Subsections
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.
[1461]
Ployd is the number of chromosomes in a cell. The haploid
number is the number of chromosomes in a gamete of an individual. This is
distinct from the monoploid number which is the number of unique chromosomes
in a single complete set.Most of human cells are diploid, that
is, they contain one set of chromosomes from each parent. Sperm and eggs
contain only one set of chromosomes, they are haploid.
Plants and many amphibian, reptiles and insects contain four sets of
chromosomes. This is called tetraploidy. The Monoploid
number gives the number of chromosomes present in the cell and euplody is a
multiple of the monopliodal number. The human cell has 46 chromosomes which
is a multiple of the monoploid number 23. In humans, the monoploid number (x)
equals the haploid number (the number in a gamete, n), that is, x = n = 23. In
some species (especially plants), these numbers differ.
Commercial common wheat is an allopolyploid with six sets of chromosomes, two
sets coming originally from each of three different species, with six copies
of chromosomes in each cell. The gametes of common wheat are considered as
haploid since they contain half the genetic information of somatic cells, but
are not monoploid as they still contain three complete sets of chromosomes from
the original three different species (n = 3x).
A monoploid cell is likely to be identical to the cell it was copied from however
in haploid cells one of two differing copies of the same chromosome is in the
haploid set. Aneuploidy is when the total number is not a multiple of the
monoploid number, such as the Down syndrome where there is a single extra
chromosome, or there is a missing chromosome in case of the Turner syndrome.
[1461]
The terms homozygous, heterozygous and
hemizygous are used to simplify the description of the genotype
of a diploid organism at a single genetic locus. At a given gene or position
along a chromosome (a locus), the DNA sequence can vary among individuals in the
population. The variable DNA segments are referred to as alleles, and diploid
organisms generally have two alleles at each locus, one allele for each of the
two homologous chromosomes. Simply stated, homozygous describes two identical
alleles or DNA sequences at one locus, heterozygous describes two different
alleles at one locus, and hemizygous describes the presence of only a single copy
of the gene in an otherwise diploid organism.
F1 hybrid
[1462]
In agronomy, the term "F1 hybrid" is usually reserved for agricultural
cultivars derived from two different parent cultivars, each of which are
inbred for a number of generations to the extent that they are almost
homozygous. The divergence between the parent lines promotes improved growth
and yield characteristics through the phenomenon of heterosis ("hybrid
vigour"), whilst the homozygosity of the parent lines ensures a phenotypically
uniform F1 generation. Each year, for example, specific tomato "hybrids" are
specifically recreated by crossing the two parent heirloom cultivars over again.
Two populations of breeding stock with desired characteristics are subject to
inbreeding until the homozygosity of the population exceeds a certain level,
usually 90% or more. Typically this requires more than ten generations. After
this happens, both populations must be crossed while avoiding
self-fertilization. Normally this happens in plants by deactivating or removing
male flowers from one population, taking advantage of time differences between
male and female flowering or hand-pollinating.
An F2 hybrid is a cross between two F1 hybrids. This second-generation cross does
not produce consistent or vigorous plants.
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:
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.
[1463]
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).
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 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.
[1025]
Marker assisted selection (MAS) is indirect selection process where a trait of
interest is selected not based on the trait itself but on a marker linked to it.
The gene of interest is directly related with production of protein(s) that
produce certain phenotypes whereas markers should not influence the trait of
interest but are genetically linked. In many traits genes are discovered and
can be directly assayed for their presence with a high level of confidence.
However, if a gene is not isolated marker's help is taken to tag a gene of interest.
A marker may be:
First markers loci available that
have obvious impact on morphology of plant. Genes that affect form, colouration,
male sterility or resistance among others have been analysed in many plant
species. Examples of this type of marker may include the presence or absence of
awn, leaf sheath colouration, height, grain colour, aroma of rice etc. In
well-characterized crops like maize, tomato, pea, barley or wheat, tens or even
hundreds of such genes have been assigned to different chromosomes.
A gene that encodes a protein that can be extracted
and observed; for example, isozymes and storage proteins.
The
chromosomal banding produced by different stains; for example, G banding.
Different pathogen races or insect biotypes based on
host pathogen or host parasite interaction can be used as a marker since the
genetic constitution of an organism can affect its susceptibility to pathogens or
parasites.
A unique (DNA sequence),
occurring in proximity to the gene or locus of interest, can be identified by a
range of molecular techniques such as RFLPs, RAPDs, AFLP, DAF, SCARs,
microsatellites etc.
"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.
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 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.
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 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.
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 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 |
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)[1026], later overtaken by Novartis are deeply
modified in their genetic codes.
Soybean as protein supply for animal feed
[1464]
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.
:
: Gen engineering may produce wheat free of
gluten. This aminoacid is not tolerated by sprue patients ( a kind of severe
allergy ).
: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.
: The GMO oil of rape seed has a
modified composition of fatty acids being more valuable then normal oil.
: 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.
[60]
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
- Rennet from veal calves
- Rennet from adult cows
- rennet from pigs
- Protease from Mucor miehei
- Protease from Endothia parasitica
- Protease from Rhizomucor pusillus
- Protease from Endothia parasitica
- Protease from Mucor pusillus
GMO non-calf chymosins
- Chymosins from GMO Escherichia coli
- Chymosins from GMO Kluyveromyces lactis
- Chymosins from GMO Aspergillus niger)
- 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.
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. [61]
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.
[61]
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.
[62]
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.
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.
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[63]:
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.
[58]
Roy and colleagues 2009 describe an electrical nanogap sensor for the
detection and quantification of DNA. The device is based on the electronic
transduction mechanism. It uses standard silicon microfabrication
technologies.
A pair of micro-sized metal electrodes separated by a nanogap, in combination
with special chemical probes capture segments of DNA immobilising them,
followed by hybridization with target strands and metallization. The
resulting change in conductivity detects and quantifies the targeted DNA.
The new technique is faster, less expensive, and more practical than DNA
detecting methods which use the polymerase chain reaction (PCR).
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.
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 [59].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.
: 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.
[57] 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 alien gene from GMO Soybean produces the enzyme CP4 EPSP-Synthase.This
enzyme was compared with existing allergens.
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.
The CP4EPSP-Synthase molecule is not resistant to digestion, being destroyed
in the stomach within 15 seconds.
Typical allergens are bound to long chained sugars , the new enzyme does not
have sugar in his molecule.
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)
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.
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.
[327] 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:
- Possible health- and environment risks are eliminated,
- An acceptable solution concerning labeling of GMO food is found,
- The national agriculture and the distribution system of food is
protected against distortion of trade.
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.[877]
Only Germany and Spain have authorized the use of genetic modified maize. All
other member s of the EU do not accept it.
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).
The exporter and cereal specialist Northland Seed and Grains in
Minnesota guarantee its products to
be 100% GMO-free (April
1999)[879].
Two great cereal buyers accept only grains which can also be sold in Europe.
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
[907].
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.[950]
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. [952]
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.
[951]
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. [953]
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.
The FAO maintains the International Rice Commission IRC which coordinates
international activities to increase rice yields:
[954]
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 [954]
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).
[954]
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.
[955]
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.
Professor Joe Cummins in his review, points out some overlooked dangers of
genetic engineering of rice in Japan.
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 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.
[955]
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
[955]
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.
[955]
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.
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.
[955]
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.
[956]
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.
[957] [958]
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.
[959]
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.
[699]
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.
[700]
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.
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.
[701]
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."
[702]
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.
[702]
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)
[703]
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
[706] [707]
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.
[708]
[709]
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.
[709]
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[709] 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)
US-citizens claim for GMO-labeling in a petition which has been given to the
Congress as there are no rules from FDA.
[710]
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.
According to the WTO, the relevant EC scientific committees had recommended
approval of all 25 product applications. But for transparently political
reasons rather than concerns about consumer health or environmental
protection, EU politicians repeatedly refused to sign off on the final approvals.
France will impose a GM ban if serious safety doubts are
presented
[711]
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.
[712]
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.
[713]
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. [714]
[715]
GM maize NK603xMON810 from Monsanto was found by Juergen Zentek and
colleagues 2008 to affect reproduction in mice, but these findings cannot be
applied on humans. Female mice that were fed with the genetic modified maize
had fewer babies and fewer litters compared with mice fed with non-GM maize.
The study was presented by the Austrian health and food safety agency AGES, by
Vienna's University of Veterinary Medicine. The authors of the study call for
more research to confirm the effect of GM maize on other animals and on humans.
[716]
On the 22.05.2008 the French parliament passed a bill on general principle for
the freedom to produce and consume GM organisms as long as there is no harm
to public health or to the environment. However, it does not say how the level
of risk to public health will be determined. Long-term health risks on GM
exposure are still unknown. [717]
According to the bill the nature and location of GM cultivation will be recorded
in a national register. The distance between GM crops and conventional crops
will be dependent on the type of plant. Environmentalists say the bill is to weak
to prevent cross contamination of conventional crops.
Sabotage of the GM plantations will be severely punished with a two year jail
term and a fine of EUR 75,000 for destroying GM crops and more severe
penalties if the destroyed crops were intended for research.
The new bill will not end the ban on GM crops in France, however, observers
say it is a step back towards GM acceptance. France has the highest increase of
GM cultivation in Europe.
[718]
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.
[719]
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. [720]
[709]
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.
[721]
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.
In September 1999 the cultivation of genetic modified
soybean[844]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)
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."
Human embryonic stem cells (hESCs) are cells that are derived from the inner
cell mass of blastocyst stage human embryos, are capable of dividing without
differentiating for a prolonged period in culture, and are known to develop into
cells and tissues of the three primary germ layers. Although hESCs are derived
from embryos, such stem cells are not themselves human embryos. [847]
[845]
The U.S. government approved batches of human embryonic stem cells. These stem
cells may now be used in federal funded researches. With the Executive Order
13505 restrictions in the use of stem cells imposed by the foregoing
administration, were lifted by Obama in March 9, 2009. The Dickey-Wicker
amendment (SEC.509) imposed by the Congress is still active. This amendment
forbids the use of federal money for stem cells which require destruction of a
human embryo. The use of these cells, made by others, however, are eligible
for public funding. [846]
To avoid critics of organisations which say it is wrong to destroy human embryos
for any reason, the NIH published the NIH Guidelines for Human Stem Cell
Research. [847]
[848]
SEC.509: (a) None of the funds made available in this Act may be used for-(1) the
creation of a human embryo or embryos for research purposes; or (2) research in
which a human embryo or embryos are destroyed, discarded, or knowingly subjected
to risk of injury or death greater than that allowed for research on fetuses in
utero under 45 CFR 46.204(b) and section 498(b) of the Public Health Service Act
(42 U.S.C. 289g(b)). (b) For purposes of this section, the term "human embryo or
embryos" includes any organism, not protected as a human subject under 45 CFR 46
as of the date of the enactment of this Act, that is derived by fertilization,
parthenogenesis, cloning, or any other means from one or more human gametes or
human diploid cells.
[849]
Nuclear reprogramming is a term used to describe changes in gene activity that
are induced experimentally by introducing nuclei into a new cytoplasmic
environment.
The transplantation of a somatic cell nucleus to an enucleated egg results in
a major reprogramming of gene expression and switch in cell fate.
[850]
Tian and colleagues 2007 assessed nuclear reprogramming and the potential
applications in agriculture and biomedicine, which were, however, found to be
of low efficiency. The authors compared nuclear reprogramming cells to those
generated by conventional reproduction. They found aberrant expression
patterns of H19 and Igf2r as well as X-linked genes in term cloned calves, and
the expression profiles of cloned blastocystst were considerably different
from those of their nuclear donor cells.
The authors concluded that cloned embryos undergone nuclear reprogramming by
the blastocyst stage. They stress that re-differentiation may result in gene
expression aberrancies, and small initial nuclear reprogramming errors may
increase during subsequent development.
[851]
Bui and colleagues 2000
stress that genomic reprogramming factors are located in the nucleus rather
than the cytoplasm of oocytes or zygotes, however, methods using nuclear
factors have not succeeded in producing cloned mice from differentiated
somatic cell nuclei.
The authors found that there are functional reprogramming factors present in the
cytoplasm of germinal vesicle stage (GV) oocytes which could remodel somatic cell
nuclei. Bui and colleagues concluded that genomic reprogramming factors are
present in the cytoplasm of the GV oocyte and could be useful in cloning
technology.
[852]
According to Zuccotti experiments in 2000 have demonstrated that mouse oocyte
can remodel the genetic programme of a somatic cells nucleus. The activation
of zygotic genes occurs in the mouse by the 2-cell stage and it is a crucial
event in the life of the newly formed mouse embryo as lack or wrong timing of
zygotic gene expression leads to the death of the embryo.
The authors concluded that the genetic reprogramming due to the injected somatic
nucleus must be completed before zygotic genome activation occurs. Better
understanding of the process of cell differentiation and the reversible process,
would allow reprogramming without the use of the female gamete.
[853]
Niemann and colleagues point out thatsomatic cell nuclear transfer (SCNT) is
frequently associated with pathological changes in the foetal and placental
phenotype and has significant consequences for development both before and
after birth. It involves an erasure of the gene expression program of the
respective donor cell and the establishment of the new sequence of expression.
Implicated processes like DNA methylation, imprinting, X-chromosome
inactivation and telomere length restoration in bovine development are
discussed by the authors.
[854]
Dieter Egli and Kevin Eggan explain the technique of nuclear transfer into
unfertilized mouse oocytes. This demonstrates that the processes underlying
development, differentiation and aging are epigenetic rather than genetic processes.
An epigenetic process is the attaching of a methyl group to a
gene, altering or silencing its function, but does not change the gene itself.
The authors stress the possible derivation of stem cells from a patient to
replace damaged or missing cells. The authors present a movie on the method
of of nuclear transfer developed by the group of Prof. Yanagimachi (WAKAYAMA et al. 1998).
See the movie: Nuclear Transfer, Dieter Egli and Kevin Eggan, Harvard University
at:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2504452
[856]
Kriaucionis and Heintz 2009 identified an additional character in the mammalian
DNA code, the nucleotide as 5-hydroxymethyl-2’-deoxycytidine (hmdC) which is a
constituent of nuclear DNA that is enriched in the brain. The authors suggest
that hmdC excerts a role in epigenetic control of neuronal function.
[6]
Epigenetics is the study of nongenetic factors that manage the regulation of
gene expression. Shilatifard and colleagues 2009, proposed a definition of in
which "an epigenetic trait is a stably inherited phenotype resulting from changes
in a chromosome without alterations in the DNA sequence." The authors also
proposed three categories of signals establishing a stably heritable epigenetic
state: The first is a signal from the environment, the second is a responding
signal in the cell that specifies the affected chromosomal location, and the
third is a sustaining signal that perpetuates the chromatin change in subsequent
generations. The amino acids adenine, thymine, guanine and cytosine (A, T, G and
C) make up the DNA code. Epigenetic studies found that two other nucleotide,
5-methylcytosine (5-mC), and the 5-hydroxymethylcytosine regulate the gene
expression. Gene silencing takes place when cytosine is methylated to
5-methylcytosine, induced by the enzyme DNA methyltransferase at sites where
cytosine precedes guanine in the DNA code. DNA methylation influences the
differentiation of embryonic stem cells into the different cell types that
constitute the diverse tissues of the body in the embrionic stage. Environmental
factors and experiences may cause methylation patterns influencing behaviours
that are heritable for several generations.
[856]
The identification of the sites of DNA methylation uses bisulfite sequencing.
Kriaucionis and colleagues found that this analytical method cannot
distinguish between 5-hydroxymethylcytosine and 5-methylcytosine and early
studies must be revised, such as the Human Epigenome Project which maps all
of the sites of methylation using bisulfite sequencing.
The role of 5-hydroxymethylcytosine is not clear, but the authors suggest that
it may play a role in demethylating DNA and have a positive role in regulating
gene expression as well.
[858]
DNA cytosine methylation is crucial for retrotransposon silencing and mammalian
development Rao et al 2009 identified proteins of the TET genes as the
2-oxoglutarate (2OG)- and Fe(II)-dependent enzyme that catalyzes conversion of
5mC to 5-hydroxymethylcytosine (hmC). TET proteins have potential roles in
epigenetic regulation through modification of 5mC to hmC. This enzyme may explain
the dynamic system of the expression of silencing of genes.
[855]
Studying the nuclear transfer (NT) techniques to generate embryonic stem (ES)
cells, Wakayama and colleagues 2008 found that cloning is possible using adult
somatic cells or embryonic stem cells, and nuclear transfer- embrionic stem
cell lines (NT-ES) may be established.
The authors note, however, that embrionic stem cells derived from
parthenogenetic embryos show epigenetic disorders.
Parthenogenesis is an asexual form of reproduction found in females where
growth and development of embryos or seeds occurs without fertilization by a
male. The offspring produced by parthenogenesis almost always are female.
Parthenogenesis occurs naturally in some species, including most lower plants,
a Kalanchoe succulent plant genus of South Africa, invertebrates (e.g. water
fleas, aphids, some bees, some scorpion species, and parasitic wasps), and
vertebrates (e.g. some reptiles, fish, and, very rarely, birds and sharks.
This differs from hermaphroditic species which can reproduce by themselves
because they contain reproductive organs of both sexes.
[859]
The researchers conclude that nuclear transfer affects the epigenetic status
of a few gene regions and suggest to use the change in the methylation status of
U2af1-rs1 as a genetic marker to investigate the effects of nuclear transfer.
[860]
Ducan and colleagues 23009 report the reprogramming of mouse skin
cells which resemble embryonic stem cell
and develop to liver-like cells. These cells may perform liver functions and
can be integrated in the liver tissue.
This could lead to the development of therapies which could replace liver
transplantation in advanced liver diseases, and be useful in the treatment of
diabetes, hyperlipidemia, and hypercholesterolemia.
The research was based on the work of James Thomson and colleagues which
described the reprogramming of skin cells, similar to embryonic stem cells,
the so called pluripotent stem cells which can develop to any of the body
different tissue cells following processes through which liver cells or other
body tissues are made during embryonic development. Thomson and colleagues
2009 describe the reprogramming of human differentiated human cells to induced
pluripotent stem cells (iPS) using
nonintegrating episomal vectors. After removal of the episome, iPS cells are
derived that are similar to human embryonic stem (ES) cells. The authors
stress that, using this method, the genomic integration or the continued
presence of exogenous reprogramming factors are not needed, opening the way to
reprogramming human somatic cells for clinical applications.
[861]
The use of embrionic stem cells is limited by ethical considerations and by the
fact that they do not have the same genetic make-up as the patient. These
difficulties could be eliminated reprogramming skin cells of the patient to be
treated.
[862]
Heintzman and colleagues 2009 stress that pluripotent embryonic stem (ES) cell
identity is governed by a set of transcription factors Oct4, Sox2 and Nanog,
and additional transcriptional modulators that bind to chromatin near sites
occupied by Oct4, Sox2 and Nanog. This combinatorial control of gene
transcription is fundamental to ES cell state, according to the authors.
The variety of functions of the cell of different tissues depends on promoters,
enhancers, insulators and other cis-regulatory DNA sequences for each gene. The
authors studied their cell-type-specific gene expression role and found that the
chromatin state at promoters and CTCF-binding at insulators is largely invariant
across diverse cell types, but enhancers are marked with highly
cell-type-specific histone modification patterns. The authors defined over 55,000
of such transcriptional enhancers in the human genome explaining their role in
cell-type-specific gene expression.
[863]
Zhang and colleagues 2009 studied the cardiac differentiation potential of human
iPS cells generated using OCT4, SOX2, NANOG, and LIN28 transgenes compared to
human embryonic stem (ES) cells using the embryoid body (EB) method. The authors
found that iPS cells have a capacity like ES cells for differentiation into
specific cardiac tissue. They concluded that human iPS cells can differentiate
into functional cardiac cells and are a cell source for cardiac repair.
[864]
Wakayama and colleagues 2008 report a successful cloning animals by nuclear
transfer from bodies kept frozen at −20
for up to 16 years without any
cryoprotection.
The authors used brain cell nuclei and established embryonic stem cell lines
from the cloned embryos, leading to healthy cloned mice.
The authors concluded that nuclear transfer techniques might clone frozen extinct
species such as the woolly mammoth frozen extinct species.
[866]
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.
[865]
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 [866]. This opinion was
prepared by European Group on Ethics in Science and New Technologies .
[867]
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
[867], 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.
[868]
The Eurobarometer survey on public attitutes toward animal cloning revealed a
strong public concern related to cloning for food production such as meat and
milk. Animal cloning has already been introduced in the US food industry and
the European Commission expects that meat and milk from cloned animals will
be worldwide on the shelves of retailers by 2010.
The European Commission will decide on cloning based on the results of the
Eurobarometer survey and a report of the EFSA on the safety of foods from cloned
animals.
Animal cloning is the creation of a genetically
identical copy of an existing or previously existing animal. The Flash
Eurobarometer survey asked citizens of the EU about their perception on
cloning: to clarify their attitudes towards animal cloning, and its perceived
effects on a number of areas including food safety, ethical and animal welfare concerns.
A large majority of EU citizens (81%) said they new the meaning of animal cloning.
The vast majority of EU citizens agreed that the long-term effects of animal
cloning on nature were unknown, animal cloning might lead to human cloning,
animal cloning was morally wrong, and cloning might decrease the genetic
diversity within livestock populations.
The majority of EU citizens would not accept animal cloning for food
production purposes, food industry would ultimately be benefited, only a
quarter of the population trust.
25% of the interviewees selected scientists as the most trusted source for
information. about the safety of cloned animals.
A majority of EU citizens said that it was unlikely that they would buy meat or
milk from
cloned animals, even if a trusted source stated that such products were safe to eat.
Eight out of 10 EU citizens said that special labelling should be required if
food products from the offspring of cloned animals become available in the shops.
[869]
The European Food Safety Authority (EFSA) is the keystone of European Union (EU)
risk assessment regarding food and feed safety. The EFSA in its opinion on the
safety of foods from cloned animals stated: “There is no indication that
differences exist in terms of food safety for meat and milk of clones and their
progeny compared with those from conventionally bred animals. However, such a
conclusion is based on the assumption that meat and milk are derived from healthy
animals which are subject to relevant food safety regulations and controls. Only
pigs and cattle are addressed in this opinion: the two species of animals where
adequate data were available.” The agency, however, stressed that data were
limited, samples were of small size and log time observation was not available.
[870]
The The European Group on Ethics in Science and New Technologies to the
European Commission (EGE) said in a Report in January 2008 that it did not see
convincing arguments to justify the production of food from clones and their offspring.
Considering the current level of of animal clones, the EGE find it ethically
not justified to clone animals for food supply considering suffering and
health problems of the animals. The EGE says that it does not see convincing
arguments to justify the production of food from clones and their offspring.
The EGE explains that the Somatic Cell Nuclear Technique (SCNT) used for animal
cloning is via three main steps:
- enucleation of an oocyte, performed mechanically by fixing the oocyte and
aspirating the nucleus by using a sharp glass pipette.
- transfer of the nucleus from the donor cell into the fertilized
enucleated oocyte by using a micro-manipulator and a microscope and applying a
short electrical impulse.
- activation and reprogramming of the reconstructed embryo. The exact
mechanisms are still unknown.
When the cloned embryo resulting from SCNT starts to develop it is transferred
to a surrogate mother, which carries out the pregnancy. So far, around a dozen
animal species have been cloned via SCNT. Animal clones that are relevant for
the food market include sheep, goats, bovines and pigs.
According to the EGE report 20% of cloned calves die in the first 24 hours
of birth and a further 15% before weaning. Those that survive the early stages
are likely to suffer in later in life through high mortality rates, ill health
and susceptibility to multiple organ failure. Cloned foetuses are also often
25% heavier than normal which causes severe problems for surrogate mothers
when giving birth.
[871]
According to Neil Parish, chairman of the Agriculture Committee, and Member of
the European Parliament, the current animal cloning technology is considered
primitive and many clones die in the early stages of life. Parish concludes
that cloned animals suffer from many more ailments and generally live far
shorter lives. From an agricultural perspective, there are serious questions
over the effect of this on the gene pool, making cloned animals far more
susceptible to disease.
The European Commission should move to ban animal cloning for food until the
science has proven it is safe for them to enter the food chain.
[872]
According to the Center for Food Safety the Food and Drug Administration's
(FDA) in January 2008 determined that milk and meat from cloned animals are
safe for sale to the public. In addition, the FDA is requiring no tracking
system for clones or labelling of products produced from clones or their
offspring.
In its risk assessment of cloned food, the FDA claims to have evaluated
extensive peer reviewed safety studies to support its conclusion, yet a recent
report issued by CFS shows the assessment only references three peer-reviewed
food safety studies, all of which focus on the narrow issue of milk from
cloned cows. [873]
Recent opinion polls show the majority of Americans do not want milk or meat
from cloned animals in their food.
The Centre for Food Safety welcomes the Mikulski-Specter amendment of the Farm
Bill addresses the gaps and inadequacies of the FDA's current risk assessment.
The amendment requires a rigorous and careful review of the human health
impacts of allowing clones food into America's food supply to be conducted by
the National Academy of Science before any food products from clones are
marketed. It also directs the USDA to examine consumer acceptance of cloned
foods and their likely impact on domestic and international markets.
[874]
[2997]
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. [2998]
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.
[2999]
In its final scientific opinion on the implications of animal cloning on food
safety, animal health and welfare and the environment the EFSA stated in June
2008. Some of the key conclusions of the opinion include:
-There are significant animal health and welfare issues for surrogate mothers
and clones that can be more frequent and severe than for conventionally bred animals.
- There are only little data available concerning cloned foods.
- A high number of cattle and pigs clones presented severe health and welfare
adverse anomalies.
- Somatic Cell Nucleus Transfer (the most common technique
used to clone animals) has resulted in the production of healthy cattle and pig
clones.
- No differences between food products from clones or their offspring,
in terms of food safety, compared to products from conventionally bred animals
if healthy animals which comply with the relevant food safety regulations and
controls.
- No environmental impact is foreseen but there are only limited
data available.
- The health and welfare of clones should be monitored during
their production life and natural life span, and further causes of
pathologies and mortality, the immunocompetence and the susceptibility of
clones and their offspring to diseases and transmissible agents should be
investigated.
[3000]
The BBC News report (05.03.2008) that a commercial breeder placed two
offspring of a cloned cow to sail on an auction at Easter Comton UK. However,
the animals were withdrawn later on because of negative publicity.
The Compassion in World Farming (CIWF) group said that the selling would bring
cloning out of the laboratory and on to the farm. The group stresses that they
are opposed to cloning on the basis of the animals' welfare.and also there has
not been enough research into whether or not there are dangers of the meat or
milk entering the food chain.
The Italian farmer' group Coldiretti says that cloned foods are an unacceptable
risk. [3001]
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. [3003]
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.
[3004]
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. [3004]
[3005]
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. [3002]
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.
[3006]
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.
[3007]
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.
[3008]
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.
[3009]
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.
[466]
Foods produced from cloned animals fall under Regulation (EC) No 258/97
(Novel Foods Regulation). 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. [3011]
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.
[3012]
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.
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.
[3013]
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:
- The cloning of animals for food supply
- The farming of cloned animals or their offspring
- The placing on the market of meat or dairy products derived from
cloned animals or their offspring
- 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.
The Ethic Group in its Opinion
23[3009] stresses that it should be clarified whether
the exclusion clauses in Directive 98/44/EC (Art. 6)[3010] on
patentability of biological inventions and the EPO rules (23) to animal cloning for food
apply.
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 spread in nature contaminating other plants Farmers would be than
unwillingly colliding with patent claims. According to the German Farmer
Union are plants and animals a part of natural life basics and should not be
withdraw from general availability. Plants and animals are part of nature and
should not be put under the monopoly of certain business groups.
[3009]
Assisted reproductive techniques (ARTs)are:
![\includegraphics[width=335bp, height=450bp]{library/clone.eps}](img70.png)
Animal cloning using somatic cell nuclear transfer
(SCNT):
Whereas all of
the current methods still involve taking sperm from a male and joining it with an
egg from a female, cloning is the ability to create an exact copy of a biological
entity by means other than the joining of a sperm and an egg. Genetic diversity
is strongly reduced in the offsprings. The lack of genetic diversity makes the
species vulnerable to environmental changes like new diseases and early aging.
Artificial Insemination:
Involves the collection of semen from bulls which can then be used to
artificially inseminate cows. It is possible to freeze the semen, store it for
longer and make it more widely available. Genetic diversity is not affected.
Oestrus Synchronisation:
Involves giving hormone implants and injections to ensure a group of cows are
ready for breeding at the same time, being used together with artificial
insemination. Genetic diversity is not affected.
Embryo Transfer:
Just as artificial insemination is used to produce lots of calves from a single,
prize bull, embryo transfer is used to produce more offspring from a prize cow
stimulated with a hormone to produce a number of eggs at once. The cow is then
mated and many of the eggs are fertilised and start to develop. The embryos are
flushed out surgically and implanted into the uterus of surrogate mothers where
they are brought to term. Genetic diversity is not affected.
In Vitro Fertilisation:
This is a similar process to embryo transfer except the unfertilised eggs of the
prize cow are fertilised in an incubator before being transferred to surrogate
mothers. Genetic diversity is not affected.
Sexed Semen:
The purpose of this is to produce a higher proportion of female calves. Genetic
diversity is not affected.
GMO rapeseed in Europe
GMO-rapeseed has been released in Europe by Advanta Seeds without knowledge
of the farmer. The GMO-seed was distributed in large scale in Germany,France
and Sweden and England for two years. France and Sweden gave order to destroy
the GMO- fields. German Environment Ministry says that there is no regulation
to force the destruction of the German fields as there is no direct menace
to public heath. This is a sign of inexcusable weakness of the German
Environment Ministry which is unable to protect purity of nature. Advanta
Seeds says that it was a mistake but it is supposed to be a strategy of the
seed companies to contaminate rape seeds with GMOs in order to avoid the
GMO-free alternative to GMO-Soya which is being refused by retailers in
Europe.
The contamination of nature is getting ahead because logistics, flying
pollen, handling during processing in storage, on ships and trucks.
GMO Sugar beets in Germany
According to daily news from 10.10.2000 sugar beet plants were genetically
modified and not allowed released by KWS SAAT AG in Einbeck (Kreis
Northeim) Germany. They are resistant to the herbicide Round up. KWS SAAT
AG says that it was a technical mistake which caused the release. This is
the proof that genetic technology is being handled careless. It also may be
a part of a strategy to contaminate nature in order to avoid the GMO-free
alternative. It is possible that the gene passes over to weed turning these
plants resistant to herbicides.
To counter the growing contamination of nature with GMOs the European
retailers urge the producers to guarantee GMO-free production. Even the 1%
contamination which is granted as unavoidable contamination with GMO in
connection with GMO-free labeling is not allowed in their products.
Recall of Aventis GMO maize "StarLink"
Aventis has started a recall of its GMO maize "Starlink" according to press
release from 12.10.99 due to pressure from US- Agriculture Ministry and the
Environment Protection Agency ( EPA ).
StarLink is a variety of Bt corn that has been genetically engineered to
produce a protein, Cry9C, intended to be toxic to certain insect pests of
corn.
StarLink maize was liberated for animal feed. This GMO maize was sold by
farmers to the Azteca Mill in Texas. The maize meal produced from StarLink
seed was sold to Kraft as ingredient to the Taco-Bell foods.
Half of the crop of StarLink was sold to the farmers of Iowa. In Europe
StarLink was mingled with non-GM seeds. Now almost all plantations are
potentially contaminated with StarLink.
Starlink Maize contains a protein which is supposed to cause allergic
reactions on humans.
Some Japanese importers denied to import StarLink-Maize as animal feedstuff to
avoid the possibility of being used for human food.
Aventis Crop-Science says there will be no sells on seeds of Starlink in
20001.
Monarch butterfly and the Bt maize
Many reports affirmed that the Monarch butterfly was killed by
toxic compounds of the Bt maize which has parts of the genes of
Bacillus thuringiensis. According to the Environmental Protection
Agency (EPA) reviews of scientific informations indicates that there
are very little risks for the butterfly. Some authors even predict benefits to
the butterfly from farming of corn, cotton and potato Bt plants.
John
Obycki and Laura Hansen of the Iowa State University had demonstrated that
larvae of monarch butterflies grew more slowly and suffered a higher mortality
rate when being fed milkweed leaves with deposition of pollen from insect
pest tolerant GM maize as sole food source to monarch larvae, causing 20%
mortality in larvae within 48 hours with one variety of GM maize. The
Environmental Protection Agency trying to reach decision regarding renewal of
registrations for several Bt products argues that the situation is different
from that prevalent in natural environment.
The larvae of the monarch
butterfly feed on milkweed plants mostly in June whereas the peak time of
maize pollen shed is from mid-July to August.This allegation however is
insignificant as toxic materials for living beings are present bt maize is
therefor harmful for nature.
GM Maize Mon 863:
[3014]
At the request of the European Commission the Scientific Panel on Genetically
Modified Organism (GMO Panel) of the European Food Safety Authority (EFSA) has reviewed an evaluation report
concerning GM maize MON 863 submitted by Germany regarding the safety of the
insect-protected genetically modified maize MON 863. Results of the rodent
toxicity study with MON 863 maize did not indicate concerns about its safety
for human and animal consumption. (20 October 2004)
[3015]
The maize for animal and human in many countries, including the EU, Japan,
Mexico and the USA.
Signs of liver and kidney disruption: Seralini and colleagues at CRIIGEN
(Committee for Independent Research and Genetic Engineering) based at the
University of Caen, in a study supported by Greenpeace, found signs of liver
and kidney toxicity in rats fed with transgenic maize MON863 which expresses
the bt-toxin (Cry3Bb1) protecting against the corn rootworm pest. According to
the researchers, It appears that the statistical methods used by Monsanto were
not detailed enough to see such disruptions in biochemical parameters.
[3016]
The authors found significant differences in the weight gains data , with
differences between male and females, and suggest that this could be due to
endocrine disruption and/or hormonal metabolism differences caused by the GM
corn MON863.
It is not known whether the signs of
toxicity are caused by the Bt protein, or from some changes in the plant's own
DNA caused by the genetic engineering event. The authors cannot conclude that
GM corn MON863 is a safe product. Companies should be more rigorous in the
studies and ensure that their data stands up to scrutiny, and the regulatory
authorities such as the EFSA in Europe [3017], should demand
more complete data before approving any crop.
[1527]
The EFSA has examined a paper by Séralini et al. on the statistical
evaluation of a 90-day feeding study in animals with genetically modified maize
MON863, to identify any consequences for EFSA's risk assessment of the safety
of MON863. The paper presents an alternative statistical analysis of the 90-day
rat study that was considered in the original risk assessment.
Following a detailed statistical review and analysis by an EFSA Task Force,
EFSA's GMO Panel has concluded that this re-analysis of the data does not raise
any new safety concerns.
The main conclusions are:
- The statistical analysis made by the authors of the paper did not take into
account certain important statistical considerations. The assumptions
underlying the statistical methodology employed by the authors led to
misleading results.
- EFSA considers that the paper does not present a sound scientific
justification in order to question the safety of MON 863 maize.
- Observed statistically significant differences reported by Monsanto,
Séralini et al., and EFSA, were considered not to be biologically relevant.
Therefore, the GMO Panel sees no reason to revise its previous Opinions that
the MON 863 maize would not have an adverse effect in the context of its
proposed use. Prior to this most recent work, MON 863 maize has been subject to
a comprehensive risk assessment by EFSA and by other authorities which did not
identify any adverse effects on human and animal health or the environment. In
addition to the original Opinion in April 2004, this study has been reviewed
again twice since then, prior to this recent work.
Other related documents:
Letter to the Commission
http://www.efsa.europa.eu/en/about_efsa/structure/who_is_who/home_cgl/correspondence.html
The GMO Panel statement
http://www.efsa.europa.eu/en/science/gmo/statements0/gmo_statement_mon863_ratfeeding.html
EFSA statistical analysis of the Monsanto data
http://www.efsa.europa.eu/en/science/scientific_reports/statistical_analyses_MON863.html
[1528]
The safety assessment of GM plants
and derived food and feed follows the approach widely accepted by international
organisations such as the FAO/WHO, Codex Alimentarius and the OECD. It is
based on comparison with conventional counterparts to identify intended and
unintended differences.
The Report is a basis for deciding whether animal feeding trial studies are
needed for the safety and nutritional assessment of GM food and feed. The
report was published by the EFSA in March 2008.
The EFSA is working with member states to update risk assessment guidance for
GMOs. These guidelines remain voluntary, however all member states do use them.
[1529]
Horizontal gene transfer from genetically modified
crops to gut microflora most likely occurs with transgenes of microbial
origin. Kleter, Peijnenburg and Aarts reviewed the function and
characteristics of microbial transgenes and their horizontal transfer other
than antibiotic-resistance genes in market-approved genetically modified
crops. The authors concluded that the microbial genes reviewed in their
study do not give rise to health concerns, and recommend to include all other
transgenes not assessed in this study in the premarket safety assessment of
genetically modified crops carrying transgenes.
The authors analyse the speculations that an increased survivability of
pathogens in the environment may indirectly increase the likelihood of
exposure to these pathogens. The authors associate this with the presence in
soil fungi of analogues of the bacterial gene coding for beta-glucuronidase
might originate from a horizontal transfer between bacteria and fungi, which
have been reported.
The authors stress that safety assessment should follow internationally
harmonised approaches such as the FAO/WHO Codex Alimentarius guidelines for
the safety assessment of foods derived from GM plants and microorganisms.
[1529] [1530] [1531] [1532] [1533]
[1534] [1535]
The authors point to the fact that the transfer of herbicide resistance genes and
others may, in theory, provide a selective advantage to soil microorganisms
sensitive to herbicide action, and an increased survivability of pathogens in the
environment may indirectly increase the likelihood of exposure to these
pathogens.
[1529]
Genetic engineering of BXN into crop
plants renders them resistant to application of the herbicide bromoxynil. No
direct impact of this gene on human or animal health is foreseen if it were to be transferred
to pathogens given the apparently specific role of this gene in soil
environments, according to the authors.
The source of the cp4 epsps gene was the soil bacterium Agrobacterium
strain CP4, which was one out of a group of glyphosate-degrading bacteria. The
authors concluded that there is no indication that the potential transfer of the
cp4 epsps gene from GM crops to microorganisms would alter the pathogenicity.
The source organism Achromobacter
LBAA was one of the bacteria isolated from activated industrial and domestic
sludge that were capable of degrading glyphosate. Glyphosate, which is converted
by GOX, has no role in the treatment of human and animal disease. A potential
transfer of GOX from transgenic plants may therefore, not increase
pathogenicity of recipient microorganisms.
Streptomyces
hygroscopicus (bar gene) and Streptomyces viridochromogenes (pat gene) are
streptomycetes that occur in soil and produce the natural herbicide bialaphos
(phosphinothricin-alanine-alanine). PAT shows substrate specificity for
phosphinothricin and similar compounds, a natural antibiotic which is not used
in treatment of human and animal disease. The transfer of the PAT enzyme is
unlikely to confer increased pathogenicity to pathogens.
The genes
encoding Barnase and Barstar have been cloned from Bacillus amyloliquefaciens
which is not pathogen. The authors concluded provisionally that the potential
transfer of the barnase and barstar transgenes is unlikely to influence the
pathogenicity of recipient microorganisms.
The dam gene has been isolated from Escherichia coli. Genes
encoding adhesins, siderophores, and toxins, are linked with mobile genetic
elements are not present in non-pathogenic strains used to derive the dam
transgene. Transfer of the dam transgene would not impact on the pathogenicity
of recipient microorganisms, according to the authors.
The gene encoding
the 1-aminocyclopropane-1-carboxylate (ACC) deaminase has been isolated from
Pseudomonas 6G5. The authors concluded that the potential transfer of the ACC
deaminase transgene from GM crops is unlikely to contribute to pathogenicity of recipient
microorganisms.
The SAMase
gene encoding the enzyme S-adeno-sylmethionine hydrolase (SAMase), is derived
from the E coli bacteriophage T3, which prevents bacteriophages from degradation
by infected bacterial hosts. The authors concluded that
horizontal transfer of SAMase is unlikely to contribute to pathogenicity to
recipient bacteria.
The uidA gene, which codes
for the beta-glucuronidase (GUS) enzyme, has been isolated from E coli. The
authors concluded that the horizontal transfer of GUS will not pose a safety risc.
The native
tumor-inducing plasmid pTiC58 of Agrobacterium tumefaciens strain C58 harbours
among others the gene nos encoding nopaline synthase. The authors say that a
horizontal transfer to microorganisms would not affect human and animal safety.
The source of the cry genes used for genetic
modification of crops is Bacillus thuringiensis, which produced spores containing
crystals that are toxic to insects. Reviews of safety data found no toxicity
of Cry proteins to humans. The authors found no threat to humans and domestic
animals should a transfer to microorganism take place.
The complete genetic sequence of the nitrogen fixing bacteria
Sinorhizobium meliloti[1536]
has been published.
Nitrogen is essential for the growth of plants. It can be supplied in
form of:
1. Nitrogen fertilisers such as ammonium ions (NH
) which is
30% of the total amount needed
2. Atmospheric nitrogen are built through various natural processes
representing 40% of the total amount needed by the plants.
3. Atmospheric nitrogen obtained by reduction caused by symbiosis
between legumes and bacteria known as Rhizobium,
reducing atmospheric nitrogen into ammonium ions which can be used
for the synthesis of proteins and nucleic acids.
Field peas in Australia were heavily attacked by the field pea
weevil Bruchus pisorum.
The Commonwealth Scientific and Industrial Research Organisation (CSIRO)
developed a GM field pea which was resistant to the weevil.
A gene from beans
introduced in the field pea blocked the activity of the alfa-amylase enzyme.
This enzyme is important for digestion of starch. Weevil larvae feeding on
starch in the developing pea seed are unable to digest the starch and starve.
Beans with the alfa-amylase inhibitor gene were eaten by humans for many years
without evidence of an immune response. However, according to Dr. Simon
Hogan and Professor Paul Foster at the
John Curtin School of Medical Researche the peas with the same alfa-amylase
inhibitor gene did cause an immune response in mice, resulting in
inflammation of the lung tissue .
Subtle changes that occurred in the chemical structure of the bean alfa-amylase
inhibitor as it was introduced in the field pea are responsible for the immune
responses. These changes in structure is probably being caused by
glycosylation, which occurs when proteins are made via a particular pathway in
cells.
The introduced bean protein had to go through a pathway in cells where it would
undergo several processing steps including glycosylation. Glycosylation can
differ from organism to organism and even in different cell types within an
organism causing the immune response in GM field peas.
CSRIO decided not to progress development of these GM field peas.
[3130]
Lycopene is
the red colour of tomato and is used in nutraceuticals as strong antioxidant,
reducing risk of prostate cancer and heart diseases. It is obtained by
extraction and purification from the carotinoids from tomatoes. Agricultural
Research Service (ARS) in Illinois have genetically modified the fungus
Fusarium sporotrichoides to manufacture lycopene using corn fibre
material which is a leftover of the production of ethanol.
Timothy Leathers, a geneticist working at the National Center for Agricultural
Utilisation Researche changed the metabolic pathway of natural trichothecene
toxins of Fusarium sporotrichoides resulting in the production of
lycopene in February 2004.
The robust pepper varieties, developed at the Hebrew University of Jerusalem,
widen the ecological conditions under which the vegetable can be grown.
The new hybrid peppers, which come in various colours, have been raised to
produce high yields under night time conditions as low as 10 degrees celcius.
This is much lower than previous hybrids that required temperatures higher than
18 degrees celcius and needed costly heating to grow and develop.
The breeding project involved large-scale experiments with more than 25,000
plants a year, grown in target areas, mainly in the Arava region of southern
Israel and the south of Spain. Dr. Elkind noted that vegetable production under
mild winter conditions and using simple plastic or net protection is one of the
most rapidly expanding, protective cultivation systems worldwide.
The major areas which use this production method, in addition to Israel and
Spain, are Mexico and China.
Source: The Hebrew University of Jerusalem.
[3131]
The study said that French Bt corn acreage is expected to boom from 500 ha in
2005 to 5,000 ha in 2006, as a result of the economic advantages experienced by
Bt corn growers in 2005.
According to the Global Agriculture Information Network (GAIN), backed on
French press reports, biotech corn cultivation is increasing rapidly, since
2005. Marie-Cécile Hénard writes is this report that pervasive presence of
the European corn borer in Southern France provides strong incentive for
further expansion. Bt corn provides an effective and profitable remedy against
the European corn borer in this region.
French consumer resistance leaded by José Bové and other opponents of GM
crops in France tried to to destroy GM fields. José Bové characterized
commercial GM corn grown in France as "outlaw crops".
The findings of this pro-GM study suggest that the historical rejection of GM
technology in Europa is on the wane. The WTO of course famously ruled earlier
this year that Europe had violated its trade rules by banning GM food imports
between 1999 and 2003.
The EU's approach to GM food regulation was criticised by pro-GM lobby for
having little theoretical basis, and pandering to the fears and prejudices of
its citizens. The EU's precautionary principle says that regulators should err
on the side of caution, assuming that a prevention strategy is always
appropriate.
Drought and fungal resistant GM wheat
[3132]
The BASF plant biotechnology company, together with Australian research centre
Molecular Plant Breeding CRC, CropDesign, a Belgian biotech company, that
specialises on traits for yield-enhancement, drought tolerance and improved
nutrient use efficiency of crops such as corn and rice.
These companies have built in 2006 the platform for the development of crops
with higher yields, drought tolerance and resistance to fungal diseases.
Corn and wheat are the most important cereals. Drought and fungal diseases
reduces yields in arid areas, Australia and Europe. These new breeds will help
to overcome these serious crop losses.
Romania is growing large quantities of GM
soybeans. A large part of which is exported to the European Union for use in
animal feed. According to Simon Barber Romanian farmers would be in competitive
disadvantage versus Brazilian, Canadian and US soybean suppliers, who are
already exporting this same product to the EU. [3133]
Monsantos Maize MON 810 had been approved before the EU biotech ban in 1998.
Mon 810 has been assessed as safe for human health by the EU Commission. In
conclusion, the Panel considers that the information available for MON 863 x
MON 810 maize addresses the outstanding questions raised by the Member States
and considers that it will not have adverse effects on human and animal health
or the environment in the context of its proposed use.
In 2004 17 different seed strains of this maize have been allowed to be sold
and grown in the EU.
Greece, however, held its ban despite not having provided any validated
scientific evidence to support a ban, appealing against the EC's order at the
European Court of Justice, the highest EU court. [3136]
Luxembourg, Greece and Austria consistently vote against GMO approvals, while
the UK, Finland and the Netherlands almost always vote in favour of any new GM
authorisation.
Friends of the Earth (FoE) supports the biotech ban of Greece claiming that
Monsanto's Roundup Ready soybeans, the most extensively grown GM crop today,
has led to an increase in herbicide use. Independent reports from the US show
that since 1996, GM corn, soybean and cotton have led to an increase in
pesticide use of 55 million kilos.[3137]
Juan Lopez of Friends of the Earth International said in Kuala Lumpur that the
safety of GM crops cannot be ensured, that they are neither cheaper nor higher
quality and that they are not the magical solution to solve world hunger.
[3138] [3139]
The International Service for the Acquisition of Agri-biotech Applications
(ISAAA) argue that the benefits of the technology to the food industry have
simply become irresistible. The ISAAA is a not-for-profit organization that
delivers the benefits of new agricultural biotechnologies to the poor in
developing countries aiming to share these technologies to those who stand to
benefit from them and at the same time establish an enabling environment for
their safe use.
Emerging economies such as China, Brazil, Argentina and India are likely to be
the greatest growth regions for the use of biotech foods Iran started to plant
biotech rice in 2005 as being the first country to do so. [3140]
According to ISAAA for the first time the absolute growth in the biotech crop
area between 2003 and 2004 was higher in the developing countries (7.2 million
hectares) than in industrial countries (6.1 million hectares). The organization
highlites that the percentage growth was almost three times as high (35%) in
the developing countries of the South, compared to the industrial countries of
the North (13%). [3141]
[3142]
The European Commission decided today to require compulsory certification for
the imports of Chinese rice products that could contain the unauthorised GMO
Bt63. The decision has been taken after rice products -originating in, or
consigned from, China and containing the unauthorised genetically modified
rice "Bt 63" were discovered in the EU market between 2006 and 2007.
The presence of the unauthorised Bt63 was first discovered in the United Kingdom,
France and Germany in September 2006. Despite measures announced by the Chinese
authorities in 2007, alerts concerning the presence of the unauthorised
genetically modified rice "Bt 63" were reported until late 2007.
The emergency measures adopted by the
Commission mean that, as of April 15, only consignments of the rice products
indicated in a specific Annex of the Decision can enter the EU. These
consignments must be tested by an official or accredited laboratory using a
specific testing method and accompanied by the analytical report assuring they
do not contain Bt63.
China is responsible for ensuring that Bt63 does not enter the EU food chain
and that imports are certified as free from this unauthorised GMO. Member
State 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 Bt63.
Business operators importing rice products from China are also responsible for
ensuring that Bt63 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.
[3143]
EVIRA, the Finnish Food Safety Authority reports that samples of rice
vermicelli were found to contain the non-authorised genetically modified rice
"Bt63". The product was withdrawn from the market and destroyed. One soy bean
jelly sample contained genetically modified soy in excess of the 0.9%
labelling limit. The importer was ordered to change the labelling of the
product. The expression "genetically modified" or, e.g., "prepared from
genetically modified soy" must appear in the declaration of ingredients right
after the genetically modified ingredient if it exceeds 0.9%. [3144]
Food products containing soy and maize (e.g. tofu products and precooked food
products) as well as from Chinese and American rice products, and organic foods
were included in sampling plan. All the analysed organic samples tested negative
for GM ingredients.
[3145]
According to Green Peace a series of scandals erupted in 2006 as world rice
supplies were discovered to be contaminated with unapproved genetically
engineered (GE) rice varieties. Field trials of GE rice in the US and the
illegal sale of rice seed in China led to unapproved GE rice entering global
food supply chains. Contaminated food stocks were found and pulled from
shelves in European stores. Widespread bans on US-produced rice were enacted.
The latest GE contamination scandal shows that once GE organisms are released
into the environment, the consequences for consumers, farmers and traders are
enormous. As a result, farmers, millers, traders and retailers around the
globe are facing massive financial costs, including testing and recall costs,
cancelled orders, import bans, brand damage and consumer distrust-distrust
that could last for years.
Lawsuits have been filed by US rice farmers against Bayer CropScience already, as
farmers struggle to protect their livelihoods from GE contamination. On the other
side,WTO has published a ruling on a case brought against the EU by the US,
Canada and Argentina over Europe imposing restrictions on the importing of GE
food.
[3146]
The two giants wich dominate agricultural products joined at March 21, 2007 The
cooperation will focus on the development of crops with higher yields and crops
that lead to consistent yields under adverse environmental conditions, such as
drought.
The most promising candidate genes of both companies will be advanced for
accelerated joint development and for commercialization by Monsanto.
The two companies expect to generate a greater number of viable research
projects than they could have done on their own, accelerate the development of
new products, and bring a greater number of traits to the market at a faster
speed.
Monsanto will receive 60 percent of net profits and BASF will receive 40
percent of net profits.
Dr. Paul Verma from the Dairy Cooperative Research Centre (CRC) made
researches on the multiplication of bovine ES-like cells stem cell lines from
bovine embryos.
Results from this research have many implications for the application of
advanced breeding technologies in dairy cattle and other livestock. Advanced
stem cell technologies offer the opportunity to improve performance of
IVF-based animal breeding systems (in vitro fertilisation). In the dairy
industry, this can help to shorten the interval between generations of animals
and speed up the entire process of genetic improvement.
This system requires the use of embryos rather than semen in artificial
breeding technology. Molecular diagnostics are being developed to allow
precise monitoring of genes in embryos before they are implanted.
According to CRC the monitoring technology allows the healthiest, most viable,
embryos to be identified and implanted which will improve success rates and
lower costs. [3147]
The Scientific Panel on Genetically Modified Organisms (GMO Panel) of the
European Food Safety Authority (EFSA) issued in 2005 an opinion on genetically
modified potato EH92-527-1 (Unique identifier BPS-25271-9), with an altered
starch composition (higher amylopectin:amylose ratio).
The BASF Plant Science GM potato EH92-527-1 is derived from the cultivar
Prevalent. Potato leaf discs were transformed by Agrobacterium-mediated gene
transfer technology using kanamycin resistance gene (nptII) as selectable
marker. The modification involves inhibition of the expression of granule bound
starch synthase protein (GBSS) responsible for amylose biosynthesis. The starch
produced has little or no amylose and consists mainly of amylopectin.
Amylopectin starch potatoes are mainly used for the production of starch for
industrial purposes, and the potatoes are not intended for direct human
consumption. However it might also be used as food.
Potato rarely survives outside the cultivated environment and there is no
indication of enhanced weediness or invasiveness of potato EH92-527-1. Potato
has no cross-compatible wild relatives in Europe. Since the natural exchange of
genetic material is only possible with other varieties of potato, there is
negligible risk to the environment of any transgene flow. Therefore, no
unintended environmental effects due to the establishment and spread are
anticipated.
In the unlikely event that horizontal transfer of gene sequences would occur
between the GM potato and bacteria, the bacteria would not pose any additional
risk to human health or the environment.
No adverse effects on plant-associated organisms and soil function have been
observed or would be likely from cultivation of the potato EH92-527-1. In
addition, the GMO Panel agrees with the approach proposed by the applicant in
the environmental monitoring plan.
EFSA found that the BASF GM potato is unlikely to have an adverse effect on
human health or the environment in the context of its proposed uses.
[3148]
[3149]
The Federal Office of Consumer Protection and Food Safety (BVL) approved the
release of genetic modified potato, developed by BASF Plant Science in ten
cultivation areas in Germany between 2007 and 2011. The approval is extended
all over Germany, including Bavaria. The BVL does not expect any safety
incidences which might endanger man and animals.
The marker gene used in these potato varieties, makes them resistant against
the antibiotic kanamycin. The European Food Safety Authority has already
identified no safety concerns which may have an adverse effect upon approval.
- The safety distance to conventional potato crops should be 10 metres.
- The aerial part of the plant must be destroyed chemically or physically
before the harvest of the GM potato.
- The crops must be identified.
- The cultivation areas must be monitored for new breeds one year after GM
use, if GM potatoes are found, the monitoring must be extended for another
year.
The gene of the tale cress weed Arabidopsis thaliana together with a gene of a
wild potato changes the starch composition of the potato . 677 strains of GM
potatoes will be tested. Some strains will express amylose, other will
express only amylopectine. They are tolerant to the herbicide Imazamox.
[3150]
On 7 March 2007, The Council of State in The Netherlands judged that the field
trials of BASF concerning three GM potato herbicide-resistant varieties, two
with changed starch content and one with high late blight resistance, were
illegal and destroyed the permits immediately.
Intragenic Ranger Russet potatoes
[3151]
Compared to more commonly used Russet Burbank,
which is already 131 years old, the Ranger Russet has superior yields and
greater disease resistance. This modified variety may also be interesting for
Europe due to its excellent adaptability.
Caius Rommens indexRommens, Caius and coleagues reduced the expression
simultaneously of the Ranger Russet's tuber-expressed polyphenol oxidase (Ppo),
starch-associated R1, and phosphorylase-L (PhL) genes. For these changes no
foreign DNA was introduced. The researchers say that French fries made from
these potatoes contained about one-third the acrylamide content of control
fries.
According to the authors the Ranger Russet presented increased black spot
bruise resistance, reduced cold-induced sweetening, reduced stress-induced
sugar ends, enhanced fry aroma, reduced amounts of processing-induced
acrylamide, reduced starch phosphate content, and increased starch.
[3152]
Dong-Sun Lee and colleagues 2008 used genetic manipulation of enzymes in
plants to change aromas in fruit and vegetable. This may enable scientists to
change the flavour and taste of fruits and vegetables. The authors say that
the flavour of GM olive oil may be altered modifying the activity of enzymes
which generate the substances responsible for flavour.
The research based on changes of the allene oxide synthase (AOS) into hydroperoxide lyase HPL. This gene modifies the enzymes which produce green leaf volatiles
(GLVs), working with Arabidopsis thaliana, and used 3-D images of the enzymes
to make a small, but specific, genetic change in AOS, leading to the generation of HPL.
The AOS enzyme produces jasmonate, the scent of jasmine
flowers, and the hydroperoxide lyase HPL aromas to fruits and vegetables, GLVs.
The authors stress that this knowledge may be used for pest control. GM
modification of enzyme pass could create pest resistant plants because green
leaf volatiles and jasmonates also ward off predators, attracting predators of
plant predators.
[3153]
Unwanted gene flow from herbicide resistance canola can occur between canola
varieties over large distances, but as isolated events.
Janine Baker and Christopher Preston came to the conclusion that insect
mediated pollen transfer accounts for the low levels of gene flow that have
been observed to occur sporadically at long distances from the source.
The scientists sprayed bees with fluorescent paint and determined the level of
their movement between canola fields.They found that honeybees tended to return
to the same field when resources were abundant, but that they foraged over
larger distances when resources were scare or patchy. These findings suggest
that the honeybee has the potential to contribute to gene flow over large
distances but at a very low frequency.
The WTO has ruled in favor of the US challenge of the European Moratorium on
approvals of agricultural crops preliminary decision by a World Trade
Organization (WTO) panel on the U.S. challenge of the European Union (EU)
moratorium on approvals for crops derived from biotechnology.
The United States, joined by Argentina and Canada in the challenge, had
asserted the moratorium violates international trade rules and undermines the
development and use of biotechnology. They had argued the ban was not based on
scientific evidence and maintained that biotech crops are as safe to health and
the environment as other crops. All parties now will have a chance to review
and comment on the preliminary ruling, which was released February 7 to the
U.S. and EU governments and subsequently leaked to the press.
The WTO likely will issue a final decision on the approval challenge in late
2006 or early 2007, a U.S. trade official said in advance of the decision. The
loss of U.S. agricultural sales to Europe because of the ban has amounted to
"several hundred millions of dollars" annually, the official said. The U.N.
Food and Agriculture Organization (FAO) and World Health Organization (WHO)
also have said there are no greater risks associated with biotech-derived foods
than with conventional plants and foods.
Resistance to genetically altered crops among consumers in Europe remains
strong, therefore the lifting of the ban might not have a significant effect on
the quantity of U.S. agricultural exports to the region. [3154]
[3155]
The WTO, on 29 September 2006, issued the reports of the panel that had
examined complaints by the United States, Canada and Argentina, respectively,
against "European Communities - Measures affecting the approval and marketing
of biotech products" (DS291, DS292 and DS293).
In this report the panel concluded that the European Communities has acted
inconsistently with its obligations under the SPS Agreement in respect of the
relevant member State safeguard measures, it must be presumed to have nullified
or impaired benefits accruing to Argentina under that Agreement.
In the light of these conclusions, the Panel recommends that the Dispute
Settlement Body request the European Communities to bring the relevant member
State safeguard measures into conformity with its obligations under the SPS
Agreement.
No repercussion on the European GMO-regulation is expected.
[3156]
The University of California, Riverside is one of the few universities in the
world to support an active citrus breeding program. Professor of Genetics
Mikeal Roose developed the GeneChip Citrus Genome Arrayin classifying the
citrus genes that are associated with taste, acidic content and disease. The
citrus array will be used to develop new diagnostic tools for the improvement
of citrus agriculture and post-harvest fruit handling, as well as to understand
mechanisms underlying citrus diseases. [3157]
Citrus fruits are abundant in limonoids which are a class of chemically related
compounds present in citrus fruit. Limonoids have been shown to have
anti-cancer activity and can inhibit breast cancer cellular proliferation in
estrogen receptor negative (ER-) and positive (ER+) cells.
The researchers found that limonoids, particularly limonin, slowed tumor growth
and were able to prevent or delay the regrowth of resected tumors in these
models. Limonoids also reduced the incidence of lung metastases. These results
suggest that citrus juice components may be beneficial in the prevention of
mammary cancer. [3159]
[3160]
Consumption of 750 mL but not of 250 or 500 mL orange juice daily increased
HDL-cholesterol concentrations by 21% , triacylglycerol concentrations by
30%, and folate concentrations by 18%; decreased the LDL-HDL cholesterol
ratio by 16%; and did not affect homocyst(e)ine concentrations. Plasma
vitamin C concentrations increased significantly.
Kurowska and colleagues found in 2000 that orange juice (750 mL/d) improved
blood lipid profiles in hypercholesterolemic subjects, confirming
recommendations of the US food guide pyramid to consume about 5-10 servings of
fruit and vegetables daily.
EuropaBio, the European Association for Bioindustries,
has 50 direct members operating worldwide and 25 national biotechnology
associations representing some 1500 small and medium sized enterprises involved
in research and development, testing, manufacturing and distribution of
biotechnology products. http://www.europabio.org
The
Foundation was set up as a not-for-profit corporation, based in Saskatoon,
Saskatchewan. The Foundation's goal is to ensure ongoing opportunities for
continuous learning and networking within the agbiotech community through the
Agricultural Biotechnology International Conference.
The Foundation performs advisory, promotional and supportive functions for the
conferences. As the Foundation shapes the ABIC concept, it strives to position
the Conference at the forefront of agbiotech innovation.
The Conference on Co-existence between GM and Non GM crops in Vienna 2006
forms part of the Commission's consultations with interested parties on the
development of efficient and cost-effective strategies to ensure co-existence.
Agriculture is an open process, which means that perfect segregation of the
different agricultural production types is not possible in practice.
Co-existence of these production types which will not lead to a systematic
exclusion of one or more of them can only be ensured if the segregation
measures are designed in a way that takes these limitations into account.
Co-existence thus concerns only the economic implications of GMO admixture, the
measures to achieve sufficient segregation between GM and non-GM production and
the costs of such measures. [3161] [3162]
[3163]
It is already completely legal to grow certain GM crops within the European
Union, with this list of permitted crops likely to get longer.
On 23 July 2003, the European Commission adopted Recommendation 2003/556/EC on
guidelines for coexistence, reaffirming that measures for coexistence should be
developed by the Member States. The guidelines specify that those farmers who
introduce the new production type in a region should bear responsibility for
implementing the farm management measures necessary to limit gene flow.
Following these guidelines, measures currently being discussed by Member States
are designed to be taken by GM crop farmers. Furthermore, since seeds may be a
source of adventitious GM presence in agriculture, the European Commission
initiated discussions on setting
specific thresholds for the adventitious presence of GM seeds in conventional
seeds, lower than those allowed in the final crops (0.9%). Therefore, seed
production might have to operate under different coexistence requirements than
crop production. These discussions are still ongoing. [3164]
In 1998 Spain approved the first commercial growing of the transgenic maize BT
176 from Ciba Geigy (now Syngenta). The Spanish government continues to allow
transgenic maize growing although there is scientific uncertainty over its
safety.
Consumer organizations fear GM crops will cause widespread contamination by
genetic modified with heavy consequences for organic growers such as Enric
Navarro, an organic maize corn grower from Girona in Spain claiming that in
2005 his crop was contaminated up to 12.6 per cent by GM maize. He burnt the
crop at a massive economic loss."This year I will again sow maize. But if it is
again contaminated (with genetically engineered maize) I will abandon the
growing of organic maize. It is obvious that I cannot carry on my shoulders the
episodes of contamination like these, year after year."
[3165]
[3263]
The anti-globalisation leader Jose Bové combats junk food, US trade tariffs
and the risks to the environment of genetically modified organisms. He was
arrested and sentenced several times. He was prevented to enter Mexico to
attend a WTO summit in Mexico in 2003. He was deported from Hong Kong on WTO
talks and prevented to enter the US to speak at a conference at Cornell
University in New York state in 2006. On april 2006 Jose Bové, was arrested
attempting to occupy Monsanto's seed facility near Carcassonne in southern
France. The action had been organised by the Collectif des faucheurs
volontaires, la Confederation paysanne and Greenpeace.
According to Olivier Keller, national secretary of the Confederation Paysanne,
GM is harming the environment and is causing genetic contamination of the
food-chain and agriculture, thus threatening the right of farmers and consumers
to grow and eat GM free food.
Biotech companies and regulators argue that adequate controls are already in
place to ensure that the cross-contamination is not an issue.
Simon Barber, director of the plant biotechnology unit at EuropaBio - the
European association for bioindustries counters that thousands of European
farmers grew GM last year, successfully co-existing with their neighbours.
According to anti-GM campaigners GM crops will cause widespread contamination,
leaving consumers with no GM-free choice at all. Pro-GM forces on the other
hand argue that consumers must be given the choice, and that the WTO ruling
backs this up. But opposition to GM food will scarcely be long lasting.
Europe's food safety authority announced that the GMO Panel is of the opinion
hat there is no reason to believe that the continued placing on the market of
Bt176, T25 and MON810 maize, and Ms1xRf1 and Topas 19/2 oilseed rape is likely
to cause any adverse effects for human and animal health or the environment
under the conditions of their respective consents," said an EFSA statement this
week.
Dr Hans Kast, president and CEO of BASF Plant Science announced in 2006 that
BASF has identified plant biotechnology as the largest of five key
future-growth clusters. BASF has built its work on the cooperation of
Metanomics and SunGene companies.
Metanomics covers BASFs gene-discovery research identifying the metabolic
functions of each and every plant gene.Together with SunGene company the
gene-mapping knowledge is being applied to optimise and control specific traits
in a plant Increasing the content of valuable compounds in plants, such as
vitamins, carotenoids and proteins, such as NutriDense, the nutritionally
enhanced corn for the feed industry. It has higher content of protein,
essential amino acids, oil/energy and more available phosphorous.
Simon Barber, European Association for Bioindustries, EuropaBio argues that
co-existence between GM and non-GM crops has been a success in Europe for years
and there is no substantiated evidence to the contrary. According to Barber In
Europe alone, there are thousands of farmers and dozens of scientists with real
field experience of successful co-existence who were not asked to share their
knowledge at this conference. [3168]
[3169]
The cultivation of genetically modified organisms (GMOs) in the EU is likely to
have implications for the organisation of agricultural production. On the one
hand, the possibility of the adventitious (unintended) presence of genetically
modified (GM) crops in non-GM crops, and vice versa, raises the question as to
how producer choice for the different production types can be ensured. In
principle, farmers should be able to cultivate the types of agricultural crops
they choose, be it GM crops, conventional or organic crops. None of these forms
of agriculture should be excluded in the EU.
On the other hand, the issue is also linked to consumer choice. To provide
European consumers with a real choice between GM food and non-GM food, there
should not only be a traceability and labelling system that functions properly,
but also an agricultural sector that can provide the different types of goods.
The ability of the food industry to deliver a high degree of consumer choice
goes hand in hand with the ability of the agricultural sector to maintain
different production systems.
Coexistence refers to the ability of farmers to make a practical choice between
conventional, organic and GM-crop production, in compliance with the legal
obligations for labelling and/or purity standards.
The adventitious presence of GMOs above the tolerance threshold set out in
Community legislation triggers the need for a crop that was intended to be a
non-GMO crop, to be labelled as containing GMOs. This could cause a loss of
income, due to a lower market price of the crop or difficulties in selling it.
Moreover, additional costs might incur to farmers if they have to adopt
monitoring systems and measures to minimise the admixture of GM and non-GM
crops. Coexistence is, therefore, concerned with the potential economic impact
of the admixture of GM and non-GM crops, the identification of workable
management measures to minimise admixture and the cost of these measures.
It is important to make a clear distinction between the economic aspects of
coexistence and the environmental and health aspects dealt with under Directive
2001/18/EC on the deliberate release of GMOs into the environment.
According to the procedure laid down in Directive 2001/18/EC, the authorisation
to release GMOs into the environment is subject to a comprehensive health and
environmental risk assessment. The outcome of the risk assessment can be one of
the following:
- a risk of an adverse effect to the environment or health that cannot be
managed is identified, in which case authorisation is refused,
- no risk of adverse effects on the environment or health is identified, in
which case authorisation is granted without requiring any additional management
measures other than those specifically prescribed in the legislation,
- risks are identified, but they can be managed with appropriate measures (e.g.
physical separation and/or monitoring); in this case the authorisation will
carry the obligation to implement environmental risk management measures.
If a risk to the environment or health is identified after the authorisation
has been granted, a procedure for the withdrawal of the authorisation or for
modifying the conditions of consent can be initiated under the safeguard clause
set out in Article 23 of the Directive.
Since only authorised GMOs can be cultivated in the EU(1), and the
environmental and health aspects are already covered by Directive 2001/18/EC,
the pending issues still to be addressed in the context of coexistence concern
the economic aspects associated with the admixture of GM and non-GM crops.
A Round Table to examine the latest research results on the coexistence of GM
and non-GM crops was hosted by the European Commission in Brussels on 24 April
2003. It focused on coexistence issues raised by the introduction of GM maize
and GM oilseed rape into EU agriculture. Expert panels presented the scientific
findings, which were then discussed with a range of stakeholders representing
the farming sector, industry, NGOs, consumers and other players.
The Round Table sought to provide a scientific and technical basis, drawing
on practical farming experience, for whatever agronomic and other measures may become
necessary to facilitate the sustainable coexistence of these different
agricultural production types.
The present guidelines draw on the results of the Round Table, a summary of
which, prepared by a group of participating scientists, is available on the
following Internet site
http://www.gmo-compass.org/pdf/law/guidelines_coexistence.pdf
| Crop |
antibiotic resistance |
Antibiotic
resistance |
|---|
| |
Marker used for selection |
Genes under bacterial |
| |
|
promoters |
| Corn |
-- |
3 nptII |
| |
|
5 bla |
| |
|
1 cat |
| Tomato |
4 nptII |
-- |
| Oilseed rape |
3 nptII |
-- |
| cotton |
3 nptII |
2 aad |
| Potato |
2 nptII |
1 aad |
| Soybean |
1 nptII |
1 bla |
| Squash |
2 nptII |
-- |
| Papaya |
1 nptII |
tetR |
| Radicchio |
1 nptII |
-- |
US FDA/CFSAN 1997
[3223]
Green Fluorescent Protein was discovered and developed by Martin Chalfie,
Osamu Shimomura and Roger Y. Tsien as a companion protein to aequorin, the
chemiluminescent protein from the jellyfish Aequorea victoria. It has become
a valious marker of gene expression and protein targeting in intact cells and
organisms, and may be used as physiological indicators, biosensors, and
photochemical memories. The three researchers were awarded the 2008 Nobel
Prize in Chemistry on 8 October 2008
It has a major excitation peak at a wavelength of 395 nm and a minor one at 475
nm. Its emission peak is at 509 nm which is in the lower green portion of the
visible spectrum. GFP has a typical beta barrel structure, consisting of one
beta-sheet with alpha helix(s) containing the chromophore running through the
center. Inward facing sidechains of the barrel induce specific cyclization
reactions in the tripeptide Ser65-Tyr66-Gly67 that lead to chromophore
formation. This process of post-translational modification is referred to as maturation. The
hydrogen bonding network and electron stacking interactions with these sidechains
influence the color of wtGFP and its numerous derivatives. The tightly packed
nature of the barrel exclude solvent molecules, protecting the chromophore
fluorescence from quenching by water. [3224]
[3225]
Fluorescent organic dyes are widely used as nonradioactive labels
in biological analysis or as biomarkers in biomedical applications. Synthetic
fluorescent molecules should exhibiting high extinction coefficients, high
quantum yields, narrow emission bands, and photostability.
According to Song Lin Niu and colleagues 2009 available fluorescent substances
have poor water solubility, and low resistance to the formation of nonfluorescent
dimer and higher aggregates.
The authors report two methods to introduce (poly)sulfonated linkers onto
4,4-difluoro-4-bora-3a,4a-diaza-s-indacene (BODIPY) which are water-soluble.
The spectral properties of the resulting water-soluble BODIPY derivatives were
found to present good characteristics under physiological conditions making
them attractive as biomarkers.
[3226]
Grover and colleagues 2008 Researchers from the marked fruit fly genes with
Green Fluorescent Protein and detected the green glow of the active gene with
a camera equipped with a special filter. A second camera system tracked the
movement of each fly in three dimensions. According to the authors genes which
are responsible for certain behaviours may thus be tracked. The researchers
hope to get new insights on ageing in the fruit fly and biological processes.
The authors note that two genes, hsp70 and hsp22, which respond to oxidative
stress, spiked in the hours before the death of a fly. This suggests a sharp
increase in oxidative stress as the fly began dying of natural causes. The
phase of hsp gene expression relative to fly activity levels was different for
each fly, and remained the same throughout the life span.
Linking Green Fluorescent Protein to any gene, its expression change may be
monitored automatically and can be correlated with the animal activity, behavior
and mortality.
[3227]
Sothward and Surette 2002 describe the use of the green fluorescent protein
(GFP) from the jellyfish Aequorea victoria which can be expressed as a
fluorescent protein in any other organism and became the most common reporters in
use today. GFP is used for characterizing spatial and temporal dynamics of gene
expression, protein localization and protein-protein interactions in living cells
and bacteria.
[3228]
Scientists from National Taiwan University's Department of Animal Science and
Technology created pigs which are green through and through by adding genetic
material from jellyfish into a normal pig embryo. The eyes, teeth and trotters of
the pigslook green, and their skin has a greenish tinge. In the dark, a blue
light makes them glow. The researchers hope the green pigs will mate with
ordinary female pigs to create a new generation.
[3229] Esther
van der Knaap studied US the SUN gene from the tiny round wild ancestor and
compare it with the actual elongated tomato varieties
Furthermore, the gene encodes a member of the IG67 domain of plant proteins,
called IQD12 - a family of proteins whose discovery is relatively new.
The authors found that one of the major genes controlling the elongation of
tomato, encode a member of the IQ67 domain-containing family, resulting in an
unusual gene duplication event mediated by the long terminal repeat
retrotransposon RIDER. This resulted in the increased fruit size and
variation in fruit shape of domesticated tomatoes. Introducing the gene in the
wild small tomato, the plant produced big, elongated tomatoes. Small original
tomatoes were produced after removal of the gene.
The scientists hope to control the shape of other very diverse crops, such as
peppers, cucumbers and gourds when more researches are done on this matter.
[3230]
Healthy soils, crop rotations and the help of natural predators are used by
organic farmers to control crop pests and diseases in a sustainable
agriculture. Few crop diseases, however, are so resistant to these techniques
that additional chemique help is required such as spraying copper up to 6kg/ha
per year together with crop rotation to control potato blight. Organic farmer
say that copper does not build up in the soil, due to the crop rotations.
Copper sprayed on leaves does not accumulate in tubers like other pesticides.
[3231]
Feeding trials by two scientific teams found that GM potatoes cause lesions in
the gut wall of rats and mice. In October 1999 Ewen and Pusztai wrote that
diets containing genetically modified potatoes expressing the lectin Galanthus
nivalis agglutinin (GNA) had variable effects on different parts of the rat
gastrointestinal tract, such as the proliferation of the gastric mucosa.
The biotechnology industry reacted very aggressively and tried to mobilise the
scientific community to undermine the credibility of the work. Similar effects
have been found with GM tomatoes in two US feeding trials, which found that GM
tomatoes cause lesions in the gut wall of rats.
[3232]
Hirshi and colleagues studied the AVP1 (vacuolar H+-pyrophosphatase
(H+-PPase))gene from Arabidopsis thaliana which results in enhanced
performance under soil water deficits. According to their work, the AVP1 gene
plays an important role in root development through the facilitation of auxin
fluxes.
The scientists introduced The AVP1 gene in tomatoes resulting in more robust
root systems allowing transgenic tomato plants to take up greater amounts of
water during the imposed water deficit stress, resulting in a more favorable
plant water status and less injury. The authors are working on how this
technology could be applied to other commercial crops.
[3233] [3234]
Actual crops resulted on a selective breeding from a very small number of wild
plants. The genetic variation of wild plants is lost. Dani Zamir from
Jerusalem University believes that exhausted genetic diversity presents a
limitation for breeders to improve tomatoes.
He suggests to go back into the wild and cross domesticated crops with their
wild relatives in order to gain access to useful traits, such as pest- or
drought-resistance by developing exotic libraries Zamir explains that an exotic
library consists of a large number of lines, each of which carries a small,
well-defined chromosomal segment from the wild plant in the genome of the
domesticated crop, and the whole genome of the wild relative is represented in
a complete exotic library.
To develop drought-resistant tomatoes for the Middle East, Zamir crossed wild
Lycopersicon pennellii tomato plants from the deserts of Western Peru, with a
M82 high-yield tomato line of Israeli. In this way he developed a library of
50 introgression lines and crossed them again with three other lines and
obtained a drought-resistant tomato with 30% higher yield than the original
M82 line and does not rely on irrigation.
[3236]
Artificial ripening with ethylene is used in 80% of US tomatoes. Conventional
green tomatoes are harvested and transported. Before selling they are redened
with ethylene. The delayed-ripening tomato Flavr Savr, a from Calgene was a
genetically modified tomato that could be picked when ripe and transported
without bruising. It carries the antibiotic resistance gene (Flavr Savr) for
resistance to the antibiotic kanamycin. The enzyme polygalacturonase (PG),
responsible for the tomato's softness, is supressed and the tomato keeps longer
hard.
It was subject to heavy legal pressure from Monsanto and concerns about the use
of antibiotic resistance gene. The tomatoes were only ever sold in a small
number and then rapidly withdrawn.
Zeneca developed at that time a GM tomato also based on the kanamycin
antibiotic gene, for use in puree, a tomato to make it bulkier with reduced
water content with increased viscosity.This tomato puree was sold starting in
February 1996, attaining 60% of total sale of canned tomato puree. Due to
safety concerns, both products were withdrawn from market.
There were concerns made public that the genes passed out of the tomatoes and
entered bacteria, the bacteria could develop resistance to the antibiotic,
undermining its medical effectiveness.
Agritope, Aventis, DNA
Plant Technologies, Seminis and Monsanto.
FDA had decided that GM foods in general should not be regulated differently
to non-GM foods and would not require pre-market approval. Unlike food
additives, for which pre-market approval is required in the US, they argued
that GM foods are the same or substantially equivalent to non-GM foods.
Calgene had fed rats with either a GM tomatoes. These studies revealed
statistically significant differences between the effects of the GM and non-GM
tomatoes. gross lesions, findings of gastric erosion or necrosis lesions and
microscopic lesions were found in the rats were observed. The study methodology
was argued FDA approved the GMO tomato.
Dr Joseph Cummins warned that the inclusion of a genetic sequence from the
Cauliflower Mosaic Virus could create virulent new viruses and Dr Edwin Mathews
wrote that the genetically modified plants could also contain unexpected high
concentrations of plant toxicants.
The FDA was obliged to reveal these internal views in 1998 after a lawsuit
filed by consumer groups.
The GM potatoes were rejected in the US in 2002 by US retailers and The
British Retail Consortium has said UK supermarkets won't be stocking GM
potatoes.
[3237]
Shelagh R. Muir and colleagues modified tomatoes introducing a gene from
Petunia encoding chalcone isomerase, an enzyme involved in flavonol
biosynthesis has been used to produce transgenic fruit with an increase in peel
flavonols of up to 78 fold, mainly due to accumulation of quercetin glycosides.
The in vitro evidence for for One group of flavonoids, the flavonols (e.g.,
quercetin and kaempferol) are told to be cardiovascular protective.
Introducing the transgene gene (pBBC50) containing the Petunia hybrida chi gene
under the control of the constitutive cauliflower mosaic virus (CaMV) double
35S promoter. into the skin of a tomato, Shelagh R. Muir and colleagues were
able to increase flavonol production by up to 78 times. The taste was not
affected, and 65% of the flavonols were retained when the GM tomatoes were
processed into paste.
Shelagh R. Muir and colleagues concluded that constitutive overexpression of a
Petunia gene encoding CHI in tomato resulted in elevated flavonol end products
in the fruit peel. The tomato lines contained significantly increased levels of
quercetin glycosides, and smaller but still substantial increases in kaempferol
glycosides in fruit peel, offering potential health benefits.
The U.S. Department of Agriculture's (USDA) Animal and Plant Health inspection
Service (APHIS) is responsible for protecting and promoting U.S. agricultural
health, administering the Animal Welfare Act, and carrying out wildlife damage
management activities.
The APHIS mission is an integral part of U.S. Department of Agriculture's
(USDA) efforts to provide the Nation with safe and affordable food.
APHIS maintains the Biotechnology Regulatory Services (BRS) program regulating
the field testing, movement, and importation of genetically engineered (GE)
organisms that are known to be, or could be plant pests. BRS issues various
types of permits for each of these activities. A Compliance & Enforcement
program inspects, audits, and oversees activities under the permit process. BRS
also evaluates petitions for deregulation to ensure that products being
considered for removal from regulation do not pose a threat to U.S.
agricultural or environmental health.
USDA APHIS protects America's agricultural and natural resources by ensuring
the safe development of GE organisms using a science-based regulatory framework
controlling :
- Permits for other types of genetically-engineered organisms include
transgenic arthropods and applications for veterinary biologics.
- Permits for Non-genetically engineered articles include Plant pests, Plant
and plant products, and Animal and animal products.
Companies and organizations who wish to field test a genetically engineered
crop, must obtain USDA permission through a permit. Companies must submit all
plans for field testing for review by regulatory scientists who evaluate the
risks of the test and the protocols to be employed. USDA will approve the plan
if the proposed test conditions appear adequate to confine the regulated
article within the field test site. To ensure compliance to the permitting
conditions, field test sites are inspected and records are audited.
Depending on the nature of the genetically engineered crop, an applicant files
either a notification or a permit application. In general, most of the plants
are field tested under the notification procedure, a more streamlined approval
process that is used only for familiar crops and traits considered to be low
risk. Permitting is used for field tests of plants that have an elevated risk,
such as plants producing pharmaceutical or industrial compounds.
APHIS also published a list of isolation distances from any contaminating
source, valid for US, adapted from Table 5, 7 CFR part 201.76
Canada has its own list of isolation distances published under Canadian Food
Inspection Agency (CFIA) APPENDIX 2: MINIMUM ISOLATION distances and periods
of post-harvest land use restriction 2000. [3239]
In Europe isolation distances between GM and non-GM fields are settled in the
regulation 2003/556/EC.[3169]
[3249]
According to Professor David James oil-seed rape separation distances should be
applicable to any other crop. He ignores that rape is insect-pollinated and has
fairly heavy pollen. Other plants like cereal crops are wind-pollinated
traveling farther than rape pollen. (Val Spouge Braintree, Essex)
[3250]
According to professor of horticulture Avtar Handa of the Purdue University
tomatoes with 10% increased soluble solids in the fruits have been
geneticalliy engineered by its team. The fruits grow and ripen like traditional
varieties.
Handa and colleagues constructed a backwards gene that inhibits the tomato
ripening enzyme pectin methylesterase. This gene was introduced in an
Agrobacterium which carried the gene to the DNA of the tomato. This backward
gene resulted in higher soluble solids in the tomato making the production of
thicker Ketchup possible.
According to Avtar Handa, crossing commercial varieties with wild species
bearing the desired gene, takes years and may transfer unwanted
characteritics. Genetic engineering creates the wanted tomato in less time
compared with traditional cross- breeding.
Extended growing season for tomato [3251]
Tomatoes are sensitive to frost. This shortens their growing season. Fish, on
the other hand, survive in very cold water. Scientists identified a particular
gene which enables a flounder to resist cold and used the technology of genetic
engineering to insert this 'anti-freeze' gene into a tomato. This makes it
possible to extend the growing season of the tomato.
[3252]
While there may be risks associated with transferring undesirable traits
through conventional breeding, a major concern about gene technology is not
with the crossing of two of the same plant species, but the transfer of genes
from one species, for example a fish, into another species such as a tomato, or
a bacterium into a plant.
This ability to "cross the species boundary" through genetic engineering
introduces an additional uncertainty and potential for serious harm.
One major area of concern was the gene crossover, sometimes described as
transgenic, from one species to another. There was much less concern about
wheat genes being used in wheat than bacterial genes being used in wheat for
example. The use of viral promoter genes was a cause of even graver concern, in
particular what might be the consequences of viral changes in subsequent
generations. The Committee was told that little to no research had been done on
later generation viral consequences.
Assurances that there is "no evidence" of harm may in fact mean no research has
been done, and that worries the community. While there may be genetic exchange
between species occurring in nature, genes from fish do not get into tomatoes
under normal circumstances.
Opponents have argued that while the products of gene technology, such as
herbicide resistant crops, long shelf life melons and delayed ripening
tomatoes, are likely to bring some benefits to consumers, these products have
been mainly developed to meet the needs of those in the food supply system,
growers, transporters, wholesalers and retailers.
Notably, the crops that have been subject to genetic engineering are those that
are economically important in the industrialised not the developing nations,
for example maize, oilseed rape (canola), sugarbeet, tomato and potato.
Nevertheless some research and trials have been conducted on wheat, rice, and
cassava, an important food source in African and South American countries.20
Additionally, the main applications of genetic modification are producing
herbicide and pesticide resistant plants, with much of the benefit going to the
producers rather than consumers.
[3254]
The Canola Council of Canada is a non-profit association representing the
entire canola industry - growers, input suppliers, researchers, crushers,
processors, exporters and marketers.
The Canadian Canola-Council urges farmers to protect the reputation of
canadian canola as a safe and high quality product stressing not to grow the
canola varieties:
- HySyn 101 Roundup Ready from Zeneca. This variety is not approved in
Japan as it was not intended for widespread commercial release.
- 295BX, Cartier BX, Zodiac BX, Renegade BX, bromoxynil herbicide
tolerant, Rhone Poulenc. These varieties will not be approved because
commercial seed is no longer being sold.
- Exceed, 2631 LL, Swallow, SW Legion LL, SW Flare LL, LBD 2393 LL,
Liberty Link herbicide tolerant. They contain the transformation event T45
that is not approved in the European Union for food or seed. Within the next
year, the canola industry expects that the European Commission will complete
the approvals for Roundup Ready (event GT73) and the currently sold InVigor
(event MS8RF3) varieties allowing imports of canola. This is important to
canadian industry as Europe is now sourcing canola for their expanding
biodiesel industry. However - T45 is not approved and we do not know when, or
if, it will be approved.
- 3850, 2153, 3640, 2063 Liberty Link herbicide tolerant. These varieties
contain event MS1RF1 which is currently approved in export markets, but may
not be supported in the future. This could limit the delivery option for
growers in the future.
- 3880, 2163, 2273 Liberty Link herbicide tolerant. These varieties
contain event MS1RF2 which is currently approved in export markets, but may
not be supported in the future. This could limit the delivery option for
growers in the future.
- Innovator, Independence, HCN 14, Phoenix. These varieties contain event
Topas 19/2 which is currently approved in export markets, but may not be
supported in the future. This could limit the delivery option for growers in the future.
[3255]
The GMO Panel of the European Food Safety Authority is of the opinion that the
molecular characterisation of the DNA insert and flanking regions of oilseed
rape T45 does not raise any safety
concern, and that sufficient evidence for the stability of the genetic modification was provided.
The GMO Panel is of the opinion that the composition of oilseed rape T45 does
not deviate from that of conventional oilseed rape varieties, except for the
introduced trait.
The PAT protein induced no adverse effects in acute dose oral toxicity studies
in rodents. In addition, the PAT protein is rapidly degraded in simulated
gastric fluid and inactivated during heat treatments.
A 42-day feeding study with broilers did not indicate differences in the
nutritional value of T45 oilseed rape versus the non-GM comparator and
confirms the nutritional equivalence of T45 oilseed rape containing diet in
comparison with a conventional diet in broiler chickens.
The applications for oilseed rape T45 concern food and feed uses, import and
processing of oilseed rape T45 and all derived products, but excluding
cultivation of the crop in the EU. There is therefore no requirement for
scientific assessment of possible environmental effects associated with the
cultivation of oilseed rape T45. There are no indications of increased
likelihood of establishment or survival of feral oilseed rape plants in case of
accidental release into the environment of oilseed rape T45 seeds during
transportation and processing.
However, the GMO Panel advises that appropriate management systems should be
in place to minimise accidental loss and spillage of transgenic oilseed rape
during transportation, storage, handling in the environment and processing
into derived products.
In conclusion, the GMO Panel considers that the information available for oilseed
rape T45 addresses the scientific comments raised by the Member States and that
the GM oilseed rape T45 is as safe as its non genetically modified counterpart
with respect to potential effects on human and animal health or the environment.
Therefore the GMO Panel concludes that oilseed rape T45 is unlikely to have any
adverse effect on human or animal health or on the environment in the context of
its intended uses.
[3256]
The EFSA GMO Panel reiterates on the 17.09.2009 the previous conclusions that
GM glufosinate-tolerant oilseed rape Ms8, Rf3 and Ms8 x Rf3 is unlikely to have an
adverse effect on human and animal health or, in the context of its proposed
uses, on the environment. This also applies to the products which are the subject
of the present application.
[3257]
The genus Lycopersicon includes the cultivated tomato (L. esculentum Mill.)
together with its wild relatives. The wild species bear a wealth of genetic
variability. Less than 10% of the total genetic diversity in the Lycopersicon
gene pool is found in L. esculentum (Miller and Tanksley, 1990). The center of
diversity for tomato is located in western South America, and the cherry tomato
L. esculentum var. cerasiforme is considered as the most likely ancestor of
cultivated tomatoes. Karyotypes of the Lycopersicon species are very similar
with little or no structural difference among species (Barton, 1950). As a crop
plant, tomato is one of the best-characterized plant systems.as diploidyt It is
a diploid plant permitting self pollination, and a relatively short
generation time make it amenable to genetic analysis.
Classical genetics has created one of the largest stocks of morphological
mutations induced by radiation (X-rays, UV-light, neutrons) and chemical
mutagenesis. A major contributor in the mutagenesis area was Hans Stubbe who
developed over 300 L. esculentum mutants and 200 in L. pimpinellifolium. (for
summary see Rick, 1975). A particularly interesting example of induced
mutagenesis was the directed manipulation of fruit size of L. esculentum and L.
pimpinellifolium.(Stubbe, 1971).
The number of mapped genes in the form of cDNAs has increased considerably with
the introduction of RFLP markers.
The current tomato map is considered to be complete in that all molecular and
classical markers could be mapped to one of the 12 linkage groups indicating
that no loci failed to link up with thethe map.
[3258]
Tomato is a highly specialized crop and bred to be grown under intensive
monoculture. The distance required between foundation seed fields is 200 feet
which in practical terms is the effective distance tomato pollen can travel
under field conditions and remain viable.
[3258]
The factors that prevent cross-pollination are well documented and are
applicable to genetically engineered tomato. Tomato can be crossed by
hand-pollination to all wild Lycopersicon species with varying degrees of
success. The genus has been divided into two subgenera, the one easily crossed
with commercial tomato (esculentum complex), and those that cannot be easily
crossed (peruvianum complex). Hybridization between these two subgenera usually
leads to early embryo breakdown, which results in seed that is not viable. This
problem can be circumvented by embryo culture and other laboratory techniques,
albeit at great effort.
The closest genetic relatives of tomato are in the genus Solanum. Hybrids have
been obtained between L. esculentum and S. lycopersicoides, but these hybrids
are usually sterile (Stevens and Rick, 1986). No other member of the genus,
including S. nigrum, a common weed in tomato fields, has yielded viable hybrids
(Taylor, 1986).
There is no evidence that tomato plants can cross-pollinate with other plants
in the area of the field test. Similarly, there is no evidence that the
engineered tomato plants will cross-pollinate with any other tomato plants in
the vicinity.
[3258]
The transformed tomato has gained no measurable selective advantage over
nontransformed tomato in its ability to be disseminated or to become
established in the environment.
The risk of horizontal movement of these genes from the genetically engineered
tomato plants into the genetic environment is negligible because the genes are
incorporated into the plant genome. No mechanism is known to exist in nature
capable of transferring the genetic material from the tomato genome to another
organism which tomato does not fertilize.
[3169]
The cultivation of genetically modified organisms (GMOs) in the EU is likely to
have implications for the organisation of agricultural production. On the one
hand, the possibility of the adventitious (unintended) presence of genetically
modified (GM) crops in non-GM crops, and vice versa, raises the question as to
how producer choice for the different production types can be ensured. In
principle, farmers should be able to cultivate the types of agricultural crops
they choose, be it GM crops, conventional or organic crops. None of these forms
of agriculture should be excluded in the EU.
On the other hand, the issue is also linked to consumer choice. To provide
European consumers with a real choice between GM food and non-GM food, there
should not only be a traceability and labelling system that functions properly,
but also an agricultural sector that can provide the different types of goods.
The ability of the food industry to deliver a high degree of consumer choice
goes hand in hand with the ability of the agricultural sector to maintain
different production systems. Coexistence refers to the ability of farmers to
make a practical choice between conventional, organic and GM-crop production,
in compliance with the legal obligations for labelling and/or purity
standards.
The adventitious presence of GMOs above the tolerance threshold set out in
Community legislation triggers the need for a crop that was intended to be a
non-GMO crop, to be labelled as containing GMOs. This could cause a loss of
income, due to a lower market price of the crop or difficulties in selling it.
Moreover, additional costs might incur to farmers if they have to adopt
monitoring systems and measures to minimise the admixture of GM and non-GM
crops. Coexistence is, therefore, concerned with the potential economic impact
of the admixture of GM and non-GM crops, the identification of workable
management measures to minimise admixture and the cost of these measures.
[3169]
It is important to make a clear distinction between the economic aspects of
coexistence and the environmental and health aspects dealt with under Directive
2001/18/EC on the deliberate release of GMOs into the environment.
According to the procedure laid down in Directive 2001/18/EC, the authorisation
to release GMOs into the environment is subject to a comprehensive health and
environmental risk assessment. The outcome of the risk assessment can be one of
the following:
- a risk of an adverse effect to the environment or health that cannot be
managed is identified, in which case authorisation is refused,
- no risk of adverse effects on the environment or health is identified, in
which case authorisation is granted without requiring any additional management
measures other than those specifically prescribed in the legislation,
- risks are identified, but they can be managed with appropriate measures (e.g.
physical separation and/or monitoring); in this case the authorisation will
carry the obligation to implement environmental risk management measures.
If a risk to the environment or health is identified after the authorisation
has been granted, a procedure for the withdrawal of the authorisation or for
modifying the conditions of consent can be initiated under the safeguard clause
set out in Article 23 of the Directive.
Since only authorised GMOs can be cultivated in the EU(1), and the
environmental and health aspects are already covered by Directive 2001/18/EC,
the pending issues still to be addressed in the context of coexistence concern
the economic aspects associated with the admixture of GM and non-GM crops.
ftp://ftp.fao.org/codex/Publications/Booklets/Biotech/Biotech_2003e.pdf
The Codex Commission published risk analysis and food safety assessment of
genetic modified foods in 2003 comprising:
1- Principles for the risk analysis of foods derived from modern
Biotechnology.
2- Guideline for the conduct of food safety assessment of foods derived from
recombinant-DNA plants.
3- Guideline for the conduct of food safety assessment of foods produced using
recombinant-DNA microorganisms
While risk analysis has been used over a long period of time to address
chemical hazards (e.g. residues of pesticides, contaminants, food additives and
processing aids), and it is being increasingly used to address microbiological
hazards and nutritional factors, the principles were not elaborated
specifically for whole foods.
The risk analysis approach can, in general terms, be applied to foods including
foods derived from modern biotechnology. However, it is recognised that this
approach must be modified when applied to a whole food rather than to a
discrete hazard that may be present in food.
The guidelines represent a risk analysis on the safety and nutritional aspects
of foods derived from modern biotechnology. Environmental, ethical, moral and
socio-economic aspects of the research, development, production and marketing
of these foods are not covered.
[3240]
FDA recognizes that some manufacturers may want to use informative statements
on labels and in labeling of bioengineered foods or foods that contain
ingredients produced from bioengineered foods. The following are examples of
some statements that might be used. The discussion accompanying each example is
intended to provide guidance as to how similar statements can be made without
being misleading.
"Genetically engineered" or "This product contains cornmeal that was produced
using biotechnology."
The information that the food was bioengineered is optional and this kind of
simple statement is not likely to be misleading. However, focus group data
indicate that consumers would prefer label statements that disclose and explain
the goal of the technology (why it was used or what it does for/to the food).
Consumers also expressed some preference for the term "biotechnology" over such
terms as "genetic modification" and "genetic engineering"
. "This product contains high oleic acid soybean oil from soybeans developed
using biotechnology to decrease the amount of saturated fat."
This example includes both required and optional information. As discussed
above in the background section, when a food differs from its traditional
counterpart such that the common or usual name no longer adequately describes
the new food, the name must be changed to describe the difference. Because this
soybean oil contains more oleic acid than traditional soybean oil, the term
"soybean oil" no longer adequately describes the nature of the food. Under
section 403(i) of the act, a phrase like "high oleic acid" would be required to
appear as part of the name of the food to describe its basic nature. The
statement that the soybeans were developed using biotechnology is optional. So
is the statement that the reason for the change in the soybeans was to reduce
saturated fat.
"These tomatoes were genetically engineered to improve texture."
In this example, the change in texture is a difference that may have to be
described on the label. If the texture improvement makes a significant
difference in the finished product, sections 201(n) and 403(a)(1) of the act
would require disclosure of the difference for the consumer. However, the
statement must not be misleading. The phrase "to improve texture" could be
misleading if the texture difference is not noticeable to the consumer. For
example, if a manufacturer wanted to describe a difference in a food that the
consumer would not notice when purchasing or consuming the product, the
manufacturer should phrase the statements so that the consumer can understand
the significance of the difference. If the change in the tomatoes was intended
to facilitate processing but did not make a noticeable difference in the
processed consumer product, a phrase like "to improve texture for processing"
rather than "to improve texture" should be used to ensure that the consumer is
not misled. The statement that the tomatoes were genetically engineered is
optional.
"Some of our growers plant tomato seeds that were developed through
biotechnology to increase crop yield."
The entire statement in this example is optional information. The fact that
there was increased yield does not affect the characteristics of the food and
is therefore not necessary on the label to adequately describe the food for the
consumer. A phrase like "to increase yield" should only be included where there
is substantiation that there is in fact the stated difference.
Where a benefit from a bioengineered ingredient in a multi-ingredient food is
described, the statement should be worded so that it addresses the ingredient
and not the food as a whole; for example, "This product contains high oleic
acid soybean oil from soybeans produced through biotechnology to decrease the
level of saturated fat." In addition, the amount of the bioengineered
ingredient in the food may be relevant to whether the statement is misleading.
This would apply especially where the bioengineered difference is a nutritional
improvement. For example, it would likely be misleading to make a statement
about a nutritionally improved ingredient on a food that contains only a small
amount of the ingredient, such that the food's overall nutritional quality
would not be significantly improved.
FDA reminds manufacturers that the optional terms that describe an ingredient
of a multi-ingredient food as bioengineered should not be used in the
ingredient list of the multi-ingredient food. Section 403(i)(2) of the act
requires each ingredient to be declared in the ingredient statement by its
common or usual name. Thus, any terms not part of the name of the ingredient
are not permitted in the ingredient statement. In addition, 21 CFR 101.2(e)
requires that the ingredient list and certain other mandatory information
appear in one place without other intervening material. FDA has long
interpreted any optional description of ingredients in the ingredient statement
to be intervening material that violates this regulation.
[3240]
Terms that are frequently mentioned in discussions about labeling foods with
respect to bioengineering include "GMO free" and "GM free." "GMO" is an acronym
for "genetically modified organism" and "GM" means "genetically modified."
Consumer focus group data indicate that consumers do not understand the
acronyms "GMO" and " GM" and prefer label statements with spelled out words
that mean bioengineering.
Terms like "not genetically modified" and "GMO free," that include the word
"modified" are not technically accurate unless they are clearly in a context
that refers to bioengineering technology. "Genetic modification" means the
alteration of the genotype of a plant using any technique, new or traditional.
"Modification" has a broad context that means the alteration in the composition
of food that results from adding, deleting, or changing hereditary traits,
irrespective of the method.
Modifications may be minor, such as a single mutation that affects one gene, or
major alterations of genetic material that affect many genes. Most, if not all,
cultivated food crops have been genetically modified. Data indicate that
consumers do not have a good understanding that essentially all food crops have
been genetically modified and that bioengineering technology is only one of a
number of technologies used to genetically modify crops. Thus, while it is
accurate to say that a bioengineered food was "genetically modified," it likely
would be inaccurate to state that a food that had not been produced using
biotechnology was "not genetically modified" without clearly providing a
context so that the consumer can understand that the statement applies to
bioengineering.
The term "GMO free" may be misleading on most foods, because most foods do not
contain organisms (seeds and foods like yogurt that contain microorganisms are
exceptions). It would likely be misleading to suggest that a food that
ordinarily would not contain entire "organisms" is "organism free."
There is potential for the term "free" in a claim for absence of bioengineering
to be inaccurate. Consumers assume that "free" of bioengineered material means
that "zero" bioengineered material is present. Because of the potential for
adventitious presence of bioengineered material, it may be necessary to
conclude that the accuracy of the term "free" can only be ensured when there is
a definition or threshold above which the term could not be used. FDA does not
have information with which to establish a threshold level of bioengineered
constituents or ingredients in foods for the statement "free of bioengineered
material."
FDA recognizes that there are analytical methods capable of detecting low
levels of some bioengineered materials in some foods, but a threshold would
require methods to test for a wide range of genetic changes at very low levels
in a wide variety of foods. Such test methods are not available at this time.
The agency suggests that the term "free" either not be used in bioengineering
label statements or that it be in a context that makes clear that a zero level
of bioengineered material is not implied. However, statements that the food or
its ingredients, as appropriate, was not developed using bioengineering would
avoid or minimize such implications. For example,
- "We do not use ingredients that were produced using biotechnology;"
- "This oil is made from soybeans that were not genetically engineered;" or
- "Our tomato growers do not plant seeds developed using biotechnology."
A statement that a food was not bioengineered or does not contain bioengineered
ingredients may be misleading if it implies that the labeled food is superior
to foods that are not so labeled. FDA has concluded that the use or absence of
use of bioengineering in the production of a food or ingredient does not, in
and of itself, mean that there is a material difference in the food. Therefore,
a label statement that expresses or implies that a food is superior (e.g.,
safer or of higher quality) because it is not bioengineered would be
misleading. The agency will evaluate the entire label and labeling in
determining whether a label statement is in a context that implies that the
food is superior.
In addition, a statement that an ingredient was not bioengineered could be
misleading if there is another ingredient in the food that was bioengineered.
The claim must not misrepresent the absence of bioengineered material. For
example, on a product made largely of bioengineered corn flour and a small
amount of soybean oil, a claim that the product "does not include genetically
engineered soybean oil" could be misleading.
Even if the statement is true, it is likely to be misleading if consumers
believe that the entire product or a larger portion of it than is actually the
case is free of bioengineered material. It may be necessary to carefully
qualify the statement in order to ensure that consumers understand its
significance.
Further, a statement may be misleading if it suggests that a food or ingredient
itself is not bioengineered, when there are no marketed bioengineered varieties
of that category of foods or ingredients. For example, it would be misleading
to state "not produced through biotechnology" on the label of green beans, when
there are no marketed bioengineered green beans.
To not be misleading, the claim should be in a context that applies to the food
type instead of the individual manufacturer's product. For example, the
statement "green beans are not produced using biotechnology" would not imply
that this manufacturer's product is different from other green beans.
[3240]
A manufacturer who claims that a food or its ingredients, including foods such
as raw agricultural commodities, is not bioengineered should be able to
substantiate that the claim is truthful and not misleading. Validated testing,
if available, is the most reliable way to identify bioengineered foods or food
ingredients. For many foods, however, particularly for highly processed foods
such as oils, it may be difficult to differentiate by validated analytical
methods between bioengineered foods and food ingredients and those obtained
using traditional breeding methods.
Where tests have been validated and shown to be reliable they may be used.
However, if validated test methods are not available or reliable because of the
way foods are produced or processed, it may be important to document the source
of such foods differently. Also, special handling may be appropriate to
maintain segregation of bioengineered and nonbioengineered foods.
In addition, manufacturers should consider appropriate recordkeeping to
document the segregation procedures to ensure that the food's labeling is not
false or misleading. In some situations, certifications or affidavits from
farmers, processors, and others in the food production and distribution chain
may be adequate to document that foods are obtained from the use of traditional
methods. A statement that a food is "free" of bioengineered material may be
difficult to substantiate without testing. Because appropriately validated
testing methods are not currently available for many foods, it is likely that
it would be easier to document handling practices and procedures to
substantiate a claim about how the food was processed than to substantiate a
"free" claim.
FDA has been asked about the ability of organic foods to bear label statements
to the effect that the food (or its ingredients) was not produced using
biotechnology. On December 21, 2000, the Agriculture Marketing Service of the
U.S. Department of Agriculture (USDA) published final regulations on procedures
for organic food production (National Organic Program final rule; 65 FR 80548).
That final rule requires that all but the smallest organic operations be
certified by a USDA accredited agent and lays out the requirements for organic
food production.
Among those requirements is that products or ingredients identified as organic
must not be produced using biotechnology methods. The national organic
standards would provide for adequate segregation of the food throughout
distribution to assure that non-organic foods do not become mixed with organic
foods. The agency believes that the practices and record keeping that
substantiate the "certified organic" statement would be sufficient to
substantiate a claim that a food was not produced using bioengineering.
Directive 2001/18/EC of the European Parliament and of the Council of 12 March
2001 on the deliberate release into the environment of genetically modified
organisms and repealing Council Directive 90/220/EEC - Commission
Declaration.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:106:0001:0038:EN:PDF
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of
22 September 2003 on genetically modified food and feed.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32003R1829:EN:HTML
The article 12 (1) establishes a labelling threshold of 0.9% in European Union
(EU). This threshold is set to 3% in Korea, and 5% in Japan. In China there
is zero tollerance for labelling of 17 types of GM products. This includes
maize seeds, maize oil, tomato seeds, ketchup, soybean seeds, soybean oil,
rapeseed seeds, and cotton seeds. [3241]
This considered the almost worldwide GMO comtamination of seeds,
tranportation,storage facilities and production lines.
Commission Decision 2004/204/EC of 23
February 2004 laying down detailed arrangements for the operation of the registers for recording information on genetic modifications
in GMOs, provided for in Directive 2001/18/EC of the European Parliament and
of the Council.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:065:0020:0022:EN:PDF
| EFSA-GMO Nr. |
Event/Species |
Scope of the |
|---|
| |
|
application |
| UK-2004-1 |
NK603 x MON810 Maize |
Food, Feed |
| NL-2004-02 |
1507 Maize |
Food |
| DE-2004-03 |
MON863 x MON810 Maize |
Food, feed |
| UK-2004-04 |
Rice LLRICE62 |
Food,feed |
| |
|
import and processing |
| UK-2004-05 |
1507 x NK603 Maize |
Food, feed |
| |
|
import and processing |
| UK-2004-06 |
MON863 x NK603 Maize |
Food, feed |
| |
|
Import and processing |
| BE-2004-07 |
MON863 x MON810 x |
Food, feed |
| |
NK603 Maize |
import and processing |
| UK-2004-08 |
H7-1 Sugar beet |
Food, feed produced |
| |
|
from GM plants |
| |
|
(derived products) |
| UK-2005-09 |
MON 531 x MON 1445 |
Food, feed produced |
| |
Cotton |
from GM plants |
| |
|
(derived products) |
| |
MON 15985 and |
Food, feed produced |
| UK-2005-10 |
MON 15985 x MON |
from GM plants |
| |
1445 Cotton |
(derived products) |
| UK-2005-11 |
MIR604 Maize |
Food, feed |
| |
|
Import and processing |
| NL-2005-12 |
591223 Maize |
Food, feed |
| |
|
Import and processing |
| NL-2005-13 |
LLCotton25 |
Fodd,feed?? |
| |
|
Import and processing |
| UK-2005-14 |
Amylopectin Potato |
Food, feed |
| |
event EH92-527-1 |
|
| NL-2005-15 |
1507 x 59122 Maize |
Food, feed |
| |
|
Import and processing |
| NL-2005-16 |
281-24-236 x |
Food, feed |
| |
3006-210-23 Cotton |
Food, feed |
| UK-2005-17 |
1507 x NK603 Maize |
Food, feed, Import |
| |
|
and processing, |
| |
|
CULTIVATION |
| NL-2005-18 |
A2704-12 Soybean |
Food, feed |
| |
|
Import and processing |
| UK-2005-19 |
GA21 Maize |
Food, feed |
| |
|
Import and processing |
| UK-2005-20 |
59122 x NK603 Maize |
Food, feed |
| |
|
Import and processing |
| UK-2005-21 |
59122 x 1507 x NK603 |
Food, feed |
| |
|
Import and processing |
| NL-2005-22 |
NK603 Maize |
Food, feed |
| |
|
Import and processing |
| |
|
CULTIVATION |
| NL-2005-23 |
59122 Maize |
Food, feed |
| |
|
Import and processing |
| |
|
CULTIVATION |
| NL-2005-24 |
40-3-2 Soybean |
CULTIVATION |
| UK-2005-25 |
T45 Oilseed rape |
Food, feed |
| |
|
Import and processing |
| NL-2005-26 |
NK603 x MON810 Maize |
CULTIVATION |
| CZ-2005-27 |
MON 88017 Maize |
Food, feed |
| |
|
Import and processing |
| NL-2005-28 |
1507 x 59122 Maize |
Food, feed |
| |
|
Import and processing |
| |
|
CULTIVATION |
| UK-2006-29 |
59122 x NK603 Maize |
Food, feed |
| |
|
Import and processing |
| |
|
CULTIVATION |
| UK-2006-30 |
59122 x 1507 x NK603 |
Food, feed |
| |
|
Import and processing |
| |
|
CULTIVATION |
| NL-2006-31 |
LY038 Maize |
Food, feed |
| |
|
Import and processing |
| NL-2006-32 |
LY038 x MON810 Maize |
Food, feed |
| |
|
Import and processing |
| CZ-2006-33 |
MON 88017 x MON 810 Maize |
Food, feed |
| |
|
Import and processing |
| UK-2006-34 |
Event 3272 Maize |
Food, feed |
| |
|
Import and processing |
| NL-2006-35 |
LLCotton25 x MON |
Food,feed produced |
| |
15985 Cotton |
from GM plants |
| |
|
(derived producs) |
[3242]
The GMO Maize GA21 applyed for food and feed uses, import and processing and for renewal of the authorisation of maize GA21.
The GMO Panel of EFSAconsiders maize GA21, on October 2007, as safe as its non genetically modified counterparts with respect to potential effects on human and animal health or the environment. Therefore the GMO Panel concludes that maize GA21 is unlikely to have any adverse effect on human and animal health or on the environment in the context of its intended uses.
[3243]
The maize 59122 from Pioneer Hi-Bred International, Inc. and
Mycogen Seeds, c/o Dow Agrosciences LLC was approved on the 23 March 2007 by
the Panel of the European Food Safety Authority for food and feed uses, import
and processing of maize 59122 but does not include cultivation.
Maize 59122 was transformed by Agrobacterium-mediated gene transfer technology
and expresses CRY34Ab1, CRY35Ab1 and PAT proteins. The molecular
characterisation data established that maize 59122 contains a single insert of
the T-DNA. The structure of the insert in maize 59122 was determined by
Southern analysis and DNA sequencing. No vector backbone sequences were
detected. BLAST sequence analysis revealed that border regions of the maize
event 59122 show significant homology to maize genomic DNA and EST sequences.
None of the EST sequences showed homology to known toxin or allergen encoding
sequences. Analysis of ORFs spanning the two junction regions was performed by
bioinformatic analysis and no novel ORFs with sequence similarity to known
toxins or allergens were identified.
the GMO Panel concludes that maize 59122 is unlikely to have any adverse effect
on human and animal health or on the environment in the context of its intended
uses.
[3245]
The EFSA GMO Panel on the 17.09.2009 considers that maize Bt11xGA21 is as safe as
its non-GM maize counterpart with respect to effects on human and animal health
and the environment. Therefore, the EFSA GMO Panel concludes that maize Bt11xGA21
is unlikely to have any adverse effect on human and animal health or on the
environment in the context of its intended uses.
Dow AgroSciences is engaged to develop genetic solutions for crop production for food and non-food agriculture. With the acquisition Austrian Maize Technologies, and the Dutch germplasm company Duo Maize, Dow AgroSiences will become leading in the European market of corn seeds for grain and silage.
[3246]
The new acquisition will foster the spread of the Herculex seed in the European market which covers about 12 million hectares of corn fields.
The European registration of Dow's Herculex corn which is expected for soon, will bring more protection of corn against more destructive pests than any other trait, according to DowAgroSciences. It is the only in-plant technology that protects against western bean cutworm and black cutworm.
HERCULEX expresses the Cry 1F Bt protein and provides protection against above-ground insects like European corn borer, western bean cutworm, black cutworm and fall armyworm.
It combines Cry 1F with the binary Bt proteins, Cry 34Ab1 and Cry 35Ab1 to control all listed pests plus corn rootworm in HERCULEX XTRA and Pioneer Hi-Bred. Herculex traits also contain LibertyLink technology and many Herculex hybrids contain Roundup Ready Corn 2 technology.
Dow agroSciences presents three main traits:
Herculex I: Dow says its Herculex I cowers in one stroke the followingh pests:
European corn borer
Southwestern corn borer
Western bean cutworm
Black cutworm
Fall Armyworm
Southern corn stalk borer
Lesser cornstalk borer
Sugarcane borer
Corn earworm suppression
provides powerful, below-ground
in-plant insect protection against western, northern and Mexican corn rootworm
larvae, during the whole season.
combines Herculex I Insect Protection and Herculex
RW Rootworm Protection for powerful protection above-and below-ground. Its
whole-plant protection works all season long and shields your corn unlike any other trait.
Adopting Herculex the door is open to a large family of GM technologies where
everything is well round up. However, Dow AgroSciences warns: Application of
other, not specified herbicides to Herculex corn could result in total crop loss.
The use of Roundup Ready Corn 2 technology requires the purchaser to have
completed a Monsanto Technology Agreement.
[3247]
Bayer CropScience has developed partnerships with each of the participating seed
companies listed below to offer LIBERTY herbicide at a better value by reducing
the LIBERTY herbicide cost. See the list of corn seeds which have the Liberty
Link gene
at
http://www.bayergrowingstrong.com/liberty_rebate/
[3248]
Enzymes are naturally occurring proteins that speed up biochemical processes.
They're used to produce everything from wine and cheese to corn syrup and baked
goods.
When enzymes are genetically engineered, the manufacturer is not required to
notify the FDA that the enzymes have been modified. The FDA provides an
incomplete list of GE enzymes:
| Enzymes |
Used for |
|---|
| Chymosin |
production of cheese |
| Novamyl(TM) |
production of baked goods, preserves freshness |
| Alpha amylase |
white sugar, maltodextrins and nutritive |
| |
carbohydrate sweeteners (corn syrup) |
| Aspartic (proteinase enzyme from R. miehei) |
production of cheese |
| Pullulanase |
production of high fructose corn syrup |
[3257]
The FDA asserts in its policy on GM foods that genetically engineered crops are
no different than those created through traditional breeding methods. The
agency bases its position on the fact that foods derived from traditionally
bred crops have a history of safety. Thus the FDA takes the position that
genetic engineering is just another traditional breeding method, and reasons
that GM foods should be considered safe.
The Food and Drug Administration (FDA) issued a final guidance for industry
entitled "Recommendations for the Early Food Safety Evaluation of New Non-
Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use."
The guidance provides recommendations to developers of new plant varieties,
including bioengineered plant varieties, on the early food safety evaluation
of new non-pesticidal proteins produced by such new plant varieties, including
for example such proteins produced in bioengineered plants. The guidance
describes procedures for submitting an early food safety evaluation of such
proteins to the agency.
The guidance describes the procedure for early food safety evaluation of new
proteins in new plant varieties that are under development for food use. In
most cases, the proteins expected to become components of food, whether as a
result of the use of traditional or modern biotechnology methods, will be the
same or quite similar to proteins commonly found in food. FDA believes that
any food safety concern related to such material entering the food supply would
be limited to the potential that a new protein in food from the plant variety
could cause an allergic reaction in susceptible people or could be a toxin in
people or animals.
FDA recommends that sponsors and developers of new plant varieties intended for
food use consult with FDA about their evaluation of the food safety of any new
proteins produced in these plants prior to the stage of development where the
new proteins might inadvertently enter the food supply. Thus, the safety
evaluation recommended by this guidance is termed an "early" food safety
evaluation of new proteins.
If a protein has been evaluated in an early food safety evaluation and no
safety concerns are identified, we would not expect an additional early food
safety evaluation to be submitted if the same protein is introduced into
another plant species. Also, if a protein has previously been reviewed as part
of a biotechnology consultation and there were no safety concerns identified,
we would not expect you to submit an early food safety evaluation for such a
protein. This guidance does not apply to plant-incorporated protectants (PIPs),
which are regulated by EPA.
The Environmental Protection Agency (EPA) is responsible for evaluating the
safety of pesticides, including plant-incorporated protectants. As such, these
proteins are not subject to FDA review and are not the subject of this
guidance.
[3259]
Genetic engineering scientist are searching the way of production of food crops
with enhanced nutritional or medicinal value, the so called nutraceuticals.
Ralf Bock and colleagues from the Institute of Plant Biochemistry and
Biotechnology in Münster, Germany, in cooperation with Helaine Carrer of the
Centre of Agriculture Biotechnology of Piracicaba, Brazil, created a new
technique of genetic engineering. Instead of modifying the DNA of the nucleus
of the cell, the scientists modified the DNA of plastids such as chloroplasts.
In this way efficient production of edible vaccines, pharmaceuticals, and
antibodies in tomato can be realised, while the new genes are hindered to pass
to other crops or weeds.
This technique had already been used in genetic engineering of tobacco. Ralf
Bock and his team optimized plant tissue culture and regeneration, nutrition,
plant hormones and light intensity for the tomato plant.
Only one marker gene has been used yet, but more genes will now be focused in
the experiments of Ralf Bock.
The idea to use GM tomatoes with transformed plastids to develop edible
vaccines is also backed up by Pal Maliga from the University in Piscataway, New
Jersey. [3260]
Some of the technical issues that require resolution comprising the transfer of
foreign genes from chloroplasts to the nucleus were described by Henry Daniell
and Christopher L. Parkinson, University of Central Florida.
[3261]
[3262]
The FDA position to antibiotic resistance marker genes is given in the draft
guidance "Use of Antibiotic Resistance Marker Genes in Transgenic Plants:
Guidance for Industry" (the draft guidance) and report entitled "Report on
Consultations Regarding Use of Antibiotic Resistance Marker Genes In Transgenic
Plants."
The report summarizes FDA's recent consultations with outside experts on the
use of antibiotic resistance marker genes in transgenic plants. The draft
guidance is intended to provide information to crop developers that will assist
them on the use of antibiotic resistance marker genes in the development of
transgenic plants.
In the Federal Register of May 29, 1992 (57 FR 22984), FDA published a notice
on a policy statement (the 1992 policy) regarding foods derived from new plant
varieties, including those derived using genetic engineering techniques. In the
1992 policy statement, FDA specifically discussed antibiotic resistance
selectable marker genes and noted that both the antibiotic resistance gene and
the enzyme encoded by the gene, unless removed, are expected to be present in
foods derived from plants developed using the markers.
The agency acknowledged that, when present in food, enzymes that are encoded by
selectable marker genes and that inactivate certain clinically useful
antibiotics theoretically might reduce the therapeutic efficacy of antibiotics
administered orally. Accordingly, FDA believes that it is important to evaluate
such concerns with respect to commercial use of antibiotic resistance marker
genes in food, especially those marker genes that will be widely used. In
addition, the agency also believes that it is important to consider the
possibility that resistance to antibiotics in microorganisms has the potential
to spread through horizontal transfer of antibiotic resistance marker genes
from plants (59 FR 26700, May 23, 1994).
This second consideration was reflected in FDA's evaluation of the safety of
the use of the kanamycin resistance (kan<SUP>r</SUP>) gene product,
aminoglycoside 3'-phosphotransferase II (APH(3')II, also known as neomycin
phosphotransferase II or nptII) when the agency amended the food additive
regulations to permit the use of APH(3')II in the development of transgenic
tomato, cotton, and oilseed rape.
FDA received several comments from the public regarding the use of antibiotic
resistance marker genes in transgenic plants in response to the 1992 policy,
and in response to the agency's solicitation for comment regarding the request
of Calgene, Inc., for an advisory opinion on the use of the kan<SUP>r</SUP>
gene as a selectable marker in the development of transgenic tomatoes (56 FR
20004, May 1, 1991). FDA responded to these comments when it issued the final
rule permitting the use of APH(3')II in the development of transgenic tomatoes,
oilseed rape, and cotton (59 FR 26700 at 26706).
Since FDA's decision approving the use of the APH(3')II in the development of
transgenic tomatoes, cotton, and oilseed rape, the agency has continued to
receive inquiries from crop developers as well as from the public regarding the
safety and regulatory status of antibiotic resistance marker genes. Therefore,
FDA sought to develop sound scientific principles regarding the safety of the
use of antibiotic resistance marker genes in the development of transgenic
plants intended for food use so as to provide sound scientific guidance to crop
developers regarding the safe use of antibiotic resistance marker genes.
Toward this end, FDA undertook several consultations with outside experts
having expertise in relevant fields including gene transfer and antibiotic
resistance. The purpose of the consultations was to determine whether
circumstances exist under which FDA should recommend that a given antibiotic
resistance gene not be used in crops intended for food use, and if so, to
delineate the nature of those circumstances.
[3170]
In 1992, the Food and Drug Administration (FDA) issued a policy statement
regarding foods derived from new plant varieties including those derived using
genetic engineering techniques (U.S. FDA, 1992). In this policy statement, FDA
specifically discussed antibiotic resistance selectable marker genes and noted
that both the antibiotic resistance gene and gene product, unless removed, are
expected to be present in foods derived from plants developed using the
markers. The agency acknowledged that selectable marker gene-encoded enzymes
that inactivate certain clinically useful antibiotics, when present in food,
theoretically might reduce the therapeutic efficacy of antibiotics administered
orally.
Thus it is important to evaluate such concerns with respect to commercial use
of antibiotic resistance marker genes in food, especially those that will be
widely used. In addition, the agency believes it is important to consider the
possibility that resistance to antibiotics in microorganisms might spread
through potential horizontal transfer of antibiotic resistance marker genes
from plants to microorganisms in the gastrointestinal tract or in the
environment.
Since FDA's decision regarding the use of the kanamycin resistance (kan
)
gene product, aminoglycoside 3'-phosphotransferase II (APH(3')II, also known as
neomycin phosphotransferase II or nptII) in the development of transgenic
tomato, cotton, and oilseed rape,
the agency has continued to receive inquiries regarding the safety and
regulatory status of antibiotic resistance marker genes. Therefore, FDA sought
to develop sound scientific principles regarding the safety of the use of
antibiotic resistance marker genes in the development of transgenic plants for
food use and to provide sound scientific guidance to crop developers regarding
the safe use of antibiotic resistance marker genes.
Towards this end, FDA undertook several consultations with outside experts
between November, 1996 and February, 1997. The purpose of the consultations was
to determine whether circumstances exist under which FDA should recommend that
a given antibiotic resistance gene not be used in crops intended for food use,
and if so, to delineate the nature of those circumstances.
Overall, the arguments made concerning the improbability of the transfer of the
kan gene to gut microorganisms in the case of the Flavr Savr tomatoes
(U.S. FDA, 1994) could also be applied to other antibiotic resistance marker
genes. However, while the possibility of transfer from plants to microorganisms
is remote for all marker genes, crop developers should consider the following
factors in evaluating whether an antibiotic resistant gene is suitable for use
as a selectable marker:
1) whether the antibiotic that may be affected is clinically important,
2) whether it is frequently used,
3) whether it is administered orally,
4) whether it is unique or acceptable alternative antibiotics exist,
5) whether there would be selective pressure for transformants to be selected,
and
6) whether there already is resistance to the antibiotic in the environment.
FDA's analysis (U.S. FDA, 1994) showed that the kan gene that was used in
the case of the Flavr Savr tomato passes the paradigm outlined above. Neomycin
and kanamycin are infrequently used antibiotics, neither is unique for any use,
and rarely are administered orally. Thus, selective pressure would be minimal
for development of resistant bacteria because the drugs are not used in humans
or in animals to any great extent. Similarly, these antibiotics are not used in
agriculture or aquaculture to any great extent. Therefore, they would not
provide the selective pressure required to select for the kan determinant
if transfer from plants to soil microorganisms were to take place. In addition,
existing resistance levels far exceed any transfer that may take place from
transgenic plants to microorganisms.
However, different circumstances may apply to other antibiotics. For example,
with regard to the presence or absence of selective pressure, streptomycin and
oxytetracycline may provide selective pressure in the environment because of
their use as pesticides in agriculture. On the other hand, ampicillin may
provide selective pressure in the human gut when used in the clinical setting
but not in the environment.
The notion that it may be possible to construct a list of antibiotic resistance
marker genes that are acceptable for use in the development of transgenic crops
was discussed. The kan gene can be placed on such a list. Some experts
suggested that the hygromycin resistance gene may be included on such a list
because of its limited use in humans. It was noted, however, that it may have
important veterinary uses.
Other experts would include the beta-lactamase gene of 
UC18 (that confers
resistance to a narrow spectrum of beta-lactam antibiotics), and the
tetracycline resistance gene on such a list. There is so much resistance to
these antibiotics already in the environment that any potential transfer from
transgenic plants to microorganisms, especially when compared to transfer among
bacteria, is unlikely to add to the existing levels of resistance in any
meaningful way.
The idea was put forth that antibiotic resistance genes could be ranked on a
continuum with the kan gene on one end as the most acceptable, and the
vancomycin resistance gene on the other. It was further suggested that use of
marker genes beyond the kan and hygromycin resistance genes might be
acceptable on the basis of studies to address potential transfer and a
commitment to conduct post-market surveillance for transfer of the gene in
question.
[3170]
Some experts noted that some soil microbes may be naturally transformable and
that they may take up and incorporate DNA causing genomic rearrangements that
might help them occupy particular ecological niches.
Some experts felt that it does not make sense to expand the availability of the
resistance gene in the environment because abundance of marker genes may
compress the typical 4- 5-year time lag between first use of new antibiotic and
the emergence of resistance in hospitals.
Others felt that the risk of transfer from plant genome to soil microorganisms
is not a significant one. This latter group felt that DNA from plant debris
would be unavailable for transfer because it would be degraded by nucleases
when the plant cell lysed; in addition, there would be no selective pressure in
most cases although there are exceptions such as when streptomycin and
tetracycline are used as pesticides to prevent fire blight in fruit trees, or
when manure is used as fertilizer following use of antibiotics as growth
promoters in animals. It was noted that transfer from bacteria to bacteria
accounts for the wide dissemination of certain antibiotic resistance markers in
soil bacteria.
[3170]
Participants in the consultations discussed a
study conducted by a crop developer wherein plant DNA containing the beta-lactamase gene from an
insect-resistant transgenic corn line (intact or nuclease degraded) was
incubated with competent E. coli. The study was intended to determine if any
bacteria were transformed and acquired ampicillin resistance; the experiment
showed that transformation did not occur above a frequency of 1 in 6.8
x
.
Some experts said that if transformation were to take place, it would be more
likely to do so in experiments using competent bacteria in the laboratory than
in nature because competent bacteria have the highest transformation frequency.
They added that if transformation was not observed in the laboratory,
especially if the experiment was carried out in gram negative and gram positive
bacteria (an Enterococcus strain and an E. coli), the results would suggest
that such transfers may not take place in the natural setting to the extent
that they would raise health or safety concerns.
Other experts stated that an in vitro experiment does not give them much
confidence because it does not reflect the complex ecological system that
exists in nature. In addition, a monoculture of E. coli, is an artificial
system that would not be a strong basis on which to assess risk.
[3170]
- The approach taken by FDA in its evaluation of the safety of the use of
the kan gene and its product, APH(3')II, in the development of
transgenic tomato, cotton, and oilseed rape, is scientifically sound and
included all relevant parameters. These included: 1) evaluation of the safety
of the protein with respect to toxicity and allergenicity, 2) an assessment of
whether presence in food of APH(3')II would compromise the therapeutic
efficiency of orally administered neomycin and kanamycin, and 3) an assessment
of whether therapy with antibiotics might be compromised through transfer of
the kan gene from plants to microorganisms in the gut or in the
environment or to the cells lining the gastrointestinal tract.
- The presence in food of proteins encoded by antibiotic resistance genes
is not of great concern. They can be evaluated with respect to toxicity and
allergenicity and with respect to potential to compromise therapy with
antibiotics (in similar fashion to the approach taken by FDA for APH(3')II).
- Similarly, the potential transfer of antibiotic resistance genes from
foods derived from transgenic plants to cells lining the gastrointestinal
tract does not raise a safety concern. Most DNA is degraded in the gut and
thus, would be unavailable for transfer, and even if some DNA survived and was
available for transfer into these cells, it would not be integrated and
expressed due to lack of selective pressure. Additionally, because these cells
are continuously sloughed off and replaced by new cells, a cell that
incorporated an antibiotic resistance gene would not be long-lived and present
a safety hazard with respect to compromising therapy with antibiotics.
- The likelihood of transfer of antibiotic resistance genes from plant
genomes to microorganisms in the gastrointestinal tract of man or animal, and
in the environment is remote. Several barriers operate against such transfer.
In addition, the rate of such transfer, if any, would be insignificant when
compared to transfer between microorganisms, and would not add to existing
levels of resistance in bacterial populations in any meaningful way.
Nonetheless, caution should be the rule for antibiotic resistance markers that
inactivate clinically important antibiotics.
- The kan gene is safe to use as a selectable marker in the
development of transgenic crops. Some experts also felt that there would be
little concern with use of the hygromycin resistance gene as a selectable
marker. However, hygromycin may have important veterinary uses and, therefore,
its use should be carefully evaluated in those crops that have animal feed
applications.
- There are varying levels of concern with use of other antibiotic
resistance genes as selectable markers in transgenic plants, with the highest
level of concern for those genes that confer resistance to antibiotics such as
vancomycin, an antibiotic viewed as a drug of last resort for some infections.
Overall, use of these antibiotic resistance marker genes should be evaluated
on a case-by-case basis with the evaluation taking into account information on
1) whether the antibiotic is an important medication, 2) whether it is
frequently used, 3) whether it is orally administered, 4) whether it is
unique, 5) whether there would be selective pressure for transformation to
take place, and 6) whether there already is resistance to the antibiotic in
bacterial populations.
- Some experts suggested that surveying the current levels of resistance
to various antibiotics would be important in order to gauge the impact of any
potential transfer of antibiotic resistance genes from transgenic plants to
microorganisms. In addition, some experts recommended that developers of
transgenic crops might be encouraged to conduct surveillance to ascertain that
transfer of antibiotic resistance genes from transgenic plants to
microorganisms is not taking place. Such surveillance would safeguard against
the occurrence of drug resistance from use of marker genes in transgenic
plants and provide the public health community and the regulatory agencies an
opportunity for early intervention to prevent adverse impact on public health.
The Bavarian Environmental Agency (Bayerisches Amt für Umweltschutz)
http://www.bayern.de/lfu/gentec/index.html provides useful service for
genetic engineering projects, the registration, the release of genetic modified
organism, to place a GMO on the market, the official supervision of fields,
texts of relevant regulations, a link to the Federal Agency for Consumer
Protection and Food Safety (Bundesamt für Verbraucherschutz und
Lebensmittelsicherheit (BVL) ) is provided.
http://www.bvl.bund.de/cln_027/nn_495478/DE/06__Gentechnik/gentechnik__node.html__nnn=true
The Federal Agency for Consumer Protection and Food Safety is responsible for
the entire genetic legislation enforcement since 2004.
[3171]
is a broad-spectrum polyketide antibiotic produced by
the Streptomyces bacterium, used to treat bacterial infections, including
pneumonia and other respiratory tract infections; acne; infections of skin,
genital and urinary systems; and the infection that causes stomach ulcers
(Helicobacter pylori). It also may be used as an alternative to other medications
for the treatment of Lyme disease and for the treatment and prevention of anthrax
(after inhalational exposure). Tetracycline is in a class of medications called
tetracycline antibiotics.
are a group of broad-spectrum antibiotics whose
general usefulness has been reduced with the onset of bacterial resistance.
Despite this, they remain the treatment of choice for some specific
indications. They are so named for their four ("tetra-") hydrocarbon rings.
More specifically, they are defined as a subclass of polyketides having an
octahydrotetracene-2-carboxamide skeleton. They are collectively known as
derivatives of polycyclic naphthacene carboxamide.
![\includegraphics[width=190.50bp,height=105.84bp,angle=0]{library/Tetracycline.eps}](img74.png)
Source:Wikipedia.
[3172]
Tetracycline inhibits cell growth by inhibiting translation. It binds to the
16S part of the 30S ribosomal subunit and prevents the amino-acyl tRNA from
binding to the A site of the ribosome. The binding is reversible in nature.
Cells become resistant to tetracycline by at least three mechanisms: enzymatic
inactivation of tetracycline, efflux, and ribosomal protection. Inactivation
is the rarest type of resistance, where an acetyl group is added to the
molecule, causing inactivation of the drug. In efflux, a resistance gene
encodes a membrane protein that actively pumps tetracycline out of the cell.
This is the mechanism of action of the tetracycline resistance gene on the
artificial plasmid pBR322. In ribosomal protection a resistance gene encodes a
protein which can have several effects depending on what gene is transferred.
Six classes of ribosomal protection genes/proteins have been found, all with
high sequence homology suggesting a common evolutionary ancestor.
Possible mechanisms of action of these protective proteins include: 1.blocking
tetracyclines from binding to the ribosome, 2.binding to the ribosome and
distorting the structure to still allow t-RNA binding while tetracycline is
bound, and 3.binding to the ribosome and dislodging tetracycline.
[3173]
The tetracyclines group of dairy antibiotics is used to treat bovine mastitis in
dairy herds, and includes tetracycline, chlortetracycline, and oxytetracycline.
Quarantine of treated animals up to 4 days is necessary to avoid tetracycline
residues higher than 100 parts per billion in milk and their products,
established by the European Union. Tetracyclines are widely used in Spain and
other European countries.
A new dip-stick test from Neogen's TetraStar(R) monitoring tetracyclines in milk
charges, gives results in six minutes. Another test is necessary to control the
beta-lactam group of dairy antibiotics, which includes amoxicillin, ampicillin,
cephapirin, cloxacillin, and penicillin. This group is widely used throughout the
world in dairy veterinary medication.
Diabetes is widespread in industrial countries. It develops mainly in advanced
age, but children may also have type 2 diabetes mellitus. Overweight, lack of
physical exercise and genetic factors may trigger the disease.
It is supposed that the body on behalf of continuously high blood-sugar,
produces so much insulin that the cells do not react any more on this hormone
and at some moment the produced insuline is not sufficient any more. Type I
diabetes is somewhat of an autoimmune reaction working against the production
of insulin of the pancreas.
Robert Sladek and colleagues from the McGill University in Montreal identified
four loci in the human genome, containing variants that confer type 2 diabetes
risk, in addition to confirming the known association with the TCF7L2 gene.
These loci include a non-synonymous polymorphism in the zinc transporter
SLC30A8, which is expressed exclusively in insulin-producing beta-cells, and
two linkage disequilibrium blocks that contain genes potentially involved in
beta-cell development or function (IDE-KIF11-HHEX and EXT2-ALX4). These
associations explain a substantial portion of disease risk and constitute proof
of principle for the genome-wide approach to the elucidation of complex genetic
traits.
The researchers are developing an easy test which can identify the genetic
anomaly and direct the therapy toward the modified zinc transporter. The
authors look forward to a genetic test of persons with the predisposition to
type 2 diabetes. This can motivate these persons to a follow a specific
nutrition plan and practice more sports and avoid the development of the
disease.
[3175]
Researchers identified the MCPIP gene to regulat the fat cell formation and
blood vessel formation that feeds the growing fat tissue. Leading author
Pappachan Kolattukudy stresses that targeting this gene, a drug may shut
down its function, preventing obesity and inflammatory diseases resulting
from obesity, including diabetes and cardiovascular diseases.
The peroxisome proliferator-activated receptor gamma (PPAR gamma), had been known
to control fat cell formation which could not be induced by other factor without
the PPAR gama gene. Kolattukudy and colleagues silenced the PPAR gama gene and
introduced the MCPIP gene to living cells from mice. The cells were still
capable of fat formation. The increased inflammation of fat cells is seen to
reduces their sensitiveness to insulin, increasing the risk of type 2 diabetes.
The authors underline that MCPIP can induce adipogenesis without PPARgama.
[3176]
The two loci, FTO and MC4R are two loci which are associated with body mass index
(BMI) in humans. Hirschhorn and colleagues 2008 identified six additional loci:
TMEM18, KCTD15, GNPDA2, SH2B1, MTCH2 and NEGR1. Several of these genes are known
to act in the central nervous system (CNS) which is linked to predisposition to
obesity, demnstrating the neuronal influence on body weight regulation.
[3177]
Rüther and colleagues 2008 report that FTO gene is linked to a
predisposition of persons to become skinny or obese. The authors stress that
leptin, and adiponectin, were less expressed in mice with Fto, compared with
mice whose Fto gene were silenced. These two hormones control appetite,
energy balance and metabolic processes. Lower levels of these hormones are
associated with obesity.
The leanness of Fto-deficient mice was found in this study to result of an
increased of energy expenditure and systemic sympathetic activation, despite
decreased physical activity and high food intake. The authors suggest that the
Fto gene is energy regulation whith increased energy expenditure.
[3178]
Dhurandha and colleagues 2009 report that the human adenovirus Ad36, may
promotes obesity. The study used rodent preadipocyte cell line. A
nonadipogenic human adenovirus Ad2 was used as a negative control for viral
infection. Ad36, but not Ad2, was found to accumulate lipid in cells.
Ad36 downregulated preadipocyte marker gene Wnt10b, and upregulated expression
of early (C/EBPDelta and C/EBPbeta), intermediate (PPARgamma2), and late genes
(aP2 and G3PDH) of adipogenic cascade. The authors concluded that Ad36 is an
exogenous regulator of the adipogenic process.
The researchers van Ginneken, Sitnyakowsky and Jeffery 2009, following the
results of the studies of Dhurandha and colleagues, postulate that infection
with Ad-36 may be another factor of the global rising obesity. According to
the authors, viral infections may add another cause of obesity to the long
recognized factors such as genetic inheritance, diet, exercise, cultural
practices and stress. Four viruses have been reported to induce obesity in
animal, however these viruses were unable to infect humans. The human adenovirus
Ad36 is now recognized to affects human primary preadipocytes, and antibodies to
Ad-36 were more prevalent in obese subjects (30%) than in non-obese subjects
(11%). [3179]
[3180]
Sul and colleagues 2009 report that an enzyme, the adipocyte phospholipase A(2),
AdPLA (encoded by Pla2g16, also called HREV107) regulates lipolysis and
adiposity.
The authors found that mice without AdPLA have a markedly higher rate of
lipolysis have markedly reduced adipose tissue mass and triglyceride content,
and higher energy expenditure with increased fatty acid oxidation. They eat
more while remaining lean.
The researchers concluded that AdPLA enzyme is a major regulator of fat
physiology and is an important factor of obesity.
The nptII gene (neomycin phosphototransferase II) provides resistance to
certain antibiotics, such as the aminoglycosides kanamycin, neomycin and
geneticin, in plants. In in 2004 the EFSA found no scientific evidence that a
transfer of this gene to bacteria, animals or humans could occur.
The EC asked EFSA to consider an information of EMEA and any potential
consequences for the safety of the nptII gene as a marker gene in genetically
modified plants and for previous opinions on specific GM plants (and derived
food and feed) comprising the nptII gene.
According to the European Medicines Agency EMEA information, aminoglycosides
comprise a class of antibiotics that has become increasingly important in the
prevention and treatment of serious invasive bacterial infections in humans.
This is because bacteria, such as tuberculosis bacteria, are becoming resistant
to other classes of antibiotics. It also said that, although kanamycin and
neomycin are used relatively infrequently, the development of similar
antibiotics should be taken into account and that aminoglycosides as a group
are a class of antibiotics critically important for veterinary medicine.
The GMO Panel responded agreeing with the EMEA that the preservation of the
therapeutic potential of the aminoglycoside group of antibiotics is important.
The Panel is also of the opinion that the therapeutic effect of these
antibiotics will not be compromised by the presence of the nptII gene in GM
plants, given the extremely low probability of gene transfer from plants to
bacteria.
The GMO Panel reconfirms its earlier conclusions in its opinion on antibiotic
resistant marker genes that the use of the nptII gene as selectable marker in
GM plants (and derived food or feed) does not pose a risk to human or animal
health or to the environment.
[3182]
(i) DNA is released from plant material by normal digestion processes that take
place in the gastrointestinal tract, or by activities of nucleases present in
various organisms in the environment.
(ii)The probability that bacteria will be exposed to DNA stretches long enough
to contain the intact nptII gene is very low because of the above mentioned
digestion and degradation processes.
(iii) The nptII gene from plant material can only be taken up by competent
bacteria via natural transformation, a process that occurs infrequently in many
bacteria and in most environmental conditions.
(iv) If the intact nptII gene enters the bacteria, it will be rapidly degraded
by restriction endonucleases inm many bacterial cells which possess DNA
restriction systems in order to destroy foreign DNA.
(v) If the intact nptII gene does indeed survive, the probability of its
incorporation into the bacterial genome is very low unless there are homologous
regions already present in the bacterial genome. Gene transfer from plants to
bacteria has only been demonstrated under laboratory conditions when regions of
homology were already present in the recipient bacterium.
(vi) Expression of the incorporated nptII gene is unlikely considering that in
GM plant material the nptII gene is under the control of a promoter with
preferential expression in plants, which does not support its efficient
expression in bacteria.
(vii) Stable integration and inheritance of the nptII gene in the host
bacterium is not likely in the absence of selective pressure from a relevant
antibiotic.
When all of the above mentioned aspects are taken into account, the probability
of functional gene transfer from plants into microorganisms is extremely low.
It is not surprising that transfer of an antibiotic resistance marker from GM
plants to bacteria has not been observed under natural conditions.
The EMEA has indicated that under laboratory conditions gene transfer from
plants to bacteria has been demonstrated. According to EFSA, however, gene
transfer from plants to bacteria has only been demonstrated in a few highly
transformable bacterial species (e.g., Acinetobacter sp. BD413 or Pseudomonas
stutzeri) under artificial and forced laboratory conditions when regions of
homology were already present in the recipient bacterium. In the absence of
this optimisation of the process and selection pressure, resistance gene
transfer from GM plants to bacteria, even in the laboratory, could not be
demonstrated.
[3182]
Antibiotic resistance is a common feature in natural microbial communities in
soils, aquatic systems, and habitats associated with animals and humans. There
is already a widespread presence of nptII in the soil environment.
Studies indicate that, as expected of a gene located on a transposable genetic
element, nptII is located on a wide range of replicons in bacterial clinical
isolates from humans The nptII gene was present in 2.5% of bacterial clinical
isolates resistant to kanamycin and neomycin collected between 1987 and 1991 in
several European and Central and South American countries (Shaw et al., 1993).
Studies on the prevalence of the nptII gene in animal-associated bacterial
populations have not been found in the scientific literature.
[3182]
Kanamycin-resistant bacteria are ubiquitous in nature. Only a fraction of
kanamycin-resistant bacteria contain the nptII (aph(3')-IIa) gene, the other
resistant bacteria having different genes and/or other mechanisms conferring
kanamycin resistance.
The nptII gene has been reported to occur naturally only in eubacteria. In one
survey, 3 out of 184 kanamycin resistant bacterial isolates from three stream
sites in the USA (Leff et al., 1993) and 44 out of 355 from different habitats
in the Netherlands (Smalla et al., 1993) contained nptII sequences.
[3182]
Resistance towards amikacin, an important reserve antibiotic could be obtained
under laboratory conditions and was the result of a mutated nptII gene and a
diminished rate of amikacin uptake into the bacterial cell. However, to date no
clinical amikacin resistant strains with a mutated nptII gene have been
identified.
Researchers from the from Hamburg University and the University of Hyderabad
(India) found in 2007 GM rice with high antiooxidant activity. The rice
contains the anthocyanidin synthase (ANS) enzyme. ANS enzyme is involved in the
biosynthesis of flavonoids, transforming leucoanthocyanidins into coloured
anthiocyanidins. The transgenic rice 10TC is a mutant strain of the rice called
Nootripathh.
The authors compared the favonoid content of the transgenic Rice with that of
normal non GM rice:
| Flavonoids |
Produced in 10TC Rice |
Normal nonGM
Rice |
|---|
| |
micrograms per milligram |
micrograms per milligram |
| |
|
|
| Anthocyanins |
2.52 |
0.12 |
| |
|
|
| |
|
|
| Quercetin |
1.37 |
0.55 |
| |
|
|
| |
|
|
| Proanthocyanidins |
0.09 |
0.40 |
| |
|
|
The content of flavonoids had 22% higher antioxidant activity than
untransformed rice. The authors claim that their method can be used to enhance
the nutritional value and resistance against biotic and abiotic stresses of
different food crops. This would strongly support genetic modification of
staple foods.
[3184] [3185]
The UK's department for the environment, food and rural affairs (Defra), which
originally gave approval in December for BASF to undertake research trials of a
GM potato at two sites in England, one in Cambridgeshire and the other in
Derbyshire, said that it would now consider BASF's proposal as a new
application in accordance with the Genetically Modified Organisms (Deliberate
Release) Regulations 2002. Similar trials are already underway in in Sweden,
Germany and the Netherlands. But before reaching a definitive decision, Defra
said that it would consider any representations that people may wish to make
about the risk of environmental damage posed by the GM trial. The deadline for
representations is 20 April 2007.
Defra announced in its News Release from 01.12.06 the approval of an
application of BASF to undertake trials of a late potato blight disease GM
potato on two sites in England, starting in 2007.Evaluation of the application
by the Advisory Committee of Releases to the Environment (ACRE ). found that
the trials will not result in any adverse effect on human health or the
environment. [3186]
Clare Oxborrow Friends of the Earth says that the trials pose a significant
contamination threat to future potato crops, claiming that there is no need for
GM potatoes and no consumer demand for them. This was backed by Lord Peter
Melchett from the Soil Association warning that other crops risk contamination
by GM. [3187]
Professor Philip Dale of the plant-breeding John Innes Centre argued that the
Soil Association is opposing this project because the Association see these
kinds of advances in general agriculture to be a threat to the profitability of
organic farming.
In 2004 the company, Ventria Bioscience, Californis, started to cultivate rice
engineered to produce lactiva and lysomin. These proteins are found in breast
milk and should improve recovery from diarrhoea. [3188] The
company has now received approval from the US Department of Agriculture to
cultivate this rice in the state of Kansas. According to Robert Wittler, from
Kansas University School of Medicine at Wichita the outcomes of a clinical
trial using the new rice suggests that children suffering from diarrhoea may
recover sooner compared with traditional traditional medication.
[3189] GeneWatch UK and Friends of the Earth, point out the danger of a
broad contamination of staple foods with pharmaceutical producing genes. The
genes, cultivated and copied in a laboratory to produce a synthetic version,
are carried into embryonic rice plants inside bacteria.
[3190]
The California Rice Commission was created by the government of California to
serve the interests of the California rice industry by expanding and
maintaining the industry's markets. California ranks second in the United
States behind Arkansas in rice production, accounting for 20% of the U.S. total
production.
In 2000, the California legislature, in response to a proposal advanced by the
CRC, enacted the Rice Certification Act of 2000279 with the broad intent of
enhancing and protecting the reputation of California's rice industry
throughout the nation and around the world.
Lonnerdal in a review states that expression of recombinant human milk proteins
in rice is realistic and a possibility for the addition of bioactive factors to
infant formula and baby foods. The protein composition of infant formula is
still quite different than that of human milk, as there are proteins in cow's
milk which are absent in human milk, and many proteins in human milk are absent
in cow's milk such as lactoferrin. Addition of human milk proteins to infant
formula may be necessary to obtain some of the nutritional and health benefits
that breast-fed infants enjoy.
Recombinant human milk proteins can now be expressed in a variety of systems.
Recombinant human lactoferrin and lysozyme added to a rice-based oral
rehydration solution were found to increase recovery of children with acute
diarrhea. [3195]
Ventria rice expresses human lactoferrin or lysozyme protecting the
intestinal tract similarly to subtherapeutic antibiotics. The GM rice has
potentials to to be used as a substitute for antibiotics in broiler diets.
[3196]
Saccharomyces is used for expression of human lactoferrin but has low
expression levels. Aspergillus is being used in the production of recombinant
human lactoferrin but the cost is too high for use as a food additive.
[3194]
In the fall of 2002, Ventria began formal discussions with the CRC on its
intent to commercially plant its pharma rice during the 2004 planting season,
and, in December 2003, Ventria submitted an application to APHIS to renew its
California field trial permits.
In order for Ventria's pharma rice product to be commercialized in California,
APHIS would have to authorize the necessary planting through the issuance of an
appropriate permit. Of the 84 permits for the field testing of pharma crops
that APHIS has issued nationwide, nine have been issued for trials in
California, including for pharma rice, but APHIS has not to date authorized
commercial production for any pharma crop.
Ventria stipulated that its pharma rice had characteristics of commercial
impact. The advisory board of CRC worked with Ventria to develop proposed
conditions for the production and handling of the company's pharma rice. These
included growing the pharma rice in Southern California, which is outside the
state's rice belt; not seeding the rice from the air, ensuring a buffer zone of
100 feet between biotech rice and other crops; ensuring seed containers are
sealed and numbered and silos are labeled and locked in order to keep pharma
rice separate from other rice; and testing for the presence of the biotech
pharma trait.
On March 29, 2004, by a vote of six to five, the advisory board recommended to
the secretary of agriculture conditions and protocols under which Ventria's
pharma rice could be planted commercially with adequate identity preservation
and containment.
California Department of Food and Agriculture CDFA Secretary Kawamura denied
the recommendation of the commission's advisory board for an emergency
exemption to plant its pharma rice crop during the spring 2004.
Ventria said the company has plans to reapply in California and is also
considering other options, such as planting in Hawaii and states in the South.
Japan imports 40% of the California's production of rice. The Japanese Rice
Retailers Association has been concerned about biotech products in general and
the commercialization of pharma rice specifically which will evoke a distrust
of U.S. rice as a whole among Japanese consumers,
The Biotechnology Industry Organization (BIO) argues that the health benefits
of pharma crops outweigh the risks and that the risks are adequately regulated
by the federal government.
The industry also points out that food crops are good platforms for pharma crop
development and production.
Acording to Ventia the health benefits of the technology outweigh the risks,
claiming that producing these proteins through crops is the most cost-effective
and efficient means of reaching the most people. Planting 65 acres of pharma
rice, they say, could generate 1,400 pounds of lactoferrin, which would be
enough to treat 650,000 children with dehydration, a condition that kills 3
million infants each year worldwide, mostly in developing countries.
However, a report by the National Research Council on the biological
containment of genetically modified organisms concluded that crops used to
produce common food products would be a "poor choice" for use to produce pharma
and industrial crops unless they can be grown under "stringent conditions of
confinement."
The USDA's Animal and Plant Health Inspection Service (APHIS) had discovered GM
in a variety of long grain rice seed from BASF, all of them outside of the
California state. Following this announcement, the California Rice Commission
(CRC) called for a suspension of field testing of all genetically modified
rice cultivars in the State of California for the 2007 crop, and for future
crops, until safety is guaranteed.
These arguments made the California Rice Commission, to call for a moratorium
on GM field testing in the state, allowing for an opportunity to evaluate
federal regulations that safeguard the rice industry.
John Shanklin looking for better understanding of the enzymes and metabolic
pathways that produce oils in oil plants found how to manipulate the
accumulation of fats using genetic techniques. They found that reducing the
levels of the gene Arabidopsis KASII convert temperate oilseed composition of
temperate oil plants , such as canola, soybean, and sunflower to that of a
palm-like tropical oil.
Temperate oil add two carbons with a desaturating activity of the expression
of the gene KASII. Reducing the expression of this gene the double bounded
elongation of the fatty acid chain from C16 to C18 is reduced. A higher
melting point of the fat is attained which resembles that of palm oil.
This may reduce the pressure on the forests in Asian countries saving thus
precious wildlife.
[3198]
Environmental concerns about the destruction of Indonesian forests and peatlands,
increasing greenhouse gas emissions and damaging habitats for animals are driving
big corporations to develop new varieties of oil palm plants which present
higher yields and are more resistant to diseases. The University of Reading,
working with Sumatra Bioscience, BioHybrids International Limited, and the
University of Aberystwyth are developing F1 oil palm hybrids which are are more
economically viable and environmentally sustainable. The F1 hybrid from Sumatra
Bioscience is to be marketed by 2018. The F1 oil palm hybrids are the result of
crossing two distinctly different oil palm parental lines. These lines are
genetically uniform, resulting in higher yield per unit area and may be developed
to present specific oil profiles to meet specific demands . Other companies,
also looking for oil palm plants with higher yields are the US-based Synthetic
Genomics and the Asiatic Centre for Genome Technology.
Colony Collapse Disorder (CCD) is a poorly understood phenomenon involving the
massive die-off of a beehive or bee colony. CCD is alternatively referenced as
Vanishing Bee Syndrome (VBS). CCD was originally found only in colonies of the
West honey bee in North America, but European beekeepers have recently claimed
to be observing a similar phenomenon in Poland, Greece, Italy, Portugal and
Spain, Switzerland and Germany. From 1971 to 2006 approximately half of the
U.S. honey bee colonies have vanished.
The cause (or causes) of the syndrome is not yet well
understood and even the existence of this disorder remains disputed. Theories
include environmental change-related stresses, malnutrition, unknown
pathogens, mites (Varroa mites), pesticides such as neonicotinoids, emission
from cellular phones or other man made devices, and genetically modified
crops.
This set of symptoms has in the past several decades been given many different
names (disappearing disease, spring dwindle, May disease, autumn collapse, and
fall dwindle disease).
[3200]
Jeff Pettisan entomologist from the USDA Agricultural research Service,
Maryland says that varroa mite infestations have become such a serious problem
that maintaining bee colonies without chemical treatment is virtually
impossible. Apistan—a strip that contains the chemical tau-fluvalinate is being
used. Varroa, however, have begun to show resistance to the chemical.
Pettisan looking for alternatives introduced a sticky paper which is located
beneath the hive bottom. Mites get stick to the paper and can be removed from
the hive. As safe and effective chemical controls continue to be researched and
developed, the sticky paper will complement Apistan in assisting beekeepers
with the control of invading varroa.
Other causes of the Colony Collapse Disorder, according to Pettisan, may be an
unknown virus, Bacteria, pesticides or a combination of these causes.
The honey bee has a reduced number of genes which
express resistance to toxics and diseases, compared with the genetic code of
the fruit flies and ants. According to May Berenbaum from the University of
Illinios this could make the bees more vulnerable to toxics and diseases.
Berenbaum caled for improving genetic stocks of bees. He stressed the fact
that supplies of animal-pollinated foods - most fruit, vegetable, and nut
crops, which provide the bulk of vitamins and other necessary nutrients in our
diets - may well be dramatically affected in case of further losses of hives.
[3201]
[3202]
Honeybee decline is thought to be caused by a combination of factors like
climate change, parasites (like the varroa mite), diseases, overexposure to
pesticides and the loss of suitable habitat. Dr Dave Chandler examines naturally
occurring fungi that kill the varroa mite. Varroa destructor, formerly V.
jacobsoni, feed on the circulatory fluid of honey bee pupae and adult bees,
activate and transmit diseases, reducing bee life expectancy and causing the
colony to decline.
Presently, the control of varroa is based on the use of
chemical pesticides. To avoid growing mite resistance, biological control
technologies, such as fungus which kill the varroa mite, could offer an
alternative pest management strategy of varroa, but had a low impact on the bees
and worked in the warm and dry conditions typically found in bee hives and find
the best ways of applying this weapon across the hive. This includes fungal
footbaths at the main entrance to hives and powder spays.
[3203]
Fluvalinate (Apistan strips): Fluvalinate is the active ingredient of Apistan
strips. It is a synthetic pyrethroid applied as a contact miticide.
Coumaphos(CheckMite+ strips): Coumaphos is the active ingredient of CheckMite+
strips. The product is an organophosphate, applied as a contact miticide.
Sugar esters: Sugar esters (Sucrocide) in spray application Formic
Acid: Formic acid is effective against Varroa and tracheal mites (Acarapis
woodi).
Oxalic Acid: Oxalic acid (Oxalic acid dihydrate) should only be applied in
late fall when the colony has no brood. Non Chemical Control: Traps and oils.
Diana Cox-Foster and colleagues 2007 reported a correlation between colony
collapse disease and the presence of Israeli acute paralysis virus
(IAPV), a highly pathogenic virus.
According to Cox-Foster infected bees present paralytic-type movements and
die. The researcher say, however, that the virus may not be the the sole
cause of CCD, and additional stresses are needed to trigger the disease.
[3204]
A variety of environmental chemicals such as pesticides, found on pollen, wax,
adult bees and brood may be such a trigger.
[3205]
[3206]
Colony collapse disorder (CCD) made one third of US honey bees to disapear in
late 2006. The researchers linked pathogens and other environmental stresses,
including pesticides to the disease. However, a convincing causal
relationship could not be presented.
Berenbaum and colleagues 2009 studied the gene expression of bees sampled
before CCD spread, and compared it with bees from CCD colonies. The
researchers found 65 transcripts as potential markers for CCD status.
The unusual ribosomal RNA fragments are possible remnants of picorna-like
viral infection, including deformed wing virus and Israeli acute paralysis
virus. Ribosomals are cell structures which produce proteins. The authors
speculate that viruses invaded the ribosomes resulting in heavy alterations
in protein synthesis in CCD colonies.
Impaired protein production reduces resistance to pesticides, fungus or bacteria
infections or even malnutrition. The authors propose that these unusual ribosomal
fragments establish a link to other suggested causes of CCD. These RNA
fragments are the primary cause which open the door to other factors of the
disease. Ribosomal fragment abundance and presence of multiple viruses are being
suggested by the authors as diagnostic markers of CCD.
[3207]
According to Berenbaum and colleagues honey bee mortality may occur when
tau-fluvalinate and coumaphos are simultaneously present in the hive.
Both varroa mite miticides the organophosphate coumaphos (Checkmite+), and the
pyrethroid tau-fluvalinate (Apistan) are lipoohilic and build up in wax
structures of the hive. Honey bees may thus become exposed to both miticides
as a result of repeated treatments.
The authors found a large increase in the toxicity of tau-fluvalinate in hives
when coumaphos have been used before. This synergism was less accentuated whit
treatment of coumaphos followed tau-fulvinate. The authors stress that the
detoxification of the miticides is mediated by cytochrome P450 monooxygenase
enzymes (P450s). A competition between both chemicals for access to detoxicative
P450s may cause rising toxicity which would not be lethal when only one of the
chemicals is present.
[3208]
Jerry Bromenshenk from Montana describes the signs of the disorder as follows:
Colony Collapse Disorder (CCD) is the latest problem facing bee keepers today.
Symtoms of CCD are:
1) In collapsed colonies
- The complete absence of adult bees in colonies, with no or little build
up of dead bees in the colonies or in front of those colonies.
- The presence of capped brood in colonies.
- The presence of food stores, both honey and bee bread
i.which is not immediately robbed by other bees
ii.when attacked by hive pests such as wax moth and small hive beetle,
the attack is noticeably delayed.
2) In cases where the colony appear to be actively collapsing
- An insufficient workforce to maintain the brood that is present.
- The workforce seems to be made up of young adult bees.
- The queen is present.
- The cluster is reluctant to consume provided feed, such as sugar syrup and protein supplement.
Jerry Bromenshenk is a member of a team of researchers studying the disorder.
He developed a questionnaire, "National Bee Loss Survey" which can be found at
http://www.beesurvey.com/
[3209]
Higes and colleagues 2009 report that the depopulation in two Spanish colonies
known as colony collapse disorder (CCD) were due to the infection by Nosema
ceranae (Microsporidia), an emerging honeybee pathogen. No other significant
pathogens or pesticides (neonicotinoids) were detected and the bees had not been
foraging in corn or sunflower crops. The treatment with fumagillin avoided the
loss of surviving weak colonies.
The microsporidia are spore-forming unicellular parasites, infesting insects
crustaceans, fish and vertebrates, including in humans. Some species produce
deadly infections ans some are even used as biological control of insects pests.
Colony collapse disorder (or CCD) is a phenomenon in which worker bees from a
beehive colony abruptly disappear. Honeybees are important pollinators of
crops.
The eastern hive bee Apis cerana, were found to be infected by Nosema apis and
the western hive bee Apis mellifera is susceptible to Nosema ceranae.
According to Professor Fries Nosema ceranae differs in their ultrastructure and
genetics from Nosema apis. Paxton writes that Nosema ceranae jumped host from
Apis cerana to Apis mellifera within the last decade. It is found nowadays in the
western honey bee in North and South America, the Caribbean, across Europe and
Asia [3210]
Possible causes of CCD were cited such as Varroa mites and insect diseases
including Nosema apis and Israel acute paralysis virus, environmental
change-related stresses,malnutrition and pesticides, and migratory beekeeping.
Other unproved causes were cited, such as cell phone radiation and genetically
modified (GM) crops used to control pests. Some researchers suggest that the
combination of many factors may finaly be the cause of the disease.
[3211]
Otterstatter and Thomson in 2008 suggests that a disease caused by Crithidia
bombi (a trypanosome parasite) is being spread to wild bumble bees from
commercially reared bumble bees used to pollinate greenhouse crops.
The Colony Collapse Disorder (CCD) of commercial bees is somehow spreading to
wild bumble bees which suffer serious declines. Bees are important to
pollinate greenhouse crops. Commercial bumble bees are used to pollinate
tomato bell pepper, almond and a lot of berries.
Infection with Crithidia bombi causes the bees to loose their ability to
distinguish between flowers that contain nectar and those that don't. They
make many mistakes by visiting nectar scarce flowers and in so doing, slowly
starve to death. Commercially bred bees are used in greenhouses, to pollinate,
for example, tomatoes and these bees typically harbour this parasite, while
wild bees do not. It is believed that the commercial bees transmitted the
parasite to wild populations in some cases. they escape from the greenhouses
through vents and a simple mesh could help prevent their escape. [3212]
On a study in 2007 Otterstatter and Thomson found that within colonies, a bee's
rate of contact with infected nestmates emerged as the only significant
predictor of infection risk. The authors stress that the activity of bees, in
terms of their movement rates and division of labour (e.g., brood care, nest
care, foraging), do not influence risk of infection. [3213]
The authors predict that the spread of C.bombi from the population of greenhouses
will spread to all wild bumble bee species (Bombus spp.).
A remarkably high degree of genetic diversity of C. bombi among infections was
found by Schmid-Hempel and Funk 2004. The authors suggest that genetic
diversification of the population of C.bombi results from strong genotypic
host-parasite interactions. [3214]
To control the disease the authors suggest improved management of domestic bees,
such as the reduction of the parasite loads and the contact with wild bees.
[3215]
The winter of 2006/2007 and 2007/2008 were marked by large-scale unexplained
losses of honey bee colonies. These losses of colonies were named Colony
Collapse Disorder (CCD).
Vanengelsdorp and colleagues 2009 believe that CCD involves an interaction
between pathogens and other stress factors. The researchers found higher
loads and greater number of pathogens in CCD colonies than in healthy
populations. The authors write that an increased exposure to pathogens or a
reduced resistance of bees toward pathogens may be the cause of the disease.
Analysis of samples of adult bees, wax comb, pollen and brood the presence of
parasites such as varroa and tracheal mites; infection by bacteria, viruses and
fungi; pesticide levels; nutritional factors; and bee physiology could not
specify a single factor as cause of CCD.
In this study no association between increased pesticide levels and CCD was
found.
In fact higher levels of the acaricide coumaphos and the pyrethroid
insecticide Esfenvalerate were found in healthy colonies, compared with
CCD-affected colonies.
The authors suggest that the condition may be contagious or the result of
exposure to a common risk factor impairing the immune systems of the bees.
The higher pathogen loads are likely to have caused CCD symptoms, however, the
cause of the high number of pathogens found in the affected colonies remains
unknown causes the bees to become infected with so many pathogens is still not
known. The authors add that it seems that pathogens play a secondary role in
the development of the disease, with evidence that the condition is contagious
or the result of exposure to a common risk factor.
Further attention on monitoring parasite, pathogen and pesticide loads, as well
as potential interactions among pesticide and pathogen loads are being suggested
by the authors.
[3216]
The EFSA in a 2009 report on Colony Collapse Disorder says that their review
of relevant literature clearly highlights an absence of shared
epidemiological indicators, common surveillance procedures and comparable
populations. Trend analysis and mapping suggests some periods of higher colony
loss rates, but these findings should not be over interpreted.
The FSA notes that there is a consensus amongst the scientific community that
the causes of colony losses in Europe and in the United States are likely to
be multifactorial (in the two aspects of this term: combination of factors at
one place and different factors involved according to place and period
considered). Factors implicated include beekeeping and husbandry practices
(feeding, migratory beekeeping, treatments and so forth), environmental
factors (climate, biodiversity, etc.), chemical factors (pesticides) or
biological agents (Varroa, Nosema, etc.) which together create stress, weaken
bees' defense systems allowing pests and pathogens to kill the colony (e.g.
one or several parasites, viruses, etc.).
High concentrations of pesticides have rarely been identified in relation to
colony losses (CCD in USA and winter colony losses in Europe) although acute
events of pesticide toxicity are well described during the production season
(and clearly differentiated from CCD and winter colony losses). However, the
questions of possible synergistic effects of various pesticides and the effect
of chronic exposure to sublethal doses of pesticides remains, and requires
further investigation. Biological agents such as parasites, viruses or
bacteria, alone or in combination, have clearly been identified as important
factors in colony losses. Nevertheless, there is still a lack of knowledge
about the exact mechanisms and/or interactions involved, this must also be
addressed. Even though the multifactorial origin of colony losses is well
acknowledged, the respective role of each factor as a risk or causative agent
is unknown, and no hierarchy of relative threat posed by each one has been established.
There are many inconsistencies in the ways in which "colony losses" are defined,
leading to confusions when reports not always refer to the same phenomenon.
The EFSA call for an
appropriate tool to monitor colony losses at a European level which may
provide accurate figures about colony mortality which, in turn could focus
control and research activities.
- Implementation of a sustainable European network for coordination and
follow-up of surveillance, and research on colony losses to underpin
monitoring programmes;
- Strengthen standardization at European level by harmonization of
surveillance systems, data collected and by developing common performance
indicators;
- Build on the examples of best practice found in existing surveillance
systems on communicable
and notifiable diseases already present in some countries;
- Undertake specific studies that build on the existing work in progress to
improve the knowledge and understanding of factors that affect bee health (for
example stress caused by pathogens, pesticides, environmental and
technological factors and their interactions) using appropriate
epidemiological studies (case control and longitudinal studies);
- The set up of the coordination team at European level. This is a crucial issue
and the coordination team should be organized in such a way so as to ensure its
sustainability and to enable effective surveillance programme activities at the
European level.
The actual discussion on the
introduction of drought resistant transgenes facing the climate change may
include the outcomes of the findings of Ortiz-Garcia in 2004 concerning maize
transgenes in the Mexican state of Oaxaca which find no danger to maize diversity in that region.
The presence of transgenes in maize landraces in the state of Oaxaca, Mexico
had been reported by Quist and Chapela [3218] in 2000, but
there were doubts the methodology used. However, he Mexican government
confirmed the presence of transgenes in Oaxaca in 2000 and 2001
[3219] [3220]. Ortiz-Garcia et al.in 2003 and
2004 [3221],found no transgenes in the area. It is
presumed that their frequency had diminished greatly over the course of 2-3
years, and the genes may even have disappeared.
Peter Raven believes that whether or not transgenes are present in landraces in
Oaxaca at present, they will inevitably be found in them as time passes,
because of the nature of the indigenous agriculture. There they will persist if
they confer a selective advantage on the plants in which they occur, or they
may disappear if they do not confer such an advantage in the prevailing
conditions.
As Ortiz-Garcia et al. [3221] have pointed out, it
is unlikely that the presence of transgenes could reduce the genetic diversity
of the landraces in which they might occur. In general, for the landraces of
maize in Mexico or for any other populations, their genetic characteristics
should remain essentially unchanged unless there is strong selection for whole
constellations of characteristics from radically different strains of maize,
conditions that have not been observed in southern Mexico.
Raven concludes that the introduction of the transgenes currently in use for
maize poses no danger to maize near its center of origin, to the Mexicans, or
generally.
[3222]
In an article by Cath O'Driscoll 2007 in Chemistry and Industry genetic
modification of cows to produce skim milk is reported. The authors claim that
special genes could be used to breed herds of animals producing only skimmed
milk.
The authors say that a commercial herd will be available by 2011. The research
is being done by the biotech firm ViaLactia at the dairy co-operative
Fonterra which already makes milk from one of the GM cows which was named
Merge. The new GM cow will fit very well into the good selling market of low
fat products.
According to the authors this could reduce the surplus of cream and there
would be no need for disposal. However, the cream is used to make butter and
other products such as ice cream, confectioneries,and bakeries.
Another exciting development of their cows they are working on is to produce a
GM cow which gives butter that is spreadable straight from the fridge.
Experiments to soften butter using special feed are not so successful as the
change to GM cows.
[2781]
Miguel Herrero and colleagues 2007 presented a new technique detecting
significant differences% D-aa values for the different conventional varieties
(Aristis, Tietar, and PR33P66 maize).
The transgenic maize Tietar-Bt with the new inserted Cry1Ab transgene
presented % D-aa values which were similar to conventional maize Trietar.
According to the authors this indicates that, in these maize samples, no
metabolic pathway were modified in Trietar-BT.
The method is based on changes of the "L" or "D" form of amino acid (the so
called chiral amino acids). Such changes may affect nutritional quality and
digestibility. The method combines micellar electrokinetic chromatography
with a chiral selector and laser-induced fluorescence to investigate the
prevalence of L- and D-amino acids.
The authors suggest this new method to be used as proof of substantial
equivalence of GM maize and conventional plants.
[2782]
Natural normal grown food is acute endangered to be contaminated by the
genetic engineering escapades of a handful global enterprises. Governments bow
their head to their lobby and rise the threshold labelling of contamination
instead of combating the underlying cause which would be to phase out GM food.
EU agriculture ministers last week agreed that food accidentally contaminated
with up to 0.9% genetically modified content could be labelled "GM free". But
the Soil Association and Organic Farmers and Growers, which together certify
more than 90% of the UK's organic food, today pledged to keep their own
criteria at the current 0.1 per cent.
On 21 June 2007, a delegation representing 70 organic businesses, urged the
Secretary of State for the Environment not to make organic consumers pay for GM
contamination. The Government currently proposes to allow up to 0.9% GM in
organic food without the GM companies being liable for this damage. This is
despite the fact that in European law, 0.9% is not a general GM threshold, but
rather a threshold below which accidental contamination does not have to be
labelled.
The UK ognanic associations confirmed that they would maintain their current
non-GM standards for organic food, at the effective minimum detectable level of
0.1% GM, whatever the Government decides.
During their consultation, the Government met with a number of GM companies,
including AstraZeneca, BASF Plant Science, Bayer CropScience, Dow AgroSciences,
Du Pont (UK) Ltd, Monsanto UK Ltd, and Syngenta Ltd. Not one organic business
was consulted directly, and this is the first meeting the Government has had
with representatives of organic businesses.
On the 29. July 2007 the Council of Ministers postponed the decision over
whether GM potato Amflora may be commercially cultivated in Europe
in December.
On 14. July 2007 the trade commissioner Peter Mandelson delivered a strong
exhortation to the EU to take a lead in shaping global rules on GM trade warned
about the economic consequences. Na statesman can take the risks of acting
hastily and place financial and trade interests in front of safety. The trade
commissioner Mandelson would be well advised to look after his trade and leave
the biotechnology to the board of scientific advisers whose job is to look
after food and environmental safety.
Amflora is deeply modified in the starch it produces. Non-GM potatos produce
two components starch. 80% are amylopectine with a long molecule with
thickening properties. and 20% amylose with short molecule with gelling
character. Amflora produces only amilopectin, which is more useful for the
industry as amylose.
[2783]
According to BASF the corporation signed cooperation and licensing agreement
in biotechnology with Korea and China on GM crops such as corn, soybeans and
rice. It will use a family of genes, such as license rights from CropDesign,
which increase crop yield and can be transferred into a range of other crops.
Asia Pacific due to its emerging economy avoids everything which curbs quick
development regardless to environment, ecology and food safety. One of these
rapid development experiments had been the Green Revolution in India which is
now driving local peasants to suicide. It is wellknown that food politics in
China is very far from excellent and China food is being warned from, so the
GM traits of BASF suits well in this market.
Representatives from the
27 EU member states will vote on the 25 of June 2007 to authorise imports GM
Maize 59122 known as Herculex RW with the bt protein resisting the maize
rootworm. Approval will be for use in food, feed and processing.
Herculex RW has been planted for the first time in US in 2006 and was approved.
Australia, New Zealand, Canada, China, Japan, Korea, Mexico, Philippines and
Taiwan.EFSA approved it in March 2007. Only Austria and Luxenburg may block the
vote. Overrunning Austria and Luxenburg will not be to difficult for Herculex
RW which will contaminate the whole European feed (meat, eggs, aquaculture),
the glucose-fructose syrup (broadly used in all fruit yoghurt and dairy
products, bakery products).
The European Green Party is against the authorisation claiming that there are
serious and legitimate health concerns about Herculex RW maize as changes in
the blood parameters and in liver weight in rats fed with this GM variety were
found in a research.
This is being sustained by the Italian Green Party and the Italian farmers'
union which also protested against the plans to test GM versions of GM olives
and tomatoes. Organic associations strongly protest against an increasing
contamination of their products by GM intrusion.
[2784]
To improve plant resistance of sunflower plants to downy mildew, caused by the
fungus Plasmopara halstedii. the USDA's AgriculturalResearch Service (ARS)
and North Dakota Agricultural Experimen developed the HA 458, HA 459 and HA
460 lines crossing elite sunflower lines with wild plants collected from
Idaho and Texas.
The downy mildew fungus affects seedlings and mature plants. The oleic fatty
acid has been increased, resulting an increased frying stability.
In 2003 the Archer Daniel Midland's NuSun, a mid-oleic oil became commercially
available. It has
less than 10 per cent saturated fat and oleic levels of between 55-75 per cent.
According to ARS, 15 new races of downy mildew developed resistance to the
fungicide metalaxyl, the new germplasms will acquire outstanding imortance to
reduce crop losses.
In 2004 it released three others, known as RHA 439, RH 440 and HA 441,
intended to fight sclerontinia sclerotiorum, a disease that causes stalk and
head rot in the plants.
The oleic acid concentration of HA 444, HA 445, and HA 446 was 83.6, 85.9, and
81.7%, respectively, compared with the oleic acid concentration of 86.1% for HA 434.
[2785]
ARS plant pathologist Tom Gulya is researching the integrated control of
Sclerotinia wilt and headrot, and control of metalaxyl-resistant downy mildew
through new resistance genes complimented with the new fungicides. Other research
topics include finding resistance to a new strain of Verticillium wilt and
continued work on Phomopsis stem canker. [2786]
[2787]
Jay Morris and colleagues 2008 modified genetically carrots increasing the
absorption of calcium by 41 per cent in humans.
According to the authors the new calcium enriched carrot could help to
compensate for a worldwide nutritional calcium deficiency.
The increased absorption was attained by altering the sCAXI gene which
controls the absorption and transport of calcium in plants.
The authors stress that the technology may be applied to various crops because
it involves the over-expression of a gene found in all plants.
[2788]
The New Zealand's Hort Research and Genesis Research and Development
Corporation in 2008 published a collection of 130,000 DNA sequences of kiwi fruit,
which enables breeders to tailor new fruits to meet consumer tastes and market needs.
The expressed sequence tags (EST), from plant genes expressing flavour,
colour, shape, and vitamin content, ripening and storage time are now identified.
The authors stress that using Marker Assisted Selection (MAS) breeders may
identify the specific genes of interest. The outcomes of this research will be
used in the New Zealand kiwi production which amount up to 34.000 tonnes per
year.
[2789]
Silent mutations are DNA mutations that do not
result in a change to the amino acid sequence of a protein. They may occur in
a non-coding region (outside of a gene or within an intron), or they may occur
within an exon in a manner that does not alter the final amino acid sequence.
The phrase silent mutation is often used
interchangeably with the phrase synonymous mutation; however, synonymous
mutations are a subcategory of the former, occurring only within exons
[2790].
Plotkin et al., 2009, found a hidden code that determines the expression level
of a gene, providing a way to distinguish efficient genes from inefficient
ones. The research revealed how a cell each protein produces the amount of
proteins needed to maintain homeostasis. The researchers concluded from their
data that synonymous mutations determine mRNA folding and thereby the eventual
protein level.
According to the authors synonymous mutations do not alter the encoded
protein, but they can influence gene expression. The researchers created 154
of synthetic green-glowing genes. all encoding the same green fluorescent
protein (GFP). The mRNA folding was found to determine the amount of proteins
produced by individual genes, whereas codon bias influences global
translation efficiency and cellular fitness. They explained that the
inefficient genes produced tightly folded mRNA molecules that could not be
accessed by the protein-making machinery.
[2791]
Researchers found that the expression of genes required for invasion is
tightly regulated by environmental conditions and a variety of regulatory
genes in Salmonella enterica serovar Typhimurium. The hilA regulator activates
the expression of invasion genes in response to both environmental and genetic
regulatory factors. The regulation of hilA expression is a key point for
controlling expression of the invasive phenotype.
According to Jones 2005 positive regulators of hilA expression were found to
be csrAB, sirA/barA, pstS, hilC/sirC/sprA, fis, and hilD and HilD and
negative regulators are hilE, hha, pag, and lon.
The author says that the HilE gene Salmonella-specific regulator inactivates
the hilA expression. The work of the author focuses on how the environmental
signals that affect hilA expression of invasiveness may act through the hilE pathway.
[2792]
The spaceflight environment induces novel changes in microbial pathogenesis
not observed using conventional methods. Nickerson et al. report that
spaceflight-induced changes increase the virulence of Salmonella regulated
by media ion composition, and that phosphate ion is sufficient to alter
related pathogenesis responses in spaceflight conditions.
The authors identified evolutionarily conserved molecular pathways in
Salmonella that respond to spaceflight. These findings open new ways to
control microbial responses during the infection and improve vaccines.
[2793]
Cooper and colleagues 2008 found that intergenic DNA playing a physical role
in protecting and linking chromosomes are accompanied by short segments of DNA
which seem to be coding DNA. These non-random sequence patterns are called
pyknons. They have the same sequence and size as small segments of RNA that
regulate gene expression through gene silencing.
Pyknons had been discovered only in human genome. Analysing the genome of the
plant Arabidopsis thaliana the author found pyknons which are similar to the
human pyknons. The authors stress that Arabidopsis thaliana has approximately
the same number of genes as the human genome but a higher number of their genes
are silenced. The authors suggest that pyknons are involved. A better
understanding of the effects of pyknons may be applied in the improvement of
transgenic plants by regulating gene silencing.
[2794]
Non-coding DNA outside of genes had been considered material without
biological function, such as tandem repeats, short stretches of DNA and are
now called pyknons.
The repeats determine how tightly the local DNA is wrapped around specific
proteins called 'nucleosomes', and this packaging structure dictates to what
extent genes can be activated. These tandem repeats are very unstable and the
changes affect the local DNA packaging, which in turn alters gene activity.
This allows fast shifts in gene activity to match changing environments
boosting the evolution.
Experimenting with yeasts cells of Saccharomyces cerevisiae, the authors found
that when a repeat is present near a gene, it is possible to select yeast mutants
that show vastly increased activity of this gene. However, when the repeat region
was removed, this fast evolution was impossible. only cells with the repeats
would be able to swiftly adapt to changes, thereby beating their repeat-less
counterparts in the game of evolution. As many as 25% of all gene promoters
contain tandem repeat sequences.
[2795]
Kim, Waterman and Li 2007 infered a complete sequence of the chromosomes of
Ciona intestinalis, a marine invertebrate, from existing sequencing data. The
applied method focused on the high rate of genetic mutations in this organism.
Other organisms with high genetic variability, such as certain fish, also may
be suitable. The method is not suitable to be applied to the human genome
because of the low human mutation rate.
However, sequencing parts of the human genome that display high variability may
be possible wqith this methode. The authors stress that small DNA structures,
called pyknons, may express proteins which may regulate gene function, and were
highly conserved during evolution.
[2796]
In 2006 Yin and Lin discovered tiny piRNAs structures in mammalian
reproductive cells which may control gene functions. In a study published in
2007 both scientists found more than 13,000 Piwi-associated piRNAs in fruit
flies. The most prominent piRNA was found to form a complex with the Piwi
protein which binds to chromatin which controls the activity of the gene.
The authors explain that the role of chromatin is to package DNA so that it will
fit into the cell, to strengthen the DNA to allow cell division, and to serve as
a mechanism to control gene expression. The authors call for more researches on
the silenced part which comprises 99% of the genome. These studies may be
important to understand essentials for germline stem-cell maintenance.
[2797]
Osteoblasts (bone cells) help controlling energy metabolism while expressing
cell-specific regulatory genes called activating transcription factor 4
(ATF4). This gene regulates all functions linked to the maintenance of bone mass.
Karsenty and colleagues 2009 report that ATF4 inhibits insulin secretion and
decreases insulin sensitivity in liver, fat, and muscle. ATF4 Atf4 increases
expression of the Esp gene, which makes a protein that decreases the activity
of osteocalcin. Osteocalcin is a molecule which increases the activity of insuline.
The authors concluded that endocrine functions of osteoblasts play a role in
energy generation through the protein ATF4 via osteocalcin.
[2798]
The Gene Ontology project is a major bioinformatics initiative with the aim of
standardizing the representation of gene and gene product attributes across
species and databases. The project provides a controlled vocabulary of terms
for describing gene product characteristics and gene product annotation data
from GO Consortium members, as well as tools to access and process this data.
OurFood (c) 1998 - 2010 by Karl Heinz Wilm - Imprint (Impressum)
May