Biosafety

The advances in the disciplines of life sciences have not the least encompassed technologies to modify the genetic material in a highly specific and controlled manner. The potential of recombinant nucleic acid technology, developed in the 1970s, fueled early discussions about potentially new associated risks and, starting in the late 1980s, biosafety legislation for genetically modified organisms (GMOs) has developed both nationally in many parts of the world, and internationally. Regulatory systems are one way for society to find a balance among the potential benefits, risks, and concerns emanating from biotechnologies. It is important to consider the emerging international framework for biosafety and food/feed safety as part of a broader emerging and expanding international regime regulating the access and use of technology and genetic resources for food and agriculture. This broader international regime affects the development and deployment of new agricultural technologies by regulating, and sometimes restricting, access to essential research inputs (genetic resources, proprietary technology) and the release of research outputs such as GM varieties.

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity entered into force in 2003 and regulates the safe transfer, handling, and use of living modified organisms (LMOs) resulting from modern gene technologies. The objective of the Protocol is to contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of LMOs resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements. The protocol makes clear that the handling of products from new technologies must be based on the precautionary principle and it allows countries to balance public and environmental protection against economic benefits.

Different countries and/or regions have also adopted slightly different approaches to biosafety legislation for the products of gene technologies. In the EU, a centralized procedure, including an elaborate risk assessment under the auspices of the European Food Safety Authority (EFSA) as well as risk management via comitology with full EU member state representation, has developed in accordance with the precautionary principle to protect human health and the environment. In the light of newer technology developments, particularly for genome editing, much recent discussion has centered on the scope of the GMO biosafety legislation, not only in the EU but also elsewhere.