Memorandum by Horticulture Research International
CONTEXT: HRI'S PERSPECTIVE
1. Horticulture Research International (HRI)
is a Public Sector Research Establishment (PSRE) with the principal
objective of carrying out horticultural research and development.
It is the principal contractor for horticultural R&D in the
UK and is recognised as a centre of excellence providing cost-effective
R&D. HRI has a significant research effort in genetic modification
which is used in two distinct ways. The first as a research tool
to identify gene properties and functions and the second is to
produce improved cultivars by incorporating specific genes through
genetic engineering. Targets are primarily fruit and vegetables
for fresh consumption or processing and ornamental species for
amenity and leisure purposes.
2. Containment (90/219/EEC). HRI has
carried out basic research involving genetic modification for
over 10 years, including the first transformations of apple and
strawberry. Most of the current work is carried out under the
provisions of 90/219/EEC. This has provided a safe, effective
framework for contained research. Risk assessments use well-established
methods and information, which has proved to be robust The assessments
and supporting practical protocols protect operators from potential
risks and avoid harm to the environment.
3. Release (90/220/EEC). The release
of GMOs arising from HRI R&D into the environment is so far
limited to studies on long term stability of transgenes in Apple.
The application procedure for consent for release of GMOs for
experimental purposes requires comprehensive details on the transgenic
organism and a detailed assessment of the risk of harm to human
health and the environment. Where consent has been given and the
trials carried out in accordance with the protocols detailed in
the application, the system has been successful in allowing experiments
to proceed without adverse consequences. The system is open and
releases are publicised. This has led to problems such as vandalism
and attacks on GMOs. There is thus currently a conflict between
the need for transparency in GMO trialling, essential to retain
public confidence, and the need to maintain security of the trials.
4. Consent for Marketing under this directive
requires the agreement of all 15 member states of the EU and is
consequently a major barrier to GMOs reaching the marketplace.
This is in contrast with the relatively streamlined system for
consent in the USA. While protecting the rights of individual
states is a political necessity, it is important that agreement
for non-controversial GMOs does not place European firms and their
products at a competitive global disadvantage.
5. Novel Foods (EC) 258/97. Regulations for
the approval of Novel Foods is based on the concept of substantial
equivalence. This approach, used by ACNFP, WHO and OECD is based
on the demonstration that a novel food produced by or representing
GMO is as safe as its conventional counterpart. The levels of
variation must be within the natural range of conventional counterparts.
This is a rational approach, but needs to be combined with an
appropriate labelling strategy to sustain public confidence. For
example, a refined oil derived from herbicide-tolerant oilseed
rape would be substantially equivalent to the conventional product.
However, consumers will demand the right to know that the ingredient
is derived from a GMO.
6. The labelling of Novel Foods derived from
or containing GMOs must be open and informative. If possible the
type and reason for the modification should be available
to the public to enable them to make informed choices. This could
possibly be achieved through a code or symbol system. Labelling
should be clear, avoiding statements such as "this product
may contain". Consumers will be suspicious if labelling is
based on the measurable amounts of product from GMOs, although
information on the content should be available for monitoring
and enforcement of regulations. Consumers will need to know the
provenance of the ingredients in Novel Foods and traceability
should apply to GMO derived products, even where substantially
7. GM horticultural products will, in many cases,
be the GMO itself, e.g., where fresh products are modified to
maintain quality on the supermarket or consumers shelf. In some
cases, these foods may contain elevated levels of compounds known
to have positive health benefits, i.e., functional foods or nutraceuticals.
By definition, these products will not pass the test of substantial
equivalence, being outside the natural range of variance. Regulation
for Novel Foods should anticipate this situation. Full safety
evaluation of such products will be required to sustain consumer
8. Genetic modification offers substantial benefits
in terms of environmental enhancement through reduced chemical
inputs and health and quality enhancement. For the Horticulture
industry to take advantage of the opportunities, the regulatory
regime will need to be rigorous, rational and transparent, to
reserve public safety and confidence. A regime, which is over-complicated,
slow and expensive, or only nationally based, will inhibit the
application of this important technology.
4 June 1998