are appropriate. I provide this for your information and hope it is helpful. Thank you Andrea Sissons IPPC Secretariat
posted on 2011-04-05 15:21 UTC by Andrea Sissons, International Plant Protection Convention
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RE: Comments on the Roadmap
[#2159]
POSTED ON BEHALF OF LETICIA PASTOR CHIRINO, CUBA
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1st message to post in the Comment on the Road Map Thread
I consider that the document:
a. Represents a useful tool for the work of the risk assessors of LMOs. b. It respects every stage of the annex 3 of the Protocol. c. It provides the countries with no much expertise in this field, with several explicative and illustrative elements about how to proceed, using very useful examples. d. It is applicable to any of the possible cases to assess considering its holistic approach. e. It is a very flexible instrument, while gives the countries the opportunity to make their own decisions according their specific reality. f. The possible changes of this instrument will depend on its effective and practical implementation.
posted on 2011-04-06 16:32 UTC by Ms. Manoela Miranda, UNEP/SCBD
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RE: Comments on the Roadmap
[#2163]
Whilst I respect Leticia's view, my own is that (a)a number of important concepts are not adequately explained (b)the language is complex and front end heavy (c)and (harping back to a previous intervention), the importance of context is not highlighted adequately.
If the guidance is to be useful and effective for countries who do not currently have an understanding of risk or expertise in risk analysis then (a) and (b) need to be addressed.
posted on 2011-04-06 19:49 UTC by Janet Gough, Environmental Protection Authority
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RE: Comments on the Roadmap
[#2169]
Sorry that putting the mssage also to this thread as there are two active threads which share common points. My understanding on this round of the on-line forum, is to comment on the appropriateness of the guidance docs reported at MOP-5 in terms of practicality and feasibility for beginners on RA. I see some deviation which is going back to the past discussion and touching again rather than moving ahead to try elaborating the guidance docs. Some issues have been well discussed in the previous on-line forums over past two years or at much larger extent at different forums/conferences with more number of specific experts. Encouragements shall be made to those who are new to review the past information and documents residing the website. Obviously the debates are welcome but this discussion group shall recognize the mission and expectation given to this group: http://bch.cbd.int/onlineconferences/discussiongroups_ra.shtml#outcomes Quote: Objective and expected outcomes The objective of the current online discussions is to advance the work of the Open-ended Online Group and the AHTEG towards achieving the expected outcomes as mandated by the COP-MOP in decision BS-V/12: i. A revised version of the "Guidance on Risk Assessment of Living Modified Organisms"; ii. A mechanism, including criteria, for future updates of the lists of background materials; iii. Further guidance on new specific topics of risk assessment, selected on the basis of the priorities and needs by the Parties and taking into account the topics identified in the previous intersessional period. Each of these outcomes will be a topic of discussion taking place between 28 March and 17 April 2011. The first outcome will be addressed during the first two weeks of discussion, followed by the other two outcomes in the third week of discussions. Quote end. With the given tasks, the present RA on-line forum should be careful with deviating to individual philosophical thoughts and national policy issues which are not mandated. Yes some intervention dilutes focus, which may give diversion of the mission of the forum. However, things to discuss forward may be placed but jumping to one to another subjects as shotgun approach may not be proper at this stage of the on line forum. The present discussion basis may stay with FINAL REPORT OF THE AD HOC TECHNICAL EXPERT GROUP ON RISK ASSESSMENT AND RISK MANAGEMENT UNDER THE CARTAGENA PROTOCOL ON BIOSAFETY (UNEP/CBD/BS/COP-MOP/5/INF/15 3 August 2010) but further topics deviation from the doc shall be carefully reserved in order to effectively wrap up this session with the given time line to feed back to the present guidance doc and future RA AHTEG task settings. I understand that many of the RA AHTEG members are rather keeping observation, reserved for giving more opportunities for open-discussion to those who have not participated in RA AHTEG or in the past on-line forums, and this may be a fair consideration for not giving biases to the fresh audience and new participants of the present discussion group on guidance docs which the RA AHTEG members proposed, and encouragement should be made to anybody other than RA AHTEG members to comment in a forward thinking how to elaborate including the points and questions made by parties, non-parties with substantial experiences on RA and other agencies. The statistics of the consent/dissatisfaction over the present guidance docs, does not tell us jumping to considering new subjects discussion and analytic approach should be made over the feedbacks/comments from governments. Especially, clarification of languages and technicality of the terms in the guidance docs, could be raised for further elaboration as in the comments from some parties. Kind regards, Kazuo Watanabe
posted on 2011-04-07 05:20 UTC by Prof. Dr. Kazuo Watanabe, University of Tsukuba
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RE: Comments on the Roadmap
[#2172]
Dear Participants, The way uncertainty is stressed throughout the guidance is confusing and does not assist evaluators on how one deals with it in the Risk Assessment (RA) in a practical way. Uncertainty is not unique to LMOs and certainly not unusual in science. Therefore the accumulated experience in dealing with uncertainty or the ways to see if the data is altogether appropriate, substantial and reliable in a workable way should be reflected in the guidance. This is particularly of importance to enable the effective completion of the RA process. Besides, one of the main aims of the guidance is to assist making own assessment especially by those who are unfamiliar with RA. Thus, it should contribute to facilitating the decision making process consistent with the objective the Protocol. I would like to remind that: a) The Protocol recognizes “that modern biotechnology has great potential for human wellbeing if developed and used with adequate safety measures for the environment and human health” (in the preamble). Besides “The Protocol thus creates an enabling environment for the environmentally sound application of biotechnology, making it possible to derive maximum benefit from the potential that biotechnology has to offer, while minimizing the possible risks to the environment and to human health.” (introduction of the protocol) b) Precaution makes sense, especially if one includes the consideration or the comparison between the risk of the application of biotechnology with the risk of not employing biotechnology. best regards,
posted on 2011-04-07 12:24 UTC by Ph.D. Lúcia de Souza, PRRI - Public Research and Regulation Initiative/ANBio (Associação Nacional de Biossegurança - Brazilian Biosafety Association)
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RE: Comments on the Roadmap
[#2190]
Dear all,
As some participants mentioned previously, the present Annex III is well written with sufficient manner. Re-interpretation of Annex III should be avoided during the developing process of “Guidance on Risk Assessment”.
“Depending on the case”, in Paragraph 9 of Annex III will be the points that we have to pay more attention with “scientifically sound and transparent manner.” Although Risk Assessment frequently contains scientific ambiguities, any information should be provided with transparent manner for risk management. In contrast, the priority of Risk Management will be “depending on the case” and the decision should be made according to the stakeholders in each cases.
<specific comment> In current Road Map, Risk Assessment from ecological background is not sufficiently included. This may lead the confusion of adequate interpretation, such as “receiving environment” and “biological diversity”. Adequate scientific evaluation of related area (e.g. Oka et al. (2001) Ecological risk-benefit analysis of a wetland development based on risk assessment using “expected loss of biodiversity”. Risk Analysis, 21,1011-1023.) will help further developing process of “Guidance on Risk Assessment” without re-interpretation of Annexes.
Kazuaki Matsui
(edited on 2011-04-08 10:32 UTC by Kazuaki Matsui)
posted on 2011-04-08 10:31 UTC by Kazuaki Matsui
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Revision guidance RA-LMOs - Comments on roadmap
[#2174]
Dear participants, Here some comments guided by some previous messages of some participants. Several participants asked to make a better distinction in the roadmap between RA for field trials ( having other purposes than putting on the market ) and RA for commercial releases, which I find a good idea, but it should be noticed that the terms of the Protocol do not make that distinction. Related to that demand, it could also be interesting to discuss a question of upscaling the experimental phases of the RA, in particular for LMOs to be introduced into the environment. One could for ex. imagine an upscaling of the field trials themselves, to get, by steps and precaution, closer to the natural ecosystem where the LMO should be released. Linked to that idea, the possibility to use "tiered aproaches" ( which means upscaling steps of the RA from the laboratory to the field, passing through a scale of semi-field trial like green-houses ), which is one of the proposals suggested in the submissions made by Parties in their previous written comments to the SCBD for reviewing the roadmap, as summarized by the SCBD and reminded by Hans Bergmans. This could indeed be interesting but delicate, in particular concerning the conclusions that can be drawn from each tier level, an aspect on which there is no consensus presently among all experts. One aspect that could also be taken into account in the RA is the question of the duration of each potential impact identified for the LMOs under evaluation (transient or persistent effects). That "time" consideration leads me to the question of the "impacts chains" discussed by some participants. I think that the "context" in which the LMO release would take place, that has to be taken into account in the process of the RA ( with great attention, as reminded by some participants ), inevitably can/should take into account "impacts chains" , indirect effects; these have to be taken into account in particular in step 3 of the RA ( for the evaluation of the magnitude of the consequences of the potential hazards ) . But once again, each Party can handle this in function of its own determined "protection goals" ( N.B. : it should be clear how these protection goals, assessment endpoints, have to be defined by each country in order to be taken into account in the RA . Would there be written with precision in some national legislation? Would a general engagement in some international agreement be suffisant ? ), which should at least respect its various related international engagements. Concerning the fact that monitoring would not always be necessary ( cf. message of Lucia de Souza, Brazil ): this could indeed be the case if no any potential adverse effect has been pointed, and if no any uncertainty persists. To be seen if this could fit with the real world and the scientific/technical means able to be involved in the RA. We must not forget that the objective of the Protocol is to preserve and insure sustainable use of and agrobiodiversity and wild biodiversity. With best regards. Lucette Flandroy P.S. : Gene banks have indeed become very useful for the preservation of agrobiodiversity ex-situ. But experts also recognize that another necessary aspect, in particular facing climate change, is the protection and use of agrobiodiversity in situ, facing the real conditions of the evoluting environment. Disclaimer : http://www.health.belgium.be/eportal/disclaimer/index.htm
posted on 2011-04-07 13:20 UTC by Ms. Lucette Flandroy, Belgium
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RE: Revision guidance RA-LMOs - Comments on roadmap
[#2180]
Dear participants, Taking in mind the outcomes expected from this phase of the open forum, and also that the items “b” and “c” outlined by Dr Manoela (see her opening message of this forum) will be discussed from 11th on, I will concentrate on the outcome “ a” issues as already touched by some of you.
My considerations/contributions: 1- I agree with Dr Paulo Andrade, and some others, who considered that the item of co-existence is not part of the risk analysis and should not be included as an AHTEG topic of discussion for ERA 2- “Establishing the context” is extremely important for the initial steps of the process and so should carefully show and reflect the meaning and the scope of the proposal/text associated to the Roadmap. It has been well pointed out by Drs Janet and Beatrix, and I agree with Dr Hans proposal (message from March 29th)regarding what is covered by the roadmap, clarify about the receiving environment and the possibility of reaching other no-expected environment; some clarification about exchange of genetic material; the discussion in the Roadmap will necessarily stay away from other related issues, like the political and socio-economic issues, that are not within the scope of Annex III. 3- As the mosquitoes issues are not familiar to most of the groups/parties nor for most of the expert members of the AHTEG and neither for experts in this open forum (some exemptions recognized), I consider it premature to include such case in the roadmap, partII. 4- The uncertainty should be included in the scope/introduction of the document – it will better contextualize the user of the Roadmap. I fully agree with Dr Adriana (from Mexico) when she says“ in a guide like this, we must orient to the users in how to address the two options that the Protocol on the Anex III mentions, and no more than that.” 5- Regarding Part II of the roadmap, where specific types of organisms are discussed, it is not clear for me why or how such 3 LMO´s and traits will really help in giving guidance for any user of the Roadmap (I mean in the structure it is presented now). The “results of the scientific review of the Guidance on Risk Assessment of LMOs” , offered as source for this open-ended forum, shows the recognition of the effort and quality attained by the working group, the relevance of the effort done, but also indicates lack of relevant issues. I could see a big effort of the AHTEG members in building such document (what could be also detected in the comment presented at the present forum by Dr Eliana who coordinated the group for LM mosquitoes); but, as this Roadmap has to be broad enough and concise at the same time, I feel it is a “never-ended” document if it incorporates each case or specific LMO to consideration. We know that the propose of the AHTEG was that the Guidance should be a “live document” and then, they probably proposed this 3 LMO´s as a start-point to discuss and structure other types as they appear in the pipeline, but… it seems not to be the case for a Guidance document. Maybe this is the case to rearrange the exercise already done, include considerations within the scope and structure of the main document, not including this “Part II” as it is now presented.
Deise Capalbo Embrapa Environment
posted on 2011-04-07 19:32 UTC by Dr. Deise Maria Fontana Capalbo, Brazil
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Revision of the RA-LMOs guidance - LM Mosquitoes
[#2176]
Dear forum participants, Agreed with former message (of Leticia Pastor Chirino ) that the AHTEG should work further on this particular subject, beside the fact that special arrangements should maybe be thought about at the international level and in the contxet of the Protocol to deal with living organisms of which the dispersal could almost impossibly be contained inside a country. Here, some more reflexions made by experts in our Belgian Biosafety advisory Council, concerning the risk assessment of these LM mosquitoes. The taking into account of the context of their release and further life is very important, in particular in case of self-propagating strategy. In particular, the consequences, for their life, expression, and dispersal, of the land use and casual changes ( like water management practices, irrigation, sewage water treatment) , , should be considered. The potential dispersal of LM mosquitoes by anthropogenic activities ( like trade of breeding sites as tyres, ...) should be considered. The potential interaction of the LM mosquitoes with current medical or veterinary treatment of the population, with pesticides treatment of the environment, should be considered. The potential effect of parasites or symbionts on the expression of the LM mosquitoes should be considered. With best regards. Lucette Flandroy Disclaimer : http://www.health.belgium.be/eportal/disclaimer/index.htm
posted on 2011-04-07 14:25 UTC by Ms. Lucette Flandroy, Belgium
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RE: Revision of the RA-LMOs guidance - LM Mosquitoes
[#2196]
Dear forum participants, Please find bellow our comments on specific topics of the “Summary of comments“ prepared by the CBD Secretariat about the reviews on the Roadmap. With our best regards, Carmen Pires, Débora Paula and Edison Sujii
1) Seventy-eight percent of respondent Parties agreed that the overall quality of the Roadmap is good.
CPires, DPaula & ESujii:We agree that the Roadmap is good. However, it is not for people that are beginning work with environmental risk analysis. For someone follow the Roadmap, he need to understand the basic concepts involved in the environmental risk analysis, such as, the concept of problem formulation, adverse effects, risk exposition and risk hypothesis. And we are not sure if only a list of definitions of terms will be enough to clarify the ERA process. To illustrate better the whole process, examples of some case studies (already included in the references) could be point out directly in the document.
2) However, only 12.5% of the respondent other Governments and 27.5% among relevant organizations agreed that the overall quality of the Roadmap is good. The level of agreement among all three respondent groups combined was 54%. The majority of respondent Parties indicated that the Roadmap is consistent with the Cartagena Protocol and a useful tool to assist countries in conducting and reviewing risk assessments (i) in a scientifically sound and case-by-case manner, and (ii) of LMOs introduced into various receiving environments.
CPires, DPaula & ESujii: We agree, but it is necessary to clarify the mean of “case by case” analysis. The roadmap emphasizes the necessity to take in account the LMOs and the receiving environments, and list many aspects that need to be included in the analysis. However, in our point of view, the non-target organisms, (pollinators, natural enemies and other beneficial species), also need to be chosen in the context of a “case-by-case” analysis. This is not clear in the document. We understand that the parties can adopt different methods to point out those species to be test in the ERA, however the AHTEG could discuss and showed in the roadmap the different methods (different published papers) that is already listed in the references.
3)On the other hand, when asked if the Roadmap is applicable to the risk assessment of LMOs of different taxa, many respondent Parties shared the view that although the Roadmap is meant to give guidance on the risk assessment process for all types of LMOs this aim is not entirely met. It was noted that there was a bias towards crop plants in the terminology used and in many aspects of the Roadmap. For example, it was noted that several aspects which are relevant to LM micro-organisms are not included in the Roadmap.
CPires, DPaula & ESujii: We totally agree and this is perfectly understood that the emphasis on crop plants is natural since we have more experiences and results with this LM group of organisms. However, as emphasized right in the beginning of the document (second sentence in the page 1), the proposal is that the Roadmap should be a dynamic document (“living document”) that “will be improved with time as new experience becomes available and new developments in the field of applications of living modified organisms (LMOs) occur, as and when mandated by the Parties to the Cartagena Protocol on Biosafety”.
4) To address this issue, it was recommended that there is a need to include examples related to non-crop LMOs in the Roadmap or further develop guidance on other types of LMOs such as fish, trees, insects, microorganisms and viruses.
CPires, DPaula & ESujii: We agree and one possibility is to include some case studies as example.
5) With regard to the completeness of the Roadmap, a number of issues were identified that should either be included or be further elaborated in the Roadmap. These issues included guidance on: • The use sound statistical tests in the risk assessment process and the importance of describing these tests in the risk assessment report;
CPires, DPaula & ESujii: More important than describing or pointing a list of tests that could be used in risk assessment process is to discuss the basic assumptions of experimental design and statistical analysis with focus on ERA, to avoid failures in experimental designs that could lead to erroneous results and decisions. See: Marvier M (2002) (already included in the references), Andow, D. (2003) (attached PDF).
• How to deal with conflicting scientific data, especially data from publications and how to inform the decision makers of the difficulties encountered during the risk assessment such as high degrees of uncertainties, ambiguities or contradictory information;
CPires, DPaula & ESujii:Taking into account these potential conflicts between research data published, legislators necessarily have to rely on the assistance of experts from different fields to critically analyze the processes of risk analysis and based on that advice, take their decision. The problem is not the conflict per se (this is science!), but the big challenge for most of the parties is to have experts in different fields (molecular biology, ecology, plant physiology, entomology, etc) that understand the whole concept of ERA for criticizing the data.
posted on 2011-04-08 19:00 UTC by Carmen Sílvia Pires, Brazil
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RE: Comments on the Roadmap
[#2224]
Dear participants,
I appreciate the opportunity to participate in this forum in this last 2 weeks. After reading all the coments and also based ont he scientific review of the RA Guidance I´d like to present some sugestions and comments with the objective of improving the applicability and the use of the RA guidance. The suggestions and comments are in the documment sent attached to this message, hoping they will be usefull for the guidance review.
Best regards, Luciana P. Ambrozevicius
posted on 2011-04-10 23:59 UTC by Ms. Luciana Ambrozevicius, Brazil
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RE: Comments on the Roadmap
[#2243]
THIS MESSAGE WAS SUBMITTED SHORTLY AFTER THE CLOSING OF THIS DISCUSSION AND IS BEING POSTED ON BEHALF OF PHILIP BEREANO ----- Dear colleagues— Although travelling, I wanted to join in this robust discussion we are having on risk assessment under the Protocol. I hope my comments are not too disjointed as a result, however. Some comments submitted to these discussions could be useful to more than one thread; in addition, a simultaneous discussion is going on regarding “socio-economic considerations” under Art 36 which I am have been involved in. I hope participants have the time to try to access and integrate all this material (I hope the staff of the Secretariat will help us to do so). (1) Very little research has been done on the impacts of LMOs and published in the peer-reviewed open literature. And most of what exists has been sponsored by industry and thus of suspect validity due to normal conflict-of-interest cautions. The most survey of this work is: ”A literature review on the safety assessment of genetically modified plants,” by José L. Domingo and Jordi Giné Bordonaba, Environment International 37 (2011) 734–742. Some relevant conclusions: "In spite of the notable increase in the number of citations, those concerning specifically to studies focused on demonstrating the health safety of GM foods remain very limited." On the greater number of refereed health studies from industry, despite the possible conflict of interest: "Anyhow, this represents a notable advance in comparison with the lack of studies published in recent years in scientific journals by those companies (Domingo, 2007). The scientific community may finally be able to critically evaluate and discuss all that information, which was not possible until now. Scientists know quite well how different may be the information published in reputed international journals, which has been submitted to peer-review processes, from those general comments/reports not submitted to this selective procedure." Overall: "In the period here reviewed, October 2006–August 2010, a few reviews on health risks of GM foods/plants have been also published (Dona and Arvanitoyannis, 2009; Magaña-Gómez and de la Barca, 2009; Key et al., 2008). In general terms, all these authors agree in remarking that more scientific efforts are clearly necessary in order to build confidence in the evaluation and acceptance of GM foods/plant by both the scientific community and the general public. Especially critical is the recent review by Dona and Arvanitoyannis (2009), who remarked that results of most studies with GM foods would indicate that they may cause some common toxic effects such as hepatic, pancreatic, renal, or reproductive effects, and might alter the hematological, biochemical, and immunologic parameters. These authors also concluded that the use of recombinant GH or its expression in animals should be re-examined since it has been shown that it increases IGF-1 which, in turn, may promote cancer. A harsh response to that review was recently published in the same journal (Rickard, 2010). This is indeed only an example on the controversial debate on GMOs, which remains completely open at all levels." Countries should make an effort to fund such research and should also require applicant corporations to conduct it (in open and transparent fashion) in order to build up solid information for decision-making. In this regard, I second the caution offered by Dr Ossama—many of the studies which have been done are NOT based on an examination of the “holistic system” of the actual LMO in the actual receiving environment; instead they often are “managed systems” where, for example, instead of looking at a real Bt plant, only the active chemical produced by the Bt is investigated, thus rendering extrapolations shaky. Andrade cautions against “speculative hypotheses” and urges us to rely on actual references. In this regard I would make two comments—more research on LMO impacts needs to be funded and “thinking outside the box” or speculation has been recognized since the earliest days of assessment studies in the 1970s as a fruitful way to anticipate unexpected situations and to reduce uncertainty (coupled, of course, with the admonitions of the Precautionary Principle, that in the face of great uncertainty the wisest course is to not act). (2) In the face of commercial pressures to utilize LMOs, we should encourage a posture of modesty (this is also embodied in the Precautionary Principle, included twice in the Protocol). Recent studies have concluded that LMOs are NOT needed to “end hunger” (one of the most frequent arguments for pressing ahead without adequate assessment). I refer to the International Assessment of Agricultural Knowledge, Science and Technology for Development , IIAASTD (see http://www.agassessment.org ) and the recent report by the UN’s Rapporteur on Hunger, Prof Oliver de Schutter ( http://www.srfood.org/index.php/en/component/content/article/1-latest-news/1174-report-agroecology-and-the-right-to-food). Despite the industry’s repeating of the mantra of the “risks of doing nothing” (which should, of course, be specifically assessed in each case), the general opinion of those knowledgeable and without any institutional bias is that doing nothing in regard to introducing LMOs is often the preferred course of action. (3) A risk assessment performed under the Protocol must include all impacts reasonably flowing from the subject action (i.e, the importation, transit, use etc of LMOs). Impacts (or consequences) are indirect as well as direct; these so called “second and higher order effects” may well be what is driving the introduction of the LMO (eg, profits to the manufacturing corporation or patent-holder) and/ or stimulating opposition. It is therefore imperative that the assessors trace out these “impact chains” to capture all impacts that are important to the decision to be made, not just those which are merely proximate. In this, I agree with Mme. Flandroy’s posting. (4) Risk assessment must also take into account the distribution of the costs/risks/benefits. One cannot simply add up the positives and negatives in an algebraic sense. After all, the whole push to develop and deploy LMOs is based on benefits to a narrow class of actors (the industry) even if they are attempted to be justified on the basis of claimed benefits to wider slices of society. The costs and risks usually fall on other social segments. This reality means that all risk assessments—no matter how dispassionate and professionally conducted—exist in a political context. (5) As regards to the separation between risk assessment and risk management, I agree with Gough that this is somewhat artificial even though it is a frequent mantra. The reality in practice is that there is overlap and substantial iteration between the policy/political function of the managers and the more technical work of the assessors. The Codex materials referenced by Dr Yoshikura are clear on this interaction. (6) The discussions about “substantial equivalence” or “conventional counterpart” are really about ANALOGY. Analogies involve difference as well as similarity (otherwise the two items would be identical, not analogous), and the problem with reliance upon substantial equivalence is that it ignores such differences which may be of critical importance. In the literature review cited above, it is noted that "Probably, one of the most important problems related with the lack of studies (at least not published in the scientific literature) on the safety assessment of GM foods/plants was the use of the “substantial equivalence” concept. This notion is based on the principle: “if a new food is found to be substantially equivalent in composition and nutritional characteristics to an existing food, it can be regarded as being as safe as the conventional food” (SOT, 2003). Although application of the concept is not a safety assessment per se, it enables the identification of potential differences between the existing food and the new product, which should then be further investigated with respect to their toxicological impact. Why must it be thought that two plants (GM and non-GM) with the same nutritional capacity should also imply similar health risks (or absence of risks)? Why a similar principle is not used, for example, for chemical substances of commercial interest such as pesticides, drugs, food additives, etc.? In fact, the “substantial equivalence” principle is a starting point rather than an end point (Kuiper et al., 2002). If this seems to be reasonably obvious, and taking into account the great controversy generated by the debate about GM plants safety, why the published information is so scarce?" The researchers add that: "The conclusions of our 2006 review concerning the doubts on the use of the principle of “substantial equivalence” in GM plants, as well as the lack of toxicological studies (Domingo, 2007), were quite in agreement with the conclusions of other reviews (Zdu_czyk, 2001; Bakshi, 2003; Pryme and Lembcke, 2003), as well as with those of our previous review (Domingo, 2000; Domingo-Roig and Gómez-Arnáiz, 2000). In a recent paper (Dona and Arvanitoyannis, 2009), it was reported that the results of most studies with GM foods indicated that they might cause some common toxic effects. There is no doubt that one of the main issues concerning GM food safety assessment is based upon detection of their potentially toxic properties, which could provoke unintended effects of the genetic modification (Tyshko et al., 2007)." More research needs to be done by direct testing of the LMO without such comparisons, such as is done for new drugs; counties should either fund it or demand it from companies applying for permits. (7) There have been some expressions of concern that conducting an assessment under the Protocol may run afoul of the WTO agreements. In fact, this is not the case. A recent major study by authors coming from “pro-LMO” backgrounds is clear that the WTO allows countries to articulate protective goals and seek to implement them. See Thorn and Brosch, “The Cartagena Protocol on Biosafety and the World Trade Organization-- Implementing a WTO-Consistant Biosefty Regulatory Framework: Guidelines for Biosafety Regulators” 15 December 2005“ (DTB Associates): In addition, a posting on the discussion about Socio-Economic Considerations has observed: With respect to the WTO Agreements, which are legally-binding for its Members, and over which there is some concern about whether decisions which take into account socio-economic considerations are WTO-consistent, it is worth pointing out that the WTO is not about “trade at any cost”. WTO Agreements have a context for trade. For example, the preamble of the Marrakesh Agreement Establishing the World Trade Organization (1994) affirms “…the objective of sustainable development, seeking both to protect and preserve the environment…”. Article XX of the General Agreement on Tariffs and Trade (GATT) 1994, which provides general exceptions to trade liberalization, is also of importance. Article XX contains several general exceptions, among them for trade-restricting measures: - “necessary to protect public morals”; - “necessary to protect human, animal and plant life and health”; - “relating to the conservation of exhaustible natural resources if such measures are made effective in conjunction with restrictions on domestic production or consumption”. This means that WTO Members may adopt or enforce measures for these purposes, even though they restrict trade. Thus, there is scope for WTO Members to take protective measures and to restrict trade of certain products, including agricultural products, for moral, environmental and health purposes. How this will play out in the case of a dispute involving socio-economic considerations for LMO products has yet to be tested, as there has been no such case yet. The WTO Agreements do not a priori exclude socio-economic aspects, although more analysis is needed on the specific agreements to identify the flexibilities and policy space available. For example, risk assessment under the SPS Agreement can already involve a mix of scientific and economic considerations. When assessing risks to animals and plants, “Members shall take into account as relevant economic factors: the potential damage in terms of loss of production or sales in the event of the entry, establishment or spread of a pest or disease; the costs of control or eradication in the territory of the importing Member; and the relative cost-effectiveness of alternative approaches to limiting risks” (Article 5.3). (There is no similar reference to economic concerns in relation to impacts on human health.) Lim Li Ching Third World Network And another: . . . this is a joint reply from several of the participants nominated by Norway. Dr. Casper Linnestad of the Ministry of the Environment, Dr. Anne I. Myhr from GenØk - Centre for Biosafety and Dr. Nina Vik from the Directorate for Nature Management have discussed this topic. . . . . With regards to obligations according to the WTO we would just like to refer to pages 14-15 in the proceedings of the International Conference on GMOs in European Agriculture and Food Production, 25-26 Nov, 2009, The Hague, The Netherlands. These pages refer to the presentation "The GMO Debate Under the Rules of the World Trade Organization" by Mr. Joost Pauwelyn (Professor of International Economic and WTO Law, Graduate Institute of International Studies, Switzerland). We include here the reference to Mr. Pauwelyn's presentation in the proceedings: "The WTO allows more regulatory measures by national governments than is generally perceived. Mr. Pauwelyn highlighted that WTO rules do not allow any discrimination in favor one of several sources of the same product. Any measure should be rationally motivated, that is, related to a legitimate objective and based on scientific or other evidence. In developing their line of argumentation countries need to define socioeconomic aspects as risk, health- or trade-related to make them subject to either of three WTO Agreements, each of which represents a specific ‘box’ of arguments. 1. The WTO Agreement on Sanitary and Phytosanitary Measures (the SPS Agreement) 2. The General Agreement on Tariffs and Trade (GATT) 3. The Agreement on Technical Barriers to Trade (the TBT Agreement) Examples showed that restrictions based on concern for “public morale” are sometimes allowed under the WTO. In the discussion, specific aspects of both legal frameworks were covered. It is clear that in WTO terms, “risk” has to be defined ‘in the real world’, beyond laboratory tests. Socio-economic criteria are not a priori excluded, as long as they are verifiable and transparent". A formatted version is attached. Philip L. Bereano Washington biotechnology Action Council
posted on 2011-04-12 18:09 UTC by Ms. Manoela Miranda, UNEP/SCBD
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