Genetically Modified Foods

Transcription

DRZE/In Focus
Last update: July 2010 Contact: Lisa Tambornino
I. Technical and scientific aspects
Genetic modified (GM) foods (see module Genetically modified 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 breeding methods (selection, cross-breeding, hybrid and mutation breeding),
however, this new green genetic engineering (see module 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 (see module Genetic engineering) covers all the
methods and in-vitro-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 foreign 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 (see module
Genetically modified micro-organisms): such classes of organisms are particularly suitable due to their asexual
reproduction and easy cultivation. Genetic engineering in vertebrates (see module 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 the context of food production, genetic engineering is used for various different purposes:
http://www.drze.de/in-focus/genetically-modified-foods (1)
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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 transgenic corn (e.g. Bt corn or MON 863 (see module GM corn
MON 863) and MON 810 (see module GM corn MON 810)) and GM potatoes have been injected with
bacterial genes to make them resistant to certain pests, while other plants such as soy beans and rape (see
module Genetic soy beans A2704-12 and genetic 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 natural products 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 example is the the potato grade Amflora (see module
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 regards to genetic modifications a distinction needs to be made between the application or non-application
of dissimilar genes. In cases where dissimilar genes are applied the outcomes are called "transgene" plants,
organisms etc. If, on the contrary, only characteristic genes are applied for the modification, the term smart
breeding (see module Smart Breeding) is employed. Although laborarotory techniques are made use of here as
well, the procedure rather resembles classical breeding methods due to the constriction to characteristic genes.
There are a number of ways in which food can be made from genetically modified 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 (see module Flavr-Savr tomatoes) .
• Many milk products and drinks contain micro-organisms as starter cultures (see module Starter cultures)
. Such micro-organisms may also be genetically modified.
• 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 made with additives (see module 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.
• The work of researchers from the International Rice Research Institute (IRRI) ( see module International
Rice Research institute) is an example for the so called "smart breeding".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
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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 some cases the discussion surrounding the use of GMO includes concern in respect of cloned farm animals
(see module Cloned farm animals) and their exploitation. 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) (see
module ISAAA) genetically modified crops were being cultivated over a total of 125 million hectares
worldwide in 2008. The area under cultivation had thus grown by 9.4% relative to the previous year. Altogether
25 countries grew genetically modified crops, including seven European countries (Spain, Germany, Portugal,
France, Poland, Slovakia and the Czech Republic). By far the bulk of the cultivated area for genetically modified
foods continues to be in the USA (62.5 million hectares or); Argentina (21.0 million hectares) placed second
ahead of Brazil (15.8 million hectares), India (7.6 million hectares), Canada (7.6 million hectares) and China
(3.8 million hectares). With a share of approximately 53% of the area under cultivation genetically modified
soy beans dominate the worldwide production, followed by maize (30% of the area under cultivation), cotton
(12%) and canola (5%).
So far, only Bt-corn MON 810 (see module GM corn MON 810) of the company Monsato had been authorized
for commercial cultivation in Germany. Since 14th April 2009 the cultivation of MON 810 is prohibited in
Germany as well. The German Federal Minister of Agriculture, Ilse Aigner, founded this decision (see module
Prohibition of cultivation of MON 810 in Germany) on the fact that, according to new studies, MON 810
posed a threat to the environment. In 2007, MON 810 was grown on an area of approximately 2,700 hectares.
This equals circa 0.15 percent of Germany's overall are of corn cultivation. The cultivation of MON 810corn has been authorized in the EU since 1998. The initial authorization expired in April 2007. Even though a
readmission of this genetically modified corn breed has taken place, numerous EU-countries, such as France,
Greece, Hungary, Luxembourg and Austria have called on so-called national hedge clauses and have prohibited
the cultivation of MON 810 in their countries.
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II. Ethical aspects
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
(see module 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
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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
modified food could cause allergic or even toxic reactions (see module Health risks posed by genetically
modified foods) . If those GM foods contain antibiotic resistance genes as marker genes, for example the
potato grade amflora (see module Potato grade Amflora) , their consumption could unintentionally make
humans resistant to antibiotics. In spring 2007 scientists of the French organisation CRIIGEN (Committee for
Independent Information and Research on Genetic Engineering) announced that the consumption of genetically
engineered corn type MON 863 (see module GM corn MON 863) can cause damage to liver and kidney.
A re-evaluation of a 2002 study, where rats ingested corn, shows that there are possible health risks when it is
used as either foodstuffs or animal feed. Therefore it must be considered as alarming.
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 (see module Genetically modified 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
rape (see module Study on genetically modified rape) , 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 developing countries
context a key role will certainly fall to the issue of patenting.
A duty to protect non-human life?
(see module Developing Countries) . In this
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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.
Weighing 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
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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.
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III. Legal aspects
Following a protracted and heated debate, an amended version of the Genetic Engineering Act (GenTG)
(see module Genetic Engineering Act) entered into force on 4 February 2005; it implements into national
law 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.
On April 1st 2008 the bill on the changes in the Genetic Engineering Act (see module Bill on the Changes
in the Genetic Engineering Act) was enacted.
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 (GMOs)." 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
2 Labelling regulation
3 Liability and
4 Patent protection.
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 risks 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
(see module Changes for Operators of 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
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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, where licences are required and where
those licences are subject to a risk assessment of the potential impact on people 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
(see module Equivalence (Substantial 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 (see module Safety levels in genetic engineering) to be taken are laid
down, not by the law itself, but by statutory regulations.
Labelling
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
(see module Labelling of genetically modified foods) 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.
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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, which states that if, under the actual circumstances of the individual
case, several neighbours come into question as generators and it cannot be determined which of them has
generated the adverse effect through his or her actions, then each of these is responsible for the adverse
effect. Critics believe this constitutes a form of "group liability" against which growers of genetically modified
organisms cannot protect themselves.
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)
(see module Patents), while European patents are applied for under
the Convention on the Grant of European Patents (EPC) (see module European Patent Convention). 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
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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 (see module Biotechnology Patents Directive))
Art. 6 no. 2d. These are "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". While the EU Directive does not apply directly to the EPC, it has been included as part of the
implementation regulation.
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Authors
Martin Heyer, Ingo Hillebrand, Dirk Lanzerath, Christian Noack, Michael Weiffen, revised by Bert Heinrichs
(2007), revised by Lisa Tambornino (2009), revised by Lisa Tambornino, Verena Braun, Lisa Retterath (2010),
revised by Robert Ullrich, Lisa Tambornino (August 2010), revised by Lisa Tambornino (September 2010),
revised by Lisa Tambornino (October 2010).
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Modules
Modules of Genetically Modified Foods
Additives
Additives
Here, bacteria and yeast are modified to produce large quantities of enzymes identical to those found in nature,
which are used in food production. In the course of the large-scale production of the sweetener Aspartame
genetically modified bacteria are being used to produce a basic component of Aspartame. Aspartame itself is
used as a sugar substitute in many light and diet products.
Bill on the Changes in the Genetic Engineering Act
Bill on the Changes in the Genetic Engineering Act
Bill on the changes in the Genetic Engineering Act
Biotechnology Patents Directive
With the Biotechnology Patents Directive of July 1998, the European legislators have for the first time taken
a step in dealing with the problem of the patentability of biotechnological inventions. The Directive allows
both biological material (product patents) and methods used in making, processing or using such material to
be patented in principle, although it excludes inventions which relate solely to certain plant varieties or animal
species.
The Directive does not create any new rules over and above the existing practice under the EPC: biological
materials and methods can be patented per se provided they meet the requirements of patentability otherwise.
Changes for Operators of Plants and Installations in Which Genetic
Engineering Takes Place
Changes for Operators of Plants and Installations in Which Genetic Engineering Takes Place
Reorganization for operators of plants and installations in which genetic engineering takes place after the
changes in the law on genetic engineering 2008
Cloned farm animals
Cloned farm animals
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The term ‘cloned farm animal’ is understood to refer to a creature which has been borne naturally by a mother
animal, but whose fertilization took place in vitro. Its defining characteristic consists in the fact that the cloned
animal has exactly the same genetic material as the previously selected donor individual. That individual’s
genome is isolated and introduced into an empty, unfertilized ovum. By means of biotechnological techniques,
the two components are then brought together and activated, so that as a result the now fertilized egg can be
implanted and a ‘twin’ of the donor animal can develop. A reproductively cloned animal is not declared as being
a genetically modified organism (GMO), since no genetic engineering techniques have been employed in its
production. As it is still very expensive to clone animals at present, they are not simply used for consumption,
but only as particularly valuable breeding animals whose characteristics are to be passed on to a large number
of offspring. There is now debate as to whether the offspring of cloned animals should be specially identified,
whether indeed they should be available for sale altogether and whether the consumption of such individuals
may be associated with any kind of risk. The way the discussion is conducted and the public view of the matter
are, in part, very reminiscent of the situation regarding GMO. Whereas the majority of the participants in
an opinion poll conducted for the Eurobarometer 2008 rejected the cloning of animals for food production
(58% regard it as being on no account justifiable), both the European Food Safety Authority (EFSA) as well as
its counterpart the United States Department of Agriculture (USDA) concluded in 2008 that the consumption
of cloned domestic animals and their offspring almost certainly represents no danger to health. However, the
European authority expressed its disquiet over the fact that the number of scientific studies remains very low
to date and that the ethical concerns in respect of the animals from the point of view of health and well-being
are very great. On 19th October 2010, the European Commission announced that it proposes to place a ban on
the cloning of animals for food production as well as on the importation of cloned animals and their meat for
the next five years. Whether the ban on cloning and importation should also cover the meat and milk obtained
from the offspring of cloned animals remains under discussion at this stage.
European Parliament Press Service (2010): Press release. MEPs call for ban on food from cloned animals.
European Food Safety Authority (EFSA) (2008): Press release. EFSA adopts final scientific opinion on
animal cloning.
Flash Eurobarometer (2008): Europeans’ attitudes towards animal cloning.
Schweizerische Eidgenossenschaft, Bundesamt für Gesundheit BAG (2008): Fragen und Antworten.
Lebensmittel aus geklonten Tieren? (Swiss Confederation, Swiss Federal Office of Public Health SFOPH
(2008): Questions and Answers. Food from cloned animals?)
Transgen (2010) Vorschlag für EU-Verordnung. Zulassungspflicht für Lebensmittel von Klon-Tieren.
(Proposal for EU regulation. Authorisation requirement for food from cloned animals.)
United States Department of Agriculture (USDA) (2008): Statement by Bruce Knight, Under Secretary for
Marketing and Regulatory Programs on FDA Risk Assessment on Animal Clones. Release No. 0012.08.
Developing Countries
Developing Countries
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Especially in developing countries, the use of genetically modified foods is intended to bring about an
improvement in living standards. Genetic modifications are supposed to produce higher yields, pest resistance
and an improved ability to withstand adverse weather conditions, hence helping to relieve the supply shortages
in "Third World" countries.
Critics, however, assert that the introduction of genetically modified foods will increase small farmers'
dependence on multinational corporations, often causing the situation to deteriorate. The dramatic rise in the
suicide rate among smallholders in the Indian state of Andra Pradesh in recent years would appear to support
this criticism. Yet it would seem questionable whether the impoverishment of farmers can be attributed solely
to problems associated with the genetically modified Bt-cotton that they have been growing. Not least due to
protracted criticism from farmers, the 51st Meeting of the Genetic Engineering Approval Committee (GEAC)
(03 May 2005) did not renew permission for commercial cultivation of certain types of genetically modified
cotton developed by the company Mayhco/Monsanto in the state of Andra Pradesh.
On the increased suicide rate among small farmers in the state of Andra Pradesh cf.
Stone, Glen D. (2002): Biotechnology and Suicide in India.
Minutes of the 51st Meeting of the GEAC:
Decision of the 86th meeting of the GEAC
Eidgenössische Ethikkommission für die Biotechnologie im Ausserhumanbereich (EKAH) (2004): Gentechnik
und Entwicklungsländer
Equivalence (Substantial Equivalence)
Equivalence (Substantial Equivalence)
The licensing requirements for introducing novel foods raise the question as to what criteria should be used in
assessing their food safety. Even conventional foods contain anti-nutritional substances and potential toxins.
If - looking merely at their composition - this applies to all foods in principle, the question must ultimately
be whether a given food as a whole is harmful to the health of the consumer or not. This question can only
be answered reliably in the light of long-term experience with that food, however. Conventional foods meet
this requirement because long-term experience has been gathered on their consumption and its effects; with a
novel food, this is impossible by definition.
For assessing new foods and their compatibility with health, the criterion of "substantial equivalence" has
therefore been developed. On the basis of this criterion, a food can be assumed not to present a risk to health,
if it is essentially similar to a conventional food; but the more difference there is between the novel food and
tried and trusted comparable products, the greater the attention that has to be paid in the course of the further
safety assessment.
The concept of substantial equivalence was developed by various groups of experts (WHO, FAO, OECD) from
1995 onwards, and also served as the basis of the Novel Food Regulation (NFR). The NFR adopted the concept
both for licensing and labelling novel foods. In using the substantial equivalence criteria, three case groups
can be distinguished:
DRZE/In Focus
1 The novel food is completely identical to a comparative conventional product in terms of composition, and
is therefore completely substantially equivalent. The product does not require any safety assessment on its
own account; notification is sufficient.
2 The novel food is identical to a comparative conventional product, in all essential aspects bar one. The
aspect in which it differs is precisely that in which the novelty of the product lies. The safety assessment is
limited to the novel aspect, resorting to a number of different processes, such as toxicological studies.
3 The novel food has been modified in essential product characteristics, there is no comparable conventional
product. The complete product must undergo an extensive safety assessment. The assessment method has
to be geared to each individual case.
This concept has now been accepted as the guideline for assessing novel foods, but opinions differ on the
following aspects:
• The type and extent of the testing required in each case.
• The scope of the database used as the basis for the licensing decision.
• The possibility of secondary effects caused by the genetic modification in a given gene. These effects are
unforeseeable, and may not therefore be detectable, even in specific procedures.
• The allergenic effects of the new product are hard to assess in principle, as the occurrence of harmful effects
depends on a group's specific constitution.
Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning
novel foods and novel food ingredients (Novel Food Regulation)
European Patent Convention
European Patent Convention
Convention on the Grant of European Patents
Flavr-Savr tomatoes
Flavr-Savr tomatoes
The intervention of genetic engineering has made it possible to create tomatoes that last longer. For this purpose
a gene governing the degradation of cell walls was modified such that tomatoes retain their firmness longer
once they have been picked and do not turn mushy. While this does not make tomatoes age any more slowly,
it makes them look better, despite the normal ageing process.
In 1996 the company Calgene launched a tomato on the market that had been genetically modified in this way
under the name "Flavr Savr", the first genetically modified fruit to be brought to market. However, the "Flavr
Savr" tomato was not a commercial success and production was stopped less than a year after its launch. In
the meantime Calgene has been bought out by the Monsanto Group, which is not pursuing the development
of the "Flavr Savr" tomato. Zeneca also developed a genetically modified tomato similar to the "Flavr Savr".
It was on the market from 1996 to 1999.
DRZE/In Focus
Genetic engineering
Genetic engineering
The terms "genetic engineering" and "biotechnology" are often used synonymously. But, originally,
biotechnology was a general term covering all methods in which micro-organisms such as bacteria and yeasts
were used in processing raw materials. While biotechnology has been used for centuries, for example in the
production of alcoholic drinks from hops or of cheese and yoghurt from lactic acid bacteria, most genetic
engineering processes were only developed in the second half of the twentieth century.
Genetic Engineering Act
Genetic Engineering Act
On 21.12.2004, following protracted political debate surrounding the amendment of legislation on genetic
engineering, the governing coalition of the day adopted a bill that became law on 04.02.2005.
Genetic Engineering Act (GenTG)
Directive 2001/18/EC
A detailed chronology of the parliamentary passage is here available
It appears questionable whether the Genetic Engineering Act will survive long in its current form. In the
Coalition Agreement reached between the CDU, CSU and SPD on 11.11.2005 ("Working together for
Germany ? With courage and compassion") the parties agreed inter alia in Item 8.9 to amend the Genetic
Engineering Act. The stated objective is to promote research into and the use of genetic engineering in
Germany.
"Working together for Germany ? With courage and compassion". Coalition Agreement between the CDU,
CSU and SPD of 11 November 2005 (English translation).
Genetic soy beans A2704-12 and genetic rape
Genetic soy beans A2704-12 and genetic rape
Since September 2008 soy beans of the type A2704-12 are allowed to be imported to Europe from the USA
and Canada to be further processed into foods or animal food.
The soy type is genetically modified in such a way that it is resistant to the herbicide glufosinate. As with the
soybeans, the rape was genetically modified in a way that it is resistant to glufosinate. These plants have proven
to be very resistant. Even ten years after the sowing on test areas can offspring of these plants be detected.
Since the long term effects of this genetic modification cannot be anticipated, the area-wide sowing has not
yet been approved. As early as in 2005 British scientists warned about the fact that genetic rape might be able
to decimate the bee and butterfly population.
At the moment genetic rape produced by the company Bayer Crop Science is being sold in the USA, the place
where it is grown.
DRZE/In Focus
Genetically modified foods
Genetically modified food
A more detailed treatment of the subject is available as a reader compiled with the participation of DRZE
research staff in connection with the "Diskurs Grüne Gentechnik" organised by the German Ministry of
Consumer Protection, Food and Agriculture in April 2002. The reader covers scientific, ethical and legal
aspects.
Reader "Grüne Gentechnik" (pdf file-only available in German)
Genetically modified honey
Genetically modified honey
Studies have shown that honey often contains traces of genetically modified organisms. Since the flight radius
of bees is several kilometres wide, there is high danger that the bees collect the pollen of genetically modified
plants and thus contaminate the honey.
In May 2008, the administrative court of Augsburg ruled that honey containing pollen of the genetically
modified corn 810, is no longer marketable. Since MON 810 is only licensed as animal feed but not as food,
apiculturists are neither allowed to sell genetically modified honey, nor to give it away as a present; rather, they
have to make sure it is disposed of. Presently, it is being discussed who is responsible for the honey remaining
free of genetic pollen. It is debated whether the operators of genetically modified fields have to make sure
that the bees do not carry the plants' pollen or whether the apiculturist himself is responsible for his bees not
approaching contaminated pollen.
Administrative court Augsburg (2007): Decision of 4th April 1007. Au 7 E 07.257.
Online-platform bee und agro genetic technology (German only)
Wraneschitz, Heinz (2009): Bienen müssen Gen-Mais weichen. In: Technology Review 03/2009 [Bees have
to give way to genetic corn] (German only)
Genetically modified micro-organisms
Genetically modified micro-organisms
In micro-organisms, suitable for use in food production genetic engineering is used mainly in bacteria (such as
starter cultures in milk products and enzyme production) and yeast fungi (e.g. in brewing beer).
Genetically engineered chymosine has now established itself in cheese production. To turn milk into cheese,
rennet is used as a thickening agent; it was traditionally obtained from the stomachs of calves when they were
slaughtered. The main agent in rennet is chymosine. At present there are no recognised methods available for
the detection of genetically modified chymosine in whey.
It is conceivable, that genetically modified yeast or genetically produced enzymes could be used in brewing
beer. In the production of beers made in accordance with German purity laws at present, the use genetic
engineering is excluded. Where enzymes are used in foreign beers, these can be produced using genetic
DRZE/In Focus
engineering. Germany does not allow isolated enzymes to be used in the brewing process; the application of
modified yeast - and this also includes genetic engineering techniques - to increase its performance is, however,
compatible with the purity law. A number of genetically modified yeasts have been developed to the point
where they are ready for use in industry, especially in low-alcohol or low-calorie beers; but they have been
little used so far. German brewers plan to do without them.
GM corn MON 810
GM corn MON 810
Same as MON 863, MON 810 a genetically modified breed of Bt-corn of the US-company Monsanto. The
Bt-corn was authorized on 22nd April 1998 through a decision by the EU-Commission. Nowadays, several
corn breeds, which contain the genetic construct of MON 810-corn, are on the market. Newer research results
according to which the Bt-toxin used in this corn can harm the environment more strongly than had been
anticipated so far, led to a nationwide sales prohibition of the product in Germany by the Federal Office of
Consumer Protection and Food Safety (BVL) on 27th April 2007. The BVL called on the seeds company
Monsanto to present a plan regarding the monitoring of possible impacts on the environment. When the
company followed this request in December 2007, the corn breed could initially be released for commercial
purposes again. Other EU-countries (France, Greece, Austria, Luxembourg and Hungary) have decided for
a prohibition of the cultivation of MON 810. In March 2009, the EU-Commission initiated an attempt to
lift coercively these bans in Austria and Hungary; with its proposal it could, however, not stand up to the
EU-environment secretaries: the EU- Commission's proposals, through which Austria and Hungary should be
barred from creating national regulations regarding the ban of the cultivation of MON 810, were rejected.
EU- Commission: Decision regarding the authorization of MON 810 of 22nd April 1998 (German only)
Publication of a notification regarding the constraint of putting, after the genetic engineering legislation by
the Federal Office of Consumer Protection and Food Safety (BVL) of 27th April 2007, genetically engineered
organisms into circulation (German only)
Tentative statement by the Federal Office of Consumer Protection and Food Safety (BVL) regarding the
Monsanto company's monitoring plan for the observation of the environment of MON 810 in Germany (German
only)
Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms
Scientific statement regarding the prohibition of MON 810-corn in France by the GVO-expert committee of
the EFSA
Studies which casted doubts on the safety of MON 810:
Harwood et al. (2005): Uptake of Bt endotoxins by nontarget herbivores and higher order arthropod predators:
molecular evidence from a transgenic corn agroecosystem. In: Molecular Ecology 14, 2815-2823.
GM corn MON 863
GM corn MON 863
DRZE/In Focus
The genetically engineered type of corn, tagged as MON 863, was developed by a seed corporate group called
Monsanto. Due to alterations MON 863 is resistant to certain pests compared to conventional corn. In the
laboratory the soil bacterium Bt (Bacillus thuringiensis) is injected into the corn, so it can build up the so-called
Bt toxin, which protects the plant against the corn root worm, a corn damaging pest. Furthermore MON863
consists of an antibiotic resistant gene.
After a 90-day experiment on feeding rats which was completed by Monsanto, the GM corn was rated as safe
and hence licensed by the European Licensing Authority. MON 863 is cultivated in the USA and Canada
and used as feeding and foodstuffs in the EU, Australia, China, Japan, Mexico and the Philippines. The
results of the 90-day feeding experiment were re-evaluated by independent scientists of the French organisation
CRIIGEN (Committee for Independent Information and Research on Genetic Engineering). They found out
that the statistic methods which were used by Monsanto in the first evaluation, were not exact enough to be
able to discover the health harming effect. In the new analysis of findings on blood, urine, liver and kidney, the
researchers could proof MON863 had harmful effects on liver and kidney. Comparing to animals which were
fed with conventional corn, differences in the composition of blood and urine could be found in animals which
were fed with GM corn (amongst others such as blood fat level, blood sugar level, phosphorus percentage and
sodium percentage). Moreover, the re-evaluation of the feeding experiment showed abnormal changes in terms
of the rats growth and weight.
Due to the results of the new study the consumption of GM corn MON 863 and the usage as feed is currently
in discussion. A global prohibition of marketing is demanded by different sides, especially Greenpeace.
On the occasion of the publication of the CRIIGEN-study, the European Food Safety Agency (EFSA)
conducted a comparative survey of both studies regarding the statistical methods respectively employed.
The EFSA came to the conclusion that the divergences in the results of both studies were only caused by a
different interpretation of the data laying the basis of the studies. The survey of the data itself by Monsanto
had been conducted correctly. The critical findings of the CRIIGEN-study could be ascribed to the application
of imprecise statistical methods. In a precise statistical survey, the results were inconspicuous regarding
all parameters examined, in particular growth and weight. Therefore, the EFSA does not see a reason for
annihilating the authorization of MON 863.
The Monsanto study
New analysis of the Monsanto study by independent scientists from the French Organisation CRIIGEN
New analysis by the EFSA
Green genetic engineering
Green genetic engineering
Especially in the political debate, colour labels are used to designate the various field of application for genetic
engineering: "green" genetic engineering thus denotes the use of genetic engineering methods in nutritional
and agricultural applications. The following labels are also in common use:
• red: medical applications
• white: environmental technology and ecology
DRZE/In Focus
• blue: marine biology
• brown: waste water treatment
• yellow: natural resource modification
Greenpeace levels criticism against Nestlé
Greenpeace environmental actionists level criticism against Nestlé
In May 2010, the ecology group Greenpeace attacked the food company Nestlé by accusing it of selling
genetically modified foods in Germany without properly labelling them.
The criticism concerns the distribution of the chocolade bars "Butterfinger" and "Baby Ruth". According to
Greenpeace, these two Nestlé-bars are being produced with extracts from gene-soy or ingredients from six
different types of genetic corn but are not labelled correctly. In Europe, the sale of non-labelled gene products
is punishable.
Nestlé rejected the accusations and proclaimed that it self-evidently attended to the respective regulations. They
further explained that Nestlé did not sell any genetically modified foods in Germany. The chocolade bars in
question were probably produced for the U.S. market and labelled accordingly. Obviously, the chocolade bars
had been imported to Germany by an independent company.
Greenpeace called for comprehensive controls of food inspection and referred to the wish of most consumers
in Germany to not "have slipped" any genetically modified foods.
US-Import. Greenpeace attackiert Nestlé wegen Gen-Schokolade. SpiegelOnline-Artikel vom 26. Mai 2010
(German only)
Health risks posed by genetically modified foods
Health risks posed by genetically modified foods
Whether or not the consumption of genetically modified foods is associated with health risks has been a matter
of protracted controversy. In 2004 the "Commission Green Biotechnology" ("Kommission Grüne Gentechnik")
of the Union of the German Academies of Sciences and Humanities published a memorandum in which it
clearly rejected such a risk.
Union of the German Academies of Sciences and Humanities, "Commission Green Biotechnology" (2004):
Are there health hazards for the consumer from eating genetically modified food?
An experiment reported by Australian scientists in 2005 in the Journal for Agriculture and Food Chemistry
provoked quite a stir. The researchers fed mice with a genetically modified species of pea. The modification
with a bean gene was intended to make the peas resistant to pea weevils. The mice fed with the genetically
modified peas displayed an unexpected immune reaction during the experiment. In the case of the mice in
control groups, which were fed with either unmodified peas or beans, there was no immune reaction despite
the fact that the beans had the same gene. The researchers deduced from their research that the expression of a
protein in a foreign organism can lead to a modified protein structure and immunogenicity. In response to their
findings the Australian researchers broke off their work on the genetic modification of peas.
DRZE/In Focus
The original work carried out by the Australian researchers was published in the Journal of Agriculture and
Food Chemistry:
Prescott et al. (2005): Transgenic Expression of Bean alpha-Amylase Inhibitor in Peas Results in Altered
Structure and Immunogenicity. In: Journal of Agriculture and Food Chemistry 53: 9023-9030.
International Rice Research institute
International Rice Research institute
International Rice Research Institute
ISAAA
ISAAA
International Service for the Acquisition of Agri-biotech Applications (ISAAA)
Labelling of genetically modified foods
Labelling of genetically modified foods
Information about the labelling of genetically modified foods
Patents
Patents
Patents can be used to protect by force of law the results of an intellectual process of creation (intangible
property). Patent protection is a special case of commercial property rights and applies to technical inventions.
The protection is obtained by being awarded a patent on applying to the competent patent office for a product
or method patent.
Patents have both direct and indirect effects. Depending on the type of patent, the indirect effects of a patent
(§ 9 PatG) comprise a number of actions which are reserved to the patent holder. Any third party who engages
in any of these actions (without authority) infringes the patent.
• A product patent protects the production, offering, marketing, use, possession and import of the subject
matter of the patent.
• A method patent protects using and offering the method. Para. 10 PatG also protects against indirect
infringements of the patent. Such would be the case, for example, if - without infringing the rights under §
9 PatG - third parties are involved in an infringement that may not come about until some time in the future.
Patent protection lapses in respect of any subject matter of the patent as soon as it is marketed by the patent
holders or with their consent.
Patent holders can take legal action against any infringement of their patents. Patents run for up to 20 years
from the date of application.
DRZE/In Focus
Patent Act (PatG) (available only in German)
Bill on the improvement of the enforcement of the rights to intellectual property (2008)
Potato grade Amflora
Potato grade Amflora
"Amflora" (EH92-527-1) is the name used for a potato grade developed by the company BASF Plant Science,
whose starch production has been genetically modified in such a way that it is more suitable for particular
industrial purposes. In Europe, approximately half of the processed starch stems from potatoes. Starch is not
only used in the foods industry but is also a component of numerous products in the so-called non-food-sector.
Conventional potatoes contain two different grades of starch, amylopectin and amylomaize; the genetically
modified potato grade Amflora, however, develops only the amylopectin starch. While both ingredients are
important for human nutrition, for many technical applications, such as the paper-, yarn- and glue industry,
only amylopectin is needed.
According to its manufacturer, Amflora is a safe product, which offers a broad application spectrum and helps
to safe both energy and costs since an expensive separation of the starch blend can be avoided. Meanwhile,
critics point to the dangers which, according to their view, are connected with the cultivation of the genetically
modified potato grade. A gene was added to Amflora, which renders the organisms resistant against the
antibiotics kanamycin and neomycin. The critics fear an unforeseeable transmission of this gene to ground
bacteria and eventually an unintentional resistance against antibiotics in humans.
The genetically modified amylopectin-potato has been examined in outdoor tests with regards to crop,
resistance to rodents and diseases as well as harmful impacts on humans, animals and the environment. In
Germany, too, outdoor tests with Amflora have taken place in various locations. Since 1993 the genetically
modified potato has repeatedly been released for research purposes on small areas; larger cultivation tests took
place between 2006 and 2008. At the end of May 2007, the Federal Office of Consumer Protection and Food
Safety (BVL) authorized under strict conditions release tests with Amflora on an area of more than 155 hectares
for a period of two years. For the years 2009 and 2010, BASF applied for an approval of a new cultivation
trial on an area of approximately 35 hectares in Mecklenburg-Western Pomerania. The Federal Minister of
Food, Agriculture and Consumer Protection, Ilse Aigner, authorized this trial since this release apparently does
not pose a threat for human health or the environment. However, BASF has to ensure that the crop does not
enter into the food and animal feed cycle as well as into the environment. Furthermore, BASF has to fulfil
additional security measures for the cultivation trial of Amflora. These include, amongst others, the reduction of
the cultivation trial from originally 150 hectares to 20 hectares in one single location in Mecklenburg-Western
Pomerania as well as the erection of a guarded veterinary fence around the entire testing area. Since 2nd March
2010 Amflora is authorized in germany for the starch production as well as animal feeding stuff. The European
Food Safety Authority (EFSA) reconfirmed that Amflora is safe for humans, animals and the environment.
Amflora for food use by contrast is not authorized and this isn’t foreseen yet.
Aigner authorizes the release of Amflora Press release of the Federal Ministry of Food, Agriculture and
Consumer Protection (German only)
DRZE/In Focus
Statement by BASF regarding the topic "Amflora - Genehmigung Feldversuch in Bütow, MV, 2009" ("Amflora
- authorization of a field trial in Bütow, Mecklenburg-Western Pomerania, 2009") (German only)
In rejection to the continuing discussion about the resistance to antibiotics of Amflora the dutch concern
AVEBE developed another genetically modified potato grade (ID-number: AV43-6-G7) which is very high in
amylopectin as well, but shows no antibiotic resistance. An application for cultivation and use of this potato
grade has been submitted in April 2009 and is presently investigated by the EFSA.
Summary of application by AVEBE for amlyopectin potato.
In september 2010 BASF identified small quantities of Amadea potatoes in Amflora fields planted in Northern
Sweden during the course of the regular inhouse quality controls. Amadea is not authorized. BASF assert
that all Amadea plants have been removed during the growth period and did not enter the commercial starch
production. Critics however worry that BASF will use the comtamination in order to get the authorization of
Amadea.
BASF news release (06.09.2010).
Prohibition of cultivation of MON 810 in Germany
Prohibition of cultivation of MON 810 in Germany
In compliance with Article 23 of the Release Directive 2001/18/EC, the cultivation of MON 810 is allowed
to be provisionally restricted or prohibited in a Member State only if the "Member State, as a result of new or
additional information made available [...] has detailed grounds for considering that a GMO as or in a product
[...] constitutes a risk to human health or the environment."
According to the evaluation of the German Federal Minister of Agriculture, Ilse Aigner, such new scientific
information is present, meaning that a prohibition of cultivation of MON 810 is justified. A study conducted
by Thomas Bohn and colleagues arrives at the conclusion that water fleas, which ate flower processed from
MON 810, died earlier and had less offspring than water fleas, which were fed with conventional corn.
A second study, which was conducted by a group of researchers headed by Angelika Hilbeck at the Institute for
Integrative Biology of the Swiss Federal Institute of Technology Zurich, reports that the larvae of the ladybird
Adalia bipunctata had an increased death rate after they were fed with eggs which had been sprayed with the
butterfly poison that is also contained in the genetic corn MON 810.
Meanwhile, critics assume that, from a scientific perspective, these studies do not justify a prohibition.
According to the critics, the survey of the ladybird Adalia bipunctata, in particular, shows significant
methodological deficiencies and the conclusion that the cultivation of MON 810 could be harmful to ladybirds
is illegitimate. Since water fleas in their natural environment do not feed themselves with corn flower but algae,
the Norwegian study is in any case of no value, the critics conclude.
Aigner's decision is being discussed controversially. While environmental associations (BUND, Greenpeace,
Association ecological food industries (Bund ökologischer Lebensmittelwirtschaft)) request further
prohibitions, large scientific organisations (including the Alexander von Humboldt Foundation, the German
Research Foundation (DFG), the German Academic Exchange Service (DAAD), the Fraunhofer Association,
the Helmholtz Association, the Leibnitz Association and the Max-Planck-Association) published a joint
DRZE/In Focus
statement in which they resolutely object to an overall prohibition of genetically engineered products. They
call on politics to take care for an objectification of the debate and to establish a reliable framework for the
research and scientific monitoring of the future utilisation of green genetic engineering.
The US seed company Monsanto made a fast tracking motion against the prohibition of cultivation of MON
810 proclaimed by the German Federal Government. This motion was rejected by the administrative court
Braunschweig on 5th May 2009. The judges highlight in the reasons that after a preliminary examination a
danger is present as it is requested by the genetic diagnostics bill for a prohibition such as the present one.
According to the judges, no secure scientific insights from which dangers for the environment could be inferred
without any doubts have to be present. It would be sufficient if clues for possible dangers to humans or animals
could be derived from new or additional information. Despite the fact that there are currently no safeguarded
findings regarding a heightened threat to the environment posed by genetic corn, new surveys could point
towards the fact that the poison produced in genetic corn is effective not only against the rodent that is to be
fought with it; it might also be effective against other insects. Furthermore, the judges' statement says, up-todate studies suggest that the genetic corn pollen have a potential to spread significantly wider than is currently
assumed.
Directive 2001/18/EC
Prohibition of MON 810 in Germany
Bohn, T. / Primicerio, R. / Hessen, D. O. / Traavik, T. (2008): Reduced Fitness of Daphnia magna Fed a BtTransgenic Maize Variety. In: Archives of Environmental Contamination and Toxicology. 55(4), 584-592.
Schmidt, J.E. / Braun, C.U. / Whitehouse, L.P. / Hilbeck, A. (2009): Effects of activated Bt transgene products
(Cry1Ab, Cry3Bb) on immature stages of the ladybird Adalia bipunctata in laboratory ecotoxicity testing. In:
Archives of Environmental Contamination and Toxicology. 56(2):221-228.
Joint statement of the research organizations regarding green genetic engineering (German only)
also joint statement of the research organizations regarding green genetic engineering (German only)
Fast tracking of the seed company Monsanto against the prohibition of cultivation of MON 810: 2 B 111/09,
in the proceedings: 2 A 110/09
Researchers call for extended animal experiments
Researchers call for extended experiments on rats fed with genetically modified foods
In the summer months of 2010, researchers called for an extension of the tests conducted on rats fed with
genetically modified foods; up to now, these experiments are generally conducted for a period of 90 days.
Professor Gilles Eric Séralini from the University of Caen, France, explained that more thorough experiments
than those currently in use were necessary in order to exclude risks. He requested to have rats fed with
genetically modified plants for the animals' entire life-span, meaning over a period of approximately two years.
Only over such an extended period would it be possible to detect whether genetically modified corn, which,
for instance, prodices a poision against a specific vermin, also kills other living beings. Séralini also deems it
a problem that the experiments concerning genetically modified foods are being commissioned by the plant
producers themselves and that the raw data have so far been kept secret.
DRZE/In Focus
Criticism against the present testing methods was also leveled by agricultural biologist Angelika Hillbeck
from the Swiss Federal Institute of Technology (ETH) in Zurich. Hillbeck criticized the unrealistic conditions
under which numerous authorization tests are being carried out and cited the example of deficient experiments
concerning the effectiveness of the poison of a specific genetically modified plant on lacewing larva. According
to the biologist, researchers externally spray the eggs of the flour moth and feed them to the larva; the larva,
however, sting through the shell and suck the content. That way, they do not eat the poison. Despite this
deficiency in the testing method, the responsible authorities nonetheless accepted this experiment as a proof
that the poison is unharmful to the larva.
Tests von Gentech-Essen. Forscher fordern längere Tierversuche. Taz.de-Artikel vom 30. Juni 2010 (German
only)
Safety levels in genetic engineering
Safety levels in genetic engineering
Genetic engineering is divided into four safety levels. These are ordered according to the degree of their hazard
potential as established by way of risk assessment. Licensing procedures also distinguish between work carried
out for the first time and "continuing" work. At the moment of the deliberate release or the placing on the
market, there must be assurances that no unreasonable harmful effects on people and/or the environment can
be expected on the basis of current scientific knowledge. In case of work with commercial objectives carried
out at safety levels 2-4 as well as licensing procedures for deliberate release and marketing (except in the
circumstances laid down in § 18 para. 2), public hearings are also required.
Smart Breeding
Smart Breeding and cisgen
Biosafety-encyclopedia
Starter cultures
Starter cultures
The aim of genetic engineering here is to modify starter cultures (bacteria or yeast fungi) which are vital in
bread, beer, yoghurt, cheese and salami production, in such a way that they accelerate the production process,
while at the same time increasing the yield or intensifying taste. In 1995 and 1999 licences were issued in the
United Kingdom for brewer's and baker's yeast that were used on a temporary basis in pilot production. The
validity of the licences has now expired. No genetically modified microorganisms are currently authorised in
the EU, and no applications for licences are pending.
Study on genetically modified rape
DRZE/In Focus
Study on genetically modified rape
In their study, Swedish and Danish scientists came to the conclusion that the seeds of genetically modified rape
are able to sprout as long as 10 years after their initial sowing.
In 1995, the scientists planted genetically modified rape, which is resistant to the herbicide glufosinate due
to an inserted gene, on a trial field the size of 30 times 40 meters. They harvested the rape in the fall of the
same year. Subsequently, the field was sprayed with poison that was supposed to kill all plants. The field was
ploughed yearly, and wheat, barley and sugar beets were planted alternately. There was no further cultivation
of genetically modified plants in close proximity of the field.
In the spring of 2005, the scientists observed that offspring of the genetically modified rape had survived despite
the herbicide-spraying. Overall, 38 rape plants were found, planted in pots and examined. Over an interval
of three weeks, they were sprayed with glufosinate twice. 15 out of the 38 plants survived the glufosinatetreatment, meaning that they still carried the herbicide-resistance-gene. According to multiple critics of genetic
engineering this study shows that genetically modified plants cannot be stemmed efficiently. The danger of an
unintentional spread-out of genetically modified organisms must not be underestimated.
Study - D'Hertefeldt, Tina / Jørgensen, Rikke B. / Pettersson, Lars B. (2008): Long-term persistence of GM
oilseed rape in the seedbank. In: Biology Letters 4, 314-317.
The principle of human dignity
The principle of human dignity
The principle of human dignity as the agreed guiding principle in determining the duty to protect human life
is anchored in the German Basic Law as well as in other relevant codifications of human rights. This principle
formulates a direct and unconditional right to protection granted to humans first and foremost because of
their ability to set themselves "goals" and "purposes" and autonomously to determine their actions. Thus, this
right covers the ability itself and everything required to exercise it. The freedom to develop one's personality
autonomously is therefore included in this right as is the physical inviolability of human beings and the natural,
economic and social foundations of their existence.
Vertebrates
Vertebrates
To date few genetic engineering applications involving vertebrates or other types of animals have been used
in food production. The steady increase in salmon consumption, however, which is being met increasingly
through fish farming, has led to genetic engineering being used on salmon. A number of countries are currently
working on genetically modifying salmon with the aim of boosting growth and resistance and helping the
animals adjust to lower water temperatures.
One US company filed an application with the Food and Drug Administration (FDA) as long ago as
1999 to launch a fast-growing genetically modified salmon species on the market under the brand name
"AquAdvantage". A decision in this matter has still to be taken. Since 2004 aquarium owners in the USA have
DRZE/In Focus
been able to purchase genetically modified fluorescent zebra fish ("GloFish"). A similarly modified zebra fish
has been available on the Taiwanese market since 2003 under the name "night pearl".

Genetically Modified Foods

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