MONSANTO EXPERIENCE

  1. Monsanto has extensive experience in developing genetically modified crops around the world. Since 1996 we have commercialised 10 products in the United States, Argentina, Canada, Japan, Europe, Australia and Mexico and have conducted several thousand field tests with genetically modified plants in many countries around the world since 1986. Monsanto has been actively involved in European and international discussions on the levels of safety assessment and regulation for genetically modified plants, including discussions sponsored by the OECD, WHO/FAO and the TABD (Transatlantic Business Dialogue).

  2. Monsanto recognises the importance of well administered regulation, not only to ensure adequate levels of protection for human health and the environment, but also to provide public confidence in approvals and the authorities which issue them.

  3. Monsanto believes that the regulation of genetically modified plants should: be based on scientific evaluation to ensure objectivity and consistency; be timely and predictable, to accommodate investment planning; be internationally consistent to ensure competitiveness; and be appropriate to the level of risk.

  4. The following evidence will apply these criteria to the existing and proposed EU regulation of genetically modified plants, and where appropriate, contrast the situation in the EU with that in other world areas.

THE APPROPRIATENESS AND EFFICACY OF THE CURRENT REGULATIONS AT EUROPEAN UNION LEVEL

(a) Research

  5. The EU directives 90/219/EEC and 90/220/EEC part B were established in the 1980s to regulate the research and development of genetically modified plants under contained conditions and unconfined conditions, respectively. National regulations were in force in some EU countries well before the implementation of the EU directives. After 12 years of research and more than 100 field releases in the EU, to our knowledge, there have been no reports of environmental damage or injury to human health. It must be concluded that the present safeguards are entirely adequate from these perspectives. The introduction of simplified procedures for certain categories of GM plants in 19941 allowed for reduced administrative procedures, whilst at the same time maintaining adequate safety precautions.

  6. The current regulations are allowing research and development to proceed in most Member States, although a number of important changes are desirable to reduce the administrative burdens, encourage academic research, and to accelerate product commercialization. Improvements could be brought by: regulating research and development within vertical product regulations e.g., variety registration procedures and further simplification of the administrative procedures for identified "low-risk" GMP's particularly where experience has been obtained. This could be done via a "notification" procedure; introducing the possibility for simple multi-state authorisations to avoid the duplication of the paperwork and resources currently necessary to conduct field trials in different Member States.

(b) release into the environment

  7. The regulation covering release into the environment includes the approval to commercialize GMP's under Part C of the Directive 90/220/EEC. The information necessary for safety assessments is described in detail in Annex IIb of the Directive.

  8. The functioning of the directive has many serious shortcomings. These are evidenced by: The Commission's report on the functioning of the Directive since its adoption²; the number of products approved compared to other world areas with comparable levels of industrial activity and the time required for these product approvals (see Attachment 1, last updated 1/97).

  9. Industry representative organisations, including EuropaBio and GIBiP, have previously documented their concerns about the current 90/220 directive, as well as the proposed revisions.

  10. The underlying causes of the major deficiencies of the current directive have varied over time, but have included:

  11. Lack of clarity of the scope of the directive and overlap with other legislation (such as Directive 91/414 concerned with the authorisation of plant protection products). This has led to confusion over the information to be provided by applicants.

  12. Failure of the standard 5-month procedure to operate as foreseen. All but one of the 25 EU marketing applications have raised objections from at least one Member State. This has resulted from the inherent lack of clarity in the scope of the Directive, as well as the inclusion by Member States of objections based on criteria outside of the scope of the Directive (e.g. labelling, insect resistance management, herbicide use). The result has been that the predictability of the process is highly uncertain, thus leading to a much greater level of speculation on investment decisions than in other parts of the world.

  13. The comitology procedure foreseen to resolve differences between Member States has not functioned. This is attributable to differences in Member States perceptions of risk and considerations of non-scientific criteria, making it difficult to find the necessary Member State support for proposed Commission decisions. The result has been regulatory uncertainty, and undermining of public confidence in the regulatory system.

  14. Lack of specific time frames for all steps in the process, from Member States review (in some, but not all Member States), the Commission proposal for a decision, and the time for rapporteur country approval. This has led to unacceptable uncertainty in determining the return on investment in decision making.

(c) Novel foods and labelling

  18. The Novel Food regulation4 has been in force since May 1997 and both industry and the regulatory authorities have had little time to develop experience with its operation. However, the issues raised during its drafting continue to be areas of concern. The principal so far identified concerns are:

(i)  (i) Lack of a clear definition of "substantial equivalence". The procedure for the regulatory clearance of products is determined by whether products are substantially equivalent or not. Member States and the Commission have not formally agreed on a uniform definition, such as that developed by FAO/WHO and OECD.5-6-7 This is resulting in major uncertainty over expected approval timelines; and

(ii)  Lack of a clear definition of "equivalence". "Equivalence" has yet to be fully defined because of the lack of uniform Community standards for the techniques to be employed and the acceptable sensitivity limits. Products which are no longer equivalent must be labelled as being genetically modified, in many cases for information, rather than for health and safety purposes.

  19. As many of the products concerned by the Novel Foods Regulations are present in international trade there must be consistency with international rules and obligations to avoid trade disputes in food and agriculture products. Labelling obligations for information, rather than for scientific reasons, also risks creating difficulties in trade.

  20. A more detailed review of the functioning of the Novel Food regulation will be appropriate once greater experience has been gained with the regulation.

(d) Other regulatory considerations-variety registration

  21. The existing plant variety registration legislation does not distinguish between GM varieties and non-GM varieties. However legislation is in development which would allow for a transfer of the environmental and human health safety assessments from Directive 90/220/EEC and the Novel Food regulation into variety registration procedures. Notwithstanding these future changes, some Member States are using national variety registration procedures to add further conditions to the marketing of GM varieties. These conditions are, in some respects, contrary to Community (90/220/EEC) decisions, are not science-based and are an additional burden to industry, which decreases the competitiveness of European agriculture without providing additional safeguards.

(e) Current trends and future developments

  22. Approval timelines: It was to be hoped that the functioning of the EU regulatory process would improve over time, as familiarity with the technology, product applications and safety assessments advanced. This has turned out not to be the case. Despite overwhelming evidence of the benefits of products commercialized in other world areas (James, 1997; Attachment 5) [not printed] and the lack of any demonstrated negative effects on the environment or human health, product approvals are regularly delayed beyond reasonable time limits. These delays are becoming longer rather than shorter. Failure of the Member States to reach scientific consensus on all but one of the marketing applications (a carnation with altered flower colour) has contributed to these increasing delays. It is to be hoped that the recent introduction into the 90/220 process of reviews by the Commission's Scientific Committees will be a positive step towards a more science-based review and improve the overall functioning of the 90/220 process.

  23. Data requirements: A further development which is contributing to the uncertainty in the regulatory process are the continual changes in the interpretation of the data requirements for safety assessments. Data requirements are outlined in Annex IIb of the Directive 90/220/EEC, but details are not provided. In the EU 90/220 process, a total of 16 scientific safety assessments are conducted on each product (one by each Member States and one by the Commission's Scientific Committees). The result has been bureaucratic difficulties in resolving increasingly divergent views on the most appropriate safety data set, and usually a requirement for applicants to respond to the combined data set. This has led to unanticipated delays and discrepancies between the European and international data requirements.

THE APPROPRIATENESS AND EFFICACY OF THE CURRENT REGULATIONS AT THE LEVEL OF THE UNITED KINGDOM AND OTHER MEMBER STATES

  24. An assessment of the operation of the current regulations at the UK or any Member State level cannot be easily distinguished from the operation at the European Union level. Many of the problems with the operation of the European Union regulation of biotechnology products stem from difficulties at the Member State level such as delays caused by uncertainties over eventual Member States decisions when drafting Commission decisions in preparation for referral to Member States for qualified majority voting.

  25. Problems at the Member State level have been caused by various factors:

  26. The original concept whereby other Member States would generally accept the rapporteur Member State's review throughout the Community has not functioned. All products must effectively undergo complete reviews in all Member States. It should be considered whether this current process should not be replaced by a Community-wide process such as a Standing Committee decision, as is the case in other areas of regulation, such as the approval of Plant Protection products.

  27. Member State reviews usually involve consultation with several Ministries. In some cases this had led to conflicting scientific conclusions (for example between ACRE and ACNFP in the UK). These conflicts can only be avoided by strict adherence to well defined scientific criteria.

  28. The introduction of local political factors, such as the timing of elections, or consideration of non-scientific factors, outside of the scope of the regulations, have often led to objections which contribute to the undermining of public confidence in the regulatory process.

  29. Delays in formal approvals have also resulted from rapporteur delays in completing the approval process once the decision has been published in the European Official Journal, in some cases for as long as 12 months. Products may not be marketed until the rapporteur country approval ("consent") is issued.

THE MOST APPROPRIATE JURISDICTIONS (INCLUDING INTERNATIONAL REGULATION AND HARMONISATION) FOR DECISIONS ON GENETICALLY MODIFIED ORGANISMS

  30. International harmonisation of the regulation of GM crops is one of the major challenges facing the industry and the European Union. The EU and the United States are the world's two leading trading partners, and differences in the regulation of GM crops has already led to trade tensions arising from the following:

  31. Differences in the fundamental approach to the regulation of GM crops. The "process-based" approach to the regulation of GM crops in Europe has often been contrasted with the "product-based" approach in other world areas.

  32. There are no separated and gradated "risk categories" for marketing applications. Products approved for import into the EU for processing purposes only are subject to the same procedures and risk analyses as products destined for wide-scale planting in Europe.

  33. Excessive bureaucracy and lack of time limits on Member State/Commission interaction, means that the time for product approvals is considerably longer in Europe, compared to other world areas, including the United States, Canada and Japan.

  34. The unpredictability of the process resulting from various factors, including lack of clarity in the scope of the regulation, lack of transparency and predictability in the procedures to be followed and failure of Member States to comply with the directive.

  35. The regulation of products in the EU which are not regulated ex-EU, such as varieties developed by hybridising previously approved genetically modified varieties.

  36. Trends towards differing data requirements. Despite general agreement to date on the appropriate information necessary to support product safety assessments, there are widening gaps between the EU risk assessments and those in other world areas. For example, some EU Member States are requesting that animal feeding studies be routinely included in safety assessments, contrary to OECD recommendations.

  37. The EU requirement to label for process, without any safety or other scientific basis, risks creating barriers to the international trade in foodstuffs.

  38. The result of these differences, particularly the delays and the lack of predictability of the EU process has been interference with global trade in agriculture and food products. There is clearly a need for a more harmonised international approach to the regulation of GM crops.

THE EFFECT OF REGULATION ON DIFFERENT SECTORS OF THE INDUSTRY AND ON COMPETITION

  39. The style and operation of the regulatory system as it affects biotechnology in agriculture impacts the whole food chain from efficiency and cost of food production through to access to higher quality and more nutritious food products. Further, the Commission's 1994 White Paper on biotechnology, growth and competitiveness and employment reports that "in future the entire system of related provisions on biotechnology must ensure that the [regulatory] controls are always in proportion to the risks which exist, the need to build up confidence in the public and to the competitive development of the industry, whilst at the same time human health and the environment must be protected".

  40. Europe's agri-food industry possesses the potential for innovation which combines cutting edge technology with responsible and sustainable use of resources and Europe can have the same strong record in innovation and a leadership role in agri-biotechnology as that which already exists in several other key industries, including communications technology, pharmaceutical research and development and environmental technology: this is provided the regulatory systems which govern the introduction of the technology are effective in practice, have the general confidence and trust of the public and correctly weigh the benefits against any possible risk.

POTENTIAL BENEFITS

  41. The many identified benefits of agri-biotechnology include:

  42. An innovative and sustainable agri-food sector matching consumer needs and the demands of an expanding modern economy. Strengthening of the agriculture and rural community as a responsible and important partner in Europe's growth and development. Better land and resource management to help preserve natural resources and ecosystems. Access to food crops with improved nutritional value resulting in a healthier society. Access to crops with built-in protection from insect pests and resistance to viral and fungal diseases resulting in new and more effective options for the farmer. Access to crops with enhanced temperature, salinity and drought tolerance which make better use of available land. Diagnostic agents for plant and animal diseases resulting in healthier crops and food products. Reduced post-harvest losses, longer storage life and reduced agricultural waste. Agriculture as a source for renewable raw materials for industrial production of such items as fuel, lubricants, plastics, pharmaceuticals and other consumer products, with significant environmental benefit. Opportunities for investment in modern and clean new enterprise.

  43. Access to global markets for Europe's food and agricultural production. Reduced cost of agri-food production. Crops, and food and feed products of improved quality.

  44. Access to essential supplies from world markets. Security of crop supplies. Availability of competitive supplies of raw material food and feed materials.

  45. Enhanced employment opportunities. Renewal of agriculture and rural communities by providing profitable opportunities for farmers and incentives for new, young farmers. Diversification opportunities for farmers and rural communities. Creation of new small and medium enterprises throughout the agri-food chain. Source of new, innovative and interesting jobs. Creation of a biotechnology know-how in Europe.

  46. International and domestic credibility. Playing a role in establishing world standards in agricultural production. Consistency in trade negotiations. Confirmation of the EU's commitment to the thoughtful and responsible development of new technologies underpinning the creation of a modern, sustainable and competitive economy. Europe as a partner in innovation in all sectors and in all phases of product development.

BENEFIT DATA

  47. Quantified in-use benefit data and experience is required to establish the exact nature and size of these benefits. Data is so far however only available from the United States, Canada and Argentina where products have been approved for marketing and production since 1995. The Table below gives a summary of benefit data obtained by Monsanto over a total crop area of more than 19 million acres in 1997 in the United States and which therefore gives an indication of what might be expected in the EU. Data cannot be directly compared because of different climatic, operating and crop production conditions.

TABLE
Monsanto cost benefit experience of on-farm use of biotech crops in 1997
	Yield Benefit	Value Potential	Farmer Satisfaction	Repurchase Intention
Crop	Per cent	Per acre	Per cent	Per cent
Roundup Ready Soybeans	5	$12-20	90	90
YieldGard Bt Corn	8	$20-35	90	80+
Bollgard Bt Cotton	10	$35-70	80	70+
Roundup Ready Cotton	5-6	$12-30	90	95
NewLeaf Potatoes	5	$60-140	85	90

  49. The cost benefits are an expression of the sum of a number of elements: Primarily reduced cost of chemical usage on crops, energy savings in farm and crop maintenance and lower farm equipment costs. The measured benefits identified in the Table do not include any quantification of the higher quality of delivered products (e.g., reduced contamination by weed and other foreign seeds), and the general improved peace of mind for farmers as they tend their crops.

  50. A more complete evaluation covering products from other companies is included in Attachment 5.

EU BENEFIT DATA

  51. At the time of writing, the EU has still only issued one product approval (in 1998) for unrestricted domestic production of a plant crop and one for import from third countries so therefore no real data is available. Many further products are in the approval pipeline but have also been significantly delayed for procedural reasons in the regulatory process.

  52. Thus, the EU has already missed four years in the important initial stages of improved commodity and production in the competitive global agriculture markets, while at the same time has missed the domestic opportunities of improved environmental performance and increased sustainability of agriculture, lower costs of production and greater opportunities for farmers.

  53. The importance of this technology and its introduction is even more important to the EU than other world areas because of the structure of European agriculture and the common agricultural policy and its relationship to the newly agreed arrangements under the Uruguay Round. That agreement reduces the volumes of commodity agricultural products which have incurred a production subsidy, which can be placed by the EU into export global markets. The only way for the EU to enter such markets is to reduce subsidies. Thus the EU faces the dilemma—how to maintain farmer income and reduce subsidies. The answer lies in reduced production costs and increased farm efficiency which should allow the farmer to maintain income and profitability in the face of lowered subsidies.

  54. The introduction of the new biotechnology into crop production can help in this process although it should not be viewed as a universal panacea. The other world areas with whom the EU is directly competing have already adopted this approach, which means that it is urgent that the EU also does so in order to preserve its competitive position in open world markets.

SUMMARY AND REASONS FOR LACK OF EU BENEFITS

  55. Much of this lack of crop introduction and therefore lack of benefits can be laid at the door of the bureaucratic and slow regulatory process. There is no reason that the EU should be any slower in coming to the same scientific conclusions from very similar data packages as regulatory authorities elsewhere in the world.

4 June 1998

ATTACHMENTS

  1. Industry comparison of EU and US approval timelines (as of January 1997).

  2. EuropaBio position paper on the need to improve the operation of Directive 90/220 on the deliberate release of GMOs. EuropaBio Position Paper 22 July 1997. (See pages 328-331).

  3. EuropaBio position paper on the revision of Directive 90/220 (COM(1998) 85 final, 23 February 1998. (See pages 326-328).

  4. GIBiP position paper on the revisions of EU Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms. March 1998. (See pages 293-294).

  5. James, C 1997. Global Status of Transgenic Crops in 1997. ISAAA Briefs No. 5 ISAAA: Ithaca, NY page 31. (Not printed.)

REFERENCES

  1. Commission decision of 4 November 1994 establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6(5) of Council Directive 90/220/EEC. Official Journal of the European Communities No. L292/31. 12 November 1994.

  2. Report on the review of Directive 90/220/EEC in the context of the Commission's Communication on biotechnology and the white paper. Commission of the European Communities, Brussels, 10 December 1996, COM(96) 630 final.

  3. Proposal for a European Parliament and Council Directive amending Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, 98/C 139/01, Official Journal of the European Communities, C139/1, 4 May 1998.

  4. Regulation (EC) No. 258/97 of the European Parliament and of the Council of January 1997 concerning novel foods and novel food ingredients. Official Journal of the European Communities. No. L43/1. 14 February 1997.

  5. FAO, 1996. Biotechnology and food safety. Report of a Joint FAO/WHO Consultation. Food and Agricultural Organisation (FAO), Rome.

  6. OECD, 1996. Food safety evaluation. Organization for Economic Co-operation and Development (OCED), Paris.

  7. WHO, 1995. Application of the principles of substantial equivalence to the safety evaluation of foods and food components from plants derived by modern biotechnology. Report of a WHO Workshop. World Health Organisation (WHO), Geneva. WHO/FNU/FOS/95.1

ATTACHMENT 1

Determinations of non-regulated status of genetically modified plant products at USDA (as of January 1997)
Company/Institution	Crop	Trait	Time required for determination1 Months
Calgene	Tomato	Fruit Ripening	~4.5
Calgene	Cotton	Herbicide Tolerance	7
Monsanto	Soybean	Herbicide Tolerance	8
Calgene	Rapeseed	Modified Oil	7
Upjohn	Squash	Viral Resistance	~29
DNA Plant Technology	Tomato	Fruit Ripening	5
Monsanto	Potato	Insect Protection	~6
Ciba-Geigy	Corn	Insect Protection	~6
Monsanto	Cotton	Insect Protection	~7.5
AgrEvo	Corn	Herbicide Tolerance	6
Zeneca/Petoseed	Tomato	Fruit Ripening	~8
Monsanto	Tomato	Fruit Ripening	~7
Monsanto	Corn	Insect Protection	~4.5
Monsanto	Cotton	Herbicide Tolerance	~5
Dekalb	Corn	Herbicide Tolerance	~7
Northrup-King	Corn	Insect Protection	~6
Du Pont	Cotton	Herbicide Tolerance	~5.5
Plant Genetic Systems	Corn	Male Sterility/Herbicide	Tol~6
Agritope	Tomato	Fruit Ripening	4
Monsanto	Potato	Insect Protection	5
Asgrow	Squash	Viral Resistance	6
AgrEvo	Soybean	Herbicide Tolerant	~4.5
Cornell U.	Papaya	Viral Resistance	~6.5
Average			2~7
1 Approximate average time from submission to USDA to approval. 2 The average time for USDA approval was six months if the Upjohn squash product that was prolonged based on resolution of technical issues is excluded.

Genetically modified plant products approved according to European Directive 90/220 (as of January 1997)
Company/Institution	Crop	Trait	Time required for determination1 Months
Rhone-Poulenc	Tobacco	Herbicide Tolerant	~9
Plant Genetic Systems	Corn	Male Sterility/Herbicide Tol	~24
Monsanto	Soybean	Herbicide Tolerance	17
Bejo-Zaden	Chicory	Male Sterility/Herbicide Tol	~18
Ciba-Geigy2	Corn	Insect Protection	~25
Average			18-19
1 Approximate average time from submission to rapporteur country to publication in the European Official Journal. 2 Eu delay for ~six months for resolution of technical issues.

Genetically modified plant pesticidal products approved by the US EPA (as of January 1997)
Company/Institution	Crop	Trait	Time required for Approval Months
Monsanto	Potato	Insect Protection	20
Ciba Geigy/Mycogen	Corn	Insect Protection	12
Monsanto	Cotton	Insect Protection	20
Northrup King	Corn	Insect Protection	14
Monsanto	Corn	Insect Protection	19
DeKalb	Corn	Insect Protection	11
Average			16