Scientific-Technical Backgrounds for Biotechnology Regulations / Edition 1by F. Campagnari
Pub. Date: 05/31/1994
Publisher: Springer Netherlands
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.
Table of ContentsIntroductory Remark. Part 1: Genetic Engineering: Research Activities. Genetic Engineering: an Overview; V. Sgaramella. Gene Transfer in Nature: Its Mechanisms and Limitations; J. Davies. The Blood Coagulation Cascade: the Proteins and Their Biosynthesis by Recombinant DNA; E.W. Davie, B. Carter. Development of Genetically Engineered Microorganisms and Testing of Their Fate and Activity in Microcosms; D.F. Dwyer. Research Activities of the European Communities in Biosafety; I. Economidis. Part 2: Genetic Engineering: Industrial Applications. Safety in Biotechnology and the Large in vitro Propagation of Animal Cells for Derived or Recombinant Products; M.J. Comer, D.V. Hoerschelmann, U. Behrendt, J. Wahl, K.H. Sellinger. Industrial Fermentations with Genetically Modified Microorganisms; J.L. Mahler. The Production of Human Insulin; J. Thorley. Industrial Production of Vaccines and Therapeutic Molecules by rDNA Technology; G.C. Viscomi. Part 3: Genetic Engineering: Agricultural Applications. Basics of Plant Gene Transformation; G. Van den Eede. Field Releases of Transgenic Plants in Practice; W. De Greef. The Widespread Use of Transgenic Crops -- Opportunities and Perspectives; P.J. Dale. Part 4: Regulatory Issues. Regulation and Bio-Industry Development; R. Ugo, V. Lungagnani. Public Reaction to Biotechnology and to the Release of GMOs in Europe; F. Terragni. Uncertainty and Regulation; S.O. Funtowicz, J.R. Ravetz. Part 5: Regulatory Framework. Regulation of Medicinal Products Derived from Biotechnology in the European Community; P. Brunko. General Principles of the Council Directive on the Protection of Workers from the Risks Related to Exposure to Biological Agents at Work; H. Martin. Patenting Biotechnological Inventions; C. Gugerell. The Deliberate Release into the Environment of Genetically Modified Organisms, GMOs; J. Kioussi. The Contained Use of Genetically Modified Microorganisms; F. Campagnari. The EPA Perspective on Biotechnology; L. Zeph.
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