**2.2 National biosafety framework**

*Elements of Bioeconomy*

**2.1 Global management of biotechnology**

of biotechnology are regulated and undergo risk assessment. For example, seeds developed through selective breeding are managed through phytosanitary regulations as well as seed varieties legislations. Risk assessment is a process used every day when choices and decisions have to be made, and is the most critical component of biosafety implementation. Although risk assessment is necessary for all biotechnologies applied in agriculture, health, and environmental work, the attention appears concentrated on genetic engineering and its products (GMO). The risk assessment process used for GMOs closely resembles the assessments made for environmental impact. Before a GM crop is released to the market, regulators worldwide require these products to undergo rigorous risk assessments to ensure an adequate level of safety to humans, animals, and environment. As such, all GMO products available in the market today have undergone a risk assessment. Products of genetic engineering (GMO) are managed through a more stringent regulatory system, often referred to as National Biosafety Frameworks (NBFs). As such, biotechnology policies for most countries are all about GMO and similar products developed through "modern biotechnology"—a term used to refer to more advanced biotechnologies that include tissue culture, molecular marker technology, and genetic engineering, which generally require laboratories and significant level of skills to perform.

One of the decisions of the United Nations Conference on Environment and Development (UNCED) in 1992 was the adoption of the Convention on Biological Diversity (CBD), to regulate biotechnology (Articles 8 (g) and 19). In response to Article 19 (3), a decision was made during the Conference of Parties (COP5) in 1995 to develop a protocol on biosafety. The Cartagena Protocol on Biosafety (CPB) was a direct international legal response to the CBD contributing toward the conservation and sustainable use of biological resources. The entry into force of the protocol (2003) obligated signatories to the protocol to localize it within their national laws. Current intergovernmental mechanisms governing the application of modern biotechnology in which African countries actively participate include: (1) The *Codex Alimentarius* Commission, (2) Cartagena Protocol on Biosafety (CPB) to the Convention on Biological Diversity (CBD), and (3) Plant Protection Convention (IPPC). Signatories to the CPB obligated themselves to localize the protocol within their national laws. So far, nearly all SSA countries have ratified or complied with accession requirements of the CBD, except for Equatorial Guinea, Liberia, Sierra Leone, and South Sudan.

Within regional trading blocks of SSA, frameworks of action for biotechnology require a collective understanding among member states, and a regional framework on biosafety. Many regions have made attempts to foster a united framework, but none of these have progressed beyond mere intentions. For example, the East African Cooperation (EAC) Protocol on Environment and Natural Resources (2006) urges partner states to "develop and adopt common policies, laws and take measures to ensure that the development, handling, transport, use, transfer and release of any living modified organisms are undertaken in a manner that prevents or reduces the risks to environment, natural resources and human health" (C 3, A 27(1)). However, implementing such a recommendation would first require a regional discussion to enable member states to understand current issues, trends, challenges, and opportunities for agricultural biotechnology, and to have a collective understanding that will catalyze common policies and biosafety regulations, in line with the goals of regional integration, and to eliminate some of the non-tariff trade barriers associated with transboundary movements of GMOs. At the national level, the National Biosafety Frameworks (NBFs) provide the overall policy, legal and institutional mechanisms for development, deployment and use of biotechnology.

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A National Biosafety Framework (NBF) is a combination of legal, administrative, and technical instruments put in place to build a country's competence to handle biotechnology research, development, and commercialization. Specific components of these instruments are the national biosafety policies, statutes passed by parliament and specific regulations linked to the statutes, administrative and technical systems for risk assessment, public awareness and participation, decisionmaking, enforcement and monitoring. An NBF is also a tool to be used in the implementation of the CBP. These frameworks often focus on GMOs, and have been generally driven by the crop sector, although they are meant to cover broad biotechnology research and applications. Although varying from country to country, NBFs usually contain a number of common elements, such as policy on biosafety, regulatory regime for biosafety, a system to handle notifications or requests for authorizations for certain activities, field releases of GMOs into the environment, among others. All these involve public participation and risk assessment, a mechanism for monitoring and inspections, and a system for public awareness and public information.

The next section appraises the state of enabling policy environment within the SSA in the broad sense, examining specific indicators such as: evidence that a country has an agency that promotes the application of biotechnologies, support for biotechnology development through research funding, support to adoption through extension services, existence of policies, laws and regulations, and specific agency that regulates the use of biotechnology—how efficiently these systems function.
