Regulations in Biotechnology: Administrative Handling and Scientific Content

Abstract

The administrative handling of regulatory oversight procedures differs from country to country, whereas the scientific data required for the safety assurance are similiar in most instances. Safety issues for contained biotechnology applications are mainly a matter between industry and the government agencies involved. Deliberate release of transgenic organisms and the market introduction of transgenic food, however, produce much public debate. It is assumed that shortcomings related to risk-assessment methodology as, e.g., the lack of accepted protection goals and the continuing discussions about the validity of comparative risk assessment may be reasons for the current situation.