Memorandum by the American Soybean Association
1. The United States is the world's major producer
and exporter of soybeans, the principal world source of vegetable
protein, and a major source of vegetable oils and other food products.
At present, US area under soybeans lies at around 72 million acres,
a figure which approximates to the combined land area of the United
Kingdom and the Republic of Ireland.
2. In 1997, US production of soybeans reached
a figure of some 75 million tonnes, mainly from states in the
Mississippi basin, of which about 50 per cent will prove to have
been exported, 15 per cent to Europe in the form either of whole
beans or of soy meals produced after oil extraction.
3. The American Soybean Association (hereinafter
"the ASA") headquartered in St Louis, Missouri, represents
32,000 producer members on national and international policy and
issues important to all US growers of soy. Its commitment to international
markets is attested by its thirteen international offices spread
throughout the world, and by its ongoing promotion program for
US soy products to a wide range of customers.
4. The ASA welcomes and appreciates the opportunity
to contribute to the Sub-Committee's enquiry. The Sub-Committee
will be aware that the US soybean sector in particular has been
the focus of much attention in the European debate on the uses
of biotechnology in agriculture. Criticism has been directed at
it by European opponents of biotechnology, frequently founded
on misinformation, and considerable confusion in Europe has resulted.
5. It is hoped that the present observations
will open the way to a better understanding of what the US soybean
farmer can do to meet the needs of his European customers in terms
of securing product with the characteristics they require and
are prepared to pay for.
6. Soybean production in the US has grown from
a near-zero base in the 1920s to current levels on foot of growing
demand from the world food and feed industries. The climatic conditions
in which it is carried on vary widely across the US, with 11 different
identified climate patterns requiring different approaches to
variety choice and to agronomic management.
7. The number of varieties cultivated runs into
thousands, with seed provided by a range of large- and small-scale
multipliers to suit local conditions. As with agricultural crops
in general, there is an observable tendency in most cases for
a soybean variety to peak in use and to decline over about a 25
year commercial life-cycle.
8. The genetic resource base is therefore in
a constant state of development and renewal, and about a hundred
new varieties obtained through classical selection procedures,
enter commercial production each year.
9. With the development over the past 25 years
of modern biotechnology, additional genetic options have become
available to soybean producers. The advent of recombinant DNA
technology has enabled improvements which have a favourable impact
on agronomic practice, in terms of production costs, both of inputs
and labour, in terms of farm health and safety, and in terms of
good environmental practice.
10. The 1996 US planting season saw the first
use of seed in the production of which recombinant DNA techniques
were used to insert a specific agronomic trait into the genetic
material of soybean seed of a number of varieties. The Monsanto
Company had made available to seed multipliers the technology
to incorporate into the genomes of soybean varieties an event
which gives the soybean plant enhanced tolerance of the systemic
herbicide glyphosate. It is estimated that the modification event
is currently on offer in about two hundred varieties of soybean.
11. Commercial plantings of these beans, known
commercially as "Roundup Ready" beans (or "RR beans"),
only began after all existing regulatory requirements had been
complied with both in the US and in major export markets for soybeans.
To date, RR beans are the only transgenic soybeans in production
that are exported from America, although authorization procedures
are underway for several other modification events in the soybean.
12. In the European Union, the principal regulatory
requirement was a decision authorising the clearance of such beans
for deliberate release into the environment under Council Directive
13. That decision (96/281/EC) was taken by the
European Commission on 3 April 1996, following a favourable recommendation
after detailed examination from the United Kingdom's competent
authority for release of transgenic organisms into the environment,
and a qualified majority in favour of such a decision from the
member states of the EU meeting within the relevant committee.
14. In the first planting season, about 2 per
cent of America's soybean acreage was planted to RR beans, with
about 15 per cent in 1997, and about 40 per cent in 1998. The
limiting factor on RR acreage for 1998 was the availability of
seed, provision of which could not keep pace with demand. In future
years, and as the RR technology is incorporated in soybean varieties
of all maturity groups, it is expected that the technology will
become the norm.
15. As neither the US nor EU regulatory authorities
have seen any need to require separation of RR beans from other
beans, the harvesting and marketing of all soybeans entering the
bulk commodity system does not in general involve such separation.
16. This does not mean however that it is not
possible to ensure that small quantities in container-sized lots
can be supplied to order in response to specific customer requirements,
but the costs involved would reflect the additional growing, handling
and guarantee operations undertaken.
17. Hitherto, no standard specifications or
form contracts to underpin such limited deliveries of non-transgenic
beans have been elaborated, and the ASA has not been approached
by any customers in Europe with a view to drafting them and recommending
them to its membership.
18. The ASA would like to respond to the sub-committee's
invitation specifically under the following heads:
the appropriateness and efficacy
of current regulation of novel foods and their labelling at European
Union level (point 1(c) in the notice of invitation);
the most appropriate jurisdictions
(including international regulation and harmonisation) for decisions
on genetically modified organisms (point 3 in the notice of invitation);
19. The ASA does not feel competent, in the
present context, to comment on the UK's national approach to genetic
modification in agriculture, and believes that the implications
for soy arise essentially at EU level, something that may not
be the case for other genetically-modified crops.
20. In the ASA's view, the EU's provisions on
novel food labelling have yet to be effectively applied or observed
in operation. Apart from the basic novel foods regulation (258/97),
no implementing regulation thereunder has been adopted, whether
of a general nature or relating to a specific product. The system
has yet to function.
21. The EU Council's adoption in late May of
Regulation 1139/98, under the 1979 food labelling directive (79/112/EEC),
on the exhaustion of a complex legislative procedure, merely targets
those soybean and maize varieties which incorporate two specific
proprietary modification events, and submits them, and products
derived from them, to testing and labelling constraints in the
name of consumer information.
22. In so doing, however, the Council has acted
on an assumption, embodied in the sixteenth and eighteenth motivating
grounds of the regulation, that both modification events render
the products covered, and products derived from them, not equivalent
to existing counterparts, on the grounds that there may be detectable
variations in DNA and protein attributable to the events.
23. This would seem to do violence to the concept
of substantial equivalence of novel foods as developed in the
OECD and the WHO, which seeks to evaluate a novel food by comparing
it with an established counterpart, and determining whether there
are additional safety concerns which need to be taken into account
in the authorization of the novel food.
24. It may well be that the Council considers
that the required labelling is unrelated to health and safety,
and only addresses a consideration of consumer information. However,
the ASA believes that this approach will give rise to conflict
when it comes to establishing a sound international system for
the control and management of biotechnology in agriculture.
25. The ASA believes that the broad lines of
areas of potential international disagreement on biotechnology
in agriculture are already clear. They would seem to be:
differing positions, perhaps of an
ethical or social nature, unrelated to food safety and environmental
protection, on the use to be made of transgenic plants in agriculture;
the role of law and public authority
in favouring or discouraging resort to transgenic plants;
attempts to impede trade in and market
access for transgenic plants using new policy considerations to
justify new non-tariff barriers of a kind unacceptable within
serious divergence in approach to
the authorization of individual products, whether founded on general
evaluation principles, or on differing durations for completion
26. The ASA believes that the WTO should remain
the agency of choice for settling disputes in trade in transgenic
products, albeit with the technical support and specialized advice
of agencies such as the WHO (in particular through the Codex Alimentarius)
and the OECD.
27. The ASA believes that the principles underlying
the Agreement on the Application of Sanitary and Phytosanitary
Measures, annexed to the 1994 Marrakesh Agreement establishing
the WTO, offer the best existing framework to resolve differences
which might arise.
28. The ASA would view with disquiet any suggestion
that the Agreement, or any successor arrangement, should admit
any public policy measures which, for reasons other than those
based on sound science, would abridge the liberalisation of trade
in farm products which has been achieved so far.
29. The ASA also feels that cooperation between
regulatory authorities, founded perhaps on mutual recognition
of approvals, would do much to eliminate difficulties in trade,
where the pace of approvals differs between jurisdictions.
8 June 1998