MEMORANDUM SUBMITTED BY NOVARTIS UK LTD
(R8)
1. INTRODUCTION
1.1 Public interest and debate overe GMOs
and their derivatives in foodstuffs has been exacerbated by confusion
over the implementation of EU labelling regulations to achieve
consumer choice. Novartis believes that to deliver genuine consumer
choice a number of issues regarding labelling and identity preservation
standards and procedures need to be resolved. Only a verifiable
and scientifically valid system of labelling and identity preservation[1]
will achieve the intended goal of providing the consumer with
choice.
1.2 Novartis welcomes the opportunity to
respond to the Agriculture Committee's inquiry into the identity
preservation of GM foods. Novartis is a major investor in biotechnology
research worldwide, across both our healthcare and agribusiness
sectors. We believe that the responsible application of biotechnology
has a significant contribution to make in the development of new
medicines and environmentally sustainable options for modern agriculture.
1.3 All of Novartis' activities in biotechnology
have three guiding principles: its use must be safe, it must bring
benefits and it must be used in a responsible manner.
1.4 Forty per cent of today's harvest is
still lost to weeds, pests and disease. Biotechnology, alongside
other advanced technologies, offers an additional option for significantly
improving crop productivity and quality in a sustainable way.
1.5 Novartis is currently developing GM
crops that bring benefits in terms of greater productivity, more
environmentally sustainable agricultural production and better
food quality.
1.6 Novartis has developed genetically-improved
BT-maize that protects itself from the European Corn Borer, a
major pest of the crop that can destroy up to 20 per cent of the
crop in the US and parts of Europe. On average, 7 per cent of
the world's maize harvest is eaten by the pest each year—in
calories, this amount is equivalent to feeding the whole of the
UK. Novartis' Bt-maize is approved and grown in the USA, Canada
and parts of Europe. In the UK, Novartis Bt-maize is approved
for import in food and animal feed but will not be grown, as the
European Corn Borer is not a pest in this country.
1.7 Novartis is currently developing GM
sugar beet suitable for the UK, which will allow farmers to simplify
and reduce the use of herbicides to control weeds, whilst maintaining
yield. Currently, just four weeds per square metre can reduce
the harvest of sugar beet by 10 per cent but as most herbicides
control only selected weeds, weed control is a complicated and
costly process, with farmers needing to use a number of different
herbicides. Broad spectrum herbicides cannot be used as the crop
would also be affected. Novartis' GM sugar beet variety, currently
in field trials in the UK, is tolerant to a broad spectrum herbicide,
allowing the use of one crop agent as opposed to several and reducing
the number of applications.
1.8 Novartis is an advocate of informed
consumer choice and we fully endorse the clear, informative labelling
of goods that contains GM ingredients, where the market or local
regulations demand it, and where the food supply chain can meet
this need in a scientifically validated way. We work in good faith
with authorities to provide data and advice that can help facilitate
informed policy-making. We have experience of regulatory systems
in other countries where the topics of labelling and consumer
choice have been under consideration and resolved.
2. CONSUMER CHOICE
2.1 The ability of the consumer to exercise
a choice whether or not to consume food containing GM crops should
not be confused with the safety of that food or GM ingredient.
Before GM foods are approved for sale in the EU, they are rigorously
assessed for safety in accordance with the requirements of the
EU Novel Foods and Novel Feed Ingredients Regulation (258/97).
2.2 Novartis firmly believes that to provide
for informed and genuine consumer choice there has to be consistent,
verifiable and scientifically valid standards for labelling and
identity preservation all along the food chain.
2.3 For the food chain to deliver consumers
GM-free food via identity preservation, a number of issues concerning
labelling and threshold levels need to be resolved.
2.4 Novartis Seeds supplies seeds clearly
labelled at source. However, we have no control over the use of
our seeds, clearly identified as GM or non-GM, once they are supplied
to the grower. This means that much of the input required to secure
an adequate identity preservation system will naturally have to
originate from growers, food commodities suppliers and the food
industry.
2.5 Novartis will support every effort to
help farmers, grain merchants and food processors achieve identity-preserved
lines and to comply with any identity preservation controls that
are put in place. However, for such a system to be successful,
consistent and workable, threshold levels and credible validation
systems must be established.
3. LABELLING,
LEGAL STANDARDS
OF FOOD
PURITY AND
THRESHOLD VALUES
3.1 The current EU system is committed to
standards of GM-free purity that amount to zero tolerance but
no food production system can provide this standard.
3.2 The labelling requirement that came
into force on 1 September 1998 meant that all foods in which a
detectable level of GMO products was present would have to be
labelled as "containing GM products". However many foods
identified as "GM-free" can contain traces of GM ingredients
because detection methods of DNA today are so sensitive. The difficulties
of the present labelling system in the EU originate from this
de facto zero tolerance.
3.3 As the detection levels of current DNA-based
measurements are easily in the range of 1 in 10,000, almost all
commodity crop shipments test positive.
For example, if a "GM-free" shipload
of soya beans is transported across the ocean it may be in a ship
that has transported GM soya beans during the previous trip. The
dust in the ship may comprise minute particles of seed skins from
that previous shipment which may mingle with the "GM-free"
shipment and could give a positive GM reading.
3.4 The standards of purity of certified
seed for commodity crops is typically in the range of 5 per cent
to 0.2 per cent, depending upon the crop. It is impossible to
produce food with greater standards of purity than the seed from
which it is derived without major production changes and cost
increases.
3.5 For these reasons, the current de facto
zero tolerance level cannot be guaranteed and is not practically
possible. Therefore, threshold values and detection methods need
to be established to properly provide the consumer with a valid
choice.
3.6 The practical solution would be to introduce
a threshold value or level of purity below which food products
are considered to be free from GM content.
3.7 Some guidance can be taken from the
EU rules on labelling of organic foods. It is accepted that organic
foods can contain up to 5 per cent of compounds from non-organic
foods. There is no reason, based on science, to suggest that different
standards should be applied to GM crops.
3.8 In discussions about thresholds, the
range of 1-3 per cent is often mentioned. Novartis believes that
2 per cent is technically feasible at a cost that would be reasonable
for the consumer.
4. IDENTITY PRESERVATION
AT THE
START OF
THE FOOD
CHAIN: SEED
PURITY LEVELS
4.1 For food manufacturers to deliver specific
levels of purity, seed producers, at the beginning of the food
chain, need to be able to provide a sharper level of thresholds.
For example, to achieve a 2 per cent threshold level at the finished
food stage, a seed producer would need to deliver a lower than
2 per cent threshold on the seeds.
4.2 As a seed producer, Novartis believes
that the seed industry cannot consistently guarantee the seed
purity levels required for food manufacturers to deliver absolute
standards of zero GM content in "GM-free" food. In some
countries, we would consider that relative risk and potential
damage to our business and reputation and would consider withdrawing
from the market.
4.3 Working experience with seeds identity
preservation by variety shows that it is difficult to achieve
seed purity levels below 1 per cent and maintenance of such standards
is very difficult.
4.4 There are variations between different
crops in achieving levels of seed purity and a strict standard
across the board would not be practical. Certain established commodity
crops, eg corn and soya, have seed supply mechanisms that can
be adapted to adhere to any identity preservation controls. Other
crops may have a supply chain that is far more diverse and therefore
not as easily adaptable. For this reason, we would recommend that
standards and thresholds are set either on a crop specific basis
or at such a level that is flexible enough to be achieved by a
range of crops. The World Seed Federation (FIS) are currently
reviewing this topic.
4.5 A workable identity preservation system
needs to take into account the trade-off between cost and achievability.
The purity of any seed variety, GM or conventionally bred, can
only be guaranteed to certain practical levels. Increased levels
of specified purity will carry a cost implication.
5. TRACEABILITY,
VALIDATION AND
CERTIFICATION OF
GM-FREE IDENTITY
PRESERVATION SYSTEMS
5.1 To develop and maintain public confidence,
and to provide the consumer with genuine choice, identity preservation
systems and "GM-free" labels need to be independently
validated.
5.2 For retailers to label products as "GM-free",
self-certification is not sufficient because of the potential
for fraud.
5.3 Novartis proposes validation by independent
and reliable institutions, using consistent and reproducible methods
of audit, scientific detection and validation, harmonised at an
EU level.
5.4 To achieve this, Novartis also recommends
the establishment of a European certifying authority that would
issue standard reference materials.
5.5 To adhere to proper regulatory standards,
any certification system needs to provide for a method of appeal.
6. OFFICIAL DETECTION
METHODS
6.1 The EU currently requires de-facto DNA
detection based on PCR, since this standard is the limit of detectability,
and since this is the most sensitive method. PCR, while being
very sensitive, is not accurate though.
6.2 Once a workable threshold is in place,
the EU will need to establish, as a matter of urgency, the range
of methods, DNA or protein based, that are allowable and certify
them.
7. GM CROPS IN
ANIMAL FEED
7.1 Reinforcing our commitment to consumer
choice, Novartis supports any decision to create a channel for
the production of meat and dairy products that are produced without
the use of GM crops in animal feed, provided that the supply chain
can adequately meet these demands and allow independent verification
of this status.
8 October 1999
1 Segregation is the commonly used term to identify
GM crops from non GM crops. Novartis prefers to describe the concept
as "identity preservation" and this is the term used
throughout this document. Back
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