Revised IRMA II Project Plan Stresses Regulatory Issues and New Management Structure

November, 2004

The Insect Resistant Maize for Africa (IRMA) project was launched in 1999 with the primary goal of increasing maize production and food security for African farmers through the development and deployment of improved maize varieties that provide high resistance to insects, particularly stem borers. To achieve this goal, KARI and CIMMYT scientists will identify conventional and novel sources of stem borer resistance and incorporate them into maize varieties that are well suited to Kenyan growing conditions and to farmer and consumer preferences. Major funding for the project is provided by the Syngenta Foundation for Sustainable Agriculture.

A revised project plan for IRMA II, geared to better address regulatory issues related to Bt maize and to enhance project management, was released in October 2004, the culmination of months of intensive planning meetings and workshops. “In the course of implementation of IRMA II it became clear that the regulatory issues were not exhaustively covered in the original project plan,” explains IRMA Project Manager Stephen Mugo. The need to more thoroughly address regulatory issues (through the assembly of regulatory dossiers) emerged full force as field testing and eventual release of Bt maize in Kenya became more imminent.

In June 2004, consultant Willy De Greef provided IRMA parties with an overview of regulatory issues related to transgenic crops. At that special IRMA Steering Committee meeting, a working group was established to formulate and oversee IRMA II strategies for fulfilling regulatory regimens. Appointed to the group were B. Odhiambo (KARI), S. Mugo (CIMMYT), J.K. Ng’eno (MOA), and F. Nang’ayo (Kenya Plant Health Inspectorate Service [KEPHIS]). Dr. Simon Gichuki (KARI) was appointed to be the IRMA Project Internal Regulator.

To get the ball rolling, five scientists were designated to attend an intensive two-week course on regulatory issues and processes, conducted in August at Ghent University, Belgium. The scientists were involved in either IRMA II or regulatory processes: A. Pellegrineschi and S. Mugo (CIMMYT), M. Mulaa and S. Gichuki (KARI), and R. Onamu (KEPHIS). On the heels of the regulatory workshop, a two-day workshop to develop, plan and incorporate regulatory activities in the IRMA II project plan was held in Nairobi in September 2004. Twenty-one participants from seven institutions attended the workshop: KARI, CIMMYT, KEPHIS, National Council for Science and Technology (NCST), Syngenta Foundation for Sustainable Agriculture, African Agricultural Technology Foundation (AATF), and International Biotech Regulatory Services. The objectives of the meeting were to (1) update the status of Bt maize in IRMA project; (2) identify information needed for a dossier on Bt genes to be deployed by the project;(3) determine sources of the needed information and identify gaps to be filled through research; (4) determine activities needed to fill the gaps, including resources and assigning responsibilities; and (5) update the IRMA II project plan, specifically on regulatory issues. After agreeing on the components of a regulatory package, the team split up into working groups and identified the required information, and developed activities over time, including budgets and responsibilities. Subsequently, a small task group incorporated the regulatory strategies into the project plan and created a revised structure for IRMA II. Ten themes were recommended:

• Bt maize event, development of Bt source line, and human health safety assessment
• Development of conventional and Bt products and compositional analysis
• Environmental impact assessment
• Insect resistance management and contingency plans
• Regulatory issues and requirements
• IPR/licensing
• Seed production
• Market assessment and analysis
• Economic impact assessment
• Communication/promotion (public awareness, media relations, extension)

Each theme is interdisciplinary and involves a team of entomologists, biotechnologists, breeders, economists, communications experts, IP counsels, extension officers, policymakers, regulatory officials, and most importantly, Kenyan farmers. The first testing of Bt maize source lines will be in the biosafety greenhouse complex in 2004 and in the field in 2005. OPVs will be pre-released in 2010, with large-scale release in 2011. Hybrids will follow a year behind OPVs. In developing the project plan, probabilities of success and risks, and contingency measures were identified. Milestones were set, against which progress will be measured. These fall in four broad categories: (1) facilities and permits; (2) breeding; (3) environmental safety assessments; and (4) socioeconomic impacts. Dispersal of funds by Syngenta Foundation will take these milestones into account.

To actualize the milestones and objectives, a new project management structure was developed. Under the new scheme, an Executive Committee (EC) composed of KARI, CIMMYT, Syngenta Foundation, MOA, and The Rockefeller Foundation directors, and CIMMYT African Livelihoods Program director was established with overall responsibility for the project. The position of Project Manager was instituted and given overall responsibility for the projects day-to-day activities and oversight, and reporting to the EC. An advisory board of experts from the public and private sectors will be appointed by the EC to provide expertise in their respective areas and to monitor progress on the project plan. A project management team, composed of the 10 project theme leaders, will hold quarterly meetings and report monthly to the project manager.

The five-year budget for the project is approximately USD 6,670,000. Although the Syngenta Foundation will be the principal development partner, The Rockefeller Foundation will provide support for seed issues. Other potential donors will be approached to provide support for one or more of the specific outputs of the project. Collectively, these development partners, together with those involved with IRMA I, and especially the farmers of Kenya, will work to ensure that the products needed by the farmers of the nation and sub-Saharan Africa actually reach them.