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Makara Kampala 2011 Convened by Science Foundation for Livelihoods and Development (SCIFODE) Regional Universities Forum for capacity Building in Agriculture (RUFORUM)   Convened by: Science Foundation for Livelihoods and Development (SCIFODE) Plot 27 Nakasero Road P. O. Box 36587 Kampala, Uganda. Tel: +256 392 833 email: scifode@scientist.com www.scifode-foundation.org Regional Universities Forum for capacity Building in Agriculture (RUFORUM) Plot 151 Garden Hill, Makerere University P.O. Box 7062 Kampala - Uganda Tel: +256 414 535939Fax: +256 414 531645 Email: secretariat@ruforum.org www.ruforum.org Cosponsors: Uganda National Council for Science and Technology (UNCST) Program for Biosafety Systems (PBS) National Agricultural Research Organisation (NARO) AU/NEPAD Agency African Biosafety Network of Expertise (ABNE) African Agricultural Technology Foundation (AATF) Citation: Nampala, P. and Makara, M. A., (Eds.) 2011.Proceedings of the International Conference on Agro- Biotechnology, Biosafety and Seed Systems in Developing Countries, Kampala, Uganda, March 8-11 2010. Science Foundation for Livelihoods and Development, Kampala. Handling Editor: Herbert K. Oloka Graphics and design: Brenda Nantongo ISSN 2227-9466 Copyrights © 2011.Science Foundation for Livelihoods and Development.All rights reserved. No part of this publication may be reproduced or transmitted by any means without prior permission from SCIFODE. Permissions can be obtained from the SCIFODE address above.  i C O N T E N T S Acknowledgements and Disclaimer..................................................................................................................1 Preface........................................................................................................................................................................2 Biotechnology regulation in a developing country context: the role of scientists A. N. Kingiri.....................1 A Social Audit model for Agro-biotechnology Public Private Partnesrships E.C. Obidima, J. Deadman, J. Mabeya, P. A. Singer and A. S. Daar...............................................................................................................7 Capacity Developmet for Agricultural Biotechnology and Biosafety Decision Making: Facilitating Implementation of Confined Field Trials in Uganda. T. Sengooba and J. Komen............................9 Biosafety risk communication and a multidisciplinary approach: The key to adoption of agro-biotechnology applications in Sub-Saharan Africa A. Y. Sefasi and S.B. Mukasa.....................................................................19 Exploiting the use of biotechnology in sweetpotato for improved nutrition and food security: Progress and future outlook. R.O.M. Mwanga, M. Ghislain, J. Kreuze, G. N. Ssemakula, C. Yencho...................................25 Bioconversion potential of common agricultural lignocellulosic wastes. I. Nakalembe and J. Wong................33 Industrial Biotechnology Opportunities and Progress in Uganda. D. Wendiro...............................................39 Sources of resistance to stem rust resistance among selected wheat germplasm. F. M. Nzuve, S. Bhavani, G. Tusiime, D. Singh, P. N. Njau and R. Wanyera. ...............................................................................................45 Does horizontal gene flow occur in transgenic banana/ Fusarium oxysporum (V5W2-9 NH3) associations? D. Kabuye, L. Tripathi, E. Niyibigira, J. Tripathi, and P. Okori. ............................................................................49 Advances in insect pest management technologies of agricultural crops: an integrated approach. C. P. Rugumamu, M. H. S. Muruke, K.M. Hosea and F. A. R. Ismail...................................................................55 Potential role of GMOs in adapting Agriculture to Climate change in Sub-Saharan Africa. B. M. Zawedde..................................................................................................................................................63 Prevalence of Columnaris, ecto-parasite and fungal conditions in selected fish farms. A. Tamale, F. Ejobi, J. Rutaisire, N. Isyagi, J. Nakavuma, L. Nyakarahuka, D. Amulen. ......................................................................71 Assessment of the potential for horizontal gene flow from transgenic bananas to rhizosphere inhabiting microorganisms. D. Kabuye, L. Tripathi, E. Niyibigira, J. Tripathi, P. Okori. ........................................................71 Communiqué..........................................................................................................................................85 Local Organising Committee...........................................................................................................................86 ii A C K N O W L E D G E M E N T S A N D D I S C L A I M E R The Science Foundation for Livelihoods and Development (SCIFODE) and the Regional Universities Forum for Capacity Building in Agriculture (RUFORUM) thank all partners and individuals who provided support to the AGBIOSAFESEED2010 conference and the publication of proceedings thereof. We particularly thank the Uganda National Council for Science and Technology (UNCST); Program for Biosafety Systems (PBS); National Agricultural Research Organisation of Uganda (NARO); AU/NEPAD Agency African Biosafety Network of Expertise (ABNE); African Agricultural Technology Foundation (AATF); International Service for Acquisition of Agri-biotech Applications (ISAAA); and African Biotechnology Stakeholders’ Forum (ABSF). This conference and proceedings would not have been a reality without the dedicated time and resource commitment by conference planning team members who organized the conference. Scifode and RUFORUM cannot recognize you enough, but we are very grateful for your support to this noble cause. The editorial team for the proceedings, Dr Paul Nampala and Mr Arthur Makara, with ground support from Mr Herbert K. Oloka, are acknowledged for the tireless efforts to ensure that these proceedings became a reality. AATF is humbly acknowledged for providing direct financial support for publishing these proceedings. We are also grateful to the authors who responded to our after-the-conference call and submitted papers for these proceedings and responded to the thorough peer reviews and editing recommended during the review process. Your support to this process will help expose research and critical thinking into the use of agricultural biotechnology in shaping the future of development in developing countries. The opinions expressed in articles presented in these proceedings are those of authors and do not represent the collective views of the conveners and cosponsors of the AGBIOSAFESEED2010 conference in any way. iii P R E F A C E The International Conference on Agro-Biotechnology, Biosafety and Seed Systems in Developing Countries was held in Kampala during March 8-11 2010 at the Imperial Royale Hotel and attracted over 150 participants form various countries in Africa, Europe and North America. Over 50 presentations were made on various aspects of biotechnology including governance, biosafety, genetic engineering for crops, seed systems, communication, and industrial applications, among others. Thirteen papers were submitted for publication after conference and these covered nearly all themes of biotech above. The potential role of biotechnology, specifically modern biotechnology in contributing to development has been the subject of debate for more than fifteen years in developing countries. With the exception of newly industrialised countries such as India, Brazil and China, many developing countries have not fully tapped the potential of using modern biotech in agriculture, only South Africa, Burkina Faso, and Egypt have to date commercialised products of modern biotech in agriculture on the African continent. Papers here show the potential, challenges, options, and the need for an integrated approach covering communication, biosafety, and development of relevant biotechnologies if developing countries, particularly in Africa, are optimise biotech tools in national and regional development. For the first time ever, this conference also addressed the closely intertwined areas of biotechnology research and development, biosafety, regulation and seed development and delivery in the context of genetic engineering revolution. After the conference, the resolutions the stakeholders were presented in a communiqué (see page 85) that was widely circulated in different media outlets and direclty among stakeholders through variuos communication channels. The general recommendation from the conference was the call for African governments to take bold steps and fast track decisions geared at establishing feasible regulatory regimes for development of biotechnology while at the same time ensuring biosafety for the benefit of their citizens. 1 Biotechnology regulation in a developing country context: the role of scientists A. N. Kingiri African Centre for Technology Studies (ACTS), P.O. Box Box 45917 – 00100 GPO, Nairobi, Kenya Email: ankingiri@gmail.com Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 1 - 5 Scientists for a long time have been associated with the role of generating the evidence-base and reliable knowledge that ultimately informs public policy with a view to ensure evidence-based and/or research-informed policy decisions. However, recent demands for accountability in management of controversies associated with biotechnology have created a new platform for experts in biotechnology research and regulation. This has challenged the previously undisputed knowledge production role with the public demanding to be part of the biotechnology governance and policy decision-making process. The role of scientists in biotechnology regulation in practice is investigated using Kenya Biosafety Act formulation process and implementation as a case study. Based on interview data solicited from different stakeholders who participated in the process, this paper exposes challenges that exist when scientists get entangled in public policy formulation process due to the underlying value based practices. It appeals for reflexivity in order for the process to accommodate different values and interests towards a biotechnology development for the benefit of the poor. Keywords: Biosafety Act Kenya, reflexivity Received: 1 December 2010, Accepted: 27 November 2011 A B S T R A C T Introduction New advanced biotechnology applications involving genetically engineered (GE) technology particularly in agriculture are poised to revolutionalize the sector through transformation of specific traits to increase productivity, manage pests and weeds as well as enhance nutritional value of products (FAO, 2004; 2010). ). Despite this progress, the focus on ensuring effective technology transfer pathways has generated scepticism regarding the process of technology transfer to contribute to significant social and economic impact, especially considering the fact that process of developing transgenic crops and subsequent adoption has been very slow (FAO, 2010). Some of the factors that have contributed to this slow progress are linked to the political economy of biotechnology governance and particularly biosafety regulation (Paarlberg, 2008). Governance is a contested subject both in theory and practice. It has been applied in public policy-making to reconcile the role of multiple actors in debating, defining and achieving policy goals where the role of the respective governments becomes that of coordinating and steering (Lyall et al., 2009a: 4). Indeed in new biotechnologies, there is a clear call to engage a wide range of stakeholders in regulatory policy-making (Tait et al., 2006). Analysis of governance is thus heavily anchored in the decision-making approaches that broadly define governance based on the rules, institutions, practices and power that shape the behaviour of different actors (Harsh and Smith, 2007:252). Biotechnology regulation has been debated widely and it is now understood that regulation is a key device available to governments interested in shaping governance of technology to promote the public interest. At the global level, this regulation is provided through the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (CBD secretariat, 2000). Regulation of biotechnology allows consumers’ health and environmental protection and at the same time leaves room for harnessing the potential benefits (FAO, 2004). However, regulation implementation is multifaceted involving very many players at different levels (Fukuda-Parr, 2006). This complicates the process of arriving at a consensus since these multiple actors have different views around how this process should be advanced. The scientific communities are caught up in this and their viewpoints have become a subject of debate in public policy making. w w w. s c i f o d e - f o u n d a t i o n . o r g Proceedings of the International Conference on Agro-Biotechnology, Biosafety and Seed Systems in Developing Countries 2 A. N. Kingiri / Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 1 - 5 This paper looks at the renewed role of scientists as experts in the context of the political environment under which they operate and disseminate policy relevant knowledge in biosafety regulation and implementation. The term ‘expert’ is understood from the perspective of expertise that denotes the mechanism by which problems are framed whereby experts are called upon to respond to these problems. In the process, they incorporate scientific judgments and basic social, political and cultural predispositions and commitments (Nowotny et al., 2001: p. 215). The expertise advanced in the process therefore, captures technical knowledge in both scientific and non-scientific domains (Nowotny, 2003). The paper seeks to bring to the limelight the dynamics around biotechnology regulation and how this can be brought to bear on productive practice for biotechnology development. It is informed by experiences of Kenya in developing requisite regulatory structures for management of biotechnology research and development (Kingiri, 2010). Research context and methodology Kenya presents an excellent case to investigate the dynamics associated with modern biotechnology in terms of regulatory policy environment and context. This is because the initiation of biotechnology research activities that commenced in 1990’s paralleled the establishment of the requisite regulatory process providing an exemplary context to investigate the dynamics around knowledge production with both technological and regulatory orientations. This parallel process engaged communities in research, policy and public arenas in an iterative manner bringing about interesting biotechnology and institutional innovations. Secondly, policy initiatives like the strategy for revitalising agriculture (RoK, 2005) and the Vision 2030 embraces an integrated approach to innovation towards economic development. This context created a conducive environment to undertake qualitative in-depth semi-structured interviews with over 50 individual knowledge actors who had (or claimed to have) a stake in decisions pertaining to biotechnology as researchers, policy makers, employees of nongovernmental organisations (NGOs) and members of the public (mainly consumers and farmers). The research period was between 2006 and 2010. This was complemented by observation carried out during different scientific and public workshops in biosafety and biotechnology held during this period, and analysis of relevant secondary documents. Interviewees’ points of engagement in the regulatory activities and decision processes are seen in the context of effort to provide knowledge (e.g. information, expertise and other resources) to influence policy outcomes. Consequently, the data analysis captured the different ways knowledge is used in the regulatory processes and what factors come into play. In some cases, codes are used to report information cited in this paper in order to guarantee anonymity of some of the interviewees as requested. Milestones in Kenya’s biotechnology sector Modern biotechnology has revolutionised many sectors including agriculture and embraces a wide range of applications including tissue culture, markers assisted selection and genetic engineering (GE) also referred elsewhere in this paper as modern biotechnology. All these are being applied in Kenya, but the latter is the focus of this paper. Just like many African countries, GE is relatively new, but GE products have been handled indirectly through trade in form of food aid (Kagundu, 2008). Actual work involving advanced GE commenced in 1991 when Kenyan scientists went to USA and in collaboration with scientists there, engineered a virus resistant sweet potato (Odame et al., 2003). Thereafter in 1998, the transformed plants required regulatory approval for this research to continue in Kenya. However, actual process of regulatory process and implementation had commenced prior to 1998. To date, over six GE research initiatives have been evaluated in public institutions in conjunction with local and international partners (see Kingiri and Ayele, 2009). These activities include Bt maize and Bt cotton engineered for resistance to insect pests, cassava for resistance to viruses and sorghum for resistance to striga weed. The recombinant rinderpest vaccine initiative targeted control of rinderpest disease in cattle and other viruses in small ruminants. Other initiatives are in the pipeline for example the sorghum fortified with nutrients funded by the Bills and Melinda gates foundation through the Africa Harvest Biotechnology Foundation International (see www.africaharvest.org). Since the approval of the first transgenic crop- the sweet potato in 1998, no product has reached the farmers and the furthest the biotechnology activities have gone towards a product is the confined field testing. It is hoped that with the establishment of a functional biosafety framework, the situation will change. Biosafety regulatory mechanism Biosafety encompasses the regulatory mechanisms that the government has put in place for the governance of GE activities. Article (8g) of the Convention on Biological Biodiversity (CBD, 2000) and Article (16) of the Cartagena Protocol provide for establishment of appropriate mechanisms to regulate, manage and control risks associated with Living Modified Organisms (LMOs). The protocol emphasises on risk assessment (RA) and risk management, and provides guidelines to achieve this (Annex III). At the early stages of biotechnology research activities, Kenya opted to use the existing infrastructure, the Science & Technology Act (RoK, 1980) to institute regulatory mechanisms through the drafting and adoption of the Regulations and Guidelines for Biosafety in Biotechnology in Kenya (RoK, 1998). Thereafter, in an effort to legalise the regulations as well as the biotechnology activities, the National Biotechnology Development Policy was drafted and later approved in 2006 (RoK, 2006). This was followed by different versions of the biosafety bill which became Biosafety Law in Feb. 2009 (RoK, 2009). 3A. N. Kingiri / Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 1 - 5 Kenya signed and ratified the Cartagena Protocol in May 2000 and January 2002 respectively. This further obligated the government to put up regulatory structures to operationalise it. This Biosafety Act therefore primarily seeks to operationalise the Protocol. The controversial developments surrounding its formulation over the years are at the centre of this paper where different actors were proactively engaged particularly between 2002 and 2009. Previously, all the involved government actors and other nongovernmental players involved in biotechnology governance were brought together as a Committee (NBC) under the umbrella and coordination of the National Council for Science and Technology (NCST) that acted as a boundary organisation overseeing the management of biotechnology research through regulation. This role has since been taken over by the National Biosafety Authority (NBA) formed under the provision of the Biosafety Act. Theoretical framework To analytically situate the discussion in sound theoretical debates, this paper draws upon insights from science policy literature in particular governance debates on the policy formulation process (see for instance Lyall et al., 2009a; Tait and Lyall, 2005). These scholars try to explain the changing role of science in policy deliberations and the changing integrated knowledge production architecture prompted by new technological developments (Gibbons et al., 1994). In the case of biotechnologies, this brings about governance challenges linked to biosafety regulation imposed to promote technological competitiveness and encourage public acceptance of these new technologies (Lyall, 2007). Dynamics associated with biotechnology regulation: implications for knowledge production In this section, practical reasons why and how scientists got entangled in Kenya’s regulatory process is explored and the kind of reactions this generated. This helps us understand the controversies and challenges associated with biotechnology and how this may hamper a productive regulatory process that may lead to pro-poor biotechnology development. Scientists’ proactive role in regulatory process The section tracks empirically the Kenya’s regulatory trajectory paying attention to the involvement of scientists in this process, and exposes the tensions that this generated. It is important to note that many interviewees desired a regulatory environment that would enhance deployment of products of GE science. Biosafety bill was a gateway towards achieving that goal. Media reports analysed during field work confirm some activism by the scientific and non scientific communities in support or against the biosafety bill. Biosafety formulation process as a pertinent step in legalising the regulatory regime engaged the scientific community intensely. Scientists collectively educated policy makers and journalists, sensitizing them on GE thus making “a case for biotechnology” as well as persuading them to support it (interview with RSIn-GP2, Dec. 2007). This was however viewed with suspicion by some interviewees, who were concerned with what they viewed as biotechnology promotional agenda and associated politics. Several documents obtained during field work and numerous media reportage by both proponents and opponents seemed to confirm this pro-activeness. Scientists as experts Empirical data revealed different roles played by the scientific communities in the policy, academic and NGOs arena under the umbrella of experts and advisors. The scientists’ early involvement in drafting and steering the regulatory process was not disputed because as argued by one of the members, they had the needed technical capacity to understand the purportedly technical and complex science: “The constitution of the first team that wrote the guidelines was predominantly scientists. It was historical in that capacity of other groups such as consumers and other groups was limited in understanding the science behind the development of biotechnology.” (Interview with a technological & biosafety policy advisor, Public University, Nov. 2007) Research scientists from Kenya Agricultural Research Institute (KARI) were instrumental in shaping the Kenyan regulatory process and were widely mentioned by both scientist and non scientist respondents as having pushed for the drafting of the first regulations and guidelines. KARI’s role actually revolutionized the government operations and priorities. Consequently, the NCST actually shifted its focus from general science and technology to the establishment of a regulatory regime in order to support GE research (Sander, 2007). A respondent undertaking biotechnology research explained how this occurred: “If there was no KARI or research institution trying to push, the priorities of NCST would have been different because their work is not exclusively GE. What they [KARI scientists] were doing created need for regulations to be developed. It was a need-based initiative. KARI as a research institute was vital in defining the priorities of NCST with regards to GM research.” (Interview with a research scientist, international intermediary organisation, Nov. 2007) The key policy scientists interviewed in this study claimed that they were relied upon extensively to advise the Ministry of Agriculture and regulatory agencies on both biotechnology and regulatory issues. Consequently, this advisory role impacted upon the regulatory process trajectory. Additionally, in the formulation of the Biosafety Act (2009), the scientific communities were actively involved in various capacities namely; technology experts, regulatory experts and advisors as well as lobbyists (this is clearly demonstrated in Karembu et al., 2010). The nature and role of the ensuing 4 A. N. Kingiri / Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 1 - 5 relationships formed around the formulation of the bill were consequently interpreted in different ways as collaborations, facilitation or activism, lobbying and advocacy, spurred by different factors. Scientists’ role and implications National efforts to establish a legally binding regulatory regime in compliance with Cartagena Protocol engaged stakeholders in various ways. One of the roles of the NBC according to RoK (1998) was to draw policies and procedures to govern biotechnology. In this regard, this gave NBC the legal powers to spearhead the policy-making process. However, NBC coordination role in the biosafety bill formulation process was perceived to be blurred by the activism of other actors, a view shared by both scientists and non scientists. Arguably, the scientists and their allies became the main drivers of the bill formulation process: “The main players were the biotechnology industry, and the scientists make much of the industry. The whole process was supposed to be an initiative of the government but the interest was with people from the biotechnology industry than what we would call the broader section of Kenyan society.” (Interview with JO-NS6, journalist, local daily, Apr. 2008) NBC was also largely made up of scientists representing different organisations with two representatives from the civil society. This being the case, it can be concluded that scientists and their affiliated institutions played vital roles as technical experts. This role is however threatened by perceived motivations and interests likely to bring about conflicts of interest. It was a concern of non-scientists from the civil society that technical information used in risk assessments (RA) and consequent decision making pertaining to GE trials was solicited by scientists from technology developers who are interested parties. The relationships established around the regulatory process in the Kenyan context were mutual in that the participating players expected to benefit. Scientists and the government were for instance receiving financial support from non-state actors and donors. These relationships and partnerships were perceived by many interviewees to have positively enhanced the regulatory process. Further, some interviewees were in agreement that the government has inadequate capacity to support the regulatory process, so these other supporting parties were filling in that gap. From these accounts, resources and in particular financial support was a key incentive cementing these relationships (for a detailed account of the role of scientists and controversies this generates, see Kingiri, 2010). Despite the potential conflict of interests, scientists were perceived to be key players in regulatory process as facilitators, and through their active involvement provided a regulatory mechanism through which the biosafety institutional regime could operate. Conclusion and recommendations From the foregoing, it is clear that the roles played by the scientists directed the regulatory process without any contestation. The paper suggests that scientists are not disinterested actors in the regulatory instruments formulation process, and are inspired by different motivations and interests. This has an impact on the ensuing regulatory practice prompted by the unprecedented biosafety revolution. This leads to a compelling urge to reconsider how policy and regulatory formulation processes are conceptualised and articulated. Biotechnology regulation, if it is to achieve greater effect in reconciling the governance agenda of modern biotechnology on the one hand, and role of actors in providing evidence-based expertise into the process; it must factor into the process the different inspirations. In addition, effective policy and regulatory processes must first acknowledge the potential of experts to influence policy directions. Consequently, strategies should be devised that encourage a reflexive and responsive behaviour (Lyall, et al., 2009b: 261). This may enrich how policies are implemented considering that cultural practices in biotechnology are linked to values and interests (Laurie et al., 2009). In conclusion, the paper appeals to the policy, public and scientific communities to adopt a reflexive approach to biotechnology regulation in order to enhance convergence of knowledge for sustainable pro poor biotechnology development. Acknowledgements This paper is based on research conducted in Kenya over the period 2006-2010 funded by the Open University, UK, the UK Economic and Social Research Council (ESRC), Innogen centre and partly by the DFID-Research into Use program. The author gratefully acknowledges this support. The views expressed in the paper are those of the author and do not necessarily reflect those of the Open University, ESRC Innogen centre and DFID. References Convention on Biological Diversity (CBD) Secretariat. 2000. Cartagena Protocol on Biosafety to the CBD: text and annexes. Montreal, Canada. Food and Agriculture Organisation (FAO). 2004. The state of food & agriculture. Agricultural biotechnology: meeting the needs of the poor? FAO, Rome, Italy. FAO, 2010. 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Odame, H.; Kameri-Mbote, P. and Wafula, D. 2003. Governing modern agricultural biotechnology in Kenya: implications for food security. IDS Working Paper, 199, Institute of Development Studies (IDS), University of Sussex, Brighton, UK. Paarlberg, R. 2008. Starved for science: how biotechnology is being kept out of Africa. Harvard University press, Cambridge, MA. Republic of Kenya (RoK). 1980. The Science and Technology Act. Government printer, Nairobi, Kenya. RoK. 1998. Regulations and Guidelines for Biosafety in Biotechnology for Kenya. NCST: No. 41. RoK. 2005. Strategy for Revitalising Agriculture (SRA): 2004- 2014. (Short version), Feb 2005. RoK. 2006. National Biotechnology Development Policy. Government Printer, Nairobi, Kenya. RoK. 2009. The Biosafety Act, 2009. Kenya Gazette Supplement No. 10 (Acts No. 2), Government Printer, Nairobi, Kenya, 13 February, 2009. Sander, F. 2007. A construction of Kenya’s Biosafety Regulations and Guidelines. How international donor agencies interact with regulatory innovation actor- network. Msc. Thesis. Science and Technology Studies, Faculty of Social and Behavioural Sciences, University of Amsterdam. Tait, J., and Lyall, C. 2005. A new mode of governance for science, technology, risk and the environment? In Lyall, C. and Tait, J. (Eds.), New modes of governance. Developing an integrated policy approach to science, technology, risk and the environment, pp. 177-188. Aldershot, Ashgate. Tait, J., Chataway, J., Lyall, C., and Wield, D. 2006. Governance, policy, and industry strategies: pharmaceuticals and agro-biotechnology. In Mazzucato, M. and Dosi, G. (Eds), Innovation, growth and market structure in high-tech industries: the case of biotech-pharmaceuticals, pp. 378- 401. Cambridge: Cambridge University press. A Social Audit Model for Agro-biotechnology Public-Private Partnerships E. C. Obidimma, J. Deadman, J. Mabeya, P. A. Singer, A. S. Daar McLaughlin-Rotman Centre for Global Health. University Health Network and University of Toronto. Toronto, M5G 1L7 Canada. Corresponding author: Obidimma Ezezika Email: Obidimma.ezezika@mrcglobal.org Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 7 - 8 The Challenge of Trust-building in Agro-biotechnology Public-Private Partnerships (PPPs) Projects in agro-biotechnology, led by public-private partnerships (PPPs) are advantageous due to their integrated approach to innovation and delivery of agro-biotechnologies (World Bank, 2007), but face public resistance due to issues of trust around genetically engineered crops and the complex nature of the public and private partners’ varied interests and priorities. Building trust among project partners, and between the project and the community they aim to serve, can help to mitigate the risks threatening projects’ success. The purpose of this brief communication is to explain our Social Audit Model and show its utility in agricultural biotechnology public private partnerships. Keywords: Trust, public private partnership, social audit, accountability, stakeholder engagement Received: 1 December 2010, Accepted: 10 January 2012 The Ethical, Social, Cultural, and Commercialization (ESC2) team at the McLaughlin-Rotman Centre for Global Health, of University Health Network and University of Toronto, have developed a Social Audit Model for agro-biotechnology PPPs with humanitarian goals (Ezezika, et al., 2009). The model includes an assessment of project needs and goals, development of social audit tools, engagement of internal and external stakeholders, social auditing service1, a communications strategy, and provision of feedback to project management, governance and funders, and the public. Implementation of the model can facilitate accountability and transparency in the project, and improve project management, which, in turn, can help build public trust and mitigate risk for the project (Figure 1). How the Model Works This Social Audit Model has been applied to the Water-Efficient Maize for Africa (WEMA) project, a PPP aimed at developing and delivering conventionally bred and genetically modified drought-tolerant maize varieties to small-scale farmers, royalty-free, in five countries in sub-Saharan Africa (Kenya, Mozambique, South Africa, Tanzania, and Uganda). The 2009 and 2010 Social Audit Reports of the WEMA Project, along with the WEMA management responses to the reports, are available on one of the managing partners’ - the African Agricultural Technology Foundation (AATF) - website: http:// www.aatf-africa.org/wema/audit_reports/2009_social_ audit_report/en/. This is the first time a Social Audit Model has been applied to a project of this type and we believe it has great utility for other large-scale, agro-biotechnology and global development initiatives led by PPPs. We believe it can help to align the goals and interests of project partners and the public, and help to build trust to mitigate risk in the project2. w w w. s c i f o d e - f o u n d a t i o n . o r g Proceedings of the International Conference on Agro-Biotechnology, Biosafety and Seed Systems in Developing Countries 8 E. C. Obidimma et al. / Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 7 - 8 Figure 1: Social Audit Model. The model involves five stages which include stakeholder identification, framework development, social audit, communications strategy, and impact. The first stage is stakeholder identification which involves engagement of internal project stakeholders as well as external stakeholders and the development of social audit tools, including a qualitative semi-structured interview schedule and quantitative questionnaire. Development of a framework for assessing the ESC2 issues in the project is the second stage of the model. This framework is developed in line with project needs and goals, which involves further engagement and input from project stakeholders. The framework shown here consists of seven domains critical to most agro-biotechnology PPPs and through which we can examine ESC2 issues illuminated through application of the model. Stage three is the social audit of the project during which stakeholders are interviewed using the ESC2 interview schedule and questionnaire. The findings from these questionnaires and interviews are analyzed and reported on in the fourth stage of the model – communication strategy. The audit report is presented to and discussed with project management, governance, and funders, and shared publicly with the project stakeholders. In the fifth stage of the model, we see the impact of communicating the Social Audit information. Improved management practices, holding project management accountable to project funders, and ensuring transparency of the project to all stakeholders are the three main envisaged outcomes to help build trust among project partners and between the project and the public. 1 Social auditing can be likened to financial auditing. The difference between these processes is that financial auditing deals with financial accounts while social auditing or ESC2 is focused on social accounts. It can be defined as a “process whereby an audit team collects, analyses, and interprets descriptive, quantitative and qualitative information from stakeholders to produce an account of a project’s ethical, social, cultural and commercialization performance and impact” (Ezezika, et al., 2009). 2 For information on the Social Audit Model, please refer to: http://www.mrcglobal.org/social_audit_model Acknowledgement The project from which this article was generated was funded by the Bill & Melinda Gates Foundation and supported by the McLaughlin-Rotman Centre for Global Health, an academic centre at the University Health Network and University of Toronto. The messages presented are those of the authors and do not necessarily reflect official positions or policies of the Gates Foundation. References Ezezika, O.C., Thomas, F., Lavery, J., Daar, A.S., and Singer, P.A. (2009) A social audit model for agro-biotechnology initiatives in developing countries: Accounting for ethical, social, cultural, and commercialization issues. Journal of Technology, Management & Innovation, 4: 24-33. World Bank (2007). World Development Report 2008: Agriculture for development. p. 170-171, Washington, D.C. Stakeholder Identi ication Communication Strategy Impact Social Audit Report Management Governance and Funders Public Improves management PRACTICES Holds management ACCOUNTABLE Ensures TRANSPARENCY Framework Development REGULATORY CAPACITY BUILDING DEPLOYMENT CHARITABLE PURPOSE PROJECT MANAGEMENT TECHNICAL COMMUNICATION Social Audit Stakeholder Interviews Project needs and goals Stakeholder Input Engage internal and external stakeholders Design social audit tools Internal stakeholder engagement TRUST BUILDING Capacity Development for Agricultural Biotechnology and Biosafety Decision Making: Facilitating Implementation of Confined Field Trials in Uganda T. Sengoobaa* and J. Komenb a Program for Biosafety Systems, International Food Policy Research Institute, P. O. Box 28565 Kampala, Uganda. b Program for Biosafety Systems, International Food Policy Research Institute, Duinoordstraat 69, Haarlem, The Netherlands. * Corresponding author: t.sengooba@cgiar.org Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 9 - 17 This paper draws upon experiences gained in Uganda, where a hands-on, integrated program for capacity development in agricultural biotechnology and biosafety regulations was implemented, spearheaded by national research and policy-making organizations and financially supported by the Government of Uganda, multilateral and bilateral donor agencies. Uganda is now regarded as a regional hub for agricultural biotechnology innovations, and connected with a range of international projects and programs aimed at developing relevant agricultural innovations. The paper analyzes key factors contributing to progress in biotechnology decision making in Uganda in the last 10 years, which are: (i) Building regulatory capacity and confidence; (ii) developing a biosafety regulatory framework: (iii) scientific and infrastructure capacity; (iv) working on a priority commodity and trait; (v) developing and implementing a communication plan; and, (vi) financial resources and partnerships for engagements in agricultural biotechnology and biosafety. Keywords: Agricultural innovations, Biosafety Regulatory Framework, Research Received: 8 December 2010, Accepted: 30 November 2011 A B S T R A C T Introduction A growing body of literature confirms the farm-level and societal economic benefits of growing genetically modified (GM) crops, as recently summarized and analyzed by Brookes and Barfoot (2009) and Smale et al. (2009). As the emerging “bioeconomy” expands to include second generation biofuels and biomaterial production, biotechnology and GM crops may play an even greater economic role. It is however, widely accepted that GM crops must be assessed for food, feed and environmental safety before they can be released for commercialisation (McLean et al., 2003). These principles are reflected in an internationally binding agreement, the Cartagena Protocol on Biosafety, which by now (March 2011) has been ratified by 160 countries (SCBD, 2000). Each State Party is obliged to domesticate the Protocol through enactment of relevant policies and regulatory frameworks. Farmers and economies, therefore, will only be able to take full advantage of the bioeconomy under a functional biosafety policy environment. Despite significant effort and resources devoted to biosafety capacity development, and notwithstanding some good progress, many countries still do not have adequate capacity to design and implement biosafety regulations (SCBD, 2010). This remains a significant barrier to the testing and adoption of new transgenic crop varieties that would offer farmers a means to grow more food, enhance incomes and reduce environmental impacts of agriculture. Furthermore, an uncertain regulatory environment discourages private and public sector investment into the development of the crops and traits that poor farmers need the most. Numerous programs have attempted to build global capacity for the regulation of biotech crops, with mixed success. Generally, countries with existing capacity for biotechnology research and development (R&D) and high-level political support to biotechnology and biosafety capacity building have made significant advances so far. This paper draws upon experiences gained in Uganda, where a hands-on, integrated program for capacity development in agricultural biotechnology and biosafety regulations w w w. s c i f o d e - f o u n d a t i o n . o r g Proceedings of the International Conference on Agro-Biotechnology, Biosafety and Seed Systems in Developing Countries 10 T. Sengooba and J. Komen / Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 9 - 17 was implemented, spearheaded by national research and policy-making organizations and financially supported by the Government of Uganda, multilateral and bilateral donor agencies. Uganda is now regarded as a regional hub for agricultural biotechnology innovations, and connected with a range of international projects and programs aimed at developing relevant agricultural innovations. The lessons learned in Uganda can be applied to ongoing and future biotechnology and biosafety capacity building efforts to ensure that individuals and institutions involved are enabled to make decisions on biotechnology and biosafety in a timely, transparent and science-based manner, and to ensure that all countries can participate in the emerging bioeconomy. The following sections analyze the key factors contributing to progress in biotech decision making in Uganda in the last 10 years, which are: (1) Building regulatory capacity and confidence; (2) Developing a biosafety regulatory framework; (3) Scientific and infrastructure capacity; (4) Working on a priority commodity and trait; (5) Developing and implementing a communication plan; (6) Financial resources and networking. Building regulatory capacity and confidence During the period 1998-1999, the UNCST undertook a scooping study with support from the UNEP-GEF to establish the status and potential for biotechnology applications in Uganda. The profile of biotechnology applications and services revealed that there would be need to develop a National Biosafety Framework for Uganda. The scoping study defined the parameters within which the various institutions involved in biotechnology and biosafety may operate in order to facilitate decision-making across institutions with varied but related mandates for biotechnology. Uganda ratified the Cartagena Protocol on Biosafety (CPB) in November 2001. Under the CPB, member countries are expected to establish a national biosafety framework (NBF) that will ensure that biotechnology applications, particularly the transboundary movement of “living modified organisms” (LMOs), are regulated in a manner that will minimise any negative effects to human health and the environment. As a follow up to the scoping study and ratification of the CPB, the UNEP-GEF in 2002 provided support through the biosafety global projects to Uganda to development a National Biosafety Framework. National Biosafety Frameworks may have different components but in the case of Uganda, the following components were pursued during the implementation of the UNEP-GEF project under the auspices of the National Council for Science and Technology (UNCST): 1. A policy on biosafety, which is often part of a broader national policy on biotechnology; 2. A regulatory regime for biosafety, which usually consists of a law or act in combination with implementing regulations; 3. A system to handle notifications or requests for authorisations for certain activities, such as field test releases of GMOs in the environment. The system typically provides for public participation and risk assessment and public participation; 4. A system for monitoring and enforcement; and 5. A system for public information, i.e. a system to inform stakeholders about the development and implementation of the national biosafety framework. The above components were viewed to constitute a a minimum package for developing a framework that would enable Uganda to fully oblige to the provisions of the CPB and other related international conventions to which Uganda is signatory. Thus, the Government of Uganda has been a consistent and strong supporter to the judicious introduction and application of agricultural biotechnology research in the country. A key component of the NBF, the proposed national policy on biotechnology and biosafety, aiming to build and strengthen national capacity in biotechnology through research and development; promote the utilization of biotechnology products and processes as tools for national development; and, provide a regulatory and institutional framework for safe and sustainable biotechnology development and application was finalized and presented by the UNCST for enactment in 2002. Following stakeholder consultations and multi-sectoral reviews, the Cabinet of Uganda approved the policy in April 2008. The policy reconfirmed government’s balanced position on biotechnology and genetically modified organisms (GMOs), and that the best way to evaluate potential benefits and risks is to have the necessary research and risk/safety assessment capacity in place. This overall position is reflected in the country’s regulatory framework. Biosafety Focal Point and Biosafety Desk established The Ministry of Water, Lands and Environment serves as the National Focal Point for Uganda and has represented the Country at various Conference of the Party (CoP) engagements. The UNCST is the designated Competent Authority for biosafety in Uganda and has a mandate to coordinate, regulate and make decisions regarding applications and use of biotech in the country. Right from the time of signing the CPB, the functions of the Competent Authority were executed by UNCST using a project 1 UNEP = United Nations Environment Programme; GEF = Global Environment Facility. UNEP manages a range of GEF-funded biosafety capacity building projects worldwide. 11T. Sengooba and J. Komen / Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 9 - 17(2011) 9 - 17 mode approach. During a consultancy exercise conducted in 2002 (Quemada and Traynor, 2002) under USAID support, there was general agreement among UNCST, the research community and government bodies that rising interest and activity in biotechnology and biosafety had created a need for administrative structures for coordination, management and information exchange. This recommendation was implemented in 2004 when a Biosafety Officer was appointed at UNCST to be in charge of the Biosafety Desk. This biosafety desk serves as a central facility to manage, support and effect environmental and health safety in the use of modern biotechnology, and to serve as a national information center. It provides the primary contact point at the Competent Authority Secretariat for national, regional and international activities related to biosafety. Functional linkages were established with other country biosafety coordinating bodies and international support programs in the area of biotechnology and biosafety. The biosafety desk also serves as Secretariat to the National Biosafety Committee (NBC). It receives and processes applications for the experimental introduction of GM plants in the environment and forwards them to NBC members. It schedules and keeps records of meetings, acquires and delivers relevant publications and provides administrative support to the NBC. The biosafety desk at UNCST is also expected to maintain a roster of local and regional experts and recruit ad hoc expertise for technical assistance as needed. Acting as a bridge between the NBC, government officials and applicants, it facilitates biosafety reviews and decision making, regulatory inspections and monitoring, reporting and record keeping. The managers of this office have been supported by international biosafety initiatives such as the Program for Biosafety Systems (PBS) for training in the management of biosafety as well as in risk assessment, management and risk communication. Having designated biosafety officers at the UNCST to support NBC operations, has been instrumental in enabling review, approval and implementation (including monitoring for compliance) of confined field trials (CFTs), through their support to the application processes, participation in developing the necessary regulatory documents and in the training of regulators, trial managers and inspectors. Clearly, the Government of Uganda assigned high priority to putting a framework in place for developing and regulating modern biotechnology and this has been a key factor in building the necessary institutional and human capacity in biosafety. Training NBC, IBC and scientists on evaluating applications Before authorizing GM materials to enter the country, Ugandan scientists had to be trained in preparation of applications while at the same time regulators had to learn how to evaluate such applications. The National Biosafety Committee was established by UNCST in March 1996 when there was an urgent need to make a decision on a livestock product — bovine somatotropine (BST) hormone produced by genetically engineered bacteria. The hormone was intended to be tested for growth and boosting milk production in indigenous cattle. Currently, the main function of the NBC is to provide technical advice to UNCST on science and technology matters related to the safe development and application of biotechnology in Uganda. The NBC comprises members coming from different sectors of government as well as the private sector and general public and these members are selected on personal merit. Given the rapidly changing and dynamic landscspe of biotechnology applications and services, many members of the NBC took it as their responsibility to learn more about biotechnology and attain competence to advise government from a well informed position. The NBC members attended several training programs to build their capacity for evaluation of applications. Research scientists and other relevant regulators also benefitted from these trainings. Some of the trainees later formed the Institutional Biosafety Committee (IBC) at NARO, when it was established in 2004 through PBS support. The UNEP-GEF initiated training of biotechnology regulators during their two projects implemented from 1998 to 2005. Several workshops were conducted for various purposes including: improving general understanding of biotech applications and implications for Uganda; risk assessment and risk management principles; monitoring and enforcement mechanisms. Training courses were also conducted to improve knowledge on biosafety legislation, other countries’ biosafety practices as well as legal and administrative aspects. Another capacity building initiative, the BIO-EARN2 project was implemented in Uganda as one of the partners in the region and this project also contributed to capacity building for biosafety through workshops and short courses as well as formal university training leading to the award of postgraduate degrees. Several Ugandans were trained in aspects of risk assessment, monitoring and risk mitigation and management. When the PBS started its work in Uganda it built on what the UNEP-GEF and the BIO-EARN projects had achieved and continued with capacity building for regulators but initially targeted enabling CFTs of GM crops likely to be planted in Uganda. Capacity for risk assessment and risk management of genetically modified crops was strengthened for biosafety regulators, including members of the National Biosafety Committee (NBC) and the NARO Institutional Biosafety Committee, who were trained through workshops and study visits. The trainings focused on authorization and safe conduct of CFTs, providing information on the characteristics and purpose of these field trials, and providing hands-on 2 BIO-EARN = Eastern Africa Regional Programme and Research Network for Biotechnology, Biosafety and Biotechnology Policy Development. BIO-EARN ran from 1999 – 2009 supported by the Swedish International Development Agency, SIDA. 12 T. Sengooba and J. Komen / Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 9 - 17 experience in evaluating applications for introducing GM plants for CFTs. Training and supporting scientists to develop applications The first successful application to establish a CFT came from NARO in collaboration with the Catholic University of Leuven, Belgium, where a Uganda scientist had participated in transforming “Gros Michel” banana plants for resistance to black Sigatoka disease (Mycosphaerella fijiensis). The PBS worked together with the Agricultural Biotechnology Support Project (ABSP-II) and NARO to put together a team to produce the field trial application dossier. The team comprised of two Uganda scientists who travelled to Leuven to gain first- hand experience as the banana application was worked on. These Ugandan scientists presented the application to the NBC and continued to participate in addressing queries that came from the NBC before approval. A similar process was followed when field trial applications for testing of insect- resistant (Bt) and herbicide-tolerant cotton were prepared. Again Ugandan scientists traveled to South Africa to participate in completing the application. In the case of GM cassava with resistance to mosaic virus, experts from the Donald Danforth Plant Science Center (DDPSC) collaborated with Ugandan scientists to prepare the CFT application. Currently the capacity to prepare application for CFTs of GM plants is well developed. For example the NARO banana team prepared an application for field trials of GM bananas with improved vitamin-A and iron content and one for bacterial wilt resistance. The NARO IBC is increasingly taking on the role of reviewing applications and helping scientists to complete their dossier before submission to the NBC. Capacity for environment risk assessment and risk management strengthened Members of the NBC, IBC, crop inspectors as well as biotech scientists have been targeted specifically for evaluation of applications intending release of GM plants for confined trials and to a limited extent for advanced trials that may have to apply less stringent confinement measures due to their larger size and use of multiple locations. The regulators need to build competence to enable them assess risks that may be associated with products of modern biotechnology and how such risk may be managed. Both NBC and IBC members need to be aware of environmental and socioeconomic implications of adopting or rejecting particular products of modern biotechnology. These committee members and other decision makers need to be conversant with the overall advances in modern biotechnology and its implications to agricultural research advancement and the overall agricultural and industry development. The regulators need technical backstopping from scientists in their decision-making. The regulators and the scientists may access and use existing information for risk assessment but there are cases where locally generated information is critical due to ecological, social economic and other local factors. Hence knowledge and information on risk assessment and risk management is important for both regulators and scientists. The PBS trained both regulators and scientists for risk assessment and risk management with a focus on plants or products that are likely to be introduced or developed in the country in the foreseeable future. In the same regard physical infrastructure that may be required for containing specific GM plants as they are studied for safety and other desirable traits was designed and later constructed by ABSP-II. Some risk assessment studies of local interest were pursued as part of graduate training programs. Capacity for regulatory compliance and inspection Hands-on, on-site trainings were conducted prior to implementing the CFTs to ensure that regulators and scientists clearly understood their role in conducting the trial according to established guidelines and detailed standard operating procedures (SOPs). These trainings were organized by PBS and partners with emphasis on: equipping participants with all SOP requirements in the management of specific crop CFTs; training biosafety inspectors on the procedures in CFT monitoring and evaluation; and, to educate CFT personnel on best practices for communication about the trials. These courses were designed to help participants understand what CFTs are and why there are needed, as well as the critical aspects of compliance and the biology of the test plant as it may relate to the confinement measures adopted. The trainings also covered the CFT reporting requirements in accordance to the SOPs as well as preparedness for incidents and contingency planning. The crop inspectors were particularly assisted to understand the inspection forms that would be used to assess for compliance during the GM crop growth and the post-harvest period. All trainings for compliance had a field visit component to help participants understand the expected layout of the trial and to assess compliance at that stage of implementing the trial. Learning tours for key regulators and policy makers Another form of capacity building for policy makers and regulators was achieved through study tours. Ugandan government officials have in different forums pronounced commitment and support to biotechnology application for over a decade. These consistent efforts have yielded desired results and in recent years, Uganda has made very encouraging progress in agricultural biotechnology research, human and infrastructural capacity building, development of regulatory frameworks and technology transfer activities. However, there was need to learn from countries that are intensively using biotechnology applications with regard to overall biotechnology policy design and implementation within the framework of national economic development strategies. In response, PBS in partnership with others players organized a 7-day study tour in 2007 to the Republic of South Africa for key agricultural biotechnology policy makers, regulators and capacity builders in Uganda. The objective was to acquire knowledge and share experience 13T. Sengooba and J. Komen / Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 9 - 17 about biotechnology capacity building, regulation and application from an African country that has made progress with both small and large-scale farmers. There were fifteen (15) participants for this tour including the Minister of State for Industry and Technology; Members of Parliament; senior policy makers from the Ministry of Agriculture; Office of the President; representatives from the Uganda National Council of Science and Technology; the Environment Authority and the National Farmers’ Federation and consumer protection representatives. The team visited government research and development biotech programs, University and other training institutions, private sector supporting biotech applications as well as farmers growing GM crops. A similar visit to India was conducted in 2008 for another set of participants nominated from the same institution but with significant participation from Parliament of Uganda. These study visits helped participants to understand how GM crops are evaluated, grown and their benefit to the farmers. In addition to international trips, policy makers and regulators have visited CFTs planted in the country including those of banana, cotton and cassava and they have been constantly impressed by the CFTs. As Charles Ngabirano, the Former Member of Parliament and Chairperson of the science and technology committee observed “Uganda has capable scientists who are doing a commendable job. The trial is showing positive results. We need to support them by ensuring that there are laws to enable them conduct research which in my view has great potential to address development concerns.” Developing the Biosafety Regulatory Framework Having a biosafety regulatory framework is critical to enable proper implementation of CFTs. At the time of ratifying the Cartagena Protocol, Uganda was already in process of establishing the national biosafety framework. In 2000, the UNEP-GEF project working in close collaboration with the NBC and other stakeholders assisted the UNCST in developing a proposed National Biosafety Framework, referred to as NBF. Though not fully complete the Uganda NBF has advanced through the support of Uganda Government and other development partners. The NBF derives its authority from the UNCST Statute 1 (1990) which designates the Council as the competent authority in developing strategies for integrating S&T in the national development process. It is under this statute and specifically under the general guideline for biosafety that guidelines and manuals were developed by UNCST and partners through a participatory process to enable handling and implementation of CFTs. Specifically, guidance documents were developed, including the following3: a. The Confined Field Trial Guidelines for Uganda: These guidelines provide for a clear and concise summary of the regulatory requirements governing confined field trials of GM plants in Uganda, in accordance with the “Guidelines on Biosafety in Biotechnology for Uganda”, which are administered by UNCST. The guidelines are meant for use by applicants and respective regulatory agencies. b. Trial Manager’s Handbook: This provides detailed instructions for all aspects of biosafety for confined field trials in Uganda in form of Standard Operating Procedures (SOPs). The SOPs give procedures for shipping and storage, establishment, maintenance and confinement of CFTs; termination and post-harvest management of the trial site; and reporting of results to NBC. The procedures provided are for the use of all Trial Managers, Technical personnel, agents of the Authorized Party, and government officials engaged in planning, conducting or overseeing confined field trials of GM plants in Uganda. Procedures for the conduct of CFTs are intended to accomplish three important goals: 1) preventing the spread of novel genes in pollen, seed or other plant parts from the trial site; 2) preventing GM plant material from CFTs being consumed by humans and/or animals before a full food and feed safety assessment is conducted; and 3) preventing GM plants from escaping from confinement and establishing and persisting in the environment. With the achievement of these three goals, novel genes and their products may be confined to the field trial site, and their release into the general environment prevented. In addition to this manual crop specific manuals have been develop to guide research on those specific crops like bananas, cotton and cassava. c. National Guidelines for Containment: These guidelines seek to assist establishment and maintenance and use of containment facilities in order to ensure safety in biotechnology research and development as well as the development of national capacities to identify, assess and manage potential risks as well as establish codes of practice for containment of GM research. These guidelines have been useful in guiding laboratory and screenhouse research involving GM plants at the various NARO institutes. d. Biosafety Inspection Manual: These guidelines provide detailed procedures for inspecting CFTs of regulated genetically modified crops during the crop growth and post-harvest period. e. Resource Book for Regulators: This manual provides procedures and models for regulation of field trials for genetically engineered plants. The manual was also developed to assist NBC in the conduct of their work as they evaluate applications, authorise and oversee implementation of CFTs. Besides its use in field experiments of genetically modified plants, the booklet also provide a useful platform, or expanding and sustaining collective scientific efforts of promoting the safe application of genetic engineering techniques in agricultural production systems in Uganda. 3 Approved guidelines are available online at URL: http://www.biovisioneastafrica.com/regulatory.html 14 T. Sengooba and J. Komen / Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 9 - 17 Scientific and infrastructure capacity The Uganda agricultural research system embraced biotechnology towards the end of the 1990s when the then Director General of the National Agricultural Research Organization decided to join the international agricultural research consortium under the Consultative Group on International Agricultural Research (CGIAR). This decision was tied to a request for support to biotechnology capacity development, including plant transformation technology for Uganda. A multi-million dollar project on “Novel approaches to the improvement of banana production in Eastern Africa - the application of biotechnological methodologies” was developed and implemented between the banana network of Bioversity International, National Agricultural Research Organization – Kawanda Agricultural Research Institute (NARO-KARI), Uganda; Catholic University of Leuven (KU Leuven), Belgium; Forestry and Agricultural Biotechnology Institute, University of Pretoria (FABI), South Africa; and, the University of Leeds, UK. This project focused on highland bananas, which is an important staple food for the country. Several PhD scientists were trained in various universities with a focus on molecular biology and banana transformation technology. Phase II of this project focused on developing transgenic East African highland bananas with resistance to banana weevil and nematodes in Uganda. In addition to efforts to develop human resource under this project, a well equipped biotechnology laboratory at NARO-KARI (now the National Agriculture Research Laboratories, NARL), was constructed, so that when the trained officers returned they had good facilities to continue conducting molecular biology research. This facility was officially launched and inducted to conduct research on biotechnology application by H.E. the President of the Republic of Uganda (Y.K. Museveni) August in 2003. Among the products from PhD training and research efforts were transformed plants, notably bananas transformed to resist black Sigatoka. These plants were developed at KU Leuven by a Ugandan PhD student and their being transferred to Uganda for evaluation needed both the scientific and regulatory and infrastructure capacity in place. The trained molecular biologists could easily understand the language involved in completing a CFT application and so participated in the preparation of the banana application from a well informed position. The regulators including both the IBC and the NBC had also been trained on evaluating CFT applications hence they could consider the application with confidence. At the time of establishing the molecular biology laboratory, NARO-KARI already had a modern tissue culture facility. On that foundation, a biosafety containment facility level II was constructed with financial support from USAID, and technical guidance by PBS and ABSP-II. This biosafety facility was a great incentive for regulatory agencies to have confidence in the scientific capacity available at NARO to handle GM plant materials. In addition to the biosafety facility, a biotech centre was supported to establish a confinement facility to enable field testing of GM plants under appropriate confinement conditions. Working on a priority commodity and trait Highland bananas provided excellent entry point to start CFTs in Uganda not only because a Ugandan scientist was involved in developing the product but also because banana is a key staple crop in Uganda. More than 12 million people depend on banana for food and income. The crop is grown on about 1.5 million hectares of land, which represents about 38% of total arable land in the country. Farmers in various parts of the country rank banana as their most important staple for various reasons including availability of harvest through the year and the relatively low production costs (Kalyebara et al, 2003). Despite its importance, banana productivity has been in continuous decline in the last 30 years (Insert reference). In the past, banana was a highly sustainable crop in Uganda, with long plantation life and stable yields. Indeed in some areas, one would find women of over 80 years saying that “I found this plantation here when I got married” (insert reference). More recently plantations are short lived requiring replanting every 3-5 years particularly in central Uganda. The most devastating production constraints that have become increasingly serious over the years are black Sigatoka, weevils and nematodes and more recently also the bacterial wilt. These four biotic constraints are very difficult to overcome through conventional approaches hence transformation technology is a welcome option to explore in fighting them. Under these circumstances the CFT application for GM banana was embraced by regulators and scientists considering that it could be a solution to a serious farmers’ problem. Having been developed in Belgium, it was also appreciated that the materials needed to be evaluated under field conditions in Uganda where the product was expected to be grown. Government of Uganda has in the past 5 years earmarked and provided funds for research in banana biotechnology. Communication plan for education, information and creating an enabling environment While building regulatory capacity for CFT review was in process, program partners were mindful of the needs of policy makers and the public in general to get information on biotech and biosafety, and supporting an enabling environment for its research and development processes. A biotechnology communication strategy (UNCST 2009) was developed to guide the procedure and process for the transfer of relevant knowledge and information to diverse audiences, and to promote public awareness and participation in discussions around the CFT and the development of the biosafety framework in general. The critical audiences within the Ugandan context were defined as: (i) the media (print, broadcast, electronic, multi-media); (ii) policy makers (legislators and regulatory bodies); (iii) scientists; (iv) agricultural extension workers; (v) the private sector (seed companies, processors, exporters); and, (vi) general public (consumers, farmers). 15T. Sengooba and J. Komen / Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 9 - 17 Each of these audiences requires specific communication approaches and activities tailored to suit their information needs with regard to achieving the CFT implementation and overall biotech advancement in Uganda. The communication strategy identified gaps in the transfer of biotechnology information and knowledge to these audiences and on this basis, facilitated audience segmentation and setting objectives for communicating to the different groups (Fig. 1). Figure 1: Identified audiences for communication strategy The unique role of the media was recognized. The media, generally, are both a beneficiary and an effective channel for delivering messages to key audiences including policymakers and other decisionmakers (e.g., farmers) Therefore, the communication plan identified the needs of the media and how they could be addressed in order to transform the Uganda media into a communication partner for advancement of the biotechnology. Apart from the media, policy makers, scientists and extension workers were identified as critical audiences in the communication process for biotechnology development and adoption. It was recognized that each of these audiences play a critical role with regard to biotechnology development and use in the Ugandan context, and consequently formed the focus of the communication activities in the strategy. The core objectives for communicating with each of the identified audiences were defined (Table 1). 16 T. Sengooba and J. Komen / Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 9 - 17 Table 1 Core objectives for communication across stakeholders The Media Policy makers Scientists Extension workers General public Private sector Create awareness and promote understanding of Biotechnology Educate about status of global and regional legislation in biotechnology Provide opportunities for sharing research and feedback Educate and inform on global and national biotech advancements and relevant case studies Enhance awareness and promote understanding Increase understanding of biotechnology policy and regulatory system Enhance the image of biotechnology Stimulate discussion and debate of biotechnology Stimulate discussion and debate of biotechnology Demonstrate benefits of bio- tech Provide avenues for information acquisition Provide knowledge on investment opportunities in biotechnology Educate and inform on biotechnology advancements Change attitudes about biotechnology Change attitudes about biotechnology Create dependable information links with farmers Participate in regular dialogues Provide avenues for information acquisition Increase interest in, and coverage of bio-tech issues Increase/Expand attendance of dialogue sessions Develop pressure group pro-biotech Provide information on benefits Provide consumers with access to relevant and accurate information Galvanize strategic action like speedy decision making on biotechnology issues such as the policy Develop skills and resources to provide accurate information to other audiences Source: Modified from UNCST (2009) Various channels and instruments were used to communicate about the CFT, advances in the regulatory system and biotech in general. Radio was often used to report about specific events, research activities, to host panel discussion and talk shows with an intention of keeping listeners abreast of progress with the technology. The talk shows were particularly useful to capture feedback from the public and provide a two-way communication channel. Besides the Government radio station, Uganda has over 80 private FM radio channels in operation and these have been used to report on biotech and biosafety, particularly by reporters who have attended biotech communication training courses. Television stations have been used with a similar approach but also to air documentaries on the status and advances in biotechnology research and the regulatory system in the country. Other tools of communication that have been used include newspaper articles, brochures and newsletters, policy briefs and posters. A PBS-supported newsletter, BioVision, is published quarterly. This newsletter particularly targets members of parliament and other policy makers to keep them abreast of developments in biotechnology in Uganda and beyond. The communication process was guided by developing messages that would facilitate acceptance and informed discussion about biotech in the country particularly regarding the safe use of GM crops. The messages were developed according to the audience based on six thematic areas: 1) Definition of biotechnology; 2) Use and footprint of biotechnology; 3) Regulation of biotechnology / biosafety issues; 4) Benefits of biotechnology; 5) Impact of biotechnology on human health and environment; and 6) Product development process (e.g., why CFTs are needed). The communication strategy was implemented by partners each taking a lead role where they had comparative advantage or core responsibility. The NARO commodity programs took a lead role in communicating about their CFTs while PBS played key role in capacity building for biotech and biosafety communication and for communication to facilitate progress on the legislation process. Two participating civil society organizations, SCIFODE and Consent were the main players for communication to create public awareness. UNCST was responsible for monitoring implementation of the overall communication strategy. Financial resources and partnerships Obviously, as noted in the sections above, Uganda has benefited from strong external support in developing its national capacity for agricultural biotechnology and biosafety. However it would be mistaken to regard the process as externally driven, as the leadership and coordination roles are clearly performed by national agencies and organizations, ensuring that international support contributes to a national agenda and does not lead to duplication of efforts. 17T. Sengooba and J. Komen / Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 9 - 17 Building biotechnology and biosafety capacity requires significant levels of funding. By providing an enabling environment for modern agricultural research, Uganda is very well connected in a range of agricultural biotechnology programs (e.g., BIO-EARN, ABSP-II, AATF/WEMA) which have all contributed to establishing R&D infrastructure for safe research and experimentation with GM crops. All international programs active in Uganda have organized hands-on training programs and, in some cases, longer term degree training abroad in relevant disciplines. In addition, and connected with the above, several international programs support biosafety regulatory capacity development in Uganda. Notable examples include the UNEP-GEF biosafety implementation projects and USAID- supported programs such as PBS and ABSP-II. Other projects supporting biosafety development and training include BIO-EARN and the Danish-supported BioSafeTrain. These programs have operated at the regional level and have contributed significantly to capacity building efforts in the different countries of Eastern Africa. It should be stressed that those programs would have had limited impact without the strong support from, and active involvement by Ugandan individuals and institutions – UNCST, NARO, Universities (especially Makerere University) and regulatory agencies involved in the overall NBF that have worked in a coordinated fashion to ensure that international investments in agricultural biotechnology and biosafety have paid off over the last 10 – 15 years. Concluding remarks The preceding sections exemplified Uganda’s progress in developing and implementing biosafety capacity, tailored to the overall needs and development objectives of the country. It has taken a long-term and product-orientated approach, in order to ensure that regulatory development and training were put in practice. In addition to the activities and developments described above, primarily governing confined field trials, the biosafety regulatory framework’s authority and scope would be strengthened when a comprehensive biosafety law is in place. Drafting a biosafety law started in 2002 under the UNEP-GEF project and has advanced since then, through various rounds of review and stakeholder consultations. The Draft Biosafety Bill is currently being finalized for submission and adoption by Parliament as the National Biosafety Act. The Act (biosafety law) will be an essential next step in bolstering Uganda’s capacity in the judicious use of agricultural biotechnology. References Brookes, G. and P. Barfoot. 2009. Global Impact of Biotech Crops: Environmental Effects, 1996-2008. AgBioForum 13 (1): 76-94. URL: http://www.agbioforum.org/v13n1/ v13n1a06-brookes.htm Kalyebara, R., Nkuba, J. M., Byabachwezi, M. S. R., Kikulwe, E. M., and Edmeades, S. 2003. Overview of the banana economy in the Lake Victoria regions of Uganda and Tanzania Pages 25-36 in: Smale, M. and Tushemereirwe, W. K., An economic assessment of banana genetic improvement and innovation in the Lake Victoria region of Uganda and Tanzania. Research Report 155, International Food Policy Research Institute, Washington D.C. McLean, M.A., R.J. Frederick, P.L. Traynor, J.I. Cohen and J. Komen. 2003. A Conceptual Framework for Implementing Biosafety: Linking Policy, Capacity and Regulation. Briefing Paper No.47. The Hague: International Service for National Agricultural Research. SCBD. 2000. Cartagena Protocol on Biosafety to the Convention on Biological Diversity: text and annexes. Montreal: Secretariat of the Convention on Biological Diversity. SCBD. 2010. Expert Review of the Effectiveness of Various Approaches to Biosafety Capacity-Building: Identifying Best Practices and Lessons Learned. Note by the Executive Secretary. UNEP/CBD/BS/COP-MOP/5/INF/9. Montreal: Secretariat of the Convention on Biological Diversity. Smale, M., P. Zambrano, G. Gruère, J. Falck-Zepeda, I. Matuschke, D. Horna, L. Nagarajan, I. Yerramareddy, and H. Jones. 2009. Measuring the Economic Impacts of Transgenic Crops in Developing Agriculture during the First Decade: Approaches, Findings, and Future Directions. Food Policy Review No.10. Washington, DC: International Food Policy Research Institute. Quemada, H. and P. Traynor. 2002. Assessment of Biotechnology in Uganda. Final Report to the U.S. Agency for International Development, Office of Agriculture and Food Security, Economic Growth, Agriculture and Trade, the Africa Bureau, and Michigan State University, Agricultural Biotechnology Support Program. UNCST. 2009. Revised Strategy for Biotechnology and Biosafety Communication and Outreach for Uganda (2009-2012). Kampala: Uganda National Council for Science and Technology. Biosafety risk communication and a multidisciplinary approach: The key to adoption of agro-biotechnology applications in Sub-Saharan Africa A.Y. Sefasi* and S.B. Mukasa Makerere University, College of Agricultural and Environmental Sciences, School of Agricultural Sciences, Department of Agricultural Production, P.O. Box 7062 Kampala * Corresponding author: e-mail, abelsefasi@yahoo.co.uk Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 19 - 24 The number of people lacking adequate food in the world is increasing, especially among the poor communities in Sub-Saharan Africa (SSA). Constraints to crop production in SSA are many including pests, diseases, weeds, environmental degradation and inadequate food processing facilities. Agro-biotechnology applications hold potential in solving some of the constraints. Two related challenges to the application of agro-biotechnology in SSA are inadequate capacity and public concerns. There are five main public concerns that have hampered adoption of agro-biotechnology in SSA: biosafety issues related to human health, concerns about detrimental environmental impacts, regulatory concerns, economic concerns and ethical concerns. This review will discuss the basis of these fears and concerns. We also identify risk communication as a major factor influencing public concerns and perceptions towards GM agriculture in SSA. We further suggest that scientists have a major role in clarifying issues about the adoption and use of genetically modified (GM) crops in agriculture. Keywords: Genetically Modified Crops, public concerns, safety issues Received: 3 December 2010, Accepted: 19 November 2011 A B S T R A C T Introduction The number of people lacking adequate food in the world is increasing, especially among the poor communities in Sub-Saharan Africa (SSA) (Dalgado, 1997). Constraints to crop production in SSA are many including pests, diseases, weeds, environmental degradation, soil nutrient depletion and inadequate food processing facilities (Scherr, 1999). Biotechnology tools like tissue culture, genetic transformation and molecular markers can improve efficiency in crop improvement efforts and overcome some of the challenges faced by conventional plant breeding strategies for improvement of food production (Machuka, 2001). The UN Human Development Report (HDR) “Making New Technologies Work for Development” (UN, 2001) identified biotechnology as a key avenue for the socio-economic advancement of the developing countries. As a tool of biotechnology, genetic transformation is faster, and able to deliver genetic changes that would never occur through conventional methods (Kung and Wu, 1992). Genetic transformation is already being applied in the improvement of crops that are important in SSA. For instance, programs using genetic transformation to enhance nutritional content, to solve environmental constraints such as chilling, freezing, soil salinity, heat stress and biotic constraints such as weevils and viral diseases in sweetpotato have yielded promising results (Yamaguchi et al., 2004; Kasukabe et al., 2006). Despite the documented potential of agro-biotechnology applications in transforming agricultural economies, its adoption has remained low in SSA (James, 2003). This contrasts with the increase in global area of agro- biotechnology. The global biotechnology crop area reached 250 million hectares in 2006, with more than 10 million farmers in 22 countries planting 102 million hectares of biotechnology crops, up from 90 million hectares planted by 8.5 million farmers in 21 countries in 2005 (James, 2006). The increase of 30 million acres between 2005 and 2006 was the second highest in five years and equivalent to an annual growth rate of 13% in 2006. Of the countries that grew biotechnology crops in 2006, South Africa was ranked eighth in terms of the hectarage devoted to growing biotechnology crops in the world. It is important to note that South Africa w w w. s c i f o d e - f o u n d a t i o n . o r g Proceedings of the International Conference on Agro-Biotechnology, Biosafety and Seed Systems in Developing Countries 20 A. Sefasi and S.B. Mukasa / Proc. Inter. Conf. Agbiotech, Biosafety & Seed Systems (2011) 19 - 24 is the leading country in terms of GM commercialization in Africa (James, 2006). Apart from inadequate capacity in terms of human resource and infrastructure, the dominating public concerns and fears towards agro-biotechnology applications threaten sustainable adoption of the technology in SSA. Other authors have shown that some perceptions have arisen due to a big failure to address concerns that currently fall outside scientific risk assessment; for example fears that agricultural economies will be changed fundamentally by the use of GM crops, leading to undesirable social or political change (Johnson et al., 2006). In this review, we identify risk communication as a key to addressing public concerns and therefore speeding up the adoption of agro-biotechnology in SSA. We briefly review the concerns that have affected adoption of agro-biotechnology in SSA. With the aim of improving effectiveness in biosafety risk communication, we also highlight the historical basis of current perceptions towards genetically modified organisms (GMOs). We finally suggest how scientists can communicate risks and benefits of agro-biotechnology applications to influence opinions and perceptions by the public towards understanding GM agriculture. We also propose how scientists can handle sentiments from commentators who have opted to be denialists regarding GM agriculture. The major concerns towards GM agriculture There are five main public concerns that have hampered adoption of agro-biotechnology in SSA: safety issues related to human health, concerns about detrimental environmental impacts, regulatory concerns, economic concerns and ethical concerns. Some of these concerns are legitimate while others clearly result from lack of information and/or misinformation about the technology, whereas others are deliberately not genuine. Commentators who argue that GM interferes with nature need to understand that GM is a development in a long line of plant breeding techniques. Older techniques shuffled the plant’s genes, leading to lots of unintended changes, whereas GM is more precise. The comments that it is “unnatural” are just as true of plants generated through conventional plant breeding programs. It is also surprising that some commentators still talk about “releasing” or “freezing” GM as though it is a one-off decision yet to be taken (James, 2007). GM research and plant trials are on- going worldwide. Loss of wildlife diversity on farm land is also not a problem specific to GM but of agriculture in general; the losses of habitat, use of fertiliser and pesticides, and changes in crop rotations have all reduced the number of plants, insects and birds (ABE 2002). Research into how GM maize crops influence non-target insects in the environment found that whether the maize is GM or not has much less of an impact than how much insecticide is used (USDA-ARS, 2002). There are also food safety issues regarding GM agriculture. This still creates fear although in the US, foods containing GM ingredients have been eaten for over a