Elements of an Enabling Biosafety and Regulatory Environment

Abstract

Regardless of whether countries use existing laws to regulate genetically modified organisms, or develop stand-alone biosafety Acts with regulations and guidelines, the existence of legislation alone does not ensure a workable or an enabling biosafety framework. Elements essential to implementing an enabling biosafety system include clear policy objectives, the political will to make decisions, coordinated inter-ministerial decision making, efficient and transparent decision making, and all the aspects needed to implement a functional biosafety framework. These include iterative consultation with applicants, science-based risk assessment, risk management that is commensurate with the identified level of risk, a cost-effective process, and fast-tracking procedures for activities known to have low risk. Functional regional biosafety processes could facilitate coordinated decision-making across many countries, which would increase the access farmers and end users have to better planting materials and other improved products of genetic modification. In addition to reviewing the key elements for an enabling biosafety and regulatory environment, this chapter reviews historical reasons for the high number of unworkable national biosafety frameworks in Africa, and provides links to useful resources for countries wishing to revise their biosafety systems in order to enable access to the benefits of biotechnology in Africa.