Assisting the development of effective safety and regulatory systems for the products of modern biotechnology in selected countries of sub-Saharan Africa

BACKGROUND

The Biosafety Unit, in partnership with the Bill & Melinda Gates Foundation, is implementing a Project focusing on enhancing the ability of regulatory authorities in sub-Saharan Africa (SSA) to regulate the development and/or commercialisation of the products of modern agro-biotechnology (genetically modified [GM] products).The strategy involves the development of a resource pool of African expertise by which biosafety regulatory systems can be staffed effectively and sustainably. The first phase (2009-2012) of the Project focused on: i) enhancing local knowledge in biosafety, through the completion of 8 training workshops in which 214 Africans participated, and by supporting 39 delegates to 9 international meetings, and; ii) integrating biosafety research results into national/regional biosafety regulatory frameworks, by supporting the completion of a MSc programme in GM crop risk assessment by 16 African regulators and technical advisors. The content of the MSc programme was specifically tailored to the needs of African Competent Authorities, and was developed following extensive discussions between ICGEB and Aberystwyth University, UK.

The second phase (2013-2016) is building and expanding upon the first and involves: i) provision of advanced academic training in biosafety; ii) re-integration of personnel academically-trained during the Project into their national biosafety regulatory systems; iii) organising biosafety training workshops tailored to local and regional needs; iv) offering a number of regulatory exchange opportunities to African regulators and their scientific experts to visit established and high throughput regulatory offices, and; v) offering opportunities to experienced non-African regulators to visit a limited number of regulatory offices in SSA to provide local assistance in improving regulatory effectiveness. In addition, acknowledging that there are numerous on-going biosafety programmes currently operating in SSA, efforts are being made to enhance partnerships with these programmes.

Project beneficiary countries in the current phase of the Project include Burkina Faso, Ethiopia, Ghana, Nigeria, Tanzania and Uganda. This document highlights some of the Project activities during this current second phase.

 

PROJECT ACTIVITIES 

Master Programme

Advanced academic training in biosafety

Eighteen regulatory officials/scientists from SSA have been offered 2-year Master fellowships in Biotechnology, with a special focus on GM Crop Regulation. 13 fellows (2013-2014 and 2014-2015) have completed the Masters programme, and graduated while 4 have recently completed their studies and awaiting graduation. The Masters programme was specially developed for the Project at the University of Adelaide (Australia), and also includes Confined Field Trial (CFT) site visits and mentoring by Australia's Office of the Gene Technology Regulator (OGTR) staff.

Papers published by Master Fellows:

Kitimu SR, Taylor J, March TJ, Tairo F, Wilkinson MJ, Rodríguez López CM, 2015. Meristem micropropagation of cassava (Manihot esculenta) evokes genome-wide changes in DNA methylation. Frontiers in Plant Science 6: 590.

Nzeduru CV, Ronca S, Wilkinson MJ, 2012. DNA barcoding simplifies environmental risk assessment of genetically modified crops in biodiverse regions. Plos One 7(5): e35929.

The ICGEB-funded students (1st intake [2013-2014; left] and 2nd intake [2014-2015; right]) undertaking the Master Programme in Plant Biotechnology at the School of Food and Wine of The University of Adelaide, Australia.

Re-integration of personnel accademically-trained during the Project into their national biosafety regulatory systems

Each ICGEB-supported Master fellows spends a period of 3-6 months in the second year of the programme in their home country carrying out research projects targeted to existing local biosafety data deficits. National Biosafety Authorities assist in scoping and planning the research projects to help maintain relevancy.

                  

Left: ICGEB Master Fellow, Peter Ketting sorting out insect pests of cowpea for morphological identification and DNA extraction in the Biotechnology Laboratory of Savanna Agricultural Research Institute (SARI) Nyankpala, Tamale, Ghana, during his home research project. Right: ICGEB Master Fellow Lorretha Emenyeonu, isolating DNA from seed aerosol samples during her home research project.

                    

Development of a Masters Programme in Africa

The Project is working with the Universities of Ghana and Nairobi to develop a Master of Biosafety programme in sub-Saharan Africa. These are institutions with strong credentials in education and training, biosafety research, policy and regulation. ICGEB has several years of experience in biotechnology and biosafety research, and training and has worked extensively in SSA. ICGEB is coordinating the development of the programme and providing both technical input as well as partial financial support to the process. The Universities of Ghana and Nairobi, where the course would be offered, are among the most highly ranked Universities in SSA. The programme is being developed to make it possible to have selected modules taken online. Sub-modules of some courses will also be developed for use in in-house training by National Biosafety Authorities/National Competent Authorities (NBAs/NCAs). There has also been active interest from, and discussions with, a number of other Universities in SSA to adopt the curriculum that has been developed under this activity.

Left: L-R - Prof. Kwabena Bosompem (UoG), Dr. Dennis Ndolo Obonyo (ICGEB), Dr. Daniel Dzidzienyo (UoG), Mr. Eric Okoree (NBA), Dr. Paul Keese (OGTR) and Prof. Eric Danquah in discussions regarding the possible establishment of a Master of Biosafety degree programme at the University of Ghana.

Right: Dr. Dennis Ndolo Obonyo (ICGEB), Dr. Paul Keese (OGTR), Professor Kwabena Bosompem and other University of Ghana faculty discuss the curriculum for the proposed Master of Biosafety degree programme at the University of Ghana.

                                     

Biosafety training workshops/mentored fora

A number of workshops/mentored fora are being offered to a significant number of regulators, NBAs/NCAs, scientific advisors, and inspectors, in order to enhance their capacity to effectively contribute to GMO decision-making. The format of the Project workshops has evolved since the first year of the Project, from the more typical/traditional template of providing training via presentations and Q&As, into more mentored fora, which place greater emphasis upon participants producing outputs e.g. regulatory documents, outlines of regulatory processes, etc. in a conducive, mentored and supportive environment, based upon guidance provided during the meeting. These fora are highly targeted to NBA/NBC/NCA members and address pressing regulatory issues. Below presents a list of biosafety training workshops/mentored fora that have been during this phase of the project:

  • Risk Analysis for the general release of GMOs, 30 October - 03 November 2016, Abuja, Nigeria
  • Confined Field Trials of GMOs: Biosafety and Regulatory Considerations, 29 August - 02 September 2016, Addis Ababa, Ethiopia;
  • Monitoring confined field trials of genetically modified plants, 25 – 26 August 2016, Addis Ababa, Ethiopia;
  • Key Considerations for developing an effective and sustainable biosafety regulatory system, 30 May - 02 June 2016. Kampala, Uganda;
  • Development of pathways to harm for environmental risk assessment of GMOs, 29 June 2016, Kampala, Uganda;
  • Monitoring and inspection of confined field trials of GM crops, 23-25 June 2016, Kampala, Uganda;
  • Risk Assessment of GMO’s, 25 – 28 January 2016, Ouagadougou, Burkina Faso
  • Risk Communication for GMOs, 21 – 23 September 2015, Accra, Ghana;
  • Introduction to GMO regulation, 23 – 27 March 2015, Addis Ababa, Ethiopia;
  • Risk communication for GMOs, 03 – 05 December 2014, Nairobi, Kenya;
  • Effective implementation of biosafety regulation and regulatory decision-making, 15 – 19 September, 2014, Dar es Salaam, Tanzania;
  • GMO containment, 29 July – 02 August 2014, Ouagadougou, Burkina Faso;
  • African Legal Biosafety Training Course, 7 – 11 April 2014, Cape Town, South Africa;
  • Food/feed safety assessment of GM crops: From theory to practice, 10 – 14 March 2014, Accra, Ghana;
  • Building an effective and sustainable biosafety regulatory system, 29 – 31 January 2014, Kampala, Uganda;
  • Problem formulation in biosafety risk analysis, Accra, Ghana, 30 September - 4 October 2013, Accra, Ghana;
  • Integrating problem formulation into the process of risk analysis of GMOs, 10 - 14 June 2013, Dar es Salaam, Tanzania.

Left: A cross section of participants at the GMO containment training workshop held in Ouagadougou, Burkina Faso: Right: Dr. Wendy Craig , Project Director, giving an introduction of ICGEB activities, and in more detail the activities of the Biosafety Group.

Opportunities to African regulators and their scientific experts to visit established regulatory offices.

A limited number of 2 - 6 week regulatory experience exchange placements are being offered to African regulators and/or scientific experts to visit established regulatory offices including the Office of the Gene Technology Regulatory (OGTR), Australia; the Canadian Food Inspection Agency (CFIA), Canada; the Uganda National Commission on Science and Technology (UNCST), Uganda; and, the National Advisory Commission on Agricultural Biotechnology (CONABIA), Argentina. During these visits the regulatory officials get to actively participate in on-going biosafety regulatory processes at the various agencies, and hence gain further insight into the role of administrators, regulators, risk assessors and inspectors in how to effectively implement GMO regulations.

Mr. Eric Okoree, EO (the Acting CEO of the National Biosafety Authority, NBA), Prof. Kwabena Bosompem, KB (Member of the NBA Board) and Dr. Julius Ecuru, JE (UNCST) have visited OGTR (EO & KB for 4 weeks, JE for 3 weeks); Dr. Oumar Traore (Director of the National Biosafety Laboratory in Burkina Faso) and  Dr. Teklehaimanot Haileselassie Teklu (a biosafety technical expert for Ethiopia) have visited CFIA (both for 3 weeks); Mr. Belete Geda Torbi and Mr. Wondwossen Tadesse Debelle (from the Ministry of Environment, Forest and Climate Change of Ethiopia) visited the UNCST (both for 2 weeks),  and; Mr. Musa Kwehangana (a biosafety officer at the UNCST) went on a five week regulatory visit to Argentina.

Left: Dr. Oumar Traore (fourth from the left) from Burkina Faso is visiting, together with Dr. Phillip Macdonald (2nd from the left), the staff of CFIA Laboratories at Fallowfield Canada. Right: Dr. Julius Ecuru (centre) visits OGTR.               

Offering opportunities to experienced non-African regulators to visit a limited number or regulatory offices in SSA to provide local assistance in improving regulatory effectiveness.

The Project organises for 2-4 week site visits (referred to within the Project as in-Country Working Partnerships, IWPs) by experienced GMO regulator(s) to Project countries to provide support locally in the development and implementation of enduring regulatory procedures, while ensuring compliance with national legislative requirements. In collaboration with national officials, these visits usually begin with the analysis and identification of needs of the pertaining national regulatory system, followed by the development of key decision-making tools and processes to make the system more effective in regulating all aspects of GMO use, from R&D in laboratories (containment), through confined field trials (CFTs) and, ultimately to general/commercial releases.

 

The first such visit was to Ghana from 26 August - 27 September 2013. A follow-up visit to Ghana took place from the 24 September – 23 October 2015. Other visits have included: Burkina Faso (18 January – 05 February 2016), Uganda (06 June – 02 July 2016), Ethiopia (08 – 26 August 2016), Ghana (06 June – 08 July), Nigeria (20 October – 04 November). Dr. Martin Lema (Biosafety Expert) and Dr. Dennis Ndolo (ICGEB) also travelled to Tanzania (from 14 – 18 November 2016) on a scoping exercise to lay the groundwork for a first IWP in Tanzania.

Cross section of participants at a public awareness meeting in Tamale on the first field trial of GM cowpea in Ghana (left) and Dr. Dennis Ndolo Obonyo and one of the technicians at the CFT site (right).                                           


The number and type of beneficiary which have benefitted to date from the second phase of the Project

Project beneficiary type

Phase 2

Academic fellows

17

Visit to high-throughput regulatory offices

6

Workshop participants

395

Workshop resource personnel

28

 

Regular project updates can be found on the dedicated Facebook page.