About Biotech

So what is 'biotechnology'? A quick look at the word suggests a technology that is based upon bio-logy, the study of living things, and this is reflected in the definition which first appeared in the 1982 OECD publication Biotechnology: - International Trends and Perspectives and which is still accepted today: 'the application of scientific and engineering principles to the processing of materials by biological agents to provide goods and services'

Want to know more? Just click on:

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.

  • 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.
     

  • 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.
     

  • 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.
     

  • 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:

  • Most Europeans mistrust politicians and experts.

  • Consumers doubt that genetic engineering and the extent of its use may be controlled.

  • 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.

 

 

Homepage  |   Contact  |   EuropaBio Team © 2000-2007   |  EuropaBio aisbl - VAT BE 477.520.310