Module IV: Biotechnology and Biosafety

Measures to ensure the safety of genetically modified organisms are indispensable to the conduct of research in this area. New technologies have risks that demand careful consideration in advance of wide-scale adoption in the field. Biosafety measures are necessary as a matter of sound public policy; they are also increasingly required as a precondition for donor funding of biotechnology research.

There are two main areas of concern: environmental/ecosystem effects and human health. More particularly, specific concerns include:

• Weediness: There is some concern that the herbicide-resistance trait introduced into crops might be passed on to non-targeted species, which could foster tough new weed varieties that would be difficult to control.
  
  
• Geneflow: Geneflow refers to the transferability of traits among domesticated and wild plant species, i.e., it is a general concern that traits introduced into a target species could be passed on to other species unintentionally, with unpredictable results (with "weediness" being just one example). Built-in resistances to pests and herbicides that are desirable in a target species might be highly undesirable if translated to other species, and could create significant disruption of ecosystems over time.
  
  
• Toxicity and Allergenicity: The long-term human health effects of crops that have been genetically modified, e.g., for pest resistance and herbicide resistance, are not known. How much testing is enough? With whom should the burden of proof reside? Is labeling ever or always necessary? Is labeling sufficient?
  
  
• Pest and Pathogen Effects: The concern here is over non-target species effects, such as virus resistance resulting in mutations that produce new viruses, pest resistance resulting in mutations that produce novel pests, or non-targeted insects suffering from introduced pest-resistance traits.

These concerns have prompted both developing and industrialized countries to implement biosafety guidelines governing testing, safe use, and handling of GM crops in the environment. In West Africa, all countries have ratified the Convention on Biodiversity (CBD), in which biosafety is a priority. Nigeria and Cote d’Ivoire have developed biosafety guidelines already; Cameroon, Mauritania, Ghana, and Niger are at the initial stages of delineating a regulatory framework for biosafety. Many countries, within and outside West Africa, are participating in negotiations to develop an International Biosafety Protocol, as called for by the CBD. Ideally, international protocols would be based on strong national protocols, yet in practice there are only 40 to 45 national biosafety systems currently in place worldwide; thus there is a need for prompt action at the national level in those countries that are not currently active in this area.

Sufficient experience exists from which to draw the general outlines of an effective biosafety system. In addition to the safety guidelines themselves, proper oversight of GM crops must also involve a communications structure that allows for the participation of all stakeholders; a biosafety review process; and mechanisms for ongoing feedback and evaluation. Meeting these management challenges requires multilateral education and sensitization efforts and coordination of numerous government agencies, universities and research institutions, private-sector interests, individual scientists, and the public, as for example represented by NGOs or community organizations. The management challenge is to establish a system in which all these elements function well together and produce decisions that safeguard human health and the environment.