**2. Regulation and management of biotechnology**

Application of biotechnology requires, among others, at least the following to be in place: systems that ensure there is adequate capacity to develop and apply the technologies; systems that promote research, extension, and wider adoption; and systems that regulate the sector to assure sustainable use of resources, environmental and human safety. With growing urbanization and the supply crisis from food production deficits, and as more and more people gain interest in agribusiness, there is urgent need to develop guidelines and policies that create a conducive climate for agricultural investment while providing safeguards against environmental and social risks. Although biosafety relates to all biotechnology applications, and genetic engineering is just one of the many biotechnologies in use today, most discussions about biosafety in many countries worldwide revolve around whether a country has projects involving genetic modification (GMO), and hence some internationally agreed way of treating safety and associated assessments. The GMO-centered handling of biosafety emanates from the erroneous interpretation among non-experts that biotechnology = GMO. Biotechnologies (whether low- or high-tech) may introduce certain risks. Both modern biotechnology such as genetic engineering and traditional techniques commonly used such as crossbreeding (with wild counterparts) may confer the same kind of risks but which many people generally do not know about. From a scientific perspective, therefore, the controls should be the same if the risks (real or perceived) are the same, or nearly same. Practically across the world, however, this is not the practice. The level of protection required for a product should necessarily relate to its intrinsic characteristics rather than to the method of obtaining it, a position taken both by world toxicologists in their valuable position paper on genetically modified foods [5].

As a country determines an appropriate level of protection for any product, social and political considerations have to be built-in within the scientific decision framework in order to calibrate the balance between controls and safety, against accessibility/benefits. Agricultural wisdom dictates striking a balance between economic development and human as well as environmental health. Thus, an enabling policy environment comprises deliberate actions intended to promote technology development (such as trained personnel, research and development (R&D) infrastructure and R&D funding, efficient extension or advisory services that link labs to farms, policies, laws, and regulations for development and application of biotechnologies in the sector, among others). Consequently, all products

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.
