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6-Genetech §§: BIOSAFETY - GE risk assessment - a self-fulfilling prophecy?



-------------------------- GENET-news ---------------------------

TITLE:  Licensing procedure for genetically modified organisms
        turns out to be fallible
SOURCE: Netherlands Organization for Scientific Research
DATE:   January 24, 2000

----------------- archive: http://www.gene.ch/ ------------------


Licensing procedure for genetically modified organisms turns out
to be fallible

The procedure used by Dutch, European and global authorities when
granting licenses for genetically modified organisms is a flawed
one. Although applicants are required to provide information
about the dangers of the newly developed biotechnology to man and
the environment, they themselves decide to some extent what
information is relevant. This has been demonstrated by an
analysis carried out by philosophers at Leiden University as part
of a project funded by the NWOŒs Council for the Humanities. The
applicant ­who is naturally an interested party­ is therefore in
a position to influence the outcome of the approval procedure by
deciding that certain information is irrelevant to the risk
assessment.

The explanatory notes accompanying the questions on the current
(Dutch) application form show that the governmentŒs decision
whether or not to grant a license is based on the information
provided by the applicant. It is stated, for example, that
"synthesis of all the information provided in this application
form is intended to result in a complete analysis of the risks."

The questions which a biotechnology company is required to answer
are phrased in general terms. For instance, applicants are asked
about differences between the modified plant species and the
original species and whether they expect hereditary changes to be
spread within the environment. By formulating the questions in
this way, the body awarding the licenses places the
responsibility for the provision of information in the hands of
the applicant.

The Leiden philosophers say that licenses can only be awarded in
a responsible manner if the authorities have a list of questions
which are relevant in assessing the dangers to man and the
environment posed by modified organisms. As a start, they have
drawn up a definition of the hazards posed by a modified
organism, according to which a danger exists if "it carries an
agent P which can produce an effect Q which is considered
undesirable in context R on an affected item S by means of a
mechanism T in an environment X as a result of application Z".

By making use of these categories, the relevant questions and the
arguments for their relevance can be listed in a systematic
manner. In the case of an agent, for example, the following
question is in order: To what extent can the transgene survive
without the genetically modified organism? The argument for the
relevance of this question is that the transgene may constitute a
danger by being transferred to other organisms.

The relevance of questions needs to be discussed by such parties
as ecologists, molecular biologists, license applicants and the
bodies granting the licenses. This would minimise unexpected
environmental risks. In the past, the environmental dangers
associated with DDT, CFCs and some synthetic chemicals have
mainly been discovered by alert individuals and not by research
institutes and companies. According to the philosophers, expert
discussion in such leading periodicals as Science and Nature has
to a large extent involved artificial controversies because the
matter of the relevance of certain research questions was hardly
considered. The omission in the bureaucratic licensing procedure
is also to be found in the European Union's Directive 90/220/EEC
and In the Familiarity policy pursued by OECD. The philosophers
have now passed on their findings to the Commission on Genetic
Modification (COGEM), the body which advises on license granting
in the Netherlands. 


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