National Strategy for Implementation of Biosafety Framework.

The National Strategy for Implementation of Biosafety Framework is a national multi sectoral strategy of Rwanda. Its main objective is to implement the provisions of the current policy on Environment and Climate Change. It will provide a general framework for safety in research, development, release, trans-boundary movement, use and application of biotechnology products containing organisms with novel traits. To this end the Strategy sets up 3 overall objectives which are: (i) Ensure and guarantee public and environmental safety with regard to accident prevention, containment and waste disposal when GMOs are utilized in research and development (R&D) as well as industrial production processes. (ii) Determine the measure for risk assessment, monitoring, evaluation and reduction in all operations involving GMOs or any other processes of biotechnology, including but not limited to the prescription of appropriate conditions for the use of biotechnology and its products. (iii) Promote biosafety in the application and exploitation of innovative biotechnology products for the general wellbeing of humanity.
Guided by the precautionary principle, ethical considerations, the principle of alignment with the national development objectives, the access to information and inclusiveness, the institutional, regional and international collaboration and the principle of dynamism, the Strategy seeks to facilitate the establishment and development of national capacities to assess and manage potential risks associated with Biotechnology. This would be specifically achieved by the: (a) Assessment and identification of priorities in human resources development and the implementation of national capacity building programmes for biosafety; (b) Development and establishment of a comprehensive and up-to-date scientific database, infrastructure for information exchange upon which risk assessment and evaluation of products can be made and mechanisms for effecting AIAs; (c) Strengthening research and development (R&D), industrial applications, commercialization and the risks associated with the application of GMOs. The strategy addresses human and environmental safety of all types of applications of biotechnological products containing or consisting of organisms with novel traits including but not limited to GMOs. It further recognizes and addresses the need for such products to comply with any specific product requirements such as food safety, efficacy and acceptable risks before their release into the environment; (d) Intellectual property rights and traditional knowledge; (e) Biodiversity conservation and utilization; (f) Biosafety funding and mobilization of resources; (g) Promotion of public awareness on Biosafety through initiatives involving the community, policy makers, legislators, gender, partnership, the private sector and the industry; (h) Gender considerations; (i) Linkages and partnerships; (j) Legal, institutional framework and enabling environment; (k) Regulations, guidelines and safety operating procedures for the research, manufacture, transportation, and handling, accident prevention, release, containment, and waste disposal and end-use of biotechnology products; (l) Promotion and use of regular monitoring to verify the assumptions made in risk assessment and to evaluate whether the recommended risk management procedures are appropriate and effective; (m) Bioethics and conduct.
Institutional coordination and collaboration are prerequisite for ensuring compliance and enforcement of this strategy. In this regard, the National Biosafety Committee and the Institutional Biosafety Committee shall be responsible for ensuring the implementation of this strategy and regulations to be formulated hereunder. Biosafety, as a cross-cutting and integrated issue, brings about convergence of sectors. It enables technologies developed in one sector to find direct application in other sectors. The Government will employ a multi-sectoral and coordinated approach to ensure effective implementation and to give a voice to all key stakeholders in decision making. Implementation of the biotechnology aspect of this strategy will be by all institutions involved in biotechnology research and development, and promotion. Such institutions are required to constitute and capacitate an Institutional Biosafety Committee (IBC).
The competent national authority with the mandate to regulate the research, development, application and commercialization of biotechnology will be Rwanda Environment Management Authority (REMA). Monitoring and evaluation (M&E) will be done regularly to check effectiveness. The M&E framework will include specific objectives, indicators, source of data, baseline data, desired targets, key milestones, responsibility for implementation and timeframe.