·Genesis of Regulation – The Asilomar Conference of 1975
The history of biotechnology under regulation came from a meeting held in the USA in 1975 called The Asilomar Conference on Recombinant DNA. The overarching goal of the conference was to put together a think tank on the fallout assumed biohazard presented with the Recombinant DNA technology with safety at the heart of conducting science with benefits to human and environment. There are principles set in consensus such as that containment should be made an essential consideration in the experimental design. A second principle was that the effectiveness of the containment should match the estimated risk as closely as possible, among others.
·The birth of UN biodiversity as a global body
The birthplace of biosafety systems at the international level is the Convention on Biological Diversity (CBD) that came into force in 1992. It recognizes the benefits of biotechnology and calls for safe management of biotechnology to ensure its safety to human health and the environment in general. Article 19.3 of CBD anchored on the demand for precautions and safe handling of biotechnology products. The article was the brainchild of the Cartagena protocol on biosafety (CPB). The CPB was adopted on January 29, 2000 and entered into force on September 11, 2003, which was a mechanism for the regulation of trans-boundary movement, trade and GMO crops. The main feature of CPB is the use of the “Precautionary Principle‟ as a policy tool of regulation of LMOs especially in risk management.
·African Model Law (AML) on safety in biotechnology
Many of the African countries’ biosafety law lean heavily towards the AML developed in 2001 through consultants with little knowledge of genetic engineering or biosafety regulations. This saw the law’s projected restriction to the technology failing the overarching role projected from the founding objects of Asilomar meeting of 1970. The African Model Law (AML) embodies a strict view of the Precautionary Principle.
The Precautionary Principle as framed in Principle 15 of the Rio Declaration (United Nations Conference on Environment and Development (UNCED) 1992), and adopted in the CPB text states: Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing costeffective measures to prevent environmental degradation.
The AML also addresses the issue of Liability and Redress, which applied strict liability against the fault base liability. For the many years of its existence, the adoption of the strict AML has not stimulated the adoption of any biotechnology products or the development of modern biotechnology within the African countries.
·Freedom to Innovate endorsed by African Ministers of Agriculture, Science and Technology (AMCOST)
The approach of the African Model Law, although promoted by the AU, seems to be at odds with the report of the African Union High Level African Panel on Modern Biotechnology (African Union 2006) that “the AU should adopt the ‘co-evolutionary’ approach in which the function of regulation is to promote innovation, while at the same time safeguarding human health and the environment” and the recent support of African Ministers of Agriculture Science and Technology which endorsed the need “to take advantage of modern technologies such as biotechnology”.
On these premises was the birth of ABNE in 2008 under AU-NEPAD which is a biosafety resource network for African regulators and policy makers. The overall goal of ABNE is to enhance the capacity of African countries to build functional biosafety regulatory systems. This will enable these countries to harness modern agricultural biotechnology while minimising potential risks to the environment and human health.
ABNE was conceptualized under the NEPAD Agency’s Consolidated Plan of Action and fulfills the recommendation of the High-Level African Panel on Modern Biotechnology – Freedom to Innovate, by Juma and Serageldin (2007). ABNE was approved officially in 2008 by the African Ministerial Council on Science and Technology (AMCOST) to promote advancement of science and technology for agricultural development in Africa.
·African Union Member- State decision on the adoption of safe biotechnology through science-based regulation
There are more than 70 per cent of the African countries that have signed and ratified the international treaty on biosafety regulation and UNEP-GEF fund have supported countries for the development of national biosafety frameworks. The major essential elements of enabling biosafety regulatory systems in Africa includes a clear political will, clear policy objectives that support biotechnology adoption, efficient and transparent science-based decision-making system, with participatory administrative process to enhance countries benefitting from modern biotechnology that is safe for the environmental, and human health.
Although many of the decisions are sovereign to each member- state, the following countries – Burkina Faso, Eswatini, Ethiopia, Kenya, Malawi, Nigeria, South Africa have tested the functionality of their regulatory system with the approval of GMO crops being planted on the farmers field since the adoption of the technology.
The adoption of the technology involves other agencies in each country according to the regulation and mandate for their operation. Such agencies are seed council, varietal release committee, environmental impact assessment agency (this is not universal but country specific). The role of these agencies was explained in the recently published scientific journal in frontiers plant science by the AUDA NEPAD Team led by Akinbo et al 2021. It is an open assessed article.
Other multiple actors in the value chains to the farmers are the following: government extension services, government agriculture seed inspectors, risk communicators and custom officers in a country where the seeds are not produced locally (e.g. Eswatini, Ethiopia), farmers, handlers, processors, distributors, and retailers.
Dr. Olalekan Akinbo wrote in from the African Biosafety Network of Expertise (ABNE). He can be reached on email@example.com.