positeve - genetically modified organisms

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Genetically Modified Organisms (GMOs)

R Peter and J Mojca, University of Ljubljana, Ljubljana, Slovenia

P Primoz, Zalog, Postojna, Slovenia

& 2011 Elsevier B.V. All rights reserved.

Abbreviations

BSE bovine spongiform encephalopathy

EFSA European Food Safety Agency

EPA Environmental Protection Agency

EU European Union

FDA US Food and Drug Administration

GM genetically modified

GMO genetically modified organism

IPPC International Plant Protection Convention

LMO living modified organism

OECD Organisation for Economic Co-operation

and Development

USDA US Department of Agriculture

Introduction

Directive 2001/18/EC of the European Parliament and

of the Council on the deliberate release of genetically

modified organisms (GMOs) into the environment de-

fines a GMO as an organism, with the exception of the

human being, in which the genetic material has been

altered in a way that does not occur naturally by mating

or by natural recombination.

Natural recombination is a technique using re-

combinant nucleic acids, which also include new genetic

material by adding nucleic acid molecules. Molecules can

be formed outside the organism, for example, with the

help of virus, bacterial plasmid, or other vector in a host

organism. Vector does not harm the host organism, but is

successfully multiplied in it. This is a method involving

the direct introduction of heritable material, formed

outside the organism, including microinjection, macro-

injection, and microencapsulation. It is a cell fusion or

cell hybridization technique, in which live cells with new

combinations of heritable genetic materials are formedthrough the fusion of two or more cells by methods that

do not occur naturally.

From the Cartagena Protocol on Biosafety to the

Convention on Biological Diversity, a new term living

modified organisms (LMOs) is used instead of GMO. It

stands for living modified organisms that have been

genetically modified through the application of modern

biotechnology.

Modern biotechnology includes nucleic acid tech-

niques in vitro, including recombinant DNA, direct

injection of nucleic acids into cells or organelles, and cellmerging above their taxonomic category, which reaches

above natural physiological reproductive barriers and

techniques, which are not used in traditional multipli-

cation and selection.

GMOs have already entered the food chain in most

parts of the world. Many microorganisms, mainly bac-

teria, have been modified to increase the production

of proteins, amino acids, and commercial chemicals.

Pioneer works with GMOs are related to the discovery

of a natural phenomenon mutagenesis, which helped to

develop different kinds of microorganisms. These mutants

were the first scientific tools in this field, but represented acommercial profit for the fermentation industry at the

same time. Plants were the first generation of micro-

organisms, but were available only in few markets.

The GMO market has been released by the devel-

opment of science and genetic information of a wide

range of organisms. A consequential expansion has

caused increased concern over genetic engineering use in

food industry and eventual harmful impacts on human

health and environment.

State of the Art in GMO Research and

Development

The creation of the first recombinant bacteria was in

1973, that is, Escherichia coliexpressing a Salmonellagene.

Herbert Boyer then founded the first company to use

recombinant DNA technology, Genentech, and in 1978,

the company announced the creation of an E. coli strain

producing the human protein insulin. In 1986, field tests

were conducted of bacteria genetically engineered to

protect plants from frost damage at a small biotechnology

company called Advanced Genetic Sciences. In the

same year, Monsantos proposed field test of a microbe

genetically engineered for a pest resistance protein was

dropped.

Status of GMOs in Agriculture and Food

Production

The first commercially grown genetically modified (GM)

food crop was a tomato created by Calgene called the

FlavrSavr. Calgene submitted it to the US Food and Drug

Administration (FDA) for testing in 1992, following the

FDAs determination that this transgene was actually a

tomato, did not constitute a health hazard, and did not

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At the end of the 1980s the food safety assessment of

genetically engineered foods was for the first time discussed

at the international level. The point of the safety assess-

ment should be to determine whether the modified food is

as safe as its traditional counterpart. In these discussions

the concept of substantial equivalence was introduced as a

means of establishing a benchmark definition of safe food.

This concept was introduced by the Organization forEconomic Co-operation and Development (OECD)

Group of National Experts on Safety in Biotechnology as

an approach to assessing the food safety of GMOs, and has

been further elaborated on by other groups. The de-

termination of substantial equivalence is not the point of a

safety assessment, but rather a practical approach that

guides the safety assessment process. When there are rea-

sonable grounds for concern that potential hazards may

affect the environment or human, animal, or plant health,

and when at the same time the available data precludes a

detailed risk evaluation, the precautionary principle has

been politically accepted as a risk management strategy inseveral fields. At the international level, the precautionary

principle was first recognized in the World Charter for

Nature produced by the UN General Assembly in 1982.

In the European Union (EU), EC Regulation 1829/

2003 on GM food and feed provides the legal basis for

the approval procedure for GMOs as specified in the

General Food Law. The safety of foods derived from

GMOs is assessed by the Scientific Panel on Genetically

Modified Organisms of the European Food Safety

Agency (EFSA). It is for testing food safety, and en-

vironmental and animal health aspects of GMOs (one

doorone key). The overall risk assessment should consist

of the following points:

I. Information of parent crop

1. Identity, and phenotypic and agronomic per-

formance

2. Geographical distribution/source

3. History of safe use

4. Compositional analysis

5. Nutrients, anti-nutrients, toxins, and allergens

II. Information of the donor, transgene, and delivery

process

1. Description of the donor

2. Description of vector DNA

3. Transgene delivery

4. Characterization of introduced DNA sequences

5. Characterization of insertion site

III. Information on the gene products: recombinant

proteins and metabolites

1. Characterization of proteins and metabolites

2. Mode of action and target specificity

3. Assessment of toxicity

4. Assessment of allergenicity

IV. Information of the whole crop

1. Identity, and phenotypic and agronomic analysis

2. Compositional analysis

3. Safety and nutritional analysis and the use of

animal test methods

V. Exposure assessment

1. Data sources used to estimate food consumption2. Evaluation of exposure to a new altered level of a

food consumption

The key information from each food safety protocols are

the following:

Hazard identificationis the determination of whether a

substance, such as a constituent in food, is or is not

causally linked to particular health effects.

Doseresponse evaluation is the determination of the

relationship between the magnitude of exposure and the

probability of occurrence of the adverse effect under

study. Doseresponse assessment is the mechanism used

to assess the potency or severity of the hazard in question.Exposure assessment is the determination of the extent

of exposure to a toxicant under a particular set of

exposure circumstances. Exposure assessment includes

the determination of the magnitude of the exposure,

the frequency of the exposure, and the duration of the

exposure.

Risk characterization considers these first three factors

and is often reported as a quantitative assessment of the

probability of an adverse effect under defined exposure

conditions. The effects of GMOs on human health and

the environment are of two kinds:

Direct effects refer to primary impacts on humanhealth or the environment, which are a result of theGMO itself and which do not occur through a causal

chain of events.

Indirect effects refer to primary impacts on humanhealth or the environment occurring through a causal

chain of events, through mechanisms such as inter-

actions with other organisms, transfer of genetic

material, or changes in use or management.

Time frame impacts can be due to various reasons:

Immediate impacts on human health or the environ-ment are observed during the period of consumption

of the GMO or immediately after that.

Delayed impacts are effects on human health or theenvironment that may not be observed during the

period of the release of the GMO, but become

apparent as a direct or indirect effect either at a later

stage or after termination of the release.

GMO Benefits and Adverse Effects

GM foods provoke many ethical debates among scientists

and people in general about new technology that enables

Genetically Modified Organisms (GMOs) 881


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to create new forms of plant and animal life that otherwise

would not exist (Table 2). From human history, it is ob-

vious that agricultural crops have been genetically modi-

fied in the past. People always strive to get as much as

possible from nature. To increase yields in agriculture and

support people to improve their nutrition, the methods of

selective breeding and crossbreeding of plants were used.Crosses between separate species were made mostly as a

result of planned human action and occasionally by un-

predictable natural processes that cannot be controlled.

World global changes have influence on agriculture

and economic development. Today many food crops are

unable to propagate or survive without human inter-

vention. Biotechnology, environmental science, and so-

cial sciences are important tools for studying the worlds

growing population. It is estimated that total world

population is increasing rapidly and will be over 9 billion

by 2050. This raises the question of providing enough

food to developing and developed countries. GM

food technology, as a modern biotechnology technique,

has the potential to deliver a new dimension of food

safety and quality. Advances in modern biotechnology

can be linked to environmental and health issues.

More sustainable agricultural practices with reduced use

of chemical pesticides, fertilisers, and drugs can be

expected. The positive aspects of biotechnology can

also result in health care benefits, allowing for the pro-

duction of cheaper, safer drugs in large quantities.

Personalized and preventive medicines based on genetic

predisposition, targeted screening, and innovative drug

treatments are among the possibilities on offer. A mul-

tidisciplinary and innovative approach is required indiscussing a field that provides quick and effective re-

sponses to maintain health and safe environment that has

additional advantages in the food supply chain with

consumer in the end. With these aspects the need for

responsible policies at EU and international levels are

highlighted to ensure the protection of the environment

and human health as a priority at all times. This would

involve acknowledging the importance of the subjective

comprehension of health and safety concepts, which is a

component of well-being.

GMO Benefits and Adverse Effects on

Biodiversity

Agriculture is a primary human activity and is directly

connected with environment. Agriculture is widely de-

termined by the environment and the two are inter-

twined both healingly and destructively. Human activitiesare burdening for the environment and thus can influ-

ence human health through food chain.

A financial perspective of the EU policy aims at more

focus on general requirement assurance (food safety, food

quality, product diversity) and added value (animal wel-

fare, environment, and health protection) to achieve a

higher quality of life (Table 3). It is distinctive for

current agriculture to aim at environmentally friendly

agricultural practices, which preserve and improve en-

vironment and at the same time assure quality and safety

of agricultural products, because of the concern for

consumers and agricultural activity.

In plant production and in the entire agricultural

sector, the production system is connected with the en-

vironment through strong and complex relationships:

improvement of corn hybrids and certain short-stalk rice

and wheat species gave excellent results in connection

with soaking and fertilizing as long as they were pro-

tected against pest and diseases by pesticides. Researches

in this field have shown harmful impact on human and

animal health, mainly because of their genotoxic and

mutagenic activity.

Lately, there have been more and more researches and

technical and scientific discussions regarding GMO use in

agriculture. The majority of concerns are caused due toGMOs impact on the environment and human health

and their short history of use. GMOs are globally not

something new, because they have been present since

1970, but they have been used widely for a little more

than a decade, mainly in America, Canada, and Argentina.

There is danger of so-called genetic pollution and for-

mation of so-called super weed.A question of resistance

against pesticides and other harmful impacts on the bio-

topes is arising as well. All this intensification has not left

out the animal production either (e.g., bovine spongiform

Table 2 Listing of main open issues regarding benefits and adverse effects connected with GMOs

Main open issues Benefits Adverse effects

Agriculture/environment Resistance of insects, illness, herbicides Potential transfer of GMO genetic material to

other plants and appearance of super plants

that are resistant to pesticides

Reduction of pesticide usage

Food processing Better sensory characteristics Disadvantages of GMOs in food

Quality Longer lifetime

Nutrition and health Higher nutritional value Presence of allergens

Bananas with HBV vaccine Unknown effect on other organisms

Tobacco that can produce human hemoglobin

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of the many produced, only two have shown the en-

vironmental induction of a toxic compound that had not

been detected during routine testing. It was found

that one of these (psoralen), which had accumulated

in insect-resistant non-GM celery in response to

light, causes skin burns. Toxic accumulations of solanine,

induced by cold weather, caused the withdrawal of

the non-GM Magnum Bonum potato line in Sweden(http://dsp-psd.pwgsc.gc.ca/Collection-R/LoPBdP/BP/

prb9912-e.htm#%2818%29).

The concept of substantial equivalence, used by

regulatory authorities, has also been criticized. The

concept was not exactly defined, and scientists are not yet

able to predict reliably the biochemical or toxicological

effects of a GM food from knowledge of its chemical

composition. Others believe that substantial equivalence

is a useful tool that identifies differences between a GM

crop and a non-GM crop so that they can be further

scrutinized. In spite of the many proponents of GMOs

who argue that there is currently no evidence that GMfoods pose a greater risk than traditional foods, op-

ponents point to the lessons of the mad cow disease crisis

in Europe: just because there is no proof that a food

product poses a risk does not necessarily mean that

it is safe. The best that science can do is to dispel

some of the uncertainty on both sides of this issue

(http://dsp-psd.pwgsc.gc.ca/Collection-R/LoPBdP/BP/

prb9912-e.htm#%2818%29).

Regulatory Issues on GMO

There are several important international mechanisms in

the context of GMOs:

The Cartagena Protocol to the Convention on Biological

Diversity was adopted in January 2000. It covers the

transboundary movement, transit, handling, and use of all

LMOs (except pharmaceuticals) that may have adverse

effects on the conservation and sustainable use of bio-

logical diversity, also taking into account risks to human

health. It allows for standard setting in relation to the

handling, transport, packaging, and identification of

LMOs.

The food safety aspects of GMOs are, at internationallevel, dealt with by the FAO/WHO Codex Alimentarius

Commission, which covers all aspects of food safety. The

Codex is currently working on standards for risk assess-

ment for labeling, and for several other food safety as-

pects of GMOs. The Codex standards are recognized by

the SPS and TLC Agreements.

The International Plant Protection Convention (IPPC) has

the objective of preventing the spread and introduction of

plant and plant product pests, including weeds and other

species that have indirect effects on both wild and

cultivated plants, and promoting appropriate control

measures. This also applies to risks associated with

LMOs.

EU Legislation

The EU legislation about GMOs is very abundant and

restrictive:Directive 90/219/ECC about contained use of GM

microorganisms governed measures for limited use of

GM microbes, measures for avoidance of adverse effects

on human health and environment, and emergency plan

in case of an accident and regular inspections. It amends

Directive EU 98/81/EC.

Directive 90/220/EEC governed experimental releases

and marketing authorization of all GMOs. The directive

set out an approval process requiring the case-by-case

assessment of the potential risks to human and animal

health and environment due to all GMOs (except for

pharmaceuticals which are regulated separately). Thedirective was revised to draw strength on the existing

requirements for risk assessment and the decision-

making process.

Revised Directive 2001/18/ECon the deliberate release

of GMOs introduces mandatory labeling and traceability.

Regulation 1829/2003/ECon GM food and feed provides

the legal basis for the approval procedure for GMOs as

specified in the General Food Law. The safety of foods is

assessed by the EFSA.

Regulation 1830/2003governs traceability and labeling

of GMOs and food and feed product from GMOs.

Directive EU 2004/204/EC about arrangements for the

operation of the registers for recording information on

genetic modifications in GMOs provides the legal basis to

the list of information on genetic modification in GMOs,

which should be available to the public.

Directive EU 2004/643/EC governs equivalence prin-

ciple. The GMOs should be as safe as conventional.

Placing on the market of a maize product (Zea maysL.

line NK603) GM for glyphosate tolerance (handling,

packaging, and protection) as conventional, obligatory

recordation of the code measures for labeling and

traceability in all stages of the market promotion.

Directive EU 2004/657/ECgoverns that product should

be as safe as conventional. It replaced Directive EU 90/220/EC.

Regulation (EC) 258/97 governs novel food and novel

food ingredients. It is about placing foods and food in-

gredients on the market that have not been used for

human consumption to a significant degree within the

community before. It also governs specific requirements

for labeling and specific procedure for foodstuffs

containing GMOs.

Regulation (EC) 1139/98governs the compulsory indi-

cation of the labeling of certain foodstuffs produced from

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market, through the production and distribution chains.

Anybody who sells GM products (products containing

GMOs or products produced from GMOs) must update

consumers with specific information on GMOs. Special

identification marks are designated for each GMO to

make traceability assurance easier. Traceability is used to

check unsuitable labeling and for tracing and surveillanceof potential impact on health and environment. Suitable

traceability enables GMO recall from the market in case

of subsequent determination of its harmful effects. Food

or feed, containing more than 0.9% GMOs in each

separate compound, provided that the presence of GMOs

is unintentional or technically unavoidable, must be

suitably labeled. Labeling is regulated by the above-

mentioned legislation. Labeling of GMOs is strictly

regulated in most of the countries in the world, but many

countries do not demand it. Researches of public opinion

have showed that in the EU, only a quarter of the

population is willing to consume GMOs; this is why it is

important to enable a possibility of choice to every

consumer. In the EU, labeling of food and feed containing

GMOs has been obligatory for several years now. Con-

sumers can make a choice and decide to choose products

produced from GMOs.There are still only few foodstuffs labeled as GMO-

containing in thee EU market, but there is plenty of feed

labeled as GMO-containing.

The production of GM plants is differently regulated

in countries across the world. In some countries there are

strict rules, but not in others. As there is a possibility of

mixing between GM and non-GM plants on the fields

and during transportation, especially by pollen, some of

the EU countries had to develop conditions of coexist-

ence of traditional and GM production. Ecological

Table 5 Methods for tracing and tracking of GMOs

Field of analysis Title Type of analysis

(qualitative/quantitative)

Detection of screening elements Determination of 35S promotor by PCR Qualitative

Determination of NOS terminator by real-time PCR

Determination of NOS terminator by PCR

Determination of CaMV virus by real-time PCR

Determination of 35S:BAR by real-time PCRDetermination of 35S promoter by real-time PCR

Determination of specific genetic

elements

Quantification of soya MON-432-6 (RRS) by real-

time PCR

Qualitative and quantitative

Quantification of Bt 176 maize by real-time PCR Qualitative and quantitative

Quantification of T-25 maize by real-time PCR Qualitative and quantitative LOD

12 copies LOQ 10 copies

Quantification of Bt 11 maize by real-time PCR Qualitative and quantitative

Quantification of MON 810 maize by real-time PCR Qualitative and quantitative

Quantification of GA 21 maize by real-time PCR Qualitative and quantitative

Quantification of MON 863 maize by real-time PCR Qualitative and quantitative

Quantification of NK 603 maize by real-time PCR Qualitative and quantitative

Quantification of RT73 maize by real-time PCR Qualitative and quantitative

Quantification of TC 1507 maize by real-time PCR Qualitative and quantitative

Determination of rice LL601 by real-time PCR Qualitative

Determination of rice LL62 by real-time PCR QualitativeDetermination of H7-1 sugar beet by real-time PCR Qualitative

Quantification of DAS-59122-7 maize by real-time

PCR


Quantification of potato EH92-527-1 by real-time PCR Qualitative and quantitative

Determination of reference genes Quantification of lectin gene by real-time PCR Qualitative and quantitative

Quantification of invertase gene by real-time PCR Qualitative and quantitative

Determination of zein by PCR Qualitative

Determination of lectin by PCR Qualitative

Determination of metal carboxypeptidase inhibitor by

real-time PCR

Qualitative

Determination of metal carboxypeptidase inhibitor of

potato by real-time PCR

Qualitative

Quantitative determination of phosphoenolpyruvate

carboxylase by real-time PCR


Determination of phospholipase D (rice) gene by real-time PCR

Qualitative

Quantification of glutamine synthetase (sugar beet)

gene by real-time PCR




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farming is specially stressed upon. The EU countries

adopted different rules, but they must be approved at the

EU level. Measures include safety distances between

fields, additional area between fields, which prevents

movement of pollen, and compensation of damage re-

funds in cases of economic loss.

Public Opinion on GMO

In Europe the first major discussion on gene technology

was in the late eighties, when GM food was not yet

commercialized and only separate applications were used

in the industry. At first there were sporadic reactions

within national legislations, which were later harmonized

in the EU countries. First reactions to the first European

directives calmed conflicts regarding gene technology.

There were fewer debates on GMOs. Disputes were less

intensive. But the calmness was only temporary. In 1996,

the second major international dispute arose due to thepresence of GM soybeans in the European harbors. GM

soybeans were much more resistant to herbicides. This

was followed by other applications of biotechnology in

different scientific fields. The result was growing public

interest in bizarre phenomenon, especially GMOs in

food. Public debates have caused an increase in the

number of nongovernmental organizations and in de-

mands for involvement of society in general in these

debates, formation of legislation, scientific strategies, and

also importance of a consumer, who either approved or

disapproved genetic modification of products by buying

or by boycotting such products.

Identification of a hazard can be displayed as a special

behavior against a special object representing a potential

hazard. In other words, it means that when people perceive

there is a hazard present, they respond with a reaction.

So, public resentment against GMOs is related to the

opinion that even small-scale use of GMOs is forced and

uncontrolled. To understand human behavior it is im-

portant to know public opinion regarding science and

technology because some of the social groups have values

that oppose globalization, for example, of wholeness of

nature and the like. It is obvious that various types of

behavior, which appear not to be connected, influence

public opinion and shopping habits.In democratic societies, where choice is possible,

people do not buy food with the negative connotation.

There are several reasons for such second thoughts: an

opinion about negative influences on the environment,

agricultural tradition, and hazards connected with public

or animal health. In research of public opinion the ethical

reasons must not be ignored. Messing with nature, un-

intentional influences are unpredictable, so they were not

yet discovered by science, and the like are mentioned.

The public reacts to technological innovations in such a

way due to a fear that technology will influence a social

structure and relation between its parts. Researches spe-

cially stressed on the understanding of negative public

attitude toward GMOs in food. This negativism was

particularly expressed around 1990 much to the surprise

of legislative authorities, science, and industry.

Public opinion moves from more to less concrete

worries: unintentional effects such as allergies, cross-breeding between unrelated species of plants and animals,

super plant phenomenon, and worries related to uncer-

tainness, unintentional effects on humans and the en-

vironment, as well as potential negative irreversible

effects. Qualitative and quantitative approaches dis-

covered some details regarding moral issues connected

with GMOs, like unnaturalness, messing with nature,

animal welfare, balance between industry and consumers,

democracy, differences between developed countries and

the third world, and the like. The range of public concern

regarding GMO field of application is unusually constant.

Some of the concerns are intrinsic, mainly in the field oftechnology, whereas others are related with second

thoughts on risks.

In a comparison of consumers opinion in Europe and

the United States, it was determined that US consumers

are more perceptive about GM food than European

consumers. The reason is based on three factors: influ-

ence of the media, trust in surveillance, and knowledge of

biology and genetics. Technological disputes are much

more covered by the media in Europe than in America,

which has a certain impact on consumers. Individuals

in America trust surveillance authorities as they do in

Europe. Europeans are supposed to demand more in-

formation about GMOs than Americans, and if the latest

incidents in the food industry are added, it is under-

standable that Europe is more skeptical than America.

People have different opinions regarding GMOs.

Some encourage it; some strongly oppose. But regardless

of the consumers opinion GMOs have both useful and

harmful effects in many areas.

See also: Entomological Risks of Genetically Engineered

Crops, Labelling of Genetically Modified Foods.

Further Reading

Arvanitoyannis IS , Choreftaki S, and Tserkezou P (2006) Presentation

and comments on EU legislation related to food industries-

environment interactions: Sustainable development, and protection

of nature and biodiversity Genetically modified organisms.

International Journal of Food Science and Technology41:

813--832.

Banati D and Lanker Z (2003) Modern biotechnology and the

Hungarian consumers. Acta Alimentaria 32: 5--23.

Colono FC (2008) Simulation and evaluation of GM and non-GM

segregation management strategies among European grain

merchants. Journal of Food Engineering 88: 306--314.

Genetically Modified Organisms (GMOs) 887


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Dezider T (2007) Genetically modified organisms and food safety.

In: McElhatton A and Marshall RJ (eds.) Food Safety: A Practical and

Case Study Approach, pp. 122--133. New York: Springer

ScienceBusiness Media, LLC.

Engel KH, Frenzel Th, and Miller A (2002) Current and future benefits

from the use of GM technology in food production. Toxicology

Letters127: 329--336.

Fewer L, Lassen J, Kettlitz B, et al. (2004) Societal aspects of

genetically modified foods. Food and Chemical Toxicology42:

1181--1193.Gaskell G, Allandsdottir A, and Allum N (2006) Europeans and

Biotechnology in 2005: Patterns and Trends, Eurobarometer

64.3 A Report to the European Commissions Directorate-General

for Research. Brussels: European Commission.

OFallon MJ, Gusory D, and Swanger N (2007) To buy or not to buy:

Impact of labeling on purchasing intentions of genetically modified

foods. Hospitality Management26: 117--130.

Plahuta P and Raspor P (2007) Comparison of hazards: Current vs.

GMO wine. Food Control18: 492--502.

Rizzi A, Sorlini C, Mannino S, and Daffonchio D (2007) Ensuring

biosafety through monitoring of GMO in food with modern analytical

techniques, a case study. In: McElhatton A and Marshall RJ (eds.)

Food Safety: A Practical and Case Study Approach, pp. 281--294.

New York: Springer ScienceBusiness Media, LLC.Varzakas TH, Arvanitoyannis IS, and Baltas H (2007) The politics and

science behind GMO acceptance. Critical Reviews in Food Science

and Nutrition47: 335--361.


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