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Biotechnology-
Introduction
1.1. What is biotechnology?
Biotechnology has been defined in many ways. But the
definition given by the OECD (the Organisation of Economic Co-operation and
Development) may be one of the most useful. It defines biotechnology as "
…the application of scientific and engineering principles to the processing
of materials by biological agents ". One could also say that biotechnology
means using biological processes to make useful products. Production may be
carried out by using intact organisms, such as yeasts and bacteria, or by
using natural substances (e.g. enzymes) from organisms.
Traditional Biotechnology : Biotechnology is in fact
already thousands years old : the ancient Egyptians developed fermentation,
bread-making, brewing and cheese making. Yeasts are living organisms meaning
that bread- and cheese making etc… are biological processes.
Our ancestors sought new ways to produce more food or new foods.
It was an extremely slow process : plant breeders for example crossed plants
to produce varieties with particular traits or characteristics (such as a
particular petal colour or better resistance against a virus). But as each
plants has tens of thousands of genes, this was very much a matter of trial
and error.
Crossing animals, was just as difficult, which, however, did not
discourage the breeders : a cow today gives many times more milk than its
19th century ancestor.
Modern biotechnology has changed all that. Scientists can now
precisely identify the one particular gene that governs the trait one wants.
It will extract this gene from one organism, copy it and insert this copy
into an other organism, which will transmit it to its offspring. This
process is called genetic modification. Modern biotech is applied to
manufacturing processes in healthcare, food and agriculture, industrial
processes, environmental clean up, etc.
1.2. Genetic modification and food
The beginning of the 1980s marked the beginning of an
upsurge of genetic modification in the area of plant
breeding. Today, research in plant breeding invariably uses
these methods. In 1986 the first genetically modified plants
(herbicide tolerant tobacco) were produced in the USA. In
Europe, the first GMO plants were produced at the Max Planck
Institute in Cologne, Germany, in 1989. The plants were
petunias in which the colour of the flowers was altered.
Four years later, the first genetically modified food plants
with commercial potential, virus-resistant sugar beets, were
released. The introduction of the FlavrSavr® tomato onto the
American market (1994) marked the first time that a
genetically modified food was given official marketing
approval.
There are currently 56 genetically modified varieties that
have been granted marketing approval worldwide (status:
December 1998). Various transgenic plants, including four
varieties of maize (Novartis, AgrEvo, Monsanto, Pioneer),
one variety of soybean (Monsanto), and three of oilseed rape
(AgrEvo, PGS) - have successfully passed through the
European Union approval procedure (Directive 90/220/EEC).
Tomato pulp from genetically modified tomatoes (Zeneca) had
been on the market in the United Kingdom, and the
application for a license for the release and marketing of
the tomatoes themselves has already been submitted (Zeneca).
As well as contributing to food production, in future,
genetically modified plants promise to offer alternative
means of production of vaccines, drugs, and human
antibodies. A further important area involving the use of
transgenic organisms is the production of additives and
processing auxiliaries, employing genetically modified
microorganisms. In Europe, for example, there are about 30
enzymes made in this way that are used in the processing of
food products.
The worldwide cultivation area for transgenic plants in 1998
amounted to approximately 27.8 million hectares, which
roughly corresponds to the entire area of the United
Kingdom. Universities, research institutes, and companies
all over Europe are actively engaged in the research.
Commercial-scale cultivation of genetically modified plants
plays a subordinate role in Europe presently, but with
respect of the advantages for the farmers it will increase
in the coming decade. The safety of humans, animals, and the
environment is imperative in all applications of genetic
modification methods. In addition to comprehensive food laws
and the corresponding plant-protection regulations, there
are a number of supplementary acts and decrees at both the
EU level and at respective national levels that apply solely
to genetic modification. In Germany, the relevant regulation
is the "Gentechnikgesetz" (GenTG, Genetic Engineering Act)
that took effect in 1990 as an implementation of the EU
Directives 90/219/EEC (System Directive) and 90/220/EEC
(Release Directive, reviewed in 2001 and renamed Directive
2001/18/EEC).
In the course of the harmonisation of national legal acts
within the EU and the introduction of the EU internal
market, the Novel Food Regulation (NFR) has been elaborated;
this decree foresees special provisions regulating the
marketing of novel foods.
1.3. Genetic modification and healthcare
1.3.1. Introduction
Although the subject of controversial debate some ten years
ago, the value of genetic modification in the production of
human pharmaceutical products is nowadays widely acknowledged by
the public. In 1997, a 16 billion Euro share of total worldwide
pharmaceuticals sales of 225 billion Euro was accounted for by
products manufactured using genetic modification. Worldwide, the
pharmaceutical product Erythropoietin alone achieved a sales
figure of roughly 2.4 billion Euro in 1998, even though the
packaging explicitly stated "manufactured using
genetic-engineering methods".
This is an indication of how products of proven quality will
create acceptance.
1.3.2. How 'red' biotechnology works
Biotechnology in health care uses the human body's own tools
and weapons to fight disease. Biotechnology medicines and
therapies use proteins, enzymes, antibodies and other substances
naturally produced in the human body to fight infections and
diseases, as well as to correct genetic disorders. Biotechnology
also uses other living organisms - plant and animal cells,
viruses and yeasts - to assist in the large-scale production of
medicines for human use.
There are four primary areas in health care in which
biotechnology is currently being used: medicines, vaccines,
diagnostics and gene therapy.
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Medicines
The human body naturally produces literally thousands of
proteins that fight disease and control everything from
blood sugar levels to human growth. The biotechnology
medicines approved for use today are proteins that help the
body fight infections or carry out specific functions.
Currently, biotech medicines have been approved in the U.S.
as well as in Europe to treat anemia, cystic fibrosis,
growth deficiency, hemophilia, leukemia, hepatitis, genital
warts, transplant rejection and many forms of cancer.
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Vaccines
Biotechnology contributes to human health through the
development of new vaccines. Vaccines help the body
recognise and fight diseases. Conventional vaccines use
weakened or killed forms of a virus to introduce antigens,
proteins on the surface of viruses that the immune system
uses to identify the virus. The body then produces
antibodies that build resistance to the disease.
A biotechnology vaccine consists only of the antigen, not
the actual virus. By isolating antigens and producing them
in the laboratory, it is possible to make new vaccines that
cannot transmit the virus itself.
In the case of hepatitis B , for example, a biotech
vaccine is produced by inserting the gene responsible for
producing the hepatitis antigen into yeast cells. During the
fermentation process, which is similar to brewing beer, each
yeast cell makes a perfect copy of itself and the antigen
gene. The antigen is later purified. When injected into the
body, the antigen stimulates the production of antibodies
that combat the hepatitis virus.
Researchers are also working on vaccines to combat
influenza, AIDS and herpes viruses, to work against cholera
and Rocky Mountain spotted fever and against several
diarrheal diseases in humans and animals.
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Diagnostics
Biotechnology diagnostics are used to detect a wide
variety of diseases and genetic conditions. For example,
donated blood is screened to protect the blood supply from
HIV and hepatitis. Home pregnancy tests are also examples of
biotech diagnostic products. A new blood test has been
developed through biotechnology to measure the amount of
low-density lipoprotein (LDL), or "bad" cholesterol, in
blood. Conventional tests require a total lipid profile,
including expensive tests for total cholesterol,
triglycerides and high-density lipoprotein cholesterol. The
old tests also require a patient to fast 12 hours before a
blood sample can be drawn. The new biotech test allows
patients to be tested with one simple test that can measure
LDL directly, without the need to fast.
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Gene Therapy
Gene therapy is a promising technology that uses genes
themselves as drugs to correct hereditary genetic disorders.
In gene therapy, a faulty or missing gene can be replaced to
correct a genetic cause of a disease. Gene therapy has been
used, for example, to treat severe combined immunodeficiency
disease (SCID), commonly known as the "bubble boy disease."
Sometimes, in gene therapy, cells are removed from a
patient, altered to correct a genetic defect or omission and
put back into the body. Sometimes new cells are introduced
to produce needed cell-growth factor or perform a beneficial
cellular function.
1.4. Reservations among the public
Modern biotechnology is the strategic technology of the new
millennium. But while biotechnologists and their supporters tend
to see enormous opportunities for progress through the
application of this science, opponents often see
biotechnologists "playing god". Although it has an extraordinary
potential for our future world biotechnology and especially gene
technology has been a subject of interest not only for the
scientific community, the industry or national and international
institutions but has also been discussed by various public
groups as consumers, environmental groups or individual
citizens.
Pharmaceutical products based on so called 'red' biotechnology
now have become widely accepted, for the simple reason that they
offer direct and very obvious benefits. Progressively, however,
promises of agricultural or 'green' biotechnology have started
to become reality and so did the farmers´ acceptance of
transgenic crops. It took about fifteen years until hybrid corn
was completely accepted, now it may take a comparable amount of
time for the use of biotechnology crops and food to be accepted.
All the same, a wide number of surveys show that a significant
number of people have a negative attitude towards the use of
genetic modification in the area of food production. This lack
of confidence does not appear to be based on a general hostility
to technology. As a representative survey carried out by the
Stuttgart "Akademie für Technikfolgenabschätzung" (Academy for
Estimation of the Consequences of Technology) presented in May
1998 was able to show, less than 10% of the population look upon
computer technology, solar technology, or telecommunication
technology disapprovingly. More than 30%, however, are afraid
that their quality of life will deteriorate over the next 20
years as a consequence of genetic modification. While 75% of the
population approve of the use of genetic modification in the
medical area, food manufactured using genetic modification meets
with the approval of less than 10% of those surveyed.
Many of these reservations exist because broad sections of the
population feel they are not being adequately informed.
Newspaper headlines such "Gene food clandestinely moves onto the
supermarket shelves" (BILD, 1996) or "GM foods are playing games
with nature. If cancer is the only side-effect we will be lucky"
(Daily Mail, 1999) disconcert people and do not present the
facts objectively. In connection with food and genetic
modification in particular, the link between health and
nutrition is openly questioned. In order to present the future
benefits provided by genetic modification in the food sector
plausibly, it will not suffice to cite a list of reasons for
rationalization or profit maximization for the companies
involved. While emphasis on environmental and health benefits
are important, in the long term only positive product examples
will ultimately convince the consumer of the benefits of this
technology. There are presently only a few products that have
reached market maturity, with the result that the consumer
usually associates only the "FlavrSavr®" tomato with genetic
modification, and this has so far been marketed solely in the
United States.
In February 1999 surveys showed that American consumers trust
food biotechnology and regulatory safeguards more than ever (IFIC,
1999). At the same time the acceptance level for genetically
modified crops and food in Europe has reached a low,and this has
triggered a discussion about labelling in the US, too. So we
will have another heat debate concerning the WTO-round this
year. Coming back to reasons for the low consumer acceptance
there can be summarized the following core statements:
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Most Europeans mistrust politicians and experts.
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Consumers doubt that genetic engineering and the extent of
its use may be controlled.
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The confidence in statements issued by industry is low.
What
can be done to address these reservations? The lack of
confidence in experts, politicians, and also the industry is
surely not merely a problem related to the utilization of
genetic modification methods, but rather more a general social
problem. There is no feeling of ownership to be discerned.
Engagement of the general public requires a common language and
also the acknowledgement of the competence of the practitioner,
and this applies not only to the area of genetic modification.
Arousal of interest, the conduct of an honest and open dialogue,
and the creation of transparency by involving everyone - these
are the goals for the future that must be heeded and
implemented.
1.5. The political debate
The focal point of current political debate in the EU generally
centres on questions regarding the long-term ecological,
economic, and health-related consequences of the application of
genetic modification.
At the same time, the commercial release of transgenic plants is
already being practiced on a major scale worldwide. Some plants
such as GM soybeans were granted approval for marketing and
further processing in the EU three years ago and have already
found their way into the food chain.
Although there have been no instances of unpredictable behaviour
of transgenic plants reported in any of the over 35,000 release
experiments carried out so far, and there have also been no
unforeseen events in connection with any of the products
involved, ongoing discussion regarding hypothetical risks has
resulted in political indecision. This is expressed, for
example, in continuing disagreement regarding the implementation
of the Novel Food Regulation, which became effective on May 15,
1997. While there are still many details that have to be
elaborated, this delay is likely to result in the consumer being
given the impression that GM food products do pose a certain
risk after all, since otherwise the products would already be on
the market, appropriately labelled.
There is agreement at all political levels concerning the
necessity of labelling GM products, but the questions as to
which products these will be and which form the labelling will
take, still await clarification. In the case of products such as
sugar produced from GM sugar beets, or soy oil from GM soybeans,
the products are indistinguishable from their conventional
counterparts. It therefore does not make sense to label such
products as being GM in origin. The scientific context of
genetic modification is difficult for the layperson to follow,
although such enlightenment is certainly necessary. In the
following sections of this Compendium the intention is to
explain this context and the authors hope that this will
contribute towards putting the debate back on an appropriate
objective footing.
Biotechnology-
Key Messages
2.1. Safety
As with conventional foods, safety for the consumer with regard to foods
produced by genetic modification has utmost priority. Safety is an absolute
pre-condition for the marketing of GM products. Specific tests are necessary
when genetic modification methods are employed. For example, investigations
are carried out to detect any toxic by-products that may have been formed,
or to find whether the products themselves possess increased allergenic
potential. The products that ultimately reach the customer are thus
at least as safe as conventional foods.
The FDA (U.S. Food and Drug Agency) has carefully evaluated the use
of genetic engineering techniques to produce food and food ingredients
and "has not found that these new techniques present any unique safety
concerns. The agency intends to be vigilant as the technology advances
and will make any necessary adjustment in its policy to ensure that
foods that reach consumers are safe, wholesome, and properly labelled.
" The OECD comes to the conclusion that "it is recognized that the safety
of an organism is independent of the process of genetic modification
per se ... safety in biotechnology is achieved by the appropriate application
of risk/safety analysis and risk management".
Until today, after this technology has been used for more than 20 years,
none of the predicted risks has come true.
2.2. Agriculture and ecology
Long lasting laboratory research and greenhouse studies preceding the
commercial-scale cultivation of genetically modified plants. Before
a licence for commercial-scale cultivation can be issued, comprehensive
safety tests are run to confirm the harmlessness of the plants in question.
When the application dossier for marketing approval is submitted, it
must be shown that the genetically modified organism is at least as
safe as the donor and recipient organisms.
In this connection the origin of the transferred gene must be explicitly
stated, the recipient organism must be precisely characterized, and
evidence must be submitted that shows that this organism does not exhibit
any new features that are of special ecological relevance.
2.3. Benefits for the environment, for the consumer
For many thousands of years it has been one of mankind's principal aims
to breed high-yielding, robust plants, that are capable of resisting
diseases and pests. Genetic modification offers new methods by which
these age-old aims can be achieved more efficiently.
Herbicide and pest resistant plants produced using genetic modification
methods allow the farmer to reduce chemical applications and save energy,
time, and money. This marks a major ecological contribution towards
relieving our soils and water resources. In the longer term, enhanced
nutrient uptake by plants, leading to reductions in fertilizer applications,
will further fulfill the consumer's wish for food produced in an environmentally
compatible manner.
When enzymes or additives are produced using genetically modified microorganisms
instead of conventional organisms or artificial synthesis, significant
savings in raw materials, energy requirements, and the amount of waste
are achieved.
In future, genetic modification can contribute towards reducing food
allergies by rendering allergens in food inactive, or by eliminating
them altogether. In addition, physiologically optimized food products,
so-called functional foods, will become increasingly important. These
will include, for example, products with an optimized fatty-acid composition.
2.4. Increasing Global Food Production
Genetic modification can make a contribution towards securing the nutritional
requirement of the world's population. There are already some 800 million
people who are suffering from hunger. Food production will have to be
more than doubled by the year 2025 if we are to feed the world population,
which will then total some eight billion people. By facilitating the
breeding of drought- or salt-resistant plants, genetic modification
may in future permit the use of relatively unfavourable locations for
agricultural purposes.
China and developing countries in Asia, Africa, and Latin America are
already staking their hopes on genetic modification methods. Over the
long term the use of genetically modified plants will enable harvest/crop
losses to be reduced and harvest yields to be secured and increased.
It will also be possible to produce plants with enhanced nutritional
value, like rice varieties with enhanced contents of vitamin A.
2.5. The legal framework
In the European Union, a set of guidelines and regulations govern the
use of genetically modified organisms (GMOs) in the laboratory as well
as in closed systems (e.g. in fermenters) and also their release into
the environment, (EU Directives 90/219/EEC and 90/220/EEC) (the latter
-about release of GMOs has been revised and is now being referred to
as Directive 2001/18.
Prior to EU regulations, in 1978 the United Kingdom was the first country
in the world to pass legislation controlling genetic modification. Similar
regulations were also introduced in the USA and elsewhere in Europe
(the most stringent in Germany and Denmark).
The German "Gentechnikgesetz" (GenTG, Genetic Engineering Act) oversees
an approval procedure for all genetic modification operations in Germany
and the implementation of the EU guidelines as national legislation.
The European Novel Food Regulation sets standards for the marketing
of novel products. Here, for example, approval and notification procedures
and also labelling regulations are specified (cf. Section 6.4). A supplementary
regulation of the EU labelling directive (regulation 79/112/EEC) governs
the aspect of labelling of products processed from herbicide-tolerant
soybeans and insect-resistant maize.
In a national regulation, guidelines for the labelling of products as
"manufactured without genetic modification methods" are currently being
elaborated.
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