Uncertainty and reluctance Europe and GM food

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					Biotechnology and Development Monitor, No. 47, p. 16-19.                                      Page 1 of 6




            Uncertainty and reluctance: Europe and GM food
                                                   by
                                       Piet Schenkelaars



Keywords:      Europe, Genetic Engineering, Public acceptance
Correct        Schenkelaars, P. (2001), "Uncertainty and reluctance: Europe and GM food."
citation:      Biotechnology and Development Monitor, No. 47, p. 16-19.

It was not until autumn 1996, when European environmental activists tried to block
the first imports of genetically modified (GM) soya, that the USA and European media
started getting serious about biotechnology. This article examines how regulatory
structures to deal with GM crops have evolved within the European Union (EU) in
recent years and describes how public uncertainties about foods containing GM
products continue to shape legislation.

The controversial approval of GM maize by the European Commission (EC) in 1997 fuelled the
emerging public controversy over GM foods, heightening the interest of all stakeholders involved in the
food production chain. Many Europeans suddenly became aware that soya and maize derivatives were
widely used in the production of everyday foods. Public interest groups expressed concerns about the
environmental and food safety assessments of these novel varieties and the increasing global control of
food production by a limited number of biotechnology and food processing companies. The
biotechnology industry, governments and scientific organisations countered these concerns by
emphasising the environmental and agronomic benefits of novel crops. As a result there was a real
public relations (PR) battle by all stakeholders for the hearts of the public. In the ensuing debate
scientific knowledge and empirical evidence on the risks and benefits of GM crops, if it existed, often
played a marginal role.

Investment climate

The advent of recombinant DNA techniques aroused considerable interest in industrialized countries. It
seemed to have economic potential and was described as a key technology of the 21st century. The EC,
national governments, industry and science expected benefits to accrue in areas such as healthcare,
industrial chemicals, food and feeds, agriculture and environmental clean-up services. It was anticipated
that innovation and growth stimulated by the application of biotechnology would mean increased
investments in supplies, services and hardware, that would ultimately have a positive effect on
employment.

As a result the EC and national governments started to create an attractive investment climate for the
biotechnology industry in order to remain economically competitive with North America and Asia.
European and national knowledge infrastructures were built by providing financial incentives for
biotechnology research programmes at universities and public research institutes, for small start-up
biotech companies and for innovation and technology transfer by industry. In addition, the EC and
national governments also began implementing regulatory frameworks to address aspects like patenting
rights on biotechnological inventions and the safe use of genetically modified organisms (GMOs).




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Emergence of critical groups

Since the mid 1980s groups critical of specific aspects of biotechnology have emerged in EU countries.
Much of their criticism has been directed towards the political, socio-economic, ecological and ethical
issues associated with the application of genetic engineering. Whilst perceptions and arguments were
influenced by national, political and cultural factors, these groups generally regarded biotechnology as
an ill-conceived attempt to repair the damage to human health and the environment caused by the
chemical technologies employed in industry, agriculture and food production. Since these technologies
had been developed by the same companies that were now using genetic engineering, expectations about
its benefits and risks held by industry, science, national governments and the EC were greeted with
suspicion. Biotechnology was viewed as a technological fix that would only perpetuate existing
industrial, agricultural and food production practices.

From such perspectives, public interest groups started to inform consumer, environmental, animal
welfare, small farmers', women's, trade union, Developing countries and church organizations on the
developments taking place in biotechnology and, in doing so, started to establish national networks.
These networks immediately began interacting with each other at the European level - regularly
facilitated by the environmental parties in the European Parliament - to counteract the lobbying pressure
being exerted on the EC by the biotechnology industry.

Bovine Growth Hormone - BGH

At first, major consumer and environmental organisations had little interest in campaigning about
biotechnology. But this changed when in 1988 four USA companies applied for a European license to
market a genetically engineered bovine growth hormone (BGH, also known as recombinant bovine
somatotropin, rBST) as a veterinary drug to increase milk production in dairy cows. This triggered the
first campaigns by coalitions of different types of public interest groups. Whereas the producers of BGH
argued that its use to enhance milk yield was simply another 'management tool', those who opposed its
introduction were very critical of this 'instrumental' approach to animals. They also questioned the safety
of BGH and its effects on animal health and welfare and were concerned that the introduction of BGH
would drive many small dairy farmers, who were already struggling with the heavily subsidized milk
surplus in Europe, out of business. It was argued that if BGH were to be approved, milk from cows
treated with BGH should be kept apart and labelled so consumers could choose which type of milk they
wanted.

This wave of protest created a serious dilemma for the EC. If BGH was granted a product license in the
USA, failure to license it in Europe could provoke the USA to evoke trade sanctions. Nevertheless, in
1989 the EC decided to adopt a 15-month moratorium on the commercial use of BGH. In 2001, eight
years later, the EC has still not given its consent and the controversy about safety, socio-economic
impacts, consumer choice and ethics has now extended to include GM food.

No patents on life

Another controversial issue was the proposal by the EC in 1988 to allow intellectual property rights
(IPRs) on biotechnological inventions. The EU aim was to work towards harmonizing national patent
laws. While the European Patent Office (EPO) had already begun issuing the first European patents on
GM plants and GM animals, public interest groups and the Greens in the European Parliament declared
it was unacceptable to allow 'patents on life'. Besides moral concerns, there were also more specific
criticism that patents would prevent plant breeders exchanging breeding material, farmers from saving
seed from one harvest to the next and scientists from exchanging information. Public interest groups




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brought several cases against patents granted on GM plants and animals to the Court of Appeal of the
EPO.

In May 1998, after more than ten years of discussion, the European Parliament approved the European
Patent Directive (EPD). But the controversy continues with the Netherlands, Italy and Norway
challenging the directive before the EU Court of Justice. Other countries such as Belgium, France,
Germany and Denmark have made it clear to the EC that they have difficulties implementing the
directive into their national patent legislation.

Regulating risks

The development of recombinant DNA techniques in the 1970s lead to immediate discussions among
scientists and government policy makers as to whether the use of genetic engineering involved unique
hazards and whether the application of these techniques should be regulated. In 1983, the Organisation
for Economic Cooperation and Development (OECD) started working out general safety guidelines for
the use of GMOs in industry, agriculture and the environment. These were published in 1987 and
although they were not binding, they have had considerable influence on the implementation of national
safety regulations in most industrialized countries.

The way these guidelines have been implemented has varied from country to country. Countries such as
Germany, for example, decided to adopt completely new legislation to specifically regulate research and
use of GMOs whereas others, including the Netherlands, preferred to adapt existing legislation.

The EC subsequently tried to harmonize the national safety regulations of member states. On 23 April
1990, it adopted two directives: Directive 90/219 on the contained use of GM micro-organisms and
Directive 90/220 on the deliberate release of GMOs into the environment. In its communication, the EC
pointed out that appropriate legislation was seen as an important part of developing an atmosphere of
acceptance and public confidence. Public consultation in decision-making on the use of GMOs was
viewed as a key element in creating such an atmosphere.

Scientific evidence

In 1993 the biotechnology industry concluded that in contrast to that of the USA, the European approach
to regulations seemed to imply that genetic engineering was a potentially hazardous technique. The EC
responded by issuing proposals for simplifying both directives, which in turn led to criticism from
various public interest groups. These groups saw this simplification as deregulation, initiated to decrease
the impact of central recommendations on how to proceed with risk assessments of GMOs. However,
neither the methodologies nor the data for a reliable prognosis on their long-term ecological effects were
available.

Directive 90/220 in particular caused serious disputes between the EC and national authorities during
the approval procedures for the commercial cultivation of the first GM crops such as insect resistant
Bacillus thuringiensis (Bt) maize and herbicide tolerant oilseed rape in 1996 and 1997. There were, for
example, disputes over the burden and type of scientific evidence relevant for the predictability of
effects, over the role of new scientific knowledge in decreasing or increasing uncertainty about potential
effects, and over the types of 'adverse effects', which should be evaluated and prevented. The definition
of 'adverse effects' appeared to be particularly problematic from a regulatory policy point of view, as this
involves a normative (and non-scientific) judgement about the acceptability of potential effects. Some
member states like the Netherlands, France and the UK took existing agricultural practices as a
normative baseline and the impact of a GM crop was judged against the impact of a conventional crop.




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Other countries including Austria and Sweden adopted a more stringent baseline that a GM crop should
cause relatively less harm than a conventional crop and should not jeopardize any crop protection
methods that contribute to sustainable agriculture.

Traceability and labelling

These regulatory disputes led to a cumbersome review of Directive 90/220 by the EC, national
regulatory authorities and the European Parliament. In June 1998, the European Council of Environment
Ministers agreed to a proposal for a revision of the directive from the EC. An important difference was
that approvals for commercial use of GMOs would only be granted for a limited period of time, i.e. ten
years. Furthermore, post-marketing monitoring would be required and bags of GM seed would have to
be labelled. In addition, threshold values for 'adventitious' contamination with GM material and
requirements for traceability of GMOs would be established.

Despite the Ministerial agreement, France, Greece, Denmark, Italy and Luxemburg declared that as long
as there were no concrete regulations for labelling and traceability, they would not give any further
consent for the marketing of GM crops. Blocking by these five EU states resulted in a de facto
moratorium, which was explicitly contested by countries such as Austria, Belgium, Finland, Germany,
the Netherlands and Sweden. Subsequently, to conform with EU law, the proposal revising the directive
had then to be adopted by the European Parliament. Since public concerns about GM foods were
mounting all over Europe, a lengthy procedure had to be followed to reconcile differences in views
between the EC and the major political factions in the European Parliament.

The reconciliation procedure took more than 18 months and resulted in the publication of Directive
2001/18 in February 2001 to be implemented into national legislation before October 2002 as an
amendment to Directive 90/220. Passed on 25 July 2001, the EC regulation on the traceability and
labelling of food and feed products produced from GMOs, amended the new Directive 2001/18. It now
allows the 'adventitious' presence of unauthorised GMOs in conventional foodstuffs up to a threshold of
one per cent without labelling.

Campaigns against GM crops

Public interest groups claim that freedom of consumer choice can only be exercised if GMO foods are
labelled and GMO-free foods remain available. In several European countries, public interest groups
started issuing 'green' lists of GMO-free food and 'red' lists of GM foods. As a result, food
manufacturers and retailers in Europe started seriously reconsidering their position on the use of GM
soya and GM maize and set about investigating options that would make it possible to exclude
ingredients from GM crops from their (brand) products. This was, however, far from easy, as the USA,
which had already approved many GM crop varieties, did not consider it desirable to segregate GM soya
and GM maize from conventional varieties because it would seriously disrupt existing global trading
practices in bulk commodities and limit their exports.

The first imports of GM soya into Europe had also attracted the attention of the health food and organic
food industries where soya products play an important role. Against this background of anxiety on
consumer markets, associations for organic produce began marketing their produce as free of genetic
manipulation, and organic farmers' organisations explicitly rejected the use of GMOs. However,
bringing this into practice and keeping organic products GMO free has proved to be a complicated
business. For example, in the case of some crops such as maize, there was the risk that outcrossing from
GM maize could contaminate the organic crop. From 1998, several grain handlers, food companies,
retailers, member states and the organic sector started to develop systems of documentary and technical




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control to monitor the supply lines of (identity preserved) non-GM raw materials.

Labelling

Meanwhile pressure was being exerted on the EC and national governments by the food industry and
retail, consumer and environmental organisations to issue regulations on the labelling of GM foods. The
first European regulations formed in 1997 provided that GM food or ingredients derived from them
should be labelled if traces of DNA resulting from genetic engineering were detectable in the final
consumer product. This meant that a consumer product containing oil refined from GM soya was not
required to carry a GM label.

However, this labelling scheme did not meet the degree of freedom of consumer choice that consumer
and environmental organisations appeared to require. In EC labelling proposals adopted in July 2001 all
foods produced from GMOs, irrespective of whether DNA or protein of GM origin is detectable in the
final product, must be labelled. Such labelling also requires that GM food can be traced to their origin
'from farm to fork'. However the proposals allow for the presence of unauthorized GMOs up to a level of
one per cent without labelling. This one per cent clause has been criticized by the opposition to GMOs
as creating "a license to pollute".

Outlook

Since the mid 1990s, Europe has had to deal with several food scares. The way these have been
managed by European and national officials has led to a serious decrease in the public's confidence in
regulatory authorities. GM crops subsequently became the focus of more general concerns about
intensive agriculture. This led to greater scrutiny of production methods throughout the food chain, a
process that has been fostered by many globally operating food processing and retail firms in an effort to
restore consumer trust in food quality.

Many European farmers and their organizations still have ambiguous feelings about biotechnology and
view developments in this area from the perspective of an industry that is well aware that today's food
markets are driven by consumer demand.

De facto moratorium

Since June 1998, a series of applications to introduce GM crops on the European market have been
blocked by a de facto moratorium by five EU member states. Although the EC has now proposed new
regulations, these still have to be implemented in national legislation. From a procedural point of view,
this could easily take more than two years. As a result, compared to other parts of the world, there is
little demand in Europe for GM food crops. At the same time, the EC proposals have further upset the
USA and other major grain exporters at the forefront of the commercialization of GM food crops and
trade conflicts have been threatened.

Against this background, the biotechnology industry, government and science, have all increased their
efforts to inform the general public about the GM issue using a variety of means including media
campaigns, citizens juries and broad public debates and have become increasingly aware of the strategic
importance of engaging public interest groups in 'stakeholder dialogues'. However, many public interest
groups have greeted these efforts at communication with a mixture of suspicion and scepticism and have
intensified their campaigning activities. Radical groups in countries such as France, the UK, Germany,
Belgium and the Netherlands have sabotaged many GM field trials in the last two years and as a result,
the controversy over GM foods is again high on the agenda of EU member states.



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Scientific evidence

At the moment, Europe has limited experience with the cultivation of GM crops. Sound scientific
investigation into the potential benefits and risks of growing GM crops compared to conventional and
organic products may, therefore, provide the empirical evidence lacking in the current debate. Scientific
investigations should seek to engage all stakeholder parties in the research design and evaluation of
findings. But given the plurality of values across European countries and among stakeholders, science
alone will not be able to advance the debate. Extended communication processes of knowledge sharing,
deliberation, justification and negotiation between all stakeholders need to be developed urgently to
ensure informed discussion on whether GM crops can lead to more sustainable agriculture in Europe,
and if so, under what conditions.


Piet Schenkelaars

Schenkelaars Biotechnology Consultancy, Niels Bohrweg 11-13, 2333 CA Leiden, the Netherlands.
Phone (+31) 71 523 5089; Fax (+31) 71 523 5090; E-mail pschenkelaars.sbcbiotech@planet.nl
URL: http://www.sbcbiotech.nl

Sources
Schenkelaars, P. (1996), "Outlooks on Public Information and Participation in the Context of the
European Biotechnology Directives 90/219/EEC and 90/220/EEC". In: Van Dommelen, A. (ed.),
Coping with Deliberate Release: The Limits of Risk Assessment.. Tilburg, The Netherlands: International
Centre for Human and Public Affairs.

Durant, J., Bauer, M.W., and Gaskell, G. (eds.), Biotechnology in the Public Sphere: A European
Sourcebook.. Michigan, USA: Michigan State University Press.

Tokar, B. (ed.) (2001), Redesigning Life: The worldwide challenge to genetic engineering.. London,
UK: Zed Books.



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http://www.biotech-monitor.nl/4707.htm                                                        13/11/2002