Memorandum by Co-operative Wholesale Society
1. We are concerned that there are gaps in the
statutory arrangements for the authorisation and regulation of
genetically modified organisms (GMOs).
2. In the UK there are several committees concerned
with different aspects of the regulatory/authorisation process;
the Advisory Committee on Releases into the Environment (ACRE),
the Advisory Committee on Novel Foods and Processes (ACNFP) and
the Food Advisory Committee (FAC). Each has its own, specific
remit. Members are discouraged from discussing issues outside
the remit of the particular committee even where such issues fall
outside the authorisation process.
3. In particular, the ACNFP and FAC focus exclusively
on use for human food. The question of animal feedingstuffs is
largely beyond their remit. So, for example, the FAC considers
labelling aspects from the viewpoint of use of GMOs directly in
human foodstuffs. They do not consider labelling aspects of animal
feedingstuffs nor of the human foodstuffs derived from animals
4. The committees are all wanting in that they
consider each GMO in isolation concentrating on a particular product.
This does not provide a forum for looking at the overall impact
of GMOs. For example, the safety of a particular modification
is assessed but no account is taken of similar modifications and
the overall impact they might have. For example, there is no official
check that would prevent every crop being genetically modified
to be resistant to the same pesticide/herbicide. Such a development
would be a potentially disastrous scenario in that it would place
too much reliance on that particular pesticide. Serious consequences
could result from the development of strains resistant to that
pesticide. Similarly, if the safety of that pesticide was subsequently
brought into question, it would have a devastating effect on food
5. Similar criticisms can be applied to European
and World-wide regulations.
6. The European regulatory process gives greater
cause for concern with its emphasis on compromise rather than
judgment of the scientific facts. We are thinking particularly
of the judgment with regard to Novartis (Ciba-Geigy) maize containing
an antibiotic marker. The UK regulatory process, quite rightly
in our opinion, identified a slight risk with this antibiotic
marker from which they concluded it was prudent to prevent its
inclusion in animal feeds in the raw state. Three European committees
debated the issue. Their deliberations were largely inconclusive,
yet the UK decision was overturned.
7. The European regulatory process is highly
bureaucratic. This may be effective in reaching decisions. It
is not necessarily effective in reaching the right decisions.
It is also very flexible and therefore inappropriate for a fast
moving field such as this where what is right one day may be found
inappropriate at a later date. This is especially true in the
field of consumer information where we are at one point considering
the introduction of a new technology but, in time, it has the
potential to be commmonplace. Indeed, potentially it could be
the non-GMO of which the consumer needs to be informed. We do
not have confidence that the European system could accommodate
such a shift in opinion/approach.
8. Biotechnological innovation and the development
and bringing to the market of GMOs is costly. There is therefore
much at stake if a company's application is at risk of being rejected.
A country's prestige is also, potentially, at stake particularly
where Governments have invested heavily in biotechnology research.
These very real pressures also call into question the thoroughness
and adequacy of the regulatory process.
9. World-wide the approach of considering each
GMO application in isolation and to different criteria is of even
greater concern, particularly from the viewpoint of world trade.
What is deemed safe/acceptable in one country may not be considered
so in another yet there are no mechanisms to contain GMOs within
the country in which they are approved. Differences in approaches
to labelling make for further complications.
10. This is further exacerbated where GMOs are
co-mingled with their regular counterpart. This does appear to
be a prime example of something which has slipped through the
regulatory net without due consideration of the potential ramifications.
Clearly co-mingling of an internationally traded crop by a major
producer effectively precludes any other regulatory system reaching
a different conclusion on safety, etc. It compromises any labelling
commitment. It may, of course, be perfectly justified and any
concerns may be esoteric. Something may, in the course of time,
emerge which questions the original approval. If this pinpointed
a safety risk with the particular GMO it would be impossible to
react; to remove it from the marketplace without the removal of
all, or all but small amounts of identity-preserved sources of
the product in question. This could have catastrophic consequences
in the case of a staple food such as wheat.
11. World-wide there are also concerns that
conditions of approval linked to an authorisation in one country
may not be applied in a second or third country. What is seen
as a benefit in developed countries may be assumed to be a panacea
for exploitation in third countries where the ability and expertise
to instigate such controls is wanting.
12. In addition to wilful exploitation of GMOs
throughout the world, the question of uncontrolled expansion should
not be forgotten. Crops, and even animals, on their own will not
respect borders. There is therefore a feeling of uncertainty as
to ultimately how GMOs can be controlled world-wide.
13. These concerns lead us to the belief that
there must be international regulation and harmonisation.
14. Labelling goes hand in hand with regulation.
As with regulation, there must be international harmonisation.
The arguments parallel these detailed above with labelling policies
in one country being dictated and/or compromised by different
policies in another country.
15. The question of so-called substantial
equivalence and co-mingling is the fundamental issue in this
compromise. As indicated above, where a country permits co-mingling
it precludes any other country receiving co-mingled sources from
accurate labelling. Indeed, any material which is not labelled
at source can not be subsequently labelled with confidence. There
must be traceability of GMOs from sowing to final product. This
labelling is reduced to the least onerous policy within the chain.
16. At the present time it is not at all clear
to what extent products of GMOs should be labelled. There has
been an assumption that only materials containing modified DNA
and/or protein need to be identified. This philosophy supports
a policy of monitoring the impact of such changes on, for example,
diet. It does not, however, address the wider concerns of the
consumer who wishes to avoid products downstream which
have an environmental impact upstream.
17. Labelling and traceability are essential
if there is to be any form of monitoring the long-term consequences.
18. This is a new technology and there has been
a recognition of the need to monitor its impact both in the wider
sense of its environmental impact but also from the viewpoint
of product safety.
19. Safety evaluation is only as good as the
tests applied. Long-term consequences of GMO consumption may emerge.
The science of insertion of GM material is acknowledged to be
imprecise and may, in certain cases, result in a change to a particular
food or ingredient which results in an adverse reaction or changed
nutritional value adversely affecting expected dietary intakes.
It has to be recognised that each, individual, modification of
a particular commodity is unique. It is therefore potentially
not merely a case of tracking GM soya but of a need to look at
each individual GM soya. Such impacts may not be immediately apparent
but may emerge only from long-term dietary studies of populations.
It is therefore important to monitor the consequences of such
20. A major concern with any technological innovation
is whether it offers advantages which benefit society or whether
it merely pushes back the frontiers of science. There are greater
concerns with the introduction of a technology which is not confined
to specific, discrete areas but which promises to be all pervasive
throughout the animal and human food chain and throughout agriculture.
It is therefore worrying that there appears to be no overall co-ordination
21. First and foremost, with the development
of such a technology it would have been beneficial to involve
recipients (consumers) of the technology before it was forced
upon them in an uncontrolled way in the marketplace. It is appreciated
that, without real-life examples, it is difficult to involve ordinary
consumers. There are, however, some fundamental issues which could
have been elucidated, for example, the question of traceability.
22. As indicated above, there is a lot at stake
commercially from the exploitation of GM research. It is important
therefore that there is some certainty in the regulatory outcome
if a research programme is successful. It is therefore of concern
that through this lack of co-ordination later developments in
a similar field may be rejected because of concerns of proliferation.
We are thinking particularly of the concerns raised with regard
to over-use of individual pesticides.
23. We are equally concerned that there seems
to be no detailed consideration of the acceptability and overall
consequences of research techniques. We are thinking of the use
of antibiotic markers, a perfectly acceptable research technique
but with long-term and wider implications when considered in the
context of antibiotic resistance. This is not a new phenomenon
which has emerged since the development of the early GMOs. It
has been an issue for decades which has come to the fore in this
decade. In view of the commercial drivers it is worrying that
there is apparently no system which would highlight unacceptable
techniques such as these. If their use could not be prevented,
at least the likely consequences of non-authorisation could be
flagged up, thereby highlighting the commercial risks of pursuing
such a course.
27 May 1998