Sub-Regional Workshop for Latin American Countries on ... · The workshop was coordinated by UNEP...

United Nations Environment Programme

UNEP-GEF Project on Development of National Biosafety Frameworks

Global Environment Facility

Sub-Regional Workshop for Latin American Countries on:

Development of a Regulatory Regime and Administrative Systems

25-28 November 2003, Santiago, the Republic of Chile

UNEP-GEF Project on Development of National Biosafety Workshops Latin America Sub-Regional Workshop on Development of a Regulatory Regime and Administrative Systems

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TABLE OF CONTENTS

Abbreviations ................................................................................................................................................3 Introduction...................................................................................................................................................4 Formal Opening of the Meeting ....................................................................................................................5 Introduction to the Workshop........................................................................................................................6 Ground rules, presentation of participants and "Expectations and Concerns” ...........................................7 Introduction to the UNEP-GEF Biosafety Project........................................................................................7 Revision of key components of National Biosafety Frameworks...................................................................8 Overview of the current situation of the region ............................................................................................9 National presentations ................................................................................................................................10 Introduction to national obligations and rights under the Cartagena Protocol on Biosafety ....................12 Introduction to other international instruments that can affect the regulatory system of NBFs.................13 Introduction to the regulatory regime .........................................................................................................14 Introduction to regulatory regime options ..................................................................................................14 Introduction to the elements of the regulatory regime and general provisions ..........................................15 Introduction to operational provisions of the regulatory regime................................................................17 Introduction to other elements of the regulatory regime ............................................................................18 Introduction to the administrative system ...................................................................................................20 Introduction to general administrative tasks ..............................................................................................20 Introduction to relevant administrative tasks under Advance Informed Agreement procedures ................20 Introduction to relevant administrative tasks under the procedures of Art. 11 ..........................................21 Panorama of when and how to apply the Advance Informed Agreement (Art. 7-10) or FFP procedures (Art. 11) .......................................................................................................................................................21 Case study on administrative tasks .............................................................................................................23 Sub-Regional Cooperation ..........................................................................................................................25 Closure Session and Evaluation of the Workshop.......................................................................................26 ANNEXES Annex 1. List of participants .......................................................................................................................27 Annex 2. Work plan ....................................................................................................................................40 Annex 3. List of Expectations and Concerns and their Evaluation in the Plenary ....................................44 Annex 4. Description of optional provisions ..............................................................................................46 Annex 5. Synthesis of the first Working Group..........................................................................................51 Annex 6. Synthesis of the second Working Group on administrative measures.........................................53 Annex 7. Workshop Evaluation Form.........................................................................................................55 Annex 8. Evaluation of the Workshop ........................................................................................................58


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Abbreviations

BCH Biosafety Clearing-House CBD Convention on Biological Diversity CMS Convention on Migratory Species COP Conference of the Parties FFP (LMOs intended for direct use as) food or feed, or processing GATT General Agreement on Tariffs and Trade GEF Global Environment Facility GMO Genetically Modified Organism ICCP Intergovernmental Committee for the Cartagena Protocol IPPC International Plant Protection Convention IUCN International Union for Conservation of Nature and Natural Resources LMO Living Modified Organisms MOP Meeting of the Parties NBF National Biosafety Frameworks NCC National Coordinating Committee NGO Non Governmental Organization NPC National Project Coordinator SPS Agreement on Sanitary and Phytosanitary Measures TBT TRIPS

Agreement on Technical Barriers to Trade Trade-Related Aspects of Intellectual Property Rights

UNFCCC United Nations Framework Convention on Climate Change UNCCD United Nations Convention to Combat Desertification UNCLOS United Nations Convention on the Law of the Sea UNDP United Nations Development Programme UNEP United Nations Environment Programme UPOV International Union for the Protection of New Varieties of Plants WTO World Trade Organization


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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 developing countries to prepare for the entry into force of the Cartagena Protocol on Biosafety, approved by the 16th GEF Council in November 2000. 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 sub-regional 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 the 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 sub-regional collaboration, including harmonization of the implementation of national regulations

f) Raising public awareness and improving information flow to the public on the issues involved regarding the release of LMOs, to promote informed debate and to ensure transparency with respect to the regulation of LMOs;

g) Providing all those concerned with an opportunity to be involved in the design and implementation of the NBF.

2. The project is coordinated by the UNEP-GEF Biosafety Development 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.

3. Parallel with the work with individual countries, the Biosafety Team has already held regional workshops in Africa (Kenya, 16-19 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). Such workshops - addressed to National Project Coordinators (NPC) – are aimed at improving the understanding of participating countries of key issues for the development of NBFs.

4. To assist progress at the sub-regional level, a series of 12 training workshops have been planned from November 2002, to help build capacity in: the decision-making process (risk assessment and risk management); public participation; administrative systems; and regulatory systems. The first 6 workshops were carried out in the following sub-regions: Francophone Africa; Anglophone Africa; Asia; Small Island Developing States (SIDS); Latin America; and Central and Eastern Europe, including Central Asia. The rationale behind the sub-regional workshops lay in the country-driven preference for more regional meetings; the need to promote networking within a region and sub-


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regions; a desire to help to meet special development needs; the need to increase opportunities for participation; the need to optimize human resources; and the desire to achieve large scale economies.

5. The first subset of 6 sub-regional Workshops, addressed Risk Assessment and Management, and Public Awareness and Participation. They were carried out in Anglophone Africa (Namibia, 12-15 November 2002), Latin America (Mexico, 10-13 December 2002), Asia (Malaysia, 21-24 January 2003), Small Island Developing States (SIDS, Fiji, 18-21 February 2003), Francophone Africa (Senegal, 22-25 April 2003) and Central and Eastern Europe, Caucasus and Central Asia (CEECCA, Lithuania, 27-30 May 2003).

6. It was decided that the second series of workshops be held between October 2003 - May 2004, and would address key issues on Regulatory Frameworks and Administrative Systems.

7. The first workshop of the second series for Asian countries was held in Shiraz, the Republic of Iran, (19-22 October 2003). The second one, aimed at Latin American countries, was held at Marriott Hotel, Santiago de Chile, 24-28 November 2003. The workshop was coordinated by UNEP Biosafety Development Project team, in collaboration with the Government of Chile.

8. A list of participants is attached as Annex 1, and the programme of work as Annex 2.

Formal Opening of the Meeting

9. The Sub-regional Workshop for Latin American Countries on the Development of a Regulatory Framework and Administrative Systems was opened on Tuesday 25th, November 2003, by Mr. Christopher Briggs, Global Programme Manager, UNEP-GEF Biosafety Unit.

10. Mr. Briggs initiated the meeting, speaking on behalf of the United Nations and its Environmental and Biosafety Programme. He said that it was an honour to be in this event, with the countries of the region, after a long process of discussion and further approval of the Cartagena Protocol on Biosafety. He stated that UNEP and its Biosafety area had constantly promoted the idea that countries should endorse and implement the Protocol, and that the Project on the Development of National Biosafety Frameworks was a key element in supporting that Protocol. He expressed gratitude to the Government of Chile, acting as host, and to all participants for their interest and willingness.

11. The opening ceremony continued with the address of the representative of the Government of Chile, Mr. Álvaro Díaz, Subsecretary of Economy, Ministry of Economy. On the Chilean government’s behalf, he welcomed all participants and expressed gratitude to the organizers. Then the Subsecretary described the situation of Chile concerning biotechnology and Biosafety, where there is an Advisory Commission of the President of the Republic, integrated by several entities of the public sector.

12. He continued his exposition stating that biotechnology has several uses and benefits trade and development of the countries of the region. As an example, he mentioned the use of biotechnology in the production of copper in Chile. With this reference he demonstrated the importance of developing a national biotechnology policy and a National Biosafety Framework.

13. He defined 4 characteristics and weaknesses of Latin American systems on Biosafety and biotechnology:


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Latin American and Caribbean countries have incomplete regulatory frameworks;

Multiple standards and regulations have provoked regulatory chaos, with incoherent frameworks;

There is no global regulatory convergence on this matter (e.g., he mentioned the difference between the United States and the European Union);

Lack of coordination of public institutions related with regulation and inspection. He stated that public institutions do not always have the same approach, creating major conflicts on how to address Biosafety and who is expected to deal with it.

14. From these items, identified as common and controversial for the region, he stated that there was a need to advance towards coherent, transparent frameworks, and with proactive policies in the different international fora, to influence the course that these frameworks should take. That is why this seminar is so important, and it also shows the complexity associated with the construction of these regulatory frameworks.

15. Afterwards, he noted the process and approach chosen by Chile for the construction of its framework. Given the existence of two options, the first to take advantage of existing standards, the second, to create a unified normative framework, Chile had chosen a Biosafety framework law, in which a component of Biosafety principles would be set up and further articulated, which would affect different functional bodies, thereby strengthening the dimension of control. He argued that a framework law would allow society, through the parliament, to hold an open and transparent discussion on what should be done. Parallel to this framework law, efforts would be made in two further areas: the elaboration of participative regulations on Biosafety and the implementation of an Interministerial Commission on Biosafety, which would ensure the necessary coordination between relevant public bodies and civil society organizations and interested corporations.

16. To conclude, he highlighted the importance of an initiative such as this, as it provides a chance to learn from existing experiences within the region how to face similar problems. This process of regional dialogue and exchange permits progress in the affirmation of a strengthened and consistent Latin American “voice” in international Biosafety fora that will be listened to.

Introduction to the Workshop

17. Mr. Giovanni Ferraiolo, Regional Coordinator, Latin America and the Caribbean, UNEP -GEF Biosafety Programme, introduced the agenda of the meeting and the goals of the workshop:

To discover the options of developing a regulatory regime and administrative systems in connection with the NBF. The aim is to inform participants with regard to lessons and practises so that they can contribute to the development of their NBF in their respective countries.

To address the different options and obligations countries will face in establishing their NBF. The main items that will be discussed in the workshop include the design of regulatory and administrative systems, the exchange of experiences between different countries and discussions on the different alternatives.


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Ground rules, presentation of participants and “Expectations and Concerns”

18. Mr. Briggs mentioned the following ground rules:

Respect and consideration among participants

Respect and consideration of the time scheduled in the programme. Interventions in plenary would be a maximum of 2 minutes per person.

Priority on the floor would be given to governmental representatives and UNEP -GEF project participants, and then to observers;

In working groups, only governmental representatives and official participants will be permitted to intervene directly.

19. Comments made referred to this last item and it was agreed that each working group should specify if it would adhere to this rule or allow the participation of observers.

20. Each group indicated their nationality, name and post.

21. Mr. Ferraiolo requested delegates to express their expectations and concerns in order to include them in the development of the workshop.

22. The list of expectations and concerns, and their further evaluation during the final day of the workshop is attached as Annex 3.

Introduction to the UNEP-GEF Biosafety Project

23. Mr. Briggs synthesised the scope and achievements of the UNEP-GEF project in its different phases and countries of implementation. Firstly, he noted that the Biosafety Protocol fitted within the work of the onvention on Biological Diversity. In this light, the GEF had defined a strategy and programme of support to countries concerning these issues through the following objectives:

a) To collaborate in the development of NBFs;

b) To promote cooperation;

c) To promote the exchange of information on Biosafety among regions and sub-regions.

24. He continued his exposition pointing out that UNEP was implementing these goals through two projects:

A project on Development of NBFs, approved for 100 countries, with receipt of more than 123 applications for inclusion to date. Additional GEF funds are expected for these 23 countries.

Demonstration Projects on Implementation of NBFs. In progress in 8 countries with the support of UNEP: Bulgaria, Cameroon, China, Cuba, Kenya, Namibia, Poland and Uganda; in 2 countries with the support of UNDP: Mexico and Malaysia; and in 2 countries with the support of the World Bank: Colombia and India.

25. Mr. Briggs reported on information on these projects in the workshops and activities carried out in different regions.


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26. The project on Development of NBF includes 4 stages:

Phase 0: Initiating the Project

Phase1: Collecting information

Phase 2: Consultation and analysis

Phase 3: Drafting the Framework

27. The situation of the countries of the region, according to Mr. Briggs’ exposition, is that the majority of them are finalising Phase 2 and initiating Phase 3 corresponding to the elaboration of a draft national regulatory framework. It is estimated that by the end of 2004 the majority of countries will have completed this framework. In this sense, continued Mr. Briggs, the workshop is attempting to address in detail the elements referring to the necessary regulatory and administrative systems to be considered in such a draft.

28. In conclusion, he noted that after the Conference of the Parties (COP) to the Convention on Biological Diversity (CBD), held in February 2004, decisions will be taken concerning financing extensions and further training activities.

Revision of key components of National Biosafety Frameworks

29. Mr. Ferraiolo noted that from the start of the project, and as a product of the experiences discuss in training, it was decided to rethink the pillars of the NBFs, in order to offer a more structured and clear format to support the compliance of national project goals as follows:

The original model of NBF key components was:

Regulatory regime

Administrative system

Risk assessment and management

Public awareness and participation

After modification, the following has been proposed:

A Biosafety policy

A regulatory regime

A system for handling applications (includes administrative rules)

Monitoring activities (observance and verification of effective compliance of the regulatory regime and the environmental impact of the release of Living Modified Organisms)

Public awareness and participation system

30. In the plenary, the questions and comments made were answered by the workshop and project coordinators (Mr. Briggs and Mr. Ferraiolo), and by Ms. Xueman Wang, Programme Officer, Legal and Policy Affairs, CBD Secretariat.

31. Regarding the normative components of the project and its implications on NBFs, the questions related to the project’s connection with other projects and institutions. On this subject, Mr. Briggs explained how the coordination activities were carried out and the possible areas of cooperation.


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32. There were significant questions about the changes that rethinking the pillars of the project would imply in the national processes already initiated. The response offered by the panellists was that the rethinking of the pillars answered a desire to facilitate discussion and implementation of the NBFs at national level, but it was up to each country to choose how to address this matter.

33. A fourth item addressed referred to the next Meeting of the Parties (MOP) to the Cartagena Protocol on Biosafety, and to the situation of those countries that endorse the Protocol, once the deadline has passed but before the MOP. In this respect, Ms. Wang, noted that it was an item already discussed and therefore it was proposed to consider them informally as Parties, but they will not be entitled to participate in decision-making.

34. Other questions referred to the translation of documents and laws into Spanish and the costs involved in monitoring activities that NBFs must include.

35. The Brazilian delegation formally announced the deposit of the Cartagena Protocol by that country the day before the meeting. The plenary celebrated the announcement made by Brazil.

Overview of the current situation of the region

36. Mr. Ferraiolo presented the scenario of the situation of the countries of Latin America and the Caribbean region regarding Biosafety and the implementation of the Cartagena Protocol on Biosafety. To date (23 November 2003), 14 countries plus Brazil are Parties to the Protocol (Bolivia, Colombia, Cuba, Ecuador, El Salvador, Mexico, Nicaragua, Panama, Venezuela, Antigua & Barbuda, Barbados, Saint Kitts and Nevis, Saint Vincent and the Grenadines, Trinidad and Tobago), 11 are signatories (Argentina, Chile, Costa Rica, Honduras, Paraguay, Peru, Uruguay, Bahamas, Grenada, Haiti, Jamaica), and 7 do not belong to any of these categories (Dominican Republic, Guatemala, Belize, Dominica, Guyana, Saint Lucia, Suriname). The regional scenario mentioned above is based on the information sent by the national coordinators of 14 countries to the regional project coordinator (reports are available at the project’s Web site: http://www.unep.ch/biosafety).

37. Hence, the following situation of the region was developed:

There are countries producing and exporting biotechnology that have laws and frameworks;

There are countries potentially exporting and producing biotechnology, that are developing laws and frameworks;

Other countries are producers and importers with limited regulations, but without clear laws;

A fourth group of countries are importers with limited regulations

Finally, there are importing countries without regulations or standards.

38. The main institutions relating to Biosafety in the region are the Ministries of Agriculture, Health, Environment or Interministerial Committees.

39. The weaknesses identified in the surveys sent by the countries are:

Lack of coordination / institutional cohesion (need to resolve competence conflicts);

Lack of technical, institutional and scientific knowledge, etc. (need for capacity building);


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Insufficient risk assessment procedures;

Existing regulations that are not focussed on the use of all the different uses of genetically modified organisms (GMO) (trials, release, market, food safety, importation, exportation, etc.);

Lack of control procedures;

Limited determination of responsibilities (both in regulatory and administrative systems);

Limited public awareness and participation;

Labelling;

Lack of regulatory and administrative frameworks.

40. Finally, countries noted the following as relevant agreements on Biosafety:

International agreements: Basel Convention (Hazardous Wastes), Cartagena Protocol on Biosafety, CBD, CITES (Endangered Species), Codex Alimentarius, IPPC, UPOV, Vienna Convention, WHO, WIPO, WTO (GATT, SFS, TBT, IPR, etc.)

Regional agreements: Andean Community, Free Trade Area (FTAA), Marco regulatorio tipo, MERCOSUR, RIOPPAH, Pan American Health Organization, Union Aduanera Centroamericana, Regional Plant Health Committee (COSAVE), Caribbean Single Market and Economy (CSME).

National presentations

41. Some countries were invited to present their situation, addressing the following questions:

What is the existing regulatory and administrative system for decision-making on LMO in their country?

Why did they select this regulatory and administrative model in particular?

How did they develop these administrative and regulatory systems?

42. The regulatory and administrative system of Argentina was summarized. The regulatory framework is divided into 3 stages:

Risk assessment for agro-ecosystems

Assessment of food material for human and animal use

Statement on the question of marketing (the only country that has this)

43. The regulatory and administrative system of Cuba was summarised. It originated from the economic context of the country, controlled by a regulatory Framework that identifies a central authority (National Council of Biosafety), and 2 subsystems: one for inspection and one for approvals. It was emphasized that the concept of Biosafety used was wide and includes the introduction of exotic species and pests as well as GMO.

44. The regulatory and administrative system of Jamaica was summarised. In 1990 biotechnology was considered a key element in the country’s development strategy. Since then a process of discussion and analysis has been carried out among the different parties involved. The promotion of


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biotechnology and Biosafety was among the definitions made. However, processes do not yet permit compliance with the obligations of the Protocol.

45. Some of the challenges faced by Jamaica are:

increasing the participation of key parties

increasing knowledge on Biosafety issues

strengthening institutions

building capacity

developing a regional view of Biosafety.

46. The regulatory and administrative system of Guatemala was summarised. The country does not have a policy, vision or general framework of Biosafety. There is no formal normative system, except for a specific standard for the agricultural sector, referring to seeds for the purpose of experimentation in confined conditions.

47. To undertake trials and tests, certain steps have been defined:

identification of project managers

details of the development of research

description of packages and containers, transport, quantity of the product to be used

dates and biological material

Biosafety procedures and actions

goals concerning GMO control, description of the recipient organism, donor, and potential impact on the environment.

48. It is considered that the company that develops the biotechnology is financially responsible for potential damages.

49. After each presentation, clarifying questions were allowed from the floor. There were only questions for Argentina (on marketing and labelling) and Guatemala, on the participatory process.

50. After the four presentations a plenary was held where questions and comments were received for all exponents of the previous block.

51. The questions and comments answered by the representatives of Argentina, Cuba, Jamaica and Guatemala were on:

52. Implementation and scope of the precautionary principle in the respective legislations. Countries represented on the panel stated that they applied the precautionary principle to their legislation.

53. In relation to confidential information, they commented that they try to keep confidentiality as low as possible, with due respect to the processes of the respective industries.

54. Each country present on the panel also clarified the procedures contemplated to include public participation.


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55. On the incorporation of socio-economic considerations in the evaluation and regulation processes, it was argued that there is not a specific procedure, but that it was one aspect that could be considered by a country under the Protocol.

56. An item where a detailed discussion was maintained was the simultaneity of processes and coordination mechanisms among the different parties involved in the realisation of the different stages of risk evaluation.

57. Some specific items dealt with in the plenary were: genetically modified aquatic organisms, the centres of origin and diversity of species, the costs of risk assessment and national capacity to assume them, and labelling procedures, where exporting countries noted that they had not yet developed labelling mechanisms in their respective legislations.

58. The plenary rejected the idea of adopting foreign legislation, agreeing that each country should define their law in compliance with their particular biological, economic, social and political situations. As an example, Mexico shared the situation it had gone through with a moratorium and subsequent release for transgenic maize surveys. In relation with existing capacities in the region to assume risk assessment costs, the existing experiences in Central America and the Andean Area on trials and scientific evidence shared were noted.

Introduction to national obligations and rights under the Cartagena Protocol on Biosafety

59. Ms. Xueman Wang presented a synthesis of the objectives and scope of the Cartagena Protocol on Biosafety and the implications for Parties in terms of obligations and rights.

60. As introduction, she stated that the CBD, in implementation since 1992, has 3 objectives: sustainable use, the conservation of biological diversity, and the fair and equitable sharing of the benefits arising out of genetic resources. Within the obligations stipulated in the Convention, Article 8 (g) considers the national control of potential risks from Living Modified Organisms. From this precept a complex process of international negotiation was developed that ended with the approval of the Cartagena Protocol on Biosafety, which recognises the benefits derived from biotechnological development and the need to contain risks.

61. From this historic context, Ms. Wang explained the structure, architecture, and details of the implementation of the Protocol, all of which imply obligations and rights for the Parties. It is important to understand that the Protocol establishes a minimum ceiling. Parties can raise the requirements, on the condition that they are consistent with the Protocol and other international agreements to which they are Parties.

62. She explained the architecture of the Protocol, which includes, among others, procedural requirements (AIA procedures and Article 11 procedures), risk assessment and management, documentation requirements and information sharing. She further indicated the rights and obligations embedded in the Protocol and the importance of translating them into national implementation.

63. Finally she also presented the main issues to be addressed at the first meeting of the Parties to the Protocol, which include capacity building, compliance, liability and redress, documentation requirements, and the modality of the BCH.

64. After Ms. Wang completed her explanations there were questions from the floor:


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65. Several people asked for clarification on the implications for NBF of certain articles of the Protocol, such as Art. 17, 11, and the 270 days considered in the Advance Informed Agreement (AIA) procedure, among others.

66. It was asked about the particular case of pharmaceuticals. On this item, Ms. Wang stated that the Protocol does not cover pharmaceutical products intended for human use that are already provided for in other relevant agreements or international organizations such as the World Health Organization (WHO).

67. Finally, regarding the languages for communications and especially for information subject to the Biosafety Clearing-House, she stated that for the moment the original language is acceptable, but the continuation of this situation will be discussed at the next MOP.

Introduction to other international instruments that can affect the regulatory system of NBFs

68. In this presentation, Mr Christian López Silva, Research Assistant, Sheffield Institute of Biotechnological Law and Ethics, described and introduced some of the International Agreements that are related to or affect compliance of the Cartagena Protocol on Biosafety. There are several relevant instruments in different areas (trade, environment, among others) that show the complexity and wide range of Biosafety issues as well as the wider context in which Biosafety operates.

69. Some of the most relevant are the following:

Agenda 21

Rio Declaration

Convention on Biological Diversity

UNEP Technical Guidelines

Cartagena Protocol on Biosafety

Agreement setting up the WTO

WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SFS)

Codex Alimentarius

International Plant Protection Convention

World Organisation for Animal Health (OIE)

Agreement on Technical Barriers to Trade (TBT)

Intellectual Property Rights Treaties

70. The questions of the plenary with regard to the presentation of Mr. López Silva were on:

71. The compatibility of labelling requirements of the Cartagena Protocol on Biosafety with those set up in the WTO Agreement on Technical Barriers to Trade. On this matter, Ms. Xueman Wang, the representative of the CBD Secretariat, answered that the Protocol does not technically regulate labelling, and so possible relations between them have not yet been identified.

72. A second question was focussed on certain aspects of intellectual property in relation to the UPOV Agreement and the International Treaty on Plant Genetic Resources for Food and Agriculture (sometimes known as FAO Agreement). There were specific points raised about the relation


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between farmers’ rights stipulated in the latest Agreement and farmers’ privileges set up in the UPOV Agreement, both in relation to the use of seeds. On this matter it was noted that UPOV establishes minimum requirements to grant a specific intellectual property right, that of plant breeder, and that one of the exceptions corresponds to the use of seeds by farmers, which in the literature is known as farmers’ rights. Afterwards, it was clarified that FAO Agreement talks about recognition of farmers’ rights and their right to participate in the benefits, but it does not go any further, establishing only very general rules. Finally, it was added that both rights are different but are conceptually connected.

Introduction to the regulatory regime

73. Mr. Giovanni Ferraiolo discussed the relation of the regulatory regime with national projects. He stated that among the components of these projects, stage 3 considers the design of a draft structural framework –of which the regulatory regime was a key component. The majority of the countries were finalising stage 2, so they should start to address matters such as: How to start thinking about the legal draft?, Who will write it? etc.

74. Mr. Ferraiolo, asked some countries that had already started stage 3 to comment on what they had done:

75. The representative of Bahamas noted that to develop the process, interested parties met to propose several scenarios for further consideration and analysis.

76. The representative of Guatemala indicated that the participation of all the sectors of civil society had been a key component of the process, so they facilitated relevant information on Biosafety, creating working groups throughout the country. She stated that afterwards they would hold a national workshop on existing regulatory frameworks in other countries, in order to commission the working group to prepare the draft. Finally, the organization of a training workshop and the discussion of NBF key components were considered.

77. In the case of El Salvador, it was noted that surveys and diagnosis were carried out, through which the existing rules were identified by which specific processes could be derived for LMOs.

78. In Argentina they have worked, based on the information obtained from stages 1 and 2 of the project, with which they started working on the final document (based on the 4 initial pillars), where they identified major deficiencies or weaknesses of the current framework. The idea is to make known the draft and to discuss it with non-governmental, organizations (NGO), legislators and authorities. Finally, it will be disseminated through a general seminar.

Introduction to regulatory regime options

79. The comments of Mr. Orlando Rey, Director, Environmental Division, Ministry of Sciences, Technology and Environment, Cuba, consisted of the description of legislative options on Biosafety assumed by the countries of the region and their implications for appropriate implementation of the Cartagena Protocol on Biosafety. He stated that the performance of the region had been in general terms reactive to international demands on the subject, which has generated considerable inequality in terms of treatment of Biosafety:


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80. The speaker defined 3 stages in the configuration of national legal frameworks:

a. pre-biotechnology-Biosafety system. Use of legal frameworks already available (mainly agricultural and environmental). This permitted learning.

b. development of more specific legislation. Orientation on agricultural issues, which is still reactive.

c. development of National Biosafety Frameworks.

81. In conclusion, he stated that the development of a specific policy on Biosafety, was the most desirable path to follow, given that:

a. A specific national legislation allows adaptation to new and complex issues.

b. Facilitates better organization of the institutional framework.

c. Permits meeting successfully the requirements of the Protocol at national level.

82. After the comments of Mr. Rey, the discussions and interventions of the Plenary focussed on the relations of political decisions on Biosafety and their becoming a legal set of rules. In this respect, Mr. Rey stated that each country is responsible for defining the principles that sustain their NBF. He also indicated that the issue of institutionality has basically been resolved in the region, with the creation of commissions on Biosafety, given the intersectoriality of this issue.

83. One of the items addressed was the relation of these frameworks, the ecological, social and political reality of the countries of the region, and the agricultural and financial realities of the countries.

84. The Plenary requested that countries with experience on this matter share their experiences in terms of coordination and cooperation for the design and implementation of the rules. Brazil shared its experience after 8 years of laws on Biosafety.

85. The political question was discussed in terms of interference in the decision of scope and the rationale of the rules and the translation into a simple language of scientific scope that facilitates decision-making on Biosafety. On this item Mr. Rey argued that law is a political expression and so it is supposed that it is preceded by political debate. Therefore, law has an advantage to generate public debate and broad participation that validates it and strengthens it to face other implicit and explicit policies that conflict with Biosafety.

86. Some observers made proposals related to consideration within the NBF of the definition of transgenic-free areas, on the understanding that the simple fact of having a regulatory framework does not guarantee protection, but that it simply facilitates the entry of GMO, without having the technical capacity of controlling them. In addition, they raised the necessity of excluding those who have commercial or other interests in them from the decision-making on transgenics (in the commissions referred to).

Introduction to the elements of the regulatory regime and general provisions

87. Mr. Julian Kinderlerer, Professor, Sheffield Institute of Biotechnology Law and Ethics, United Kingdom, presented the structure and processes to prepare a national regulatory regime on Biosafety. As a first step, he noted the need to identify existing laws, and how they are related to the objectives of the Protocol. Afterwards, he defined the types of provisions set up in the Cartagena Protocol on Biosafety that have to be incorporated in NBFs.


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88. General provisions, according to Mr. Kinderlerer, constitute the basis of the regulatory regime, e.g. objective, scope, definitions, institutional provisions and general obligations. He discussed the scope and rationale of each of these provisions, as each country has to identify them and develop them according to their priorities, either in a similar way to the Protocol’s provisions, or, more demanding, but always in line with the objectives of the Protocol.

89. In his review of the objective of the Protocol, he analysed the implications for countries and the possible legal solutions that have been created (providing as an example of opposing cases of United States and the European Union).

90. Work was done on answering the questions of what, why, who and how, arising from the development of the general provisions of the Protocol in national regulatory frameworks and the legal challenges countries have to face.

91. After the presentation of Mr. Kinderlerer, the questions and comments of the Plenary referred to the following issues:

92. The discussion and compatibility between biotechnology and Biosafety and the objectives of promoting both. In relation to this issue, the plenary agreed that they are two different situations and scopes, that have to be treated legally in a separate way, but all countries have the right to regulate Biosafety and biotechnology.

93. As for the applicability of foreign experiences in the region, answers and comments raised in the debate reflected the fact that it is important to consider that nowadays decisions and actions can vary in the future and that is why it is important to know experiences and discuss them, but each country has to find its own system according to its needs.

94. On key conditions to be included in the definition of regulation, it was noted that legislations and their contents are national options that have to answer to the respective commitments and the institutionality of each country.

95. A fourth issue addressed in the plenary was the need for national regulation on Biosafety to be consistent with other international agreements assumed by each country.

96. During the discussion, the importance was emphasised of distinguishing existing regulatory mechanisms under existing “Common Law” and Civil Law systems, both in the countries of the region.

97. Regarding the way of addressing and defining the scope of the standard and public participation, the plenary agreed that participation should be as wide as possible, including those that develop or apply biotechnology and Biosafety, as it is necessary to coordinate efforts and concepts on this matter.

98. Finally, when considering the different approaches and risk of overprotection, Mr. Kinderlerer argued that each country has to find a system that works according to its agricultural reality (importing/exporting country, etc.).


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Introduction to operational provisions of the regulatory regime

99. Mr. Rey introduced the discussion in which national legislation options on operational provisions were addressed. He pointed out that the list presented was not perfect, but it followed the tenor of the Protocol: release in the environment, confined use, etc. He reminded delegates that the Protocol requires that national regulatory frameworks be consistent with it in spirit.

100. To clarify this item, he referred to the treatment of operational aspects of the Protocol and examples were provided.

101. The implications of some operational provisions are detailed below:

Confined use: This is excluded in the Advance Informed Agreement, but it can be subject to risk assessment before deciding on importation. The remaining provisions are equally applied.

Intentional introduction into the environment: This requires significant national normative development. It requires rigorous application of Risk Assessment, monitoring, control and liability regimes.

Placing on the market: An additional element of economic character. It requires commercial authorities to assess potential impacts on the national economy of the introduction of LMOs and the respective regulation of Biosafety.

Exportation: Regulated in Art. 8. of the Protocol. The national legislation has to guarantee the accuracy of the information provided on procedures and exported products.

Importation: The procedure of the Protocol can be adopted; the one that allows the development of a Regulatory Framework consistent with the Protocol.

Sustainable use of biological diversity: Allows adopting a more protective range than the one set out in the Protocol.

Bilateral or multilateral arrangements: The Protocol allows coordination under bilateral or regional agreements on the subject as long as it is consistent with its objectives.

Transit: Excluded in the Advance Informed Agreement, but it can be regulated by national legislations, and all the activities involved in the transit (handling, transport, packaging, identification).

Living modified organisms intended for direct use as food or feed, or for processing: Regulated by Art. 11, by a specific procedure. The requirements stated in the Protocol can be applied at national level as a minimum ceiling or, national regulations can be defined (with Risk assessment) consistent with the Protocol.

102. Questions and comments addressed in the plenary referred to the following items:

103. Some delegates asked for clarification of the concept of transit and transboundary movement. Mr. Rey clarified that there is no definition of transit in the Protocol, and therefore this item should be specified in national legislation.

104. A second item addressed by the plenary referred to compatibility with documents defined in CODEX. To this respect, it was noted that this is not binding, unlike the Protocol; therefore there would be no incompatibility.


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105. A concern expressed by delegates was the existence of trade pressures to speed up the approval of the release of LMO by third parties in the country. On this item, Mr. Rey considered that decisions on the first movement of LMO could imply more complexity, but it would be useful to seek simplifications afterwards that are consistent with Biosafety and trade decisions.

106. Finally, the discussion of the plenary focussed on the implications for countries of what it is stipulated under Art. 25 on the withdrawal of illegally introduced material and the liabilities of the Parties.

107. Ms. Wang indicated that it is important to note that interpretation of the Protocol lies with the meeting of the Parties to the Protocol. At the same time, the compliance committee that may be established at MOP1 may help resolve the problems of different interpretations of the Protocol.

Introduction to other elements of the regulatory regime

108. Ms. Marie Claire Cordonier Segger, Director, Centre for Sustainable Development Law, Mc Gill University Faculty of Law, Canada, presented a discussion on the implications of including some optional provisions in national regulatory frameworks.

109. The optional provisions addressed were the following:

A. Normally Included:

Enforcement.

Accountability

Transparency

Information & Public Participation

Monitoring and control / Auditing

Confidentiality

Emergency Measures

B. Other Elements (often covered by other aspects of a country’s regulatory system):

Knowledge Management

Appeal System

Transition Period

Offences and Penalties

Liability & Redress

New Information

Revision of Decision

Labelling and Traceability

Entry into Force

Ethical Issues


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110. Each disposition answered to the following questions:

What?

Why?

Who?

How?

When?

111. Annex 4 contains a chart with the description of each of these provisional clauses under the aforementioned outline.

112. After a brief survey of each element, the presentation of Ms. Cordonier Segger continued with the introduction of a hypothetical case, one that did not yet have a Biosafety policy in place. The case in question was the fictitious country ‘Cascadia’, which had to define the optional provisions it would include into its national regulatory framework, taking into account the following characteristics: the country has a fragile and endemic ecosystem, is clearly an importer, but they do not know whether they have imported LMOs. While the public does not have much knowledge of Biosafety, some NGOs are initiating information campaigns. Law is in process of drafting, but they do not know how to achieve compliance, so they promote voluntary compliance, which is controlled by a central authority. She explained a few ‘working examples’ of potential regulatory provisions for the Biosafety law of a country under these conditions, reviewing draft text for such provisions.

113. Finally, a short exercise was carried out in order to give countries an opportunity to speak further with each other about potential regulatory provisions. Delegates were requested to form 4 working groups and advise ‘Cascadia’ on the incorporation of the following optional provisions: Transparency and Public Participation, Enforcement, Emergency Measures and Confidentiality. Each group was asked to identify important characteristics which might have helped shape a country’s Biosafety policy goals (social, economic and environmental conditions, strength of existing Biosafety laws and institutions, level of public awareness of Biosafety), and then to further brainstorm answers to three questions. Why would ‘Cascadia’’s Biosafety laws contain such a provision? What are the elements of this provision? How could it be implemented? The working groups wrote up the ideas that were raised in their discussions, and posted these for all to review.

114. Outputs of the working groups are available in Annex 5.

115. Questions and comments raised during the plenary that followed referred to: consistency between the transparency of objectives mentioned and how the WTO SFS Agreement is understood, and other clarifications.

116. A second area of the discussion, dealt with the concept of damage and the identification of consequent redress. In this respect, Ms. Wang reminded delegates that one of the relevant items of the CBD was the definition of damage. Traditionally there are 3 components: first, damage to persons, second, loss of property, third, damage to the environment. The first two are easy to measure, unlike the third, but the CBD representative pointed out the Parties’ liability.

117. Finally, the option of dealing with items on liability and redress was discussed. Ms. Cordonier Segger noted that, as with other ‘optional’ elements, one option is to include this element specifically, with reference to Biosafety, as an alternative to the application of general legislations on damage and redress set up in the respective national legal systems.


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Introduction to the administrative system

118. Mr. Ferraiolo introduced the session on the administrative system and the need to differentiate it clearly from the discussion maintained in the previous session on regulatory frameworks. The aim is to focus on who does things and how things are done. Laws grant competencies to institutions that, at the same time, have to resolve how to execute the tasks contemplated. It is important that such tasks are very clear, because the main conflict identified at the moment of implementing NBF is the coordination of the administrative tasks and competencies of the institutions involved in them.

Introduction to general administrative tasks

119. Mr. Briggs initiated the discussion asking participants to review some relevant documents such as Article 19 of the Protocol, the IUCN guide on the Protocol and a letter of notification from the CBD Secretariat. In his comments he addressed two items: competent national authority and focal point.

120. Through a series of questions and dialogues with the plenary, the identification and definition of Competent National Authorities and the National Focal Point required for administrative tasks of the Cartagena Protocol on Biosafety were discussed.

121. The implications of the existence of one Competent National Authority, or more, the coordination and the assignment of functions and tasks, and relations with the National Focal Point, in terms of effective application of Protocol’s provisions.

122. Mr. Briggs noted that the objective of this dialogue was that delegates understood that all these disquisitions have administrative implications that countries have to know and understand with regard to decision-making and the costs of such procedures.

Introduction to relevant administrative tasks under Advance Informed Agreement procedures

123. Mr. Ferraiolo discussed the practical application of the administrative procedures defined by the Protocol for the Advance Informed Agreement in the case of the imaginary country of Cascadia. The difficulties and decisions that have to be taken throughout the process and the need to clarify administrative procedures that have to be considered in the elaboration of NBFs were discussed in the plenary.

124. From a quick survey, it was identified that the majority of countries present had not yet faced the application of the procedures discussed, except Chile and Uruguay, which have developed similar procedures but not under the framework of the Protocol.

125. The discussion also addressed a translation error in the Spanish version of the Protocol, arising at the beginning of deadlines contemplated in the Advance Informed Agreement, and how to solve it (Art. 10.3). Ms. Wang explained the legal procedure and process to correct the errors in the Spanish version.


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126. From this item delegates discussed the languages in which it is possible to send information to the Biosafety Clearing-House (BCH) and the need for the next MOP to resolve this item.

Introduction to relevant administrative tasks under the procedures of Art. 11

127. In his comments Mr. Kinderlerer reviewed in detailed Article 11 of the Protocol, in relation to the administrative tasks it implies. Addressing the plenary, he posed some administrative questions that each country should answer during the development of national regulatory frameworks and proposed alternatives on how to address those elements.

128. He highlighted as the most complex items to resolve administratively, the definition of the information to be sent to the BCH under Article 11, the moment and the procedure to send the information required in Annex II (such as the report on risk assessment), and the responsibilities of the importer and/or the exporter.

129. Summarizing the above presentation, the following items can be emphasised:

As an exporting country, the responsibility lies with the country;

As importer the responsibilities vary;

The companies in the country have a responsibility and each party has to ensure that what they say is true (veracity of the information they deliver).

Parties have to be attentive to the procedures they establish to achieve those responsibilities.

130. Questions referred to the contents, extension and opportunity of the risk assessment report, requested under this article.

Panorama of when and how to apply the Advance Informed Agreement (Art. 7-10) or FFP procedures (Art. 11)

131. Ms. Wang initiated the discussion sharing the progress and reasons for differentiating both procedures, inter alia:

Scope: the Advance Informed Agreement operates for LMOs intended for intentional introduction into the environment, while Art. 11 refers to LMOs intended for direct use as food or feed, or processing (FFP) and includes a simplified procedure.

Opportunity: the Advance Informed Agreement operates before the first release into the environment and before the first transboundary movement.

Counterparts: the Advance Informed Agreement is of bilateral nature, while Art. 11 is of multilateral nature (involves information distribution among all interested countries).

Decision-making: the Advance Informed Agreement possesses a decision-making process set out in great detail in the Protocol, while decisions under Art. 11 fall within the decisions defined in national legislation.

Treatment of developing countries: the Advance Informed Agreement does not have a different treatment in the case of developing countries, but Art. 11 includes several paragraphs where countries can seek help for their actions.


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National Implementation: for the Advance Informed Agreement national law has to reflect its steps and basic structure, whereas Art. 11 relies on national legislation.

132. Delegates were put in working groups at random, where they discussed the following questions as applied to the case of the imaginary country ‘Cascadia’.

List the main administrative tasks required for implementation:

The procedure for the importation of products (Article 11).

The Advance Informed Agreement procedure (AIA).

The approval procedure of LMOs produced in the country, in relation to Article 11.

When and how will you notify your decision to other countries?

133. A representative of each of the groups explained the discussions and answers agreed in his group for the questions on the case of Cascadia.

134. Annex 6 contains a synthesis of the group work.

135. After the respective comments the plenary was opened to the intervention of delegates. Mr. Ferraiolo clarified the basis of the Advance Informed Agreement, and Art. 11.

136. The discussion and questions on his session focussed on clarifying the obligations and scopes set out both in the Advance Informed Agreement and Article 11 on the procedures and the information required by the Parties to be delivered to the BCH.

137. Ms. Wang clarified that in the Protocol each Party is free to define the procedure to be followed to approve the entrance and transit of LMOs intended for direct use as food or feed, or processing. This process can be equal to or stricter than the procedure defined in the Advance Informed Agreement, but must be consistent with the objectives established in the Protocol.

138. Another question raised by the Plenary was the political pressure exercised through Free Trade Agreements between Parties and Non-Parties to agree a mechanism for Article 11 of minimum requirements, before the MOP decides on this matter.

139. A third item of the discussion was the rationale and scope of what is set out in Article 18 on identification, that underlines the need to add a sentence such as “may contain”. On this issue, Ms. Wang noted that under article 18, each Party is obliged to ensure that LMOs intended for food (that are not processed) are accompanied by documentation that identifies them, the question is to establish the criteria that will be used to define that a shipment “may contain” LMOs. There is disagreement, and it is expected to be resolved in the next meeting of the MOP, next February.

140. A fourth item subject to discussion was the Protocol’s purpose and the possibility that if it is recognized that a LMO does not imply a hazard to the environment, it can be excluded from the procedures contemplated in the Protocol. In this respect, Ms. Wang clarified that it was a complex item, because who decides that it has no adverse effects on the environment? The meeting of the Parties to the Conference may decide that certain LMOs are safe or not for the environment. In this sense some participants suggested that an interpretation that leaves outside the Protocol certain LMOs whose impacts have been considered safe by all Parties is still not applicable.

141. In this item of the discussion, Mr. Ferraiolo reminded delegates that the Protocol was an international obligation, but it did not constitute the NBF, which can be stricter. It is not necessary


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to set the articles of the Protocol as national obligations, as each country has to develop its own legislation, taking into account the Protocol, but not just limited to it.

142. Finally, questions were raised on the procedures after a decision of refusal on the transit of a LMO by a country. Ms. Wang noted that in this case, the decision has to be communicated to the BCH.

Case study on administrative tasks

143. Mr. Christian López Silva made a presentation on some administrative difficulties in the regulation development on Biosafety in Mexico (describing the context, the two (regulation) technical standards covered, the special law on Biosafety and comments on the ratification of the Protocol), under the item of the implementation of administrative tasks.

144. First he explained the discussions concerning the development of a technical standard on commercial release of LMOs. He explained the process of interpretation for the assignment of institutional responsibilities on Biosafety between different Mexican authorities (specially the difficulties in assigning competence to the Ministry of the Environment). He commented in detail how a new interpretation that recognized the competence of the Ministry of the Environment through international treaties was finally recognized. He also commented that because of the Ministry of Health it was not included in the common system of permits; consequently uncertainty was generated among farmers on the final approval of cultivated crops.

145. On the release permit, he analysed thoroughly the discussions on several items, for example, the deadlines to grant permits (trade concern). Furthermore, in legal terms what justified that a certain authority made further controls of the release was not who had undertaken the risk assessment, but who had signed the permit. In the same way, regarding information sharing, they tried to achieve efficiency among the parties involved (authorities, ministries, companies, subcommittees).

146. Continuing his comments, Mr. López Silva, stated that, given the Mexican legislation, the planned establishment of LMO prohibited areas through a normative instrument of very low hierarchy was unconstitutional. He explained that they finally used the concept to refer to the possibility of limiting the presence of LMOs in National Protected Areas, which were regulated in normative instruments of higher hierarchy.

147. On the protection of the centres of origin (CO), Mr. López Silva commented that it was a very controversial item. He explained that the Convention on Biological Diversity and the Protocol define the concept in an incomplete way, with the FAO International Treaty on Plant Genetic Resources for Food and Agriculture the one that describes it better. He explained that 3 problems were raised:

A conceptual problem related to the extent of the concept; in geographic terms, it was not possible to talk about small specific areas;

A practical problem of insufficient national biological information;

A conceptual and practical problem related to the fact that it is a historical concept: it represented a particular moment and did not consider new distributions of species.

148. Therefore, a dynamic concept was required, with the concept of centres of genetic diversity (CGD) becoming relevant, which would mean that it would not be necessary to first have biological information but to undertake assessments case by case. He commented on the discussion on


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whether it was necessary to protect the occurrence of both concepts or if the occurrence of a single concept was sufficient to justify protection. He stated that it was decided to justify protection before the occurrences of both concepts only. He also commented on the final discussion on the term “genetic reserve” contained in the definition of CGD, as an example of an excessively specific drafting and as an example of the lack of trust between the parties involved.

149. He also explained the discussion on transit and transport. He commented that it was agreed that this matter be studied case by case, given the economic costs of general rules that implied the modification of pre-established and operating commercial routes.

150. As for the second technical standard covered in the discussion, referring to the experimental release of LMOs, Mr. López Silva commented the revision process of the standard. He described the resistance of the agricultural sector to establish a common system of permits that includes, as the technical standard for commercial release, the participation of the Ministry of the Environment. He explained the arguments of practical and legal nature that were used to justify the resistance and those used to validate it. Finally it was commented that this conflict had not yet been resolved.

151. On the other hand, he commented on a particular aspect discussed regarding a law initiative that is currently in National Assembly and that was prepared by the Academy of Sciences. This aspect referred to the nature and functions that the Commission on Biosafety should have, which was reflected in specific normative designs with different consequences. And to conclude, he provided a description of the process of ratification of the Protocol, where the complexity and multiplicity of the parties involved was highlighted (Senate, Ministries), as well as the lack of coordination between them and the lack of a common policy on Biosafety. For example, he described how the Ministry of Commerce, believing in the existence of problems on the compliance of commercial commitments (such as NAFTA), caused delays in the endorsement process.

152. The questions of the Plenary focussed on obtaining more details and clarifications concerning the Mexican experience.

153. A first item addressed was the size and scopes of the scales for field trials. To this effect, Mr. Agustín López Herrera, Coordinator of the Project on Capacity Building for Biosafety in Mexico, was invited to answer the question in more detail. He noted that areas depend on the type of crop. There are 3 levels in the scale: experimental, pilot (bigger) and commercial. However, he stated that illegal situations were caused because they were using a standard intended only for experimentation for releases on a greater scale.

154. A second area of the discussion centred on complex items of law, on the matter of standard hierarchy and the implications of the Mexican solution (criteria of the Supreme Court of Justice that established the primacy of international standards over national ones). First, it was desired to know whether the primacy decision operated only in the case of conflict between standards or as a general standard. The answer provided was that the criteria operated as a general standard, which implied a hypothesis of conflict, but it was underlined that, obviously, there were preliminary requirements of form and content in place to include international treaties into the Mexican legal system. Afterwards, delegates wished to know how the hierarchy of the decisions taken by different authorities or based on different normative instruments operated. It was explained that the hierarchy of a specific act of an authority was determined by the hierarchy of the standard in which it was based.

155. A third group of questions was orientated to a better understanding of the implications of the common use of the concepts of centre of origin and centre of biological diversity. It was explained


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that such a regulation was not yet approved, and therefore it had not yet been applied, consequently we do not yet completely know the practical implications of such a distinction.

Sub-Regional Cooperation

156. Mr. Briggs said that the objective of addressing this item was to receive suggestions to coordinate and channel useful cooperation initiatives and experiences on Biosafety, given the numerous demands that the Biosafety Programme had received on this matter. Some suggestions aimed at issues such as standard harmonization, transparency, etc. Mr. Briggs also stated that the coordination of efforts contributed to the reduction of costs and the improvement of the implementation of the Protocol. He suggested working in a participative way in the plenary applying the brainstorm method, to identify possibilities and topics to be addressed in those initiatives.

157. Some of the ideas and initiatives raised by the plenary were:

To develop a communication network through Internet. To meet every so often to exchange experiences. The network should have a legal base at governmental level, to justify gatherings and maintain the network.

Mexico offered to share training courses for farmers and experts. It stated that they were about to finish the risk analysis methodology for agriculture, and its willingness to share software to whom it may request it.

To create a regional BCH, to have a site for posting information; to harmonize and carry out research.

Cuba noted its experience on this matter, and repeated its offer of courses on Biosafety for experts, and the development of a master’s degree that would be extended to foreign participants from next year. Moreover, in Chile they had backed the University of Chile (Faculty of Law) on a study.

The existence of a network of experts on Biosafety initiated as a result of the NBF event, and created after a seminar organized by INCA, was noted.

In order to plan initiatives in the future it was suggested that the secretaries of national commissions on Biosafety established links, and through them the exchange process could be channelled and UNEP could generate a bulletin.

Furthermore, it was noted that the national network on Biosafety for Latin America and the Caribbean existed and that every year courses on traceability were organised, with the assistance of Latin American countries. Interest was expressed in this course, organized every year in Venezuela in collaboration with the University of the United Nations.

As for specific items that should be addressed in these initiatives the following were noted: courses should avoid talking about the promotion of biotechnology and should focus on Biosafety; the rationale and use of the precautionary principle should be discussed, as well as the level of confidentiality that countries have in their legislations that are relevant to the Protocol on Biosafety, how to provide redress in case of damage, risk assessment and management, and access to and dissemination of information.

An appeal was launched to harmonise national capacity building initiatives existing in the region, to avoid overlapping and the loss of resources.

158. On the possibility of participating in projects of support in the implementation of NBFs, Mr. Briggs noted that UNEP has this sort of projects, but at this moment they were waiting for GEF to open up


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the possibility ofmore projects aiming at supporting the implementation of national regulatory frameworks, a question that would be resolved after the next COP/MOP. He further clarified that the UNEP project did not have enough resources to finance travel to every training and coordination gathering.

159. Mr. Ferraiolo noted that they were working to create in the (UNEP) Projects Website a site per participating country to upload the information each one of them sends, obviously, with the authorization of the country. In relation to the diploma offered by the Universidad de Concepción on Biosafety, he stated that they were negotiating to identify possible mechanisms of cooperation.

160. Mr. Briggs explained the scopes of the BCH training project. It will begin by February 2004 and a “template” or operative format will be developed, so that each country uploads information in its national website, and moves the information to the BCH (with a communication to the Secretariat of the CBD), with the support of the Secretariat of the CBD. Efforts will be made so that the information uploaded by a country is uploaded on line or by post. There will be a support module in the BCH to spread training and information on how to work. In May-June training of monitors will be initiated. These will learn to use the databases, link them with national databases and then they will have to provide training in their country on the BCH. This training will be supported by UNEP and GEF. So far, only Parties to the Protocol are eligible for the project.

Closure Session and Evaluation of the Workshop

161. At the beginning of this closure session delegates were requested to evaluate the workshop through the achievement of the expectations included in the list prepared on the first day. Annex 3 contains the expectations and concerns and their evaluation.

162. Afterwards, the organisers distributed an evaluation form to participants. The form can be found in Annex 7 and the outputs are contained in Annex 8.

163. Finally, words of gratitude were addressed to the Plenary by the following persons:

Ms. Xueman Wang, Programme Officer, Legal and Policy Affairs, CBD Secretariat. On behalf of the Secretariat she expressed gratitude for the support provided by countries to the Protocol; she stated that this workshop had taught her a lot on the challenges the countries of the region are facing in implementing it. She also expressed gratitude for the participation of countries and wished delegates a safe journey.

Several countries (Guatemala, Jamaica, Chile, Brazil), thanked GEF and UNEP for organizing the workshop, given the importance of the biotechnological issue in the region. Observers also expressed gratitude for the invitation to participate and the continuing efforts of dialogue and cooperation on these matters.

164. Mr. Christopher Briggs, Global Programme Manager, UNEP-GEF Biosafety Unit, expressed gratitude to the Government of Chile, to all participants for their work during the workshop, to the interpreters for their clear translation, and to the hotel’s logistic support for the services provided those days, specially the support personnel and the project team. He declared the meeting and the workshop closed.

Proyecto UNEP/GEF sobre el Desarrollo de Marcos Nacionales de Bioseguridad Taller Subregional de América Latina sobre el Desarrollo de un Marco Regulatorio y Sistemas Administrativos

Annex 2. Work plan

UNEP-GEF Biosafety Sub-Regional Workshop for Latin America

on the development of Regulatory Regime and Administrative Systems

in National Biosafety Frameworks

Santiago (Chile), 25-28 de November de 2003

TUESDAY 25 NOVEMBER (DAY 1)

INTRODUCTION

9:00 – 9:30 Official opening of workshop

- Welcome speech by UN Resident Coordinator

- Opening speech by Chile Government Representative

9:30 – 10:00 Introduction to the workshop

- Objective of the workshop

- Introduction to the Work plan

- Ground Rules

10:00 – 10:40 Introduction of participants (nationality, name, title, working place)

COFFEE BREAK (10:40 – 11:00)

SETTING THE SCENE

11:00 – 11:20 Plenary exercise: Expectation & Concerns

11:20 – 11:40 Introductions to the UNEP-GEF Global Biosafety Project 11:40 – 12:00 Overview of key components of National Biosafety Framework (Biosafety Policy,

Regulatory regime, System to handle requests, Follow up activities, Public Awareness and Participation)

12:00 – 12:45 Plenary discussion

12:45 – 14:15 LUNCH

OVERVIEW OF THE PRESENT STATUS OF THE SUB-REGION


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14:15 – 14:30 Overview of NBF rationale and synthesis of regional experiences

14:30 – 15:15 Country presentations


COFFEE BREAK (16:15 – 16:30)

INTERNATIONAL OBLIGATIONS

16:30 – 17:00 Introduction to national obligations and rights under the Cartagena Protocol


17:30 – 17:50 Introduction to other international instruments that may affect NBF regulatory systems


END OF DAY 1

WEDNESDAY 26 NOVEMBER (DAY 2)

REGULATORY REGIME

9:00 – 9:15 Introduction to “Regulatory Regime”

- How to pass from Phase 1 and 2 to Phase 3 of the Project

- What elements to consider in drafting the NBF

- How to draft

- Where to start

- Who will draft, etc.

9:15 – 9:45 Introduction to Choices on the Regulatory Regime.

- Introduction to different approaches for a regulatory regime

- Explanation of different approaches for a legally binding system (including use of existing or new regulatory system)

- Factors that may influence the choice and examples of legal approaches

9:45 – 10:45 Plenary guided discussion:

- Identify rationale for choosing one of the approaches

- What factors influenced the choice?

- How did you make and justify the choice?


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COFFEE BREAK (10:45 – 11:00)

11:00 – 11:40 Introduction to elements of a Regulatory Regime and General provisions

- Introduction to main elements of a regulatory regime: General provisions, Operational provisions, and other elements

- Introduction to General provisions: objective, scope, definition of terms, institutional arrangements, general obligations

11:40 – 12:40 Plenary guided discussion

LUNCH (12:40 – 14:00)

14:00 – 14:30 Introduction to Operational Provision of a Regulatory Regime (e.g. contained use, release, placing on the market, import/export/transit, institutional procedures).

- Working example on one Operational Provision

14:30 – 15:30 Plenary exercise on an other Operational Provision

COFFEE BREAK (15:30 – 15:50)

15:50 – 16:30 Introduction to Other elements of a Regulatory Regime

- Elements that are usually included (e.g. Enforcement, Transparency, Accountability, Information & Public participation, Monitoring, Confidentiality, Emergency measures),

- Elements that could be included as a country’s choice (e.g. Knowledge management, Offences and penalties, Appeal system, Transition period, Liability & Redress, New information, Revision of decision, Labelling and traceability, Entry into Force, Ethical issues).

16:30 – 17:30 Plenary exercise on Other elements of a Regulatory Regime

END OF DAY 2

THURSDAY 27 NOVEMBER (DAY 3)

ADMINISTRATIVE SYSTEMS

9:00 – 9:30 Introduction to Administrative Systems

9:30 – 10:00 Introduction to General Administrative Tasks

10:00 – 10:30 Introduction to administrative tasks relevant under the AIA procedures


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COFFEE BREAK (10:30 – 10:45)

10:45 – 11:15 Introduction to administrative tasks relevant under Art. 11 procedures

11:15 – 11:45 Overview of main differences between procedures required by AIA (Art 7-10) and FFP (Art. 11)

11:45 – 12:45 Focus Groups

END OF DAY 3, LUNCH AND FREE AFTERNOON

FRIDAY 28 NOVEMBER (DAY 4)

ADMINISTRATIVE SYSTEMS (CONTINUED)

9:00 – 9:45 Report from Focus Groups


COFFEE BREAK (10:45 – 11:15)

11:15 – 11:45 Case study presentation on Administrative tasks


LUNCH (12:45 – 14:00)

14:00 – 16:00 Plenary discussion: list of topics for sub-regional cooperation, how to meet the needs, next steps

16:00 – 16:20 Response to “Expectations & Concerns”

16:20 – 16:40 Workshop evaluation by participants on standard forms

16:40 – 17:00 Closure of the workshop

SATURDAY 29 NOVEMBER (DAY 5)

9:00 – 16:00 Technical meeting reserved to National Project Coordinators (NPCs)


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Annex 3. List of Expectations and Concerns and their Evaluation in the Plenary (☺ )

Expectations

Exchange of information

• To know experience and levels of progress in NBF of other countries ☺

• To know experience in other countries concerning the distinction between biotechnology and Biosafety

• How to conciliate interests in the risk assessment

• To share different experiences in risk assessment

• To develop links of technical cooperation between countries ☺

• To develop strategies for the incorporation of NBFs into the BCH ☺

• To know the experience of other countries that are in different phases in the development of NBF projects ☺

• To share experiences considering that some standards of the CP are minimum, these being a wide margin for the implementation of different options ☺

Harmonization and Unification

• How to harmonize NBFs between countries

• To unify legal and administrative criteria

• How to unify processes at sub-regional level

General Context

• To know the relation with other international agreements, mainly commercial

• To discuss incidence with free trade treaties


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Coordination of institutions, public participation and dialogue

• To reconcile the interests of different parties involved. To know the strategies to coordinate and balance different national institutions ☺

• To identify mechanisms for public participation, with a view to a major integration of interests

• How to generate the required information to establish a debate using simple language

Isolated matters

• To identify in the CP items conflictive for implementation ☺

• To discuss strategies for the item on the relation between Parties and Non-Parties (traceability, labelling, etc.)

• To evaluate the incorporation of the army and security forces for the implementation of NBFs

• To discuss the item on Liability and Redress ☺

Concerns

• How to counteract economic power exercised on all areas of life

• Lack of national capacities for the ratification and implementation of the Protocol ☺

• To distinguish between biotechnology and Biosafety to define a public policy ☺

• Effective implementation requires independent technical advice. However, there is a lack of resources for research and advice on Biosafety, considering other national priorities ☺

• To include products of biotechnologies other than the definition of LMOs

• The great amount of confidential information concerning GMOs


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Annex 4. Description of optional provisions

Optional provision What? Why? Who? When?

USUAL OPTIONAL PROVISIONS

Enforcement Strong and consistent application of national Biosafety framework. Includes enforcing compliance with LMO approval procedures and punishing wrongdoers

Strong enforcement will encourage present and future compliance with the national framework.

• responsible enforcement authoritiespublic

• industry

Ongoing

Accountability Specific people have responsibility of care for complying with the Biosafety framework, and for ensuring compliance.

Encourages public and industry trust in the system.

• Individual government officials responsible for specific parts of Biosafety framework;

• proponents responsible for content of their applications;

• members of public responsible for content of their submissions

For cases of non-compliance or evasion

Transparency Clarity and predictability of decision-making procedures in national Biosafety framework for foreign and national industry, and for the public

Encourage trust in and use of Biosafety framework

• Competent national authority that performs administrative functions of Biosafety system.

Throughout the process of creating a Biosafety framework and throughout the application process for approval of an LMO


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Information and Public Participation

To provide information on Biosafety framework and its applications to public and industry. To encourage and facilitate public participation in formation of framework and its implementation

To encourage industry and public trust in system; to create a Biosafety framework that addresses public concerns.

• Government authority manages public participation; concerned members of public (civil society organisations, citizens) participate.

Preferably throughout entire process (should be preceded by and build on Transparency).

Monitoring and Control

Monitoring, to ensure that measures comply with their regulatory objectives, with the successful implementation of the framework and the Protocol’s obligations

To ensure goals of framework are being met, impacts are what was expected and no review of decision is necessary; sustainable use and conservation of biodiversity under Protocol; risk management being followed.

• Both industry and government can track impacts; government should monitor its obligations and implementation of Biosafety framework.

Ongoing for implementation of framework; post-approval for LMOs.

Confidential Information

Protection of sensitive business information submitted by proponent. Must be balanced with public participation

Information may be proprietary, may contain critical information about the product that would be helpful to competitors. Maintaining confidentiality will build trust of industry in system.

• Government departments which handle the information, and industry actors which supply it.

Ongoing, from time confidential is received.

Emergency Measures

Procedures established to address emergency situations where LMO has serious negative consequences.

Approval of LMOs is not a zero-risk proposition. Also have possibility of unintentional introductions and introductions where approval procedures have not been followed

• Authorities responsible for deciding when measures activated and for carrying out the measures; industry and/or public to report emergency situations.

To be used in pre-defined emergency situations only.

(ADICIONAL) OPTIONAL PROVISIONS


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Knowledge Management

Systematization and sharing of knowledge gained from implementation of Biosafety framework (e.g. from technical information in applications).

To aid in understanding possible effects of LMOs, and managing future applications from proponents.

• Application assessment and other authorities

Ongoing

Appeal System System to allow proponents and/or opponents to appeal denial or approval of LMO importation.

To ensure accurate application of law and/or technical information

• May be conducted by administrative and/or judicial body; proponent may file for appeal or be called before one; public may also be allowed to file or participate in appeals.

For use after authority that reviews applications has issued its decision (different for systems with judicial review of decision process

Transition Period Period to allow industry and government to adapt to new Biosafety framework and relevant rules.

Difficult for industry to change overnight in order to comply with new Biosafety framework. Also allows government to organize itself / gain capacity to implement new system

• National authorities • Customs officers • Industry actors

Period of defined duration between promulgation of new Biosafety framework and implementation/entry into force.

Offences and Penalties

Defining what constitutes offences under Biosafety framework, e.g. intentional release without approval, and what penalties for these offences are, i.e. criminal or civil.

Helps in enforcement, accountability and monitoring

• Government authorities involved in enforcement,

• proponents introducing LMOs to country, members of public may also be involved in introductions

Upon discovery and proof of a violation, should be covered in standard legal system


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Liability & Redress Civil or criminal liability of officials, industry or individuals for damages from LMOs through transboundary movements and / or illegal introductions (including misleading applications). (This concept is different from liability between states, which will be addressed in future by COP/MOP).

Encourages compliance with Biosafety system, builds trust in system, helps pay for measures that may need to be taken to repair the impacts of illegal activity

• National authorities • Justice systems

Upon proof of violation and quantification of damages

New Information New information on impacts of LMOs may lead to a need for review of decisions / re-assessment of risk.

Improves quality of regulation of LMOs.

• Proponent, national authority, individuals who may discover new information and bring it to attention of government authorities.

Ongoing, after creation of Biosafety system.

Revision of Decisions

Countries may want to review decisions on approval/denial of LMO in light of new information or change in circumstances.

Improves quality of regulation of LMOs

• National authority may independently initiate review of decision;

• proponent or individuals may request review.

May arise after decision on LMO has already been made.

Labelling and Traceability

Optional requirement that proponent or producer label some or all LMOs as such, or retain information on, or mark LMO in a way that allows its traceability in food systems.

To encourage public trust, protect public choices, reflect public demands, address health and safety concerns.

• Industry and government cooperate to establish system for labelling and traceability of LMOs, as it involves separating conventional organisms from modified organisms.

System will be continuous after its creation for as long as deemed necessary.


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Entry into Force Setting date and provisions for national Biosafety framework to enter into force, where Biosafety Protocol will enter into force in national law.

Helps industry and affected officials as well as public understand when new LMO obligations will come into effect.

Affects: • industry • government – both

competent authorities and • other concerned

departments / officials.

Specific dates or time periods when national system and international law will come into effect.

Ethical Issues Some national Biosafety systems include consideration of socio-economic factors / ethical issues in reviewing LMOs.

Particular public concerns re: ethical aspects of biotechnology development / LMO introduction. Possible impacts include effects on traditional agricultural systems, consumer choice, aboriginal values, religion.

• Industry may need to prepare ethical information as part of application;

• government may need to have competency to review these concerns; public may want to make submissions

Part of LMO approval process for some / all LMOs


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Annex 5. Synthesis of the first Working Group

Question Group 1 (yellow): Emergency Measures

Group 2 (green): Confidentiality

Group 3 (red): Transparency and Public Participation

Group 4 (the Caribbean) Enforcement

Why should this provision be included?

• Because risk must be managed

• To reduce or avoid damage

• Comply with participation

• Increase confidence in the system

• Access to more information for risk assessment

• Protect intellectual property (non-registered)

• Clarity and transparency in the system

• Provide legal security to the applicant

• Ensures credibility in the system (public training)

• To ensure that the objective of the legislation are met. To maintain trust, integrity in the legal system

• To protect the fragile ecosystem

• To balance the twin economic objectives of importing and exporting GMOs to safeguard Cascadia’s market

• To gain public trust and confidence in the legislative system of Biosafety policies and programmes


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Question Group 1 (yellow): Emergency Measures

Group 2 (green): Confidentiality

Group 3 (red): Transparency and Public Participation

Group 4 (the Caribbean) Enforcement

Who will use this measure?

• Applicant • Evaluator

• Those involved (affected): Regulators, Applicants (national or foreign), and universities.

• Those in charge: regulators, Government, advisors

• Competent authority. If there is more than one activity (responsibility) they must be differentiated

• Multisectorial and multidisciplinary coordinating committee

• Affected: • -importers+ exporters • -trading partners • -consumers • -general public • -regulators (competent

authorities) • producers, farmers, etc • tourism sector • indigenous communities • who will play a role: • governmental authorities• non government

organization (NGO) • other interested parties • indigenous population • international trading

partners How would it be incorporated in the law?

• contingency (implementation) plan

• risk assessment

• -training • -web page • -statements • -media • -training levels

• -criminal penalties e.g.: fines, imprisonment,

• civil remedies • incentives • codes of conduct • disincentives – e.g.

clerical of benefits • industry standards.


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Annex 6. Synthesis of the second Working Group on administrative measures

List main administrative tasks required to be implemented:

Procedure for the importation of LMO products (Article 11). Advance Informed Agreement procedure (AIA). Procedure for the approval of LMOs produced nationally, in relation to article 11.

When and how will you notify your decision to other countries?

Procedure Group 1 (yellow) Group 2 (green) Group 3 (red) Group 4 (the Caribbean)

Importation of products (article 11).

• notify (BCH – exporter / importer). Compulsory aspects: The decision, Art. 11 (5).

• BCH: Accepts; rejects due to lack of information and more information is required; refuses

• decision: country with regulation (it proceeds according to 1) without regulation (declare to BCH)

• Focal point • Competent

authority through the Biosafety Clearing-House (BCH)

• place in the BCH: legal requirements (importer), details of the products (applicant ) Annexes II and III (previous actions)

• present standard application to importing country: details (importer and exporter)

• (Transparency guide and clear rules)

• analysis of the application according to the National Framework (importer)

• notification of the decision to the BCH and exporting country (importer). Include elements used in the analysis

• (monitoring and revision)

• The competent authority or others declare through the BCH the decision that prior to the first import of LMO the following must take place: a risk assessment in accordance with Annex III.

• Set up or use a committee to review / verify the risk assessment and make recommendations to the authority

• Set up mechanism for conducting risk assessment

• Develop schedule for decisions / activities

• Implement capacity building activities.


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Procedure Group 1 (yellow) Group 2 (green) Group 3 (red) Group 4 (the Caribbean)

Advance Informed Agreement (AIA)

• How: BCH, written notification

• When: once the decision has been taken

• Notify the BCH

(15 days) • Notify the

placement in the market

• Notify the decision

• The exporter notifies, the importer acknowledges receipt.

• BCH to focal point. • Committee /

Commission on Biosafety to focal point.

• Competent authority (health, agriculture, environment) documents decision (yes / no / yes but with conditions)

• deadline of 270 days

• application by the exporting country (manual of procedures and form)

• spokesperson with BCH (importer)

• authority (importer)

• put in place institutional arrangements

• authority to receive or acknowledge

• notification within 90 days.

• inform public of receipt of application

• implement the risk assessment process

• make decision (include public participation)

• (post) public notification of decision

• send information to BCH (within 270 days)

Approval of LMOs produced nationally

• Strictly observe Annexes II and III of the Protocol and national regulations.

• Item 2, consider risk assessment and local conditions. Environmental Impacts

• Substantial equivalence (defined analysis)

• Transgenic nature

• Detailed risk assessment conducted

• Notify trading partners trough the BCH


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Annex 7. Workshop Evaluation Form

Instructions:

1. Please take a few minutes to help us to evaluate our workshop by answering the following questions. .

2. In each case, indicate your answer by circling the number which best describes your assessment of the workshop

Part A: Regulatory and Administrative issues

On a rating of 1 to 6, assess how useful the workshop has been in:

(i). Improving your understanding of national rights and obligations under the Cartagena Protocol and other international agreements that may impact on your NBF?

1 2 3 4 5 6 Not Useful Useful Very Useful

(ii). Improving your understanding of the specific needs of your country in terms of national priorities and policies in setting up the regulatory regime and administrative systems for your NBF?


(iii). Improving your understanding of what are the main elements of a regulatory regime for an NBF?


(iv). Improving your understanding of the different approaches that can be taken in developing a regulatory regime for your NBF;


(v) Improving your understanding of what general provisions need to be included in the regulatory regime of an NBF?


(vi) Improving your understanding of what operational provisions need to be included in the regulatory regime of an NBF?


(vii) Improving your understanding of what other elements or consideration need to be included in the regulatory regime of an NBF?



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(viii). Improving your understanding of the linkages between a regulatory regime and administrative systems in an NBF;


(ix). Improving your understanding of the legal and administrative requirements for AIA in your NBF?


(x). Improving your understanding of the legal and administrative requirements for Article 11 (FFP) in your NBF?


B: Overall workshop assessment:

Please rate the overall workshop on a scale of 1 to 6 by circling the appropriate number:

(i). Has the workshop improved your understanding of how to develop a regulatory regime for your NBF?


(ii) Has the workshop improved your understanding of how to set up the necessary administrative systems for your NBF?


(iii) Has the workshop improved your understanding of how your country could handle individual applications for the importation and/or release of LMOs?


(iv) Has the workshop helped you to learn more about how other countries in Latin America and Caribbean are developing or implementing their NBF?


(v). How useful was the workshop for you as an individual?


(vi). How well organised was the workshop?



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(vii). How did you find the balance of presentations and discussions?


(viii). How well did the speakers present their materials?


(ix). Overall, how would you rate the workshop?


Your personal comments on the Workshop:

(i). What did you consider to be the most helpful part of the workshop? (ii). What did you find the least helpful about the workshop? (iii). What suggestions do you have for improving future workshops? Please hand your completed form to one of the organisers before leaving the room. Thank you


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Annex 8. Evaluation of the Workshop

The analysis of the evaluation forms filled by the participants revealed a very positive reception of the workshop with an overall level of 82% for the general appreciation for the workshop (Q9B).

Both A and B sections of the evaluation forms were equally well received with a 75% level of appreciation for “Regulatory and Administrative issues” and a 78% for the “Overall workshop assessment”. The average of both sections was a level of 77% of appreciation.

Highest level of appreciation (after the outstanding 88% recognition of the workshop organization in Q6B) was reached in answering to questions on general appreciation (9B: 82%), the usefulness of the workshop (5B: 83%) and the understanding of specific needs of countries in terms of setting up a regulatory regime and administrative systems for their NBF (2A: 80%).

The lowest levels of appreciation, but still within the level of 70% of appreciation, have been reached in answering questions on whether participants have increased their understanding on how to handle individual applications for the importation and/or release of LMOs (QB3: 70%) and of what other elements or consideration need to be included in the regulatory regime of an NBF (QA6: 72%). These areas need attention in later workshops.

The greatest difference of opinion in participants’ appreciation has been reached in answering to questions on the understanding of national rights and obligations under the Cartagena Protocol and other international agreements (QA1: 76 ± 21%) and on how well the speakers presented their materials (QB8: 75 ± 21%).

The analysis of the written comments has, as usual, not been easy, due to the high degree of heterogeneity.

Clear appreciation was expressed for the opportunity to exchange ideas and experiences among different countries of the region as well as for improving the understanding of how to develop a national Biosafety framework. Positive comments were also expressed with reference to:

a) NBF presentations from countries, b) the explanation of the Cartagena Protocol (with special reference to the session on AIA and Art. 11), c) the general understanding of elements of a regulatory regime as well as d) administrative issues (with special appreciation for the Mexican case study).

Among the elements less appreciated by participants it is possible to identify a clear dissatisfaction in the use of an imaginary case study, and a strong request for real case studies. One more element of dissatisfaction has been indicated in the topic of how international agreements, other than the Cartagena Protocol, may have an impact on the development of NBFs. It is probably worthwhile to mention that a high number of participants chose not to express any negative comments in the appropriate space and conveyed to us their full satisfaction for the workshop.

All the other elements mentioned in the written comments of the evaluation form are quite controversial:


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• The presence and participation of observers in plenary discussion has definitely produced strong and opposite reactions (more space to observers! vs. less observer in these meetings!).

• The use of Working Groups has been highly praised as well as criticized, though everybody agreed that time for discussion in groups has been too limited.

Among the recommendation received, many participants agreed on having a higher number of regional experts (compared to international) and presentation of case studies from both developed and developing countries.

Isolated comments offered us other useful hints for the improvement of future workshops:

• More focus on working groups • More respect for basic rules such as the respect of participant opinions or for the length of

interventions • Better preparation of the participants to the workshop by using background documentation • Use of Spanish speakers ONLY • Translation of more international documents in Spanish • More time for plenary

We wish to take this opportunity to thank once again all the participants for their precious comments and for the very supportive and constructive comments that we received during the workshop and in the final evaluation.


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Results of the evaluation of the workshop (sections A and B of the form)

77%

75%

76%

80%

78%

76%

75%

72%

70%

74%

74%

74%

78%

77%

76%

70%

79%

83%

88%

74%

75%

82%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

TOTAL SECTION A+B

Total Section A

(i). Improving your understanding of national rights and obligations under the Cartagena Protocol and otherinternational agreements that may impact on your NBF?

(ii). Improving your understanding of the specific needs of your country in terms of national priorities and policies insetting up the regulatory regime and administrative systems for your NBF?

(iii). Improving your understanding of what are the main elements of a regulatory regime for an NBF?

(iv). Improving your understanding of the different approaches that can be taken in developing a regulatory regimefor your NBF;

(v) Improving your understanding of what general provisions need to be included in the regulatory regime of anNBF?

(vi) Improving your understanding of what operational provisions need to be included in the regulatory regime of anNBF?

(vii) Improving your understanding of what other elements or consideration need to be included in the regulatoryregime of an NBF?

(viii). Improving your understanding of the linkages between a regulatory regime and administrative systems in anNBF;

(ix). Improving your understanding of the legal and administrative requirements for AIA in your NBF?

(x). Improving your understanding of the legal and administrative requirements for Article 11 (FFP) in your NBF?

Total Section B

(i) Has the workshop improved your understanding of how to develop a regulatory regime for your NBF?

(ii) Has the workshop improved your understanding of how to set up the necessary administrative systems for yourNBF?

(iii) Has the workshop improved your understanding of how your country could handle individual applications for theimportation and/or release of LMOs?

(iv) Has the workshop helped you to learn more about how other countries in Latin America and Caribbean aredeveloping or implementing their NBF?

(v) How useful was the workshop for you as an individual?

(vi) How well organised was the workshop?

(vii) How did you find the balance of presentations and discussions?

(viii) How well did the speakers present their materials?

(ix). Overall, how would you rate the workshop?

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