Letter from the John Innes Centre
1. The appropriateness and efficiency of current
regulation at European Union level of:
The EU has funded research on GM
organisms in agriculture to make safety assessment more scientifically
informed (e.g., BAP, BRIDGE programmes). The research has tended
to be fragmented across the EU member states, and because of the
complex method of choosing and managing research projects within
the EU, research programmes have sometimes lacked the optimum
level of co-ordination and unity of purpose.
(b) release into the environment;
The procedures at EU level have been
very poor, and have frequently disregarded agreed timetables.
There has been considerable political interference in decision
(c) novel foods and their labelling;
At EU level assessments and decisions
have been slow and subject to considerable political pressures.
This is principally because of the frequent difficulty the regulators
have in deciding whether judgments should be based principally
on scientific evidence or on public feelings and perceptions.
2. The appropriateness and efficiency of current
regulation at the level of the United Kingdom and other/member
Within the UK the regulatory process
governing the release and food use of GM organisms has proceeded
satisfactorily. ACRE and ACNFP and their Secretariats have generally
performed well and efficiently within the constraints of the current
EU regulatory procedure. There is some variation in the interpretation
of the EU Directives in different EU member states. Some member
states place more emphasis on a consideration of potential benefit
(in addition to assessing risk) than others. There are some concerns
that the regulation should pay greater attention to impact on
agricultural practice and wildlife diversity in the agricultural
and wider environment.
3. The most appropriate jurisdictions, for decisions
on genetically modified organisms:
Within the UK the current system
of committees, made up of independent experts advising Government
on decisions, works well. Some member states send release proposals
to many different organisations for comment. These are then analysed
by the appropriate Secretariat (Competent Authority) and they
come to a conclusion on the evidence presented. The merit of an
advisory committee (as in UK) is that members can debate the issues
in detail, and their thought processes can evolve with advances
in the science and application.
Decision making at the EU level is
likely to remain demanding for some time, where there is heterogeneity
in the decision making process in each member state (all apply
the same EU Directives). It is important that agreed timetables
are adhered to within the EU regulatory process, otherwise decisions
often take an inordinate length of time.
Harmonisation at a scientific risk
assessment level is progressing reasonably well. Often delays
arise because of the different weighting applied in member states,
to matters of public perception and opinion.
4. The effect of regulation on different sectors
of the industry and on competition:
The indecision at EU regulatory level
is having a very considerable inhibitory effect on the development
of GM crops for agriculture. The list of GM crops approved in
USA is about as long as the list of GM crops submitted for regulatory
approval in the EU. The difference is that the decision is pending
for most applications on the EU list. Research in the UK is at
the cutting edge of scientific development. The sluggishness of
application within the EU seriously risks jeopardising the competitiveness
of our agriculture in the foreseeable future.
Professor R B Flavell
Dr P Dale
19 June 1998