A critical and very controversial aspect of the antibiotic resistance issue is the utilization of antibiotic resistance genes as selection markers in genetically modified organisms (GMOs). Antibiotic resistance genes are used as selection marker during the initial production of GMOs, but afterwards they don't have any function in the GMO anymore. The main safety concern relates to the escape or transfer of the antibiotic resistance genes to sensitive bacterial strains when these GMOs are introduced into the environment.
In the EU, antibiotic resistance markers have been phased out for by the 31 December 2004 in the case of GMOs placed on the market according to part C. Antibiotic markers in field trials are still allowed until 31 December 2008 (2001/18, Article 4).
biotechnology
According to the Cartagena Protocol on Biosafety "modern biotechnology means the application of:
a) in vitro nucleic acid techniques
b) fusion of cells beyond the taxonomic family that overcomes natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection."
The terms biotechnology and genetic engineering are often used interchangeably (see below), even though the traditional definition of biotechnology only included technologies such as fermentation (used for example for baking bread or brewing beer).
Bacillus thuringiensis (Bt)
a soil bacterium that produces toxins against insects (mainly in the genera Lepidoptera, Diptera and Coleoptera). Bt preparations are used in organic farming as an insecticide, but such sprays show fundamental differences to GM Bt crops because they contain a higher number of different Bt toxin in an un-processed form and because they degrade fast due to UV light.
Bt plants however continuously produce one (or maybe two) toxins which increases the selection pressure for the development of resistances. In addition, Bt plants produce a modified form of the toxins that can have impacts on wider groups of insects or other organisms.
Bt crops
GM crops that are modified to produce one (or maybe two) Bt toxins as pesticide against specific pests. The toxin is produced continuously through the whole lifetime of the plant, but toxin levels vary between different parts of the plant and throughout the seasons.
Bt crops only contain toxins against one or maybe two groups of insects, but not against any other pests. They are not "insect resistant" or "pest resistant" even as those terms are often used for them. Farmers still need to deal with other pests.
Bt cotton
is genetically modified to control budworms, and bollworms.
Bt maize (corn)
a number of different GM maize varieties which are genetically modified to provide protection against the European corn borer (Ostrinia nubilalis, ECB) and Mediterranean Corn Borer (Sesamia nonagrioides) and/or against corn root worm (Diabrotica virgifera).
The Bt maize MON 810 has been approved for cultivation in the EU.
canola
is a type (cultivar) of rapeseed developed and grown in Canada. Canola is a registered trademark. Canola was developed through conventional breeding, but in recent years GM herbicide tolerant varieties have been developed.
regulates the international trade of GMOs with those countries that have ratified the CPB. Regulations about information and approval procedures should ensure especially for developing countries that GM crops are not imported and grown without the knowledge of the national authorities. Like in other national and international regulations on biotechnology, the Precautionary Principle is applied in the Protocol.
It is a supplementary agreement to the 1992 Convention on Biological Diversity that "seeks to protect biological diversity from the potential risks posed by living modified organisms resulting from modern biotechnology. It establishes an advance informed agreement (AIA) procedure for ensuring that countries are provided with the information necessary to make informed decisions before agreeing to the import of such organisms into their territory." 103 states have ratified the CPB which came into force in 2003. The US, Canada, Australia and a number of other countries have not signed or ratified the CPB.
http://biodiv.org/biosafety/articles.asp?lg=0&a=bsp-03
The CBD, negotiated under the auspices of the United Nations Environment Programme (UNEP), was opened for signature at the Earth Summit in Rio de Janeiro in June 1992, and entered into force on 29 December 1993. To date, 168 countries have ratified the Convention. The three objectives of the CBD are to promote "the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising out of the utilization of genetic resources."
The convention serves as a practical tool for the implementation of the Agenda 21.
General Confederation of Agricultural Co-operatives in the European Union. As an officially recognized representative body of all agricultural and fishery co-operatives in the EU, COGECA represents their general and specific interests vis-à-vis the Community authorities: European Commission, Council of Ministers, European Parliament, Economic and Social Committee, Committee of the Regions.
Committee of Agricultural Organisations. When the Committee of Agricultural Organisations first started out it was made up of 13 member organizations from the then six Member States. Today COPA is made up of 29 organizations from the 15 members of the European Union.
cross-species GMO detection (using PCR)
determines GMO content from one or more sources. It is useful for determining GMO content in multiple ingredient products, but will not identify the GM species or variety.
cumulative long-term effects
accumulated effects on human health and the environment, including inter alia flora and fauna, soil fertility, soil degradation of organic material, the feed/ food chain, biological diversity, animal health and resistance problems in relation to antibiotics.
delayed effects
effects on human health or the environment which may not be observed during the period of the release of the GMO, but become apparent as a direct or indirect effect either at a later stage or after termination of the release.
deliberate release
According to the EU directive 2001/18, a deliberate release is "any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with or to provide a high level of safety for the general population and the environment."
It should however be noted that GMOs are also released during field trials, but the idea is that during trials the contact to the environment is reduced.
The deliberate release regulation 2001/18 does not apply to the transport of GMOs.
DNA (Deoxyribo-Nucleic Acid)
the molecule that encodes genetic information in the cells that determines an organism's physical traits. DNA constitutes the building blocks from which genes are constructed. Every inherited characteristic has its origin somewhere in the code of the organism's complement of DNA.
ELISA (Enzyme Linked Immunosorbant Assay)
immunological method which can be used for the detection of (known) GMOs in foods and other products. While PCR (see below) detects the modified gene(s) in a GMO directly, the ELISA method uses antibodies to detect the protein(s) that are expressed by the modified gene(s). This method only works if the GMO in question is known and if a suitable antibody is available.
environmental risk assessment (e.r.a.)
In the context of 2001/18 an e.r.a. is "the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose." The e.r.a. has to be carried out in accordance with Annex II of EU directive 2001/18, but experience with the current notifications for GM crops show that there are different interpretations of what can be considered sufficient as an e.r.a.
gene
segment of DNA specifying a unit of genetic information; an ordered sequence of nucleotide base pairs that with which one or several proteins can be produced by the cell. Other DNA sequences only code for RNA which is not translated into a protein. At the moment there is no clear definition what a gene actually is (for example whether the additional DNA of the so-called intros in the 'gene DNA sequence that is not translated into protein actually belongs to a gene or not)The term "gene might "therefore be used different in different contexts.
gene flow
(also known as gene migration) is the natural transfer of genes from one population to another.
Gene flow into or out of a population may be responsible for a marked decrease or increase of the number of members of a population with a particular trait.
gene transfer
Genes can be transferred vertically from an parent to child, but also horizontally between organisms. Horizontal gene transfer is mainly known between bacteria but for example also possible between bacteria and plant or even between bacteria and animals. In genetic engineering, GM Agrobacterium tumefaciens is used to transfer genes into plant cells.
Horizontal gene transfer is discussed as a risk of GMOs when transgenes can be taken up by bacteria from food, or transferred from bacteria to other organisms.
genetic engineering
the selective, deliberate alteration of genes (genetic material) through the introduction of new, transgenic DNA or destruction of existing DNA. Some other words often applicable to the same process are gene splicing, gene manipulation, or recombinant DNA technology (techniques).
genetically modified foods and food ingredients
consist of or contain genetically modified organisms, or are produced from such organisms.
genetically modified higher plants (GMHP)
plants in which the genetic material has been modified in such a way that does not occur in Nature and/or is not a result of natural recombination.
This term is used to distinguish between GM plants and GM microorganisms for which different regulations apply.
genetically modified organism (GMO)
As defined in the EU regulation 2001/18, a GMO is "an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination."
genome
entire genetic material in an organism
germplasm
means the reproductive or vegetative propagating material of plants: all living tissue from which new plants can be grown. These are mainly seeds but can also include other plant part such as a leaves or a piece of stem Germplasm is more than only the genetic information, but the basic ‘material’ to grow the plant.
glyphosate
the chemical component of the heribicide Roundup by Monsanto. Glyphosate tolerant crops are mainly sold under the brand name "Roundup Ready" or "RR"
glufosinate
(or glufosinate ammonium) is the main chemical component of the heribicide Liberty or Basta, developed by Hoechst and now owned by Syngenta. Glufosiante tolerant crops are sold under the brand name "Liberty Link" or "LL".
herbicide-tolerant (HT) crops
Insertion of a herbicide tolerance gene enables farmers to spray wide-spectrum herbicides on their fields killing all the plants but the HT crop. The most common herbicide-tolerant crops (cotton, maize, soybeans, and rapeseed) are tolerant to glyphosate and/or to glufosinate-ammonium, active ingredients of common wide-spectrum herbicides. There are also HT rapeseed and cotton which are tolerant to bromoxynil.
A growing problem of HT crops are the development of herbicide resistant weeds, as well as volunteer crops from previous seasons which are tolerant to the same herbicide. Reports from Canada show that crosspolination lead to the unintended development of triple-herbicide tolerant rape seed populations.
identity preservation
a system of documentation by food manufacturers of the genetic purity of both GM and non-GM ingredients, accomplished by preserving the identity of a crop from seed to final product. Identity preservation enables the various players in a supply chain to document traceability, from the crops from which ingredients were manufactured to the final product.
International Federation of Organic Agriculture Movements' EU Regional Group is an independent regional group formally constituted in February 2000 following its first general assembly. IFOAM describes its mission as ‘leading, uniting and assisting the organic movement in its full diversity." Its goal is "the worldwide adoption of ecologically, socially and economically sound systems that are based on the principles of Organic Agriculture."
immediate effects
refers to effects on human health or the environment which are observed during the period of the release of the GMO. Immediate effects may be direct or indirect.
The International Seed Federation (ISF) is an international organisiation representing the seed industry. Its members are regional and national seed industry organizations as well as the big seed corporations such as Bayer or Monsanto.
International Seed Testing AAssociation was founded in 1924, with the aim to develop and publish standard procedures in the field of seed testing.
labeling
Under the EU regulation 1830/2003 all food and feed products containing GM ingredients have to be labelled with the words "This product contains genetically modified organisms".
However there are a few exemptions:
- Animal products (such as meat, eggs or milk products) from animals fed on GM feed do not have to be labelled.
- Contamination with GMOs does not have to be labelled if they are "traces of authorised GMOs in a proportion no higher than 0,9 % […], provided that these traces are adventitious or technically unavoidable." (1830/2003).
GM contamination still has to be labelled if it is higher then 0.9% or if it could have been avoided. This should not be confused with a labelling threshold that allows low levels of GMO in food and feed products.
Under the CPB, that regulates the transboundary movement of GMOs, labelling requirements are still discussed, often referred to as "Article 18".
living modified organism (LMO)
is defined in the Cartagena Protocol on Biosafety (CPB) as "Living modified organism" means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology". The CPB uses the term LMO to distinguish living GMOs from non-living GMOs or GM products such as flour from GM maize, because the scope of the CPB is the protection of biodiversity.
LMO-FFP’s are "living modified organisms intended for direct use as food or feed, or for processing" (CPB, Article 11) which means they are not intended for cultivation. However, in practice such definitions can become blurry when for example grains of maize can be classified as LMO-FFP but still can be planted as seed even if that was not intended by the importeur.
marker gene
gene used during genetic engineering that helps to identify cells that have succesfully received and incorporated into their genome new DNA. Genes usually include either a selection advantage, e.g., antibiotic or herbicidetolerance, or visualization advantage (a trait, when expressed, that is visible to the naked eye).
MON810
a Bt maize variety producing a Bt toxin to protect maize against European stem borer infestations. MON810 has been approved for cultivation in the EU under the old deliberate release directive, but it is not included in the seed lists of all EU countries.
In Germany, MON810 has been inlcuded in the seed list in Decembr 2005 and can therefore legally be cultivated in 2006.
novel food
"Novel food" as defined in the Novel Food Regulation 258/97 are all new food and food products. Originally this included GM foods, but since 2003 GM foods are approved under the regulation 1829/2003.
placing on the market
means "means making available to third parties, whether in return for payment or free of charge;" (2001/18). This does not include GMOs that are given to others for field trials.
plant breeding
use of techniques involving crossing plants to produce varieties with particular characteristics (traits) which are carried in the genes of the plants and passed on to future generations. Conventional/traditional plant breeding refers to techniques others than modern biotechnology, in particular cross-breeding, back-crossing.
plant protection products
is an euphemistic term for agrochemicals such as "insecticides, acaricides, fungicides, herbicides, plant growth regulators".
These chemicals do not protect plants in general, but only the crop for which they are used. Herbicides for example protect one crop but destroy other, unwanted crops such as weeds but also volunteer crop plants if they are growing somewhere at the wrong time and place.
Polymerase Chain Reaction (PCR)
is a molecular biology technique for emzymatically amplifying (creating multiple copies of) DNA without using a living organism, such as E. coli or yeast. The technique allows a small sample of DNA to be copied multiple times so it can be used for analysis, for example to detect contamination with (known) GMOs. Unknown transgenic DNA cannot be detected by PCR.
For details and a description of the procedure check Wikipedia
precautionary principle
is the idea that if the consequences of an action are unknown, but are judged to have some potential for major or irreversible negative consequences, then it is better to avoid that action.
The Rio Declaration on Environment and Development (Principle 15) proclaims "In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation."
The precautionary approach was reaffirmed in the Cartagena Protocol on Bisafety on 28 January 2000. Only 4 days later, on
2 February 2000 the EU Commission adopted the Communication on the use of the Precautionary Principle.
qualitative analysis
reports the presence or absence of GMO material, but will not quantify how much GMO material is present.
segregation
implies setting up and monitoring of separate production and marketing channels for GM and non-GM products.
single-species GMO detection
provides total GMO content of a single species and is most suitable for products such as grains, flours, soy isolates, etc., where there is a single source of GMO.
single-threshold analysis
reports GMO content above or below a single threshold, for example: "Greater than 1%" or "Less than 1%". The following threshold levels are available: 0.1 %, 0.5 %, 1%, 2%, 3%, or 5% GMO.
traceability
"Traceability’ means the ability to trace GMOs and products produced from GMOs at all stages of their placing on the market through the production and distribution chains" (1830/2003 Article 3). It demands a complete overview over the production and supply chain of the ingredients of a food or feed product.
Operators should keep adequate records of suppliers of raw materials and ingredients so that the source of the problem can be identified. Measures include also the obligation for feed and food businesses to ensure that adequate procedures are in place to withdraw feed and food from the market where a risk to consumer health is possible.
New specifications need to be developed with clearly defined expectations about purity and filling/transport. Control systems need to set up in such a way that they ensure conformenc of farmers, silo operators, processors and food producers.
transformation
process of introducing new genetic information into an organism.
Transformation is a key event in genetic engineering. During transformation foreign (transgenic) DNA is brought into the host organism (for example a plant cell). This DNA has been isolated from one or several donor organism (bacteria, other plants etc.) or produced artificially. A successful transformation leads to a genetically modified cell, also called a transformation event.
For the transformation of plant cells, different technologies can be used; all of which carry their own risks for unintended effects in the GMO.
transgenic
organism that contains genetic materials introduced through recombinant DNA techniques. Usually implies that organism contains DNA from another organism.
The foreign DNA incorporated in a host organism is also described as "transgenic DNA".
transgenic plants
result from the insertion of genetic material from another organism so that the plant will exhibit a desired trait. The term is used synomous for GMO or GM plant.
International Union for the Protection of New Varieties of Plants. An intergovernmental organization with headquarters in Geneva (Switzerland) established by the International Convention for the Protection of New Varieties of Plants. The Convention was adopted in Paris in 1961 and it was revised in 1972, 1978 and 1991. The objective of the Convention is the protection of new varieties of plants by an intellectual property right.
variety-specific GMO detection
identifies individual GMO varieties such as StarLink corn. The Varietal ID tests are precise, definitive, and cost-effective and are designed to specifically detect and quantify GMO varieties that are not approved in a particular country or region.
Regulation
is binding in all its parts and applies in all member states immediately after publication. Quite often a regulation deals with explicit definitions of technical norms, for example the percentage above which GM contamination has to be labelled.
In the name of a regulation the number is given first, and then the year. For directives, it's the other way round.
Directive
In contrast to a regulation, a directive only obliges the member states only concerning the goal which they have to implement in a given period of time. An example is the deliberate release directive. How the national law is implemented in detail, lies in the responsibility of the indiviual member state. Thereby directives are vulnerable for erosion on the national level.
However, a state that doesn't implement a directive properly can be sued at the European Court of Justice. In addition, if a state does not implement a directive in time, she can be hold accountable for damages to companies and individuals.
Regulates the deliberate release of GMOs into the environment, in other words the introduction of GMOs into the environment for experimental purposes (e.g. for field testing), as well as the placing on the market of GMOs (products containing or consisting of GMOs), e.g. for cultivation, import or processing into industrial products. The deliberate release directive 2001/18 however does not apply to the transport of GMOs.
It replaced the older directive 90/220.
Regulation on genetically modified food and feed governing the placing on the market of GMOs intended for food or feed and of food or feed products containing, consisting of or produced from GMOs. This regulation can also include giving approval for cultivation of a GMO. In contrast to applications under 2001/18, an application under 1829/2003 is handed in with EFSA and not with a national competent authority.
Concerns the traceability and labelling of genetically modified organisms and the traceability of feed and feed products produced from genetically modified organisms.
Regulates transboundary movements of genetically modified organisms, including unintentional movements of GMOs between Member States and exports of GMOs to third countries.
To avoid contamination of conventional crops by GM crops, the EU Commission has developed guidelines for the development of national strategies and best practices to ensure the co-existence of genetically modified crops with conventional and organic farming. The EU Commission allows all member states the possibility to take measures against the adventious occurrence of GMOs in conventional products. However, the main responsibility to avoid such contamination lies with the companies.
