The Royal Society of Edinburgh (RSE) is pleased to respond to the Food Standards Agency (Scotland) consultation on Developments on European Commission proposals on traceability and labelling of Genetically Modified Organisms (GMOs) and food and feed products derived from them, and on genetically modified food and feed. The RSE is Scotland’s premier Learned Society, comprising Fellows elected on the basis of their distinction, from the full range of academic disciplines, and from industry, commerce and the professions. This response has been compiled by the General Secretary with the assistance of a number of Fellows with substantial experience in crop science and agriculture.

In principle, arrangements for labelling and tracing Genetically Modified (GM) food and feed and GMO’s are to be welcomed as a means of reassuring the public. However, the Regulations need to be workable, not excessively onerous to administer and understandable by the public and those who have to administer them. At present, the proposals have a number of shortcomings in terms of meeting the needs of consumers who wish to exert their choice to avoid foods produced with the application of GM technology, and in terms of monitoring and enforcement.

The specific issues identified in the consultation paper are addressed below:

Proposal for a Regulation of the European Parliament and of the Council on Genetically Modified Food and Feed

Are the proposals an adequate response to consumer demands for clear, meaningful labelling? What added value do they offer?
The attempts to provide increased transparency and consumer input are to be applauded. However, the proposals will not fully meet consumer demands for clear labelling and in some cases they could add confusion and mislead the public, adding little value.

The proposals argue, justifiably, that some consumers wish to exercise their choice to buy ‘non-GM’ products. As a result the proposals have extended the labelling and traceability proposals not only to products containing GM DNA and protein but also to purified and manufactured products (where GM DNA and protein would not be detectable). However, the proposals then fail to recognise that consumer objections are to the application of GM technology. The fine distinctions that the proposals make between products made from GMO as distinct from products made with GMO will not meet consumers’ labelling needs, and in some cases they are likely to mislead rather than inform.

As consumers begin to understand the detailed nature of the proposals they are likely to voice concerns across a range of areas where the regulations will produce misleading inconsistencies in labelling policy, or labelling policies that do not meet consumer requirements. Notable amongst these will be the legislation’s failure to address the question of labelling animal products, since consumer surveys indicate that this is the single greatest point of consumer demand for clear labelling.

Thresholds - Is the concept of a threshold for non-approved GM material practical? If so at what level should it be set? What are your views on thresholds for approved GM material? Is there a practical constraint on the level at which thresholds can be set?
If a GM product has not been approved by the relevant European Union (EU) Committee, the 0% tolerance is the only approach that will satisfy requirements and the demands of those who have concerns about GM technology. However, it is the adventitious, non-intentional and unavoidable presence of GM seed in conventional seed lots, which is to be regulated. Given the EU annually imports some 37 million tonnes of maize, soya and rapeseed or derived feed products, predominantly sourced from a world market that contains a substantial and increasing proportion of GM material, and given the supply chain through elevators and silos, and barges, ships, lorries and holding bins, the likelihood of adventitious presence is sufficiently high that a 0% threshold will not be practicable. If the EU has approval systems for GM products that broadly keep pace with those in exporting countries the issue of non-approved material being imported will not be a major consideration. However, it will become an increasing concern if the approval systems of the EU fall behind those in other countries, as is presently the case.

In terms of approved GM material, in the harvesting and transport of bulk commodity crops there is some inevitable mingling of varieties. The Commission is considering legislation which modifies current separation distances between GM and non-GM crops in the field and which would restrict the presence of GM seed in seed lots to between 0.3% and 0.7% (depending on the crop species in question). However, even with systems designed for identity preservation, it is unlikely that the present threshold of 1% adventitious contamination that is required for non-GM crops can be achieved consistently on a routine basis. It will also be very difficult to monitor, with the likelihood of picking up contaminants depending upon the methods used to sample, with practical difficulties in particular for crops such as soya, maize and rape.

Labelling – Are the requirements adequate to prevent the consumer being misled? What are the practical constraints? How can the requirements for the labelling of products derived from GMOs be enforced?
To better meet consumer demands for labelling, one approach would be to draw a distinction between those food and feed products that are produced without the application of GM technology and those that involve the application of GM technology (including products made from and products made with GM technology). Some countries, for example Germany, Austria and the Netherlands, already have legal provision for a labelling classification of products ‘Produced without genetic engineering’. This classification could be extended across the Community together with the introduction of a second labelling classification ‘Produced with the use of genetic engineering’. This would then provide a simple and easily understood labelling system, which would fully meet the needs for consumer choice and avoid complex and potentially misleading labelling of products. This would also simplify the systems of traceability so that they could be more easily and cost-effectively monitored. As it stands, there is confusion and inconsistency between the use of GM and GMO in the current Regulations. In particular GMO is often used where "products from GMOs" is meant. The labelling of foods with "…containing a genetically modified organism" is also highly misleading in that there is an implication that the labelled product is viable (and liable to escape!).

Alternatively, informed choice could be improved by providing information on the derived value (or otherwise) of the product to the consumer, or the genetic modification involved, or the involvement of GM technology. For example, the removal of allergenicity, the presence of herbicide resistance genes or the use of genetically engineered enzymes in the making of cheese. The labelling could then be made through the use of the specific code number/letters on the label with the full identification outlined in an official codex in much the same way as E-numbers are presently defined.

In terms of enforcement, the procedures for ensuring compliance should be similar to those at present in force for non-GM content. Enforcement could also be mediated via traceability controls, that is, the origin of all constituents in the manufactured end-product will be known, and so enforcement can be exerted at the level of the manufacturer, importer, distributor and/or point of sale.

Detection methods – the proposal requires an applicant to supply detection methods; how would these be applied to products derived from GMOs e.g. oils?
Testing the status of a GM foodstock requires detailed knowledge of the transgene that it carries (or carried). This information is usually readily available and in principle such testing is straightforward. However, there will need to be an obligation on the exporter to provide appropriate documentation. Considerable resources will also need to be deployed for detection methods to be made sufficiently sensitive to apply to a wide variety of products. For highly processed foods, with a complex matrix and in which significant denaturing and losses of DNA occur, protocols which provide definitive answers may be difficult to obtain. In addition, as national laboratories will carry out the safety assessments on behalf of the EFA, on a rota basis, their methods will need to be standardised and verified with consequent resource implications.

Testing for GM contamination is more problematical, because it requires knowledge of all the many transgenes that might be carried by the contaminating GMO, or which might have entered the crop itself by accident. Thus, it is possible to devise tests for the presence of known GMOs of the same and other species, but tests cannot be devised to detect unknown GMOs in most cases. From this it follows that detection of contamination will be simpler and more secure in countries that maintain a database of GMOs approved for both trials and release. The presence of contaminants modified in a manner which is not in the public domain is unlikely to be detectable.

In addition, the identification of oils from GMOs will be difficult. The methods of detection normally rely on the detection of DNA or protein. These methods will be difficult/impossible to apply to products with little or no DNA or protein present. If the oil (or other product) is or contains a variant produced as a result of genetic modification, then testing will be simple. Otherwise, if it is free of DNA and protein and is effectively identical to the equivalent product prepared from non-GM organisms, then no test is currently possible.

Commenting on applications – would the summary document be an adequate basis for inviting public comments?
Whatever is written for the general public needs to be very carefully prepared and explained. While it seems unlikely that many members of the general public will have the scientific knowledge easily to understand the summary document, for those informed members of the public a summary document may not be adequate and the full documentation may be required for transparent review.

Authorisations – do you consider it necessary for applications to be renewed every 10 years? What would be the gains and drawbacks?
Under present law any exotic, newly discovered, food plant or any novel plant produced through non-GM breeding could be introduced to the market without restriction of time of approval. The Commission also already has in place Article 16 which allows Member States to bring new information on risk to the Commission at any time. Therefore, as long as Member States have regular access to information from post-release monitoring, the ten-year limit would not seem necessary and would add additional cost and bureaucracy. However, a 10-year review would allow regulators to keep pace with changes in product production techniques and improved analytical techniques.

Proposal for a Regulation of the European Parliament and of the Council on Traceability and Labelling of Genetically Modified Organisms and Traceability of Food and Feed Products Produced from Genetically Modified Organisms

Would the proposed rules on traceability and labelling provide the information needed for clear and meaningful labelling, for environmental monitoring and for withdrawal of products if necessary?
Traceability is desirable where the withdrawal of a product may be required. However, as noted above, the labelling of foods with "this product contains genetically modified organisms" is highly misleading in that there is an implication that the labelled product is viable. The use of the term "Produced with the use of genetic engineering" should be adequate where appropriate and terminology standardised with the proposed Regulation on genetically modified food and feed.

How would importers apply the requirements in practice?
Responsibility for accurate labelling would lie with the importer, who would in turn require the exporter to supply an adequate description. In many cases this would bestraightforward, since it would relate to documentation supplied by the primary producer (e.g. Monsanto, Aventis or Zeneca). In practice, importers may state that imports may contain the full range of GM varieties that might be present as a result of mingling during harvesting and transport.

How would such traceability requirements be enforced?
Enforcement is likely to be undertaken by a similar mechanism to the traceability scheme for beef products, laid down under Regulation (EC) 1760/2000. Responsibility for the traceability systems would be placed on the businesses operating in the feed/food chain, and enforcement authorities would need to operate an audit system at the stages of import, storage, manufacturing/processing, distribution and sales. Analytical testing would likely to be required at specific stages along this sequence.

What impact would the traceability requirements have on small businesses and catering establishments?
There seems little doubt that the impact of these proposals on trade outside the EU and on small businesses and catering establishments will be significant. The requirements will increase the complexity and cost of small business operation, withoperators in all groups and businesses involved in the production, purchasing and utilisation chain (including catering companies) having to maintain all necessary records relating to traceability and product identity. This is likely to be met by increased food costs to the consumer.

What are the practical constraints of the requirements and what are the cost implications?
The proposals for labelling and traceability will add an additional layer of bureaucracy to the operation of the food chain and the long-term reliability and practicality of the process need to be considered. Storage, transport and shipping of grain from the US involves millions of tonnes and the scale of production may prove problematic for the records of all grain batches to be accurately maintained for a number of years once doors are more fully open to GM imports and when production accelerates in Europe.

Another practical constraint will be the success of the determination of the traceability of GMOs and their products from third countries. Detection methods, in particular for certain products such as oils derived from GMOs, are likely to be difficult or impossible to set up and the implementation of the proposals will require comprehensive monitoring and enforcement at all levels. Where it is possible, it will require efficient and effective administration.

The cost implications could only be established through an appropriate business analysis but, as indicated by the general cost of identity preservation and audit systems, estimated increases in food production costs might be in the order of 10-15%. In addition, as there will be no requirement for the traceability systems to be adopted by those who are producing food outside the EU, the additional costs involved could make EU food production less competitive against imports than at present. In effect this could result in the EU importing more food of more doubtful provenance.

Additional Information
In responding to this inquiry the Society would like to draw attention to the following Royal Society of Edinburgh responses which are of relevance to this subject:
Review of the Framework for Overseeing Developments in Biotechnology (February 1999); The Scientific Advisory System-Genetically Modified Foods Inquiry (March 1999); The OECD Edinburgh Conference on the Scientific and Health Aspects of Genetically Modified Foods (February 2000); Inquiry on European Community Food Safety Policy (March 2000); The Assessment of Risk to Biodiversity from GM Crop Management (December 2000); The Adventitious Presence of GM Seeds in Seed of Conventional Varieties (April 2001); Possible Scenarios for the Uptake of GM in Agriculture (August 2001) and Commission Proposals on Adventitious GM Presence in Non-GM Seeds (August 2001)
 
September 2001

Further information is available from the Research Officer, Dr Marc Rands