Memorandum by Monsanto Services International
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
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
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.
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
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
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.
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
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
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
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
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
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.
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.
41. The many identified benefits of agri-biotechnology
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.
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.
|Monsanto cost benefit experience of on-farm use of biotech crops in 1997
|Crop||Per cent||Per acre
||Per cent||Per cent|
|Roundup Ready Soybeans||5
|YieldGard Bt Corn||8||$20-35
|Bollgard Bt Cotton||10
|Roundup Ready Cotton||5-6
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
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 dilemmahow 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.
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
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.)
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
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
|Determinations of non-regulated status of genetically modified plant products at USDA (as of January 1997)
|DNA Plant Technology||Tomato
|Du Pont||Cotton||Herbicide Tolerance
|Plant Genetic Systems||Corn
|Cornell U.||Papaya||Viral Resistance
|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)
|Plant Genetic Systems||Corn
||Male Sterility/Herbicide Tol||~24
|Bejo-Zaden||Chicory||Male Sterility/Herbicide Tol
|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)
|Northrup King||Corn||Insect Protection