Report of the Subregional Workshop. for Francophone Africa on: Risk Assessment and Management. and. Public Awareness and Participation

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1 United Nations Environment Programme UNEP-GEF Project on Development of National Biosafety Frameworks Global Environment Facility Report of the Subregional Workshop for Francophone Africa on: Risk Assessment and Management and Public Awareness and Participation April 22-25, 2003, Dakar, Senegal 1

2 INTRODUCTION 1. The United Nations Environment Programme (UNEP) - Global Environment Facility (GEF) Project on the Development of National Biosafety Frameworks (NBFs) is one of the main components of the GEF Initial Strategy for assisting countries to prepare for the entry into force of the Cartagena Protocol on Biosafety, approved by the 16 th GEF Council in November The project, which was initiated in June 2001 for a three-year duration, is designed to (a) assist up to 100 eligible countries to prepare their NBFs; and (b) to promote regional and subregional collaboration and exchange experience on issues of relevance to the NBFs. The overall objective of the project is to prepare countries for the entry into force of the Cartagena Protocol by, inter alia, assisting in the implementation of the following activities: (a) Assessing current technological capacity to manage biosafety issues, and the implications of this for implementation of an NBF; (b) Strengthening national capacity to develop national regulatory biosafety frameworks; (c) Strengthening national capacity for competent decision-making on notifications and requests relating to living modified organisms (LMOs), including the establishment of administrative systems to assist in this; (d) Applying other measures, according to the Protocol, taking into account the work of the Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP); (e) Supporting regional and subregional collaboration, including harmonization of the implementation of national regulations; (f) Raising public awareness and improving information flow to the public on the issues involved around the release of LMOs, to promote informed debate and to ensure transparency with respect to the regulation of LMOs; (g) Providing all stakeholders with an opportunity to be involved in the design and implementation of the NBF. 2. The project is coordinated by the UNEP-GEF Biosafety Project Team. A regional coordinator for each region is available within the Team, to provide advice and support to countries throughout the implementation of their national projects to develop NBFs, which are intended to last a maximum of 18 months. 2

3 3. In parallel with the work with individual countries, the Biosafety Team has already held regional workshops in Africa (Kenya, January 2002), Central and Eastern Europe (Slovakia, 5-9 February 2002), Asia-Pacific (China, 4-8 March 2002) and Latin America and the Caribbean region (Buenos Aires, 8-10 May 2002), in order to improve countries understanding of the key issues of the development of NBFs. The workshops were targeted at National Project Coordinators (NPCs) of participating countries or potential NPCs from countries yet to join the project. 4. To assist progress at the subregional level, a series of 12 training workshops have been planned from November 2002, to help build capacity in: the decision-making process (risk assessment, risk management, etc.); public participation; administrative systems; and regulatory systems. It was decided that the first subset of six workshops, scheduled for November May 2003, would deal with risk assessment and management, and public awareness and participation. The following six subregional groupings would be addressed: Francophone Africa: Anglophone Africa; Asia; Small Island Developing States (SIDS); Latin America; and Central and Eastern Europe, including Central Asia. The rationale behind the subregional workshops lay in the country-driven preference for more regional meetings; the need to promote networking within a region and subregions; a desire to help to meet special development needs; the need to increase opportunities for participation; the need to optimize scarce human resources; and the desire to achieve economies of scale. 5. The first in the series of workshops, the Anglophone Africa Subregional Workshop: Risk Assessment and Management, and Public Awareness and Participation, was held from 12 to 15 November 2002 in Windhoek, Namibia. The Workshop was convened by the UNEP/GEF Biosafety Project Team, in collaboration with the Government of Namibia. 6. The second in the series of workshops, the Latin America Subregional Workshop: Risk Assessment and Management, and Public Awareness and Participation, was held from 10 to 13 December 2002 at the Hotel Presidente Intercontinental Conference Centre, Mexico City, Mexico. The Workshop was convened by the UNEP/GEF Biosafety Project Team, in collaboration with the Government of Mexico. 7. The third, the Asian Countries Subregional Workshop: Risk Assessment and Management, and Public Awareness and Participation, was held from 21 to 24 January 2003 at the Hotel Pan Pacific Kuala Lumpur, Malaysia. 3

4 8. The fourth in the series, the Small Island Developing States (SIDs) Subregional Workshop: Risk Assessment and Management, and Public Awareness and Participation, was held from 18 to 21 February 2003 at the conference centre of the Hotel Outrigger Reef Fiji, Sigatoka, Fiji. The Workshop was convened by the UNEP/GEF Biosafety Project Team, in collaboration with the Government of Fiji. 9. The fifth, the Francophone Africa Subregional Workshop: Risk Assessment and Management, and Public Awareness and Participation, was held from 22 to 25 April 2003 at the conference centre of the Hotel Ngor-Diorama, Dakar, Senegal. The Workshop was convened by the UNEP/GEF Biosafety Project Team, in collaboration with the Government of Senegal. 10. A list of participants is attached as Annex I to the present report. I. Opening of the Workshop 11. The joint plenary session of the Workshop was opened at 8.30 a.m on Tuesday, 22 April Mr. Charles Gbedmah., Regional Coordinator for Africa, UNEP-GEF Biosafety Unit, welcomed participants. Mr. Christopher Briggs, Global Programme Manager, UNEP-GEF Biosafety Unit, also welcomed participants and expressed gratitude to the Government of Senegal and to its Ministry of Environment and Nature Protection for hosting the Workshop in such excellent facilities and for the assistance with logistical and administrative arrangements. 12. In his address to mark the formal opening of the proceedings, Mr. Babacar Ndaw, Permanent Secretary at the Ministry of Environment and Nature Protection of Senegal, on behalf of the Minister of the Environment and Nature Protection of Senegal, welcomed participants and underlined the importance of the current Workshop. Senegal was committed to the implementation of the Cartagena Protocol, and he expressed gratitude for the help provided by UNEP-GEF to that end. Senegal hoped to soon be developing a national programme, covering all operational aspects of risk assessment and risk management for LMOs. Senegal had also set up a National Committee, bringing together representatives of all sectors of society, and it was expected that, in the near future, a national programme for public participation would also be developed. 13. As importers of foodstuffs, many African countries that were also developing countries faced real risks in the importing of LMOs, and they were not always able to control such risks. Evidence from East Africa had highlighted the risks from releases of genetically modified seeds and the so- 4

5 called terminator technologies. LMOs could have serious consequences for agriculture, and there was also the problem of economic dependence. Moreover, the potential medium- and longterm risks to human health were not certain. In addition, ethical and religious questions had to be taken into account. Africa thus faced a very difficult situation, and he expressed his commitment to the consideration of possible solutions. 14. However, LMOs represented the future and their potential benefits could not be rejected out of hand. They held clear advantages for the people and for the economy and offered a way for African countries to emerge from their situation of dependence, to tackle the important issues of poverty and to promote truly sustainable development. The UNEP-GEF Biosafety Project offered important assistance in helping to resolve the problems that could arise in the use of such technologies. Senegal was very glad to host the current important Workshop and he wished all participants success in their work and an enjoyable stay in the country. 15. Lieutenant Colonel Demba Ramada Ba, Director of the Department of National Parks of Senegal, welcomed participants and stressed that the Workshop provided an opportunity for an in-depth discussion of the problems arising from LMOs, with the aim of creating an appropriate framework for the safe use of LMO technologies. He extended an offer to provide assistance to facilitate the work of the meeting and to make the participants stay in Senegal a pleasant one. In conclusion, he expressed the hope the Cartagena Protocol would enter into force soon. 16. The Workshop had the following agenda: 5

6 Day 1 Joint Session Day 2 Risk Assessment &Management Day 2 Public Awareness and Participation Day 3 Risk Assessment &Management Day 3 Public Awareness and Participation Day 4 Joint Session Presentations by participants on: Action plans for public involvement in the NBF process; Risk assessment and management process; Checklist and matrix on public involvement in the decision-making process. Panel and plenary discussion on the role of public participation in decision-making on LMOs. Drawing of individual country decision-making process Final discussion (incl. BCH questionnaire and UNEP/CBD project on BCH and Assistant Regional Coordinator); Evaluation of workshop Closure of Workshop 17. The participants agreed to follow the programme of work as set out in Annex II to the present report, whereby the Workshops would hold joint sessions on 22 and on 25 April The two Workshops themselves, on Risk Assessment and Risk Management, and on Public awareness and Public Participation, respectively, were convened on 23 and 24 April Within each of the Workshops, focus groups were set up to consider specific tasks and issues. UNEP/GEF Biosafety Project update 18. At the joint session on 22 April 2002, Mr. Christopher Briggs, Global Programme Manager, UNEP-GEF Biosafety Unit, gave a presentation on the background of the GEF Initial Strategy on Biosafety. After outlining the history of the Biosafety Enabling Activity Project and the process leading to adoption of the Cartagena Protocol, he stressed that, from the outset, there had been an emphasis on the creation of synergies between relevant international organizations and on the coordination of their activities. He pointed to the adoption of the GEF Initial Strategy by the GEF 6

7 Council, and enumerated its main objectives and proposed activities. He noted the overall objectives of the UNEP-GEF Global Project on the Development of NBFs, which had been initiated in June 2001, and pointed to the approval by the GEF Council of the demonstration projects to provide support in the implementation of NBFs (in Bulgaria, Cameroon, China, Colombia, Cuba, India, Kenya, Mexico, Namibia, Poland, Uganda, Malaysia). 19. Describing the different elements of the project a the global, regional, subregional and national levels, he noted that four regional workshops had been held in 2002 to improve the understanding of the key issues involved in developing NBFs. The first series of six subregional training workshops, on risk assessment and risk management and on public awareness and public participation, had been initiated in November He underlined the fact that countries had stressed the value of the regional process and had expressed a wish for more regional workshops. A further six workshops were planned, on administrative systems and regulatory systems, starting in June Concerning progress made at the national level, he gave a regional breakdown of the 116 countries that were on board as at 14 April 2003 and pointed out that more countries could still join the project (six in Africa; three in Central and Eastern Europe; one in the Latin America and Caribbean region; and three in the Asia-Pacific region), but they needed to join the project before 30 June 2003, in order to take full advantage of the human resources available. He enumerated the key elements of the project and outlined the four phases of the approach that was to be applied in drafting the NBF. In conclusion, he introduced the members of the UNEP-GEF Biosafety Team. 21. In answer to a query pertaining to the OAU model law for biosafety for Africa, it was explained that the Cartagena Protocol represented the bare minimum the countries had to put in place. Beyond that, countries were free to develop their own biosafety frameworks as extensively as they wished. However, for the UNEP-GEF biosafety project, the mandate was strictly dictated by the provisions of the Cartagena Protocol. Introduction to the purpose of the Workshop 22. Mr. Gbedmah said that the Workshop offered an opportunity to focus on two main areas of the Cartagena Protocol: risk assessment and risk management; and public awareness and participation. He stressed that participants would not be carrying out a risk assessment itself, but 7

8 would hopefully be given a better understanding of the process for conducting such an assessment. Risk assessment represented an important tool in the formulation of a decision on whether to import an LMO. Interaction between countries was an important factor in the process, and a network was needed to allow for such interaction. It was important for those participating in the Workshop on risk management and risk assessment to also interact with those who were attending the Workshop on public awareness and participation, since there had to be one single vision among those who would be involved in developing the draft NBF. 23. The parallel Workshops were intended to explain to participants the kind of structures they needed to put in place to carry out their task, and to point to existing examples of such structures. That also applied with regard to public participation, which was mandated under Article 23 of the Cartagena Protocol. The Workshop on Public Awareness and Public Participation aimed to look at mechanisms and tools to involve the public the decision-making process. In conclusion, he noted that the current Workshops represented a two-way process, whereby the Biosafety Unit also learned about the needs, requirements and views of the countries involved in the development of their NBFs. Expectations and concerns 24. Participants were invited to express their expectations and concerns in connection with the outcome of the Workshop. The resulting comments are summarized in the table contained in Annex III to the present report. Ground rules of the Workshop 25. Participants nominated and agreed to adhere to a set of ground rules for the Workshop, as contained in Annex IV to the present report. Introduction to public awareness and public participation 26. Introducing the item, Mr. Atamana Bernard Dabire, Facilitator of the Workshop on Public Awareness and Public Participation, gave an introductory presentation on public participation. Noting that such participation presupposed the idea that people were expected to become involved in the decision-making process and were able to express their views, he said that there were certain conditions that had to be met to allow for such participation. It was also important to 8

9 see at what level the public participation was possible, how and to what extent people were able to express their views and take part in decision-making, and how they could contribute to policy formulation. The Cartagena Protocol stipulated that the public should participate in decisionmaking, but it prescribed no set method. How such participation could take place would vary from country to country, depending on different cultural and political factors. 27. To ensure effective public participation, four main pillars were needed: mechanisms for participation; capacity-building to ensure informed participation; access to information; and transparency and accountability in the process. Article 23 of the Protocol highlighted four key elements, without clearly defining them: public awareness; public education; public participation; and access to information. 28. Following the introduction, using a selection process which ensured that a country s delegates were not in the same focus group, participants were invited to form six focus groups to address the following questions: Question 1: What do we mean by public awareness, public education and public participation? Question 2: Why do we need public participation, awareness and education in developing an NBF? 29. The rapporteurs of each of the focus groups convened informally to produce a synthesis report on the outcome of their discussions on the two introductory questions. The designated rapporteur for the focus groups reported the results to plenary. 30. Concerning question 1, the focus groups considered that the public comprised all social layers: decision makers (parliamentarians, elected local officials, NGOs, media, academics, consumers, agriculturalists, producers, religious communities, youth, women s groups, scientists, private society, the man in the street). 31. Information was considered to be everything that could be brought to the knowledge of the public as verbal or non-verbal (gesture, visual) messages. 32. Public awareness was considered to mean all the activities, using appropriate channels, to make the public conscious in order to enable people to perceive the elements of a problem. In the case of LMOs, it entailed informing the public and making people aware of the risks and the benefits associated with the use, handling and transfer of LMOs. Moreover, the public had to be informed about success stories relating to the Cartagena Protocol. 33. Public education was considered to mean placing the necessary and sufficient (scientific, legal and economic) knowledge about LMOs at the disposal of the public in order to enable people to understand and react appropriately. Public education in biosafety integrated the framework of the 9

10 principles of environmental education. It could be conducted in an informal or formal way. It entailed an organized, practical and active stage of awareness-raising. 34. Public participation implied the involvement of the public in the implementation of those programmes of which people had been made aware and in which they had been educated. The public had to have the choice to decide on a given problem, and on the acceptability of an action or not. Participation was essential for giving the public a sense of responsibility. 35. Concerning question 2, the focus groups considered that public awareness and participation were needed so that the public could participate in the management of LMOs. It was necessary to ensure that decisions were properly applied by giving the public a stake. That would minimize the risks of having the process blocked, and would ensure its success and its sustainability. How do we explain science to the public? 36. Mr. Julian Kinderlerer, UNEP consultant, citing examples from the European and other media and the results of surveys, drew attention to the concern at LMOs resulting from modern biotechnology that was currently prevalent among people in Europe and elsewhere. In some cases, for reasons that were not entirely clear, but which involved fear of the new technology, concern over food safety and the possible environmental impact, concern at globalization and the concentration of power in too few hands, there was considerable concern at the use of modern biotechnology for food. However, he cautioned against glib formulations, which endeavoured to explain the reasons for the public s rejection of modern biotechnology for specific applications. 37. Referring to the Public Perception of Agricultural Biotechnologies in Europe (PABE) report, commissioned by the European Union, he cited a number of statements, which purported to explain the public s attitude, and challenged participants to ask themselves whether the statements represented myths or truth. He stressed the importance of public engagement, which really sought to involve people in the decision-making process, as opposed to their mere participation, which often handed down information and decisions from above. The main task lay in providing people with the information, which allowed them to make a choice to accept or reject the technology in question. He offered to make available English-language versions of the reports cited to those participants requiring further data. 38. In answer to a query about zero-risk situations, Mr. Kinderlerer explained that such a situation could never exist in reality. What one could endeavour to achieve would be to make a risk as small as possible. On the question of whether LMOs were unnatural or not, he pointed out that 10

11 many modern commercial crops, while not in themselves LMOs, were the result of human interventions and techniques that were far removed from the situation in nature. 39. Responding to a query on how to differentiate between genuine scientific information and the pseudo-science provided by unscrupulous scientists who had been hired by producers of modern biotechnology, Mr. Kinderlerer said that the answer was not to accept unconditionally the risk assessments provided by producers, but to carry out audits of such information and to conduct one s own assessment, based on the specific conditions of use in the importing country. 40. Concerning the impact of political factors in the process of deciding whether to permit import of an LMO, Mr. Kinderlerer considered that it was necessary to take many aspects of such factors into account. They included the type of agriculture in the country, the way the product would be used if it were a foodstuff, and the overall impact on the domestic agriculture. 41. In answer to the observation that, despite their trumpeted advantages, LMOs would not solve Africa s famine problems, Mr. Kinderlerer said that, currently, the main agricultural LMOs on the market were cotton, maize and soya and, as yet, they had had no major impact on solving the problem of food shortages. But the nature of famine called for the ability to provide an increase in the availability of food in the right place at the right time, while protecting human health and the environment. Many factors entered into play in that equation, and no single solution met all the requirements. LMOs could be just one of the technologies used in a multifaceted approach to tackling the food problem. Introduction to risk assessment and risk management 42. Mr. Kinderlerer introduced the concepts of risk assessment and risk management, noting that those concepts were not simple, nor were they familiar to everybody. He turned first to the question: what is risk? He explained that, while different fields of activity used different definitions, one possible definition of risk for LMOs might be the probability that an organism introduced into the environment might cause a harmful event, coupled with the magnitude of the consequences of that event. Risk arose from exposure and hazard. There was no risk, regardless of how hazardous a particular organism might be, if there was no exposure. Hazard might be regarded as the potential to cause harmful effects, and he invited participants to ask themselves: what kind of hazards? What would be their magnitude? Their probability? Their consequences? The Protocol itself did not define risk, but a common understanding of risk during the current workshop would be required to discuss risk assessment and risk management issues. Moreover, at 11

12 times one had to consider the possible benefits of LMOs. In real life it was often necessary to accept a small possibility of a negative effect in exchange for a perceived benefit, and he also invited participants to think about that idea. 43. He noted that there was a widely held belief that uncertainty was associated with a lack of experimentation and of results therefrom. However, in the context of biosafety it was necessary to understand that more experimentation did not necessarily produce more evidence or reduce the element of risk. Bio-variability meant that one could not reduce the variability between organisms and he invited participants to give thought to the concept of the impossibility of knowing all the elements. The concept of sufficient scientific evidence also needed to be examined, since the absence of evidence of hazard was not evidence of the absence of hazard. He invited participants to consider the idea that, in considering LMOs, biologists often made a presumption of danger, until something had been proven to be safe. 44. Using a selection process which ensured that all of a country s delegates were not in the same focus group, participants were invited to form six focus groups to address the following questions: Question 1: What do we mean by risk assessment? Question 2: What do we mean by risk management? Question 3: Why do we need to develop risk assessment and management systems and procedures for an NBF? 45. The rapporteurs of each of the focus groups convened informally to produce a synthesis report on the outcome of their discussions on the introductory questions. The designated rapporteur for the focus groups reported the following results to the plenary. 46. Concerning question 1, the focus groups considered that risk assessment meant the identification of the nature of the dangers and the potential harm to health and the environment, taking into account the specific features of the surroundings. It involved determination of the frequency with which risks occurred or the probability of their occurring. It entailed studying the impacts by measuring the extent of the hazardousness to human health or the harm to the environment. 47. Concerning question 2, the focus groups believed that risk management meant setting up and implementing a system for observing, following up on, and monitoring the risk factors. It comprised all appropriate legal and technical measures to reduce and even eliminate the hazards associated with the transfer, handling and utilization of LMOs. 12

13 48. Concerning question 3, the focus groups considered that risk assessment and risk management measures needed to be developed in order to provide the required capacities (legal, technical, regulatory and institutional framework) to enable informed decision-making on the transfer, handling and utilization of LMOs within the framework of sustainable use of biological resources. 13

14 II. Proceedings of the Workshop on Risk Assessment and Risk Management 49. The Workshop on Risk Assessment and Risk Management held four sessions, on 22 and 23 April Mr. Francois Pythoud, Facilitator of the Workshop on Risk Assessment and Risk Management, welcomed participants and explained that the aim of the Workshop was not to conduct an actual risk assessment but, rather, to present the structure and the necessary resources to be able to conduct risk assessment and to enable the various institutions involved to carry out the tasks that would befall them. Introduction to risk management 50. Mr. Julian Kinderlerer, UNEP consultant, stressed at the outset that the current Workshop was not intended to be a conference but, rather, an exchange of ideas. The small number of suitably qualified people inevitably led to a crucial problem in further capacity-building. He then briefly outlined the background to modern biotechnology, particularly genetic manipulation. 51. The first transgenic manipulation had given rise to concern in the scientific community. A conference was organized which agreed that such experiments should be authorized only under condition that they respect rigorous safety precautions. Those experiments were actually conducted in a contained environment. That situation was to engender a new logic within the framework of biotechnology regulation. It was no longer necessary to wait for harm before taking action it was necessary to react well in advance. Thus, the situation moved from logic requiring action a posteriori, to logic requiring action a priori. Governments reacted to the conference by setting up regulatory regimes for biotechnology, which varied from one context to another. Citing examples from Europe, the United States and the United Kingdom, he explained that there was no single model for the regulating of LMOs. A number of systems existed, and it was up to each country to chose its own, based on its own needs and objectives. 52. He defined risk from modern biotechnology as the probability that an organism introduced into the environment could cause harmful effects on that environment. That definition comprised two elements: namely, the consequences of a particular event; and the probability of the event occurring. He posed the question whether risk assessment should be based solely on scientific considerations, or whether it should take into account non-scientific aspects. 14

15 53. Risk assessment was the first stage in reducing to a minimum or eliminating the possible harmful effects of LMOs on the environment. A refusal to introduce LMOs into the environment could be considered a preventive measure, in light of the likelihood that the organism might entail risk. However, such a decision would deny a country the opportunity to enjoy the possible benefits that the LMO might bring, if the risk were not certain. Thus, there was a certain acceptability of risk and its level varied from one context to another, depending on the benefits to be gained, but also on the political context. In any case, the minimizing of risk called for certain conditions and management measures. 54. Turning to the question of competence, Mr. Kinderlerer noted that no single specialist would have all the requisite knowledge or expertise to conduct a risk assessment, since that called for a multitude of skills in different disciplines. Pointing to Article 15, paragraph 2 of the Cartagena Protocol, he said that in some countries the national authorities conducted risk assessments and examined the information provided by the applicant. In others, the national authorities audited the risk evaluation carried out by the applicant. He said that there was also the possibility of seeking outside expertise to examine the information supplied and the risk evaluation provided by the applicant. 55. Concerning the potential harmful effects of LMOs, he pointed to the need to differentiate between direct effects, whereby the consequences of introduction of an LMO for human health and the environment were immediately manifest, without any intermediary, and indirect effects, which showed up as a result of a causal chain of events, for example through interaction with other organisms, or as a result of changes in use, in which the risks might be different. 56. Mr. Kinderlerer stressed that risk management, which was the stage that followed risk assessment, called for the setting up of adequate means to manage the identified risks. He pointed to Article 16, paragraph 1, of the Cartagena Protocol which, following Article 8 (g) of the Convention on Biological Diversity, called for the establishment of a national mechanism and for measures and strategies to regulate, manage, and monitor the risks identified during the assessment. He also underlined the importance of taking into account socio-economic, geographic and many other factors when dealing with LMOs. 57. In the ensuing discussion, questions were asked concerning the link with scientific objectivity, the need to take the context into account in risk assessment, the link between delayed effects and cumulative effects, the relevance of a new risk assessment for an LMO already assessed in another country, and identifying the nature of the LMO by reference to its risk assessment. 15

16 Risk assessment and risk management in the Cartagena Protocol 58. Mr. Pythoud recalled that there were two procedures in the Cartagena Protocol: the first, for advance informed agreement, and the second for LMOs destined for food and animal feed, and capable of being processed. He pointed to the different phases and stages of the two procedures, and underlined the individual roles of the actors, particularly at the national level, in order to show precisely what needed to be put in place and to illustrate the functions of the structures that would be in the NBF. The role of importing countries was extremely important within the framework of such a procedure, since they were called upon to make a decision. 59. He described the provisions of Article 15 of the Cartagena Protocol, relating to risk assessment; Article 16, on risk management; Annex III, on the conduct of risk assessment; and Annex I, on information to be provided by the notifier to permit identification of the tasks and obligations of those conducting the risk assessment. In conclusion, he pointed to the main principles governing risk management. 60. During the discussion the following points were raised: the validity of a risk assessment made by an exporter; whether proven scientific methods were set out in the Protocol; means to identify unlabeled LMOs; the problem of possible introduction of LMOs into Africa before the Protocol had entered into force; and the stricter nature of advance informed agreement, as compared to the procedure envisioned under Article 11 of the Protocol. Other international legal instruments 61. Mr. Pythoud described the range of other international agreements, which in one way or another, touched upon the issue of LMOs. He referred to the Codex Alimentarius, which had set up a working group on products derived from LMOs and which was working on issues of labelling such products. He also described the work of other agreements that was likely to be linked to the Cartagena Protocol. They included: the World Organization for Animal Health (Office International des Epizooties, OIE); the International Plant Protection Convention; and the World Trade Organization (WTO), particularly its Agreement on Sanitary and Phytosanitary Measures (SPS) which touched on aspects of LMOs. 16

17 The precautionary principle 62. Mr. George Nakseu Nguefang, Faculty of Law, University of Montreal, pointed to the difficulty surrounding the concepts of the precautionary approach and the precautionary principle since, in a legal sense, they unfortunately did not have the same meaning. He outlined the differences between the two. The precautionary principle had a historic background, since it had been applied in another field, notably in Germany, before being transposed into an environmental context. International consideration of the precautionary principle dated from the 1992 Rio Declaration. 63. Recalling the salient points and aims of Principle 15 of the Rio Declaration, he noted that the Declaration had no legal constraining force, as opposed to the 1948 Declaration of Human Rights, for example. However, by pursuing the analysis further, he considered that even the Rio Declaration could also have a constraining force. He underlined the legal relation between the Convention on Biological Diversity and the Cartagena Protocol and analysed the legal value of the precautionary principle in the Protocol. He noted that, if the principle were simply referred to in the preamble, it would have no legal value. But by including it in the text of the Protocol, namely in Article 10, paragraph 6, and Article 11, paragraph 8, the precautionary principle benefited from a certain legal value. In conclusion, he pointed out the differences between the SPS Agreement and the Protocol, particularly in the field of risk assessment, highlighting several potential conflicts in the manner of operation. 17

18 Practical exercise 64. Participants undertook an exercise in setting up a regulatory system for dealing with applications for handling transgenic organisms. It was explained that there were many decision points in a regulatory system to address risk assessment, risk management and risk communication. The questions set for participants are contained in Annex V to the present report. Participants were requested to supplement and explain any omissions they felt had been made. 65. Questions 2,3 and 7 were addressed in detail in plenary, where participants were given a set time to provide their own answers to what type of LMO products the Cartagena Protocol covered and how that could relate to the coverage in the national frameworks. 66. For the remainder of the questions, participants were divided into groups to hold discussions and decide on their answers. Each group subsequently reported to plenary on the outcome of its deliberations. The results of the exercise are contained in Annex VI to the present report. 67. On the basis of the knowledge gained during the discussions and exercises, participants prepared a comprehensive checklist setting out the actions to be taken and the elements to be considered within the establishment of a regulatory system for handling applications for the release of LMOs. It was explained that the checklist would be presented to the joint plenary session of both Workshops. The checklist is contained in Annex VII of the present report 18

19 III. Proceedings of the Workshop on Public Awareness and Public Participation 68. The Workshop on Public Awareness and Public Participation held four sessions on 23 and 24 April Mr. Briggs welcomed participants and, by reading out the provisions of Article 23 of the Cartagena Protocol, illustrated the way in which public participation was anchored in the Protocol. He stressed that, while some of the terms used in the provisions could be open to different interpretations, countries needed to be clear of the intent of the Article itself. In that connection, he drew attention to the Explanatory Guide to the Cartagena Protocol on Biosafety, produced by a team of international environmental legal experts under the auspices of the World Conservation Union-IUCN, which provided a lengthy and detailed analysis of the individual elements of the Protocol from a legal point of view. Noting that the guide was currently in translation, he explained that an electronic version in English would be made available to participants. 69. The key elements of Article 23 were public awareness; public education; public participation; and access to information. The first of the pillars of public participation comprised mechanisms for participation. A number of possible modalities for such mechanisms existed, in order to ensure that the public had their say. Those mechanisms could be based on an existing structure and on the cultural, social and political context of the country. They had to be appropriate to the stage of the NBF or to the decision-making process. 70. The second pillar, capacity building, was necessary in order to provide the public with the tools and skills to enable them to contribute to the decision-making process. It might be necessary to target specific groups for special capacity building, in order to enable them to understand the issues. Policy and decision makers needed capacity building to enable them to communicate. 71. The third pillar, access to information, was necessary for all stakeholders and for compliance with the Protocol. The question arose: what information and when? The fourth pillar, transparency and accountability, was required to build trust. The results of the public contribution to the process should be made clear, and the results of decisions should be made available to the public. 72. He noted that the study carried out by the Institute of Development Studies (IDS), examining public participation in the development of NBFs, had identified four key challenges: high 19

20 science; polarized views; commercial confidentiality; and international trade obligations. An executive summary of the study had been distributed to participants. 73. During the discussion, several participants expressed concern at the apparent contradiction between the call for public participation and the withholding of confidential information. By way of reply, it was explained that the country itself determined what information in a notification would eventually be classed as confidential, in discussions with the notifier. If an applicant disagreed with the request for release of information, they were free to reformulate and resubmit the application, or to withdraw it altogether. In that connection, it was important that those assessing the notification had the requisite knowledge to be able to judge what information should be kept confidential and the point of view of the notifier. 74. In answer to a query about the relationship between environmental impact assessments (EIAs) and the Cartagena Protocol, it was explained that, while EIAs were relevant to risk assessment and public participation, an EIA was usually an assessment of the immediate direct effects of a given specific project. Risk assessment for LMOs was a much more complicated matter, and endeavoured to take into account the direct and the potential, longer-term, indirect effects of introduction of an LMO. Notwithstanding that, country experiences in EIAs could provide very important information that could be shared for the risk assessment process. 75. One view held that it was difficult to involve the public in Africa, since the information base was very limited, particularly with regard to complex scientific issues and new concepts. Moreover, the polarization of views on LMOs had impacted on the public. By way of reply, it was stressed that the subject was not easy, but each country itself had to find the most efficient way of communicating in an appropriate way with the different elements of the public. The methods chosen might entail tribal village meetings, advertisements, radio broadcasts, etc. The process was slow and involved learning for both sides. Under the UNEP-GEF project a toolkit was being prepared to support countries, explaining the background to the issues and setting out examples and materials. Some participants pointed to the need for a strategic objective for the consultative process and for public participation. One participant pointed to the importance of opinion leaders and NGOs in raising public awareness. Attention was also drawn to the question of when and at what stage to involve particular stakeholders. 76. Stressing the key role of the Biosafety Clearing House (BCH) for the Cartagena Protocol, Mr. Briggs explained that, as an Internet-based system of information exchange, it allowed countries and the public to access the information they needed on notifications and LMOs already on the 20

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