BIOTECHNOLOGY
33. Who is legally responsible (and would pay
damages) if environmental damage was done as a result of an authorised
release of a GMO?
Civil liability for damage caused by GMOs is
governed by the common law as developed by the courts. On this
basis, a firm marketing a GM crop may be liable in law for any
damage arising from ill effects attributed to the crop. In addition,
a public authority regulating the marketing of a GMO may also
be liable, but only if it acted negligently. Depending on the
facts of the case, the statutory regime for product liability
may also be relevant.
34. What is the current position on labelling
of GM food? Can MAFF Guarantee that all GM food will be labelled
positively and that food manufacturers will be able to use a "Does
not contain. . ." label? Can we avoid the position where
a manufacturer has no label on food that may contain GM ingredients?
The EC Novel Foods and Novel Food Ingredients
Regulation requires specific labelling when a food is judged,
on the basis of a scientific assessment, not to be equivalent
to an existing food. Food will also require labelling if there
are any health or ethical concerns or if it contains a GMO. The
Government is determined that all foods which contain GM ingredients
should be clearly labelled so that consumers know what they are
buying. In the absence of detailed EC rules, UK retailers and
manufactures have announced that from Janaury 1998 they will be
voluntarily labelling products containing GM soya or maize protein.
The European Commission announced its intention
last year to introduce a coherent approach to the labelling of
GM foods throughout the food chain. As a first step, in December
1997, it put forward a proposal to require the labelling of foods
or food ingredients derived from GM soya and maize where any protein
or DNA arising from the modification could be detected. However,
this failed to secure a qualified majority at the Standing Committee
for Foodstuffs when it was put to the vote in Janaury 1998. The
UK, and most other Member States, felt that the proposal needed
some further refinement before it could be made to work effectively.
The UK Presidency has therefore proposed some amendments and these
are the subject of ongoing discussion in Brussels. The principal
aim of these amendments, which have the support of a large majority
of Member States, is to clarify the proposal to ensure that the
resulting labelling is practical and meaningful to consumers.
It will not in any way undermine the intention to ensure that
all foods are labelled where it can be shown that they contain
genetically modified ingredients.
Neither the Novel Foods Regulation nor the proposal
on labelling of GM soya and maize prevent the making of voluntary
claims, such as the absence of ingredients produced from GM soya,
provided such claims comply with the provisions of the Food Labelling
Directive 79/112/EEC, as amended.
All Member States are agreed that food ingredients
such as refined oils which contain no DNA or protein and are therefore
identical in every way to oils produced by conventional technology
will not require labelling. To require labelling in those cases
would result in virtually all processed foods having to be labelled,
which provide little useful information to consumers and could
indeed be very confusing.
35. What is the Government's view on herbicide
resistant crops?
The Government believes that herbicide tolerant
crops offer new options for weed control, which may be beneficial,
if their use is managed properly. There are comprehensive statutory
controls in place to protect human health and the environment.
The evidence suggests that those genetically modified crops for
which consent has been granted to date, including genetically
modified herbicide tolerant (GMHT) crops, are unlikely to pose
a risk to human health and the environment. The Government does
however agree that the use on the farm of these crops should be
managed and that the existing statutory mechanisms do not offer
sufficient scope for controlling their use by third parties, such
as farmers. The farming, agrochemical and seeds sectors have proposed
the introduction of a code of practice on the management of these
crops. Following the issue of a discussion paper on the subject
last year, the Government is considering the position and will
announce a decision as soon as possible.
Does the Minister accept this could:
(a) Encourage pesticide use
Herbicide tolerance has been inserted into arable
crops on which herbicides are currently almost certain to be used
on more than one occasion. The technology of genetic modification
is likely to lead, in the foreseeable future, to the substitution
of one herbicide by another, rather than to greater overall use.
As the herbicides involved offer some advantages for weed control
in herbicide tolerant crops, it may be that total herbicide usage
in those crops will be reduced. Experience with herbicide tolerant
soybean in the USA has indicated a reduction in the amount of
herbicide applied of between nine and 39 per cent. Research in
Europe has shown that in GM sugar beet, two herbicide sprays may
be effective as opposed to the four or more currently used.
(b) Reduce biodiversity
All applicants for pesticide approval must show
that their products pose no unacceptable risks to the environment
(as well as to people) and statutory conditions may be attached
to pesticide approvals to ensure environmental safety. In seeking
approval of a pesticide for use with herbicide tolerant crops,
applicants will have to supply detailed data on environmental
effects.
Complex mixtures and sequences of herbicides
are currently used in crops that are not herbicide tolerant, to
control a wide range of weeds. With herbicide tolerant crops similar
levels of weed control may be achieved with the application of
a single herbicide.
MAFF has recently commissioned studies into
the effect of genetically-modified crops on biodiversity, and
the concerns about the effects on biodiversity resulting from
the introduction of GMHT crops have been brought to the attention
of the Advisory Committee on Releases into the Environment, who
are the Government's statutory advisers on genetically modified
organisms. The Government wishes to ensure that these wider issues
are addressed properly.
(c) Get around the expiry of individual
patents
Whether a patent is granted for an invention
depends on whether any particular patent application meets the
legal requirements laid down in the Patents Act 1977. This assessment
is made in the light of existing case law decided by the courts.
However, each application is decided upon its own merits. It should
be noted that two of the requirements for patentability demand
that an invention is both new and not obvious.
MAFF is not involved with issues of patents
for the crops or the associated pesticides. However, periods of
protection are assigned to the data which are submitted to support
the use of the pesticides. During the period of protection, the
data may not be used to support an application for approval unless
that application comes from the data owner or is to be used with
the owner's express permission.
Applications for use of pesticides on GMHT crops
will be treated no differently from any other application for
pesticide approval in terms of data protection. The approval holder
will receive a maximum of 10 years data protection from the date
that the product to be used was first approved for any use.
36. What is the UK doing to prevent the US using
the World Trade Organisation to railroad through a position in
the interests of the US Biotechnology companies?
Since external trade policy is a matter of Community
competence, it is the Commission (rather than Member States themselves)
which acts in WTO negotiations.
Current WTO rules contain no special provisions
for biotechnology or its products. The US authorities have suggested
that, in the forthcoming WTO negotiations starting in 2000, they
might ask for some such special provisions, but have not set out
what they have in mind. In the meantime the basic requirement
in WTO rules, which the Government supports, that any trade measures
should be based on scientific principles, remains.
Decision-making in the WTO requires consensus
amongst all members, of which there are over 130. It is not possible,
therefore, for a single country to force changes to WTO rules
against the wishes of others.
37. What is the Minister's assessment of the dangers
of:
(a) Genetic pollution—herbicide resistant
crops conferring their tolerance to wild relatives;
It is recognised that the introduction of GMHT
crops could result in the transfer of genetically modified material
between crops and wild relatives. However, the Advisory Committee
on Releases into the Environment has advised, for the applications
that they have considered so far, that the consequences of gene
transfer, in terms of harm to the environment are likely to be
negligible.
MAFF has commissioned a programme of three research
projects to determine the impact on the agricultural environment
of the introduction of herbicide tolerant crops which include
determination of the frequency and consequences of the transfer
of genetically modified material between crops and weeds. Work
started on these projects last year, interim results are expected
this summer and completion is schedule for 2000. The DETR also
has a research programme on the risks to the environment from
the release of GMOs, and this includes a study started in 1994
by NIAB into the first releases of oilseed rape tolerant to the
herbicide glufosinate ammonium. Monitoring has included studies
of cross pollination with, inter alia, wild species. The
results of the monitoring have not indicated any enhancement of
the ability of the glufosinate tolerant crops to establish volunteer,
weed or feral populations or that the behaviour of the GM plants
was in any way abnormal. Approval has recently been given to a
Sustainable Arable Production through Precision and Input Optimisation
(SAPPIO) LINK collaborative research project on the impacts and
management of herbicide tolerance which includes research into
the effects on plant diversity within arable systems.
(b) Resistance of target organisms—existing
bacteria such as Bacillus thuringiensis used in organic farming,
if incorporated in GM maize, for example, could render it ineffective
in its traditional role;
Development of resistance to pesticides is a
general issue, not confined to use on GM crops. Resistance management
strategies have been put forward jointly between industry and
the independent advisory bodies, but these need to be developed
for the introduced genes which cause pesticide resistance to be
expressed in crops. Where Bacillus thuringiensis (Bt) producing
crops have been introduced in the USA, measures such as leaving
non-GM refuges have been used to manage the risk.
GM maize which produces Bt can only lead to
resistance developing in pests which attack that crop. However,
the pests that attack maize in the UK do not infest the crops
on which organic growers traditionally use Bt. This means the
growing of Bt-producing maize should not compromise the use of
Bt to control pests on organic crops. Introduction of genes for
the expression of Bt toxins in other crops will be considered
on a case by case basis in terms of the risk that they may pose
to both human health and the environment.
(c) Antibiotic resistance in marker genes?
In the UK the assessment of novel foods is carried
out by the Advisory Committee on Novel Foods and Processes (ACNFP),
a body of independent experts whose expertise is acknowledged
world-wide. In 1991 the Committee first identified the use of
Antibiotic Resistance Markers (ARMs) in GM food organisms as an
area for concern. They subsequently conducted two wide-ranging
consultations on this subject and as a result published two reports
in 1994 and 1996 which have been deposited in the Library of the
House. The Committee identified four possible food safety problems
which might arise from the use of ARMs. However, the ACNFP considered
that of these only the transfer of the ARM gene into, or its expression
by, the cells lining the gut or gut micro organisms could pose
a significant threat to public health. Even in this case, the
Committee felt that the possibility of transfer of an ARM gene
from a GM food organism to gut microflora or to the cells lining
the gut was extremely small, and that it would be even less likely
that such a transfer would take place in GM plants. This conclusion
is reflected in the Committee's recommendation that GM micro-organisms
intended for consumption live should not contain ARMs and that
the inclusion of ARMs in GM plants should be considered on a case
by case basis. The ACNFP therefore scrutinise each use of an ARM
very carefully before giving its approval.
38. What position is the UK taking within (a)
the EU and (b) the World Trade Organisation on the commercial
introduction of GM crops (a) in the UK, (b) in the EU and (c)
elsewhere?
Provided a GM crop has been granted an EU marketing
consent, following a rigorous human and environmental safety assessment,
there are no grounds to prevent its commercial introduction in
the UK or EU. If a GM variety of the main agricultural and horticultural
species is intended for commercial cultivation, it will also need
to be added to the National List.
The UK will press for the EU to take a position
in any future WTO discussions on biotechnology which avoids the
introduction of any unjustified barriers to trade, whilst upholding
the right of member countries to assure themselves of the safety
of products before authorising them. We will seek to ensure that,
as under the present rules, decisions relating to safety are based
on sound scientific principles.
March 1998
