Biosafety in Industrial Biotechnology

1. Front Matter

   Pages i-xv

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2. The development of European legislation on genetically modified organisms

   • A. J. Taylor

   Pages 1-13

3. Occupational and environmental safety: the UK legislative framework

   • A. N. Cottam

   Pages 14-31

4. Regulation of biotechnology in the United States, Canada, and Latin America

   • D. T. Kingsbury

   Pages 32-56

5. The legal and regulatory framework for biotechnology in Japan

   • T. Salusbury

   Pages 57-66

6. Biotechnology and industrial microbiology regulations in Russia and the former Soviet republics

   • A. Rimmington

   Pages 67-89

7. Physical aspects of the uncontrolled release of material in biotechnology operations

   • K. P. Norris

   Pages 90-108

8. Health hazards in biotechnology

   • A. M. Bennett

   Pages 109-128

9. Containment of unit processes

   • P. Hambleton, J. Melling

   Pages 129-148

10. Containment in downstream processing

    • J. S. Deans, I. W. Stewart

    Pages 149-177

11. Freeze-drying of biohazardous products

    • G. D. J. Adams

    Pages 178-212

12. Interpretation of regulatory requirements to large scale biosafety — the role of the Industrial Biosafety Project

    • G. Leaver

    Pages 213-239

13. Managing the effluent from bio-industrial processes

    • J. R. Court

    Pages 240-267

14. Sampling methods for testing and monitoring biosafety of biotechnology equipment and activities

    • J. E. Benbough

    Pages 268-292

15. Back Matter

    Pages 293-302

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As an industry, biotechnology may be likened to the Hymn Book, being both ancient and modern. Whereas activities such as baking, brewing, the fermenting of foods date from our earliest attempts to control and utilise the environment, the application of recombinant DNA technology is recognised as being at the forefront of novel industrial development. Perhaps because of its association with processing foodstuffs together with the benefits derived from applications in the early organic chemistry and pharmaceutical industries, biotechnology has been regarded as being inherently safe. Yet unlike other modern industries, such as chemical and nuclear, where regulation has followed from incidents or accidents, modern biotechnology has been subject to close scrutiny and regulation almost from its inception. The process of regulation itself is somewhat unusual in that it was initially self-imposed by the very scientists who developed the fundamental techniques of recombinant DNA technology. They recognised the signific­ ance of their development but were concerned of the effects on humans and the environment of uncontrolled application of the new, powerful technology. Concern about the possible consequences of genetic manipula­ tion has undoubtedly been the driving force behind the regulations that are now in place in many parts of the world and which are the subject of this book. Safety issues in the biotechnology industry can be categorised under three headings: worker, environmental and consumer (product) safety.

• Downstream Processing
• Fermentation
• biology
• biotechnology
• development
• ecotoxicology

Worth having for anyone that has involvement or interest - Integrated Environmental Management

• Centre for Applied Microbiology and Research, Porton Down, Wiltshire, UK

  P. Hambleton, J. Melling

• Science and Technology Section, British Embassy, Japan

  T. T. Salusbury

Policies and ethics