Scientific-Technical Backgrounds for Biotechnology Regulations (1994)

Genetic engineering has already produced impressive results in biological research. The gene transfer and cloning methods are changing biotechnology into an innovative activity with potentially great impact on health care, on chemical, pharmaceutical and food industries, on the agricultural and the natural environment. It has thus attracted a great deal of attention from the public and regulatory authorities. There is a need to reconcile technological progress with safety assurance and civic acceptance. Technologies are regulated according to the inherent risk evaluated, through criteria based upon existing scientific evidence, new rigorous information, and/or records of safe applications and good performances. This should also apply to biotechnology. The title Scientific-Technical Backgrounds for Biotechnology Regulation is only intended to indicate that regulatory provisions for biotechnological activities should be in agreement and not in open contradiction with scientific knowledge and established technological experience.