Development of the Roadmap for Risk Assessment
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Opening of the Discussion Group on the “Development of the Roadmap for Risk Assessment”
[#1185]
Dear Forum participant, The Discussion Group on the “Development of the Roadmap for Risk Assessment” is now open for discussions at http://bch.cbd.int/onlineconferences/roadmap_ra.shtml . The objective of this discussion is to provide input to the AHTEG Sub-working Group (SWG) for the preparation of a guidance document on this topic. An advance draft of the guidance material being prepared by the SWG is attached to this message (the attachment is visible only in the Forum website on the link above). This document provides a basis for the discussions. An introduction to the work of the SWG as well as guiding questions and suggested reading materials are also available to assist in the discussions. The guiding questions are also copied below for ease of reference. You may reply to this posting or create a new “thread” of discussion by email following the appropriate link below, or directly from the Forum website in the link above. In order to post your contribution through the Forum website, you must be signed-in to the BCH. Your contribution is very important. We are looking forward to your views on this topic. If you need any assistance, please do not hesitate to contact us at: riskassessment.forum@cbd.int . Thank you and best regards, Manoela ______________________________________________________________ ** Guiding questions ** The following questions were prepared to assist in the discussions on this topic: · Does the Roadmap provide a clear description of the risk assessment process in the context of Annex III? do you have suggestions for improvement? · Is the Roadmap useful for you, to improve your grasp on the LMO risk assessment process, and for capacity building purposes; do you have suggestions for improvement? · Could you consider the discussion items that are referred in several footnotes in the document, and that are listed at the end of the document, and provide us with your points of view and reflections on these items? Your textual comments and comments on content, e.g. items or considerations that are missing, as well as further discussion items that you feel should be considered, are very much appreciated. · Do you see value in the Roadmap as a structure for the effective use of information and guidance documents on risk assessment, as explained above; do you have suggestions for improvement? · Could you please provide us with more examples of information documents, and indicate where in the Roadmap they should be assigned?
posted on 2009-06-22 00:10 UTC by Ms. Manoela Miranda, UNEP/SCBD
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RE: Opening of the Discussion Group on the “Development of the Roadmap for Risk Assessment”
[#1227]
The interventions to date have been interesting, and I would like to extend special thanks to Hans for his work to get us started on the roadmap. I have not yet completed responses to all of Hans’s discussion questions, but I would like to make a brief comment about the issue of “coexistence” now. Even though some comments have suggested including the issue of coexistence in the work of the AHTEG, it is not part of the risk assessment to address impacts to biodiversity as outlined in Annex III. Typically, the coexistence of agricultural production systems is related to choices that growers make in response to markets.
This AHTEG is already dealing with an ambitious schedule and a tremendous amount of information related to its mandate. It seems that it would be best for the AHTEG to exclude discussions of complex topics such as coexistence that are outside of the scope of our task.
posted on 2009-07-01 20:04 UTC by David Heron, United States of America
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RE: Opening of the Discussion Group on the “Development of the Roadmap for Risk Assessment”
[#1278]
United States comments on Roadmap (advancedraft_roadmap_100609[1].doc)
Dear Hans,
Thanks for all your hard work so far. I would like to offer some overall comments on this current draft (10 June 2009) of the roadmap text, with the knowledge that we are likely to revisit these issues again with our colleagues in the AHTEG over the coming months. The general comments fall into two main categories: (1) the roadmap itself and (2) the testing of the roadmap to evaluate to what extent it meets the goal of being a useful tool to risk assessors using Annex III of the protocol. After these general comments, I would like to turn to the 13 discussion items you appended to the roadmap in your draft of 10 June. 1. Based on my understanding of the charge given to the AHTEG, I find it’s helpful to keep some general thoughts in mind: • The roadmap is intended as a tool for risk assessors doing assessments under Annex III • As a tool, the roadmap does not place any requirements on assessors or on those who are submitting information as part of a request for a transboundary movement. We are not trying to update or amend Annex III. • The roadmap is intended as a “living document” that will be subjected to testing to evaluate if it really does provide added value to risk assessors. 2. Regarding “testing” of the roadmap, we have provided some suggestions about how the roadmap might be tested over the coming months. This is perhaps one of the more challenging aspects of the task from the parties, to not only develop a roadmap but test it to see if it actually does make it easier for a risk assessor to use Annex III. Here are some initial thoughts, and we welcome further discussion among the AHTEG: • Who will do the test? Perhaps the most realistic test would be a scientist in a country that has no national system, and would be using Annex III. Countries with extensive experience are probably less likely to be able to identify the parts of the roadmap that are ambiguous or incomplete (a chief goal in any test of a map). • Which LMO will be tested? Perhaps it would be best to choose a well-characterized LMO for which the information is already in the public domain (perhaps a corn or cotton engineered with a BT-gene). • What type(s) of environmental release? Here it’s probably best to choose one example for a small-scale, confined field test, then use the same LMO for a request for an unconfined commercial release to growers. This could be a useful way to illustrate something that countries have invariably found over time, namely that the information relevant for a confined environmental release is far less than a case wherein the release is unconfined, such as those found in the release of a new plant variety to growers for commercial cultivation. Perhaps once the initial round of testing is completed, we can consider alternative approaches to testing, other countries doing the testing, additional types of LMOs, etc.
I hope these general comments will be useful as we move forward with both the roadmap and its testing. Now, let’s turn to the discussion questions you sent for us to consider for the roadmap. I realize that some of these discussion items have been evolving a bit during the online exchanges, but the responses we provide below are limited to the items you provided in the 10 June draft. We we regret that haven’t been able to fully acknowledge the comments of others that are being submitted during the forum that are relevant to some of our responses below. This exercise has reminded me a bit of trying to aim at a moving target. I suppose we should just be thankful that so many people have provided their thoughts on the draft and your discussion questions.
Discussion items These discussion items are listed here for use in the Internet Forum from 22 June through 6 July 2009. They may not be part of the final text of the Roadmap. Discussion item 1: We propose to add a glossary of terms, that explains terms and concepts that are not straightforward. We ask you to provide suggestions for items that could be mentioned in the glossary. RESPONSE: Since text is likely to come and go over the coming months, it might be best to wait until the roadmap is farther along to consider a glossary. In many cases, the roadmap might be able to use illustrative examples rather than glossary definitions. Discussion item 2: The notion that evaluation and quantification of the level of risk may be subjective in some cases has been brought up, as an issue that should also be mentioned, as a separate paragraph, in this Chapeau section. Do you agree that this is an issue to be mentioned here; if so, do you have a text suggestion? RESPONSE: As we discuss further in our response to discussion item 10 (below), the risk assessment involves evaluation of potential risks, and different aspects of this evaluation can be qualitative and/or quantitative. Both qualitative and quantitative approaches can be valid, depending upon the circumstance. In both cases, however, comparison becomes important in order to evaluate relevance of the potential risk that has been characterized. The word “subjective” can give the impression of lack of rigor in the risk assessment, and perhaps it should be avoided so that readers do not get the impression that the rigor of an assessment is determined solely whether it is qualitative or quantitative. Discussion item 3: Annex III, 3 states that “Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account expert advice of, and guidelines developed by, relevant international organizations”, but does not specify any particular standards, e.g. for transparency, accessibility, reproducibility, relevance or quality. Still, it is clear that these standards will (have to) be set, e.g. by Parties or by standard setting bodies. Do you agree that we can refer to standards against this background?
RESPONSE: You state that “it is clear that these standards will (have to) be set”, but this gives the impression that there are some separate standards yet to be established upon which the risk assessment is built. I think this gives the wrong impression. Risk assessments for environmental releases of LMOs have been conducted in many countries for over 20 years, and these used the best available scientific information and analysis; they did not require some special standards for transparency, accessibility, reproducibility, relevance, and quality. In general, reproducibility and quality are statistical features of scientific data and usually addressed in the experimental design. Relevance is especially important in eco-risk assessment as the environment varies so much from country to country, and judgment about how a particular data element generated in one environment may or may not be a relevant consideration for another environment. The terms transparency and accessibility really seem to me more about public access and communication. These issues are also relevant for discussion item 4.
Discussion item 4: It has been pointed out that the need for a dialogue with stakeholders and the promotion of public awareness is a statement on procedures governing the risk assessment process, not on risk assessment itself. How do you feel about taking on board this kind of statements that go beyond the risk assessment process?
RESPONSE: It would seem best to keep to the charge of the AHTEG, namely to develop a roadmap that can help people to use Annex III to conduct a risk assessment. Although public participation can be a useful part of the decision-making process in some countries, the risk assessment should precede the decision-making. Its summary and recommendations should ideally be sufficiently clear that the interested members of the public (stakeholders) can understand the assessment.
Discussion item 5: ‘Ecological function’, or ‘ecological services’, provided by an organism refers to the role of this organism in ecological processes. For example organisms may be part of the decomposer network playing an important role in nutrient cycling in soils or be important as pollen source for pollinators and pollen feeders. In relation to LMO risk assessment, the ecological functions of the parental organism may trigger specific concerns, e.g. if pollen of the LMO is an important source for a pollen feeding insect, the exposure of the insect to the LMO (or at least to its pollen) could be high. It has been pointed out that any crop that is grown in a field as such will dominate what happens with carbon/nutrient cycles, pollinators, hydrologic cycles, etc. All these are however (potential) in-field effects, that can be handled as a separate question from the out-of-field or off-site considerations. On the other hand there will be a gradient: in-field, border rows, broader area around the field, out-of-field. The gradient may be different for different aspects: e.g. effects on mineral cycling in the soil vs. pollen flow.
RESPONSE: It is important to identify the potential hazard before spending too much time on the exposure question. One of the stumbling blocks for inexperienced risk assessors can be the need to over analyze aspects of the environment for which there is no reason to be concerned with regard to a particular LMO. Frequently comparing the LMO to its non-LMO counterpart can clarify which aspects of the LMO are likely to be different.
Discussion item 6 It has been pointed out that in Annex III it is stated that “to fulfill its objective, risk assessment entails, as appropriate, the following steps”. This can be interpreted that it will not be necessary in all cases to perform all the steps in order to fulfill the objective of risk assessment. I am not certain that this is the case: all steps will be performed, but the level of detail of performing each step may be very different, depending on then experience that a risk assessor has with the particular LMO and the conditions of use. This may look like you are ‘skipping a step’, but as a matter of fact it means that the step has already been performed many times for the LMO in question, and the risk assessor is using his/her familiarity with the problem and its solution.
RESPONSE: It seems that the phrase “as appropriate” is intended to give flexibility when following the steps. The key is often for the risk assessor to make clear why certain steps were carried out in a certain manner, including a consideration of extensive experience or familiarity with similar cases.
Discussion item 7 (embedded in footnote 10): I would prefer to add this enumeration to the text, but as it is now, it is too extensive to do that. We may need further reflection on the necessary detail of the attributes mentioned, in order to make it more concise. Do you have text proposals?
RESPONSE: I think you may be right that further reflection may be needed before we add more text on this point. So, we don’t have any text proposals at this time.
Discussion item 8 Do you agree that this paragraph may be deleted, as it appears to be redundant, given the detailed description in paragraph (d).
RESPONSE: Hans, I’ve tried to follow your footnotes to indicate the text in question, but I’m not really confident on which text you want to delete. Maybe this can be addressed in the next iteration of changes to the roadmap text.
Discussion item 9: One important purpose of the Roadmap is, that it can serve as a structure on which we can ‘attach’ information documents that are available in the BIRC of the BCH, that provide information that is useful and important for specific steps in the risk assessment process. One information document may be useful in one particular step, but it may also be useful in different steps, and may therefore figure in different places in the document. At this moment only a few documents are shown in the text, and you are invited to add references to other documents, and if necessary indicate why you think they are relevant.
RESPONSE: We certainly support the idea of linking the ideas to relevant documents, especially if the documents are part of actual risk assessments.
Discussion item 10: There is discussion whether the points on a conclusion are clear and useful. Conclusions, and the way they are formulated, are directly linked to decision making, and are the responsibility of the Party. The terms used (‘highly likely, likely, unlikely, highly unlikely’ for likelihood, and: ‘major, intermediate, minor, marginal’ for consequence) are open to subjective interpretation. It is argued that this step finishes with a number of assumptions (not conclusions) that are taken along to the next step, like step 1, that finishes in a similar way.
RESPONSE: It seems that this discussion item has two points which are distinct. The first point concerns the issue of risk assessment conclusions and their relationship to decisions that might be made in light of these conclusions. It seems important to reiterate in the roadmap the concept that the risk assessment informs the decision-making, but the risk assessment does not equal the decision regarding the proposed transboundary movement of an LMO. The second point concerns the use of descriptors which are qualitative rather than quantitative when summarizing a particular aspect that has been part of the risk assessment. These qualitative descriptors are most relevant when placed in the context of an example that can be used for comparison. Such comparisons can make interpretation more relevant in the risk assessment. In many cases, the qualitative descriptors are sufficient for the assessment of LMOs as they are for evaluation of potential risks to biodiversity from other activities or occurrences (e.g., choices for land use).
Discussion item 11: There is some difference of opinion on the rationale behind Step 3. To some this step is a summary evaluation integrating step 1 and 2. However, I think that this integration is done in step 4, where the likelihood is taken into account. To me the essential point in this step seems to be the comparison of the consequences with the ‘baseline’. What is your opinion?
RESPONSE: This does seem to be a point for consideration of the baseline, although this comparison comes into play at other steps, also.
Discussion item 12: The issue of risk / benefit may also in addition be taken on board in the chapeau. The purport of the text should be, like it is now, that potential benefits are not taken into account in risk assessment under the Protocol. Should there be a paragraph in the chapeau, and do you agree in general with the way I suggest the risk / benefit question should be approached?
RESPONSE: This could be addressed in the chapeau or elsewhere in the roadmap. Part of the risk assessment in the Annex takes into account the existing situation, and this is a time when some risk assessors evaluate relative risk and benefit. For example, in the case of plants engineered with a BT-gene, the use of this plant in agriculture is compared with existing use of chemical insecticides that can harm not only the insects that feed on the plant, but also insects that are in the vicinity of the plant. Likewise, if one were to evaluate the current exposure of people working in the fields, use of the BT-plant could result in reduced exposure of farmers to chemical insecticides that are currently used to control the target pest.
Discussion item 13: The issue of co-existence concerns the potential economic loss and the impact of the admixture of GM and non-GM crops; one item in this discussion concerns the appropriate management measures to minimize admixture. The co-existence discussion as such does not have a direct relation to environmental risk assessment, but management strategies adopted for co-existence issues may be also be relevant also for reduction of environmental impacts of LMOs. In my opinion that is what is meant in this paragraph. Examples of such strategies would include: additive measures to prevent pollen flow to neighboring fields that may have synergistic effect: scheduling different flowering times, use of crop varieties with reduced pollen production, pollen traps, hedgerows, combined with isolation distances between fields with the same crops.
RESPONSE: Typically co-existence considers the ability of people to choose from a range of potential safe options, whether these use LMOs or non-LMOs. Before co-existence is considered, there would have to be a decision to use an LMO, and that decision would typically take into consideration a risk assessment on the potential impacts on biodiversity. It would seem best for the AHTEG to keep focused on the risk assessment outlined in Annex III. Market considerations are beyond the scope of the work of this AHTEG.
I know it's a long post, but I look forward to continuing to work with Hans and the other AHTEG members as we work to develop and test the Roadmap.
Best, Dave Heron
posted on 2009-07-10 16:58 UTC by David Heron, United States of America
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RE: Opening of the Discussion Group on the “Development of the Roadmap for Risk Assessment”
[#1301]
I recognize that the roadmap is a tool and is not intended to place any requirements on assessors or those submitting information for a request for transboundary movement. However, the roadmap will be viewed as guidance by countries that do not have domestic regulatory frameworks. From my experience working with countries that are currently developing regulatory systems for biotechnology, I can guarantee you that the roadmap will shape the approach to risk assessment that will be built into domestic regulatory frameworks as they are developed. For capacity building purposes, the SWG working on this roadmap need to be aware of this, and avoid confusion for this reason.
Not only is the information less for a confined release, it is different and it is used differently. We do not need to do a ‘test’ to demonstrate this. This is standard practice in countries that already have domestic regulatory frameworks.
See the suggested readings submitted to the online discussion of the AHTEG SWG on ‘abiotic stress tolerance’ for additional examples of how risk management factors into the decision to allow approval for a field trial before there is a risk assessment for unconfined release: OGTR 2005; OGTR 2008; Schenkelaars 2007 submitted in comment #1200 by Hans Bergman. The OGTR clearly considers risk management in their assessment and have approved field trials without the details necessary to assess the impacts of unconfined release, and anticipate a subsequent risk assessment before approval for an unconfined release. Similarly, in the analysis by Schenkelaars 2007, it is clear that the risks from unconfined release will still be assessed in the US and the EU, even though field trials for drought tolerant maize have already been approved there. That document is considering novel attributes for risk assessment for ‘unconfined, large scale or commercial release’ (See p. 9 of that document). On p. 54 of that document it states: ‘Furthermore, since the release would be of limited size and short duration and the applicant proposed a number of measures to limit spread and persistence, no risk in relation to weediness, spread or persistence is identified outside the trial site’. In this case, the measures for confinement for the field trial were clearly considered in the assessment of risk.
Once again, I encourage the SWG to focus the roadmap on ‘unconfined’ releases.
posted on 2009-07-11 16:30 UTC by Dr. Karen Hokanson, Agriculture and Food Systems Institute
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RE: Opening of the Discussion Group on the “Development of the Roadmap for Risk Assessment”
[#1302]
I recognize that the roadmap is a tool and is not intended to place any requirements on assessors or those submitting information for a request for transboundary movement. However, the roadmap will be viewed as guidance by countries that do not have domestic regulatory frameworks. From my experience working with countries that are currently developing regulatory systems for biotechnology, I can guarantee you that the roadmap will shape the approach to risk assessment that will be built into domestic regulatory frameworks as they are developed. For capacity building purposes, the SWG working on this roadmap need to be aware of this, and avoid confusion for this reason.
Not only is the information less for a confined release, it is different and it is used differently. We do not need to do a ‘test’ to demonstrate this. This is standard practice in countries that already have domestic regulatory frameworks.
See the suggested readings submitted to the online discussion of the AHTEG SWG on ‘abiotic stress tolerance’ for additional examples of how risk management factors into the decision to allow approval for a field trial before there is a risk assessment for unconfined release: OGTR 2005; OGTR 2008; Schenkelaars 2007 submitted in comment #1200 by Hans Bergman. The OGTR clearly considers risk management in their assessment and have approved field trials without the details necessary to assess the impacts of unconfined release, and anticipate a subsequent risk assessment before approval for an unconfined release. Similarly, in the analysis by Schenkelaars 2007, it is clear that the risks from unconfined release will still be assessed in the US and the EU, even though field trials for drought tolerant maize have already been approved there. That document is considering novel attributes for risk assessment for ‘unconfined, large scale or commercial release’ (See p. 9 of that document). On p. 54 of that document it states: ‘Furthermore, since the release would be of limited size and short duration and the applicant proposed a number of measures to limit spread and persistence, no risk in relation to weediness, spread or persistence is identified outside the trial site’. In this case, the measures for confinement for the field trial were clearly considered in the assessment of risk.
Once again, I encourage the SWG to focus the roadmap on ‘unconfined’ releases.
posted on 2009-07-11 16:31 UTC by Dr. Karen Hokanson, Agriculture and Food Systems Institute
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RE: Opening of the Discussion Group on the “Development of the Roadmap for Risk Assessment”
[#1310]
I support the interventions by Dr. Hokanson and others who have encouraged the SWG to limit the focus of the roadmap to unconfined environmental releases of LMOs. From a policy standpoint, it is important to distinctly separate the risk assessment and management of experimental confined field trials from unconfined releases. At the level of an unconfined (general) release, the focus must be on rigorous risk assessment as the intent is widespread environmental introduction of the LMO, usually with few or no provisions for risk mitigation. For unconfined releases, there is little or no possibility of controlling the exposure component of risk; therefore, to minimize risk both to the environment and to people and animals, regulators must be satisfied that potential hazards are not significant. Conversely, for an experimental confined field trial, where the potential hazards may not be fully appreciated without data collected during the trial, the focus must be on minimizing exposure through risk management – the terms and conditions that are necessary to permit safe trial conduct.
Because of the high level of control (i.e., risk management) that can be applied to the conduct of confined field trials, the information requirements for risk assessment and review of field trial applications can be significantly less burdensome than for unconfined, or premarket, review. The information required on applications for confined field trials must be relevant to risk management. These include issues related to: ensuring reproductive isolation (i.e., mitigating gene flow through outcrossing); control over the trial site; and controlling the movement, handling, and fate of all LMO-derived material. Most everything else falls in the category of “nice to know” but not “need to know” for confined field trials.
The crucial distinctions between unconfined environmental releases and confined field trials need to be appreciated by regulators and national biosafety committees, and are at risk of being lost if these activities are treated together under the roadmap.
posted on 2009-07-12 14:03 UTC by Dr. Donald MacKenzie, Donald Danforth Plant Science Center
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RE: Opening of the Discussion Group on the “Development of the Roadmap for Risk Assessment”
[#1311]
I beliveve that assessment regarding both confined and unconfined releases is the purpose of annex III in the biosafety protocol. We cannot miss any of them.
posted on 2009-07-12 15:53 UTC by Mr. Wei Wei, China
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RE: Opening of the Discussion Group on the “Development of the Roadmap for Risk Assessment”
[#1313]
I also agree that Annex III should consider risk assessment of LMOs that might be release in different scales, as confined or unconfined; as well as for different time frames and in different environments. All those are issues that the risk assessment must take into account. It is important also to notice that the information provided for a small scale confined release, is different from the information provided for a commercial large scale release, since in the former one, the objective could be to gather more information needed for a large scale release.
posted on 2009-07-12 21:16 UTC by Ms. Sol Ortiz García, Mexico
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Particular standards, discussion item 3 and the RA matrix
[#1318]
Dear all,
This is a specific comment on Discussion item 3: ... particular standards, e.g. for transparency, accessibility, reproducibility, relevance or quality. I do agree with Hans that they have to be set (even though there is experience of 20 years in some parts of the world) and yes, we should refer to this in the text. I think that some problems that we have encountered over the years may be due to the fact that we have not set standards to these issues.
A quick comment on the matrix under step 5. I think that the text should say that it is only guiding i.e. the risk estimates are. I think that for instance intermediate x likely = should equal with moderate/high. This needs to be further discussed.
Marja Ruohonen-Lehto
posted on 2009-07-12 22:34 UTC by Marja Ruohonen-Lehto
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RE: Opening of the Discussion Group on the “Development of the Roadmap for Risk Assessment”
[#1314]
Dear Hans and colleagues: Please find comments on the latest version of the Roadmap, and for the different discussion items in the attached document. Thank you for the hard work.
posted on 2009-07-12 21:20 UTC by Ms. Sol Ortiz García, Mexico
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RE: Opening of the Discussion Group on the “Development of the Roadmap for Risk Assessment”
[#1322]
Something to think about.... If this roadmap on risk assessment applies to ALL TYPES of LMOs and applications within the scope of the Protocol, then we must think about the need or not of extra guidance documents for some types of LMOs as Staked genes, mosquitoes and resistant or tolerant to abiotic stress.
Discussion item 1: glossary of terms Terms like stacked events, protection goals, end-points, management strategies, problem formulation could be part of the glossary.
Discussion item 2: The quantification of the level of risk may be as objective as possible. I am not agree that subjective evaluations must be even mentioned here.
Discussion item 3: Yes, I think the application of standards can be refer as the guidelines developed by relevant international organizations (Following the Anex iii.3), as OECD consensus docs for example.
Discussion item 8. yes it is redundant.
Thanks to Hans for the draft and to all the colleagues for their comments.
posted on 2009-07-12 23:57 UTC by Dr. Adriana Otero-Arnaiz, Mexico
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