Scientific-Technical Backgrounds for Biotechnology Regulations

By: F. Campagnari (Editor), V. Sgaramella (Editor), Guy Van den Eede (Editor)

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Hardcover | 31 May 1994

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196 Pages

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25.4 x 17.15 x 1.91

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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.

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Keynote Speakers
Introductory Remark
Genetic Engineering: An Overview	p. 1
Gene Transfer in Nature: Its Mechanisms and Limitations	p. 11
The Blood Coagulation Cascade: The Proteins and Their Biosynthesis by Recombinant DNA	p. 15
Development of Genetically Engineered Microorganisms and Testing of Their Fate and Activity in Microcosms	p. 23
Research Activities of the European Communities in Biosafety	p. 31
Industrial Fermentations with Genetically Modified Micro-Organisms	p. 37
The Production of Human Insulin	p. 43
Industrial Production of Vaccines and Therapeutic Molecules by rDNA Technology	p. 53
Basics of Plant Gene Transformation	p. 59
Field Releases of Transgenic Plants in Practice	p. 71
The Widespread Use of Transgenic Crops - Opportunities and Perspectives	p. 81
Regulation and Bio-Industry Development	p. 91
Public Reaction to Biotechnology and to the Release of GMOs in Europe	p. 121
Uncertainty and Regulation	p. 133
Regulation of Medicinal Products Derived from Biotechnology in the European Community	p. 143
General Principles of the Council Directive on the Protection of Workers from the Risks Related to Exposure to Biological Agents at Work	p. 151
Patenting Biotechnological Inventions	p. 157
The Deliberate Release into the Environment of Genetically Modified Organisms, GMOs	p. 167
The Contained use of Genetically Modified Micro-Organisms, GMMs	p. 169
The EPA Perspective on Biotechnology	p. 173
Table of Contents provided by Blackwell. All Rights Reserved.

Scientific-Technical Backgrounds for Biotechnology Regulations

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Hardcover

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