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Theme
II-6: Biosafety and Risk Assessment: Ethical Systems and Use
of Data – M. Krichevsky
Brief presentation
abstracts appear below.
The introduction
of genetically modified organisms in the food chain and the environment
gave rise to strident debate, political activity, and civil disobedience.
Scientists and commercial institutions interpret data as "proving"
safety. Other scientists and social activists interpret data as
"proving" risk. Wherein lies the "truth"?
This symposium considers the nature of the data used in the process
of assessing risk, how the data are used, ethical perspectives
leading to disparate views of safety, and public perception of
data and the derived conclusions.
Topics include:
- Introductory
Remarks on Biosafety and Risk Assessment
Micah I. Krichevsky, Bionomics International, US
What is biosafety? What are the generally accepted aims of biosafety?
Biosafety concerns transcend genetic engineering. However, the
overwhelming controversies involve organisms modified by gene
splicing used in agriculture. Pharmaceuticals and other commercial
products produced by the same techniques and agricultural products
derived from selective breeding engender little or no controversy.
- Data
Needs to Support Risk Assessment Decisions
Morris A. Levin, University of Maryland, Baltimore, MD, USA
Mark Segal, U.S. EPA, Washington, DC, USA
Procedures and methodologies employed by regulatory authorities
for assessing risk vary widely throughout the world. Nevertheless,
when considering applications for release of modified organisms,
the set of data elements required for such decision making varies
little. The variation occurs in considering whether all, or
key subsets, of the data are needed and how and when to apply
the data during the evaluation process. This presentation will
discuss the kinds of data needed and the variations on a common
theme employed to assess risks.
-
Use and Misuse of Data in Biosafety Debates: Antibiotic Resistance,
Butterflies, Mustard
Micah I. Krichevsky, Bionomics International, US
The polarized
debates on biosafety often espouse conclusions far beyond those
warranted by the experiments themselves. Such extrapolation from
experimental data assumes absolutes whereas statistical processes
best describe most ecologic phenomena. The proponents of genetic
modification often assume safety if no demonstration of a problem
exists. The opponents often decry the modifications based on the
assumption of major harm without regard to assessment of the level
of probability of harm. Brief discussion of specific examples
will illustrate the data interpretation issues.
- The
"Precautionary Principle" - When Data Are Inconclusive
Julian Kinderlerer,
University of Sheffield, Sheffield, UK
Giovanni Ferraiolo, International Centre for Genetic Engineering
and Biotechnology, Trieste, Italy
The "Precautionary Principle" was first enunciated under German
Law. The next application was in a treaty on protection of the
North Sea from possible harmful chemical dumping. In 1992, a
number of treaties involving various aspects of the environment
incorporated the Principle. However, the definitions of the
"Precautionary Principle" vary among the treaties. None of the
previous treaties considered genetically modified organisms.
The recently agreed "Biosafety Protocol" under the Convention
on Biological Diversity incorporates the Principle. In all its
incarnations, the Principle involves considering the possibility
of harm even if little or no direct evidence of such harm exists.
Interpretation and implementation of the Principle is controversial.
- Round
Table on Conflicting Ethical Systems for Evaluating Biosafety
Data
Giovanni Ferraiolo,
International Centre for Genetic Engineering and Biotechnology,Trieste,
Italy
Micah I. Krichevsky, Bionomics International, USA
Morris A. Levin, University of Maryland, Baltimore, MD, USA
Jacques Monod
in "Chance & Necessity":
...values
and knowledge are always and necessarily associated in action
just as in discourse
...the very
definition of "true" knowledge reposes in the final analysis upon
an ethical postulate
Knowledge
in itself is exclusive of all value judgement ..... whereas ethics,
in essence nonobjective, is forever barred from the sphere of
knowledge.
Yet the fact
remains that these two categories inevitably unite in the form
of action, discourse included.
...inauthentic
discourse, where the two categories are jumbled, can lead only
to the most pernicious nonsense, to perhaps unwitting but nonetheless
criminal lies.
It is in "political"
discourse, clearly, that this hazardous amalgamation is most consistently
and systematically practiced. And not by professional politicians
alone. Scientists themselves, outside their field, often prove
dangerously incapable of distinguishing between the categories
of values and knowledge.
...the principle
of objectivity as the condition of true knowledge constitutes
an ethical choice and not a judgement arrived at from knowledge....
...it is from
the ethical choice of a primary value that knowledge starts.
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