ABSTRACT
African countries face key challenges in the deployment of GM crops due to incongruities in the processes for effective and efficient commercial release while simultaneously ensuring food and environmental safety. Against the backdrop of the preceding scenario, and for the effective and efficient commercial release of GM crops for cultivation by farmers, while simultaneously ensuring food and environmental safety, there is a need for the close collaboration of and the interplay between the biosafety competent authorities and the variety release authorities. The commercial release of genetically modified (GM) crops for cultivation requires the approval of biosafety regulatory packages. The evaluation and approval of lead events fall under the jurisdiction of competent national authorities for biosafety (which may be ministries, autonomous authorities, or agencies). The evaluation of lead events fundamentally comprises a review of environmental, food, and feed safety data as provided for in the Biosafety Acts, implementing regulations, and, in some cases, the involvement of other relevant legal instruments. Although the lead GM event may be commercially released for farmers to cultivate, it is often introgressed into locally adapted and farmer preferred non-GM cultivars that are already released and grown by the farmers. The introduction of new biotechnology products to farmers is a process that includes comprehensive testing in the laboratory, greenhouse, and field over some time. The process provides answers to questions about the safety of the products before being introduced into the environment and marketplace. This is the first step in regulatory approvals. The output of the research and development phase of the product development cycle is the identification of a safe and best performing event for advancement to regulatory testing, likely commercialization, and general release. The process of the commercial release of new crop varieties in countries with established formal seed systems is guided by well-defined procedures and approval systems and regulated by the Seed Acts and implemented regulations. In countries with seed laws, no crop varieties are approved for commercial cultivation prior to the fulfillment of the national performance trials and the distinctness, uniformity, and stability tests, as well as prior to the approval by the National Variety Release Committee. This review outlines key challenges faced by African countries in the deployment of GM crops and cites lessons learned as well as best practices from countries that have successfully commercialized genetically engineered crops.
ABSTRACT
The New Partnership for Africa's Development (NEPAD) Agency recognizes that Africa is in a period of transition and that this demands exploring and harnessing safe advances made in science-based innovations including modern biotechnology. To advance the science of biotechnology in Africa effectively, while at the same time safeguarding human health and the environment, the African Union (AU) adopted a High-Level Panel report on modern biotechnology entitled, Freedom to Innovate, which advocated for a coevolutionary approach where technology development goes hand in hand with regulation. Furthermore, most AU member states are Parties to the Cartagena Protocol on Biosafety (CPB), a legally binding international agreement negotiated, concluded and adopted within the framework of the Convention on Biological Diversity. This seeks to guide Parties in developing systems for the environmentally sound management of modern biotechnology applications. Currently, 49 AU Member States have signed and ratified the CPB, of which 12 have passed biosafety laws. African Union (AU) member states are at different stages in the development of regulatory frameworks for applications of modern biotechnology, which include genetically modified (GM) products and other emerging technologies. Biosafety regulatory frameworks comprise: biotechnology and/or biosafety policy; laws, regulations and guidelines; administrative systems; decision-making systems; and mechanisms for public engagement. To assist Member States to implement functional regulatory frameworks for both agriculture and health applications, the NEPAD Agency established the African Biosafety Network of Expertise (ABNE) and the African Medicines Regulatory Harmonization (AMRH). Currently, transgenic insects and GM crops are regulated by Competent National Authorities whose mandate derives from national biosafety laws. For GM crops, a lot of research has been conducted up to the confined field trial (CFT) and multi-location trials stages in a number of African countries. Burkina Faso has fully functional containment facilities for transgenic mosquitoes while Mali and Uganda are developing theirs. The Burkina Faso regulatory agency has granted permits and has already received sets of sterile mosquito eggs for trials in the contained facility. It is instructive to note that both ABNE and AMRH have worked with national and regional regulatory bodies in Africa to enhance their technical capacities for informed decision making, adoption of best practices, and compliance with international standards. It is against the backdrop of a rich blend of on-the-ground knowledge, experience, expertise, and insight into the context and political sensitivities of member states that the NEPAD Agency seeks to expand existing support. This would include capacity strengthening in the regulation of emerging technologies, such as the application of gene drives in the development of transgenic mosquito for the control of malaria transmission.
ABSTRACT
The regulation of genetically modified (GM) crops is a topical issue in agriculture and environment over the past 2 decades. The objective of this paper is to recount regulatory and adoption practices in some developing countries that have successfully adopted GM crops so that aspiring countries may draw useful lessons and best practices for their biosafatey regulatory regimes. The first 11 mega-GM crops growing countries each with an area of more than one million hectares in 2014 were examined. Only five out of the 11 countries had smooth and orderly adoption of these crops as per the regulatory requirement of each country. In the remaining 6 countries (all developing countries), GM crops were either introduced across borders without official authorization, released prior to regulatory approval or unapproved seeds were sold along with the approved ones in violation to the existing regulations. Rapid expansion of transgenic crops over the past 2 decades in the developing world was a result of an intense desire by farmers to adopt these crops irrespective of regulatory roadblocks. Lack of workable biosafety regulatory system and political will to support GM crops encouraged unauthorized access to GM crop varieties. In certain cases, unregulated access in turn appeared to result in the adoption of substandard or spurious technology which undermined performance and productivity. An optimal interaction among the national agricultural innovation systems, biosafety regulatory bodies, biotech companies and high level policy makers is vital in making a workable regulated progress in the adoption of GM crops. Factoring forgone opportunities to farmers to benefit from GM crops arising from overregulation into biosafety risk analysis and decision making is suggested. Building functional biosafety regulatory systems that balances the needs of farmers to access and utilize the GM technology with the regulatory imperatives to ensure adequate safety to the environment and human health is recommended.
