Biotechnology- Introduction-key messages
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.
2. 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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