Memorandum by GeneWatch
1. GeneWatch believes that the shortcomings
in the way in which research into genetically engineered organisms
(GEOs) is regulated include a lack of due attention to the final
commercial intentions of the research and the lack of adequate
research on long term hazards.
2. The commercial reason for undertaking research
involving the release of GEOs should be taken into account in
assessing risks. Whilst small scale experiments may appear to
pose a minor or negligible risk, the impacts on a commercial scale
will be on a much greater. An assessment of the risks in the context
of intended use would aid in identification of the information
required to evaluate hazards at an early stage and ensure that
the appropriate data was available to assess risk when a commercial
application was made. This should improve the quality of
the research by ensuring experiments are properly designed and
likely to achieve their objectives. If it was clear that a commercial
use would not be acceptable or that the overall research programme
did not address the risks in a rigorous way, experiments should
not be allowed. Such an approach would improve the efficiency
as well as the safety of the system.
3. For example, when the first application is
made to test, say, an insect resistant plant the data requirements
for evaluation of a commercial scale should be identified. The
benefits of having this approach to research can be seen from
problems which have already arisen but could have been avoided.
In the case of the Novartis insect and herbicide resistant maize
which also contains an ampicillin resistance gene, a research
plan should have been produced following negotiation between the
authorities and the company to ensure the appropriate data would
be provided to allow a robust and agreed decision on marketing.
The continuing controversy and dispute between member states of
the European Union might have been avoided if it had been made
clear at an early stage that detailed justification for the inclusion
of an antibiotic resistance gene was needed,
that the potential of secondary impacts on non-target species
would have to be fully investigated,
and research to develop a resistance management scheme was required.
4. Having such an evaluation of research requirements
at an early stage would help address the lack of research on long-term
hazards to health, the environment and agriculture. Most experimental
field trials of GE crops focus on agronomic traits such as yield
leaving other effects such as invasiveness less rigorously addressed.
Although small scale experimental field trials will always have
limited ability to answer questions about large scale commercial
they could be made more scientifically rigorous. For example,
studies have shown that experiments to investigate the potential
for GEOs to be invasive need to be undertaken for at least three
years however many sites are used.
5. GeneWatch believes that the proposed revisions
to the Deliberate Release Directive (90/220/EEC) should include
provision for the identification of basic research requirement
for commercialisation at the initial research stage.
(b) Release into the environment
6. The fundamental problem with the Deliberate
Release Directive is that its scope has been defined far too narrowly.
This is particularly evident at the stage when companies are applying
for consents to market GEO. Not only have there been disputes
between member states about all applications to market
GEOs, but the regulations do not satisfy either the industry or
Non-Government Organisations. The report of a series of workshops
held in 1995 identified the serious mismatch which exists between
the construction of the risks under the present regulations and
the way in which industry and NGOs consider the risks. This is
appended at Appendix I. The same mismatch between the regulations
and the public's concerns about GEOs was found in research into
public attitudes towards GE foods. This is appended at Appendix
II (not printed). Unless this mismatch is corrected, public confidence
in the regulations will never be achieved.
7. The present regulatory approach is to assess
releases on a case-by-case basis, using data from small scale
experiments to determine safety. The focus is on the GEO and the
immediate changes to the organism. Whilst recognising the importance
of this aspect, GeneWatch believes that the wider impacts on the
environment and agriculture should also be borne in mind when
evaluating the risks of GEO. For example, it is questionable whether
the use of herbicide resistant crops is beneficial, because the
use of certain chemicals will increase and complex weed problems
may be created resulting in other chemical herbicides being used.
The cumulative impacts on the environment and agriculture of more
and more GEOs are also neglected in the Deliberate Release Directive.
For example, as more and more insect resistant crops are used
there may be harmful effects on non-target insects and the birds
that rely upon them for food. Looking at each application in isolation
from the others tends to make these sorts of risks seem unimportant
as the "big picture" is ignored. Although the industry
feels that the potential benefits of GEOs are not addressed, GeneWatch
believes that there is a "taken-for-granted" assumption
behind the risk assessments that GEOs represent positive progress
8. To address the mismatch between public concerns
and the present regulatory system, GeneWatch believes that the
revision of the Deliberate Release Directive must allow for:
an evaluation of the public benefit
of releases of GEOs through an evaluation of their effect on sustainable
an assessment of the cumulative impacts
of commercial scale releases through an evaluation of the hazards
of each class of crop (e.g., herbicide, insect and disease resistance)
which should take place before individual applications are considered
a mandatory segregation and monitoring
scheme throughout the food chain to allow for tracking, the early
identification of problems and consumer choice;
a system of compulsory liability
for any damage to the environment or human health arising from
the use of a GEO.
(c) Novel foods and their labelling
9. The Novel Foods Regulation has failed to
ensure a labelling system for GEOs which takes into account the
means of production. Attached as Appendix III is a briefing GeneWatch
has prepared on this subject. (not printed).
10. Only foods which contain foreign DNA of
protein as a result of the genetic modification come within the
scope of the Regulation. Therefore products of GEOs which do not
contain these will be exempt from mandatory labelling. This will
exclude, for example, oil from crops such as oilseed rape and
soybean and which are found in a very large number of GE foods.
This restriction on labelling is based on the assumption that
it is only when foreign DNA or protein is present in food that
a label can be justified on "scientific" grounds as
these alterations are the only source of any health risk. This
narrowing of the scope fails to allow people to make a choice
based on an evaluation of the whole technology and its dangers
not only to health but the environment and the course of agriculture.
Using the logic behind the Novel Foods Regulation, free range
eggs would not be labelled as their chemical composition is the
same as factory farmed eggs.
11. Such a limitation on consumer choice is
clearly unacceptable, especially given the depth of public concerns
12. GeneWatch believes that only comprehensive
labelling can fulfil consumers' rights to make choices about what
they eat. This is dependent upon the introduction of a statutory
segregation scheme for GEOs at all stages to allow food producers
and retailers to produce reliable information about the contents
13. In Europe, Member States have experienced
considerable difficulties in reaching agreement on decisions whether
to allow the marketing of genetically modified organisms (GMOs)
under Part C of 90/220. Every application has been disputed and
the French Government has now introduced a moratorium on the commercial
use of GMOs while a public consultation takes place. This has
further highlighted the problems and confusion.
14. The disputes and therefore the low efficacy
of the regulation stem, in part, from differences over the interpretation
of the scope of the Deliberate Release Directive. Some Member
States such as Austria and Denmark include indirect effects on
agriculture as part of the risk assessment. In addition there
are differences in how "harm" is defined between Member
States. Much of this comes down to different value judgments about
whether, for example, genetic pollution matters and whether current
agricultural practices form the base line against which to judge
something as harmful or not.
15. GeneWatch believes progressive standards
should be set to help remove some of the points of disagreement
to reflect the intended precautionary nature of the regulations
relating to GEOs. Current agricultural practices have proved seriously
damaging to the environment and accepting a level of harm based
on this will not protect the environment. Genetic pollution should
be considered undesirable because of its irreversible nature and
the unpredictability of its effects. Setting a standard to protect
European biodiversity by not allowing the release of GEOs which
have related wild European species would be one way of doing this.
16. In the UK, one problem with the way in which
the regulations are implemented is that it has proved difficult
in practice for members of the public to obtain data about applications
for both field trials and commercial releases. This is not simply
frustrating but means important local knowledge may be lost to
the evaluation process. For example, when the license was given
to allow the testing of genetically modified maize in Cornwall,
the advisory committee may not have realised that a neighbouring
farmer's livelihood could be threatened if there was cross fertilization
of his crop and the loss of his organic status. We believe that
information should be available more easily and quickly to the
17. To do this Member State should ensure knowledge
of a proposed deliberate release is made widely available. Any
requests for information about a proposed deliberate release must
be supplied within 10 days.
18. It is crucial that both national and international
regulations are in place. National scrutiny is required to ensure
local knowledge is brought to bear on a decision. International
regulation is required because GEOs are living organisms which
will not respect national borders.
19. There has to be effective regulation on
the release of GEOs if confidence is to be maintained in the UK's
food production systems. BSE and the collapse of the British beef
industry has underlined how important this is. If regulations
are relaxed and shortcomings not addressed, if and when risks
were to materialise farmers could be seriously damaged through
a sudden loss of consumer confidence.
20. Effective regulation which accounts for
the interests of farmers who do not wish to grow genetically engineered
crops is also important. If cross fertilisation between genetically
engineered varieties and conventional crops, a farmer may be unable
to provide the demand for non GE crops and, if they are an organic
farmer could undermine their whole farming system.
21. GeneWatch believes that all sectors of industry
will be best served by strict regulation under the precautionary
principle. Without this confidence in British food will be undermined.
4 June 1998
15 Williamson, M (1996) Can the risks from transgenic
crop plants be estimated? Trends in Biotechnology 14: 449-450. Back
Kareiva, P, Parker, I M and Pascual, M P (1996) Can we use experiments
and models in predicting the invasiveness of genetically engineered
organisms? Ecology 77: 1651-1675. Back
This is supported by research into the regulatory system, e.g.,
Levidow, L (1994) Biotechnology regulation as symbolic normalisation.
Technology Analysis and Strategic management 6: 273-288. Back
(1990 C.43). Back
(OJ No. L 117, 8 May 1990, p. 1). Back
(OJ No. L 117, 8 May 1990, p. 15). Back
(SI 1992/3217). Back