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1. Introduction
Biotechnological procedures have been employed over millennia
to produce human food stuffs such as bread, yoghurt, beer, wine
or cheese. Ancient peoples made use of microorganisms like yeast
and bacteria without even knowing of their existence. Today, we
know that there are innumerable distinct yeast and bacterial strains,
some of which are exploited in commercial fermentation processes
after having being selected for certain characteristics to optimise
product quality or production processes (Hui and Khachatourians,
1995). Only limited information is available about the genetic
background of the specific traits of most of the microorganisms
we employ today in fermentation processes. Modern techniques of
biotechnology make it possible to introduce distinct genes or
groups of genes into a variety of organisms. The application of
genetic engineering has become essential for biotechnology and
many other modern biological and medical sciences.
Apart from amylases which have been used for starch processing
since the early 1980s, chymosin was the first commercial biotechnology
product to be used in human food stuffs. It serves as a substitute
for the calf stomach preparations, traditionally used as the natural
source of chymosin, in the manufacture of cheese (Teuber, 1993).
Although approved for use in cheese production by Swiss authorities
as early as 1988, recombinantly produced chymosin has never been
commercially used in this country due to a voluntary renunciation
by the cheese manufacturers. It has since been approved in more
than 20 countries (Teuber, 1993); more than 60 % of the hard cheese
in the United States is produced by means of recombinantly produced
chymosin. Germany, on the other hand, represents one of the more
prominent countries that have not (yet) approved this product
(Krohn and Pfleger, 1994).
In some countries other recombinantly expressed enzymes and organic
molecules produced through genetic engineering have also been
approved. However, regulations with respect to enzymes and other
products produced by genetically modified microorganisms differ
significantly from nation to nation.
1.1 Field trials
Genetic engineering of agricultural crops has become a main activity
of the research departments in the agro-industry. GMOs comprising
at least 27 distinct plant species have been tested in field trials
in the European Community (EC) (Table 1).
Table 1: Field tests in the European Community and in the
United States
Plant |
EC* |
USA** |
Alfalfa |
2 |
18 |
Amelanchier laevis |
|
< 6 |
Apple |
1 |
5 |
Arabidopsis |
|
< 6 |
Barley |
|
< 6 |
Belladonna |
|
< 6 |
Broccoli |
|
< 6 |
Carnation |
3 |
|
Carrot |
1 |
< 6 |
Cauliflower |
5 |
|
Chicory |
32 |
< 6 |
Chrysanthemum |
1 |
< 6 |
Cotton |
1 |
191 |
Cranberry |
|
< 6 |
Creeping Bentgrass |
|
7 |
Cucumber |
|
12 |
Eggplant |
|
< 6 |
Eucalyptus |
3 |
|
Gladiolus |
|
< 6 |
Grapevine |
2 |
< 6 |
Lettuce |
4 |
6 |
Maize (corn) |
192 |
1019 |
Marigold |
8 |
|
Melon |
4 |
106*** |
Onion |
|
<6 |
Subtotal |
295 |
- |
|
Plant |
EC* |
USA** |
Papaya |
|
< 6 |
Pea |
|
< 6 |
Peanut |
|
< 6 |
Pepper |
|
< 6 |
Petunia |
1 |
< 6 |
Plum |
|
< 4 |
Poplar |
6 |
< 6 |
Potato |
86 |
261 |
Rape / oilseed rape |
188 |
57 |
Rice |
|
13 |
Silver birch |
1 |
|
Soybean |
6 |
278 |
Spruce |
|
< 6 |
Squash |
2 |
106*** |
Strawberry |
1 |
5 |
Sugarbeet |
109 |
23 |
Sugarcane |
|
< 6 |
Sunflower |
6 |
8 |
Sweet Potato |
|
< 6 |
Sweetgum |
|
< 6 |
Tobacco |
30 |
98 |
Tomato |
45 |
321 |
Walnut |
|
< 6 |
Watermelon |
|
< 6 |
Wheat |
6 |
14 |
Total |
746 |
ca. 2450 |
|
* Source: SNIFS (1996) as of 31 October 1996
** Source: APHIS ('Field Test Permits' and 'Notifications' 1987-1996,
as of 31 October 1996)
the numbers marked with *** represent the sum of melon and squash field
releases in the US.
Most of the field tests within the EC were performed in Belgium,
France, Italy, the Netherlands and in the United Kingdom (81 %;
>70 field tests per country); only 19 % of the releases took
place in Austria, Denmark, Germany, Finland, Portugal, Spain and
Sweden (SNIFS, 1996). Until October 1996, only 2 field tests had
been conducted in Austria and 2 in Switzerland, and 60 in Germany.
In contrast, the number of field tests in France totalled 228
and in the United States with more than 2,000
1. This uneven distribution
is only partially accountable by regulatory and climatic differences
of the countries cited; differences in the general public acceptance
of gene technology in each country apparently plays an important
role. In particular, the German-speaking populations in Europe
appear more sceptical than others towards the application of this
technology in the food industry. The public attitude towards gene
technology should not be overlooked; in 1995, more than half of
the field sites in Germany for testing transgenic plants were
deliberately destroyed (Abbott, 1996; Hobom, 1996).
Figure 1: Field tests of the most common transgenic crops.
Sources: (i) USA: APHIS ('Field Test Permits' and 'Notifications'
1987-1996, as of 31 October 1996; (ii) EU: SNIFS (1996) as of
31 October 1996; (iii) Others (Australia, Bulgaria, Canada, Japan,
New Zealand, Switzerland, South Africa and several developing
countries): OECD-database on field trials as of 24 October 1996;
DeKathen, 1996.
The list of transgenic plants which have been field tested in
the US is far more extensive than the one for the EC (Table 1,
Figure 1). In Canada1, several hundred field tests have taken
place. Approximately 150 releases have been reported in developing
countries (De Kathen, 1996)1. Until 31 December 1995, reportedly
11 and 22 field tests took place in Russia and Hungary, whereas
the figure of 60 field tests was reported for China (James and
Krattiger, 1996). A single approval for a field test can include
several field sites. This may in part be accountable for the fact
that figures for the field tests in certain countries given by
James and Krattiger (1996) are somewhat higher than e.g. the numbers
derived from the 'summary notifications' (SNIFS) in the EC.
Most of the research in the application of gene technology on
food crops has sought to improve product quality and agronomic
traits and develop resistance to pests (Table 2). Background literature
about techniques and research goals in the area of transgenic
plants can be found in recently published reviews (Lupi, 1995;
Bendiek et al., 1996; James and Krattiger, 1996; Niederhauser
et al., 1996; Estruch et al., 1997; Gaede, 1997), in special issues
of journals in German (Biologie in unserer Zeit 4/1995: 'Gentechnik
und Lebensmittel') or English (Trends in Biotechnology: 'Plant-product
and crop biotechnology', Vol. 13 [9], 1995) and in books (Brandt,
1995; Potrykus and Spangenberg, 1995).
Table 2: Research objectives
I Product quality: |
- Carbohydrate metabolism
- Colour
- durability
- Fatty acid metabolism
- Firmness
- Fruit ripening delay
- Processing value
|
II Pest resistance: |
- Bacterial resistance
- Fungal resistance
- Insect resistance
- Nematode resistance
- Viral resistance
|
III Agronomic trait: |
- Drought resistance
- Herbicide tolerance
- Hybrid system
- Nitrate reduction
- Salt tolerance
- Temperature resistance
|
IV Others: |
- Heavy metal tolerance
- Monitoring
|
1 Data from various sources on field trials
in the US, the EC as a whole and individual EC countries (Austria, Belgium,
Denmark, Finland, France, Germany, Italy, the Netherlands, Portugal, Spain,
United Kingdom), Switzerland, Bulgaria, Canada, Australia, New
Zealand, Japan and some developing countries (Argentina, Belize,
Bolivia, Chile, Costa Rica, Cuba, Dominican Republic, Egypt, Guatemala,
India, Mexico, Peru, South Africa, Thailand and the Commonwealth
of Puerto Rico) are continuously being compiled in a database
at the agency BATS.
|