The Bumpy Path Towards Knowledge Convergence for Pro-Poor Agro-Biotechnology Regulation and Development: Exploring Kenya’s Regulatory Process

1. Introduction

Contestations over the regulatory trajectory that developing countries should take to embrace the benefits of biotechnology

Here I use the term biotechnology to mean the manipulation of living organisms to produce goods and services useful to human. I make distinction between traditional (or conventional) and modern biotechnologies. The traditional approach allows the development of new products (such as seed varieties) by the process of selection from genetic material already present within a species, while the modern (transgenic) approach develops products (such as seed varieties) through insertion of genetic material from different species into a host plant. These products are popularly known as Genetically Modified Organisms (GMOs).

have been debated widely. Predominant debates in the global arena have focussed on two competing regulatory approaches namely; the more permissive approach of the United States (US) that presents biotechnology as posing no risk to the environment or human health unless proven otherwise through scientific risk evaluation and the more restrictive approach of European Union (EU) that imposes precautionary restrictions on use of products of biotechnology even when scientific knowledge about risks is uncertain. There is now a wide body of literature looking at trade conflicts brought about by these divergent regulatory policies leading to regulatory polarization (Paarlberg, 2001, 2008; Bernauer and Aerni, 2007; Bernauer, 2005; Falkner, 2007; Murphy and Levidow, 2006). Arguably, these polarised debates only expose the political dynamics of biotechnology from a very narrow view, primarily trade imperatives (Clapp, 2006). Some analysts departing from what they perceive to be a narrow approach to this subject have attempted to explain the bumpy path to biotechnology deployment and regulation in developing economies that exhibit different characteristics. Millstone and van Zwanenberg (2003) for instance looking at GM policies in the South have shown that the scientific conflicts embedded in GM safety compel countries to pursue divergent regulatory choices. Research has also shown that local context dictates technological dynamics and should be given a place in biotechnology development and regulation (van Zwanenberg et al., 2008). Falkner and Gupta (2009) have also noted that despite the EU-US international regulatory conflicts, developing countries are responding to related pressures in different and unique ways.

Important for this paper is the dynamics brought about by regulatory pressures and what this means for knowledge use towards productive debates that could lead to pro-poor biotechnology development. In view of this, there is need to re-orient the discussions around how actors in the respective value chains ought to respond to regulatory demands brought about by biotechnology, and how this impacts knowledge production dynamics. The paper argues that biotechnology development will only contribute to economic development if knowledge (regulatory, social and scientific knowledge), emanating from different knowledge nodes is allowed to converge to a point where it can consequently inform productive innovation policy processes. This argument is based on the understanding that requisite innovation capacities need to be built in order for actors to use the resources at their disposal towards behavioural change for biotechnology regulation (Hall, 2005). Knowledge is one of the resources and how it is applied is crucial for biotechnology innovation process or trajectory.

This paper relooks at knowledge production dynamics through an empirical account that documents the biotechnology regulatory trajectory in Kenya. The analytical context for the paper is backed by the political nature under which biotechnology development and biosafety regulation have co-evolved for almost two decades (Harsh, 2005; Sander, 2007; Kingiri and Ayele, 2009, Kingiri, 2010, 2011a,b). Analysis drawn from these papers suggests that scientific knowledge predominantly directs biotechnology development and regulation (cfKingiri, 2010). In addition, the fragmented nature of actors’ infrastructure and their belief systems derail the knowledge convergence efforts (Kingiri, 2011a). Although this process lacked legal direction in terms of policy (Biotechnology policy and Biosafety Act were only approved in 2006 and 2009 respectively), the paper suggests that lessons learnt in the Kenya’s regulatory process should move the country biotechnology sector to a higher level towards putting the research products which have been in the pipeline to use. The objective of the paper therefore is to explore and understand how knowledge convergence can be attained towards moving biotechnology science forward towards innovation.

The paper is structured as follows. Political scenario under which biotechnology regulation occurs is discussed first. This is followed by an analytical context under which this paper is situated. Next, the paper illuminates the dynamics associated with biotechnology regulation using Kenya as an example. Lastly, the paper discusses the emerging dynamics associated with regulation and role of knowledge actors. It then concludes by drawing lessons that might inform a productive regulatory process towards knowledge convergence.

2. Political nature of biotechnology regulation: An overview

It is now understood that agricultural production constraints like pests and diseases have been perpetuating the cycle of food insecurity and poverty in sub-Saharan Africa. The questions that many have been asking relate to whether biotechnology can be exploited as a possible solution to these and other production constraints. Proponents are optimistic about this while opponents are pessimistic citing safety concerns around human health and environment. Answers to these and related questions provide a more complex and charged debate about biotechnology development and regulation.

Despite the undisputed consensus about biotechnology as a tool for agricultural development in poor economies (FAO, 2004), political polarization on GMOs has been increasing. The participation of many interested stakeholders in charting a supposedly sustainable regulatory pathway has confounded the process due to the value based nature of divergent perspectives (Paarlberg and Pray, 2007; Leach et al., 2007). It has been noted that policy processes embraced in advanced economies particularly EU and USA has significantly shaped public opinion and regulation in most African countries (Newell, 2003). EU for instance has been associated with advocacy groups opposing biotechnology introduction even in regions where food security challenges persist (Herring, 2010; Paarlberg, 2001, 2008). Other analysts have further explored the problem more broadly and have added that a more holistic approach to biotechnology debate is needed to embrace the context that varies with regions, localities and social preferences (van Zwanenberg et al., 2008; Glover, 2010).

This paper is in line with holistic view of biotechnology regulation that take cognisance of the context specific nature of domestic knowledge dynamics prompted by biotechnology. This includes environmental and social economic context, political and cultural context in relation to how decision processes are pursued to promote legitimacy and transparency among others (Glover, 2010). Arguably, these factors shape knowledge production dynamics giving a context to the analysis.

3. Setting the scene: Conceptual and analytical context

Building on some of the studies on biotechnology governance in Kenya alluded to elsewhere; this section calls attention to the importance of the various aspects of technological, regulatory and social local contexts in which the knowledge actors (including the organisations involved) and regulatory process are embedded. It seeks to provide the analytical context for the paper as well as situate the multiple actors engaged in biotechnology research and development (R & D) for the last two decades within the process of regulation implementation. By doing this, the paper exposes the motivations and opportunities for actors in their engagement with biosafety regulatory process and formulation of regulatory instruments, and the institutional challenges and strengths related to modern biotechnology governance.

The paper seeks to analyse how biotechnology regulation (which includes instituting a biosafety regulatory system for management of biotechnology) may have affected efforts to bring about a knowledge convergence in biotechnology regulation. Kenya was selected backed by the rich political context that prevailed during the establishment of a regulatory system for management of biotechnology Research & Development (R & D).

3.1. Research context and methodology

Kenya presents an excellent case to investigate knowledge management associated with modern biotechnology in terms of regulatory policy environment and context. This is because the initiation of biotechnology R & D 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 embrace an integrated approach to innovation towards economic development.

The context described above 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 2011. This was complemented by observations 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.

Unless otherwise stated, codes are used to report all information cited in this paper in order to guarantee anonymity of some of the interviewees as requested. For instance, NGOco-NS4 refers to a non scientist interviewee from a civil society organisation.

3.2. An overview of Kenya’s biotechnology development and regulation

3.2.1. 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).

Agricultural R&D has long been recognised as central to knowledge creation, technology development and innovation. During the pre-independence period, the R & D agenda was set by the British colonial government, which recognised the importance of Science and Technology (S & T) in agricultural production (Ochieng, 2007). It is not until early 1990’s that biotechnology innovations in form of tissue culture received considerable attention (Wambugu, 2001). 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 R & D initiatives have been evaluated in public institutions in conjunction with local and international partners (see Kingiri, 2011a for details). These activities include Btmaize 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 (CFTs)

This is a field trial of GM plants not approved for general release in which measures for reproductive isolation and material confinement are enforced in order to confine the experimental plant material and genes to the trial site (Halsey, 2006:4).

. It is hoped that with the establishment of a functional biosafety framework, the situation will change. In addition, the food insecurity related issues have prompted the government to take drastic policy measures approving importation of GM maize to avert a food crisis in the country (Daily Nation, 2011).

3.2.2. 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). There are several ways in which risk identified during RA can be managed, e.g. confinement, restricted use, provision of guidance, technical advice and record keeping (Halsey, 2006).

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). There were concerns that these regulations came long before the biotechnology policy and have not been legally binding as required by the law. 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 Biosafety Act, 2009 (RoK, 2009).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. Kingiri (2011a) captures some of the main developments, revealing the dynamics that include the engaged different actors and the nature of engagement between 2002 and 2009. Within this period, various versions of the biosafety bill were drafted and discussed before the final version (RoK, 2009) was approved to become an Actin Feb. 2009. Meanwhile, regulations to be appended to the Act were drafted under the Program for Biosafety Systems (PBS) support and recently became operational from July 2011 after signing by the Minister for Higher Education, Science and Technology.

Previously, all the involved government actors and other nongovernmental players involvedin biotechnology governance were brought together under the National Biosafety Committee (NBC) coordinated by the National Council for Science and Technology (NCST). NBC acted asa 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.

3.2.3. Theoretical framework

To analytically situate the discussion in sound theoretical debates, this paper draws upon insights from the integrated knowledge management literature. 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; World Bank, 2006). 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).

4. Dynamics associated with biotechnology regulation: An empirical exploration of Kenya’s case

In this section, practical reasons why and how stakeholders got entangled in Kenya’s regulatory process is explored and the kind of reactions this generated. This helps us understand the challenges that may hamper a productive regulation towards knowledge convergence.

4.1. Challenges confronting the evolving agricultural R & D and modern biotechnology governance terrain

4.1.1. Contract research

It is widely argued that biotechnology is a key tool for 21^st century sustainable development. However, most people agree that this may remain a dream unless certain challenges are addressed that include political support through provision of incentives for research and regulation (cfBananuka, 2007). In Kenya, government support for S & T including biotechnology R & D has been minimal (Beintema et al., 2003; Odame et al., 2003). The dwindling research funds and other policy reforms have encouraged collaborative research, technology development and deployment (RoK, 2005; KARI, 2005; RoK, 2007). Although the government continues to fund public agricultural research, a significant support comes from donor organisations (Beintema, et al., 2003:5). Kenya Agricultural Research Institute (KARI) being the major research institute involved in modern biotechnology research (and the only one undertaking biotechnology CFTs) has undergone significant restructuring in response to these reforms and challenges. These changes have contributed to a rise in contract research characterised by increased donor funding (Beintema, et al., 2003:5). For instance all the agricultural GM trials are being undertaken through Public Private Partnerships (PPPs) arrangement (Ayele et al., 2006).

A lot has also been documented regarding the tissue culture bananas contract research (cf Smith, 2004). However in the case of modern biotechnology, the nature of contractual research is still under-researched and is undergoing changes at unprecedented rate due to the evolving institutional and regulatory contextual issues. What seems to lack is information on how actors in the value chain have been responding to the institutional changes associated with regulation of biotechnology science. This is crucial for related knowledge convergence efforts.

4.1.2. Biotechnology and biosafety capacity

According to Bananuka (2007), the need for regulatory capacity evolves alongside an operational biotechnology sector, and this has been the case in Kenya. Since the biotechnology programme was initiated in early 1990’s, capacity in both modern biotechnology techniques and biosafety (human, infrastructural and institutional) has been built over the years. For instance, a modern biosafety Level II greenhouse has been put up at the KARI biotechnology centre. According to a report prepared for policy makers (Handbook for Policy Makers, 2007), the number of scientists trained in biotechnology countrywide has gone up, with 45% of those trained being actively engaged in GE work. In addition, capacity in regulatory institutions like Kenya Plant Health Inspectorate Service (KEPHIS), Kenya Bureau of Standards (KEBS), Department of Veterinary Services (DVS) and Department of Public Health (DPH) has been strengthened and as argued in this report, these institutions are in a state to oversee the implementation of biosafety regulations. Arguably, these rhetorical claims were advanced by GMOs proponents, in their endeavour to lobby for the enactment of the bill (Kingiri, 2011a, b). However, these capacity building and biopolicy developmental efforts have been collaborative. Despite these milestones, both infrastructural and human capacity remains far from being adequate. This is attributed to several factors among them inadequate government support for research discussed above and lack of regulatory policy environment to spur development (Wafula et al., 2007), that would further encourage and favour capacity building efforts. The increased cross-over of trained scientists from public institutes to international organisations locally and abroad has also contributed to the unsustainable capacity building efforts, a trend which is prevalent in the African region as a whole (Hastings, 2009).

4.2. Stakeholders’ proactive role in regulatory process

From the foregoing analysis, it is emerging that various challenges have hampered the evolution of the twin processes - biotechnology innovation and regulatory regime. These relate to partly the technical and institutional capacities, but this analysis does not address an important question related to how the actors (individuals, organisations and related links) deal with the analysed challenges. The implications in terms of how challenges are dealt with are important in informing the dynamics around knowledge use and regulatory decision making processes.

This section tracks empirically the Kenya’s regulatory trajectory paying attention to the involvement of knowledge actors in this process, exposing 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 (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 (see Kingiri, 2011a for a detailed empirical account of dynamics involved).

4.2.1. Motivations, opportunities, interests and implications associated with biotechnology

When biotechnology research was initiated in early 1990’s it provided an incentive for researchers with many seizing this opportunity to pursue their knowledge and technology transfer endeavours. This triggered public reaction with this behaviour being interpreted by non scientific communities from the civil societies as unwarranted excitement and hype. To moderate the different interests and concerns, amongst stakeholders, the government imposed biosafety regulations (RoK, 1998) to guide in subsequent knowledge generation endeavours and decision making processes. Regulations were interpreted in different ways by different stakeholders (see Kingiri, 2011b for details). Perhaps because of conflicts between different motivations and opportunities presented by GE research, and the different challenges associated with biosafety regulations and implementation, the stakeholders exposed certain varying behavioural practices. This generated varying reactionsas reported in the subsequent sections.

4.2.2. Scientists credibility and transparency questioned

The conduct of GE trials was perceived to require a substantial level of credibility on the part of scientists due to sensitivity of GE technology. However, research scientists were perceived by a number of interviewees to be untrustworthy and dishonest. Perhaps credibility is one aspect that regulations should be promoting, prompting regulators to emphasise appropriate monitoring of research trials and scientists: “scientist…will do things that you cannot believe it is possible.” (RSPu-PS7, Nov. 2008). Credibility was however found to be constrained by institutional obligations and compromises that both scientists in policy and practice were forced to make. The interim regulations prior to the Biosafety Act were unclear about how credibility as an ethical practice is linked to compliance and monitoring. However, the Biosafety Act provides for intensive monitoring through designated biosafety experts (Articles 43 & 45).

4.2.3. Attitude towards regulations and regulators

Many interviewees in policy arena including regulators described scientists as having a negative attitude towards regulations. The reasons behind this negative attitude were attributed to conflicting motivations like research interests discussed previously, making scientists view regulations as “hindrance to science” (LABp-NS8, Jan. 2008). Others explained that scientists find it difficult to adjust from their normative basic research behaviour to a supposedly demanding research practice like the one demanded by GE research. The attitude of researchers towards regulators and vice versa promoted suspicions and misunderstandings amongst them, constraining effective regulatory practice.

4.2.4. Poor public communication and biased reporting

This section reports on practice of scientists related to how they disseminate research information emanating from biotechnology research trials. The regulatory instruments prior to the Biosafety Act and the Act itself are implicit about how this reporting process should be managed. They however emphasise on transparency that should promote public trust. RoK (1998) in particular recommends “openness” to “safeguard public interest” through transparent handling of information and adhering to regulations (executive summary). In RoK (2009), NBA is wholly responsible for information handling and management including consequent public awareness. A register will also be maintained as a repository for biosafety information. It is however unclear how interested parties should access it. Accounts of interviewees suggested that scientists have poor public communication skills on biotechnology matters. In addition, when they communicate (as demanded by the sensitive nature of this technology), there are weaknesses that are revealed through the reports and the communication strategies they adopt. However, many interviewees were in agreement that scientists have a very important role to play in communicating scientific and technical facts to the public about their GE work. Some perceived this as the only way of demystifying the prevailing negative publicity around GE technology. There were however perceived weaknesses and challenges in the articulation of this role which are explored next.

4.2.4.1. Communicating science versus public understanding of science

Some interviewees claimed that research scientists use “scientific jargon” that need to be “toned down” for lay people to understand. The use of technical and scientific language was perceived to be an indicator of poor communication skills that purportedly differentiates pro-GE scientists from anti-GE activists. This discussion seems to point out that scientists have not come to the level of the non scientists or the public when communicating technical aspects of GE research. This analysis does not however expose the reasons behind this seemingly uncomfortable behaviour and repercussions.

4.2.4.2. Public communication constrained by fear of misinterpretation

Scientists argued that they deliberately avoid communicating scientific findings to the public because of fear of misinterpretation, propaganda and potential negative impact this may have, for instance on their careers and research reputation. Fear of propaganda was associated with activists, who some claimed unjustifiably fight biotechnology impacting on scientists’ reporting behaviour:

“So [research scientists] have avoided bringing negative stories and even when they see them they remove them and instead keep quiet. Experience has shown that, any negative you bring will be used against you. So we have to continue in the way I think we are at least less risky.” (TAR-NSS1, researcher & technology advocacy, international NGO, Feb. 2008)

This has implications as many scientists asserted. The fear of reporting non-factual and unverified or unconfirmed findings constrain effective and timely reporting, leaving room for misinterpretation by counter groups. Arguably, scientists are held back from freely sharing their findings with the public for fear of repercussions associated with misinterpretations. This has implications for practice on the part of the scientists in respect of information and knowledge management, and how this is interpreted by others.

4.2.4.3. Communicating the positives and transparency

Majority of scientists admitted that when scientists communicate about GE science, it is basically the positive and promotional information that highlights benefits more than risks. Misinterpretation was affecting the way scientists communicate, compelling them to talk more of tangible benefits and less on unverified or “unknown” risks. Several non scientist interviewees corroborated the “biased reporting” linked to provision of information inclined more to successes:

“In Kenya, all we are hearing are the positive aspects. We know that no technology in this world is without risks. So why is the potential risk side [of GE technology] silent? That in itself sends alarm bells to us [civil society].” (NGOf-NS1, farmers’ rights advocacy, civil society, Nov. 2007)

Defending this practice, some researchers argued that, the nature of biological science training encourages them to pursue only facts, compelling them to withhold information that cannot be validated. This was discussed in connection with confidence and easiness in reporting facts as opposed to unverifiable information like cases of uncertainty. They further argued that reporting on GE risks may cause panic among the public if negative non-validated aspects related to scientific “process” are highlighted. However other interviewees claimed that, scientists withholding of some information was linked to “a normative rigid research practice” that compels them to vet what they report (ATp-PS3, Nov. 2007). This analysis seems to portray scientists as self centred, and tends to put to doubt their previous claims of fear of misinterpretation. Questionably, there is a disconnect between constrained communication and the unbalanced information consequently disseminated.

4.2.4.4. Unreliable & biased information and multiple obligations

Exogenous pressures were perceived by a number of scientists and most civil society interviewees to be limiting the reporting freedom of researchers, prompting them to produce what was referred to as “biased” and “unreliable” information, presumably manipulated to suit certain interests. Many felt that, reports emanating from research trials were unreliable because of the partnerships environment under which the trials are undertaken. This was perceived to be prompting reporting that favoured multiple obligations commensurate with different interests. This created tension amongst the civil societies: “it is difficult to say per se that in the current [donor] context the information from those researchers would be fully reliable” (NGOco-NS4, consumers’ network, Jan. 2008).

The preceding analysis suggests that certain technical and non technical factors largely influence the behavioural practice exhibited by scientists in knowledge production endeavours linked to biotechnology regulation. Some factors are associated with opportunities presented by GE science, while others are linked to challenges that confront actors including scientists as they engage in biotechnology research and regulatory process.

4.2.5. Technical experts and conflicts of interest

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.” (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 (see Kingiri, 2010). 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.

4.3. The never ending controversy

The Biosafety Act (2009) approved in Feb 2009 may be seen as a victory for agro biotechnology development towards benefiting the poor. The formation of an administrative entity, the NBA to legally manage biosafety controversies under the provision of this Act may also be seen as a plus towards development endeavours. However, the broader food security issues as well as socio economic and political environment mask smooth biotechnology development and regulation. On 14^th February 2011, the Kenyan cabinet made a political pronouncement that approved immediate importation of GM maize to avert a looming food crisis. This development received considerable media reportage which subsequently generated wide public protests led by civil society (see Opiyo, 2011; Omondi, 2011; Kinuthia, 2011). The proponents who include scientists did not see anything wrong with the importation citing scientific evidence that has shown GM products to be safe for human consumption. The opponents expressed scepticism citing unconfirmed risks posed by these products to human health. This controversy suggests that the debate surrounding biotechnology clearly continues to remain polarised making it harder for the public to endorse biotechnology products. This is a major drawback to science advancement as well as a threat to its longstanding authority in providing solutions to societal problems.

5. Discussion and conclusion

The foregoing empirical exploration of Kenya’s regulatory process exposes a controversial engagement in knowledge production dynamics. This is in part linked to weak governance structures in terms of both biotechnology delivery and related regulatory mechanisms. This has implications for productive knowledge convergence efforts. Firstly, in relation to who should be involved as stakeholders in the regulatory process and how they should be engaged, the Kenya’s case presents major participation and transparency challenges. The regulatory process although enlisting participation of both technical and non technical experts sidelined the public expertise (see also Kingiri, 2010). This may imply that expertise that may bring on board socio, economic and cultural contexts of Kenya’s broader agricultural terrain could have been ignored in decision making processes. For instance, the public private partnerships that are currently evident in Kenyan biotechnology initiatives are largely triggered by technical and financial constraints (Intellectual Property Rights-IPRs, infrastructure, funding, individual scientists interests etc) as opposed to the needs and production constraints that can benefit farmers. Secondly, the resources (including knowledge and information shared and disseminated amongst players, regulatory instruments, legal and administrative structures, media as avenue for information dissemination and experts) that purportedly steered the regulatory dynamics were not devoid of conflicts of interests and influence. This has implications for productive knowledge convergence efforts as it generates suspicion, luck of trust and perhaps potential rejection of science.

In a complex science policy terrain like biotechnology regulation, multiple contexts may work for or against the intended innovation and public policy. Thus, the following question posed by Haas, (1992:1) is very valid. Can policy makers or scientists themselves “identify national interests and behave independently of pressures of social groups they nominally represent?” He argues that, actors can learn new patterns of reasoning informed by a wider stakeholder needs and interests. The general argument advanced here is that technical experts that include scientists can genuinely play their part to influence positive change in policy-making through appropriate use of knowledge and information (Haas, 1992:3). The scientific community has a major role to play in this because they understand the complexities and uncertainties associated with biotechnology better than the non-scientists and policy makers (Bradshaw and Borchers, 2000). In addition, inclusion of a wide range of expertise that encompasses non-technical professionals is a positive way to democratise the regulatory process towards a socially robust knowledge production infrastructure (Nowotny, 2003; Nowotny et al., 2001, 2003).

The behavioural practice exhibited by Kenyan scientific experts in generation and handling of biosafety related information could be a concern for a productive knowledge convergence that is intended to promote biotechnology development and adoption. To promote credibility and transparency and consequently enhance trust associated with biotechnology; this paper further suggests a change of attitude of actors towards a socially responsible process. The scientific community and policy makers and those groups that claim to represent the farmers and public must be honest with no hidden agenda (Ammann and Ammann, 2004). In addition, reflexivity should be encouraged. As a value based practice, reflexivity is the process by which individuals involved in knowledge production try to operate from the standpoint of all experts involved (Gibbons et al., 1994). For the purpose of enhancing knowledge convergence in biotechnology development, expertise from different stakeholders should be considered in biosafety regulation and other decision making processes.

6. Lessons towards knowledgeconvergence

This section looks at insights that this paper can draw upon from almost two decades of Kenya’s biotechnology and regulatory regime co-evolution in terms of practice. Three distinct aspects are key in putting the lessons discussed here into context:

Dynamism: Biotechnology innovation is advancing at an unprecedented pace, perhaps faster than the capacities of actors and institutions to adjust in order to accommodate the requisite changes needed to foster innovation and responsive engagement of stakeholders, including regulation (Tait et al., 2006:379). This has called for new styles of governance that urge for participative decision making processes that consider all stakeholders’ interests and values (Lyall and Tait, 2005).

Multifaceted: Both biotechnology innovation and the embedded regulatory process involve many actors with each process being multifaceted. Consequently, the accompanying practices that actors chose to adopt or pursue are perceived to be problematic. According to Murphy and Chataway (2005), this may be attributed to influence of different policy cultures at the global level (e.g. EU versus US) and regional level (e.g. African Union). In the case of Sub Saharan Africa, this is also connected to influence of policy cultures at national levels (Mugwagwa, 2008).

Complexities related to shifting regulatory practice: The entire biotechnology and regulation revolution involves complex trade related and institutional dynamics (Fukuda-Parr, 2006) which inevitably impacts behaviour of actorslike scientists. In Kenya, the behavioural shifts are sometimes encouraged by the inadequate and specialised biotechnology-biosafety knowledge capacities needed to move the regulatory process forward. This may not be construed to be a bad thing because within a dynamic and functional system like biotechnology, this may promote cumulative knowledge and learning. However, how learning and knowledge are managed is important for practice.

Considering these dynamics, a number of lessons can be drawn in relation to knowledge use and policy making as explored next.

6.1. Harnessing the positive aspects and dealing with the negative aspects

We cannot rule out the important learning that has taken place in the evolving Kenya’s biotechnology regulatory system for almost two decades both at the institutional and individual levels, much of which constitute tacit knowledge. The government has to look for ways of using this accumulated knowledge. One way it can do this is to compile a list of experts who have been involved, and perhaps include and consider them as official experts. They would then be called upon from time to time in biotechnology and biosafety awareness campaigns and capacity building efforts targeting the wider stakeholder communities. In addition to sensitising people about specific technical subjects, they would also be requested to talk about their experiences in biosafety regulatory process, providing a platform for meaningful deliberations that can bring about knowledge convergence promoting pro-poor and pro-biotechnology innovation agenda.

It is possible that the regulatory dynamics discussed in Section 5above may have a negative impact on future biotechnology deployment and adoption. For instance, the scientific community’s active participation in the regulatory process may have resulted into more of technical and scientific knowledge informing the policy deliberations. This may have ignored some other relevant knowledge which may enhance convergence efforts. These possible negative aspects cannot be ignored and have to be factored into future decision-making processes. How can this be done?

• The government has a major role to play by adopting a governance approach to public policy processes through weighing and analysing the types of knowledge that inform the process. The objective would be to ensure that socially desirable knowledge informs the final policy outcome (Nowotny et al., 2001).

• The government needs to build and sustain technical capacities thereby have a wide pool of experts in which to draw expertise from. It should also spread its wings to other academic and non academic institutions to solicit expertise not only for regulatory instruments, but also for overall risk assessment and environmental safety reviews.

6.2. Reconceptualising policies formulation process

In addition to the above lessons, the significant shift in behavioural practice associated with knowledge actors demonstrated empirically in the Kenyan case that accompany the biotechnology and biosafety revolution lead to a compelling urge to reconsider how policy and regulatory formulation processes are conceptualised and articulated. Regulatory practice, 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 this inevitable change in practice. This is not to denounce the economic and institutional factors in which this shift is embodied, but rather to suggest that this becomes an additional consideration in policy processes. Since this shift is exhibited by actors spread out in different institutions (academic, policy, NGOs, public), effective policy and regulatory processes must first acknowledge its potential to influence policy directions. Consequently, strategies should be devised that encourage a reflexive and responsive behaviour (Lyall, et al., 2009: 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 development and regulation in order to enhance convergence of knowledge for sustainable development.

Acknowledgments

This paper is based on research conducted in Kenya over the period 2006-2011 funded by the Open University, UK, the UK Economic and Social Research Council (ESRC), Innogencentre and partly by the United Kingdom, Department for International Development (UK-DFID) - Research Into Use (RIU) program, and African Centre for Technology Studies (ACTS). The author gratefully acknowledges this support. The views expressed in the paper do not necessarily reflect those of the Open University, ESRC Innogencentre,DFIDand ACTS.