Subsections

• • • • GMO, Genetic Modified Organism, definition
      • Technology of genetic modification
      • Ti-plasmides
      • Selection systems
      • GMO tomatoes approved by EU Commission
      • Ingredients
      • Switzerland
      • Lecithin
      • The slow death of Soy bean
      • Soybean as protein supply for animal feed
      • Identity preserved (IP) non-GM soy bean lecithin and maize
    • Low-linolenic soyseeds
      • Detection of GMO in food
      • Competitive PCR
      • RT-PCR Real-time PCR
      • Western Blot
      • ELISA (Enzyme Linked Immuno-Sorbent Assay
      • Round Up Ready Soybean,Monsanto Co
      • Risks of genetic engineering
      • Allergy and soybean
      • Size of the molecule
      • Digestion
      • Bounding to long chained sugars
      • Degree of strangeness
      • Amount of Allergen in the final food
      • GMO soybean oil and allergenity
      • French position to GMO
      • Recall of GMO maize seeds in France
      • PTI: More unmodified Soya proteins
      • US exporters want to supply demands of GMO-free Soybeans and cereals
      • Unilever UK :Renunciation to genetic modified ingredients
      • Terminator-Gen
    • Hybrid rice
    • Genetically modified rice in Japan [549]
      • The Bayer long grain LL Rice 601 review of incidence handling
    • Liberty herbicide and NAG (N-acetyl-L-glufosinate)
      • Sequencing rice:
    • Transporter IRTI for assimilation of iron [431] [432]
      • Genetic modified potatoes
      • French retailer against genetic modified food
      • GMO-labeling in USA
      • France will impose a GM ban if serious safety doubts are presented
      • The position of the Association Generale de Producteurs de Mais
      • Herbicides at the base of imidazolinon
      • Celiac disease
    • Cultivation of genetic modified seeds in Brazil
      • GMO and worldwide famine, an interview with Ian Wilmut
    • Cloning of animals for better foods [503]
      • Opinion of the EFSA on cloned foods
      • Coldiretti Italian farmers' group:
      • FDA wants to introduce cloned foods:
      • The Mikulski and Specter amendment
      • Cloned meat and milk already entered US food chain
      • USDA encourages a voluntary moratorium
      • Cloning ethically not justified
      • Cloning of animals for food should be prohibited says MEPs.
      • Patents on GMO-plants
      • GMO rapeseed in Europe
      • GMO Sugar beets in Germany
      • Recall of Aventis GMO maize ``StarLink''
      • Monarch butterfly and the Bt maize
      • EFSA reaffirms its risk assessment of genetically modified maize MON 863
      • Nitrogen-fixing bacterium's genome
    • Australian GM field peas
    • Lycopene from Fusarium sporotrichoides:
    • GM Maize
      • BASF GM potatoes release between 2007 and 2011 in Germany
      • Measures to avoid spread out of the GM potato imposed by BVL:
      • BASF GE potato field trial considered as illegal in The Netherlands
    • Unwanted gene flow from canola
    • EU concept of coexistence
    • USDA field test permission for genetically engineered crop [1959]
    • Recommendations from the Canadia Canola Council Canola to farmers
    • Genetic regulations in the EU
      • Glyphosate-tolerant genetically modified maize GA21 from Syngenta
      • Insect-resistant GMO Maize 59122 approved in EU
    • GM corn in Europe
      • Herculex
      • Full package of GM technology:
      • Herculex RW Rootworm Protection:
      • Herculex XTRA:
      • A perfect family of seed, pesticides and herbicides:
      • Bayer CropScience
    • Genetic risk of type 2 diabetes mellitus [1923]
    • Antibiotic resistance marker genes nptII in GM plants poses no risk to human, animal or environment [1924]
      • Rice genetically modified with high flavonoid content. [1926]
    • Pharmaceutical rice [1934] [1935] [1936]
      • Ventria [1937]
      • Ventria and its GM rice [1934]
      • Japans concern about the US pharma rice
      • The argument supporting pharmaceutical rice
      • Reduction of Pressure on Palmoil production [1940]
    • Colony Collapse Disorder (CCD) [1941]
    • Transgenes in Mexican maize at the preliminary stage of climate change [1945]
      • New-Zealand GM cow produces skimmed milk
      • Detection of L and D amino acids to study modified composition of new GM plants.
      • EU rises the threshold of "GM Free" labelling
      • EU Council of Ministers postpones its decision on approval of GM Amflora potato from BASF:
      • BASF increases GM expansion in Asia
      • GM maize Herculex RW import approval on the EU agenda:
      • New germplasm lines for breeding sunflowers
      • Genetic modified carrots could enhanced calcium intake

Genetic modification of food

GMO, Genetic Modified Organism, definition

Genetic Modified Organisms according to the Gentechnikgesetz (GenTG)from 20.06.90 (Genetic Technique Law) in Germany are organisms whose genetic material were modified in a way which is not found in nature under natural conditions of crossbreed or natural recombination. The genetic Modified Organism must be a biological unit which is able to multiply itself or to transmit genetic material.
Examples of modifications covered by this law are DNS recombination techniques in which vector systems are used; techniques by which genetic material prepared outside of the cell is introduced directly in the organism. These techniques include microinjection, macroinjection and micro encapsulation, cell fusion as well as hybridization procedures by which living cells are formed with a new combination of genetic material using methods which are not found under natural conditions.

Technology of genetic modification

There are two methods used to introduces a new DNA (gene) in the cell of a plant which is going to be modified:
The "shot-gun" technique:
This technique is also called biolistic transformation which was developed by Sanford in 1987.
Cereals are not suitable to be modified by transfection with Agrobacterium tumefaciens and the regeneration of plants whose cells walls were enzymatic digested is very difficult. A device was built to shoot small particles of gold or tungsten against cells. These particles can be coated with DNA material and are so small that they can penetrate cells without lasting damage.
The machine used gun powder and later compressed helium. The particles are accelerated four times sound velocity.
This method is less labor intensive as the Agrobacterium method. The ADN which is being introduced in the host cell is not so complicated as with Agrobacterium and there is also possible to introduce more then 10 different genes at a time. Biolistic transformation can be used to transform all kind of plants, bacteria, moulds, algae and animals.

The transfection with Agrobacterium tumefaciens:[864] This bacterium infects the plant and transfers its DNA to the plant. Agrobacter tumefaciens is a bacterium found in soil. Some strains attack plants transferring a small part or its genetic material to the plant causing tumors.
In the tissue of the tumors Agrobacterium tumefaciens can live and produces there new nutrients (opines).
Opines are products of the condensation of an amino acid and a ketonic acid or an amino acid and a sugars.Examples of opalines are: nopalin(arginine + a-ketoglutaraldehyde ) and octopinOctopin(arginine + sugar piruvate)
Some strains of Agrobacterium tumefaciens have aside of its own ADN genome other plasmides of the size between 200 and 800 kBp (kilobasepairs). These plasmids are responsible for the tumor activity and are therefore called ``Tumor inducing Plasmids'' (Ti-plasmids).

Ti-plasmides

They carry genes for:

• Metabolism of opines
  
• Recognition of wounded cells
  
• Mobilization and transfer of T-DNA

The T-DNA is the part of the Ti-plasmids which is transferred to the plant ( Transfer-DNA ) and is limited by the 25Bp repetition as Left Border (LB) 0n the left side and the 25Bp repetition as Right Border (RB) on the right side which are the recognition sequence for the T-DNA.
The transfer of the T-DNA takes place only to wounded plant cells. Certain compounds such as Acetosyringon which are released by wounded cells of the plant act as a recognition for the Agrobacterium tumefaciens in order to link to wounded cells. These compounds are found mainly in dicotyledoneans and only few monocotyledoneans such as asparagus. That is why Agrobacterium can be used only in few cases of genetic modification of monocotyledoneans. With addition off syringon even moulds and important monocotyledoneans can be modified by Agrobacterium tumefaciens.
Special techniques made possible to modify the Ti-plasmids and the T-DNA to avoid the production of phytohormones responsible for the tumor activity, the opine synthesis gene were cut out and gene of the resistance to antibiotic Neomycin and Kanamycin was introduced. The binary vector system uses a big plasmid with the vir-region and a small plasmid with the LB and RB.of an Escherichia coli plasmid.
Protoplasts transformation:
Protoplasts are called cells without cell walls.
This method uses pectinase and cellulase enzymes to digest the cell walls of plant tissue.
The vectors used are similar to the method of the shot-gun. The transfer of the DNA to the host is done with the aid of polyethylene glycol or short electrical shocks. This is called electroporation. Selection of the transformed protoplasts an regeneration of the cells is very difficult with this method.
To avoid possible resistance of bacteria to these antibiotics it has been tried to substitute the resistance gene with a gene responsible to the production of isopentenyl transferase which induces a new side shoot of the plant indicating the transformation.

Selection systems

Selection of the transformed cells is being done with antibiotics Kanamycin or gentamycin and neomycin . These antibiotics act toxic on cells without transformation.
The DNA material which is being introduced in a plant must contain four parts:

• The gene coding for the new property: For instance be a resistance to dry or excessive wet weather or a resistance to a new chemical agent such as a synthetic herbicide.
• A promoter signal: It is a start signal for the cell to start the activity of the gene such as the production of a specific protein. Most of the promoters which are being used were derived from the Cauliflower Mosaic Virus ( CaMv) called 35S promoter.
• A terminator signal: It is a signal for the cell to stop at this point the information concerning the alien gene. Most of the terminator signals used are derived from Agrobacterium tumefaciens a soil bacterium. It is the nopaline synthase gene (NOS) of Agrobacterium, called terminator NOS or NOS 3.
• A marker gene: Often is a resistance to antibiotics gene used in order to select transformed cells.

A US definition of GMO: "The term "Genetically Modified Organisms" refers to plants and animals containing genes transferred from other species to produce certain characteristics, such as resistance to certain pests and herbicides." In the European community Genetic Modified Organism and its release to the environment are covered by following rules:
1.- Rule 90/220/EWG from 23.04.1990 concerning the release of Genetic Modified Organism in the environment.
2.- Rule 90/219/EWG from 23.04.1990, modified by the Rule 94/51/EWG concerning the use of GMO in closed systems. 3.- Novel Food Decree concerning foods and ingredients which have not yet been used for human nutrition in a worth mentioning extent before. This includes foods covered by the Rule 90/220/EWG; foods initial prepared by means of Genetic Modified Organism but not containing the initial GMO any more such as sugar obtained from genetic modified sugar beet, foods with modified primer molecular structure, foods which had been prepared with or from microorganism, mushrooms or seaweed, foods which had been prepared with unusual techniques which modify significantly the structure of the food.
The content of the German GenTG is similar to the content of the European Rule 90/220 EWG and Rule 90/219/EWG.
The genetic modification of food has the prime score to produce food with:

longer shelf life,

better properties,

using less insecticides in agriculture.

This is true in case of soybeans but Roundup Ready soybean can be efficiently cultivated only with the insecticide of Monsanto. The worldwide insecticides used for soybean will be monopolized therefore by Monsanto

Efforts are being made to breed cereals with better proteins, rape seed with fatty acids better suitable in case of certain diets, other plants missing proteins causing allergies and lactic acid bacteria resistant to virus in the production of milk and meat products thus turning the process of production and the product itself safer.

Please note that the tomatoes on market in Germany are not the same in taste and structure as they had been for years ago, but they have a longer shelf life as before. This however is not due to genetic modification. It is a result of natural crossing of different types of tomatoes.

One should however consider the loss of quality of fresh tomatoes sacrificed on the effort to commercialize the tomatoes and to insure a long transport and a long shelf life.

Unlike to the experiments of Gregor Johann Mendel( 1822/1884 The monk of the Augustiner Abbey who discovered the Mendelschen rules of heredity) modern genetic modification of food introduces alien genes from one species to another completely different one, such as one or more gens of bacteria to the chromosomes of plants. The modern genetic technology interferes deeply with the natural structure of nature.
Crossing plants do not introduce special parts of DNA like terminator gens, marker genes as done by extreme genetic modification techniques.

GMO tomatoes approved by EU Commission

One sort of genetic modified tomato has been approved by the Food Commission of the EU. AstraZenca plc, London has applied for this sort of tomato which has better properties for processing. It is harmless after cooking which denature its proteins and gens. It is therefore not suitable to be sold to consumers which eat the tomato without cooking.
Labeling of genetic modified food in Europe
The labeling of genetic modified food will be made according to European law EG paper 90/220/EWG. It will be made only in food having the following modifications(EG Paper Nr. 1139/98 and 79/112 EWG)
1.-Food containing alien gens, proteins or DNA .
2.-Food on which the new gens were removed by processing technologies or refining but are changed in some parts so that they cannot be compared with food of nature. An example is GMO rape seed oil with modified fatty acid composition.
Suggested labeling:"Produced with genetic modified corn." In the list, of the ingredients it can be cited "genetic modified" when Soya or rape seed oil is being used.
Food having no alien genes left are not labeled as GMO food ( Genetic Modified Food ). Soybean oil is not labeled as GMO food because refinement removes all modified genes.

Ingredients

Ingredients are also declaration free no matter how manychanges they have undergone (for instance: soybean lecithin is being used as emulsifier in margarine, chocolate and other products )
GMO chymosin, an enzyme used in the production of cheese needs no declaration.
Enzymes are produced by bacteria whose genetic code had been modified,
These enzymes have great utility in the production of monosaccharides such as glucose syrup starting from corn.
No declaration is necessary because no genes or modifications of the resulting product can be demonstrated.One reason to lower the declaration is that meanwhile 90 % of our food would be involved because they had in some way contact with genetic modification.
In October 1999 The Ministers of the EG States agreed with a papers establishing that up to 1% content of Genetic Modified Food are free of declaration.
Refining soybean oil and processing maize and maize starch in Cornflakes for instance high temperatures are needed modifying or destroying the DNA. The GMO-origin cannot be demonstrated with usual methods. These products, even 100% GMO is free of declaration.That is why great retailers gave a ban on Soybean oil because there is no way to be sure to be GMO-free. GMO corn is being introduced in Europe. The resulting corn oil, corn starch, animal feed for cattle in great amount used as silage is free of declaration.
Unilever has announced to label gen modification on food containing GMO soy and corn.
This would include however only food with genetic modified proteins, products with soybean oil are not included.
Compensation in case of GM contamination of organic crops: Denmark is to pay compensation in cases where conventional or organic production has suffered economic losses following genetically modified (GM) material contamination.

The EC ruled that GM contamination could cause economic losses to conventional foods if they have to then be labelled as containing GM material, thus attracting a lower price. Such a scenario could be especially damaging to the fast-growing organic food sector.

EC says that under the current Danish proposals, compensation will be granted only if the presence of GM material exceeds 0.9 per cent and is limited to the price difference between the market price of a crop that has to be labelled as containing GM material and a crop for which no such labelling is required. The Danish authorities will in all cases take action to recover the compensation paid from the farmer from whose fields the GM material has spread.

Switzerland

Switzerland has published a food regulation concerning GMO dated on 1.3.1995 which is mainly identical to the European regulation also here no declaration of Genetic Modified Food is necessary when tho GMO used in the production of the food and the modified genetic material has been discarded.
Meanwhile Unilever UK, Nestlé UK and Nestlé Italy announces that they are going to produce GMO free.
ADM ( Archer Daniels Midland Co), one of the greatest buyer of Soybeans and corn announces to be able to supply Europe with GMO free raw materials. ADM maintains contact with the America n company DuPontwhich makes contracts with farmers concerning GMO crops. It is obvious that the increased efforts to provide GMO free raw materials do have their influence on the price.
The competition between centers of business such as the Far East competing with dumping prices with the European market and even the competition between European countries itself could only be controlled by suppressing the transport facilities increasing worldwide the price of fuel making global marketing so expressive that local ecological isolated markets would be able to survive.
A short way between producer and consumer needs a normal shelf life making unnecessary special efforts to increase it. The great supermarkets however need special packing and other special effects.
As it is impossible to turn back these commercial organizations there is no way out of this dilemma.
Be informed what is going on. This is the only way to protect yourself.Look what is happening in the BSE story, the modification of food, the growing importance of contaminants, such as a possible comeback of DDT the powerful insecticide which deposits in food. Remember however that you are guilty of all this mishaps.
It is the constant desire of consumption that speeds up the possibilities of marketing.
You alone can turn back time by living a life concentrated on true values. Try to find pleasure on the simple things of life.Do not be a slave of savor.
Genetic technique Are the techniques to promote the transmission of hereditary material between living organism.
Organisms bearing alien genes are called transgene organism (transgene animals,transgene plants or transgene microorganism].There are food and their additives which bear alien genes, other even being genetic modified have lost their alien genes during the manufacturing or refining. The later once are similar to natural products and are therefore free of declaration.
Genetic technique is a very young science:
In 1973 genes where transferred for the first time from one bacterium to another and later on, in 1977 the soil bacterium Agrobacterium tumefaciens was used to transfer alien genes into the cell of plants, or the Bacillus thuringiensis (Bt) has introduced proteins in Novartis Bt 176 maize (bt-Maize) The antisense technique indexAntisense technique was developed in 1990. It suppresses some genes, This was used modifying tomato Flavr and Savr The gene producing ripening enzymes is suppressed and the tomato has a long shelve live
Farming in great scale in USA starts in 1996 with soy, maize, rape seed and cotton.
The European Union allows farming of BT- maize from Ciba Geigy/Novartis/Sygenta.on 1997.

Product	producer	modification or function Germany
Novamyl	Novo Nordisk ( DK)	makes flovera better
Europe Rapeseed	PGS ( B )	sterility/herbicide resistant
Tobacco	Selta/Gauloise (F)	herbicide resistant
Salad	Monsanto (USA)	herbicide resistant
Corn	Monsanto (USA)	herbicide resistant
Great Britain
Tomato	Calgene (USA)	retarded ripening
Chymosin	Gist Brocades (NL)	enzyme for cheese production
Tomato pulp	Zeneka (USA)	retarded ripening
soybean oil	Monsanto (USA)	herbicide resistant
Backery yeast	Gistbrocades (NL)	increased speed of fermentation
Netherlands
Xylanase	Primalcol (SF)	better cereal products
Xylanase	Quest(Unilever,NL)	better cereal products
Novamyl	Novo Nordisk (DK)	better cereal products
Amylopectin	starch..Ayebe (F)	additive
Rapeseed oil	PGS (B)	herbicide resistant
Lipase	Unilever (NL)	production of certain fatty acids
USA
Tomato	Calgene (USA)	retarded ripening
Tomato	Monsanto (USA)	retarded ripening
Tomato	Zeneka (USA)	retarded ripening
Tomato	NDAPP (USA)	retarded ripening
Cotton	Monsanto (USA)	resistance to insects
Soybean	Monsanto (USA)	herbicide resistant
Potatoes	Monsanto (USA)	resistance to insects

Lecithin

Lecithin is a natural emulsifier which is present in Egg yolk and in soy beans.
The world production of lecithin from soy beans is around 180.000 mt.For the production of chocolate 25% were used.The rest was used for margarine, all kind of food and last but not least for drugs and tonics.
USA produces about half of the world supply of lecithin.

Producer	Percent of world supply	GMO
USA	50 Percent	GMO positive
Europe
from soy beans of USA	17 Percent	GMO positive
from soy beans of South America	8 Percent	unknown origin
South America
Argentina	2 Percent	GMO positive
Brazil	8 Percent	only small parts are GMO free
Asia	5 Percent	For home consumption, No export

The slow death of Soy bean

In Germany soy oil is not used any more in the production of human food.Only lecithin is still present in margarine as there is no substitute for it in frying margarine.
Great efforts are being made in research to develop mono- and diglycerides compounds with equal frying anti spatter properties. The efforts to get free of soy results from retailer specifications demanding GMO - free , organic food in order to respond to the desire of the customer which is greatly concerned with the natural origin of food.
The latest great fears of BSE, Dioxins in Food and Genetic modified food created a loss of confidence on the public food control departments.

BSE or dioxins did not modify the genetic code of cattle or hens. The harm caused to the involved species by these problems are turned back as soon as the cause or the epidemie is overcome.
Unfortunately this is not the same in case of Genetic Modified Organisms such as Soy beans.
The change of the genetic code of the plant spreads out through the species.
In few years there will be no natural seed any more present a turn back will be impossible. All benefits of Soy bean such as oil, lecithin,vegetable proteins. soy milk, tofu and a variety of ingredients and foods made from soy bean get lost once for ever in their originality. The aversion to GMO soy bean is strongly present in Germany, UK, France, Australia and many other countries , sometimes hidden by other concerns. Slowly the use of soy bean is dying.
Monsanto is responsible for a loss of confidence in one of the most important agricultural export article of US. It is of main concern of public life to demand that 1.- Soybean planting, transportation, storage, shipping and processing is handled separately from GMO-free Soy bean to restore confidence on the origin of food.
2.- Make a collection of samples of seeds of Soy bean GMO - free in order to guarantee access of future generation to the original seeds. These measures are of urgent importance as the spread of the GMO seed is being forced all over the world by just one profit minded organization damaging the image and the security of an important part of US resources.
These measures should also be extended to corn as seeds from Ciba (Bt-corn, bT= bacillus thuringensis)[582], later overtaken by Novartis are deeply modified in their genetic codes.

Soybean as protein supply for animal feed

[865] Soybean meal which is left from the production of oil is by far the most important ingredient for animal feed. In 1999 the European Union used as animal feed:Million
Soybean meal 26,5 million tons
Sunflower meal 9,1 million tons
Rapeseed meal 5,6 million tons
Pea meal 5,4 million tons
Animal meal 2,4 million tons
Fish meal 0,9 million tons

Animal meal can therefore be substituted by soybean or sunflower. Safety could be increased. The costs of the ban of animal meal as animal feed is insignificant comparing with tho costs to win the battle against BSE.
Soybean meal is not possible to be substituted by other plants. It is therefore important to protect soy plant from genetic modification which might later on turn out to toxic for the plant.

Identity preserved (IP) non-GM soy bean lecithin and maize

The desire across Europe to avoid genetically modified Foods has lead to an increase of demand for organic and GM-free foods.Austria is the most developed market in Europe. 8.6% of its total farmland is dedicated to organic farming.
Germany and France is expected to develop the greatest market for organic and non-GM foods.
The growing demand of non-GM ingredients for industry creates the need for a certified supply of raw materials. Some bodies which certify organic food chains are Skal Skalin the Netherlands, Naturland in Germany Ecocert in France.
Non-Gm soy bean lecithin is now available with Identity Preserved (IP) non-GM certification coming from the state of Parana,south of Brazil. Non-GM colours such as beta carotene, curcumin, lutein, beetroot and caramelised sugar are available.
Efforts are being made to create xanthan gum derived from GM-free crops of sugar to replace maize derivates because of doubts about the non-Gm status.
Sources of Non-GM, organic, Halal and Kosher status of food ingredients are listed in the Ingrid Database from Fi Data Services, Milton Keynes, UK.
Some of the improvements of food for the future:

Gluten free cereals: Gen engineering may produce wheat free of gluten. This aminoacid is not tolerated by sprue patients ( a kind of severe allergy ).

Rice with high level of vitamin A:In Asia there are regions with undersupply of vitamin A. New seed of GMO rice is rich on provitamin A helping to overcome the deficit.

Transgenetic oil of rape seed: The GMO oil of rape seed has a modified composition of fatty acids being more valuable then normal oil.

Chymosin: Is an enzyme obtained from the stomach of calf. It is used in the production of cheese.Because of the prevention of cruelty to animals and because of hygienic aspects many people prefer cheese made with chymosin produced by transgenetic bacteria.

Production of chymosin [37]
The active ingredient of rennet is the enzyme, chymosin (also known as rennin). Rennet from calves are produced from the content newly born calfs abomasum, which is the fourth and final stomach in ruminants which secretes rennet. Calves should be younger than 4 month.

To overcome a shortage of rennet from calves six major alternatives of protease enzymes are on market:

Non-GMO non-calf rennets

1. Rennet from veal calves
2. Rennet from adult cows
3. rennet from pigs
4. Protease from Mucor miehei
5. Protease from Endothia parasitica
6. Protease from Rhizomucor pusillus
7. Protease from Endothia parasitica
8. Protease from Mucor pusillus

GMO non-calf chymosins

1. Chymosins from GMO Escherichia coli
2. Chymosins from GMO Kluyveromyces lactis
3. Chymosins from GMO Aspergillus niger)
4. Saccharomyces cerevisiae.

Other proteases had been proposed as chymosin alternative but not in use,are won from plants:
Cynara candulus, Galium verum, Wrigthia, calycina, Irpex lacteus, Fusarium moniliforme, Sunflower kernel, Calotropis procera.

Advantage of GMO chymosin
Chymosin is now being produced mainly by genetic engineered Saccharomyces cerevisiae. This technology provides chymosine which is identical to the natural chymosin from calf rennet and is being used with few exceptions in the production of all hard cheeses. It is of superior quality, because it has less impurities found in natural non-calf chymosins.

Vegetarians and some religious groups agree to this solution because it avoids killing of calves. [38]

The cheese produced with chymosin from GMO Saccharomyces cerevisiae is considered as GMO-free because the genetic engineered cells of Saccharomyces cerevisiae are not present after the purification of chymosin and the enzyme breakes down during maturation of the cheese. It is therefore not being labelled.
Genetic engineering of yeasts for the production of Chymosin[38]
The DNA encoding the protein chymosin is isolated from calf cells. A copy of this DNA is inserted into plasmids which are then introduced into yeast cells. The genetic modified yeast cells , cultivated in a fermenter vessel, produce chymosin a purer for as found in calw rennet.

Microorganisms which are used in this technology are the yeast Kluyveromyces lactis, the fungus Aspergillus niger var awamori, and a strain of the bacteria Escherichia coli.

Yield in clotting and sensorial changes in ripe cheese using different coagulats[39]
Some reports stressed that there is a higher proteolysis level for microbial coagulants, and with pH decrease, which may lead to a lower yield in clotting and to sensorial changes in ripe cheeses, compared with calf and genetic rennet.

Vasconcelos and colleagues, following these reports, evaluated the influence of pH on yield of milk coagulation with three kinds of coagulants (calf rennet, genetic and microbial coagulant). The analyzed parameters for curd and whey did not differ for the the three coagulants, regardless of milk pH.

Phytase: Is an enzyme used in vegetable food for poultry and pig diets. It liberates the phosphor which is bounded as indigestible phytate. Using phytase the amount of mineral phosphor being added to the food may be reduced and consequently the amount of phosphor which is deposited on the fields.
This turns out to be positive for environment reducing overfertilizing with phosphor. Phytase is produced by GMO bacteria and represents the good side o genetic modification of food.
Other compounds which are produced using genetic modified technologies are: Erythropoietin used in the drug Recormon to treat anemias.
rPA ( recombining plasminogenic activator) used in the drug Rapilysin to treatsever cardiac-infarct.
Monocloned antibodies are also transgenetic biochemical compounds with great chances in future
Other positive genetical products may come soon:
Genetic modified organism like Bacillus subtilis producing enzymes which hydrolyses starch in the production of glucose which is the basis of the production of citric acid and other products.
GMO microorganism will soon produce vitamins such as B1 and B2 as well as aromas and aminoacids such as flavor enhancer and aspartame.
Allergies: It is to believe that the number of allergies is not increasing with the genetic technologies.
The real cause of an increasing risk of allergies is due to a contact to local unknown proteins resulting from globalization of the food marketing by exotic food being imported from everywhere. A recent example is the kiwi allergy and other causes such as environment.

GMO soybean: On the fields of America and Brazil the main producer of soy oil is the seed of " Roundup Ready soybean"being developed by Monsanto.
This seed is tolerant to the herbicide " Roundup ", also manufactured by Monsanto.

The GMO soybean is authorized to be sold in Europe to be used as food for animals and the oil for human food.

In Germany, due to the activity of Green Peace soybean oil is not being used for food.

Low-linolenic soyseeds

Dr Kristin Bilyeu of the USDA's Agricultural Research Service (ARS) has identified the genes in soybeans responsible for the low-linolenic acid trait. Linolenic acid reduces the shelf life and stability of products made from soyoil making it necessary to partially hydrogenate it which leads to the formation of trans-fatty acids. Reducing the amount of linolenic acid in soybeans is a desired breeding objective so that oxidation stable soybean oil can be produced without the production of trans fatty acids. The objective of this work was to determine the molecular genetic basis for soybeans containing 1% linolenic acid in the seed oil fraction and to develop molecular markers specific for identified alleles. Novel combinations of mutant alleles at the three GmFAD3 loci allowed the development of new germplasm containing 1% linolenic acid in the seed oil along with SNP-based molecular markers that can be used in a backcross breeding strategy. Kristin Bilyeu characterized the genes responsible for the linolenic acid formation in the plant, submitting her markers- or identification method- to GenBank, a database of the National Center for Biotechnology Information.

Other low-linolenic soyseeds, the Vistive beans, have been developed by Monsanto.

GMO corn: The GMO corn (called B.t.corn) developed by Ciba-Geigy was authorized to be sold in Europe on the 4.2.1997. The modified corn bears the following gens :
1.- A gene for the production of a B.t.-toxin which protects the plant against a specific insect.
2.- A gene called pat'-gene for the tolerance to the herbicide "Basta " containing Phophosphinotricin. This gene was introduced only to select th plant with the B.t-toxin gene.
3.- A gen called amp'-gene which was introduced in the plant together with the B.t.-toxin gene. It is the ampicillin resistance gene.
The amp' gene produces TEM-1 beta-lactamase which is the most common beta-lactamase found and is responsible for the resistance to ampicillin from 50% of all Escherichia isolated today, from, which 90% are being caused by the RTEM1 type.
The gene is plasmid coded and is denominated as amp' or bla(Tem-1) and exist on a series of cloning vectors such as pBR 322-derivate and pUC- series.
TEM-1 has a low activity against new cephalosporin and may be inhibited by beta-lactamase blocker such as clavulane acid or tazobactame. However under certain conditions there may be created a resistance to amoxicillin / tazobactame as well other combinations of beta-lactame/beta lactamase - inhibitors.
Recently an increase of mutation of TEM-1 and SHV-1 beta-lactamase is noted producing in some cases resistance to new cephalosporin and monobactame.
These derivates are labeled as "extended-spectrum-beta-lactamases" (ESBL), These enzymes were found in Klebsiella pneumoniae, Escherichia coli, Serratia marcescens and other Enterobacteriaceae.
Mutation of TEM1 beta-lactamase such as TEM-30 to TEM-41 may be the reason why the inhibition through clavulane acid is very low.
Bush 1995 has introduced therefore a subclass labeled as "2 br" for these variants.
The "inhibitor resistant TEM-beta-lactamases" ( IRT) was found only in Escherichia coli and in certain Proteus mirabilis and Klebsiella pneumoniae.It might happen that IRT also spreads to Haemophilus influenza and Neisseria gonorrhoeae having frequently TEM-1-beta lactamase.
The use of ampicillin to treat Enterococcus and Haemophilus influenzae infections should be made nowaday preceded by a sensibility test and using suitable beta-lactamase blocker by necessity.
The possibility of a transfer of gens from B.t. corn from Ciba to bacteria cannot be completely excluded.
To transfer the amp'gene to a bacterium it is necessary that the plant releases the amp' gene together with the "origin of replication" (ori) from pUC without damage. The plant cell usually degrades DNA during release with his own nucleases.
DNA enzymes in the paunch and the digestive tract from mammals and in the soil where bacteria may grow also destroy the gens.
The ability of bacteria to take over alien gens is seldom. Only very few bacteria have this ability, together nucleases found everywhere the probability of a transfer of the amp'gene from corn to a bacterium is very low.
The formation of a replicon in the cell, as for example the binding of the extremities of a DNA - fragment could only happen through an illegitimate cross over.
The host place of the origin of a replication exists only in a very limited number of Enterobacteriaceae.
All the above mentioned restrictions make the possibility of a transfer of amp' gene from plant to a bacterium seem to be unlikely.
It is supposed that all human beings have an amp' gene bearing Escherichia coli in their intestinal tract without having been exposed to beta lactame antibiotics. Approximately 50% of all clinically isolated Escherichia coli are already resistant to ampicillin of which 90% have a TEM-1 beta-lactamase.
The amp' gene already being so frequent there is no further danger to increase significantly the number of resistance by a transfer of the gene from Ciba corn to a bacterium.
However the alien gene has no function in the new corn. In future developments it is important to avoid marker gens with resistance to antibiotic or herbicides.

Detection of GMO in food

There are many genetic modified foods on market. To supervise the declaration new methods of analysis were needed which are based on molecular biological principles.
Detection can be made looking for the new specific protein or detecting the new genetic material.
The detection of GMO is very difficult because there are so many other compounds which may interfere in the detection, such as polysaccharides which can inhibit the polymerase chain reaction leading to false negative results.
The food processing causes a denaturation of the proteins on the DNA which is being on test being responsible for failing to be recognized by primers and antibodies. The tests should therefore be suited for the specific processing methodes used. The genetic modified material is often present in very small amounts. Sometimes the transgenetic protein is located in other parts of the plant and the part which is being used as food has no or very little transgenetic material such as the Bt toxin which is present in leafs but not in maize kernels of Novartis BT 176 maize. Usual methodes of GC-MS, HPLC and capillary electrophoresis are unable to detect them. Immunological detection of the transgenetic proteins such as Western Blot or ELISA are now used.
The most effective method to determine transgenetic material is to amplify the alien sequence of the promoter and the gene.
The analytical methods contain the following steps[40]:
1.- Extraction of DNA:It is necessary to extract the genetic material free from other impurities which might interfere in further steps of the analysis.
2.-PCR reaction ( Polymerase Chain Reaction)
The PCR reactions are suited to multiply and amplify specific fragments of DNA that are alien genes to the food being analysed. The primer starter molecules used in the beginning of the reaction decides which sequence of DNA will be multiplied. To avoid false negative results due to inhibit action of impurities during extraction of the DNA it is important to include a positive reaction.
3.-Making the PCR product visible
Through gelelectrophoresis (agarosegelelectrophoresis). The products of the PCR reaction can be made visible together with the determination of the length of the base pair, the alien gen.
4.-Confirmation of the results
The confirmation of the results are being made by controlling the sequence of the base in the PCR product using specific sequence restriction, hybridization with specific sonde
Nested PCR and
Sequencing
The basic PCR gives only qualitative indications. To obtain quantitative results the Competitive PCR or the RT-PCR should be used.

Competitive PCR

Is not so expensive as RT-PCR but there are dilutions to be made which take much time. If two sequences are present with the same complementary DNA sequence for the primers to annel they compete for binding of the primers. A DNA sequence ( internal standard) which is much shorter as the target DNA The amplification products can be separated on a agarose gel. The fluorescence of these products is proportional to the amount of amplified DNA. There are two bands on the agarose gel. Dilutions must be done until the brightness of both bands are equal.

RT-PCR Real-time PCR

The amount of molecules produced during each stage is measured rather then at the end as happens with competitive PCR.
To demonstrate the Presence of modified DNA the PCR-Method is today favored. Other Methods are the gelelectrophoresis sequencer and ELISA .
These methods are used as well in food chemistry as well in clinical researches because they are based on the same principles.

Western Blot

The method of Western Blot the extraction of the transgenetic protein from the food is done by means of a nitro-cellulose membrane which binds the proteins. The membrane is immersed in a solution of a specific antibody together with an enzyme resulting in a colour reaction. This method is very labour intensive and therefore not being used in routine.

ELISA (Enzyme Linked Immuno-Sorbent Assay

It is based on the same principles used for Western Blot. The membrane is substituted by a plastic plate with 100 and more wells being therefore suitable for many tests at the same time.

Round Up Ready Soybean,Monsanto Co

The Round Up Ready Soybean is a glyphosateresistant soybean (Glycine max). Glyphosate inhibits the enzyme of the metabolism of aromatic aminoacids in plants, the so called EPSPS 5-EnolPyruvylShikrimi-3-Phosphate-Synthesis.
The gene of glyphosate tolerance comes from Agrobacterium tumefaciens, strain CP4.
The transferpeptid as carrier of the EPSPS in the chloroplast comes from Petunia hybrid (transit-signal-sequence)
The detection of GMO Soybean Round Up Ready is made using the specific primer pair B1/B2 which couples with the promoter sequence CaMV 35S and with the transit - signal- sequence,
This primer pair gives a PCR-product of 172 Bp which hybridize with the DNA- sonde H-35s-ar1 after the transfer to the membrane [36].The range of options of PCR analysis of genetically modified organisms (GMOs) is expanding from day to day. As there is a great variety of commercialized GM plants grown in USA and in Europe, being exported all over the world , laboratory work is getting always harder to detect all possible GMOs as reference materials are not always attainable.

Risks of genetic engineering

: According to a statement of Prof Wolfgang van Daelen, WZB, Berlin 1997 today there are no empirical or plausible theoretical arguments that genetic modified food represent a greater risk to the consumer as it is with normal food.
Risks can never be completely eliminated, however there are no real risks known until present date. Future research to avoid risks of genetic engineering will be handled in two ways:

	Proactive risk research: This way asks what can happen ?
	Monitoring: The supervision by experts of the fields and the processing of food.

The greatest security in genetic engineering is hoped to be attained with use of both ways.

Allergy and soybean

[35] Why such a trouble about genetic modified soybean ?
Soybean was the first genetically modified plant to be introduced in widespread agriculture.The approval of the new plant by the Food and Drug Administration in USA (FDA) is made by determining the allergenic potentials of the plant.
For this purpose the FDA has established in 1992 a guideline to determine the allergenic potential of a plant.
In 1995 followed the guideline of OECD and WHO to determine allergic components in plants.This guideline contains the principal ideas of the guideline of 1992.These guidelines have three main points:

• The origin of the new gene.
  Some origins are already known as allergenic such as Brazil nuts, peanuts, milk, kiwi, rice, corn, spices, eggs, meat, fish, crustaceans and many pollen. Being no allergic components of the origin known the identity with other known allergens has to be verified.The stability to digestion, the stability during processing the final amount in food and the identity to other non allergenic proteins must be determined.
  Being there no allergens found in these tests the new plant can be approved.
  Being allergens of the origin known the following test have to be made: In vitro RAST/ELISA being negative Skin Prick Test in vivo are made.
  When these tests are negative the object can be tested as food and in case of showing no negative actions it can be approved.
  In case of a positive reaction in the RAST or ELISA test as well in the Skin Prick Test but no allergenity detected in the resulting food can be approved with a warning about the possible allergic reaction must be given on the label.
  In case of the Round Up Ready-Soy bean allergenic tests of the origin cannot be performed because the alien gene has his origin in soil bacteria and there are no antibodies of the blood of allergic persons available.
  
  During development of the modified soybean there were genes of the Brazil nut used.Antibodies from persons allergic to Brazil nut indicated allergenity of the new plant.
  A warning on the label turned out to be necessary. The further research on this plant was therefore abandoned.
  This was an example of allergenity of the origin gene being taken over by the new host.
• Host of the new gene.
  Some hosts are already known as allergenic such as soybeans. Allergic reactions to normal soybean are known. GMO Round Up Ready Soybean had therefore be tested on regard of possible allergenity taking over from his primary host.
  The immunoblotting method shows the forming pattern of the serological antibodies resulting from the new soy proteins.
  

  The Round Up Soybean reacted identical to the normal unmodified soybean.In relation to allergenity the GMO soybean is therefore identical with the normal plant.

• The allergenic activity of the new protein There exist no antibodies for the new proteins. Direct test is not possible.
  The evaluation of the toxicity is made with the following considerations which are common to all allergic proteins:
  The proteins must be stable against the stomach acid an to enzymes like trypsin and pepsin in order to trigger an immunological reaction.

The alien gene from GMO Soybean produces the enzyme CP4 EPSP-Synthase.This enzyme was compared with existing allergens.

Size of the molecule

Only the size of the molecule was identical to known allergens.This is however not relevant because the molecule is inactivated by heat.Processed Soybean meal is therefore not allergenic because of this heat barrier.

Digestion

The CP4EPSP-Synthase molecule is not resistant to digestion, being destroyed in the stomach within 15 seconds.

Bounding to long chained sugars

Typical allergens are bound to long chained sugars , the new enzyme does not have sugar in his molecule.

Degree of strangeness

The degree of strangeness is an important element of comparison with other allergens.The new enzyme CP4EPSP-Synthase is similar to EPSP - Proteins from baker yeast and indexBacillus subtilis Bacillus subtilis.Both of them are considered as GRAS (Generally Regarded as Safe)

Amount of Allergen in the final food

The amount of CP4 EPSP-Synthase in the final food is so small that only 0,001% in total and 0,08% in the proteins of the food are found. Allergenic substances are usually the major part of the food.

GMO soybean oil and allergenity

There are no allergic reactions known from refined oil of GMO soybean.The modified allergenic residues which are left after refining are below 1 ppm.
CP4EPSP protein and Round Up Ready Soybean is therefore considered as not allergenic.

French position to GMO

[160] Some environmental organization like Agir pour l'environnement, Greenpeace, France nature environment combatte the GMO.
Some organizations like the FNPL (Federation Nationalle des Producteurs de Legumes) and the CP (Confederation Paysanne) are against transgene food.
These Organizations are united to fight health- and environment- risks. According to them everything being resistant to antibiotic should be forbidden. Other Organizations like the FNSEA and the CNJA support GMO when:

1. Possible health- and environment risks are eliminated,
2. An acceptable solution concerning labeling of GMO food is found,
3. The national agriculture and the distribution system of food is protected against distortion of trade.

Recall of GMO maize seeds in France

In the end of April 1999 there was a recall of maize seeds in France (Elsace) after being proved that the seeds were genetically modified.The recall was confirmed by Pioneer Seeds company.In Germany there were also US GMO maize seed found. DER BUND (German environment organization) says that it should be avoided that frontiers between genetic modified food and natural grown food are erased. The consumer should keep the right to choose between both foods.[507]
Only Germany and Spain have authorized the use of genetic modified maize. All other member s of the EU do not accept it.

PTI: More unmodified Soya proteins

Protein Technologies International (PTI) most important producer of soya proteins, guarantee that it can supply the demands of genetic unmodified proteins from soybeans in Germany. According to PTI it is a fairytale that US soybeans are not separated in GMO and unmodified. To make sure no modified GMO is being used PTI has developed an Identity Preservation Program which is similar to the "Cert ID" scheme for unmodified foods recently introduced by the trade companies (April 1999).

US exporters want to supply demands of GMO-free Soybeans and cereals

The exporter and cereal specialist Northland Seed and Grains in Minnesota guarantee its products to be 100% GMO-free (April 1999)[509].
Two great cereal buyers accept only grains which can also be sold in Europe.

Unilever UK :Renunciation to genetic modified ingredients

Van den Berg Foods UK and Birds Eye Wall's (part of Unilever UK) will stop the use of GMO ingredients changing the with alternative unmodified ingredients, what also includes GMO-free Soy products (April1999). The efforts to produce GMO-free products show that there is a growing market for these products.
Meanwhile Monsanto introduces for autumn 1999 the GMO Roundup Ready Soybean in Brazil
The industry likes the"Brave New World" from Aldous Huxley.Rhone-Poulenc,a chemical giant and Limagrains producer of seeds united to create the Rhobio Company being responsible for biotechnology activities.
It has even been tried to change "Geneticaly modified " to " Geneticaly improved ".
The Nestlé Group refers to rising prices on GMO-free products.
The food dealers like Carrefour, Casino, and Systeme U make sure to get guarantee as GMO-free from the producer.It has shown that it is almost impossible to guarantee GMO-free products because basic components of food are already modified.Carrefour sells products with GMO-free guarantee. The Danone company , Paris announces not to use GMO - raw materials in their production in Europe.
The dealers are afraid that customers guided by dubious publications can make their own buying decisions to get out of control.
The dealers support therefore the labeling of GMO. Other supermarket chains in Great Britain which took out of their shelves products with genetic modified ingredients including meat from animals which had been feed with GMO animal feed around July 1999: Sainsbury, Safeway, Marks and Spencer, Northern Foods, Unilever and Nestlé GB as well as Nestlé Italy. Sainsbury searches for GMO-free cereals for animal feed to produce GMO-free meat and poultry [527].

Terminator-Gen

In the EU there are rules demanding farmers to pay licenses to seed breeders when seeds from the last crop are held back to be reused once again. The seed breeders say that they are loosing much licenses in Austria where these rules are still not introduced.
USA breeders are therefore working to introduce a new gene in their seeds, the so called "Terminator Gene" which lets seeds germinate only one time.There is no use to keep seeds for the next time. Farmers have to by their seeds from the breeder. If the terminator gene spreads out in free nature all plants will stop to germinate. The use of genetic techniques should not be allowed to collect fees or other financial purposes.[544]
Monsanto has made its golden rice available free of charge to developing countries. This rice had been modified with genetic engineering being enriched with vitamin A. The rice could prevent millions of cases of blindness caused by vitamin A deficiency. Monsanto hopes to sell the specific agro chemicals for this plant.

Terminator biotech technology The Terminator technology or Genetic Use Restriction Technologies (GURTS), sterilises seeds in order to force farmers and gardeners to buy new seed each season. [546]

The Food Commission of UK argues that Terminator seed will prevent farmers around the world saving their own seed, endangering seed security, the environment and consumer choice. The United Nations Convention on Biological Diversity (CBD) launched a moratorium on the field testing and commercialisation of terminator technology, agreed in 2000.

Australian, New Zealand, US and Canadian governments tried to undermine the existing moratorium at the CBD meeting in Granada, Spain, arguing that the technology would increase productivity. It was also recommended that CBDs precautionary approach should be replaced by case-by-case risk assessment.

Greenpeace today called upon the 188 states at the 8th meeting of the UN Convention on Biological Diversity (CBD) in 22. March 2006 in Curitiba, Brazil, to maintain the moratorium on the field trials and commercial releases of Terminator seed technology which was agreed six years ago. [545]

Governments at the United Nations Convention on Biological Diversity (CBD) have unanimously upheld the international de facto moratorium on Terminator technology at the 8th meeting of the CBD in Curitiba, Brazil. According to Maria Jose Guazzelli of Centro Ecológico, a Brazil-based agro-ecological organization the Convention rejected the efforts of Canada, Australia and New Zealand - supported by the US government and the biotechnology industry - to undermine the moratorium on suicide seeds. [547]
Luxembourg, Greece and Austria consistently vote against standard GMO approvals. New patents for Terminator technology have already been granted in Europe and Canada, and applications have been submitted in China, Japan and Brazil.

Hybrid rice

The FAO maintains the International Rice Commission IRC which coordinates international activities to increase rice yields:

Hybrid rice for Egypt [548]
The International Rice Commission of FAO indexInternational Rice Commission selected rice from more than 200 hybrid varieties to help Egypt to produce more rice with less water and less land, achieving the worlds highest national average rice yield in 2005. C4 rice [548]
Converting rice from a C3 plant to a C4 plant, where the "C" refers to the carbon captured by photosynthesis for growth as land and water resources available for rice production keep diminishing as a result of urbanization and industrialization.

However, according to the International Rice Commission Secretary Nguu Nguyenit, in 25 August 2006, Rome, it will take several more years before the C4 rice varieties may become available. And, then it has to be made sure that they are safe for human and animal consumption as well as for the environment.

Concerns related to biosafety, conservation of rice genetic diversity, intellectual property rights and access are risen. The International Rice Commission believes that international capacity building is urgently required to ensure that new innovations benefit local people and do not incur long-term costs to the environment.

In the medium term, increasing rice production in some countries could require a different approach, one based on introduction of better crop management practices. The results from pilot tests in developing countries since 2000 have demonstrated that very high yield with existing varieties can be obtained with improved crop management (ICM).

Improved Crop Management ICM and increasing rice yelds [548]
In the Philippines FAO's Improved Crop Management ICM has given excellent results increasing rice yields in test regions setting planting dates to expose crops to higher solar radiation, optimising seeding density, balanced plant nutrition, careful water management and the introduction of newly-developed hybrid varieties such as SK 2034 and SK 2046.
GM rice in Japan [549]
C4 rice:C3 plants which are less photosynthesis efficient include sugar beet, rice and potatoes. C4 plants highly efficient in the use of light for their biosynthesis are maize and sugar cane.

Genetically modified rice in Japan [549]

Professor Joe Cummins in his review, points out some overlooked dangers of genetic engineering of rice in Japan.

The C4 rice
Bioengineering tried to modify rice introducing a transgene for that enzyme from maize which expresses the enzyme phosphoenolpyruvate carboxylase (PEPC) fixing carbon dioxide in C4 plants. C3 plants lack this gene and fix carbon dioxide exclusively through an enzyme called Rubisco in the chloroplasts. A hygromycin resistance marker was added to the PEPC gene in the C4 rice, but photosynthesis did not improve.

New trials are ongoing with the gene for the enzyme phosphoenol pyruvate carboxylase (PCK) from Urochloa panicoides (liver weed).

Dwarf rice:Dwarf rice resists to lodging in wind and rain. A gene was introduced in rice to degrade the hormone gibberellin controlling height of the plant. This gene did suppress seeding, reducing yields.

The rice was then transformed with the hormone-degrading gene and put under control by tissue specific promoter for gibberellin synthesis, and terminated with tnos, together with a hygromycin resistance marker. There are no final results published.

Rice for alkaline soil [549]
To avoid iron deficiency in rice, when planted on alkaline soil, a gene which expresses the enzyme nicotianamine aminotransferase (NAAT) in barley was transferred to rice. This enzyme from the root of the plant, in alkaline soil, releases molecules called phytosiderophores turning iron uptake possible. Enhanced iron uptake under these conditions, improved yiels of GM rice.

The NAAT gene transfer was achieved with a CaMV promoter and terminated by tnos, and accompanied by hygromycin-resistance and neomycin-resistance marker genes

bacterial blight control [549]
To control rice bacterial blight the gene for the expression of cecropinB peptide, as strong antimicrobial of the larvae of the silk moth, Bombyx mori, was introduced into rice. A very complicated construct was designed using a version of the CaMV 35S promoter with enhancer 5p, the omega sequence from tobacco mosaic virus followed its promoter and the first intron of a phaseolin gene, a rice chitinase signal peptide, the cecropin sequence, terminated by tnos and a kanamycin-resistance marker.

Insect resistant rice [549]
Stem borer insect resistance: To enhance resistance against stem borer insects a trypsin-inhibitor, interfering with the digestion of the stem borer was introduced into rice, following a very complicated system: A synthetic trypsin-inhibitor gene derived from the winged bean with a reduced GC (guanine-cytosine) content to improve messenger RNA production, added to an enhanced CaMV promoter , together with a tobacco mosaic virus omega sequence and the first intron of a phaseolin gene, and terminated with tnos. In addition, a hygromycin resistance marker was also inserted.

Army worm larvae: The army worm larvae became susceptible to the common soil baculovirus when ingesting the pox virus gene product of GM rice. A synthetic insect pox gene with an altered DNA sequence was introduced in the rice using a CaMV promoter, a non-coding region of the rice stripe virus RNA and terminated by tnos, together with a hygromycin resistance marker. The natural resistance of the army worm larvae against the baculovirus is destroyed when it comes to a contact with the transgene DNA of the rice.

Biosecurity concerns relating GM rice in Japan [549]
Pofessor Joe Cummins concludes that the human cytochrome p450 genes should not be used in rice because they activate carcinogens. Cummins refers to the possibility the human genomes to be invaded by trangene DNA, through illegitimate and homologous recombination, following an extensive use4 of the aggressive CaMV-based superpromoters, and the incorporation of human genes. Dangerous consequences include the creation/activation of new viruses or cancer.

Unauthorised US GMO rice Bayer ll Rice 601not allowed to enter the EU [550]
The European Commission in August 2006 has adopted a decision requiring imports of long grain rice from the USA to be certified as free from the unauthorised GMO LL Rice 601. This unauthorised GMO had been found in samples of commercial rice on the US market. The emergency measures adopted by the Commission today mean that, with immediate effect, only consignments of US long grain rice that have been tested by an accredited laboratory using a validated testing method and accompanied by a certificate assuring the absence of LL Rice 601, can enter the EU.

Member States authorities are responsible for controlling the imports at their borders and for preventing any contaminated consignments from being placed on the market. In addition, they should carry out controls on products already on the market, to ensure that they are free from LL Rice 601.

Business operators importing rice from the USA also have responsibility for ensuring that LL Rice 601 does not enter the EU food chain and that imports are certified as free from this unauthorised GMO, in accordance with the EU food law principle that operators are responsible for the safety of the food or feed that they place on the market.

The Bayer long grain LL Rice 601 review of incidence handling

[551] [552]
The FSA will review its handling in the case of the Bayer long grain LL Rice 601 in 29 November 2007. A judicial review in February 2007 found in favour of the regulatory agency, but unveiled a number of mistakes made by the Agency to avoid any further spread of the GM rice.

GM rice in USA is widespread. The crossover to crops scheduled for export to Europe is highly possible. The European control system is therefore to be strengthened, because the US is one major supplier of EU with long corn rice, followed by India, Thailand and Guyana.

Lawsuits against Bayer [553]
The EC imposes no penalties and costs against Bayer.

Bayer is being lawsuited by rice farmers from Arkansas alleging that the corporation failed to prevent Liberty Link (LL) rice 601 GM rice from entering the food chain. As a result of the contamination of rice crops the price of US longcorn rice felt considerably

Commercial rice in the United States was found contaminated with genetically engineered (GE) Liberty Link (LL) rice 601, produced by Bayer. Liberty Link (LL) rice 601 was developed to tolerate the herbicide, glufosinate ammonium. Imports were, as a result, immediately banned in Japan.

Greenpeace International calls on the EC to stop reacting to contamination 'accidents' and start preventing them instead. The EC should identify countries and products that are at high risk of contaminating our food supply with illegal or dangerous GE organisms and implement screening, preventative testing and, where there is no demonstrated capacity to prevent contamination, total bans.

Greenpeace International calls on other major importing regions such as the Americas, Africa and the Middle East to take similar steps immediately until the US can guarantee that their rice supply - and other foods - are no longer contaminated.

There is currently no evidence that LLRICE601 has been imported into Canada.

In advance of the announcement, the CFIA and Health Canada, in consultation with the USDA and Bayer CropScience, conducted preliminary assessments of the risks that this incident posed to Canadian food and feed and the environment. The assessments determined that it is unlikely that low levels of LLRICE601 pose a risk to human health, livestock or the environment.

Canadian assessment determined that there is no risk coming from low levels of LLRICE601[424]
LLRICE601 is genetically very similar to another type of genetically engineered rice ( LLRICE62) which has been thoroughly assessed and approved for feed and food use in both Canada and the US However, this line of rice is not used commercially in Canada and the US While there is currently no evidence that LLRICE601 has been imported into Canada, the Government of Canada continues to work with the USDA to actively gather information about the distribution of this product.

U.S. Food and Drug Administration's Statement on Report of Bioengineered Rice in the Food Supply [425]
The bioengineered variety of rice, called LLRICE601, expresses the phosphinothricin - N - acetyltransferase (PAT) protein which provides tolerance to glufosinate-ammonium herbicide. This rice variety, not intended for commercialization, was not submitted to FDA for evaluation under the Agency's voluntary biotechnology consultation process. However, crops containing the PAT protein have previously been evaluated for safety by FDA on a number of occasions through the Agency's voluntary biotechnology consultation process.Bayer has informed the Agency that LLRICE601 is present in some samples of commercial rice seed at low levels.

In addition, Bayer has provided information about the safety of the PAT protein, molecular characterization, and nutritional composition of grain from LLRICE601. Based on the available data and information, FDA has concluded that the presence of this bioengineered rice variety in the food and feed supply poses no food or feed safety concerns.

Liberty herbicide and NAG (N-acetyl-L-glufosinate)

Smith glufosinate Jeffrey M. Smith says that Liberty herbicide (also marketed as Basta, Ignite, Rely, Finale and Challenge) can kill a wide variety of plants, bacteria, fungi and insects, and has toxic effects on humans and animals. The herbicide is derived from a natural antibiotic, which is produced by two strains of a soil bacterium. In order that the bacteria are not killed by the antibiotic that they themselves create, the strains also produce specialized enzymes which transform the antibiotic to a non-toxic form called NAG (N-acetyl-L-glufosinate). The two genes which produce these enzymes are inserted into the DNA of GM crops.When the plant is sprayed, Liberty's glufosinate ammonium is absorbed by the plant where the enzymes convert it primarily into NAG protecting itself against the weed killing poison.

NAG, accumulates in these GM crops. NAG may be re-transformed back into the toxic herbicide inside our digestive system by gut bacteria, primarily found in the colon or rectum.
The conversion of NAG back to glufosinate was found to be up to 10% and one-third in goats.

Jeffrey M. Smith says it is believed that although these parts of the gut do not absorb as many nutrients as other sections, rats fed NAG did show toxic effects. A goat study also confirmed that some of the herbicide regenerated from NAG ended up in the kidneys, liver, muscle, fat and milk.

Low chances of consuming significant amount of NAG [426]
Christopher Preston of the University of Adelaide, Australia counters the affirmations of Jeffrey M Smith in AgBioWorld in 30.08.2006:
"Transgenic glufosinate resistant plants do convert glufosinate into NAG; however, very little if any NAG ends up in the grain and none in processed foods." "The chances of consuming any significant amount of NAG are very low."

Preston concludes: "It is true that transgenic glufosinate resistant plants metabolise glufosinate to NAG. It is also true that a small amount of NAG can be converted into glufosinate on passage through mammalian intestinal tracts. However, the rest of the steps required for Smith's "unique risk" do not occur. NAG appears only at low concentrations, if at all, in grain from glufosinate-treated crops and not at all in processed foods. Therefore, it would be exceptionally difficult to ingest sufficient NAG to even reach the ADI. The vast majority of the NAG and any glufosinate produced from it are excreted rapidly in faeces. Therefore, the chances of consuming sufficient NAG to convert to sufficient glufosinate in the gut to produce any measurable effect must be exceptionally remote."

Petition for approval of LLRICE601 for human consumption []
The USDA announced in August 2006 that a scientific review of available data revealed no human health, food safety or environmental concerns were associated with GMO LL Rice 601 (LibertyLink)

In August 2006 Bayer petitioned for the deregulation (approval) for human consumption of LL Rice 601. The USDA has said that the petition is in accordance with its Animal and Plant Health Inspection Service (APHIS) regulations concerning the introduction of GE organisms and products.

Bayer CropScience document: Application for an Extension of the Determination of Nonregulated Status for Glufosinate-Tolerant Rice (98-329-01p): Transformation Event LLRICE601 OECD Unique Identifier BCS-OS003-7 [427]
The undersigned submits this petition under 7 CFR 340.6 to request that the Director, Scientific Services, makes a determination that the article should not be regulated under 7 CFR 340.

Bayer CropScience requests a determination from APHIS that rice with glufosinate herbicide tolerance event LLRICE601 and any progeny derived from crosses of this event with traditional rice varieties, and any progeny derived from crosses of this event with transgenic rice varieties that have also received a determination of nonregulated status, no longer be considered regulated articles under 7 CFR Part 340, and that APHIS consider this document as an extension to petition 98-329-01p.

Glufosinate-tolerant rice based upon the transformation event LLRICE601 was produced by the introduction of a chimeric 35S/bar gene construct using Agrobacterium-mediated gene transfer. The rice events described in petition 98-329-01p were transformed by direct gene transfer of a chimeric 35S/bar gene construct. All events produce the same protein, the enzyme phosphinothricin acetyltransferase (PAT), which confers resistance to the herbicide glufosinate.

Agronomic evaluation has demonstrated that there were no morphological, beneficial organism, disease susceptibility or pest susceptibility differences observed when comparing the events to cultivated rice. (Bayer document, citation end

Fact sheet Maize [428]
Glufosinate herbicide- resistant GMOs use the GOX genes. The trait Glyphosate Oxireductase (GMEsyn) confers tolerance to glyphosate (Roundup) The donor-organism was originally Ochronobactrum anthropi, but now a synthetic construct is being used.

After treatment with N-acetyl glufosinate (NAG) accumulates in genetically modified plants. Glufosinate was generally a minor component of the residue whereas the main component in the forage, silage and fodder was NAG and the main component in the grain, cobs and husks was MPP (FAO, 1998; Stumpf, 1996).

Information on the metabolism of glufosinate-ammonium and NAG (N-acetyl-L-glufosinate) in laboratory rats, lactating goats and laying hens was reported. In summary, most of the administered dose of both compounds is rapidly excreted. NAG may be partially metabolized back to glufosinate.

In rat studies up to 10% deacetylation occurred at a low dose of 3 mg/kg bw as shown by the occurrence of glufosinate in the faeces. The authors concluded however that most of the conversion was caused by bacteria in the colon and rectum although toxicity findings indicate partial bioavailability (FAO, 1998).

Toxicity studies show a LD50 (orally en subcutaneous) of NAG of more than 2.8 g/kg body weight, indicating that NAG is not toxic (Trinks, 1995).

In samples of Bt-11 maize no glufosinate-derived residues are found in any maize processed fraction which are relevant food or feed items. These include flour, starch, grits and oil. Residues are not detectable in crude and refined oil. In ruminant and poultry feeding studies no detectable residues were found in meat, milk or eggs at the dose calculated to represent the highest residues in livestock feed under Good Agricultural Practice and taking into account the potential use of glufosinate herbicide in several tolerant crops (Scientific Committee on Plants, 1998).

Based on the current knowledge it can be concluded that large-scale applications of transgenic herbicide-resistant crops and glyphosate or glufosinate does not have adverse effects on the safety of food and the safety for users (Hin, 2001).

Sequencing rice:

The genetic code of rice is very similar to all the other cereals to a certain extent. Many of the shared genes are in similar positions on the respective chromosomes. A given function of a gene in rice is very likely to be located in the corresponding gene in another cereal."

According to Robin Buell of The Institute for Genomic Research (TIGR). These data can be used to develop new varieties of rice that deliver increased yields and grow in harsher conditions. Rice is genetically similar to maize, wheat, barley, rye, sorghum and sugarcane. Understanding rice opens the door to the genomics of these plants.

Transporter IRTI for assimilation of iron [431] [432]

Professor Mary Lou Guerinot of Dartmouth University and colleagues identified the transporter IRTI for assimilation of iron by plants. The identification of genes involved in iron homeostasis were done at the model plant Arabidopsis. The scientists studied the transport and regulation of gene expression by metals. Iron and zinc, for instance, influence plant growth and affect yield volumes.

The use of phosphate fertilizers, which has led to high levels of cadmium contamination in many locations around the world Cadmium, together with other metals such as manganese, zinc, and cobalt are also transported by the IRTI transporter.

Guerinot used DNA shuffling and heterologous expression in yeast to isolate alleles of IRT1, which allow the iron to be transported but not the poisonous cadmium. The new transgenic seedlings presented the same cadmium level as wild type plants which had lost their IRT1 function. The transgenic plants had twice as much iron as the wild type plants, when grown in the presence of cadmium.

This genetic technique applied in rice could overcome iron deficiency in many poor countries which use rice as staple food.

The research continues looking after which transporters affect the distribution of micronutrients within plants hoping to lead to agronomic benefits such as increased seedling vigour, higher crop yields and resistance to disease.

In her commentary on this research on Golden Rice in Science, Dartmouth biologist Mary Lou Guerinot says that engineering plants to improve their nutritional value would be of great benefit to developing countries. [433]

Genetic modified potatoes

[434] Dr. Arpad Pusztai from the Rowett Institute in Scotland responsible scientist liberated the news that rats being fed with GMO potatoesinjured in growth and in its immune system.
The results were declared as misunderstanding and Dr. Pusztai was sent into retirement.
A snowdrop-gene had been introduced in the genetical material of the potato. This alien gene should keep worms and insects away. Further research carried out by Dr. Pusztai made clear that there was a potential menace to animals and mankind. Damage of internal organs,malfunction of the immune system and alteration of growth and were demonstrated by rats being fed with the genetic modified potato.
At the moment it is not clear from where the toxicity comes. Some scientists find the promoter-gene to be responsible for it.
The same promoter-gene is being used in the Roundup Ready Soybean.
If this proves to be true all food having soybean derivates from genetic modified soybeans should be considered as harmful to health.

French retailer against genetic modified food

[434] The French retailer Carrefour, Paris announces to withdraw all genetic modified foods.About one third of their own trade-marked articles are affected.
Carrefour is not an enemy of genetic technology, but it seems impossible to predict the results of genetic modification on foods for long terms.Therefore the retailer wants to go the safe way avoiding genetic modified products.
According to Carrefour[434] GMO labeling EU directive proves to be insufficient to provide protection or information for the consumer as to many exceptions are allowed.
Seven important European retailer enterprises have founded a consortium against genetic modified foods. This consortium embraces Migros (Swiss), Carrefour (France), Sainsbury(Great Britain, Marks and Spencer, Delhaize Le Lion (Belgium), Esselunga (Italy) and Superquina (Ireland).
The aim of this alliance is to clean own trade marks from genetic modified ingredients. (vwd/1.4.99/12/mi)

GMO-labeling in USA

US-citizens claim for GMO-labeling in a petition which has been given to the Congress as there are no rules from FDA.

European GM regulation criticized[]
At an IFT conference on global acceptance and sustainability of genetically modified food 26.06.2006, Francis Smith from the Competitive Enterprise Institute in Washington DC criticized the EU GM food regulations.

She said that consumers in the EU are concerned a lot about food, especially over topics that attract a lot of media coverage, Austrians being the most affected by worries. Fourty percent of European women are deeply concerned about food safety meanwhile only 29 percent of European men feel so.

Smith believes that Europeans fear new technology. Americans do not share this feeling, they look at the benefits and have less fear and less distrust.

Because of the European distrust, triggered by food scandals like mad cow and safety of the food supply chain in the 1990s, decision-makers take into account these fears and adopt prevention strategies.

Smith argued that regulations addressing perceptions and fears rather than scientific evidence, increases the perceptions of risk when there is little basis for this, and could lead to mass hysteria.

France will impose a GM ban if serious safety doubts are presented

[435]
The President Sarkozy in October 2007 imposed a temporary ban affecting cultivation of GM crops. This ban will end at the start of February but Sarkozy will restore the ban if scientists raise serious doubts about GM crops.

Austria enforced a ban on the import and processing of MON810 and T25 maize in June 1999 expressing concern about the effects on non-target organisms and the development of resistance to toxins by target organisms but failed to present scientific evidences for their claim. In 2005 the WTO ordered the ban to be lifted.

According to French anti-GM lobby leaded by José Bové pollination could cross-contaminate non-GM crops grown in the vicinity. The long-term health effects of GM on humans are not known. Bové is on hunger strike to enforce the GM ban.

The position of the Association Generale de Producteurs de Mais

[436]
The Association Generale de Producteurs de Mais (AGPM) claims that the GM is needed because of considerable damage by corn borers in the south west and centre of the country.

According to AGPM there is absolutely no justification for this decision on a "genetic trait" which has been shown to be harmless and has been recognised as such for a long time, which is approved for use in many countries and has just been put back on the market in Germany after sales were suspended.

The AGPM highlights the implementation of a best practice guide for coexistence and traceability of GM and non-GM corn in 2004, and that no one of the plots studied went above the 0.9% limit set by regulations for labelling. [437]

According to Greenpeace in 2005 the European Commission Monsanto's approved MON810 maize under the old EU directive without a comprehensive monitoring plan. Greenpeace says that the new directive 2001/18/EC should to be applied for MON810. [438] Marker-assisted selection (MAS) accelerating traditional breeding[439] Jeremy Rifkin from the Foundation on Economic Trends reports that new technologies are making gene splicing and transgenic crops (GM foods) obsolete. He urges to look at Marker-assisted selection (MAS) as a method to accelerate traditional breeding. Rifkin says that genes associated with desirable traits such as yield or pest resistance can now be identified, and located in other varieties of the food crop or its wild relatives, which are then cross bred to improve the crop. This technology will eventually replace GM food which uses molecular splicing techniques to transfer a gene from an unrelated species.

Most of the transgenic crops introduced into the fields express only two traits - resistance to pests and compatibility with herbicides - and rely on the expression of a single gene. Marker-assisted selection (MAS) technology could overcome this limitation.

Jeremy Rifkin notes that farmers are gradually forced to used seeds and agrochemical producing crops which are not their own any more, but belong to multinational corporations of agro business and food industry. [440]

According to Nicolas Schauer marker-assisted selection (MAS) in conjunction with transcript profiling is a powerful method to identify genes of interest for the rapid identification of agronomically desirable lines. The combination of MAS and metabolite profiling might prove much more effective in the long run for the identification of metabolic traits in crops. [441]

Herbicides at the base of imidazolinon

[434] Genetic modified rapeseed resistant to the herbicide imidazolinon is already on market.
The pharmaceutical enterprise Cyanamid Canada and the University of Saskatchewan of Canada develops imidazolinon tolerant wheat. The used gene had been detected in winter wheat.

Celiac disease

[442] Celiac disease is caused by allergy to gliadin, an aminoacid from gluten of wheat, rye and barley. Gluten is present in flour of theses grains and is therefore present in all farinaceous foods as well as traces in starch of these plants. Starch is an ingredient of a long chain of industrial products.The German Ministry of Research ( BMF Bundesforschungsministerium ) coordinates researches to eliminate the genes responsible celiac causing components of the gluten.
Unfortunately industry does not help the project as there is no financial profit expected.Monsanto hopes to release a glyphosate tolerant wheat type in 2002.
Imidazolinon resistant sugar beets were already developed and are on test.

Cultivation of genetic modified seeds in Brazil

In September 1999 the cultivation of genetic modified soybean[501]will start.
Fields in the state of Rio Grande do Sul and the south of Mato Grosso and Goias will be cultivated with Roundup Ready soybeans from Monsanto over the Monsoy enterprise.The seed was released by the Brazilian commission CTNbio (Commissao Técnica Nacional de Bioseguranca).
Consumer organizations and government sectors have made resistance against GMO soybean. The GMO plant is coming over the border from Argentina.
Hoechst Schering has received the authorization to cultivate herbicide tolerant rice in Brazil.
According to CNTBio (Brazilian biotechnology safety commission) the worldwide culture of GM plants is 28 millions hectares
Soybeans are represented with 40% followed by maize, tobacco, cotton, tomatoes and potatoes.
USA has 8,5 millions hectares of GM plantations, China 1,8 millions hectares, Argentina 1,4 millions hectares and Canada 1,3 millions hectares.
Du Pont de Nemours and Co has entered the Brazilian market with Du Pont do Brasil with its head in Sao Paulo taking over Pioneer Hi-Bred international Inc in march 99.
As Du Pont has overtaken Sementes Dois Marcos the way is open to the production of genetic modified soy bean seeds together with modified wheat seeds.
The first product of Du Pont in Brazil will be a modified maize seed which was modified without gene transfer so there is no formality necessary to release the seed.This maize has a very high content of oil. (vwd/6.4.99/mi)

Good business with GM-free vitamin E, phytosterols and isoflavones
Fenchem claims to have established a solid supplier chain of indigenous soybean grown in the north-east of China. As more and more GMO soybean seed is being planted US, Brazil and elsewhere, GMO-free soybean products are getting in great demand. Fenchem received IP (identity preserved) certification for soy-derived natural vitamin E, phytosterols and isoflavones.

GMO and worldwide famine, an interview with Ian Wilmut

Can genetic techniques solve the problem of famine in the world?
Ian Wilmut, genetic specialist who cloned the sheep "Dolly" said in an interview with the Brazilian magazine veja (4.11.1998,page 14):
"It would be exaggerated to say so. The actual production of foods is more than sufficient to feed the whole planet. The trouble is that the food is unequal distributed. Instead of producing more food we have to improve the storage of already existing food and we have to distribute them in a fair way. It is sad to know that people still die of hunger just because we do not find a political and social model which enables us to distribute food in a way with more justice. The solution of the famine is political and not scientific. What genetics can do is to give a contribution that this comes true."

Cloning of animals for better foods [503]

The European Commission requested the European Food Safety Authority to advise on food safety, animal health, animal welfare and environment implication of live cloned animals, obtained through somatic cell nucleus transfer (SCNT) technique, their offspring and of the products obtained from those animals. [502]

At present in Europe cloning is not a commercial practice and there is no specific regulation on the authorisation of food products from cloned animals for human consumption in the EU. EFSA's opinion will therefore help inform any future EU measures for cloned animals and their products.

Food safety officials from the 27 member states decided that milk and meat from cloned animals and their offspring should be considered in the same way as any other novel food, such as genetically-modified organisms (GMOs).

To prepare the advice, the EFSA refers to the Opinion Nr. 9 - 28.February 1997 - Ethical aspects of cloning techniques.Opinion requested by the European Commission on 28 February 1997 [503]. This opinion was prepared by European Group on Ethics in Science and New Technologies . [504]

The Group defines cloning as the process of producing "genetically identical" organisms. It may involve division of a single embryo, in which case both the nuclear genes and the small number of mitochondrial genes would be "identical", or it may involve nuclear transfer, in which case only the nuclear genes would be "identical".

But genes may be mutated or lost during the development of the individual: the gene set may be identical but it is unlikely that the genes themselves would ever be totally identical. In the present context, we use the term "genetically identical" to mean "sharing the same nuclear gene set".

According to the European Group on Ethics in Science and New Technologies [504], in their Opinion nr. 9 - 28/05/1997 - Ethical aspects of cloning techniques express that these new technologies increase the power of people over nature and thus increase their responsibilities and duties. The Group cites the potential uses of cloning animals:
- in the field of medicine and medical research, to improve genetic and physiological knowledge, to make models for human diseases, to produce at lower cost proteins like milk proteins to be used for therapeutic aims, to provide source of organs or tissues for xenotransplantation;

- in agriculture and agronomical research, to improve the selection of animals or to reproduce animals having specific qualities (longevity, resistance,...) either innate, or acquired by transgenesis.

From the point of view of animal breeding, the technology could be useful, in particular if it increases the medical and agricultural benefits expected from transgenesis (genetic modification of animals).

By using genetic modification and selection in cultured cell lines, rather than in adult animals, it could become possible to remove genes, such as those provoking allergic reactions, as well as adding genes, for the benefit of human health.

Meat and dairy products from cloned animals in the EU

Opinion of the EFSA on cloned foods

[1781]
The European Food Safety Authority (EFSA) concluded there is no expectation that clones or their progeny would introduce any new food safety risks compared with conventionally bred animals. According to the EFSA meat and milk obtained from healthy cattle and pig clones and their offspring are within the normal range with respect to the composition and nutritional value of similar products obtained from conventionally bred animals.

The opinion, however, says that there are only limited data on safety of cloned food and information on the survival of cloned animals. The EFSA opinion may influence the approval of cloned foods in USA.

The EFSA launched a public consultation on the draft scientific opinion on the implications of animal cloning on food safety, animal health and welfare and the environment. [1782]

Cloning makes multiple exact copies of a single gene or other segment of DNA. The animals thus produced have the same genetic material as the original animal, allowing to create strains of animals with increased disease resistance and other qualities.

Coldiretti Italian farmers' group:

The Italian farmer' group Coldiretti says that cloned foods are an unacceptable risk. [1783]

FDA wants to introduce cloned foods:

According to the World Society for Animal Protection cloning results in animal suffering. with 95% of cloning attempts failing. In addition, many of the animals being cloned are those with particularly high productivity, such as cows with excessively large udders that produce more milk but also suffer from major leg problems and painful diseases. [1785]

The agency is not requiring labeling or any other additional measures for food from cattle, swine, and goat clones, or their offspring because food derived from these sources is no different from food derived from conventionally bred animals, however, there are insufficient information of other animal species, such as sheep, which are recommended not to enter the food chain. [1786]

Should a producer express a desire for voluntary labeling (e.g., "this product is clone-free"), it will be considered on a case-by-case basis to ensure compliance with statutory requirements that labeling be truthful and not misleading. The Agengy says that it did not consider moral, religious and ethical concerns aspects of cloning. The risk assessment was strictly a science-based evaluation. [1786]

The Mikulski and Specter amendment

[1787]
Amendment 3524, introduced by Senators Mikulski and Specter, calls for more information on food products from cloned animals, with specific focus on elements that have not been addressed by the Food and Drug Administration's (FDA) initial risk assessment and reassures the moratorium on cloned foods.

The Food and Drug Administration FDA's preliminary report in December concerning the safety of cloned foods was criticized for being flawed and incomplete. According to the Center for Food Safety (CFS) there are few studies on the risks of food from clones, and no long-term food safety studies have been done. FDA indicates that it will not require labeling on cloned food, so consumers will have no way to avoid these experimental foods. The US Food and Drug Administration is expectedto give its final verdict on food from cloned cattle and pigs soon. [1784]

The proposed amendment to the Farm Bill calls for studies that would evaluate the health effects of allowing the commercialization of milk and meat from cloned animals.

CSPI says that if companies begin using clones to breed food animals, they need to explain why. Will it make any food product better, safer, cheaper or more sustainable? Clear evidence of benefits must be generated if consumers are going to accept cloned animals and their products. [1788]

Cloned meat in USA
The US Food and Drug Administration (FDA) said it planned to approve cloning for food production in 2007 and to allow the product into the food chain without the need for labelling.

Cloned meat and milk already entered US food chain

[1789]
According to Washington Post the U.S. cattle cloning companies did not tracked how many offspring of clones have entered the food supply. Producer say that cloned Kansas cattle semen were openly sold to many U.S. meat producers in the past years.

USDA encourages a voluntary moratorium

[1790]
USDA says that currently, the cloning industry is adhering to a voluntary moratorium on putting cloned products into the food chain. The Agency encourages the cloning industry to continue its voluntary moratorium for a sufficient period of time to prepare so that a smooth and seamless transition into the marketplace can occur.

Cloning ethically not justified

[12]
The European Group on Ethics in Science and New Technologies (EGE) has doubts as to whether cloning animals for food supply is ethically justified. Whether this applies also to progeny is open to further scientific research. The organisation does not see convincing arguments to justify the production of food from clones and their offspring, and recommends in case of future food products derived from cloned animals introduction to the European market, that the following requirements are met:

Food safety is considered to be a pre-requisite for the marketing of foods for human consumption. Concerning animal welfare and health, the five freedoms, should be met in intensive animal breeding: from hunger, thirst and malnutrition; from fear and distress; from physical and thermal discomfort; from pain, injury and disease;and to express normal patterns of behaviour should be maintained. A Code of Conduct on responsible farm animal breeding, including animal cloning should be prepared. Current EU legislation regarding traceability of animals and their food products should be enforced.

Despite the efforts of open markets of the WTO, the import of cloned animals, their offspring and materials derived from cloned animals (e.g. semen and food products) should be conditional on proper documentation, in particular with regard to traceability provisions and animal welfare and initiatives to ensure consumers' freedom and rights should be taken. Proper measures to preserve the genetic heritage of farm animal species should be installed.

Public discussion related to the use of animal cloning should be promoted and indicators on public perception concerning the introduction of such products to the food market should be collected. Labelling procedures should be cleared prior to the marketing of such food in the EU.

The Food Standards Agency position
Foods produced from cloned animals fall under Regulation (EC) No 258/97 (Novel Foods Regulation)[273]. This means that meat, milk or eggs from cloned animals would be subjected to a safety evaluation and approved by all European Union (EU) Member States as a novel food before they could be legally marketed. In U.S. products from cloned animals and their offspring are allowed by FDA to enter the food chain. This may lead to the technology being considered for use in Europe. [1792]

According to UK Food Standards Agency foods like meat milk and eggs from cloned animals are not allowed to enter the food chain in UK. [1793]

There are no methods to detect offspring of cloned animals. As sperms from these animals are already being sent all over the world an unknown safety issue will affect the whole food industry with farming Frankenstein creatures. Cloning of animals
The Group gives their opinion concerning cloning of animals:
Research on cloning in laboratory and farm animals is likely to add to our understanding of biological processes, in particular ageing and cell commitment, and hence may contribute to human well-being. It is ethically only acceptable if carried out with strict regard to animal welfare, under the supervision of licensing bodies.

Cloning of farm animals may prove to be of medical and agricultural as well as economic benefit. It is acceptable only when the aims and methods are ethically justified and when it is carried out under ethical conditions.

These ethical conditions include:
- the duty to avoid or minimize animal suffering since unjustified or disproportionate suffering is unacceptable;

- the duty of reducing, replacing and when possible refining the experimentation adopted for the use of animals in research;

the lack of better alternatives;

human responsibility for animals, nature and the environment, including biodiversity.

The group stresses the need to preserve genetic diversity in farm animal stocks. Strategies to incorporate cloning into breeding schemes while maintaining diversity should be developed by European institutions.

On regard to human reproductive cloning the Group writes that the European Community should clearly express its condemnation of human reproductive cloning and should take this into account in the relevant texts and regulations.

According to the Group, further efforts must be made to inform the public, to improve public awareness of potential risks and benefits of such technologies, and to foster informed opinion.

Cloning of animals for food should be prohibited says MEPs.

[1794]
The European Union is currently considering whether to approve animal cloning for food production. According to Sonja Van Tichelen , director of the Eurogroup for Animals cloning is an incredibly wasteful way of producing food, and causes suffering and harm to animals at every stage of development.

Cloning has been proved to be an inefficient practice that requires the loss of many animal lives just to produce one successful clone. Scientists have found that the ones who do survive suffer more defects and die much earlier than non-cloned animals. Only 8% of sheep involved in a cloning process result in a viable offspring or embryo transferred. For cows this is 15-20%. Goats less than 3%, pigs 3-5%, rabbits less than 2%, mice less than 2%, horses less than 1%, and deer less than 1%.

Members of the European Parliament of the Intergroup on Animal Welfare, leaded by Neil Parish MEP, signed a resolution calling on the Commission to prohibit:

1. The cloning of animals for food supply
2. The farming of cloned animals or their offspring
3. The placing on the market of meat or dairy products derived from cloned animals or their offspring
4. The import of cloned animals or their offspring, semen and embryos from cloned animals or their offspring, and meat or dairy products derived from cloned animals or their offspring.

Patents on GMO-plants

The DBV (Deutscher Bauernverband)German Farmer Union has urged the German Government not to take over the European Biopatent guideline in the German Patent law. The DBV says that European Commission opens the possibility of o wide spreadread patent on plants.It is also possible that patent protected gens sp