BioSafety, Volume 3, Paper 1 (BY97001) February 27th 1997
Online Journal, URL - http://www.bdt.org.br/bioline/by
European Biotechnology Regulation: contested boundaries of environmental risk
Les Levidow, Susan Carr and David Wield
Centre for Technology Strategy, Open University, Milton Keynes, MK7 6AA, UK
tel: +44 1908-653759, fax: +44 1908 652175,
email: L.Levidow@open.ac.uk
Received February 3rd, 1997
Accepted February 14th, 1997
Code Number: BY97001
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ABSTRACT
In response to the legitimacy problems of biotechnology, the
European Community adopted the Deliberate Release Directive
90/220/EEC, as the statutory framework for regulating releases
of genetically modified organisms (GMOs). The Directive aimed
to 'establish harmonized procedures and criteria', especially
for Europe-wide approval of commercial products. In practice,
however, each marketing application has led to disputes among
member states, e.g. regarding whether to consider secondary
effects, how to define adverse effects, and whether to require
product labelling.
Some member states exclude secondary effects, arguing that the
Directive encompasses only product safety, i.e. direct
ecological effects of the GMO or its inserted genes. Other
member states emphasize the Directive's requirement that all
appropriate measures be taken 'to avoid adverse effects on
human health and the environment' - which may be interpreted
to encompass agricultural practices in using the product.
This issue has proven contentious because of the prospect that
transgenic crops may ultimately pre-empt, encourage or force
changes in crop-protection methods.
In excluding such considerations, some regulators have
acknowledged that their decisions leave a 'regulatory gap'
between environmental protection and agricultural policy. Yet
the problem also lies within risk assessment, which rests upon
judgements about what modes of crop protection are acceptable
or even desirable. Safety decisions necessarily involve an
implicit technology assessment on product design, with its
contentious assumptions about natural resources and human
practices. Moreover, these concerns have been displaced to
the consumer stage, where the labelling issue compounds the
dispute over the statutory relevance of pesticide
implications. In sum, the contested boundaries of risk
regulation arise from its origins in the legitimacy problems
of biotechnology.
Keywords: Environmental risk regulation, biotechnology, genetically
modified organisms (GMOs), step-by-step procedure, regulatory
harmonization, EC Deliberate Release Directive 90/220, European Union.
Published by Bioline Publications and Science and Technology Letters
Editorial Office: biosafe@biostrat.demon.co.uk
