Biotechnology and food regulation

The past 18 months have seen a great deal of activity in the regulation of foods developed using novel cellular and molecular techniques that have been dubbed 'the new biotechnology'. The relevant regulatory authorities and advisory bodies in the European Community, the United States, the United Kingdom, Canada, Japan, the Organization for Economic Cooperation and Development (OECD), and the Nordic countries have published proposals, policy statements, and reports detailing how the safety of such foods should be assessed. All appear to recognize that the safety of a new or modified food is dependent upon its composition and that the same principles for safety assessments apply regardless of the methods by which a food is developed. Reflecting the 'process versus product' debate (1), most would argue that they focus on the product. However, there are important differences in regulatory approaches, most notably over whether the use of certain new techniques is sufficient to trigger special regulatory oversight. This paper will attempt to summarize and discuss briefly the major elements of these policies. It should be noted that the views expressed here are solely those of the authors and not necessarily those of the Food and Drug Administration or the United States government.