At the national level, regulations affecting agricultural biotechnology will have to reflect a country’s policy objectives for the development of biotechnology capacity, and society’s desires on how technology will affect it. Prior to designing regulatory systems, governments will have to determine their objectives for the use of biotechnology in social and economic development.  Regulatory systems must be designed to meet those policy objectives, as well as a country’s obligations under international treaties (CBD/CPB).

Ethiopia ratified the Convention of Biodiversity (CBD) through Proclamation No. 98/1986 and signed the Cartagena Protocol on May 24, 2000. This Protocol was also ratified by the House of People’s Representatives as Proclamation No. 362/2001.Ethiopia prepared its Biosafety Law in 2009 as Proclamation No. 655/2009 and it was ratified by the Parliament. The Proclamation N0. 655/2009 was amended as Biosafety (Amendment) Proclamation No. 896/2015 on the 14th of August 2015 through house of people’s representative on the parliament.

The main objective of the Biosafety law is protecting human and animal health, biological diversity and in general, the environment, local communities and the country at large by preventing or at least managing down the adverse effects of modified organisms to levels of insignificance and enhancing access to and transfer of technologies, including modern biotechnology, that serve for conservation and sustainable use of biological diversity.

To facilitate this objective, a conceptual frame work was developed as a tool to help in design and implementation of Biosafety system in Ethiopia.  This frame work identifies five critical areas to development of an effective national Biosafety system.

1. Strong national policy, strategy ,regulation and research agendas regarding Biosafety and Biotechnology
2. A national monitoring and evaluation system
3. Conversation of indigenous knowledge, skill and capacity to develop and implement Biosafety system
4. Development of national  law and regulation  on Biosafety
5. Implementation of national policy

Findings: There is a need to develop the Biosafety expertise of key government officials within existing regulatory agencies to help them handle increasing volumes of applications. The concern  is about the entry of transgenic organisms into Ethiopia  outside of regular channels, such as Genetically Modified (GM) grain arriving as food aid, which could subsequently be planted by farmers. The National Biosafety advisory Committee (NBAC) currently takes a cautious approach to risk assessment. It needs to look at the potential benefits of GMOs and also the risks associated with not adopting some GM products for the future productivity and sustainability of agriculture and for the competitiveness of the economy in Ethiopia. As in most countries, public understanding of biotechnology and GM is limited. Ethiopia is well placed to take the lead in Biosafety initiatives in horn of Africa.

Key word: Biosafety, Biotechnology, Genetically modified (GM), GMO, and Risk Assessment