Conservation and Sustainable Use of the Biosphere - WBGU

Conservation and Sustainable Use of the Biosphere - WBGU

Regulations on biosafety D 3.2


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


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

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