European Information Network - Ethics in Medicine and Biotechnology

Genetically modified Food

--- General overview ----

Scientific background

(Author: DRZE staff, Germany)

Genetically engineered foods are staple or luxury foods which consist wholly or partly of genetically modified organisms or products made from them, or where a genetically modified (GM) organism or product is made use of in the production process. The genetically modified organism may be a micro-organism, a plant or an animal.

Human beings have always tried to modify plants and animals through breeding, especially in relation to food production. Unlike conventional cross-breeding methods (selection, cross-breeding, hybrid and mutation breeding), however, this "new" genetic engineering allows us to transfer, not only whole genomes, but also individual genes which may even come from entirely unrelated organisms. The aims here are the same as with conventional methods of breeding; to increase and guarantee yields, and to improve processing and quality performance, on a larger scale and with greater efficiency.

GENETIC ENGINEERING AND TRANSGENIC ORGANISMS

In the strict narrow sense, genetic engineering covers all the methods and processes involved in isolating, modifying, multiplying and transferring DNA, the genetic blueprint. Genetic engineering enables us to isolate specific sections of DNA from cells, modify them and transfer them to other cells. Genetic material may be transferred to totipotent cells, that is, those which are capable of forming multi-cellular organisms like plant cells or early embryonic mammalian cells. The transfer may also take place to cells which are at a later stage involved in forming totipotent cells, such as germline cells, or cells whose nuclei are used in nuclear cell transfer cloning techniques (as with "Dolly" the first cloned sheep). Either way, these totipotent cells develop into genetically modified or transgenic organisms which, apart from characteristics of their own species, also produce those which are encoded in the alien genetic material injected into their genome.

GENETIC ENGINEERING IN FOOD PRODUCTION

In food production genetic engineering is at present used mainly in plants and microorganisms: such classes of organisms are particularly suitable due to their asexual reproduction and easy cultivation. Genetic engineering in vertebrates , including all the animals humans have domesticated, is much more difficult, although using nuclear cell transfer cloning techniques could change this in the near future.

In terms of food production, genetic engineering is used for various different purposes:

• Genetic engineering is used to increase the efficiency of the agricultural or biotechnological production of certain human and animal foodstuffs or additives, or to enable their production in a given quality or quantity in the first place. A number of crops such as GM corn and GM potatoes have been injected with bacterial genes to make them resistant to certain pests, while other plants such as soya beans and rape were supplemented with genes to make them tolerant of certain herbicides. The aim is to reduce the amount of pesticides and herbicides used in the cultivation of these plants. In the biotechnological production of chymosine, a component of rennet from the stomachs of calves used in making cheese, the gene concerned was transferred from cattle to bacteria, thus enabling the enzyme to be produced in large quantities.
  

• Genetic engineering can be used to make individual foods more processable, improve their content or make them more digestible to humans. One example of this is "golden rice", which contains more iron and vitamin A than conventional strains of rice.
  

• Another area of application for genetic engineering in food production is in genetic testing procedures, which can be used in conventional breeding methods for diagnostic purposes and for monitoring and quality control in food.
  

There are a number of ways in which food can be made from transgenic organisms or can contain them:

• The food itself is a genetically modified organism (GMO) or a part of one, like the so-called "Flavr-Savr" tomatoes.
  

• Many milk products and drinks contain micro-organisms as "starter cultures". In future, these micro-organisms may be optimised by way of genetic engineering.
  

• The food is produced from genetically modified organisms, parts of which are detectable in the end product. Some examples of this are cornflakes from genetically modified corn, ready meals with transgenic soya, and ketchup from genetically modified tomatoes (Flavr-Savr or Zeneca tomatoes).
  

• The food is produced from a GMO, which can no longer be detected in the final product, as is the case with edible oil from genetically modified rape or soya.
  

• The food is made with additives such as sweeteners and flavour enhancers, aromas and secondary ingredients obtained with the aid of genetically modified organisms (usually bacteria and yeasts), but which are not contained in the additive itself. So far, there are only a few testing procedures which can detect residues of GMOs in individual additives.
  

Ethical arguments

(Author: DRZE staff, Germany)

Many people categorically reject any use of genetic engineering in food production as "unnatural". They see "natural" evolution and the genetic endowment of organisms as an asset worthy of "absolute protection", with which human beings must not interfere under any circumstances. What is usually referred to in this context is the "dignity" or "proper right" of Nature or, from a religious perspective, Nature as the "creation of God". In many cases, however, Nature is simply regarded as what has been tried and tested, and must not therefore be put at risk.

Proponents of the opposite point of view argue that "naturalness" itself does not constitute the obligation not to interfere. Moreover, humankind has not only always intervened in the course of nature, they argue, such interventions have also been essential for the survival of the species. So rejecting the idea categorically and out of hand would not only run contrary to many cultures and technologies, which are widely accepted; it would even put the conditions of human existence at risk.

The argument continues that the notion of Nature as "God's creation" and human beings as " God's image" within creation, may put limits on how far we can interfere with Nature. This does not mean, however, that we must not intervene at all. This would only apply if - from a primarily conservative point of view - the role of the human being would only be that of a mere custodian of God's creation. But, if we see the task of the human being as God's image not only in terms of conserving nature but also as actively participating in its formation, manipulative interventions in nature might not only be permissible, but in some cases even be ethically imperative.

ASSESSMENT CRITERIA

Even if interventions with nature are not categorically forbidden, that does not necessarily mean that they are allowed under all circumstances. If we are to assess critically genetic engineering in food production, we have to consider the significant criteria applicable in the context of such an assessment. These criteria have to be defined with regard to two aspects: first, concerning the duty to protect human beings who consume or produce genetically modified food; and second, concerning a possible duty to protect non-human life which is genetically modified for the purpose of food production.

CRITERIA CONCERNING THE DUTY TO PROTECT HUMAN BEINGS

If we assume the principle of human dignity which includes that human beings are entitled to protection, the main criteria for assessing genetic engineering in food production are first and foremost its compatibility with human autonomy and health, as well as with the environment, the economy and society. On an individual case basis attention has to be paid, however, both to potential incompatibilities, i.e. the potential risks, as well as to possible opportunities.

RISKS AND OPPORTUNITIES

Health: It is hoped that the application of genetic engineering may improve the nutritional and health value of food. There are even expectations that genetic engineering may lead to either an increase in crop yields or may help to make crops more suitable for unfavourable environments. Thus it may eventually contribute to an improvement of the global food and health situation. On the other hand, there are concerns that consuming genetically engineered food could cause allergic or even toxic reactions. If those GM foods contain antibiotic resistance genes as marker genes, their consumption could unintentionally make humans resistant to antibiotics.

Environment: The genetic modification of herbicide- or insect-resistant crops raises hopes that environmental pollution originating from the application of plant protection agents can be reduced, either by lowering the amount of plant protection agents necessary or by providing agents which are more environmentally friendly. Moreover, the application of genetic engineering may also lead to lower energy consumption and waste production, and as a consequence to a more environmentally friendly food production. On the other hand, what needs to be taken into account is the fact that genetically modified crops could propagate accidentally and transfer genes to related organisms (vertical gene transfer) or even to unrelated organisms such as soil bacteria (horizontal gene transfer), which could severely disturb the ecological balance.

Economy and society: proponents of genetic engineering argue that it could help to make food production more efficient and possibly more cost-effective. This could cut costs to consumers and make business more competitive. However, there are concerns that this could reinforce monopolistic tendencies and exacerbate the regional and global struggle for survival. This would place an extra burden on smaller agricultural businesses and might result in an even greater dependence of the so-called developing countries. In this context a key role will certainly fall to the issue of patenting (see section II, "Ethical aspects", subsection on "Patents").

A DUTY TO PROTECT NON-HUMAN LIFE?

The questions whether the duty to protect also extends to non-human life, and how much this would put limits on our right to manipulation, is highly controversial. Although these questions also arise in connection with micro-organisms and plants, the debate here is mainly about animals. There are two basic positions:

According to the first position the duty to protect living beings is bound to their actual or potential ability to set themselves goals and purposes and freely to determine their actions. But as these abilities are solely the province of humans, not animals (let alone plants or micro-organisms), the duty to protect can only exist towards human beings. This does not mean though that dealing with non-human life would be entirely arbitrary. Consideration in this context is only necessary where the interests of human beings are concerned, such as their interest in securing their natural livelihood.

According to the second position the duty to protect living beings does not result from their ability to set goals and purposes, but already applies at an earlier stage, i.e. the moment they have the capability to fulfil basic needs. These could include the ability to avoid pain and suffering, or even express "interests" or "preferences". As a consequence of this argument there is a duty to protect non-human life, and animals in particular. This duty will have to be based on the specific nature and development of the capability to fulfil basic needs. So, while the power to determine non-human life - as in the case of genetic modification - is not generally impermissible, it must be subject to case-by-case justifications. There are three points to note here: 1. the nature and development of the specific capability to fulfil basic needs in the life form concerned, 2. the compatibility of the modification with those abilities and 3. the purposes and goals of the genetic modification.

Here, too, not only possible incompatibilities, i.e. risks, but also possible opportunities will have to be considered. Transgenic engineering may make animals less prone to diseases. This may not only help to safeguard yields, but also be beneficial to the animal itself.

WEIGTH RISKS AND OPPORTUNITIES: THE RULES

Risks and opportunities have to be assessed within the framework of comparative interdisciplinary safety or risk research which can establish both the desirable and undesirable effects of any given application, using established scientific standards. In any ethical assessment of the risks and opportunities regarding the criteria which arise from the duty to protect both human and non-human life, the following aspect has to be taken into account: both the use of, as well as the decision not to use genetic engineering in food production need to be justified. The former in view of possible risks, the latter in view of possible opportunities. The aims pursued may differ in terms of their priority or urgency. The means may vary, depending on the potential risks. The greater the risk involved in the application of the means, the higher the priority attributed to the aims must be, if the means are to be justified. Using genetic engineering in food production, for example, may be justified (or even imperative), if the aim is to improve the food situation in the so-called developing countries, but less so, if the aim is (merely) to make food more attractive and thus to increase profits.

In the process of weighing the means it is necessary to examine, whether they are appropriate to achieve the stated aims. Moreover, precautions to reduce possible risks, or the availability of alternative means have to be part of the considerations. The question that arises, for example, in the context of improving the global food situation is, whether instead of applying genetic engineering to optimise crop yields, it would not hold more promise to change the political, social and infrastructural conditions.

The risks involved in genetic engineering in food production may also be present in conventional food production. What can be justified in the context of the latter cannot then be denied to GM food production as "unjustifiable". And vice versa: if a means is ranked as too risky in the context of GM food production, it cannot be acceptable in conventional production either.

LABELLING

Another widely discussed topic in relation to genetically modified foods is labelling. Information on the composition and nutritional value of food, and the production processes, may be important to consumers for health reasons, or on ethical or religious grounds, or personal convictions. Persons with allergies, for example, should be informed about possible allergenic substances or vegetarians need to know, if products contain meat.

The Novel Foods Regulation stipulates labelling requirements for end products. Genetically modified foods only have to be labelled, if the genetic modification can be detected analytically in the end product destined for consumption. Some critics say that the analytical methods available at present do not provide any definite proof, and hence that labelling controls are not possible. It is also debated whether product-based labelling is enough to protect consumers and enable them to make choices. Sceptics argue in favour of a process-based labelling obligation: they say that any application of genetic engineering at any stage in the food production process should be declared, irrespective of whether the genetic modifications in the end product can be detected under analysis, or not. But there are doubts whether such total verification is possible, and whether the effort would not be out of proportion to the ends.

PATENTS

The "life patents" debate looks at whether genes and genetically modified organisms should be patentable.

One of the major objections is that life ought not to be treated as "patentable property". Such a treatment would be incompatible with the dignity or "sanctity" of life. There are also doubts whether genes can be "invented" in the first place, or whether they can only be "discovered". If they can only be discovered, they cannot be patented, as only inventions can be subject to patenting.

Another fear is that exclusive rights to inventions in the field of genetic engineering could be an obstacle to further research and technology. Moreover, this could involve socio-economic risks: patents could push small farming enterprises off the markets and make the so-called developing countries even more dependent on the industrial nations.

The other side argues that what is patented is not "life", but merely the exclusive utilisation of a particular chemical code of the genetic material. Proponents of this position argue that while patents protect inventions against third party commercial use, they do not entitle the patent holder to use the technique or procedure patented, if, for example, the application of this technique falls under the restriction of other legal regulations. As a consequence the patent does not allow any arbitrary power to determine other living beings. If the patent application is not only restricted to a description of the structures, but also includes a possible commercial utilisation, they argue, this would fulfil the conditions for a patentable invention.

It is also argued that granting exclusive rights rewards inventors by enabling them to make money out of their inventions, which is an incentive towards scientific and technical innovation. Patents show what research has achieved, and bring science and technology to a wider audience; this can motivate others to do even more and better research to circumvent existing patented inventions by new ones. In response to the argument that patents could be harmful in socio-economic terms, it is argued that the validity of patents is not unlimited. If it is sufficiently in the public interest, there is always the basic possibility to suspend a patent or to force patent holders to issue licences. However, it is questionable whether the law as it stands is strong enough to ensure that patent rights cannot be used against an overwhelming public interest.

European legislation

(Author: SIBLE staff, United Kingdom)

CURRENT LEGISLATION

The European Community legislation on GMOs has been in place since the early 1990s. Throughout the decade, this regulatory framework has been further extended and refined to protect its citizens' health and the environment while simultaneously creating a unified market for biotechnology.

The main legislation for experimental releases and placing on the market of genetically modified organisms (GMOs) is . This Directive replaced the older Directive 90/220/EEC, putting in place a step-by-step approval process on a case by case risk assessment before any GMO or product consisting of or containing GMOs can be sold, marketed or planted in the EU.

Products derived from GMOs are not covered by this Directive but by sectoral legislation such as the . In addition, Directive 90/219/EEC, as amended by Council Directive 98/81/EC on the contained use of GMMs, regulates the contained use of GMMs for research and industrial purposes.

With regards to labelling, Directive 2001/18/EC foresees that Member States shall take all necessary measures to ensure a labelling of GMOs as or in products at all stages of the placing on the market. The Council Regulation 258/97 provides for the mandatory labelling of foods and food ingredients that contain or consist of a GMO without prejudice to the other labelling requirements of Community law. The labelling requirements for foods produced from GMOs, but no longer containing GMO are based on the concept of equivalence. Council Regulation (EC) 1139/98 lays down provisions for the labelling of foods and food ingredients derived from one maize and one soya variety based on the presence of DNA or protein resulting from genetic modification, which serves as a model providing the rules applicable to labelling of all foods and food ingredients derived from GMO. In January 2000, the Commission adopted Regulation (EC) 50/2000 ensuring that also additives and flavourings have to be labelled if DNA or protein of GMO origin is present in the final product. Genetically modified seed varieties must also be labelled, in accordance with Council Directive 98/95/EEC. The label has to show clearly that it is a GM variety.

Regulation (EC) 49/2000 addresses the problem of adventitious presence of GM material in conventional food. It introduces a 1% de minimis threshold for the adventitious presence of DNA or protein resulting from genetic modification below which labelling is not required. Operators have to be in a position to demonstrate that they have used appropriate steps to avoid the presence of GM material.

NEW LEGISLATION IN PROCESS

Following the vote in Committee on 23 May 2003, the European Parliament adopted its position in second reading on two legislative proposals: the regulation concerning genetically modified (GM) food and feed, and on the regulation dealing with the traceability and labelling of GMOs on 2 July 2003.

The regulation concerning genetically modified (GM) food and feed proposes to put in place a streamlined, uniform and transparent Community procedure for all marketing applications, whether they concern the GMO itself or the food and feed products derived thereof. This means that business operators need not request separate authorisations for use of the GMO, and for its use in feed or in food, but that a single risk assessment and a single authorisation are given for a GMO and its possible uses. The scientific risk assessment will be carried out by the European Food Safety Authority covering both the environmental risk and human and animal health safety assessment. Its opinion will be made available to the public and the public will have the possibility to make comments. On the basis of the opinion of the European Food Authority, the Commission will draft a proposal for granting or refusing authorisation. The proposal will, as it is currently the case, be approved through qualified majority of the Member States within a Regulatory Committee. Products authorised shall be entered into a public register of GM-food and feed. Authorisations will be granted for a period of 10 years, subject where appropriate to a post-market monitoring plan. Authorisations are renewable for 10-year periods. The simplified procedure for putting on the market GM-foods which are considered to be substantially equivalent to existing foods will be abandoned.

The new Regulation on traceability and labelling will require business operators when using or handling GM products to transmit and retain information at each stage of the placing on the market. Information concerning the presence of GMOs in products must be transmitted throughout the commercial chain and must be retained for five years. The industry will therefore have to ensure that systems are in place to identify to whom and from whom GM products are made available.

The new Regulation on traceability and labelling extends the current labelling provisions to all genetically modified food or feed, irrespective of the detectability of genetically modified DNA or protein. All food and feed which consist of, contain or are produced from GMOs would have to be labelled as such. GMOs to allow consumers to exercise their freedom of choice. Genetically modified feed will need to be labelled along the same principles to give livestock farmers accurate information on the composition and properties of feed. This will mean that a large number of feedstuffs currently not subject to GM labelling requirements will need to be labelled in the future.

Under current legislation the presence of GM material in conventional food does not have to be labelled if it is below 1% and if it can be shown to be adventitious and technically unavoidable. Under the new Regulation, the threshold will be 0.9 per cent for food containing traces of unauthorised adventitious GMOs (genetically modified organisms) that have nevertheless been assessed as being risk-free. There is a three-year transition period applied to this threshold. The agreement sets a 0.9 per cent threshold on labelling of all food and animal feed containing GMOs. Below this, no labelling will be required. The labelling requirement will also not apply to products derived from animals fed with GM feed (eggs, milk and meat). For the first time, the law will cover all GM feed. Under a political compromise agreement reached by the Union's Environment Ministers on 10 December 2002, the EU would become able to lift the ban on GMO products that was imposed by seven of the 15 Member States in 1999.

Links

(Collected by: SIBLE staff, United Kingdom)

European legislation on GMOs has been in place since the early 1990s. The main legislation currently in place are:

• Contained use:
  COUNCIL DIRECTIVE 98/81/CE of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms
• Deliberate Release:
  COUNCIL DIRECTIVE 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
• Labelling of Food and Feed:
  COUNCIL REGULATION (EC) No 1139/98 of 26 May 1998, concerning the compulsory indication of the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC Regulation (EC) 258/97 on Novel Foods and Novel Food Ingredients sets out rules for authorisation and labelling of GM food products and other categories of novel foods
• Council Regulation 258/97 on Novel Foods and Novel Food Ingredients of 27 January 1997
• Regulation (EC) 50/2000 of 10 January 2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from genetically modified organisms
• Regulation (EC) 49/2000 of 10 January 2000 amending Council Regulation (EC) No 1139/98 concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC

• Question and Answers on the regulation of GMOs in the EU, available at EUROPA – also available in PDF
• Biosafety in Europe, produced by the Belgian Biosafety Server