Select Committee on Environment, Food and Rural Affairs Appendices to the Minutes of Evidence


Memorandum submitted by Advanta Seeds UK (A51)



  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 budgets.

    —  Focus on new traits to fully transform crop plants.

    —  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)

    —  Proposed Regulation—Traceability and Labelling (Paragraph 3.4)

    —  Proposed Regulation—Food and Feed (Paragraph 3.5)

    —  Draft Seeds Directive (Paragraph 3.6)

    —  Draft Sampling and Testing Protocol (Paragraph 3.7)

  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 3.6)

    —  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 2.4.3)

    —  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 2.4.5)

    —  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)[34] and have responded to consultations directly (Annex 2)[35] and via our European and National Trade Associations.


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 GM varieties.

    —  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 obvious benefit.

    —  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 USA—no 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 GM:

    —  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 confusion.

  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 grown".

    —  we fail to see how this provision is practical or workable.

    —  who will determine the "official" assurance?

  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.

  2.4.7  Cost:

  All of these measures add up to a substantial cost increase for conventional as well as GM seed companies.

2.5  Representations

  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.[36]


3.1  Background

  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:

    —  Directive 2001/18—Deliberate 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 2001/18—Deliberate Release of GM

  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 of GMOs.

    —  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 include:

    —  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 products:

      —  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 required.

    —  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 environment.

      —  Use of GMO in food and feed (but use as seed is not included in this process).

    —  Establishes European Food Authority "EFA".

      —  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 with EFA.

    —  The Regulation differentiates between food produced from and with GM.

      —  From GM = GM ingredients even if not detectable in end product—eg refined goods, oil, sugar.

      —  With GM = GM used in process but not ingredient—eg enzymes which do not remain in final product.

    —  The Regulation makes no reference to feed grown—pasture, forage, silage.

    —  Products from animals fed with GM or treated with GM medicinal products are not subject to this Regulation.

    —  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 Committee.

      —  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 are:—

  3.6.1  Thresholds

Authorised Events
Unauthorised Events
Sugar Beet
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"
of GM
0.3% cross pollinating
0.5% self pollinating and maize
Oil & Fibre
0.3% cross pollinating
0.5% self pollinating
0.7% soya
0.3% cross pollinating
0.5% self pollinating

    —  A Regulation on sampling and testing to be introduced (See below).

    —  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.

  Seed production

    —  The directive proposes the following isolation distances:

Isolation distance
Time since GM crop of same species grown
Sugar Beet
2,000 metres
5 years
Fodder plants
Not stated. No change
Peas—1 year
Large seeded legumes—2 years
Others—5 years
Not stated. No change.
Maize—1 year
Other—2 years
Oil and Fibre
Hybrid swede & turnip rape
Basic seed 5,000 metres
Certified seed 3,000 metres
Soya—1 year
Brassica sp—5 years
Other—2 years
Beta vulgaris 2,000 metres
Peas—1 year
Brassica and beta vulgaris—5 years
Others—2 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 all cases.

    —  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".

  3.6.2  Labelling

    —  The threshold proposal for unauthorised events to be adapted following adoption of Traceability and Labelling Regulation.

    —  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 features include:

    —  Initial sampling to be under ISTA rules from certification seed lots.

      —  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 clarification.

    —  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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