The effective and safe use of biotechnologies requires a broad portfolio of policies, regulations, and processes to support national decision-makers. By applying an integrated, synergistic, and tailored approach, the ICGEB Regulatory Science Group assists countries to create and enhance national capacities in the regulation of biotechnology and its products.
The focus of the Group is primarily the improvement of capacities to ensure regulatory effectiveness in a changing landscape of evolving biotechnologies and human resource mobilisation. For over 10 years, the Group has strengthened the institutional capacities of governments in sub-Saharan Africa, Central America and the Caribbean to regulate the products of biotechnologies in alignment with their policy objectives.
The emergence of new biotechnologies, especially gene drives, genome editing and RNAi technologies, which result in a broader range of applications and which, by extension, help governments to attain a broader range of policy goals, has also resulted in increased requests for support. In addition to its previous work concerning the regulation of genetically modified organisms (GMOs), the Group is expanding the type of assistance it provides; to include, for example, the exploration and refinement of the regulatory arenas that cover non-GMO biotechnology products.
The activities of the Group are financially sustained through significant contributions from eminent international donors and philanthropic foundations, and provide a range of administrative and technical tools and approaches to help improve the effectiveness of National Competent Authorities (NCAs) and their technical committees. It does so in partnership with the concerned government officials and experts, such that the resultant procedures and processes are not only tailored to the national regulatory framework and are immediately applicable, but is done so in a collaborative fashion to help guide and improve the skills of regulatory officials and encourage networking with their regional and international peers. In this way, they are empowered to address their needs more autonomously, whilst becoming more aware of regulatory challenges arising elsewhere and thus can increase their preparedness. The ultimate goal is to develop robust, non-fragmented regulatory mechanisms that are independent of human resource fluctuations.
The Group has also developed a portfolio of eLearning biosafety modules that is being offered freely to regulatory authorities in sub-Saharan Africa (https://showcase-icgeb.elearning.it/index.html), and is also available to similar entities, research institutions and multi-disciplinary projects in and beyond ICGEB Member States.
ICGEB Regulatory Science Group and UN Sustainable Development Goals
The Group’s activities support and organise triangular cooperation to energise and strengthen biotechnology regulatory offices in the Global South. A strategic approach for personal and institutional capacity building has been employed, such as South-South partnerships, triangular cooperation (South-North-South), and critical alliances. The outcome of autonomous, robust and structured regulation is the availability of more healthier and safer food and products from fewer resources while reducing pressure on natural ecosystems, as well as the support of value-added commodity trade to support sustainable development. Hence, SDGs 2, 3, 9, 12, 15, and 17 are guiding these activities.
Biosafety Capacity Building in sub-Saharan Africa
Assisting the Caribbean Regional Biosafety project
GRACE: GMO Risk Assessment and Communication of Evidence
Italian BCH: Biosafety Clearing House
A portfolio of curriculum-based modules encompassing the biosafety of genetically modified organisms and related matters in biosecurity, public health, natural resource management, biocontrol and bioremediation.
Arpaia S, Christiaens O, Giddings K, Jones H, Mezzetti B, Moronta-Barrios F, Perry J, Sweet J, Taning C, Smagghe G & Dietz-Pfeilstetter A, 2020. Biosafety of GM crop plants expressing dsRNA: Data requirements and EU regulatory considerations. Frontiers in Plant Science, 11: 940-952
Devos Y, Craig W, Devlin RH, Ippolito A, Leggatt RA, Romeis J, Shaw R, Svendsen C & Topping CJ, 2019. Using problem formulation for fit-for-purpose pre-market environmental risk assessments of regulated stressors. EFSA Journal 17(S1): e170708.
Seyran E, & Craig W, 2018. New Breeding Techniques and Their Possible Regulation. AgBioForum, 21(1): 1-12
Ndolo D, Wach M, Rüdelsheim P & Craig W, 2018. A Curriculum-Based Approach to Teaching Biosafety Through eLearning. Frontiers in Bioengineering and Biotechnology, 6: 42-49
Rosado A, Craig W, 2017. Biosafety regulatory systems overseeing the use of genetically modified organisms in the Latin America and Caribbean region. AgBioForum, 20(2): 120-132
Racovita M, Obonyo DN, Craig W, Ripandelli D, 2015. What are the non-food impacts of GM crop cultivation on farmers’ health? Environmental Evidence 4:17
Obonyo DN, Racovita M, Ripandelli D, Craig W, 2014.Biosafety issues in food and agricultural systems in Africa
Racovita M, Obonyo DN, Craig W, Ripandelli D, 2014. What are the non-food impacts of GM crop cultivation on farmers’ health? A systematic review protocol. Environmental Evidence 3(1)
For more information:
Regulatory Science Group
Email: [email protected]