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PAAP’s Electronic Newsletter 22 August 2008 Volume 11 Number 16 TOWARDS A BIOSAFETY ROADMAP FOR THE COMESA REGION The overarching goal of the Common Market for Eastern and Southern Africa, (COMESA) is to achieve free trade in the region. However, the attainment of this goal will depend on the harmonization of policies, laws and regulations affecting trade in the various member countries. This issue of the newsletter highlights harmonization efforts in COMESA for policies related to trade in biotechnology and biosafety issues. This is carried out under PAAP’s rationalization and harmonization project module 4: RABESA. The synchronization of biotechnology policies and laws among COMESA countries is not only beneficial but will become essential for free trade, especially with respect to agricultural commodities in the region is to be achieved. Introduction T HE Association for Strengthening Agricultural Research in Eastern and Central Africa (ASARECA) is the COMESA region‟s implementing arm for Comprehensive African Agriculture Development Programme (CAADP) Pillar IV on agricultural research, technology dissemination and adoption. CAADP describes African leaders‟ collective vision for agricultural development. It sets an ambitious goal of 6 percent growth per annum for the sector through enabling and accelerating innovation. CAADP Pillar IV constitutes the African Union‟s New Partnerships for African Development (AU-NEPAD) strategy for revitalising, expanding and reforming Africa‟s agriculture. It is widely recognized that the most effective way to reduce poverty and improve food security in the long run is to raise the productivity of resources that poor people depend on for their livelihood. In the case of most African countries, these resources are agricultural land and labour. Agriculture-led development and the objective of a 6 percent agricultural growth cannot be attained without rapid and sustained productivity increase in the agricultural sector. The evolution of RABESA The Regional Approach to Biosafety and Biotechnology Policies in Eastern and Southern Africa (RABESA) is a COMESA initiative nested within the auspices of CAADP Pillar IV. RABESA arose out of concerns in the COMESA community that unprecedented diffusion rates of genetically modified organisms (GMOs) across borders was likely to impact on trade and access to 1 emergency food aid in unprecedented ways. Increased regional integration and pursuit of free trade arrangements had made borders porous. The unregulated transboundary movement of GMOs hence posed a threat, the dimensions of which were unclear. In November 2001 in Kampala, the COMESA Ministers of Agriculture proposed that their countries harmonize their biosafety policies. ASARECA with its strong regional orientation to research collaborated with the Programme for Biosafety Systems (PBS) and the African Center for Technology Studies (ACTS) with support from USAID‟s Regional Economic Development Support Office (REDSO) designed RABESA. In September 2003, COMESA endorsed the implementation of RABESA at the maize trade policy conference held in Nairobi and Phase I commenced in 2004 and ended in 2006. RABESA Phase 1 activities The first phase focused on studies geared at generating sufficient evidence necessary for COMESA to develop a policy position on biosafety and biotechnology issues in the region. These studies were conducted in six countries: Egypt, Ethiopia, Kenya, Tanzania, Zambia and Uganda. The studies focused on: commercial export risks, emergency food aid vis-à-vis GMOs and estimation of economic gains from GM crops. The studies revealed that: 1. The magnitude of commercial risks associated with GMOs will be relatively small for COMESA countries. African countries heavily export to Europe commodities such as tea, coffee, sugar and cocoa (commodities not available in GM form). Intra regional trade within COMESA rose from US $ 4 billion in 2001 to US $ 9 billion in 2005. Agricultural commodities comprise about 40 percent of the regional trade by volume. Intra-regional trade in commodities such as maize and cotton (available in GM form) is high in the COMESA region. Hence intra-regional commercial risks likely to be high if COMESA countries go for planting of GMOs. 2. Keeping the COMESA region GM-free would diminish access to needed food imports under emergency situations. 2 COMESA countries exhibit high dependency on food aid. Food aid shipments through the World Food Programme (WFP) to COMESA countries amounts to about 85 percent of all food aid shipments to sub Saharan Africa (SSA). A large proportion (about 65 percent) of food aid to COMESA countries is sourced by WFP from countries that plant GMOs (Canada and United States) without segregation High probability that Food aid distributed is GM 3. Farmers‟ incomes in the COMESA region would increase significantly if they adopted GM insect resistant varieties of cotton and maize compared to the conventional ones. There was hence need for harmonized regional biosafety policies not only to protect but also to enhance trade. On the basis of this analysis, RABESA organized a regional meeting that brought together 90 participants from COMESA on 30-31 May 2006 in Nairobi (ECAPAPA Newsletter 02 June 2006-Volume 9 Number 10). The meeting identified 3 priority areas for harmonization, namely: Commercial planting of GMOs- Centralized regional assessment of the GMOs followed by a national decision. Commercial trade policy for trade in GMOs- Countries would obtain advice from a central regional clearing house and take a national decision. Food aid policy for emergency food aid with GM content- Guidelines developed at regional level and the decision to be taken at the country level on a case by case basis These recommendations were presented at the 4th meeting of the COMESA Ministers of Agriculture held in Khartoum in March 2007 and the ministers endorsed implementation of RABESA phase II. At the 5th meeting of the COMESA Ministers of Agriculture held in Seychelles in 2008, the need to hasten the harmonization process was reiterated that RABESA II focuses on a roadmap for harmonization of bio-technology and bio-safety regulations in the region, put in place a panel of experts and centres of excellence for the region and should work with other initiatives in the region that have activities in the area of bio-technology and bio-safety. RABESA II Outputs PAAP, PBS and more recently, the International Service for the Acquisition of Biotech Applications (ISAAA) are working together on RABESA II. Expected outputs are: 3 1. Drafting of regional biosafety guidelines and policies for handling commercial planting of GMOs, trade in GM products and emergency food aid. 2. A guide on how designated regional centers of excellence can support COMESA harmonization efforts, risk assessment and management, identification and testing of GMOs and capacity building. 3. Develop and implement COMESA outreach and communication strategy--the strategy will define effective mechanisms for disseminating information, fostering coordination and collaboration among different regional partners and other RECs. 4. Develop a biosafety roadmap to provide guidance to countries on how to build and implement a national biosafety system. A panel of experts comprising of eminent persons on biotechnology and biosafety will provide oversight and ensure that the project remains focused and consistent with the goals of COMESA. The RABESA II outputs will be reviewed and endorsed by the panel of experts, regional stakeholders and final endorsement by COMESA Ministers of Agriculture in addition to regular updates at the COMESA Technical Committee on Agriculture and Ministerial meetings. The work on harmonization should lead to enhanced capacity of the COMESA member states to make informed decisions on handling of GMOs; enhanced level of awareness and understanding of the potential impacts of GMOs on trade and access to food imports (including emergency food aid) among policy makers and ultimately reduced trade barriers, increased agricultural productivity and food security. Some of the immediate quantifiable benefits of harmonization will be capacity building support through designated regional centers of excellence, reduced costs and duplication in testing and approval procedures, and enhanced information sharing and coordination on regulatory approvals/ transboundary movement of GMOs across RECs and countries. Why COMESA needs a biosafety roadmap National biosafety systems have been implemented in most countries on a “piece by piece” basis, usually responding to applications for research or release into the environment or as a response to international agreements such as the Cartagena Protocol on Biosafety. However, progress is very uneven across COMESA member countries; a few countries such as Egypt, Kenya and Uganda have ratified the Cartagena Protocol on Biosafety and have worked on their National Biosafety Frameworks in order to implement the Protocol at national level. A practical roadmap to guide countries will promote the implementation of national biosafety frameworks by more countries in the region in a way that allows countries to share each others experiences and decisions and benefit the region as a whole. 4 There is no single best approach or standard to biosafety that reflects national environmental, cultural, political, financial and scientific heterogeneity. However, COMESA countries can achieve significant gains from using a common conceptual framework for implementation that is attuned to ongoing COMESA-wide regional activities to pool human, financial and technical resources for risk assessments and those directed towards harmonizing principles and standards for decision making, while avoiding equally significant issues such as unapproved dissemination of technologies approved in neighboring countries. A biosafety roadmap will specify critical decision points and milestones in the development of national biosafety systems, systematically examine choices among policy options, delineate scientific and social dimensions of these options, and examine linkages with the ongoing COMESA and other efforts to develop regional biosafety systems. Despite the need to customize each country‟s biosafety system, opportunities arise for countries‟ biosafety systems to converge based on common interests, backgrounds, environmental similarities, heritage and trade interests. The need for biosafety regulatory frameworks Each country needs a biosafety regulatory framework because of the need to examine broadly potential risks and benefits from the introduction of a potential biotechnology in the country. It is critical to include all direct and opportunity benefits and costs of adopting and not adopting biotechnologies and alternatives. This helps identify which areas contribute more overall to safety and net benefits in order to focus investments while avoiding investing in issues that are trivial, manageable or irrelevant. Approaches to a national biosafety regulatory framework Irrespective of approach, each framework should specify the critical decision making points for which regulations should be specified. Biosafety regulatory decision points occur at proof of concept- determining whether the genetically engineered product is viable for national trials, at greenhouse/laboratory stage, confined field trial, commercialization and post commercialization stages. Each choice of policy option must be systematically examined to delineate its scientific and socio-economic dimensions. Furthermore, each country would benefit from examining efforts within COMESA to develop regional approaches to regulation. The first approach to a national biosafety regulatory framework is to pursue a flexible approach to biosafety. In this approach biosafety is contrived as a learning process, composed of a series of 5 steps with decision making having “start” and “end” points. A country does not have to complete every single step in-country or to have the full capacity to complete each and every step upfront. For instance, countries may complete biosafety evaluations without having complete capacity in- country. The alternative approach is to develop a complete system starting from national policies and strategies to building human and financial capacity. Evaluating national biosafety needs and existing capacity In a nutshell, conducting a country‟s biosafety evaluation would focus on the following four key elements: 1. National Policy and Strategy • Does the country need specific policies and strategies for biotechnology and biosafety? • Identification of related and/or relevant national regulatory frameworks germane to biosafety systems 2. Scientific Knowledge, Skills and Capacity Base 3. Expertise for biosafety review • Institutional biosafety committees • National biosafety committee • Implementation personnel (risk assessors, field inspectors, etc.) 4. Regulatory Development • Legislative framework • Regulatory triggers • Approaches to risk assessment, management and communication Status of biotechnology and biosafety in three COMESA countries Egypt Egypt has the highest level of biotechnology activity in the COMESA region. Biotechnology research is coordinated by the Agricultural Genetic Engineering Research Institute (AGERI), which was established in 1990. In 2008, Egypt approved the cultivation and commercialization of a Bt maize variety; marking the first legal introduction of genetically modified (GM) crops into the 6 country. Other GM crops undergoing trials include cucumbers, potatoes, squash, melons, potato and sugar cane. The process of development of the Egyptian biosafety system is distinct from the development of biosafety systems in most of the other COMESA regions. Unlike these other countries, in Egypt, the biosafety system evolved simultaneously with biotechnological research. The various components were established on a need basis. A manifestation of this is the testing requirements for GMO seed certification which were not clarified until the first applications for commercial release were submitted to the Seed Registration Committee. Policy Despite the absence of a national policy dealing solely with biotechnology, there are various government policies on the different aspects of biotechnology and biosafety. For instance the government has policies for release of crop varieties, registration and release of all seeds. The government has also set out procedures for the importation of GM crops into Egypt. Legislation Egypt currently has no specific biosafety legislation. However, a regulatory framework exists consisting of regulations, guidelines and decrees. The guidelines provide guidance on modalities of use, handling, transfer, and testing of GMOs; they address laboratory practices, greenhouse containment, and small-scale field testing. The guidelines describe the institutional mechanism for implementation of biotechnology regulation and policy. They establish a National Biosafety Committee (NBC). The NBC is the official body responsible for ensuring that biotechnology continues to be safe and facilitating access to modern biotechnology generated abroad. The membership of the NBC is drawn from across various departments in the government. It also includes private sector representatives and NGOs. Kenya Kenya is a member of the East African Community (EAC). In 2004, the EAC Council of Ministers established an EAC Partner States‟ Technical Committee of Experts to address biosafety issues on GMOs and recommended the development of an East African regional policy, legal and regulatory framework on GMOs. Kenya was involved in the implementation phase of the United Nations Environment Programme –Global Environment Facility (UNEP-GEF) Project on the Implementation of the National Biosafety Projects after having developed a national biosafety framework which comprised a combination of policy, legal, administrative and technical instruments set in place to 7 address safety for the environment and human health in the context of modern biotechnology. The broad elements of the framework include: policy on biosafety; legal/regulatory system; administrative system to handle requests for permits which includes risk assessment procedures to help in decision-making; mechanism for monitoring and inspection and; system to provide information to stakeholders about National Biosafety Frameworks and for public participation. The country has recognized the need to catalyze the process of policy and legislative enactment to ensure that the biotechnology activity results in Kenya‟s sustainable development. Policy In 2006 the Government approved a National Biotechnology Development Policy. The Policy demonstrates Kenya‟s proposed course of action with respect to biotechnology. The policy is developed ‘to consider biotechnology in the context of the need for increased food production, poverty alleviation and environmental protection.’ The document recognizes the potential role of biotechnology in poverty reduction, enhancing food security and conservation of the environment and biodiversity. The policy addresses the issue of public participation in biotechnology by highlighting the need for transmission of useful information to the public. The scope of the policy is set out as; traditional and modern biotechnology; genetically modified organisms in transit; and genetically modified organisms that are pharmaceuticals, biologicals, food and feeds for human for animal use. There is an explicit exclusion of human cloning and a general restriction on the exercise of unethical biotechnological practices. The policy sets out the precautionary principle as one of the fundamental guiding principles for regulating biotechnology, in accordance with the spirit of the CPB. The policy recognizes the regional context within which biotechnology activity is occurring. It makes reference to the regional biotechnology initiatives in which Kenya is already engaged in such as ASARECA. Mention is made of the need for international and regional cooperation but no specific proposals on how this is to be achieved are made. Legislation Despite the various implicit references to aspects of biotechnology in several sectoral legislations, Kenya is yet to enact a specific legislation to regulate all aspects of modern biotechnology. In 1995, the National Council for Science and Technology (NCST) initiated a process of developing the national biosafety guidelines and regulations. These were issued in 1998 and revised in 2003 under the Science and Technology Act 1980. The guidelines and regulations made a provision for the establishment of a National Biosafety Committee (NBC) to serve as the technical arm of the Council in overseeing coordination and implementation of biosafety issues. In absence of a primary 8 biosafety law, the NBC has applied the guidelines and regulations in reviewing and approving applications to introduce modern biotechnology products exclusively for research trials, under the ambit of existing legislation. GM products that have been approved for contained and confined field trials include insect-resistant maize and cotton, GM sweetpotato, virus-resistant cassava, GM sorghum and rinderpest vaccine. These guidelines have not themselves, been promulgated into law and as such, lack adequate and streamlined legal enforcement to permit commercial release of GM crops. The need for a comprehensive law was recognized and the process of drafting a Biosafety Bill commenced in 2002 under the leadership of the NCST. The process has resulted in the publication of Biosafety Bill 2008 in the Kenya Gazette Supplement No. 48 (Bills No. 15). The Bill was presented to Parliament in July 2008 for the first reading. The Bill seeks to bring Kenya‟s regulatory framework in line with the CPB which it has both signed and ratified. Madagascar Policy Madagascar has developed a national biotechnology/biosafety policy whose objective is to address the issue of GMOs, in line with national policy and its international obligations and in accordance with the principles of the Rio Declaration. The National Biosafety Policy outlines the objectives pursued by the Republic of Madagascar as regards prevention of biotechnological risks. These objectives are described in the policy as follows: to address the issue of GMO in a rational, objective and secure way on the basis of: well controlled information; a restricting legal tool; appropriate technical and scientific capacities; and according to a process of decision-making implying the public participation. The policy also sets out the procedures of intervention to ensure the effectiveness of the actions undertaken to achieve these goals. The policy includes priority training areas for capacity building. Legislation Madagascar has a draft Bill relating to biosafety. The objective of the Bill is to provide biosafety measures in the course of the use of GMOs. The Biosafety Bill is not to be applied independently but rather in conjunction with several pre-existing regulations. The language and structure of the Bill is simple and can be easily used by persons without a legal background. The decision making mechanism consists of several bodies: 9 The National Competent Authority (NCA), which carries out administrative duties such as the reception of the applications and the notification of the importing party. The NCA refers to the National Biosafety Committee (NBC), an inter-ministerial body. The Scientific and Technical Committee (STC) which the NBC refers to for expertise. The STC carries out risk assessment then gives opinions to the NBC. The Committee of Public Consultation (PC), which examines the information provided by the applicant and the results of the risk assessment provided by the STC. Conclusion The biosafety frameworks of most of the COMESA countries were not developed in the context of regional blocs but rather in the context of each individual country. This may have been occasioned by the difficulty created by the numerous regional initiatives in Africa, many of which are overlapping. The lack of coordination has resulted in duplication of resources and sub optimization of regional goals with respect to biotechnology. Current harmonization initiatives such as RABESA are evidence of the fact that Africa is moving in the right direction. For COMESA to eliminate the actual and potential technical barriers in the realm of biotechnology there is a need to re-conceptualize the biosafety frameworks of the various COMESA member countries in the context of the region as opposed to the current position in which each country defines its biosafety policy and law in the context of its individual needs. In the first phase of the RABESA initiative, alternative approaches to the regional policy harmonization were proposed. Given the problems associated with a „tight harmonization approach‟ a „loose harmonization approach‟ was recommended for COMESA countries in this first phase. Such an approach would require a standard from which to set minimum biosafety measures for the entire region. Once these are in place, individual countries could be allowed to exceed the minimum. However, such excesses should take into consideration the good of the entire region and not just the individual country as any other attitude would undermine the very objective of regional cooperation. This article was compiled from contributions by Dr. Michael Waithaka, Manager Policy Analysis and Advocacy Programme (PAAP, ASARECA), José Falck-Zepeda (IFPRI-PBS), David Wafula (PBS-IFPR Kenya) and Elizabeth Gachenga (Strathmore University, Nairobi). For further information on RABESA or the full text of the update on biotechnology and biosafety in COMESA please contact Dr. Michael Waithaka at: firstname.lastname@example.org and/ or the RABESA regional project leader David Wafula at: email@example.com 10 11 COMMUNICATION Vacancies 1. Opportunities at COMESA Secretariat Director Legal and Institutional Affairs Executive Support Officer Senior Customs Expert Monitoring and Evaluation Expert Detailed information about these vacancies is available on the COMESA website www.comesa.int under vacancies. PAAP received this information from Muzinge Nampito-Chibomba of COMESA, she is gratefully acknowledged. 2. Opportunities at IFPRI Research Fellow (RF)/Senior Research Fellow ISNAR, Addis Ababa or Washington DC; Postdoctoral Fellow in the Division of Development Strategy and Governance (DSG), Addis Ababa, Ethiopia. For further details about these vacancies inquire from Alma Lopez at firstname.lastname@example.org or visit www.ifpri.org. PAAP received this information from Vicki Wilde of the CGIAR Gender and diversity Program, she is gratefully acknowledged. Fellowships Vavilov-Frankel Fellowships for 2009 The Vavilov-Frankel Fellowships 2009 aims to encourage the conservation and use of plant genetic resources in developing countries by awarding Fellowships to outstanding young researchers to carry out relevant innovative research at an advanced research institute outside their own country for a period of between three months and one year. The Fellowships are supported by the Grains Research and Development Corporation (GRDC), Australia and Pioneer Hi-Bred International, Inc., United States, a DuPont Company. The closing date for 2009 intake is 9 November 2008. The application forms and guidelines for preparation of research proposals are available from Bioversity‟s web site http://www.bioversityinternational.org/index.php?id=49#c285 or directly from Elisabetta Rossetti, at: email@example.com PAAP received this information from Lewa Doris of Bioversity International, she is gratefully acknowledged. 12 This newsletter is an attempt to use e-communications to provide to a broad audience within and outside Eastern and Central Africa a mechanism for distribution and exchange of information relevant to agricultural policy issues. This newsletter is being sent to you as PAAP’s stakeholder. We want to respect your privacy and desire not to have your e-mail inbox filled with unwanted correspondence. If you do not want to receive this newsletter please send us a note at <firstname.lastname@example.org>, and we will remove your name from the distribution list. For back issues of this newsletter, visit:http://www.w1.co.ug/asareca/htdocs/ecapapa/archives.php PAAP website http://www.asareca.org/paap is still under reconstruction and several documents are yet to be uploaded. We expect this to be rectified soon, thanks. 13
"PAAP Newsletter Vol 11 No 16"