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Testing of the Guidance on Risk Assessment of LMOs

Participation in the testing

Experts involved in risk assessment were invited to test the overall utility and applicability of the draft revised version of the Guidance (revised on 15 September 2011) which was developed through collaborative efforts between the Open-ended Online Expert Group and the AHTEG on Risk Assessment and Risk Management.

Testing initiatives were conducted either as a group or individual exercise, such as face-to-face meetings, workshops or online discussions, and the results were to be reported back using a questionnaire in order to facilitate a coordinated analysis of the results. The questionnaires were mailed to the Secretariat at riskassessment.forum@cbd.int by 30 November 2011.

Results from testing initiatives conducted by Parties and other Governments had to be submitted by their National Focal Points. Results submitted by organizations had to be submitted through their head offices.


Results

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Bolivia

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Very good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?Yes
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?YesYes since it provides the fundamentals for risk assessment framework, however, it needs to be supported by specific technical guidance, which go beyond the scope of this guidance / Roadmap.
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?YesHowever if has certain focus on crops VM due to the examples used.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?YesHowever it needs this specification in the introductory text, said that it would be useful to explicit that the Guidance / Roadmap applies to all types of introductions into the environment.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?YesIt is very useful, however it will be enriched if "Related issues" are spell out in the flowchart.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?YesIdem as comment to Q9.
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?NoKey guiding questions or a check list.
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?YesIdem as comment on Q9.
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesIdem as comment Q20.
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?YesIdem as comment Q9, however, given the complexity of mosquitos VM - due to is mobility - need to be further emphasized.
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesIdem as comment Q20.
Additional Comments (Q31)
The Guidance proves to be very useful in setting the national guidance for risk assessment. The core principles included for risk assessment are useful to improve the national biosafety framework (this is the case of the Plurinational State of Bolivia, that used as reference the the section on "Overarching issues in the Risk Assessment Process" to strengthen its biosafety regulation).


Brazil

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Poor
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Poor
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Poor
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?NoA more deitaled description of Step 1 is missing in the Guidance. The definition of a risk hypothesis as "a theory that predicts the likelihood of harmful outcomes to assessment endpoints" is critical to the success of Risk Assessment and the process to elaborate this hypothesis and to analyse it based on the presented data should be better explained. Besides, The National Biosafety Committee is of the view that the RoadMap establishes criteria not foreseen in the Cartagena Protocol especially with regard to risk assessment for the environment.
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?NoThe National Biosafety Committee is of the view that the usefulness of the RoadMap to risk assessors is affected by the absence of a common thread between questions as well as a confusing language. Besides, the RoadMap doesn't seems to consider the scientific evolution in the sector nor the history of safe use of GMOs as an element of assessment. Some Brazilian risk assessors had difficulties in using the RoadMap, especially with regard to the selection and integration of essential information listed in the "points to consider" in a logical way to make the right questions about how the assessment endpoints will respond as a result to the exposition to the LMO; the use of the data presented by the applicant to answer those questions; the evaluation if the data presented was enough refined to reduce uncertainty and if the results from some field trials can be extrapolated for the potential receiving environment in the RA.
Q10. Is the Roadmap organized in a logic and structured manner?No According to the National Biosafety Committee the most critical point of the RoadMap structure is the formulation of the problem. for MAPA, although all the steps of a RA process are presented in a structured way, some aspects, like the problem context and scope are described apart from the Conducting RA section and they are indeed essential when applying step 1 of the process. Moreover, uncertainty is presented as a concept that is part of all "points to consider" without any consideration of how the uncertainty can be reduced in the LMO RA.
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesAccording to MAPA, the way it is structured with a general description of each step and the points to consider in topics the Guidance can be considered clear . Nevertheless, according to CTNbio the Roadmap could be more user-friendly if the sutructure and the language were less confusing.
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?NoAccording to CTNBio, the Roadmap doesn't seem to consider the biological peculiarities of all types of LMOs. Most part of the aspects of the RoadMap are strictly related to plants and mosquitos. Besides, according to MCTI, the Guidance should introduce the subject of genetically modified animals and microorganisms within the generation of recombinant proteins, and some assessments could be applicable as analysis and parental effects on the environment when compared to LMOs.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?NoAccording to CTNBio, the RoadMap does not address adequately the issues related to scale. Besides, the document seems to be primarily directed to plants and animals, disregarding microorganisms. In MAPA's view, for a risk assessor with limited experience it will be difficult to select which information will be essential for a RA of a small scale release, considering that not all the information in the guide is required in this case.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?YesAccording to CTNBio, the formulation of the problem could be develop in a different manner, taking into account, inter alia, the following aspects: target of protection, parental transgenic biology, identification of the receiving environment, genetic construction with emphasis on expression of GMOs, history of safe use of genes and hosts and familiarity of the biological expected behavior. Besides, the definition of risk levels should be clearly indicated. CTNBio also suggests the table prepared by FAO as an example. For MAPA the problem formulation (Step 1) should be better adressed in the Guidance. Although all the necessary information for the PF is listed in the Step 1, there is a lacking of descrition about how to link this information in a logical way to set up a exposure scenario and generate a risk hypothesis. Also the concept of "familiarity"in the RA should be better exploited. MCTI suggest the insertion of animal, microorganisms and public perception of LMOs.
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?NoThe flowchart is showed according to the process described in the Guidance, but again, all the steps listed in the Annex III and detailed in the Guidance could be further elaborated allowing the assessor to select and use the information listed in the "Points to consider" and to evaluate if the data presented is enough to make assumptions and predictions about how the new trait of a LMO could affect an assessment endpoint. According to CTNBio, the formulation of the problem is not in the 'flowchart', although it is the most important step in risk assessment. The absence of tables that define the level of risk in the flowchart makes the Step 2 very difficult to implement. Besides, since Steps 2 and 3 refer to the same object, it would be more appropriate to include a table in the flowchart to integrate these two elements.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?No
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?No
Q18. Is this section of the Guidance organized in a logic and structured manner?No
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?Yes Special attention should be given to events whose genetic material segregate. Polygenic traits exhibit different phenotypes according to the inherited genetic block. In this case the LMO should be assessed individually, particularly its interaction with human and animal health and the environment.

If the event is unique and is the multiplication of genetic material occurs by cloning, from the same founding event, the analysis will be unique and ends in the genotype and phenotype of this event, and the interactions with human and animal health and the environment.

Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Yes
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?No
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?No
Q28. Is this section of the Guidance organized in a logic and structured manner?No
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesIn the field of geneticaly modified mosquitoes, the paratransgenia is under development to control, reduce or eliminate the ability of mosquitoes to transmit pathogens, mainly but not exclusively, by blocking the development of the pathogen in the vector. The paratransgenia is being focused on the use of insect symbionts, which can be genetically modified to express molecules inside the mosquito that are harmful to the pathogens they transmit. In this sense, this technique could be used and analysed case bu case tasking into consideration that vertical transfer of genes will not occur between the mosquitoes.
Additional Comments (Q31)
With regard to Part I, the evaluation about the level of consistency of the Guidance with the Protocol was "poor" because it goes beyond the definitions of the Protocol. Besides, the Guidance takes into consideration other aspects listed in the "Related Issues" that are not part of the objective of risk assessment according to the Annex III of the Protocol. The separation of the "Setting the Context and Scope" in the so called "Planning Phase" make it difficult to understand the importance of the establishment of the "assessments endpoints" as the fundamental tool to define the risk hypothesis. An inappropriate risk hypothesis may misdirect the whole risk analysis process and lead to the imposition of unnecessary controls to reduce risk. As for Part II, Brazil appreciates the efforts made so far but believes that the text related to specific types of LMOs need to be improved in order to better address the specificities of each type of LMOs.


Cuba

This submission uses a different reporting format than the one displayed below. Please download original submission for additional details.
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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good/Very good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Good/Very good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Good/Very good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?Yes
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?Yes/No
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?Yes/No
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?Yes
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?Yes/No
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?Yes/No
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?Yes
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Yes/No
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?No
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Additional Comments (Q31)
The guidance was studied and revised by 7 experts separately , all of them closely linked to the risk assessment of GMOs in Cuba. Once this first phase was finished, the guidance was applied to two cases study, the release of a genetically modified plant and confined trials with transgenic animals. This work was conducted by two teams and once finished, the final considerations were analyzed and discussed by the whole group (7 experts) which proposes the following suggestions to be addressed:

1. In the Overarching Issues Section, regarding the identification and consideration of uncertainties, it is proposed to distinguish the uncertainties associated to the information, from those derived from the experimental systems.

2. In Related issues we propose to include the cost-benefit analysis.

3. We think that the importance of the selection of comparators should be addressed largely.

4. The “(near-)isogenic” term should be defined.

5. The experts suggested to include the analysis of individual risks for each adverse effect identified, prior to the overall estimate of risk.

6. In step 1, specifically at the points to consider about adverse effects, we proposed to be more specific about the potential effects on human health (toxicity and allergenicity).

7. In the same step, it is important to consider agricultural practices used in the trial, type of irrigation, number and doses of herbicide applications and the used method for harvesting and waste disposal.

8. From line 334 to 343, in the Receiving Environment topic, it is necessary to incorporate the aspects exposed in the example to facilitate the work of assessor (paragraph 20 at the end of the page).

9. In step 3, points to consider, subsection a) (i) and (ii), add soil microorganisms.

10. The roadmap is applicable to all LMOs in general, but very enclosed to plants and does not reflect the specifications of other cases.

11. It is suggested the use of examples that are not circumscribed only to plants but also to microorganisms and animals.

12. Previous experiences are required for the understanding and use of the guidance.

13. In the Roadmap, specifically into the strategies of risk management, the monitoring plans should be expressly mentioned.

14. The guidance on risk assessment of genetically modified mosquitoes should be a little more illustrative due to the complexity of the case and the uncertainties related to the topic.


Germany

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Poor
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Poor
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?No Focus on comparative assessment and guidance on assessment endpoints is missing.
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?No See comments above.
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?NoIt contains parts that are too speculative and do not contain guidance, e.g. application of "omics"-techniques for risk assessment or future possibilities of PCR-discrimination between single events and stacks.
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?Yes
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?No Characterization of all possible environments for large scale commerzialisation is unrealistic.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?YesBetter discrimination between saftety issues due to genetic modification and others more related to agriculture in general.
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?Yes
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?Yes
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Nosee comments under Part I.
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?NoAll aspects are completely covered by the guidance on risk assessment of LMOs.
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Nosee comments above.
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Nosee comments above.
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?Yessee comments above.
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?Yes
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Additional Comments (Q31)


Denmark

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Neutral/Good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?Yes
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?YesIdeally yes, if focussed training is supplied.
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesCould be improved with use of a route-diagram.
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?YesIt is uncertain how suited the roadmap is for other types of LMO's that plants.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?YesIn principle yes.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?YesA good presentation of relevant issues.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?YesIn the introduction a presentation of the overall structure could be an advantage.

The concept of choice of comparators induces an uncertainty by use of words like: can and may. This may be because comparators is not a very good concept. Instead an assessment (CASE BY CASE) of the insert in its background could be a suggestion.

Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?YesMost likely this will require additional training.
Q18. Is this section of the Guidance organized in a logic and structured manner?YesSee Q16 first part of comment.
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes/NoThe structure could be improved - a table or diagram for selection of choises could be added.
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance? - see comments Q16.
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?YesIt should be more clear what kinds of ABIOTIC STRESS are included. Tolerance to herbicide is also tolerance to abiotic stress. Is it included?
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?NoExcept for experience with herbicide tolerance very few assessors can say that they have more than limited experience with LM-crops tolerant to abiotic stress. The issue is that assessors of LM crops with tolerance to abiotic stress should be experienced plant ecologists.
Q23. Is this section of the Guidance organized in a logic and structured manner?YesCould be more user friendly by providing an overview giving the reader a quick idea of the structure and the idea of the structure.
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? - See comment Q23.
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?Yes
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Additional Comments (Q31)


Spain

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?Yes
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?YesLa hoja de ruta constituye una herramienta útil aunque probablemente necesite acompañarse de talleres específicos que la desarrollen, aclarando dudas prácticas y dando claridad a todos los conceptos. Para poder establecer la valoración de los riesgos hay que apoyarse en análisis de información procedentes de estudios, experimentos, etc. La guía permite identificar la lógica del proceso de la evaluación de riesgos y los pasos a seguir pero no siempre cómo conseguir la información para realizar las estimaciones.
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?YesLa hoja de ruta es aplicable a cualquier tipo de organismos vivos modificados, no obstante parece especialmente orientado a plantas, quedando otros organismos vivos modificados como animales, árboles o microorganismos menos representados.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?YesEl documento se centra más en los casos de las liberaciones voluntarias al medio ambiente de cultivos pero se adapta razonablemente bien a otro tipo de actuaciones y organismos vivos modificados.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?Nocomments.
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?YesEl gráfico resulta muy útil, clarificando todo el proceso de un solo golpe de vista, ayudando a entender la importancia de cada paso de la evaluación de la riesgos.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?Yes
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Yes
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?Yes
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Additional Comments (Q31)
En general nos parece que la nueva revisión de la guía aporta numerosas mejoras, a destacar la mayor claridad y mejor estructura de los ejemplos o el apartado nuevo con el glosario de términos.

Nos parecería positivo añadir en este último apartado alguna definición suplementaria, como la de heterocigosidad , isogénico, re-transformación y co-transformación.

Consideramos que la monitorización y los planes de seguimiento son un elemento clave para la mejora continua de las evaluaciones de riesgo ya que supone el elemento clave de contraste entre los datos teóricos o de laboratorio con la experiencia real en campo, lo que permite una fuente muy valiosa de información de cara a rectificar la evaluación de riesgo o emprender evaluaciones nuevas. Por ello, convendría que fuera claramente indicada en el texto de la guía.

Por último, creemos que es importante seguir con el trabajo emprendido y desarrollar nuevas guías específicas, considerando como prioritarias por su importancia y desarrollo actual las referentes a peces, microoorganismos y virus.


Egypt

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Very good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?Yes
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?No
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?NoThe rationale for emphasis on crop plants and managed ecosystems has been explained, but is not justified with present day developments of GMOs and worries about the integrity of ecosystems. See Q31 below.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?NoThere is need to place specific reference to the various types of releases.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?YesLinkage of RA to decision making and the overall goal of the Protocol and the CBD needs to be more explicit. See Q31 below.
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?Yes
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?NoRA is not a simple exercise which could be carried out with low capacity.
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?Linkage to the overall goals of the Protocol and the CBD needs to be reflected more explicitly. See Q31 below.
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?NoSee Q17 above. Implications for ecosystem integrity is an essential element of RA for this class of GMOs.
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?Yes
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?No
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Additional Comments (Q31)
The conclusion of this national testing exercise is that the document has been significantly improved since COP-MOP-5.

The following further observations were made:

1. It is recognized that Annex III of the protocol was a "political" compromise on a highly dynamic technical issue, reached during a dynamic period for biotechnology development, which required continuous up-dating.

2. Reference to the Precautionary principle in the preface is highly commended, but this is not adequately reflected in the "points to consider" as closely linked to "uncertainties". Reference to the importance of RA in the "potential receiving environment", country policies and regulations, local practices and habits related to the handling and use of GMOs are also commendable and should be an explicit cardinal principle.

3- While "part II" touches rightly on 2 of the non-crop plants GMOs this does not clearly anticipate further developments in biotechnologies which would bring about new elements and approaches in RA. From an environmental perspective, the rationale for emphasis on crop plants and managed ecosystems may be a practical approach but lacks in scientific validity. Reference in "Background" of part I needs to be more explicit in considering need for RA methods in response to future developments in biotechnology, hence release of new GMOs in addition to mosquitos and plants with abiotic stress traits.

4- The section on "choice of protection goals" is too narrow and would not accommodate the environmental protection goals of the CBD and the Protocol, where decisions are based on RA and all articles of the Protocol. . It needs to be categorically broadened to include socio-economic, public perception, religious, spiritual, ethical and other considerations which vary from community to community.

5- In the "choice of comparators of Part I, reference needs to be made to all articles of the Protocol and the fundamental goal which the CBD targets, including: ecological functions and services and ecological balances in both managed and un-managed ecosystem. This is now restricted to the sections on LMO mosquitos and needs to cover the entire roadmap. While reference to "additional points not explicitly mentioned in Annex III" in the section on "conducting the RA" is commendable, the rationale should include phenomena such as: gene interactions, "gene scrambling" and the possibility that gene expression and the interactions of the gene product may be influenced by environmental factors. Step I needs to include ecological services and balances, and "novel characteristics" needs to include certainty, accuracy and precision of the transformation event and interaction with other genetic constituents whether expressed naturally or not: this being reflected in several elements of the "points to consider regarding characterization of the LMO". In Step 2, the rationale needs to reflect the LMO and its products which may find its way into the environment. In Step 5, the recommendations need to take into consideration socio-economic, public perception, religious, spiritual, ethical and other considerations which vary from community to community. In the same Step, reference to "benefits" analysis is unscientifically suggestive and is best modified to "cost-benefit" analysis.

6- The "points to consider" section could benefit from reference to: in situ conservation goal of the CBD, Identity preservation, countries' capabilities and priorities and alternative options.

7- In the section of Effects on the abiotic environment and ecosystem, in "Risk Assessment of Living modified plants with tolerance to abiotic stress", the last paragraph would benefit from reference to "cost in terms of ecological services?

8- The section on Risk assessment of living modified mosquitoes is more elaborate, balanced and "frank. It is an example showing that when a non-"trade related" GMO is considered, a more open, less restricted, scientifically sound and more ecologically-relevant RA becomes more likely. RA should not be unduly biased by trade-interests. Here, species, habitats, ecosystem function and services etc. are more prominent (see Steps 2 and 3 of the roadmap. Fish and other aquatic GMOs are not much different from mosquitos but received less attention because of trade considerations.


France

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Neutral
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?YesLe texte a toutefois été jugé trop general dans l'ensemble. Points critiques soulevés par le CS du HCB:

- Les exigences en termes d'analyses statistiques devraient être plus développées.

- Il devrait être clarifié que les résultats bruts doivent pouvoir être obtenus sur demande s'ils ne sont pas inclus dans le dossier.

- Problèmes éventuels liés aux pays non signatairesdu P de C (ex: obtention de données supplémentaires d'une société d'un pays non signataire? obtention de méthodes de détection / identification de LMO importé d'un pays non signataire?) à clarifier.

- Définir "ecological function" (p. 6 l. 207).

- La question des méthodes de détection/identification des LMOs devrait être développée.

Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?YesLes commentaires exposés à la question précédente sont également valables ici.

Définir "Party involved" (l. 187 et suivantes).

Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?Yes
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?NoLacunes identifiées par le CS du HCB:

- le cas des essais expérimentaux n'est pas abordé

- la surveillance des points d'entrée et voies de transports lors d'introduction de LMO pour transformation et alimentation n'est pas développée

- les cas particuliers de LMO destinés à des usages industriels spécifiques, des utilisations pharmaceutiques ou de la phytorémédiation, ne sont pas discutés.

Q14. Is there any other issue or concept that you would like to see included in the Roadmap?YesLacunes identifiées par le CS du HCB:

les plans de surveillance post-commercialisation.

Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?Yes
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?Yes
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Yes Il aurait toutefois été judicieux de ne pas limiter tous les exemples de stress abiotique à la tolérance à la sécheresse et à la salinité.
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes Le terme de moustiques est vague. Culicidae serait plus approprié.
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?Yes Les Culicidae se nourrissent de nectar mais leur impact sur la pollinisation devrait être décrit avec plus de précision.
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes Il est toutefois important de souligner le risque majeur de résistance aux insecticides dans la première partie du texte. Ce point n'est décrit que brièvement à la fin du paragraphe. Même remarque concernant le risque de dissémination par rapport au contexte environnemental (tout endroit où l'eau stagne suffisamment longtemps pour permettre le développement larvaire de l'insecte).
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes La diversité des problèmes associés aux moustiques GM est bien décrite, mais il n'y a pas d'échelle des différents risques mentionnés. L'importance de la pollinisation devrait être mieux décrite (ex: limitée ou non).
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesL'importance de l'habitat dans la capacité des moustiques de se disperser et de se multiplier n'est pas suffisamment soulignée. L. 122: Dire qu'il y a peu d'études n'est pas totalement correct: plus de 200 articles ont été publiés sur la biologie des Culicidae.
Additional Comments (Q31)
La question de la coexistence est mentionnée (p. 15 l. 590) comme un sujet pouvant être pris en compte dans le processus de prise de décision en plus de l'évaluation des risques. Le CS du HCB remarque que le sujet n'est pas abordé dans le Protocole.


United Kingdom

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Poor
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Poor
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?NoThe Roadmap has improved significantly since the last version through simplifying and reducing the amount of text. However, it could be improved further. The guidance highlights the need for problem formulation. However, the points to consider appear disconnected from this approach. It would be very useful if the guidance provided examples as to why information such as molecular characterisation data would be useful in the risk assessment e.g. where the points to consider include information on copy number, expression levels and genotypic/ phenotypic stability. Similarly, in providing examples where persistence and geneflow may be associated with a risk. Emphasising the need to carry out steps 2 and 3 in tandem, as shown in the flow chart, will help focus on characterising risks rather than hazards (i.e. in generating information that will help decision makers).
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?NoThe list of points could be taken as a framework for a research project without more context. It might be difficult to see the 'wood for the trees' without more experience.
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? - comments.
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?NoIt is applicable to plants and works less well for animals and particularly microorganisms.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?NoSee Q9 - it might be difficult for inexperienced assessors to differentiate between the information requirements for a trial with minimal environmental exposure and those for larger-scale release, particularly with respect to molecular characterisation data.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?YesPreviously the UK recommended that systematic approaches to RA such as tiered approaches were introduced. We also suggested the inclusion of worst-case scenarios. This is particularly useful for issues such as horizontal gene transfer.
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?YesThe box under step 5 is unneccessarily complex. The main question is whether there is enough information of the requisite quality to characterise the risks posed by the LMO,which in turn will allow the risk manager to reach a decision. RM strategies are developed as part of the RA and also as part of the decision-making process- do they need to be included again. New information (of potential relevance) is an issue that could arise at any point, not just in the window between the RA being completed and the decision-making process. It could be removed from this box?
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?No We have serious reservations about the scientific credibility of this section. It conveys a lack of understanding that genomes are not fixed entities - differences/ changes are inevitable. This is compounded by a lack of problem formulation/ risk hypotheses.

The guidance does not explain that some importing countries do not regulate stacked events. In addition, the scope restricts this guidance to LMOs comprising LM events that have been assessed previously. There is a strong possibility that assessors will need to consider LMOs containing multiple events in which all of the individual events have not been considered before.

Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?No
Q18. Is this section of the Guidance organized in a logic and structured manner?No
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?NoThis section does not add significantly to the Roadmap in terms of specific issues. It is arguable that the issues highlighted could be introduced as examples in the Roadmap (where they are already referred to e.g. altered potential to persist / invade new habitats/ selection of sites for field trials). This section of the guidance places a great deal of emphasis on the potential for unexpected pleitrophic effects conferring tolerance to additional biotic and abiotic stresses. However, it does not suggest that the molecular characterisation of the LMO might include a consideration of specificity (e.g. if a transcription factor is involved - some are very specific whereas others are not).
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)? -
Q23. Is this section of the Guidance organized in a logic and structured manner? -
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?No Our previous concerns about this section remain. The document is perfunctory and fails to provide adequate details on the risk assessment or management of LM mosquitoes. Primary literature sources have been taken out of context and/or poorly understood (e.g., Benedict et al. 2008). A tiered approach to testing of LM mosquitoes must be emphasised in this sort of guidance.
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes? -
Q28. Is this section of the Guidance organized in a logic and structured manner? -
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Additional Comments (Q31)


Honduras

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Poor
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Poor
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Very poor
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?No La Hoja de Ruta deja muchas preguntas sin clarificación para ser útil como una guía de referencia. Honduras ha utilizado un enfoque mas simplificado del proceso de Análisis de Riesgo, del expuesto en la presente Hoja de Ruta, siempre tomando en cuenta los pasos apropiados para asegurar la bioseguridad resultante de la introducción de un OVM a nuestro ambiente receptor. Un enfoque mas simplificado podría ser de mayor utilidad para reguladores con poca experiencia, que pudieran sentirse intimidados por la complejidad presentada en la Hoja de Ruta que estamos evaluando (esto también aplica a la pregunta 11 – Q11: Is the Roadmap User-friendly?).

En el enfoque simplificado utilizado en Honduras, el Análisis de Riesgo se define como "el uso sistemático de la información disponible que permita la toma de decisiones, con base en los riesgos y beneficios evaluados, de la adopción de una tecnología en particular". En el Análisis de Riesgo deben ser considerados los aspectos de la bioseguridad, así como las consecuencias económicas y sociales de las nuevas tecnologías. Bajo este enfoque de consecuencias económicas, se debe también tomar en cuenta el riesgo de no adoptar una tecnología que sea valiosa para los productores y para el país.

Siguiendo este enfoque , la Evaluación de Riesgo (diferente al Análisis de Riego que es mas global e incluye la Evaluación de Riego) se define como "el uso sistemático de la información disponible sobre bioseguridad, con base en los riesgos identificados y los objetivos de protección elegidos, que permite inferir con certeza razonable acerca de la seguridad de la nueva tecnología al medio ambiente y a la salud humana y animal". En la Evaluación del Riesgo no se debe tomar en cuenta los aspectos sociales y económicos como consecuencia de la adopción de la nueva tecnología, pues éste utiliza el método científico como herramienta para responder preguntas estrictamente de carácter biológico cuantificable.

El éxito del Análisis de Riesgo depende de la correcta Evaluación de Riesgo, y que los riesgos identificados sean reales y no sólo percibidos. Una evaluación correcta es necesaria para poder concentrar los esfuerzos en las preguntas importantes para la bioseguridad ambiental. Es importante formular preguntas coherentes para obtener respuestas coherentes, siguiendo el método científico. De lo contrario, el analista ambiental o los órganos regulatorios tendrán que enfrentarse a los daños imprevistos, o tendrán que dedicar su atención, esfuerzo y recursos financieros limitados (especialmente en países pequeños en vías de desarrollo) a un conjunto de elementos que no presentan un riesgo real. Es así, que la formulación del problema es el paso más importante en cualquier proceso de Evaluación de Riesgo.

Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?No La Hoja de Ruta generaliza demasiados aspectos que pueden resultar confusos para reguladores con poca experiencia, como es la mayoría de los casos en países pequeños en vías de desarrollo. Existe la posibilidad de que reguladores con poca preparación se sientan intimidados por la magnitud y el costo de la tarea de realizar una Evaluación de Riesgo como lo establece la Hoja de Ruta y por lo tanto, no la realicen.

Línea 584: La Hoja de Ruta sugiere considerar "Aspectos Releacionados" (Related Issues) como aspectos socio- económicos y éticos, entre otros. Nuestro comité considera que estos aspectos son parte de la Gestión del Riesgo y la Toma de Decisiones.

Considerar que estos aspectos son parte de la Evaluación de Riesgo, puede resultar confuso para reguladores sin experiencia, ya que sale de los márgenes a tomar en cuenta, al realizar una evaluación en bioseguridad bajo el mètodo científico, que involucra mediciones biológicas cuantificables.

Glosario: Aunque consideramos que el glosario es un componente necesario en la Hoja de Ruta, es necesario que incluya todos los términos técnicos utlizados en el texto (ejemplo "near-isogenic lines" no incluído ) y considere hacer una revisión mas objetiva de la fuente utilizada para definir los términos, ya que las definiciones pueden variar, dependiendo de la fuente utilizada. La mayoria de terminos ya estan definidos en la literatura científica y no es necesario tratar de definirlos otra vez.

Por ejemplo, la definición de los términos "Análisis de Riesgo y "Evaluación de Riesgo" pueden tener diferentes interpretaciones (favor ver relacion en la pregunta 8)

Q10. Is the Roadmap organized in a logic and structured manner?NoNo. ( Favor ver respuesta a pregunta 11). Por ejemplo la incertidumbre debe ser considerada como un tema mas transversal y no paso por paso. No hacerlo de esta forma puede resultar confuso, ya que la incertidumbre es a veces muy difícil de medir, y hacer mas preguntas o extrapolar resultados de evaluaciones de campo, no necesariamente genera las respuestas adecuadas.
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No La Hoja de Ruta no siempre sigue un flujo lógico (ver Flujograma) y hay temas o elementos fuera de contexto como por ejemplo, consideraciones de Estrategias de Manejo de Riesgo en el proceso de Toma de Decisiones que aparecen fuera del marco lógico del Flujograma . Tampoco considera los posibles costos para un país pequeño con escasos recursos y poco personal capacitado para realizar un Evaluación de Riesgo de una profundidad como la que sugiere la Hoja de Ruta.

Consideramos que para los reguladores de Honduras la presente Hoja de Ruta es demasiado compleja y difícil de conceptualizar, ya que la Evaluación del Riesgo debe tomarse como un componente integral del Análisis holístico del Riesgo ( favor ver comentarios a la pregunta 8 con definiciones de "Análisis de Riesgo" vs. "Evaluación de Riesgo"). Sería útil ver un flujograma que integre los pasos del proceso en forma vertical, relacionando en forma trasnversal, los aspectos inherentes a cada paso del proceso.

Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?NoLa Hoja de Ruta hace mayor énfasis en aspectos relacionados a plantas que no son necesariamente extrapolables a otros organismos.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?YesSi, pero es difícil para un regulador con experiencia limitada, decidir que pasos debe seguir en una evaluación del riesgo en los diferentes niveles (ejemplo, invernadero vs. pruebas de campo).
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?YesHonduras ha acumulado 8 años de experiencia desde la primera liberación comercial de OVMs (maíz con resistencia a insectos y herbicida) y ha visto beneficios para el ambiente, que han sido cientificamente comprobados en nuestro ambiente receptor y que han sido parte de la toma de decisiones.

El Análisis de Riesgo conceptualizado en la Hoja de Ruta no parece incluir los beneficios que deben ser considerados al momento de tomar decisiones. Si las desciones solo consideraran el riesgo ineherente de la aplicación de la tecnología, nuestro grupo (CNBB) no hubiera podido aprobar su liberación.

Consideramos que es inconsistente medir un riesgo y tomar una desición basada en la medición (dificil) de este riesgo, sin realizar una Analisis de Riesgo-Beneficio. La Hoja de Ruta no considera este aspecto.

Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?NoComo ya hemos mencionado anteriormente, el Flujograma, no presenta la información de una manera lógica y consistente. Pareciera una evaluación cíclica que no tiene fin, ya que prevé la posibilidad de seguir haciendo una evaluación de riesgo después de una etapa de liberación comercial.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?NoLa segunda parte, debe responder a una presentación lógica de la primera parte, que debería seguir un enfoque sistemático, basado en la ciencia. Al tener preocupaciones con la utilidad de la primera parte, también tenemos las mismas preocupaciones para la segunda.
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?NoFavor ver comentarios a la pregunta 16.
Q18. Is this section of the Guidance organized in a logic and structured manner?NoFavor ver preguntas de la primera parte.
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?NoFavor ver preguntas de la primera parte.
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesYa las incluímos en la primera parte.
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol? -
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)? -
Q23. Is this section of the Guidance organized in a logic and structured manner? -
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol? -
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes? -
Q28. Is this section of the Guidance organized in a logic and structured manner? -
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Additional Comments (Q31)


Hungary

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Very good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?YesVery good document for assessing environmental risks, but not clearly taking into account the health risks.
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?YesThe document is weak concerning the input with regard to the health risks.
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?YesApplicable for plants, but not applicable for animals and microorganisms.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?No
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?Yes
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?Yes
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesNo history of safe use exists for any LMO. The use of an LMO as comparator should be discurraged.
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Yes
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?Yes
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Additional Comments (Q31)
A new view point should be considered, perhaps added, whether there were any previous release(s) into the same environment, and/or the individual organism being assessed had any prior exposure to the same , or similar LMO(s) (especially important in case of stacked events) which might influence the reliability of data collected during assessments.

The effects on the ecosystem services should be considered more during the assessment.

It should also be considered to assess the effect of abiotic stress in line 293.

Posttranslational effects should also be considered in line 332, point e) regarding the characterization of the LMO.


Ireland

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Neutral
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Neutral
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?YesThe roadmap does provide useful guidance however it could be improved in respect of how the document is structured and in providing further clarity in certain areas so that the document could go beyond being "useful".
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?YesPlease see comments above for Q8 and below for Q10. The document could be improved for ease of use for the end user.
Q10. Is the Roadmap organized in a logic and structured manner?YesImprovement could be made on the structure. For example the text is quite dense in places which can be confusing for the reader. In the preface it should very much stand out that part I is the Roadmap and the illustrative flowchart should be introduced at the outset (i.e. background section) rather than as an annex on page 16. The fact that the report is broken into Part(s) 1 & 2 with the latter having subsections (A, B & C) is not helpful to the overall structure either and it might be preferable to have the main document referred to as the Roadmap with A,B & C placed in Annexes. Such an approach might give more prominence to the "roadmap concept. A table of contents would also be helpful in providing additional clarity.
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesPlease see comments above.
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?YesIt is noted that roadmap has been based largely on LM crop plants and therefore this "limitation" should be acknowledged in the overall context of the guidance.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?YesAgain as per Q12 there might exist a general applicability which might be limited in respect of catering for "all types of introductions".
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?Yes
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?YesAgain the section is useful, however improvements could be made on presentation which could provide further clarity - a visual chart may help in this respect.
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?YesUseful to a certain extent but must also take into account comments in Q16 & Q19.
Q18. Is this section of the Guidance organized in a logic and structured manner? - Please see comments in Q16 & Q19.
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesYes, but only to a certain extent. The continuous cross referencing to roadmap text is not that user friendly and an alternative approach could be considered.
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?YesAgain it is useful however improvements could be made on presentation and bringing further clarity .As commented previously, a visual chart may help in this respect.
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?YesUseful to a certain extent but must also take into account comments in Q21 & Q24.
Q23. Is this section of the Guidance organized in a logic and structured manner?YesPlease see comments in Q21 & Q24.
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesYes but only to a certain extent. The continuous cross referencing to roadmap text is not that user friendly and an alternantive approach could be considered.
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?Yes
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesYes but only to a certain extent. As previously noted the continuous cross referencing to roadmap text is not that user friendly and an alternative approach could be considered.
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Additional Comments (Q31)
In the preface and on line 11 it could be helpful to state, in respect of Article 15, "that risk assessments shall be carried out in a scientifically sound manner and shall be based at a minimum …" thus giving prominence to relevant text of Art 15 from the outset.

Also for clarity would it be helpful to list steps referred to in line 251 (page 7) so as to improve overall structure?


Italy

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Poor
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?Yes
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?YesThe roadmap is useful to risk assessors with limited experience only if biosafety education and training are provided.
Q10. Is the Roadmap organized in a logic and structured manner?YesBut it should be more schematic.
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesThe addition of tables and graphs could help to better understand the roadmap.
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?Yes The roadmap is especially applicable to plants, less to the other LMOs
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?YesIt is lacking in some more specific considerations usefull for placing on the market. An ecosystemic approach should be considered at all level of RA.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?YesThe concept of baseline status of the receiving environment and the issue "unintended sequences" page 9 line 328.
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?NoThe flowchart should be simplified by using keywords or key concepts.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?YesSuitable biosafety education and training must be provided to risk assessors who have limited experience apart from the usefulness of this section of the guidance.
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesIt could be improved with tables and graphics.
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?YesSuitable biosafety education and training must be provided to risk assessors who have limited experience apart from the usefulness of this section of the guidance.
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesIt could be improved with tables and graphics.
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesTables, diagrams and graphics.
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?YesSuitable biosafety education and training must be provided to risk assessors who have limited experience apart from the usefulness of this section of the guidance.
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesIt could be improved with tables and graphics.
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesTables, diagrams and graphics.
Additional Comments (Q31)
It is suggested:

(i) the use of examples that include microorganisms and animals;

(ii) an ecosystemic approach during the RA.

1.To the introduction please add this reference:

Guidance on the environmental risk assessment of genetically modified plants EFSA Journal 2010;8(11):1879 [111 pp.]. http://www.efsa.europa.eu/it/efsajournal/pub/1879.htm

2. to para. Step 5: Points to consider related to risk management strategies:monitoring:please add this reference:

Guidance on the Post-Market Environmental Monitoring (PMEM) of genetically modified plants -EFSA Journal 2011;9(8):2316 [40 pp.]. http://www.efsa.europa.eu/it/efsajournal/pub/2316.htm

3. To "The Choice of Comparators" please add this reference:

EFSA Guidance on selection of comparators for the risk assessment of genetically modified plants and derived food and feed EFSA Journal 2011; 9(5):2149 [20 pp.]. ttp://www.efsa.europa.eu/it/efsajournal/pub/2149.htm


Japan

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?NoStep1 is a step to examine what adverse effects could occur, why and how(line 270), and to identify the scientifically plausible scenarios and risk hypotheses(line278-280). Many points to consider are listed. However, it is difficult to understand where each of points to consider should be used in the examining process of this step. As it would be thought that points to consider depend on the kind of adverse effects, it might become more understandable to exemplify what kind of adverse effects ( e.g. “gene transfer” or “weediness” as shown in the Scale-up document of OECD(1993) ) will happen, and to explain points to consider in each case of adverse effect.

Although it seems (k) in points to consider is similar to (n), they are not listed side by side. What rule is applied to ordering points to consider? As many points to consider exist, the way of ordering should be reexamined.

Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?No
Q10. Is the Roadmap organized in a logic and structured manner?No
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?NoAs the Roadmap has been developed based largely on living modified crop plants (line 54-56), it could not to say that it is fully applicable to all types of LMOs at this stage.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?Yes
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?Yes As stated in the “background” in PartⅠ, the Roadmap complements Annex III of the Protocol. It would become more understandable if a table which shows the relationship between Annex III and the steps of the Roadmap would be added in this part.
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?NoThe meaning of the both sided arrow between Step2 and Step3 in the flowchart cannot be understood. There is no description of the relationship between Step2 and Step3 in the text of Step2, neither in the text of Step3. As it is stated in the explanation of Figure1 that “the box around steps 2 and 3 shows these steps may sometimes be considered simultaneously or in reverse order”, the both sided arrow seems to have different implication.

It is stated in the text that Step4 is a step to determine the level of the overall risk based on all information from Step1, Step2 and Step3. However, there is no arrow from Step1 to Step4. It is inconsistent with the text.

Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?Yes
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Yes
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesExamples of “biotic conditions”(line983) should be shown in the text.
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol? -
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes? -
Q28. Is this section of the Guidance organized in a logic and structured manner? -
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Additional Comments (Q31)
(1) Part I Roadmap for risk assessment of living modified organisms

1) line63-64, line177-178: In order to consistent with the Annex III of the Protocol and the line 221-222 of the Roadmap, and to make it clear that the assessment is performed by comparative way, “in relation to the likely potential receiving environment” should be replaced to “in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment”.

2) line123: The sentence of “Where appropriate, in the risk assessment and be described in the risk assessment report.” may be incomplete sentence.

3) line 350: As the changes caused by the change of farm management practices, such as the change in the herbicide application followed with adoption of LMO, are not effects of the LMO, those effects should be out of the objective of assessment in the Roadmap. Therefore the words of “changes in farm management practices” should be deleted.

4) As the cumulative effects of LMO would not be the common understanding of the Parties,

a) line365:The words of “Cumulative effects with any other LMO present in the environment” should be deleted.

b) line 469:The words of “and cumulative” should be deleted.

c) line507-508:The words of “, including cumulative effects due to the presence of various LMOs in the receiving environment” should be deleted.

5) line543: The sentence of “Monitoring can be applied as a tool to detect unexpected and long-term adverse effects” should be deleted.

It is recognized that the General Surveillance (GS), which is shown in the first draft of Monitoring Document distributed on Aug.30, is based on this part.

GS will cover the monitoring of particular indicators or parameters that reflect important protection goals where no particular hypothesis for an adverse effect has been established. On the other hand, the monitoring in the Roadmap is quoted from Annex III, paragraph 8(f) of the Protocol, and is implemented where there is uncertainty regarding the level of risk (line147-150). Thus the monitoring in the Roadmap, which is implemented in case that the uncertainty exists after the risk assessment based on the risk hypothesis, is different from GS, which has no risk hypothesis.

Therefore this part is beyond the Annex III. It is not appropriate to contain this sentence in the Roadmap which complements Annex III.

(2) Part II A. Risk assessment of living modified plants with stacked genes or traits

1) As the cumulative effects of LMO would not be the common understanding of the Parties,

a) line725,739,756:The words of “and cumulative” should be deleted.

b) line765-766:The words of “and DNA fragments that could result in cumulative effects” should be deleted.

2) line741-743: As the changes caused by the change of farm management practices, such as the change in the herbicide application followed with adoption of LMO, are not the direct effects of the LMO, those effects should be out of the objective of assessment in the Roadmap. Therefore the sentence of “Also, indirect effects due to changed agricultural management procedures, combined with the use of the transgenic event LMOs, may occur.” should be deleted.


Lithuania

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Very good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Very good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Very good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?Yes
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?Yes
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?Yes
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?Yes
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?Yes
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?Yes
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Yes
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?Yes
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Additional Comments (Q31)
These criteria are properly projected and correspond to Cartagena Protocol on Biosafety and Annex III of this Protocol. No field trials are performed in Lithuania; as a result, no practical experience is gained in this area and just the theoretical estimation is provided for the guidance above.


Mexico

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Neutral
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Neutral
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Neutral
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?No Some of the considerations are not clear, for example the repeated inclusion of uncertainty as a consideration independent of each of the steps. On the other hand the definition of monitoring seems to assume that risk assessment has not been correctly and that the monitor is going to solve.
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?No Is sufficiently general to serve as a guide, but included aspects that are unclear, as the uncertainty and the monitoring. The choice of the best comparator is not quite clear, for example, does not include cases in which the modified parental may the best comparator to test pleiotropics effects in stacked events. Also the section of Related Issues, for someone with little experience could be confused as those issues are not related to risk asssessment but are still in the guidance document. In addition to the last section of RELATED ISSUES it is not part of the analysis of risk, but policies and it can be confusing for someone with little experience.

The roadmap may be easier for those with experience in risk assessment. Clarification of the information that is specified in some of the points considered necessary. We consider that regulators from developing countries must have a intensive trainning course provided by experienced evaluators international organization.

Q10. Is the Roadmap organized in a logic and structured manner?NoIn general the structure seems clear how ever there are points to consider that are on the wrong section.
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesHowever an example of risk assessment would be very helpful. Also, we would appreciate if you provide more real examples of each scenario
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?Yes The Roadmap is general enouhg to be applied to all types of LMOs, although it woulb benefit if the use of examples is more balanced and not too centered on LM plants.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?YesBut clarification when some information is needed or would be available needs to be enphasized.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No He is considered better to focus only on the points that mark the annex III and article 15 of the Protocol
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?NoIt is recognized that the process ir risks assessment is iterative, the graph gives the impression that it is a endless cycle.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?Nothe guidance may be easier for those with experience in risk assessment. Clarification of the information that is specified in some of the points considered is necessary.
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes It is considered necessary to clarify some of the concepts contained in the Guide, to facilitate its implementation.
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?Yes
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Yes
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?Yes
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol? -
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes? -
Q28. Is this section of the Guidance organized in a logic and structured manner? -
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Additional Comments (Q31)
During the round of comments pass in which analyzed the guide point to point, Mexico through the consultation of experts involved in evaluation of risks to the taking of decisions by the competent authorities, made a detailed evaluation in which it expressed the need for clarification and even delve into some of the concepts contained in the Guideparticularly what it refers to the detereminación of uncertainty.

The risk assessment is a very relevant activity that must be shared with biotech companies. Regulator must check the "available literature" to evaluate the risks. In some cases the problem is that literature is scarse International Organizations must develop some protocolos that must be part of the acompanies research duties during the GMO development as happens with synthetic pesticides.


Netherlands

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Neutral
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Neutral
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?Yes However, the guidance, in particular the guidance on the steps in de ERA process , is extremely complicated. This is mainly caused by the fact that the document tries to cover many discussions that are current in the Parties that have 'hands on' experience with LMO risk assessment. This would be acceptable, if the document would at least also focus on the basics of the ERA, for instance in step 1, the assessment of the new traits in the LMO. When trying to apply the guidance to a specific application (MON810 market application) we felt that the document does not offer the basic guidance that is needed for deciding exactly what new traits there are in the LMO, and what could be the potential adverse effects caused by these traits. The document should in the first place deal with these kinds of basic questions, and only in the second place focus on the myriad of secundary discussions that are ongoing amongst more experienced Parties.

However, this is a problem that can only partly be solved by revising the text of the Roadmap. We think that the text, being a general guidance, will never be able to fully inform the uninitiated about all the intricacies of environmental risk assessment of the specific case that they are dealing with. For that reason, the Roadmap refers to background documents, so that the available experience of others can be taken into account. For the usefulness of the document it will be vital that a mechanism is devised for continuously assembling lists of references, and for updating and managing these lists. This is a task for the AHTEG, and it is of vital importance that the AHTEG delivers a thoroughly considered proposal for a process that takes this issue into account, especially taking into account the needs of uninitiated users of the Roadmap.

Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?NoSee Q8.
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?NoSee Q8.
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?YesYes, but only in principle. The Roadmap focuses mainly on GM plants, but is applicable, mutatis mutandis, to any type of GMO.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?Yes
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?YesYes, although discussions on details remain necessary.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol? -
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits? -
Q18. Is this section of the Guidance organized in a logic and structured manner? -
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol? -
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)? -
Q23. Is this section of the Guidance organized in a logic and structured manner? -
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol? -
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes? -
Q28. Is this section of the Guidance organized in a logic and structured manner? -
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Additional Comments (Q31)
For the testing process we have put an actual application (the original application for placing on the market of MON810) side by side with the Roadmap, and we have tried to put ourselves in the position of regulators that have not before done an environmental risk assessment of this type. We agree with the test results that were posted by the UK.


Somalia

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Neutral
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Neutral
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?Yes
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?Yes
Q10. Is the Roadmap organized in a logic and structured manner?Nolack of resourses.
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?Nonot yet applicable.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?Nonot yet applicable.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?Yesit is excellent presentation related this issue.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yesit is most usefull on the guidance and introduction.
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits? - it is good if could you planning other additional training or capacity building for the new parties.
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?Noit is fine.
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yesit must be clear Abiotic Stress.
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Nofor lack of experience for abiotic Stresses.
Q23. Is this section of the Guidance organized in a logic and structured manner?Yeswe get more usefull after read it.
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?YesAfrica continental has limited experience for risk of LM mosquitoes.
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Additional Comments (Q31)
there no same capacity for the developed countries and LDCs. we suggest to will provide a training to upgrading the Focal Point came from LDCs.


Slovakia

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?Yes
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?Yes
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?Yes
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?Yes
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?Yes
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?Yes
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Yes
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol? -
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes? -
Q28. Is this section of the Guidance organized in a logic and structured manner? -
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Additional Comments (Q31)


Slovenia

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?Yes
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?Yes
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?Yes
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?Yes
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?Yes
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?Yes
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Yes
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?Yes
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Additional Comments (Q31)


Sweden

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Neutral
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?Yes
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?Yes
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?Yes
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?Yes
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?Yes
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?Yes
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Yes
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol? -
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes? -
Q28. Is this section of the Guidance organized in a logic and structured manner? -
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Additional Comments (Q31)


Thailand

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Very good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Very good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?Yes
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?Yes
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?No
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?No
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?NoIn regarding to the receiving environment, the intended scale and duration of the environmental release should be clearly indicated.
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?Yes
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?Yes
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?Yes
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Yes
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesIn the last 2 lines of page 18: "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?" it difficult to understand./ is the term "abiotic stress" include the meaning of herbicide tolerance?
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?Yes
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Additional Comments (Q31)
This Roadmap provides further guidance which can be useful as a reference for risk assessors when conducting or reviewing risk assessments. However, LMOs of different taxa would need to be evaluated differently.


Turkmenistan

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Very good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Very good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?YesThe Roadmap take into account Article 15 and Annex III of the Protocol. The Guidance consider potential environmental risk assessment of LMO – one of the major aspects of Biosafety – the issue, that have still ongoing discussions among risk assessors, scientists.
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?YesThis Roadmap is very useful for risk assessors with limited experience, because first of all it shows how the risk assessment is complicated process that have to be done step by step.
Q10. Is the Roadmap organized in a logic and structured manner?YesYes, the Roadmap organized ina structured manner, including logic steps – Phase for risk assessment process. The detailed explaining of necessary criterias for quality and relevance of information is important for RA.
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesThe Roadmap shows that RA is complex process and demand designing the environmental and health regulations and Biosafety strategies and etc.
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?YesIn general the Roadmap is applicable to LMO plants and animals (mosquitoes).
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?YesThe Roadmap applicable to small and large scale releases into the environment and consider potential adverse effects that may result from changes due to the genetic modifications(s).
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?Yes/No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?YesThe flowchart provides logic and graphic representation of RA process and facilitate the understanding of the RA process.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol? -
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits? -
Q18. Is this section of the Guidance organized in a logic and structured manner? -
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?Yes
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?Yes
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?Yes
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?Yes
Additional Comments (Q31)
It will be very interesting to get information about Strategic Environment Assessment (SEA) developed by CBD and EU, that includes the additional aspects of RA.


South Africa

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Good
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Good
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Good
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?YesThe scope of the guidance given under the term "risk assessment" in this document is generally referred to as "risk analysis" (one of which components is risk assessment) so there is some ambiguity.
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?YesThe approach has not been explained, e.g. risk hypothesis, problem formulation (there are different approaches to PF etc). Without that knowledge and experiece in applying this approach in Risk Asessment, some risk assessors may have difficulties.
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?YesReference is made to annex III of the protocol stating, "Risks associated with living modified organisms or products thereof should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment" this may not be true for all LMOs. This is recognised in the section "choice of comparators" with regards to LM plants tolerant to abiotic stress, stacked LMOs and certain LM mosquitoes. I would point this out when using the above quote to avoid confusion. In addition I would include pharmaceutical producing plants in addition to the examples mentioned above.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?YesYes, but more focus can be placed on decreasing/ addressing risk with the use of risk mitigating measures (particularly containment) during small scale releases such as field trials or applications where large scale release is unlikely e.g. pharmaceutical producing plants and animals.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?YesIntroducing the concept of using pathways to harm in risk assessments is important (in par 278-283). I would recommend fleshing out this section slightly more as it is such an important concept and including a figure to demonstrate the process.
A specific example for risk assessment of GM microorganisms.
Explain /define terminology, e.g. null hypothesis and risk hypothesis, conceptualization, harm, etc.
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?YesThe flowchart is very useful as a graphic representation of the Risk Assessment process (again this is actually risk analysis). I would include the text "(including monitoring)" in the sentence "Consideration of risk management strategies, and decision making" so that it reads "Consideration of risk management strategies (including monitoring), and decision making" because monitoring is an important risk management strategy and often a legal requirement, but it is not always clear to regulators how this fits in the process of risk analysis. Including it in the flowchart will make it easier for regulators to see how it fits into the process.
It describes the process but I suggest that the diagram of the EFSA environmental consensus document (2010) be considered, that is much clearer as to what ERA entails.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?YesA diagram would be helpful here.
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?Yes
Q18. Is this section of the Guidance organized in a logic and structured manner?Yes
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesThis section is curious in that it only deals with ‘breeding’ stacks and not stacks due to multiple gene cassettes.
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?Yes
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?YesInclude a diagram.
Q23. Is this section of the Guidance organized in a logic and structured manner?Yes
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesMore headings.
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesIf the tolerance trait does increase the persistance of the plant such as in agricultural areas (when the non modified comparator did not) there needs to be discussion on what consitutes a harm and what negative effects will be acceptable. The choice of comparator becomes important in this example, e.g. other commonly accepted agricultural practices and plants may be used for baseline informtion.
The paragraphs from lines 1031-1042 introduce concepts that may be outside the scope of a environmental risk assessment for GM crops and may be better dealt with at a national level, i.e. through national legislation and policies.
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?Yes
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?Yes
Q28. Is this section of the Guidance organized in a logic and structured manner?Yes
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?Yes
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?Yes
Additional Comments (Q31)
How is this guidance document positioned relative to the other documents? Does this document become the key guidance document of the Protocol and its signatories? Will adherence to this be enough to protect countries from liability and redress issues?

The Document is well written and thought out but difficult to apply because of the subjective nature of the assessments. I would suggest that no two people could come up with anything like a similar assessment for an application. An improvement in this direction would be a semi-quantitative approach as described by Morris, 2011. Transgenic Research DOI 10.1007/s11248-010-9480-8.

The 'approach' taken by this roadmap should be more clearly explained. The leap is too big from the framework/strategy that we are accustomed to.

  • USA

United States of America

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Poor
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Very poor
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Very poor
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?NoThe Roadmap does not provide sufficient guidance regarding the distinction between conducting risk assessments for confined, small-scale environmental releases as compared to large-scale releases. The emphasis is almost exclusively for LM plants, and primarily aimed at large-scale or unconfined releases. Most Parties are likely to be first confronted with questions about small-scale confined releases, but the Roadmap will give the impression that RA for such releases are far more complicated than is the case (based on experience in the many countries that have been doing RA for confined releases over the past two decades).
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?No \The comment for Q8. applies here as well. In addition, the Roadmap should provide more context on which LMOs have already been subjected by RA by governments, the nature of the environmental releases conducted (confined vs. unconfined), and the experience of safe use with respect to potential impacts on biodiversity. This is a central theme of the protocol itself, but the Roadmap does not emphasize this. Also, a number of independent scientist groups and governments worldwide have already concluded that using the techniques of modern biotechnology to create LMOs does not present risks to the environment that are necessarily different from the risks posed by non-LMOs. This has been borne out in the many examples of LM plants cultivated in diverse countries for many years, but the Roadmap does not make mention of this at all. In fact, the Roadmap would give inexperienced risk assessors the impression that we have little positive experience in evaluating LM plants.
Q10. Is the Roadmap organized in a logic and structured manner?NoThe organization is somewhat logical in following the layout of Annex III in part, but there is insufficient explanation of the logic of the risk assessment steps, the way in which information is actually used to support the asssessment, and the circumstances under which certain information is not needed for the risk assessment.
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?NoThe Roadmap does not appear to be very user-friendly. There are large sections of text that quote the Protocol repeatedly, but there is little information on how the concepts of Annex III have been applied in specific RAs. The Roadmap has an over-abundance of generalized statements, but few specific examples to illustrate the point and/or relevance of information that the risk assessor is to use. The Roadmap should more clearly emphasize the need for risk assessors to have a knowledge of the organism being evaluated, rather than the implied emphasis on molecular genetics. One of the lessons learned from experience with LMO risk assessment over the past two decades is the realization that the total phenotype of the LMO is far more informative in the assessment than is the molecular genetic characterization.
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?NoThe emphasis is largely on LM plants, yet the Roadmap does not acknowledge the extensive experience gained for confined and unconfined environmental releases of LM plants. This is surprising, since the Protocol emphasizes the value of sharing RA experiences of Parties and non-Parties that have done RAs of LMOs intended for releases, both confined and unconfined, into the environment.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?NoSee previous comments on Q8-12. In addition, it is not clear why the AHTEG has chosen to try to develop guidance on separate LMO topics (e.g., abiotic stress, stacked traits, mosquitoes) when the main guidance document is incomplete and has not yet completed the testing and revision phase. It would seem more appropriate to provide specific examples in the main guidance itself, if specific examples are warranted, for mosquitoes or certain types of plants. The reviewers find it surprising that so little information is provided in the Guidance on RA for confined environmental releases such as field testing of plants.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?YesThere is insufficient discussion in the Roadmap as to how the risk assessor evaluates the LMO and the existing situation (e.g., the environmental impacts arising from an LMO engineered to resist insect feeding damage versus the environmental impact arising from a current situration in which the use of chemical pesticides impacts biodiversity and human health). This is the comparative information that a risk assessor is typically expected to provide for decision-makers, but this is not developed well enough in the Roadmap. The "Glossary of Terms" needs considerable attention to bring it into better agreement with existing use of terms in other scientific disciplines, guidance documents, etc., as well as to avoid introducing concepts that are not supported in the body of the document. The guidance on choice of comparators is overly prescriptive and does not take into account the questions being addressed in the particular part of the risk assessment (e.g., in some cases, a similar LMO has been used as an appropriate comparator in risk assesssments performed by governments with experience in the RA of LMOs, but the text says otherwise).
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?NoThe flowchart adds items and emphasis that are not consistent with Annex III or the current draft of the Roadmap. In particular, the boxes on "overarching issues" and "planning phase" seem to call for risk assessors to perform certain steps before they can conduct the risk assessment. In the experience of countries that have done risk assessments of LMOs in the context of regulatory decision-making, the items listed in these two boxes do not occur prior to the start of a risk assessment. Placement of the issues of "identifying uncertainty" and "choice of comparators" in boxes prior to "conducting the risk assessment" are likely to confuse risk assessors, since these issues arise in the steps of the risk assessment, and they are influenced by the questions being addressed at various steps (i.e., they are influenced by the context of the questions being addressed at the various steps of the risk assessment). The relationship of the "related issues" to the risk assessment itself is confusing and outside the scope of the Roadmap. The flow diagram uses different terminology than used in the body of the Roadmap, and this makes it more difficult to follow.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?NoIt appears that there is nothing unique to the guidance on stacked trait LM plants that would not already have been covered under the main Roadmap guidance. In many ways, the guidance on stacked trait plants is not as well developed from a scientific or conceptual standpoint. As mentioned in the comments above for the main Roadmap, the overall phenotype of the LMO is a result of all the genes, not just those that have been introduced via the techniques of modern biotechnology. This idea is not clearly made in the guidance.
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?NoSee the comments of Q16. In addition, the guidance does not adquately explain that genetic change does not equate with risk to the environment, since organisms continually experience genetic changes without human intervention. The Guidance does not acknowledge the wealth of experience we have in evaluating the resulting phenotypic changes and their potential impacts on the environment. The discussion in the Guidance on insertional effects from transgenesis is just one instance of a missed opportunity to explain this concept (and the fact that genome changes occur at a much higher frequency in all organisms than the one-time insertion of a transgene construct. There should be more emphasis on the practical step that most risk assessors typically ask if someone else has already done a risk assessment (this is the conceptual underpinning to the mechanism of the Biosafety Clearing House, but this is not explained in the Guidance in a clear fashion that would enable a risk assessor to gain access to another relevant risk assessment).
Q18. Is this section of the Guidance organized in a logic and structured manner?NoThere seems to be unnecessary redundancy within the text of the main Roadmap guidance. There is no logic provided to explain why there is a need for a separate section in the guidance on this topic when it provides so little additional information.
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?NoThere should be a clearer explanation of the need for traditional plant breeders in the evaluation. There is already a wealth of information from non-LM plants developed to tolerate abiotic stress, and this provides context to evaluate the likely behaviour of LM plants modified for abiotic stress. Related disciplines of plant physiology, plant pathology, and entomology can provide useful context to illustrate the ways in which abiotic stresses affect susceptibility to pests and pathogens.
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance? - There should be more discussion examining the scientific rationale as to why a separate RA would be needed for a stacked trait LM plant, if the parental LM plants have already been evaluated. Our experience with plant breeding worldwide does not support such a need, and the Protocol does not presuppose such a need.
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?NoAs with the comments on the section on "stacked traits", there should be more discussion examining the scientific rationale as to why a separate RA would be needed for an LM plant modified to tolerate abiotic stress.
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?NoAs with the comments on the section on "stacked traits," this section on LM plants modified for abiotic stress does not provide sufficient context, nor does it describe relevant comparison with non-LMO plants developed to tolerate abiotic stress. There is extensive scientific literature that could be cited that would place this in clearer context, but this is not part of the Guidance. Likewise, there is no explanation in this section of the Guidance that explains cases in which plants tolerant of abiotic stress have resulted in adverse impacts on biodiversity.
Q23. Is this section of the Guidance organized in a logic and structured manner?NoAs mentioned in the comment for Q22, the scientific rationale and logic are not well supported in this section.
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?NoThe comments for Q22 apply here as well. The Guidance does not provide information that would lead the reader to seek experts or knowledge gained from the use of non-LMO plants when evaluating LM plants modified to tolerate abiotic stress.
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesThe comments for Q22, Q23, and Q24 apply here, also. There should be clearer explanation of the experience with non-LM plants developed for abiotic stress and how this relates to evaluating the LM plants.
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?NoThe guidance in this section is not well developed and fails to compare develop RA of LM mosquitoes in the context of current approaches for mosquito (and disease) control. This is perhaps one of the easier examples of LMOs with which to illustrate the consideration of human health under the Protocol, but the guidance neglects to illustrate this in a way that risk assessors can see how this aspect is included. The relative benefit in light of current practices (step 5) should be more evident in this type of RA, but it was not a well developed concept in other parts of the Guidance either (a shortcoming that is consistent through the entire guidance document).
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?NoAs with other parts of the guidance, this section prescribes what a risk assessor "should" do, but there is weak or non-existent explanation of why this should be done or how it relates to the risk assessment. Scientific expertise in this section seems frequently lacking or confused in the presentation of the text. Many of the "points to consider" are often internally inconsistent with other parts of the text, especially with the discussion of genetic constructs which block fertility.
Q28. Is this section of the Guidance organized in a logic and structured manner?NoThis section of the guidance is poorly developed. Scientific rationale or relevance of points to consider is not well supported (see comments above for Q26 and Q27 for examples).
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?NoThe section does not adequately describe the current context of trying to control diseases vectored by mosquitoes and how LM mostquito strategies relate to potential effects on the environment and human health.
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?YesSee comments above for suggestions on issues that should be more fully developed for this section of the guidance.
Additional Comments (Q31)
In summary, the main substantive concerns with the Guidance are is that it is 1) not accurate and 2) not useful.

1) Not accurate, because:

- The Guidance does not adequately reflect the experience worldwide with evaluating the impact of LMOs in the environment; in the current draft it gives the wrong impression that there is little experience with evaluating LMOs, and wrongly suggests that experience with the use of other GMOs, or indeed with the use of other organisms, cannot be used in a risk assessment;

- The Guidance does not adequately reflect the experience worldwide with the safe use of LMOs in the environment.

2) Not useful, because in its current form it raises more questions than it answers. See for example the questions raised in the submissions of the UK, for example.

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  • CERA
  • GIC
  • PRRI

Center for Environmental Risk Assessment, ILSI Research Foundation

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Very poor
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Very poor
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Very poor
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?NoSome sections of the Roadmap are noticably improved from earlier versions and may be useful if taken by themselves. However they are weighed down by some very confusing, unnecessary and unhelpful sections that ultimately make the Roadmap less useful than many other pre-existing resources that might be used to provide guidance for risk assessments. The most disappointing thing about the Roadmap continues to be a complete failure to acknowledge 15+ years of risk assessment history for LMOs. This document derives no insight from that experience and could have been written in 1995 - with the exception of quotes taken from the Protocol.
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?NoIn addition to the comment in response to Q8, the Roadmap fails to distinguish between different activities such as confined field trials, unrestricted environmental release and imports for food, feed or processing - except in the most perfunctory way. As a general rule, the guidance is too basic to be practically useful and filled with too many complex (and often trivial) concepts to serve as an introductory or educational tool.

In particular, the "points to consider," are a mixed bag of relevant general principals and others which are ill thought out and not much related to the text of the section in which they appear.

Q10. Is the Roadmap organized in a logic and structured manner?Yes/No There's nothing wrong with the structure, per se. The section on "Related Issues" stands out as being completely unnecessary.

It might also be useful to put the flowchart at the beginning of the document, instead of at the end.

Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No There are two challenges to making the roadmap user friendly. First, the language is filled with jargon that is applied inconsistently. The Roadmap is a negotiated document, and unfortunately this does not lend itself to "user friendly" language, but the inclusion of lengthy lists within the text makes it very difficult to read and comprehend. For example, although it may be important to some that the Roadmap imparts the idea that adverse effects can be "direct, indirect, immediate or delayed," this need only be mentioned once early in the document, or even better in the glossary. Sprinkling the phrase throughout the document any time the word "effects" is used is unnecessary and distracting.

Second, although there is nothing wrong with the structure (i.e. headings and subsections) of the document, the text underneath is often bizarrely disorganized, bouncing from topic to topic without much rhyme or reason, frequently mixing important considerations with highly specific or trivial ones while making no distinctions between them.

As a rule, when providing guidance on how to perform an assessment it is better to provide a solid understanding of the foundational elements and then address the various complexities that may arise using case studies or examples. The Roadmap seems to do the opposite, bypassing the foundation in order to pile on potential considerations that may have limited practical applicability.

Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?Yes/NoMost of the broad concepts included in the Roadmap are equally applicable to other organisms. However, there are sections which unneceessarily delve into details which may not be broadly applicable, and doesn't explain why or how they should be dealt with.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?NoThe Roadmap largely fails to distinguish between different scales of releases, leaving the user to guess which elements are appropriate for what scale of release. In essence, this is a failure to provide guidance. Again, this is another missed opportunity to make use of the cumulative experience of 15 years of risk assessment dealing with LMOs in the environment. There are ample examples of risk assessments for field trials, and risk assessments for unconfined release which could be used to emphasize what elements are important for each activity, but this has not been done.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?YesThe flowchart is a very nice representation of the generalized risk assessment process. It shows the simplicity of the concepts without a lot of the clutter that is weighing down the text of the roadmap.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?NoThere is very little of value presented in this section of the document. The fundamental flaw here is the failure to distinguish between the potential for changes at the genomic level and the real potential for those changes to lead to an adverse environmental effect. When organisms are crossed there are many potential interactions within the genome (regardless of whether the organisms are LMOs or not), but rarely does breeding produce an organism with the potential to have an adverse effect on the environment by crossing two parents which are benign. Instead of providing guidance that would inform a useful risk assessment, this section precludes the use of tools like case by case hazard identification and the generation of risk hypotheses (i.e. problem formulation) in favor of experimentation that is unlikely to be informative (lines 737-743) This section compounds the confusion in the Roadmap between choosing a comparator for a comparative risk assessment and choosing appropriate controls for laboratory or field experiments. Further there are lots of dubious and unsupported statements in the document (see lines 647-649, 734-736 for some examples). There is also a disproportionate emphasis on molecular characterization which will likely contribute little to the final risk assessment. Chasing down the detailed minutiae of an organism's genotype is likely to be far less informative for environmental risk assessment than looking at the organisms phenotype in the receiving environment. There is no discussion of the proportionality of some of the phenomena discussed here. For example, the heterogeneity of parental organisms is no more or less a concern for crossing one LMO with another LMO than it is for crossing an LMO with a non-modified relative.
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?NoAs it is currently written, this section provides little to no value to anyone trying to consider LMOs with stacked traits and is far more likely to confuse assessors with limited experience than help them produce a useful risk assessment.
Q18. Is this section of the Guidance organized in a logic and structured manner?NoThere is no logic for including a section devoted to "Methods for distinguishing the combined transgenes in a stacked event from the parental LMOs" here. The unlikely scenario being conveyed is that it may be necessary for the purpose of managing risks to the conservation and sustainable use of biodiversity to be able to distinguish between the presence of a gene in a stack or parental LMO. It is very difficult to imagine such a scenario.
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?NoThe only useful information presented here are the areas that point out that assessment of LMO plants with abiotic stress tolerance is the same as for other LMO plants. The rest of the document is a series of unsupported speculations about the theoretical potential difficulties and the (dubious) supposition of the utility of future technologies to address them. Once again there is confusion between a controlled experiment and a comparative risk assessment. Likewise, there are numerous unsupported statements (see line 1028-1030 for an example).
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?NoA novel risk assessor is unlikely to come away from this guidance with a good idea of what is required for an ERA of an LMO plant with an abiotic stress tolerant trait. Increasingly complex statistical comparisons between the LMO plant and its comparator are not necessary (and likely counterproductive) for determining environmental risk. This represents a huge lost opportunity to focus on potentially plausible risk hypotheses for stress tolerant plants (such as increased survival and persistence outside of agricultural habitats) and what sort of data would be useful for an assessment.
Q23. Is this section of the Guidance organized in a logic and structured manner?NoThe section on the LM plant in "representative environments" is just a complex restatement that the potential receiving environment should be considered in environmental risk assessments of LMOs. It doesn't add anything of value.
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?NoThe parts of this guidance document that are useful are the general principles which are already contained in the roadmap. The information specific to mosquitoes is generally uninformative and filled with speculation as to potential adverse outcomes that are unsupported by a scientific rationale (see lines 1159-1162, 1163-1165, 1173-1176,1178-1183, 1185) and does not include any consideration of where LM mosquitoes would fit within the pantheon of other mosquito control activities.
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?NoThis section is more of a creative "what if" brainstorming session regarding potential harms that might occur with the use of LM mosquitos. There is nothing wrong with that, but the next step for creating useful ERA guidance is to determine which of those hypothetical harms merits consideration in real risk assessment.
Q28. Is this section of the Guidance organized in a logic and structured manner?No
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Additional Comments (Q31)
There is a consistent and repeated failure in all parts of the document to adequately address the purpose of the ERA -to provide relevant information to decision makers in a timely fashion. The guidance also consistently fails to make use of the years of experience that have been accrued in conducting ERAs for LMO plants. In addition to some dubious statements, there is repeated emphasis on increasing the volume of molecular characterization data to be considered despite 15 years of experience suggesting that this has limited practical utilility. Novel risk assessors making use of this document will come away with the mistaken impression that the solution to their problem is more molecular biology when what is needed is robust, hypothesis driven problem formulation. There are currently many resources available to assist risk assessors, including many cited on links provided here, that provide better guidance than this document.

Global Industry Coalition

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Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Poor
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Poor
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Poor
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?No(Please download original submission for the comments)
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?No
Q10. Is the Roadmap organized in a logic and structured manner?No
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?No
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?No
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?Yes
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?No
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?No
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?No
Q18. Is this section of the Guidance organized in a logic and structured manner?No
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?Yes
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?No
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?No
Q23. Is this section of the Guidance organized in a logic and structured manner?No
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?Yes
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol? -
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes? -
Q28. Is this section of the Guidance organized in a logic and structured manner? -
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Additional Comments (Q31)

Public Research and Regulation Initiative

Download the original submission
Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Neutral
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Poor
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Poor
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?NoThe roadmap leaves open numerous questions that required clarification before it could be used to guide a risk assessment.

Line 280: “It may be important to define a causal link or pathway between a characteristic of the LMO and a possible adverse effect, which may be direct or indirect, immediate or delayed”.

Q: in which type of cases would identification of a causal pathway not be required?

Line 311: “its taxonomic relationships”;

Q: What is meant by “its taxonomic relationships”: is this what the calls CPB “taxonomic status” (and the EU Directives “taxonomy”) or does it refer to crossable species of maize or both?

Line 313: “its ecological function”:

Q: to what does this refer? the ecological function of maize as grown as a crop or the ecological function of the wild relatives?

Line 314: “whether it is a component of biological diversity that is important for the conservation and sustainable use of biological diversity”.

Q: What would be an example of a non modified crop plant that is a component of biological diversity that is important for the conservation and sustainable use of biological diversity?

Line 318: “ Characteristics related to the transformation method, including the characteristics of the vector such as its identity, source or origin and host range”

Q: Is this information also necessary if none of the vector DNA went into the final LMO?

Line 323: “with particular attention to characteristics in the recipient organism that could cause adverse effects”

Q: What does this mean? Does this mean that for maize, for example, there are none?

Line 326: “characteristics of the modified genetic elements”

Q: what does this mean? Example please

Line 412: "biogeographic".

Q: What is the definition of this term?

Line 466: "the behaviour of agricultural or relevant wild-type populations of unmodified animal or insect species, including interactions between predators and prey, disease transmission and interaction with humans or animal species; "

Q:What is meant by « behavior »? How would would determine what are relevant wild-type populations?

Line 507:

Q: what does the term 'broader' mean here, what is the definition of landscape considerations, how are cumulative effects related to these considerations, and why are these mentioned in particular?

Line 562: (d) 'Ability to identify, evaluate and confine adverse effects as well as to take appropriate response measures':

Q: does this refer to the ability, so the 'capability' of the risk assessor?

Line 1418: definition of cumulative effects.

Q: What is the difference between cumulative and additive (see definition of "combinatorial effects").

Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?NoSee answer to Q8
Q10. Is the Roadmap organized in a logic and structured manner?Yes
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?NoSee answer to Q8
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?No
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?No
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?No
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?Yes
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol?No
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits?No
Q18. Is this section of the Guidance organized in a logic and structured manner?No
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol?No
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)?No
Q23. Is this section of the Guidance organized in a logic and structured manner?No
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol?No
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes?No
Q28. Is this section of the Guidance organized in a logic and structured manner?No
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?No
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance?No
Additional Comments (Q31)

The results under this category were submitted by participants of the Open-ended Online Expert Group.
Click on a tab below to select the testing results of an expert.

  • L.Ambrozevicius

Luciana Ambrozevicius

Download the original submission
Quality assessmentAnswerComments
Overall Evaluation
Q5. How do you evaluate the level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III?Poor
Q6. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner? Poor
Q7. How do you evaluate the usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments?Poor
Part I: Roadmap for Risk Assessment of LMOs
Q8. Does the Roadmap provide useful guidance for conducting risk assessments of LMOs in accordance with the Protocol?NoIn the guidance I'm missing a more deitaled description of Step 1. I think the definition of a risk hypothesis as"a theory that predicts the likelihood of harmful outcomes to assessment endpoints" is critical to the success of RA and the process to elaborate those hypothesis and to analyse them based on the presented data should be better explained.
Q9. Is the Roadmap useful to risk assessors who have limited experience with LMO risk assessment?No Following the GuidanceI have trouble to select and to integrate essential information listed in the "points to consider" in a logical way to make the right questions about how the assessment endpoints will respond as a result to the exposition to the LMO and to use the data presented by the applicant to answer those questions. Another point I have difficult was to evaluate if the data presented was enough refined to reduce uncertainty and how to evaluate if the results from some field trials can be extrapolated for the potential receiving environment in the RA.
Q10. Is the Roadmap organized in a logic and structured manner?NoAlthough all the steps of a RA process are presented in a structured way, I think some aspects, like the problem context and scope are described apart from the Conducting RA section and they are indeed essential when applying step 1 of the process. Also the uncertainty is presented as a concept and part of all "points to consider" without any consideration of how the uncertainty can be reduced in the LMO RA.
Q11. Is the Roadmap user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity?YesThe glossary is an important way to standardized in the Guidance some important concepts of RA and I think the way the Guidance is described, with a general description of each step and the points to consider in topics is clear enough. Also the flowchart is important to sumarize all the steps together in a general view of the process.
Q12. Is the Roadmap applicable to all types of LMOs (e.g. plants, animals, microorganisms)?Yes Some aspects are strictly related to plants, as most of the experience with LMO releases are with these organism, but I believe some particular aspects of other organisms can be addressed in specific Guidance as the experience shows what is important in the RA process for these other organisms.
Q13. Is the Roadmap applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)?No For a risk assessor with a limited experience it will be difficult to select which information will be essential for a RA of a small scale release, considering that not all the information in the guide is required in this case, and the important biosafety measures (risk management) that has to be adopted to keep the LMO confined.
Q14. Is there any other issue or concept that you would like to see included in the Roadmap?YesI think the problem formulation (Step 1) should be better adressed in the Guidance. Although all the necessary information for the PF is listed in the Step 1, there is a lacking of descrition about how to link this information in a logical way to set up a exposure scenario and generate a risk hypothesis. Also the concept of "familiarity"in the RA should be better exploited.
Q15. Does the flowchart provide a useful graphic representation of the risk assessment process as described in the Roadmap?YesThe flowchart is showed according to the process described in the Guidance, but again, all the steps listed in the Annex III and detailed in the Guidance could be further elaborated allowing the assessor to select and use the information listed in the "Points to consider" and to evaluate if the data presented is enough to make assumptions and predictions about how the new trait of a LMO could affect an assessment endpoint.
Part II: Specific types of living modified organisms or traits
Risk assessment of living modified organisms with stacked genes or traits
Q16. Does this section provide useful guidance when conducting risk assessments of LMOs with stacked genes or traits in accordance with the Protocol? -
Q17. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LMOs with stacked genes of traits? -
Q18. Is this section of the Guidance organized in a logic and structured manner? -
Q19. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q20. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Risk assessment of living modified crops with tolerance to abiotic stress
Q21. Does this section provide useful guidance when conducting risk assessments of LM crops with tolerance to abiotic stress(es) in accordance with the Protocol? -
Q22. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM crops with tolerance to abiotic stress(es)? -
Q23. Is this section of the Guidance organized in a logic and structured manner? -
Q24. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q25. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Risk assessment of living modified mosquitoes
Q26. Does this section provide useful guidance when conducting risk assessments of LM mosquitoes in accordance with the Protocol? -
Q27. Is this section of the Guidance useful to risk assessors who have limited experience with risk assessments of LM mosquitoes? -
Q28. Is this section of the Guidance organized in a logic and structured manner? -
Q29. Is this section of the Guidance user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity? -
Q30. Is there any other issue or concept that you would like to see included in this section of the Guidance? -
Additional Comments (Q31)
My evaluation about the level of consistence of the Guidance with the Protocol was "poor" because it extrapolates some concepts of the Protocol and also takes into consideration other aspects listed in the "Related Issues" some that are not part of the objective of risk assessment according to the Annex III of the Protocol. Related to the usefulness of the Guidance I had difficult to follow the steps listed in the Conducting the Risk Assessment section. The separation of the "Setting the Context and Scope" in the so called "Planning Phase" make it difficult to understand the importance of establishment of the "assessments endpoints" in the overarching protection goals as the fundamental point to define the risk hypothesis. An inappropriate risk hypothesis may misdirect the whole risk analysis process and lead to the imposition of unnecessary controls to reduce risk.

Click on a tab below to see the testing results of the different capacity building activities.

  • Caribbean
  • Latin American
  • Anglophone Africa

Caribbean Training Course on Risk Assessment of LMOs, Belize City, Belize, 26-30 Sept 20111

Download questionnaires with the results of the testing (including comments)
Quality assessmentAgreement (%)2
Overall Evaluation
Level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III100
Usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner 85.8
Usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments100
Part I: Roadmap for Risk Assessment of LMOs
Provides useful guidance for conducting risk assessments of LMOs in accordance with the Protocol 100
Is useful to risk assessors who have limited experience with LMO risk assessment 85.8
Is organized in a logical and structured manner 100
Is user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity 100
Is applicable to all types of LMOs (e.g. plants, animals, microorganisms)57.1
Is applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)85.8
Contains all necessary relevant issues and concepts 80
The flowchart provides a useful graphic representation of the risk assessment process as described in the Roadmap 71.4

1: A total of seven participants nominated by Parties took part in the testing exercise.
2: The percentage of agreement was calculated on the basis of the answers that were equal to "good" and "very good" for questions 5-7; or that were equal to "yes" for questions 8-13 and 15; and to “no” for question 14 in relation to the total number of respondents.

Latin American Training Course on Risk Assessment of LMOs, Havana, Cuba, 7-11 Nov. 20111

Download questionnaires with the results of the testing (including comments in Spanish)
Quality assessmentAgreement (%)2
Overall Evaluation
Level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III88.2
Usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner 82.4
Usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments76.5
Part I: Roadmap for Risk Assessment of LMOs
Provides useful guidance for conducting risk assessments of LMOs in accordance with the Protocol 76.5
Is useful to risk assessors who have limited experience with LMO risk assessment 52.9
Is organized in a logical and structured manner 94.1
Is user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity 70.6
Is applicable to all types of LMOs (e.g. plants, animals, microorganisms)58.8
Is applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)88.2
Contains all necessary relevant issues and concepts 62.5
The flowchart provides a useful graphic representation of the risk assessment process as described in the Roadmap 56.3

1: A total of seventeen participants nominated by Parties took part in the testing exercise.
2: The percentage of agreement was calculated on the basis of the answers that were equal to "good" and "very good" for questions 5-7; or that were equal to "yes" for questions 8-13 and 15; and to “no” for question 14 in relation to the total number of respondents.

Anglophone Africa Training Course on Risk Assessment of LMOs, Accra, Ghana, 11-16 Dec 20111

Quality assessmentAgreement (%)2
Overall Evaluation
Level of consistency of the Guidance with the Cartagena Protocol on Biosafety, particularly with its Article 15 and Annex III100
Usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs in a scientifically sound and case-by-case manner 100
Usefulness of the Guidance as a tool to assist countries in conducting and reviewing risk assessments of LMOs introduced into various receiving environments100
Part I: Roadmap for Risk Assessment of LMOs
Provides useful guidance for conducting risk assessments of LMOs in accordance with the Protocol 100
Is useful to risk assessors who have limited experience with LMO risk assessment 92.3
Is organized in a logical and structured manner 92.3
Is user-friendly taking into account that risk assessment is a complex scientific and multidisciplinary activity 92.3
Is applicable to all types of LMOs (e.g. plants, animals, microorganisms)92.3
Is applicable to all types of introductions into the environment (e.g. small- and large-scale releases, placing on the market/commercialisation)84.6
Contains all necessary relevant issues and concepts 53.8
The flowchart provides a useful graphic representation of the risk assessment process as described in the Roadmap 100

1: A total of thirteen participants nominated by Parties took part in the testing exercise.
2: The percentage of agreement was calculated on the basis of the answers that were equal to "good" and "very good" for questions 5-7; or that were equal to "yes" for questions 8-13 and 15; and to “no” for question 14 in relation to the total number of respondents.

   
   
Update on 2012-08-15
United Nations Environment Programme United Nations