Memorandum submitted by Advanta Seeds
CONCERNS ABOUT THE POSSIBLE CONSEQUENCES
OF REGULATIONS TO DEAL WITH ADVENTITIOUS GM IN CROP PLANTS
1.1 A large number of seed businesses operate
in Europe. In the main they are small companies involved only
in conventional seed. Even the largest is small when compared
with a few multinational companies who are directly involved in
GM research. The GM companies are large multinationals who:-
Operate large dedicated research
Focus on new traits to fully transform
Introduce new genetic material to
produce a specific trait.
Patent their technology and licence
it to others.
The conventional seed companies:-
Rely on existing gene traits.
Produce varieties by crossing, assisted
by high tech tools.
Have plant breeders' rights protection
which does not restrict use of pollen.
The common interest of these businesses is workable
regulation for dealing with adventitious GM content. (Paragraphs
2.1 to 2.3)
1.2 The EU is in the process of introducing
GM legislation. It includes regulation to deal with the presence
of adventitious GM in crop plants.
Directive 2001/18. Deliberate release
of GMOs. (Paragraph 3.3)
and Labelling (Paragraph 3.4)
Proposed RegulationFood and
Feed (Paragraph 3.5)
Draft Seeds Directive (Paragraph
Draft Sampling and Testing Protocol
1.3 Advanta appeared before the Agriculture
Committee on 18 July 2000 and gave oral evidence in connection
with the presence of adventitious GM impurities in some of its
Hyola spring oilseed rape. The thrust of Advanta's argument was
the need for clear regulation. 18 months later, EU regulation
is in the pipeline. In the main, we believe that once enacted,
it will remove many of the existing uncertainties. However, some
fundamental aspects are of great concern and will, we believe,
have adverse consequences for the seed industry and its ability
to produce conventional and GM crop plants for future use in farming.
1.4 Our concerns are:
The thresholds proposed for adventitious
GM are almost certain to be unachievable. (Paragraph 2.4.1 and
The proposed sampling and testing
system is over complicated and unless clear, will lead to more
litigation. (Paragraph 2.4.2 and 3.7)
Seed production from GM free zones
will be unsustainable and impossible to monitor. (Paragraph
Traceability will not be uniformly
applied by member states and there is no comparable system for
farm saved seed. (Paragraph 2.4.4)
No transitional arrangements are
in place if renewal of a consent is refused or lapses. (Paragraph
Clarity is needed in the definition
of unauthorised GM. (Paragraph 2.4.6)
Unless these points are addressed, it seems
to us that the regulation will be unworkable (Paragraph 2.3).
We have placed our views before the Minister (Annex 1)
and have responded to consultations directly (Annex 2)
and via our European and National Trade Associations.
2. THE IMPACT
GM LEGISLATION ON
2.1 Some Salient Points
Conventional and GM breeders understand
and take steps to minimise impurities entering breeding lines.
Conventional breeding may involve
use of high-tech tools (eg, tissue culture, cell fusion, DNA fingerprinting).
This type of biotech is widely used by seed companies in producing
conventional varieties, but most of these companies do remarkably
little work on the actual transformation of crop plants to produce
Increasingly, breeders dealing with
both conventional and GM varieties are separating the two streams.
This segregation is vital to maintain purity, but it is placing
increasing costs and logistical burden on the seed industry without
The vast majority of those plant
breeders who are introducing GM traits to plant varieties, have
obtained a license from one of a few very large multinational
biotech companies. The breeders have taken these licenses for
competitive reasons. For example, in the USA, nearly every seed
company, no matter how small, sells herbicide tolerant soybeans.
Over 60 per cent of the market (40+ million acres) is planted
with this GM type of soybean. Demand from farmers is so high that
companies cannot afford to be without this product in their range.
Large biotech companies who have seed divisions are often the
first to market such products, but then seek extra market share
by licensing to the smaller pure seed companies.
Large biotech companies discover
and develop the traits (GMOs). This can take up to 10 years of
research. Such activity is simply unaffordable for even fairly
large pure seed companies like Advanta. For example, although
Advanta sells GM seed products in the USA where they are in high
demand, it has no products anywhere in the world on sale or in
development that are based on gene discoveries it has made and
developed itself. All of its GM products on sale and in development
are reliant on genes licensed in from large biotech companies.
The traits undergo a rigorous approval
process. Formal approval to release must be obtained under Directive
90/220 (to be replaced from 17 October 2002 by Directive 2001/18).
No legislation is yet in place that deals with adventitious GM
presence. The best guidelines are the so-called Interim Measures,
but these have no legal force.
Consent to release is conditional
and may be for Research (Part B) or Marketing (Part C). There
is currently an unofficial moratorium on the granting of consents.
Consents are valid for 10 years.
2.3 Advanta's Point of View
We are not against GMOs: in fact
we believe that in future they will almost certainly be an essential
part of sustainable agriculture. However, at present they are
commercially unimportant to us except in markets where our competition
sells them and would win business from us due to the high level
of customer demand. Easily the best example of this is the Roundup
Ready Soybean product in the USAno seed company could compete
effectively in the USA market without access to this product.
It seems that the EU is intent on
driving forward with unworkable regulations based on political
rather than practical and sound scientific considerations. In
their present form the regulations will have little direct impact
on large biotech companies who stand to gain most from their introduction.
Even the largest seed companies will have difficulty in coping
with them, and it is doubtful if they will succeed. The many small
seed companies who have no direct involvement in GMOs at all,
face potentially crippling costs and totally disproportionate
liabilities if their germplasm becomes contaminated with a GMO.
We are keen to see practical and workable regulation. We do not
believe this will be the case if the proposed regulations are
adopted without amendment. The more GMOs that are authorised,
the more problems we will have, and the more difficult it will
be to get anywhere near the threshold levels that are being proposed.
The lesser evil for conventional seed companies such as Advanta
could be continuation of the status quo and the moratorium.
2.4 Our principal concerns
2.4.1 Thresholds for adventitious GM. As
proposed we believe that:-
they are not proportional with the
one per cent limit set for food and feed, below which labelling
is not required.
the advice of the Scientific Committee
on Plants that the proposed thresholds are only achievable in
the absence of widespread GM sowings in Europe and in ideal seed
production conditions has been ignored. Since the 2001/18 legislation
is specifically designed to allow more GMOs to be registered,
it seems that this and the threshold proposals are diametrically
opposed to one another if one listens to the Committee's advice.
discard levels of seed due to outcrossing
will be a problem for conventional seed companies. The existing
tests on conventional seed do not reveal the extent of genetic
outcrossing because the assessment is almost exclusively visual.
the combination of the existing purity
standards and assessment techniques with the proposed testing
methods for GM seems to us to be flawed.
2.4.2 Sampling and Testing for Adventitious
The draft Seeds Directive appears
to require testing of all seed to achieve certification.
The draft Seeds Directive requires
GM impurity levels to be inside the purity levels for current
certification. The measurements used are derived from two distinct
technologies. Combining them is illogical.
The proposals for drawing samples
for test purposes are very sensible and will be well understood.
We would like to see the reserve portions of these samples become
the definitive material for re-testing in the case of any dispute.
A minimum number of aliquots from
the original sample need to be defined to avoid potential litigation.
The statistical evaluation proposed
is too complicated. The proposed thresholds are statistically
manipulated without any apparent reason. This will lead to intense
2.4.3 Seed production zones:
The draft Seed Directive provides for each crop
that "the determination of these requirements need not be
carried out if the seeds have been produced in an area for which
it has been officially ensured that genetically modified plants
of the same species, or of a closely related species, are not
we fail to see how this provision
is practical or workable.
who will determine the "official"
2.4.4 Traceability and Labelling:
As was shown in the Hyola case, the seed certification
system provides an ideal traceability medium. All bags (100 per
cent) sold in UK were traced:-
the system is not operated so diligently
in some other EU states.
there are no comparable requirements
for isolation or testing for seed saved by farmers for their own
use, but farmers must give GM information to the next operator.
We believe that there is an open door for cost
and litigation if requirements are not uniform.
2.4.5 Consents under Directive 2001/18:
Renewals of consents are mandatory
at ten years. There is no provision for transitional arrangements
if renewal if refused. Adventitious GM will still be present,
but will it be unauthorised?
2.4.6 Unauthorised GM:
The regulations still describe unauthorised
adventitious GM as "not permitted". Various statements
have been made that the presence cannot be prevented in "vanishingly
small amounts" and have indicated that 0.1 per cent may be
permitted. This needs to be clear as it is acknowledged that zero
is not a viable level. The Scientific Committee on Plants have
stated that 0.1 per cent is at the limit of scientific detection.
The legislation concentrates on single
GMOs. It is likely that more than one GM will be present when
GM productions are widespread in Europe.
Events approved in third countries
will be an increasing problem. The drafts have dropped an earlier
proposal to fast track approvals.
All of these measures add up to a substantial
cost increase for conventional as well as GM seed companies.
We have written to the Minister and to the relevant
departments of DEFRA to express our concerns, and have responded
in similar vein to the consultation on implementation of Directive
2001/18. Copies of these letters are attached.
3. NOTES ON
Issues that contribute to the present flow of
new GM regulations in the EU include:
Food scares. (BSE, Dioxins, E-coli,
Foot & Mouth disease, etc)
Public suspicion of GM technology.
Food safety. Single most important
priority of the Commission (Romano Prodi).
Incidents such as the Hyola case
brought adventitious GM into the equation.
There is great pressure on the EU to introduce
new GM laws to address the present unsatisfactory situation.
A priority for Advanta is to ensure that the
regulations that affect us are practical and workable.
3.2 New Law
New legislation is in progress:
Release of GM.
Regulations on Food & Feed and
Traceability and Labelling.
Seed Directive and Regulation on
Sampling and Testing.
These laws are related and will have significant
affects on the Seed Industry. The Seed Directive and the Sampling
and Testing regulation will prevail where they conflict with the
Food & Feed and Traceability legislation.
3.3 Directive 2001/18Deliberate Release
The new Directive has to be in law of member
states by 17 October 2002. It repeals Directive 90/220, which
remains in force until them. The main features and changes are:-
New procedures for authorising GMOs
(including public consultation).
Consents limited to 10 years. Then
subject to renewal.
All existing consents to be resubmitted
by 17 October 2006 under renewals procedure.
Monitoring post-release will be mandatory.
Antibiotic resistance markets to
be phased out. For marketing, (Part C) by 31 December 2004, for
research (Part B) by 31 December 2008.
Exceptions may be possible if not
adverse to health or environment.
Labelling is mandatory except for
technically unavoidable traces below a threshold (to be established).
Public registers must identify location
Safeguard measures allow temporary
suspension of marketing consent by member states on grounds of
risk to health or environment.
Member states are responsible for
inspection and enforcement of the Directive.
Six members voted against adoption unless traceability
legislation is also in place.
3.4 Traceability & Labelling
The proposed Regulation has been issued formally.
It is expected to pass into law in autumn 2001 (now looking unlikely).
The obligation to introduce traceability appears in Directive
2001/18. The proposed Regulation refers to Labelling of Foods
Regulation 49/2000 of 10 April 2000, which requires food to be
labelled if adventitious GM presence exceeds one per cent. The
Regulation requirements include seed to the extent that it is
not in conflict with specific seed law. Features of the Regulation
A requirement for traceability "at
all stages of placing on the market" whether for payment
or free of charge. This will apply to trial seed.
The first stage of placing on market
is the initial transaction. The start point for tracing is the
farm. This raises questions on farm saved seed.
"Operators" shall transmit
specified information to the "operator" receiving the
That the product contains or
consists of GMOs.
The Unique Code(s) relating to
the GMO(s) in the product. These codes are to be developed before
traceability measures can be applied.
Thresholds for technically unavoidable
traces of GM to be established below which no label or traceability
Pre-packed "Goods" consisting
of or containing GMO to carry label with words "This product
contains genetically modified organisms".
An exemption where legislation provides
for specific identification. An example is Seed certification.
This is an important piece of legislation and
its impact on the seed sector should not be underestimated.
3.5 Food & Feed
This proposed Regulation has been formally published
and is expected to pass into law in autumn 2001 (now looks unlikely).
It is probably of less importance to seed companies than the
other legislation. However, it cannot be ignored. Many of its
principles are similar to those contained in the other laws, but
are not necessarily consistent. This may lead to future problems
when interpreting any of the GM legislation. Its most important
feature is to bring the regulations for animal feed into line
with those of food. Other aspects include:
The Novel Food Regulation, 258/97,
is consolidated into this new regulation.
Risk assessment/application procedures
under Directive 2000/18 do not apply where more specific legislation
exists provided it is at least equivalent (eg seed).
Renewals of novel food/feed consents
are required at end of 10 years. There is a time limit set for
consideration of renewals, which are automatic, if there is no
official response before the expiry date.
No single use consent will be granted
where GM can be used in either feed or food. To obtain consent
it must fulfil both criteria.
It will be possible to file a single
application to obtain authorisation for
Deliberate release of GMO to
Use of GMO in food and feed (but
use as seed is not included in this process).
Establishes European Food Authority
Food & feed can only be placed
on the market after scientific evaluation of risk and EFA authorisation.
Applicants may propose methods
of sampling and detection that will be validated by a Community
Reference Laboratory. This differs from seed where the sampling
and testing methods are prescribed.
Reserve Samples are to be deposited
The Regulation differentiates between
food produced from and with GM.
From GM = GM ingredients even
if not detectable in end producteg refined goods, oil,
With GM = GM used in process
but not ingredienteg enzymes which do not remain in final
The Regulation makes no reference
to feed grownpasture, forage, silage.
Products from animals fed with GM
or treated with GM medicinal products are not subject to this
Threshold for "minute traces"
of adventitious or technically unavoidable GM is set at 1 per
cent for both authorised and unauthorised events. This is the
same as in the existing food labelling Regulation.
Events must have been declared
no risk to health or environment by EFA or relevant Scientific
The door is left open for the
possibility of a lower threshold to be set.
3.6 Seeds Directive
This proposed Directive has been drafted and
is currently under consultation. Formal approval is expected in
autumn 2001. The Directive is a consolidating law which pulls
together the existing seed directives for which there is one for
each crop. It then deals mainly with thresholds and isolation
distances in seed production. The main features of the Directive
|Fodder plants||0.3% cross pollinating
0.5% self pollinating
0.7% field peas
|"Unauthorised events shall not|
be present". The notes to the Commission state the intention
to set threshold for "technically unavoidable or adventitious presence of minute amounts"
|Cereals||0.3% cross pollinating|
0.5% self pollinating and maize
|Oil & Fibre||0.3% cross pollinating|
0.5% self pollinating
|Vegetables||0.3% cross pollinating|
0.5% self pollinating
A Regulation on sampling and testing to be introduced
The draft Directive states that unauthorised "genetically
modified organisms are not present in seed lots" under "defined
seed sampling and testing conditions". This is being interpreted
at present as meaning testing at 0.1 per cent with no trace found
at 95 per cent probability (See sampling and testing).
Existing seed purity levels are maximum threshold.
In some cases these are lower than the GM threshold.
The directive proposes the following isolation
||Time since GM crop of same species grown
|Sugar Beet||2,000 metres
|Fodder plants||Not stated. No change
|Large seeded legumes2 years||
|Cereals||Not stated. No change.
|Oil and Fibre||Hybrid swede & turnip rape
|Basic seed 5,000 metres||
|Certified seed 3,000 metres||Soya1 year
|Brassica sp5 years||
|Vegetables||Beta vulgaris 2,000 metres
|Brassica and beta vulgaris5 years
These rules are waived if seed is produced in
an "area" in which it has been "officially ensured"
(no definition) that GM plants of the same or related species
are not grown.
Physical or pollen barriers are recommended in
The Directive states for each crop that "Good
practice for seed production to minimise admixture and undesirable
gene flow throughout crop growth and post harvest handling, shall
be implemented by seed growers, in particular in respect of drilling,
cultivation, harvesting, transport and storage".
The threshold proposal for unauthorised events
to be adapted following adoption of Traceability and Labelling
Label must declare if seed is GM. With words "Genetically
modified variety" together with the name of the GMO.
3.7 Sampling and Testing
This draft Regulation applies exclusively to seed and is
expected to be issued in early autumn 2001 (now very unlikely)
at the same time as the Seeds Directive. The available documents
are poorly drafted and include a number of discussion documents
dealing with statistical analysis.
Although Directive 2001/18 Annex III requires a "notifier"
to provide description of detection and identification techniques,
the Seed Directive and the Regulation seem to be more prescriptive.
These provisions are entirely new and specific to seed. Important
Initial sampling to be under ISTA rules from certification
Seed lots are to be as uniform as possible.
The size of submitted sample to conform to
seed certification rules.
Sealing, labelling and security of sample
in accord with international rules.
Sample preparation for GM testing.
To be drawn from submitted sample. Not to
be less than 3,000 seeds. Can be based on 1,000 seed weight. (3,000
seeds is the quantity needed to give 95 per cent statistical confidence).
To consist of pure seed under ISTA rules for
purity analysis. No inert matter permitted.
Testing and detection according to scientific
knowledge. This allows for technology improvements and change.
Some flexibility is allowed in testing plans. Sequential testing
seems to be preferred but the requirement is not yet clear.
The final document will set rules for acceptance/rejection.
Plans must ensure requirements of risks and
implied assumptions of the testing plan are still met. This implies
some discretion in design of the testing system but needs further
Statistical evaluation of Risks (ie Confidence
levels) is described in the draft. The method proposed is complicated
and needs to be simplified. The calculations for thresholds above
0 per cent, ie authorised events are:-
Producer risk, or Acceptable Quality Level
("AQL") is calculated using 50 per cent of the appropriate
GM threshold as a base. The risk to the producer that lot below
AQL is accepted is not to exceed five per cent.
Consumer risk, or Lower Quality Level ("LQL")
is calculated using 200 per cent of the appropriate GM threshold
as a base. The risk to the consumer that lot above LQL is accepted
is not to exceed 5 per cent.
Where thresholds of 0 per cent (ie unauthorised
events) are set, LQL threshold is 0.1 per cent. This appears to
be an attempt to meet the criticism that testing for zero presence
is impossible. Further clarification is needed on this aspect
of the proposals.
The proposals are silent on the retained samples being the
only valid medium for testing if results are subsequently challenged.
They also seem to imply that testing of all seed is necessary,
as they link the tests to certification purity levels.
Advanta Seeds UK
20 December 2001
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