Conservation and Sustainable Use of the Biosphere - WBGU

Regulations on biosafety D 3.2
59
Incorporating socio-economic criteria into
the risk analysis and evaluation
There is also a heated discussion about whether
socio-economic consequences that may occur as a
result of the use of LMOs should be part of the risk
assessment. One side demands that the countries
importing LMOs take into consideration such consequences
as ‘genetic erosion and the associated loss of
income and displacement of traditional farmers and
farm products’ (CBD/BSWG/5/Inf.1). The opposing
side considers such a regulation to be misplaced in a
biosafety protocol and sees such aspects as opening
the way up for the justification of arbitrary trade barriers
(Miller and Huttner, 1998).
Wherever socio-economic aspects are the only
objection to importation it may be asked whether
and to what extent a right to sustainable development
through genetic engineering could protect
endangered traditional agricultural structures. Furthermore,
there is the question of whether it should
be possible to limit trade on such grounds.
The precautionary principle
There is disagreement on whether, when using or
releasing LMOs, the precautionary principle should
be applied in assessing safety. The main premise of
the precautionary principle is that when a possible
danger is recognized ‘the lack of full scientific certainty
should not be used as a reason for postponing
measures to avoid or minimize such a threat’ (Preamble
of the CBD; Birnie and Boyle, 1992).The precautionary
principle is international common law in statu
nascendi, although its specific demands are often not
made precise.At any rate, the safety demands grow in
step with the scale and irreversibility of the potential
damage. It may furthermore be assumed that a precautionary
principle under international law in general
would set lower safety requirements than the
current strong precautionary principle enshrined in
Germany’s laws on state-of-the-art hazard minimization
(‘Gefahrenabwehr’) and installation licensing.
The need to include the precautionary principle in
the biosafety protocol was primarily rejected by
states that export agricultural commodities, which in
general posit the harmlessness of genetically manipulated
organisms in these negotiations. Ultimately,
this dispute needs to resolve the question of whether
the country exporting or importing the LMOs bears
the burden of proof (and the research costs associated
with that) with regard to their danger. If one
uses the precautionary principle as a basis, it would
be the duty of the exporting country to prove that no
danger to biological diversity or human health can be
expected from the LMOs. If the protocol on the other
hand assumes the general harmlessness of the LMOs
then the importing countries would have to set out
why a specific case represented a threat; otherwise,
their refusal could be seen as an unjustifiable trade
barrier.
The framework in which the biosafety protocol is
embedded urges consideration of the precautionary
principle. The preamble of the CBD and the 15th
principle of the Rio Declaration of 1992 make
explicit mention of it.And the practice in several EU
states allows one to assume that they have considerable
reservations with regard to the harmlessness of
LMOs. Although the consent of the responsible
authority was given – having applied the precautionary
principle – the governments of Austria and Luxembourg
banned the use of Novartis Bt maize that
was introduced onto the EU market via the French
subsidiary of the Swiss company.
Since, according to Art. 16 para 1 of Directive
90/220, any member state may prevent the use and/or
sale of a product as long as it has the reasonable
assumption that it ‘constitutes a risk to human
health’. Greece also drew on this provision to prevent
the use of genetically modified rape. In France
and the United Kingdom it is, at least for the
moment, illegal to plant ‘GM maize’ (in France by
order of the administrative court, in the UK through
a 3-year moratorium imposed by the government
(Whyndham and Evans, 1988)). The Environment
Committee of the European Parliament urged the
Commission to order a moratorium on any further
approval for the cultivation of GMOs. The responsible
Scientific Committee of the EU, that issues recommendations
for the approval of new varieties, initially
expressed serious concerns about the safety of
a genetically manipulated potato variety from the
Dutch company Avebe and denied approval (Notification
C/NL/96/10).Then in February 1998 the Commission
in its proposal for an amendment to Directive
90/220 provided for a more intensive risk assessment
system and increased control of the production
cycle (98/0072 (COD)).
However, the precautionary principle only made it
into the preamble, not into the operative portion, of
the draft biosafety protocol in the version as last proposed
by the EU. The amorphous nature of the precautionary
principle may fan unjustified fears. But we
should refer in this context also to the SPS Agreement
that takes account of this precautionary idea
(without expressly mentioning the precautionary
principle) with its exemption provision in Art. 5 para
7 that is also applicable to the area of ‘green genetic
engineering’: for example, genetically man-ipulated
Bt maize has the ability to produce a poison that
comes from bacteria (Bacillus thuringiensis), thus
protecting itself from attack by pests, particularly the
larvae of the European corn borer. Initial independent
experiments fuel the suspicion that, as a side