Last update: October 2022
Contact: Marius Bartmann

Authors

Genetically modified foods (GMFs) are staple or luxury foods which consist wholly or partly of genetically modified organisms (GMOs). Food also counts as genetically modified if it consists of products of GMOs or where a GMO or product thereof is being used in the production process. The GMO may be a microorganism, 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 breeding methods (selection, cross-breeding, hybrid and mutation breeding), however, this new green genetic engineering allows us to transfer in a more targeted manner not only whole genomes, but also individual genes which may even come from entirely unrelated organisms with very different evolutionary histories. 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 real sense of the term, genetic engineering covers all the methods and in-vitro-processes (i.e. test tube procedures) 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 foreign genetic material introduced 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 is much more difficult. However, the employment of nuclear cell transfer cloning techniques and new techniques of genome editing could change this in the near future. Genome editing techniques make it possible to modify in a highly precise manner particular sequences of a genome, such as "rewriting", amending, deactivating or completely removing a DNA sequence. Since the techniques of genome editing are applicable, in principle, to all organisms, this way plants and animals can be modified as well.

In the context of food production, genetic engineering is used for various different purposes which can be defined more closely by employing the distinction between "input traits" and "output traits":

Modifying input traits

The term "input traits" refers to those characteristics of a plant which are relevant for its cultivation. Genetic engineering is used to modify input traits in order 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. This is mostly done by influencing tolerance and resistance traits. A number of crops such as transgenic corn (e.g. Bt corn like MON863 and MON810) and GM potatoes have been injected with bacterial genes to make them resistent to certain pests, while other plants such as soy beans and canola were supplemented with genes to make them resistent to certain herbicides. One example are the so-called glyphosate-resilient Roundup Ready crops marketed by the agrochemical company Monsanto, which is also one of the biggest manufacturers of glyphosate-based herbicides.

Modifying output traits

Output traits, unlike input traits, describe characteristics pertaining to the usage of a plant. Genetic engineering can be used to make individual natural products more processable, improve their content or make them more digestible to humans. One example of this is the so-called golden rice, which contains more iron and provitamin A than conventional strains of rice. Another example is the potato grade Amflora whose starch production has been improved.

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. With regard to genetic modifications one has to distinguish whether or not "alien" genes are introduced. In cases where genes which are foreign to a species are introduced, the outcomes are called "transgenic" plants, animals etc. If, on the contrary, only species-specific genes are applied for the modification, the result is a "cisgenic" organism. The production of cisgenic plants is enabled by what is known as SMART Breeding. Although laboratory techniques are being used here as well, the procedure rather resembles classical breeding methods due to the restriction to species-specific genes.

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

• The food itself is a GMO or a part of one, like the so-called Flavr Savr tomatoes .
• The food contains microorganisms which have been genetically modified. Dairy products such as yoghurt or cheese, beverages like beer or wine, and also baked goods or sausages may contain such microorganisms as so-called starter cultures.
• The food is produced from GMO, parts of which are detectable in the end product. Some examples of this are cornflakes from GM corn, ready meals with transgenic soya, and ketchup from GM tomatoes ("Flavr Savr" or Zeneca tomatoes).
• 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 GMO in individual additives.
• The food is produced through SMART Breeding. An example of this is the work of researchers from the International Rice Research Institute (IRRI). They were able to add a genetic sequence, which is naturally existent as a variation in only a few rice breeds, to other rice breeds. As a consequence, the new rice breeds are better equipped to adapt to the oxygen-deficient conditions under water and are thus more insensitive to floods. They can stand in the water for a longer period of time without dying, which is usually the case during prolonged floods.

In addition to the use of SMART Breeding to modifiy organisms, the CRISPR/Cas9 technique is being implemented often as of late. With help of so called ‘molecular scissors’, DNA sequences in cells can inexpensively and precisely be made inactive, cut out, or complemented through the use of enzymes. This method opens up the possibility, for example, of controlling the selection of existing DNA sequences in a soon-to-be-modified organism. That way, specific sequences of DNA can be made inactive. Through this process, similarly to the generation of transgenic organisms, the formation of characteristics coded in totipotent cells, their precursor cells or cells of which nuclei can be transferred through cloning methods can be prevented in the recipient organism. At Pennsylvania State University (USA), for example, a research group developed a white type of champignon in which the gene responsible for turning brown after cutting or long storing was made inactive. Beside aesthetic improvement, longer usability and a reduction of food wastefulness were being aimed at. If organisms modified without the use of alien or species-specific genes, but through new editing systems should be considered GMO is currently being discussed. (See also Part II. Legal aspects.)

The discussion surrounding the use of GMO occasionally includes concerns regarding cloned farm animals and their use. In this respect it should be pointed out that the genetic material of reproductively cloned organisms has not undergone any modification or in-vitro manipulation. In other words, such clones need not be designated as being GMO, and therefore are not to be included in the larger field of discussion.

Cultivated areas of genetically modified foods

According to the International Service for the Acquisition of Agri-biotech Applications (ISAAA) GM crops were being cultivated on 190.4 million hectares worldwide in 2019. The four major GM crops are maize, soybeans, cotton, and canola. 26 countries worldwide are growing GM crops. Five countries (USA, Brasil, Argentina, Canada, and India) account for roughly 90% of all GM crops being cultivated worldwide. The following table shows the numbers for 2014-2019:

Only one GM crop is currently cultivated within the European Union: The GM corn MON810 by the company Monsanto. The total area on which MON810 was grown in 2019 amounted to 112,000 ha, a decrease of 7% compared to 2018. Spain accounts for 95% (107,000 ha) of this area, Portugal for the remaining area. While in the case of Spain GM corn represents 35% of the total corn production, it only amounts to 1.3% for the whole EU. In 1998, MON810 was one of the first two GM maize varieties, which were approved for cultivation within the European Union (the second, T25, was never commercially cultivated). In 2009, Germany prohibited the cultivation of MON810 by invoking a clause of the European Deliberate Release Directive. This clause enables member states to prohibit cultivation if they have reasonable grounds for believing that a GMO poses a risk for human health or the environment. In 2015, the EU ratified the so-called Opt-out Directive, which makes prohibition of cultivation possible irrespective of scientific risk assessment. In most EU member states, among them France, Italy, and Austria, the cultivation of MON810 is prohibited on the basis of the Opt-out Directive. In Germany, GM crops are no longer cultivated.

European law

In contrast to recommendations and opinions, directives, regulations and decisions are legally binding for EU Member States. Whereas regulations and decisions are directly applicable in EU Member States, directives only formulate a legal framework, the specific implementation of which into the respective national law is left to the EU Member States. The core of the European Genetic Engineering Law consists of three EU directives:

1. System Directive (2009/41/EC)
2. Deliberate Release Directive (2001/18/EC)
3. Opt-out Directive (EU) 2015/412

The system directive regulates the interaction with genetically modified organisms (GMO) and microorganisms within genetic engineering facilities (e.g. laboratories). The Deliberate Release Directive covers animals and plants in addition to organisms and microorganisms and regulates the conditions for field trials and certain forms of market placing. The Opt-out Directive complements the Deliberate Release Directive with an opt-out clause that allows Member States to prohibit the cultivation of genetically modified plants regardless of health and environmental hazards. Member States can therefore apply to the EU Commission for a prohibition on cultivation on their territory during the GMO authorisation procedure as well as withdraw or restrict the authorization to cultivate the GMO after it has already been granted.

Licensing procedures

"Release" means the (local and temporary) emission of GMOs into the environment. "Market placing", by contrast, refers to the commercial use of GMOs, i.e. selling them to third parties. This concerns, for example, the sale of genetically modified plants, crops or seeds and includes imports for processing and cultivation purposes. The decision on releases lies with the authorities of the respective Member States (in Germany the Federal Office of Consumer Protection and Food Safety BVL). The market placing of GMOs is regulated by two different EU-wide authorisation procedures. If the GMOs are not food or feed, e.g. genetically modified decorative plants, the authorisation procedures are regulated by the Deliberate Release Directive. The approval procedure for genetically modified food and feed is regulated by an EU regulation (1829/2003/EG). 

To obtain an authorisation for food or feed containing or consisting of GMOs, an application must first be submitted to the authority of the respective Member State. After examination, the application is submitted to the European Food Safety Authority (EFSA), which carries out a risk assessment; including a scientific report on whether the GMO has adverse effects on humans, animals and the environment. On the basis of this risk assessment and by taking into account comments from the public, the EU Commission prepares a draft decision on the approval, on which the Member States then decide by qualified majority.

Controversy about genome editing

In Europe, it is currently being discussed if organisms generated through modern techniques of genome editing (such as CRISPR/Cas9) can be considered genetically modified organisms on the basis of current European directives on genetic engineering.

In October 2016, the Conseil d’État (France) submitted a request for a preliminary ruling to the European Court of Justice. In this request, the Conseil d’État inter alia asked for clarification of the question if organisms modified by the new editing techniques constitute genetically modified organisms falling under the existing EU Directive on genetic engineering. In January 2018, Advocate General of the European Court of Justice Michal Bobek concluded that organisms created using new gene-editing technologies do not fall under the Genetically Modified Organisms Directive. Contrary to this assessment, on 25 July, 2018, the European Court of Justice (ECJ) decided that these organisms are to be regarded as genetically modified organisms and thus are, in principle, subject to the obligations provided for in the GMO Directive.

The decision has been controversially discussed both in Germany and throughout Europe. Thus, members of a large number of European research organisations criticise in a joint position paper that Europe was missing the opportunities associated with the new editing methods, particularly concerning the cultivation of crops that can thrive under varying and sometimes extreme environmental conditions. They emphasise that the EU Directive on genetic engineering and its legal restrictions prevented the transition to sustainable agriculture, which is indispensable in the face of climate change, environmental pollution and population growth. Furthermore, the justification for the restrictions was not based on current scientific knowledge. Therefore, in the long term, the authors of the position paper demand a reform of the Genetic Engineering Law and, in the short term, a result-oriented, differentiated approval of plant varieties containing small edits.

The ECJ ruling equates the risks associated with mutagenesis with the risks associated with the generation and dissemination of GMOs through transgenesis. Contrary to this assessment, committees such as the European Academies’ Science Advisory Council (EASAC), stress that many products of the new breeding techniques cannot be classified as genetically modified as they cannot be distinguished from conventionally bred varieties. The German National Academy of Sciences Leopoldina, the National Academy of Science and Engineering (acatech) and the Union of the German Academies of Sciences and Humanities argued in a joint statement as early as 2015 that the safety of new plant varieties should be assessed on the basis of their characteristics and not on the grounds of the methods used to produce them. In a 2019 statement, they reaffirmed their position, particularly with regard to the CRISPR/Cas9 technique, and demanded a result-oriented approach. Against the backdrop of the ECJ ruling the European Commission, on 29 April 2021, published a study on the status of such new genomic techniques (NGT). It concludes that plant products obtained from NGTs have the potential to contribute to the objectives of the EU's Green Deal, of the biodiversity strategies, and of the United Nation's sustainable development goals (SDGs). Furthermore, it recommends reviewing current legislation since these new techniques pose new challenges to existing regulation.

Germany
The Genetic Engineering Act (GenTG)

Unlike regulations, which are directly applicable in Member States, directives need to be implemented into national law. In Germany, the legal framework for the production and handling of genetically modified food is essentially provided by the Genetic Engineering Act (GenTG). Together with the EC Genetic Engineering Implementation Act (EGGenTDurchfG), it implements directives on genetic engineering by the EC and the EU (the System Directive and the Deliberate Release Directive), respectively, into national law. The Opt-out Directive has not yet been implemented into national law, but Member States can nevertheless make use of it due to a transitional rule contained in the directive. Germany has already done so to prevent the cultivation of six corn lines and the renewal of the approval of the corn line MON810.

Pursuant to §1, No.1 the purpose of the Genetic Engineering Act is "giving due regard to ethical values, to protect human life and health, the environment with its interacting systems, fauna, flora and material assets against adverse effects of the techniques and products of genetic engineering, and to make precautions against the occurrence of such hazards." Furthermore, pursuant to No. 2, the goal is to "to safeguard the possibility of producing and placing on the market products, notably foods and feedstuffs, produced according to conventional standards, organic standards or using genetically modified organisms." Finally, the stated intention of No. 3 is "to establish a statutory framework within which to research, develop, use and promote the scientific, technological and economic opportunities of genetic engineering."

The regulations stipulating the use of genetic engineering in food production can be divided into four main areas:

1. Licensing procedures (among others for releasing GMO)
2. Labelling regulations
3. Liability
4. Patent protection

1. Licensing procedures
In the context of licensing procedures in genetically modified food production several different levels have to be distinguished. First, licences are required for the installations themselves and working procedures involved in GM food production. Moreover, there are the regulations governing the release of organisms created in the laboratory (such as seeds for GM crops). And, lastly, there are rules for the placing on the market of products, which consist of or contain genetically modified organisms

On the production side, a distinction has to be made between installation and operating licences. In German law, such licensing procedures come under §§ 2 I Nos. 1 and 2 of the the Genetic Engineering Act (GenTG). A point to note here is that, in implementing European legislation and in line with previous national regulations, the legislators have opted largely for a licensing model: what is required is not a mere mandatory reporting, but the government licence has to be applied for prior to working with genetically modified organisms. This is intended to counter the potential hazards such work might present to large parts of the population.

Under § 2 I No. 1 GenTG the law applies to plants and installations in which genetic engineering takes place. As defined in § 3 No. 4 GenTG, such an installation is a facility in which genetic engineering is conducted in a contained system, in particular making use of physical barriers. The reporting and licensing procedures apply to both constructing and operating genetic engineering installations.

Under § 2 I No. 2 GenTG the law also applies to genetic engineering work itself. This covers any kind of work with genetically modified organisms other than merely transporting them between installations and existing biotechnology processes which have been recognised as non-hazardous.

§ 2 I No. 3 GenTG governs the release of genetically modified organisms into the environment. § 3 No. 5 GenTG defines this as the intentional release of a GMO to the environment, in so far as a licence for marketing (i.e. selling seed for sowing) has not yet been granted. If GMOs escape accidentally, this does not count as releasing them under the regulations of this provision. As well as tightening up the regulations for a safety assessment, the revised Directive now limits consent to marketing to ten years. Moreover, the use of antibiotic resistance markers is to be limited step by step.

Finally, placing products on the market containing GMOs or consisting of GMOs comes under § 2 I No. 4 GenTG. In contrast to § 2 I No. 3 GenTG, this is not about releasing products into the environment, but marketing them to people. This act is always subsidiary to other acts requiring licensing, i.e., its regulations enter into force only if there is no superordinate law specifying provisions for a risk assessment of the potential impact on human beings and the environment. For example, the Pharmaceuticals Act takes precedence over the Genetic Engineering Act, if a GM product can also be classified as a pharmaceutical product. The main criterion in deciding whether to allow novel foods to be placed on the market is their equivalence to conventional foods.

Under § 6 GenTG, anyone involved in any of the activities described in § 2 I Nos. 1 to 4 is required to make a comprehensive assessment of the risks involved to people and the environment, take steps to avert those risks in line with the state of the art in science and technology and keep records of the work they do. In the interest of flexibility, the actual precautions to be taken are laid down, not by the law itself, but by statutory regulations.

2. Labelling regulations
Labelling regulations are set out in § 17b GenTG. Pursuant to § 17b I, products containing or comprising genetically modified organisms that are placed on the market shall be marked on a label or in an accompanying document with the indication "This product contains genetically modified organisms". In accordance with § 17b II, genetically modified organisms intended for genetic engineering work in genetic engineering facilities shall be labelled with the same indication. 

Pursuant to §17b III, the aforementioned labelling regulations do not apply to products that contain or consist of genetically modified organisms which have been authorised for placing on the market but which are intended for direct processing and where the proportion of approved genetically modified organisms does not exceed 0.9%, provided such content is adventitious or technically unavoidable. 

In addition, §16a GenTG provides for a (partially) generally accessible site register in which inter alia the designation and specific identification markers of the GMO, its genetically modified properties, the plot of land on which the release takes place and the size of the release area as well as the release period are to be recorded.

In early summer 2010, when Greenpeace activists revealed that two candy bars from the food company Nestlé had entered the German market using ingredients made from GM soy and GM maize without being labeled, the challenge of controlling compliance with labelling requirements became apparent. 

3. Liability
Liability for damages arising as a result of the characteristics of an organism based on genetic engineering is governed by §§ 32 et seq. of the Genetic Engineering Act (GenTG).

Diverging from the general provisions of civil law, under which liability is fault-based, the legislators here have opted for a liability regardless of fault. This covers injury to life, body and health of persons and damage to property. This departure from the conventional principles of liability can be explained by the particular propensity to create hazards involved in genetic engineering. By applying genetic engineering techniques hazards are created which are difficult to assess in terms of the threat to people and property. At the current state of scientific knowledge, neither the behaviour of GMOs nor their possible impacts on natural genetic material can be predicted with absolute certainty. This also applies in relation to a decision as to what level of safety precautions is sufficient to prevent the hazards from becoming reality, which is why limiting liability to the actual fault on the part of the operators fails to meet the particular circumstances (seen always from an ex post perspective). Instead, the operator is also liable, if he cannot be held to be at fault directly. In particular, licences for genetic engineering installations or work granted under public law do not therefore exempt from liability for damages.

At the same time, however, the liability for damages in respect of any one claim (i.e. per event, not per victim) is limited to EUR 85 million under § 33 GenTG. This limit merely relates to liability regardless of fault according to §§ 32 et seq. GenTG; under § 37 III GenTG, however, claims brought forth on other grounds are left untouched by this limitation. A victim may claim further damages or even damages for pain and suffering under the general principles of civil law, over and above the EUR 85 million. Such claims, however, are once again subject to the principle of fault-based liability.

§36a GenTG governing claims arising out of impairments of use is particularly controversial. The main point of dispute here is the provision in §36a IV regulating cases in which it cannot be determined who of several possible perpetrators is responsible for the adverse effects of releasing a GMO. According to the law, each of the possible causal agents may be held liable in such cases. Critics believe this constitutes a form of "group liability" against which growers of genetically modified organisms cannot protect themselves.

4. Patent protection
When applying for an invention to be patented, the first distinction which has to be made is that between international patents (under the international Patent Co-operation Treaty), European patents (under the Convention on the Grant of European Patents - European Patent Convention) and national patent applications. The following only covers German and European patenting procedures. Applications for German patents are made under the Patent Act (PatG) while European patents are applied for under the Convention on the Grant of European Patents (EPC) The German Patent Act has largely been harmonised with the provisions of the EPC.

Para. 1 no. 1 PatG and § 52 no. 1 EPC agree in stating that patents can be granted in respect of inventions which are new, are based on inventive activity and which are commercially usable. In relation to genetic engineering in food processing, there are a number of exceptions to patentability which are of reference. Under § 2 no. 2 PatG (§ 53 b EPC), patents cannot be granted for plant varieties, animal species or essentially biological procedures for breeding plants and animals. This exception though does not apply to microbiological methods and the products obtained using those methods. It is notable that neither German nor European patent law prohibits plants or animals being patented. It is only plant varieties and animal species which cannot be patented (on this distinction see the decisions of the European Patent Office Board of Appeal ). Notwithstanding these provisions, however, plant varieties can be protected under the Plant Variety Protection Act (SortenG)

Another reason why genetic engineering inventions may not be patented lies in § 2 no. 1 PatG (§ 53 a EPC), which states that inventions cannot be patented if they violate public order or morals. This is a legal term in need of interpretation, and of being defined in the legal systems concerned. It covers those methods stated in Directive 98/44/EC (Biotechnology Patents Directive Art. 6 no. 2. These are, for example, "processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes" (Art. 6 no. 2d). While the EU Directive does not apply directly to the EPC, it has been included as part of the implementation regulation.

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 about consumption of genetically modified foods causing allergic or even toxic reactions.

If these GM foods contain antibiotic resistance genes as “marker genes”, as for example the potato grade Amflora, their consumption could unintentionally make humans resistant to antibiotics. The corn type MON863 serves as an example of an approval procedure for genetically modified crops repeatedly leading to controversial discussions concerning possible undesirable health effects. Moreover, the scientific standards on which approval studies should be based are often disputed.

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. People are afraid that "natural products" such as honey could be contaminated by pollen of genetically modified plants. Critics further assume that, once they have been planted, it will hardly be possible to entirely dispose of genetically modified breeds. Thereby, references are oftentimes made to a study on genetically modified canola, conducted by Swedish and Danish scientists.

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 countries of the Global South. In this context a key role will certainly fall to the issue of patenting.

A duty to protect non-human life?

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

Moral anthropocentrism (gr. anthropos: human) attributes intrinsic value only to humans, which is why only humans are to be protected for their own sake. Based on the Kantian tradition, this point of view is often justified by the argument that humans, in contrast to animals, possess the ability to reason, which in turn confers intrinsic value on humans. Nature with all its elements, on the other hand, does not possess any intrinsic, but only instrumental value; it is only to be protected insofar it is valued by and useful for humans. In the context of this nature-ethical position, there are various shades and approaches to justification, each of which emphasises different possible uses of nature – for example, the necessity of using nature as the basis of human life, the contribution of nature to a good human life or the educational value of nature. 

Secondly, moral anthropocentrism is contrasted with physiocentric approaches (gr. physis: nature), which attribute intrinsic value not only to humans but also to various entities or, depending on the variant, to spheres of nature. Two of the largest approaches within physiocentrism are pathocentrism and teleological physiocentrism. 

Pathocentrism (gr. pathos: suffering), sometimes also referred to as sentientism (lat. sentire: to feel) links the intrinsic value of a living organism to its ability to feel, more specifically to its capacity for pain or suffering. This can be recognised, for instance, in physiological aspects such as shaking, screaming, or moaning, but also in flight responses. According to this position, all sentient beeings have an intrinsic value and are therefore worthy of protection for their own sake. The concept of interest is also associated with this approach – in a broad terminological sense, sentient beings have an interest in things that are beneficial to them or in avoiding suffering. Thus, the capacity for interest can also serve as an indicator for moral significance in the sense of intrinsic value and for the resulting duty of protection.

Teleological physiocentrism (gr. telos: purpose, goal) more fundamentally attributes moral intrinsic value to all entities that have basic strivings and purposeful activities, to which in turn duties of protection are linked. Intrinsic value is here linked to the purposefulness and the inner goal-directedness of entities, which, depending on the definition and scope of the concept of purpose in a broad sense, could be recognised in principle in the life-support or reproductive instinct of living beings. Depending on the line of argumentation and the concept of purpose represented therein, in a broad sense nature as such in its entirety has an intrinsic value, in a narrow sense individual organisms of nature.

These physiocentrically justifiable duties of protection are then to be measured in detail according to the species-specific expression and development of these basic strivings. Disposing of non-human life – for example through genetic modification – is thus not generally impermissible, but it is bound to a case-oriented justification. This justification must take three things into account:

1. the expression and development of the species-specific basic strivings of the living being affected, 
2. the compatibility of the interference with those specific strivings and purposes and
3. the purposes pursued by the disposition.

In addition to possible incompatibility, i.e. the risks, it is also important to consider possible benefits, i.e. the opportunities: For example, the susceptibility of animals to disease could be reduced by gene transfer – in the interest of safeguarding yields, but possibly also in the interest of the animals themselves.

Weighing risks and opportunities: the rules

Risks and opportunities have to be assessed within the framework of comparative interdisciplinary safety or risk research. This makes it possible to determine both the desirable and undesirable effects of any given application by using established scientific standards. A risk analysis includes an estimation of risks as well as a risk assessment. The challenge of risk estimation consists in defining and assessing the risks. As the classification of certain expectable consequences of the genetic modification of food already contains a value judgement, first substantial conflicts arise already on this level.

Regarding the risk assessment emerges the subsequent question according to which principles or values the risk-benefit analysis of the genetic modification of food should proceed. Proponents of a (strict) precautionary principle think that a lack of knowledge of a technique’s possible risks is sufficient to prohibit its approval or at least to restrict it. However, the development of new techniques is often bound up with a certain uncertainty about possible risks. Because of this the precautionary principle may in some circumstances be too restrictive. Proponents of a less strict assessment of risks therefore conclude that the lack of knowledge as well as the risks connected with the use of GM technology is acceptable as long as everyone can decide for oneself whether one likes to use these products. An appropriate labelling of genetically modified food should enable the consumer to make a free and informed decision for or against the consumption of GM food. But as such labelling requires clearly defined criteria for genetically modified food and their labelling, it remains doubtful whether labelling is sufficient for a free and informed decision.

With regard to any ethical assessment of the risks and opportunities arising from duties to protect both human and non-human life, the following aspect has to be taken into account: It is not only the possibility to produce and use genetically modified foods which is in need of justification in light of possible risks. Rather, also the decision not to produce and use genetically modified food has to be justified in light of missed 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 countries of the global south, but less so, if the aim is (merely) to make food more attractive and thus to increase profits.

In 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. For example, in the context of improving the global food situation the question arises whether it is more promising to improve the political, social and infrastructural conditions instead of using genetic engineering to increase crop yields.

The risks involved in genetic engineering in food production may also be present in conventional food production, as unexpected changes and effects may occur in any plant breed method. What can be justified in the context of conventional food production cannot then be denied to GM food production as "unjustifiable". Conversely, if a means is too risky in the context of GM food production, it cannot be acceptable in conventional production either. This is why in general all plant breeding methods and their products have to undergo a risk check. However, the risk assessment is usually more difficult in the case of GM technologies because of less experience and knowledge in comparison to conventional methods. Hence the genetic production of food is subject to special approval procedures (see part II of this entry).