WHY GM-SPECIFIC REGULATION?
39. Any specific regulation of biotechnology
relies on the assumption that there is risk that is in some sense
different from the risks that attend similar products. In 1986
the OECD group of national experts on safety in biotechnology
recommended "that there is no scientific basis for specific
legislation to regulate the use of recombinant DNA organisms".This recommendation depended on there being in place legislation capable of being used to ensure the safe handling of these organisms. The primary reason for the introduction of specific legislation in Europe was seen to be the need for provision of a "harmonised regulatory framework" and "to provide for the protection of human health and the environment".
RISK: FROM MEANS OR END?
40. Risks arise not from the technology used
to create a new organism but rather from the characteristics of
the new organism itself. This includes the properties of the introduced
genetic material and the organism's interaction with the environment.
It is arguable that legislation that addressed all the implications
of the introduction or use of novel organisms for human and animal
health and safety and for the environment would have been preferable
to a system for which the trigger is the use of particular techniques.
The alternative to the introduction of specific legislation in
1990 would have been the harmonisation of all law applicable to
the protection of human health and the environment. The Commission
recognised that this was not practicable in one step, but it also
envisaged that the scope of application of the EC Directives on
GMOs would gradually be reduced as new product-specific legislation
was adopted. Products covered by other EC legislation are exempted
from certain provisions of the deliberate release Directive
concerning environmental risk assessment. Moreover, the Commission
has given an undertaking that "when preparing legislation
on marketing authorisation for products consisting of, containing
or which could contain GMOs, to include in its proposals provisions
for a specific environmental risk assessment of the product similar
to that provided in this Directive. The Commission also undertakes,
where appropriate, to propose modifications to existing product
legislation in order to provide for such environmental risk assessment."
THE PRECAUTIONARY PRINCIPLE
41. Article 130r(2) of
the EC Treaty states that "Community policy on the environment
shall aim at a high level of protection taking into account the
diversity of situations in the various regions of the Community.
It shall be based on the precautionary principle and on the principles
that preventative action should be taken, that environmental damage
should as a priority be rectified at source and that the polluter
should pay. Environmental protection requirements must be integrated
into the definition and implementation of other Community policies".
The 1992 Rio declaration on environment and development (Principle
15) states: "In order to protect the environment, the precautionary
approach shall be widely applied by States according to their
capabilities. Where there are threats of serious or irreversible
damage, lack of full scientific certainty shall not be used as
a reason for postponing cost-effective measures to prevent environmental
42. This precautionary
principle is reflected in the EC directives on genetically modified
organisms. It has been asserted that the deliberate release Directive
90/220/EEC "is the first piece of international legislation
in which the precautionary principle is translated into precautionary
The preamble to the Directive identifies the necessity for "harmonised
procedures and criteria for the case-by case evaluation of the
potential risks arising from the deliberate release of GMOs into
the environment". It also states that the introduction of
GMOs into the environment should be carried out according to the
'step-by-step' principle. Under this principle "the containment
of GMOs is reduced and the scale of release increased gradually,
step by step, but only if evaluation of the earlier steps in terms
of protection of human health and the environment indicates that
the next step can be taken."
76 Recommendation of the Council of the OECD, 16 July
1986 and Mr Cantley, of the OECD, p 300. Back
77 Explanatory Notes on 90/219/EEC (XI/596/91-Rev. 1 and the Explanatory
Notes on 90/220/EEC (XI/401/91-Rev. 2), explaining the reasoning
behind Article 1 of the Directives. See also Mr Cantley, p 301. Back
78 Article 10(2). Back
79 90/220/EEC, Article 10 and Commission Declaration in the Minutes
of the Council Meeting of 23 April 1990 (see Mr Cantley, p 301). Back
80 Dr von Schomberg, author of a report to the European Parliament
on the working of 90/220/EEC (see footnote 9), pp 401-2. Back
81 90/220/EEC, OJ L117 (8 May 1990) p15. Back