A PROJECT REPORT ON GENETICALLY MODIFIED ORGANISMS

TABLE OF CONTENTS

SR NO PARTICULARS PAGE NO.

1. Introduction

2. Examples Of GMO’s

3. Advantages Of Genetically Modified Organisms

4. Criticisms Against Genetically Modified Organisms

5. Prevalance Of Genetically Modified crops and plants involved

6. Regulation Of GMO’s & Role Of government in this process

7. Detection Of Genetically Modified Organisms

8. Conclusion
INTRODUCTION

A genetically modified organism (GMO) or genetically engineered organism (GEO) is an

organism whose genetic material has been altered using genetic engineering techniques.
These techniques, generally known as recombinant DNA technology, use DNA molecules
from different sources, which are combined into one molecule to create a new set of genes.
This DNA is then transferred into an organism, giving it modified or novel genes. Transgenic
organisms, a subset of GMOs, are organisms which have inserted DNA that originated in a
different species.

History:

The general principle of producing a GMO is to add new genetic material into an organism's
genome. This is called genetic engineering and was made possible through the discovery of
DNA and the creation of the first recombinant bacteria in 1973; an existing bacterium E. coli
expressing an exogenic Salmonella gene. This led to concerns in the scientific community
about potential risks from genetic engineering, which were first discussed in depth at the
Asilomar Conference in 1975. One of the main recommendations from this meeting was that
government oversight of recombinant DNA research should be established until the
technology was deemed safe. Herbert Boyer then founded the first company to use
recombinant DNA technology, Genentech, and in 1978 the company announced creation of
an E. coli strain producing the human protein insulin.

In 1986, field tests of bacteria genetically engineered to protect plants from frost damage
(ice-minus bacteria) at a small biotechnology company called Advanced Genetic Sciences of
Oakland, California, were repeatedly delayed by opponents of biotechnology. In the same
year, a proposed field test of a microbe genetically engineered for a pest resistance protein by
Monsanto Company was dropped.

In the late 1980s and early 1990s guidance on assessing the safety of genetically engineered
plants and food emerged from organizations including the FAO and WHO.

Small scale experimental plantings of genetically modified (GM) plants began in Canada and
the U.S. in the late 1980s. The first approvals for large scale, commercial cultivation came in
the mid 1990s. Since that time, adoption of GM plants by farmers has increased annually.
2. PRODUCTION OF GENETICALLY MODIFIED ORGANISMS

Genetic modification involves the insertion or deletion of genes. When genes are inserted,
they usually come from a different species, which is a form of horizontal gene transfer. In
nature this can occur when exogenous DNA penetrates the cell membrane for any reason. To
do this artificially may require attaching the genes to a virus or just physically inserting the
extra DNA into the nucleus of the intended host with a very small syringe, or with very small
particles fired from a gene gun. However, other methods exploit natural forms of gene
transfer, such as the ability of Agrobacterium to transfer genetic material to plants, or the
ability of lentiviruses to transfer genes to animal cells.
3. EXAMPLES OF GENETICALLY MODIFIED ORGANISMS

Transgenic microbes

Bacteria were the first organisms to be modified in the laboratory, due to their simple
genetics. These organisms are now used for several purposes, and are particularly important
in producing large amounts of pure human proteins for use in medicine.

Genetically modified bacteria are used to produce the protein insulin to treat diabetes. Similar
bacteria have been used to produce clotting factors to treat haemophilia and human growth
hormone to treat various forms of dwarfism.

Transgenic Mammals

Transgenic animals are used as experimental models to perform phenotypic and for testing in
biomedical research. Other applications include the production of human hormones such as
insulin.

Fruit flies

In biological research, transgenic fruit flies (Drosophila melanogaster) are model organisms
used to study the effects of genetic changes on development. Fruit flies are often preferred
over other animals due to their short life cycle, low maintenance requirements, and relatively
simple genome compared to many vertebrates.

Mammals

Genetically modified mammals are an important category of genetically modified organisms.

Transgenic mice are often used to study cellular and tissue-specific responses to disease.

In 1999, scientists at the University of Guelph in Ontario, Canada created the genetically
engineered Enviropig. The Enviropig excretes from 30 to 70.7% less phosphorus in manure
depending upon the age and diet. In February 2010, Environment Canada determined that
Enviropigs are in compliance with the Canadian Environmental Protection Act and can be
produced outside of the research context in controlled facilities where they are segregated
from other animals.

In 2009, scientists in Japan announced that they had successfully transferred a gene into a
primate species (marmosets) and produced a stable line of breeding transgenic primates for
the first time.
Cnidarians

Cnidarians such as Hydra and the sea anemone Nematostella vectensis have become
attractive model organisms to study the evolution of immunity and certain developmental
processes. An important technical breakthrough was the development of procedures for
generation of stably transgenic hydras and sea anemones by embryo microinjection.

Fish

Genetically modified fish have promoters driving an over-production of "all fish" growth
hormone. This resulted in dramatic growth enhancement in several species, including
salmonids, carps and tilapias.

Gene therapy

Gene therapy, uses genetically modified viruses to deliver genes that can cure disease into
human cells. Although gene therapy is still relatively new, it has had some successes. It has
been used to treat genetic disorders such as severe combined immunodeficiency, and
treatments are being developed for a range of other currently incurable diseases, such as
cystic fibrosis, sickle cell anemia, and muscular dystrophy. Current gene therapy technology
only targets the non-reproductive cells meaning that any changes introduced by the treatment
can not be transmitted to the next generation. Gene therapy targeting the reproductive cells—
so-called "Germ line Gene Therapy"—is very controversial and is unlikely to be developed in
the near future.

Transgenic plants

Transgenic plants have been engineered to possess several desirable traits, including
resistance to pests, herbicides, or harsh environmental conditions; improved product shelf
life, and increased nutritional value. Since the first commercial cultivation of genetically
modified plants in 1996, they have been modified to be tolerant to the herbicides glufosinate
and glyphosate, to be resistant to virus damage as in Ringspot virus resistant GM papaya,
grown in Hawaii, and to produce the Bt toxin, an insecticide that is non-toxic to mammals.

Most GM crops grown today have been modified with "input traits", which provide benefits
mainly to farmers. The GM oilseed crops on the market today offer improved oil profiles for
processing or healthier edible oils. The GM crops in development offer a wider array of
environmental and consumer benefits such as nutritional enhancement, drought and stress
tolerance. GM plants are being developed by both private companies and public research
institutions such as CIMMYT, the International Maize and Wheat Improvement Centre.
Other examples include a genetically modified sweet potato, enhanced with protein and other
nutrients, while golden rice, developed by the International Rice Research Institute, has been
discussed as a possible cure for Vitamin A deficiency.

The coexistence of GM plants with conventional and organic crops has raised significant
concern in many European countries. Due to relatively high demand from European
consumers for the freedom of choice between GM and non-GM foods, EU regulations require
measures to avoid mixing of foods and feed produced from GM crops and conventional or
organic crops. European research programs such as Co-Extra, Transcontainer, and SIGMEA
are investigating appropriate tools and rules. At the field level, biological containment
methods include isolation distances and pollen barriers. Such measures are generally not used
in North America because they are very costly and there are no safety-related reasons to
employ them.

Cisgenic plants

Cisgenesis, sometimes also called Intragenesis, is a product designation for a category of

genetically engineered plants. A variety of classification schemes have been proposed, that
order genetically modified organisms based on the nature of introduced genotypical changes
rather than the process of genetic engineering.

While some genetically modified plants are developed by the introduction of a gene
originating from distant, sexually incompatible species into the host genome, cisgenic plants
contain genes which have been isolated either directly from the host species or from sexually
compatible species. The new genes are introduced using recombinant DNA methods and
gene transfer. Some scientists hope that the approval process of cisgenic plants might be
simpler than that of proper transgenics, but it remains to be seen.
ADVANTAGES OF GENETICALLY MODIFIED FOODS

The world population has topped 6 billion people and is predicted to double in the next 50
years. Ensuring an adequate food supply for this booming population is going to be a major
challenge in the years to come. GM foods promise to meet this need in a number of ways:

Pest resistance

Crop losses from insect pests can be staggering, resulting in devastating financial loss for
farmers and starvation in developing countries. Farmers typically use many tons of chemical
pesticides annually. Consumers do not wish to eat food that has been treated with pesticides
because of potential health hazards, and run-off of agricultural wastes from excessive use of
pesticides and fertilizers can poison the water supply and cause harm to the environment.
Growing GM foods such as B.t. corn can help eliminate the application of chemical
pesticides and reduce the cost of bringing a crop to market.

Herbicide tolerance

For some crops, it is not cost-effective to remove weeds by physical means such as tilling, so
farmers will often spray large quantities of different herbicides (weed-killer) to destroy
weeds, a time-consuming and expensive process, that requires care so that the herbicide
doesn't harm the crop plant or the environment. Crop plants genetically-engineered to be
resistant to one very powerful herbicide could help prevent environmental damage by
reducing the amount of herbicides needed. For example, Monsanto has created a strain of
soybeans genetically modified to be not affected by their herbicide product Roundup . A
farmer grows these soybeans which then only require one application of weed-killer instead
of multiple applications, reducing production cost and limiting the dangers of agricultural
waste run-off.

Disease resistance
There are many viruses, fungi and bacteria that cause plant diseases. Plant biologists are
working to create plants with genetically-engineered resistance to these diseases.

Cold tolerance
Unexpected frost can destroy sensitive seedlings. An antifreeze gene from cold water fish has
been introduced into plants such as tobacco and potato. With this antifreeze gene, these plants
are able to tolerate cold temperatures that normally would kill unmodified seedlings.
Drought tolerance/salinity tolerance
As the world population grows and more land is utilized for housing instead of food
production, farmers will need to grow crops in locations previously unsuited for plant
cultivation. Creating plants that can withstand long periods of drought or high salt content in
soil and groundwater will help people to grow crops in formerly inhospitable places.

Nutrition
Malnutrition is common in third world countries where impoverished peoples rely on a
single crop such as rice for the main staple of their diet. However, rice does not contain
adequate amounts of all necessary nutrients to prevent malnutrition. If rice could be
genetically engineered to contain additional vitamins and minerals, nutrient deficiencies
could be alleviated. For example, blindness due to vitamin A deficiency is a common
problem in third world countries. Researchers at the Swiss Federal Institute of Technology
Institute for Plant Sciences have created a strain of "golden" rice containing an unusually
high content of beta-carotene (vitamin A). Since this rice was funded by the Rockefeller
Foundation, a non-profit organization, the Institute hopes to offer the golden rice seed free to
any third world country that requests it. Plans were underway to develop a golden rice that
also has increased iron content. However, the grant that funded the creation of these two rice
strains was not renewed, perhaps because of the vigorous anti-GM food protesting in Europe,
and so this nutritionally-enhanced rice may not come to market at all.

Pharmaceuticals
Medicines and vaccines often are costly to produce and sometimes require special storage
conditions not readily available in third world countries. Researchers are working to develop
edible vaccines in tomatoes and potatoes 16, 17. These vaccines will be much easier to ship,
store and administer than traditional injectable vaccines.

Phytoremediation
Not all GM plants are grown as crops. Soil and groundwater pollution continues to be a
problem in all parts of the world. Plants such as poplar trees have been genetically engineered
to clean up heavy metal pollution from contaminated soil.
CRITICISMS AGAINST GENETICALLY MODIFIED FOODS

Environmental activists, religious organizations, public interest groups, professional

associations and other scientists and government officials have all raised concerns about GM
foods, and criticized agribusiness for pursuing profit without concern for potential hazards,
and the government for failing to exercise adequate regulatory oversight. Most concerns
about GM foods fall into three categories: environmental hazards, human health risks, and
economic concerns.

Environmental hazards

Unintended harm to other organisms

A laboratory study was published in Nature showing that pollen from B.t. corn caused high
mortality rates in monarch butterfly caterpillars. Monarch caterpillars consume milkweed
plants, not corn, but the fear is that if pollen from B.t. corn is blown by the wind onto
milkweed plants in neighboring fields, the caterpillars could eat the pollen and perish.
Although the Nature study was not conducted under natural field conditions, the results
seemed to support this viewpoint. Unfortunately, B.t. toxins kill many species of insect larvae
indiscriminately; it is not possible to design a B.t. toxin that would only kill crop-damaging
pests and remain harmless to all other insects. This study is being reexamined by the USDA,
the U.S. Environmental Protection Agency (EPA) and other non-government research
groups, and preliminary data from new studies suggests that the original study may have been
flawed. This topic is the subject of acrimonious debate, and both sides of the argument are
defending their data vigorously. Currently, there is no agreement about the results of these
studies, and the potential risk of harm to non-target organisms will need to be evaluated
further.

Reduced effectiveness of pesticides :

Just as some populations of mosquitoes developed resistance to the now-banned pesticide
DDT, many people are concerned that insects will become resistant to B.t. or other crops that
have been genetically-modified to produce their own pesticides.
Gene transfer to non-target species:
Another concern is that crop plants engineered for herbicide tolerance and weeds will cross-
breed, resulting in the transfer of the herbicide resistance genes from the crops into the
weeds. These "superweeds" would then be herbicide tolerant as well. Other introduced genes
may cross over into non-modified crops planted next to GM crops. The possibility of
interbreeding is shown by the defense of farmers against lawsuits filed by Monsanto. The
company has filed patent infringement lawsuits against farmers who may have harvested GM
crops. Monsanto claims that the farmers obtained Monsanto-licensed GM seeds from an
unknown source and did not pay royalties to Monsanto. The farmers claim that their
unmodified crops were cross-pollinated from someone else's GM crops planted a field or two
away. More investigation is needed to resolve this issue.

There are several possible solutions to the three problems mentioned above. Genes are
exchanged between plants via pollen. Two ways to ensure that non-target species will not
receive introduced genes from GM plants are to create GM plants that are male sterile (do not
produce pollen) or to modify the GM plant so that the pollen does not contain the introduced
gene24, 25, 26. Cross-pollination would not occur, and if harmless insects such as monarch
caterpillars were to eat pollen from GM plants, the caterpillars would survive.

Another possible solution is to create buffer zones around fields of GM crops 27, 28, 29. For
example, non-GM corn would be planted to surround a field of B.t. GM corn, and the non-
GM corn would not be harvested. Beneficial or harmless insects would have a refuge in the
non-GM corn, and insect pests could be allowed to destroy the non-GM corn and would not
develop resistance to B.t. pesticides. Gene transfer to weeds and other crops would not occur
because the wind-blown pollen would not travel beyond the buffer zone. Estimates of the
necessary width of buffer zones range from 6 meters to 30 meters or more 30. This planting
method may not be feasible if too much acreage is required for the buffer zones.

Human health risks

Allergenicity
Many children in the US and Europe have developed life-threatening allergies to peanuts and
other foods. There is a possibility that introducing a gene into a plant may create a new
allergen or cause an allergic reaction in susceptible individuals. A proposal to incorporate a
gene from Brazil nuts into soybeans was abandoned because of the fear of causing
unexpected allergic reactions31. Extensive testing of GM foods may be required to avoid the
possibility of harm to consumers with food allergies. Labeling of GM foods and food
products will acquire new importance, which I shall discuss later.

Unknown effects on human health

There is a growing concern that introducing foreign genes into food plants may have an
unexpected and negative impact on human health. A recent article published in Lancet
examined the effects of GM potatoes on the digestive tract in rats. This study claimed that
there were appreciable differences in the intestines of rats fed GM potatoes and rats fed
unmodified potatoes. Yet critics say that this paper, like the monarch butterfly data, is flawed
and does not hold up to scientific scrutiny. Moreover, the gene introduced into the potatoes
was a snowdrop flower lectin, a substance known to be toxic to mammals. The scientists who
created this variety of potato chose to use the lectin gene simply to test the methodology, and
these potatoes were never intended for human or animal consumption.

On the whole, with the exception of possible allergenicity, scientists believe that GM foods
do not present a risk to human health.
Economic concerns

Bringing a GM food to market is a lengthy and costly process, and of course agri-biotech
companies wish to ensure a profitable return on their investment. Many new plant genetic
engineering technologies and GM plants have been patented, and patent infringement is a big
concern of agribusiness. Yet consumer advocates are worried that patenting these new plant
varieties will raise the price of seeds so high that small farmers and third world countries will
not be able to afford seeds for GM crops, thus widening the gap between the wealthy and the
poor. It is hoped that in a humanitarian gesture, more companies and non-profits will follow
the lead of the Rockefeller Foundation and offer their products at reduced cost to
impoverished nations.

Patent enforcement may also be difficult, as the contention of the farmers that they
involuntarily grew Monsanto-engineered strains when their crops were cross-pollinated
shows. One way to combat possible patent infringement is to introduce a "suicide gene" into
GM plants. These plants would be viable for only one growing season and would produce
sterile seeds that do not germinate. Farmers would need to buy a fresh supply of seeds each
year. However, this would be financially disastrous for farmers in third world countries who
cannot afford to buy seed each year and traditionally set aside a portion of their harvest to
plant in the next growing season. In an open letter to the public, Monsanto has pledged to
abandon all research using this suicide gene technology.
 PREVALANCE OF GENETICALLY MODIFIED CROPS AND THE PLANTS
INVOLVED

According to the FDA and the United States Department of Agriculture (USDA), there are
over 40 plant varieties that have completed all of the federal requirements for
commercialization . Some examples of these plants include tomatoes and cantalopes that
have modified ripening characteristics, soybeans and sugarbeets that are resistant to
herbicides, and corn and cotton plants with increased resistance to insect pests. Not all these
products are available in supermarkets yet; however, the prevalence of GM foods in U.S.
grocery stores is more widespread than is commonly thought. While there are very, very few
genetically-modified whole fruits and vegetables available on produce stands, highly
processed foods, such as vegetable oils or breakfast cereals, most likely contain some tiny
percentage of genetically-modified ingredients because the raw ingredients have been pooled
into one processing stream from many different sources. Also, the ubiquity of soybean
derivatives as food additives in the modern American diet virtually ensures that all U.S.
consumers have been exposed to GM food products.

Soybeans and corn are the top two most widely grown crops (82% of all GM crops harvested
in 2000), with cotton, rapeseed (or canola) and potatoes trailing behind. 74% of these GM
crops were modified for herbicide tolerance, 19% were modified for insect pest resistance,
and 7% were modified for both herbicide tolerance and pest tolerance. Globally, acreage of
GM crops has increased 25-fold in just 5 years, from approximately 4.3 million acres in 1996
to 109 million acres in 2000 - almost twice the area of the United Kingdom. Approximately
99 million acres were devoted to GM crops in the U.S. and Argentina alone.

In the U.S., approximately 54% of all soybeans cultivated in 2000 were genetically-modified,
up from 42% in 1998 and only 7% in 1996. In 2000, genetically-modified cotton varieties
accounted for 61% of the total cotton crop, up from 42% in 1998, and 15% in 1996. GM corn
and also experienced a similar but less dramatic increase. Corn production increased to 25%
of all corn grown in 2000, about the same as 1998 (26%), but up from 1.5% in 1996. As
anticipated, pesticide and herbicide use on these GM varieties was slashed and, for the most
part, yields were increased.
 REGULATION OF GMO’S AND THE ROLE OF GOVERNMENT IN THIS
PROCESS

Governments around the world are hard at work to establish a regulatory process to monitor
the effects of and approve new varieties of GM plants. Yet depending on the political, social
and economic climate within a region or country, different governments are responding in
different ways.

In Japan, the Ministry of Health and Welfare has announced that health testing of GM foods
will be mandatory as of April 2001. Currently, testing of GM foods is voluntary. Japanese
supermarkets are offering both GM foods and unmodified foods, and customers are
beginning to show a strong preference for unmodified fruits and vegetables.

India's government has not yet announced a policy on GM foods because no GM crops are
grown in India and no products are commercially available in supermarkets yet. India is,
however, very supportive of transgenic plant research. It is highly likely that India will decide
that the benefits of GM foods outweigh the risks because Indian agriculture will need to
adopt drastic new measures to counteract the country's endemic poverty and feed its
exploding population.

Some states in Brazil have banned GM crops entirely, and the Brazilian Institute for the
Defense of Consumers, in collaboration with Greenpeace, has filed suit to prevent the
importation of GM crops,. Brazilian farmers, however, have resorted to smuggling GM
soybean seeds into the country because they fear economic harm if they are unable to
compete in the global marketplace with other grain-exporting countries.

In Europe, anti-GM food protestors have been especially active. In the last few years Europe
has experienced two major foods scares: bovine spongiform encephalopathy (mad cow
disease) in Great Britain and dioxin-tainted foods originating from Belgium. These food
scares have undermined consumer confidence about the European food supply, and citizens
are disinclined to trust government information about GM foods. In response to the public
outcry, Europe now requires mandatory food labeling of GM foods in stores, and the
European Commission (EC) has established a 1% threshold for contamination of unmodified
foods with GM food products.

In the United States, the regulatory process is confused because there are three different
government agencies that have jurisdiction over GM foods. To put it very simply, the EPA
evaluates GM plants for environmental safety, the USDA evaluates whether the plant is safe
to grow, and the FDA evaluates whether the plant is safe to eat. The EPA is responsible for
regulating substances such as pesticides or toxins that may cause harm to the environment.
GM crops such as B.t. pesticide-laced corn or herbicide-tolerant crops but not foods modified
for their nutritional value fall under the purview of the EPA. The USDA is responsible for
GM crops that do not fall under the umbrella of the EPA such as drought-tolerant or disease-
tolerant crops, crops grown for animal feeds, or whole fruits, vegetables and grains for human
consumption. The FDA historically has been concerned with pharmaceuticals, cosmetics and
food products and additives, not whole foods. Under current guidelines, a genetically-
modified ear of corn sold at a produce stand is not regulated by the FDA because it is a whole
food, but a box of cornflakes is regulated because it is a food product. The FDA's stance is
that GM foods are substantially equivalent to unmodified, "natural" foods, and therefore not
subject to FDA regulation.

The EPA conducts risk assessment studies on pesticides that could potentially cause harm to
human health and the environment, and establishes tolerance and residue levels for pesticides.
There are strict limits on the amount of pesticides that may be applied to crops during growth
and production, as well as the amount that remains in the food after processing. Growers
using pesticides must have a license for each pesticide and must follow the directions on the
label to accord with the EPA's safety standards. Government inspectors may periodically visit
farms and conduct investigations to ensure compliance. Violation of government regulations
may result in steep fines, loss of license and even jail sentences.

As an example the EPA regulatory approach, consider B.t. corn. The EPA has not established
limits on residue levels in B.t corn because the B.t. in the corn is not sprayed as a chemical
pesticide but is a gene that is integrated into the genetic material of the corn itself. Growers
must have a license from the EPA for B.t corn, and the EPA has issued a letter for the 2000
growing season requiring farmers to plant 20% unmodified corn, and up to 50% unmodified
corn in regions where cotton is also cultivated 41. This planting strategy may help prevent
insects from developing resistance to the B.t. pesticides as well as provide a refuge for non-
target insects such as Monarch butterflies.

The USDA has many internal divisions that share responsibility for assessing GM foods.
Among these divisions are APHIS, the Animal Health and Plant Inspection Service, which
conducts field tests and issues permits to grow GM crops, the Agricultural Research Service
which performs in-house GM food research, and the Cooperative State Research, Education
and Extension Service which oversees the USDA risk assessment program. The USDA is
concerned with potential hazards of the plant itself. Does it harbor insect pests? Is it a
noxious weed? Will it cause harm to indigenous species if it escapes from farmer's fields?
The USDA has the power to impose quarantines on problem regions to prevent movement of
suspected plants, restrict import or export of suspected plants, and can even destroy plants
cultivated in violation of USDA regulations. Many GM plants do not require USDA permits
from APHIS. A GM plant does not require a permit if it meets these 6 criteria:

1) The plant is not a noxious weed;

2) The genetic material introduced into the GM plant is stably integrated into the plant's own
genome;
3) The function of the introduced gene is known and does not cause plant disease;

4) The GM plant is not toxic to non-target organisms;

5) The introduced gene will not cause the creation of new plant viruses; and

6) The GM plant cannot contain genetic material from animal or human pathogens .

The current FDA policy was developed in 1992 (Federal Register Docket No. 92N-0139) and
states that agri-biotech companies may voluntarily ask the FDA for a consultation.
Companies working to create new GM foods are not required to consult the FDA, nor are
they required to follow the FDA's recommendations after the consultation. Consumer interest
groups wish this process to be mandatory, so that all GM food products, whole foods or
otherwise, must be approved by the FDA before being released for commercialization. The
FDA counters that the agency currently does not have the time, money, or resources to carry
out exhaustive health and safety studies of every proposed GM food product. Moreover, the
FDA policy as it exists today does not allow for this type of intervention.

Labelling Of GM Foods:

Labeling of GM foods and food products is also a contentious issue. On the whole,
agribusiness industries believe that labeling should be voluntary and influenced by the
demands of the free market. If consumers show preference for labeled foods over non-labeled
foods, then industry will have the incentive to regulate itself or risk alienating the customer.
Consumer interest groups, on the other hand, are demanding mandatory labeling. People have
the right to know what they are eating, argue the interest groups, and historically industry has
proven itself to be unreliable at self-compliance with existing safety regulations. The FDA's
current position on food labeling is governed by the Food, Drug and Cosmetic Act which is
only concerned with food additives, not whole foods or food products that are considered
"GRAS" - generally recognized as safe. The FDA contends that GM foods are substantially
equivalent to non-GM foods, and therefore not subject to more stringent labeling. If all GM
foods and food products are to be labeled, Congress must enact sweeping changes in the
existing food labeling policy.
There are many questions that must be answered if labeling of GM foods becomes
mandatory. First, are consumers willing to absorb the cost of such an initiative? If the food
production industry is required to label GM foods, factories will need to construct two
separate processing streams and monitor the production lines accordingly. Farmers must be
able to keep GM crops and non-GM crops from mixing during planting, harvesting and
shipping. It is almost assured that industry will pass along these additional costs to consumers
in the form of higher prices.

Secondly, what are the acceptable limits of GM contamination in non-GM products? The EC
has determined that 1% is an acceptable limit of cross-contamination, yet many consumer
interest groups argue that only 0% is acceptable. Some companies such as Gerber baby
foods42 and Frito-Lay43 have pledged to avoid use of GM foods in any of their products. But
who is going to monitor these companies for compliance and what is the penalty if they fail?
Once again, the FDA does not have the resources to carry out testing to ensure compliance.

What is the level of detectability of GM food cross-contamination? Scientists agree that

current technology is unable to detect minute quantities of contamination, so ensuring 0%
contamination using existing methodologies is not guaranteed. Yet researchers disagree on
what level of contamination really is detectable, especially in highly processed food products
such as vegetable oils or breakfast cereals where the vegetables used to make these products
have been pooled from many different sources. A 1% threshold may already be below current
levels of detectability.

Finally, who is to be responsible for educating the public about GM food labels and how
costly will that education be? Food labels must be designed to clearly convey accurate
information about the product in simple language that everyone can understand. This may be
the greatest challenge faced be a new food labeling policy: how to educate and inform the
public without damaging the public trust and causing alarm or fear of GM food products.

In January 2000, an international trade agreement for labeling GM foods was established.
More than 130 countries, including the US, the world's largest producer of GM foods, signed
the agreement. The policy states that exporters must be required to label all GM foods and
that importing countries have the right to judge for themselves the potential risks and reject
GM foods, if they so choose. This new agreement may spur the U.S. government to resolve
the domestic food labeling dilemma more rapidly.
 DETECTION OF GENETICALLY MODIFIED ORGANISMS

The detection of genetically modified organisms in food or feed is possible by biochemical

means. It can either be qualitative, showing which genetically modified organism (GMO) is
present, or quantitative, measuring in which amount a certain GMO is present. Being able to
detect a GMO is an important part of food safety, as without detection methods the
traceability of GMOs would rely solely on documentation.

Polymerase chain reaction (PCR)

The polymerase chain reaction (PCR) is a biochemistry and molecular biology technique for
isolating and exponentially amplifying a fragment of DNA, via enzymatic replication,
without using a living organism. It enables the detection of specific strands of DNA by
making millions of copies of a target genetic sequence. The target sequence is essentially
photocopied at an exponential rate, and simple visualisation techniques can make the millions
of copies easy to see.

The method works by pairing the targeted genetic sequence with custom designed
complementary bits of DNA called primers. In the presence of the target sequence, the
primers match with it and trigger a chain reaction. DNA replication enzymes use the primers
as docking points and start doubling the target sequences. The process is repeated over and
over again by sequential heating and cooling until doubling and redoubling has multiplied the
target sequence several million-fold. The millions of identical fragments are then purified in a
slab of gel, dyed, and can be seen with UV light.It is not prone to contamination.

Quantitative detection

Quantitative PCR (Q-PCR) is used to measure the quantity of a PCR product (preferably real-
time, QRT-PCR).[1] It is the method of choice to quantitatively measure amounts of transgene
DNA in a food or feed sample. Q-PCR is commonly used to determine whether a DNA
sequence is present in a sample and the number of its copies in the sample. The method with
currently the highest level of accuracy is quantitative real-time PCR. QRT-PCR methods use
fluorescent dyes, such as Sybr Green, or fluorophore-containing DNA probes, such as
TaqMan, to measure the amount of amplified product in real time. If the targeted genetic
sequence is unique to a certain GMO, a positive PCR test proves that the GMO is present in
the sample.

Qualitative detection

Whether or not a GMO is present in a sample can be tested by Q-PCR, but also by multiplex
PCR. Multiplex PCR uses multiple, unique primer sets within a single PCR reaction to
produce amplicons of varying sizes specific to different DNA sequences, i.e. different
transgenes. By targeting multiple genes at once, additional information may be gained from a
single test run that otherwise would require several times the reagents and more time to
perform. Annealing temperatures for each of the primer sets must be optimized to work
correctly within a single reaction, and amplicon sizes, i.e., their base pair length, should be
different enough to form distinct bands when visualized by gel electrophoresis.

Event-specific vs. construct-specific detection

When producers, importers or authorities test a sample for the unintended presence of GMOs,
they usually do not know, which GMO to expect. While EU authorities prefer an event-
specific approach to this problem, US authorities rely on construct-specific test schemes.

Event-specific detection

An event-specific detection searches for the presence of a DNA sequence unique to a certain
GMO, usually the junction between the transgene and the organism's original DNA. This
approach is ideal to precisely identify a GMO, yet highly similar GMOs will pass completely
unnoticed. Event-specific detection is PCR-based.

Construct-specific detection

The construct-specific detection methods can either be DNA or protein based. DNA based
detection looks for a part of the foreign DNA inserted in a GMO. For technical reasons,
certain DNA sequences are shared by several GMOs. Protein-based methods detect the
product of the transgene, for example the Bt toxin. Since different GMOs may produce the
same protein, construct-specific detection can test a sample for several GMOs in one step, but
is unable to tell precisely, which of the similar GMOs are present. Especially in the USA,
protein-based detection is used for the construct-specific approach.

Shortcomings of current detection methods

Currently, it is highly unlikely that the presence of unexpected or even unknown GMOs will
be detected, since either the DNA sequence of the transgene or its product, the protein, must
be known for detection. In addition, even testing for known GMOs is time-consuming and
costly, as current reliable detection methods can test for only one GMO at a time. Therefore,
research programmes such as Co-Extra are developing improved and alternative testing
methods, for example DNA microarrays.
Alternative detection methods

Improving PCR based detection

Improving PCR based detection of GMOs is a further goal of the European research
programme Co-Extra. Research is now underway to develop multiplex PCR methods that can
simultaneously detect many different transgenic lines. Another major challenge is the
increasing prevalence of transgenic crops with stacked traits. This refers to transgenic
cultivars derived from crosses between transgenic parent lines, combining the transgenic
traits of both parents. One GM maize variety now awaiting a decision by the European
Commission, MON863 x MON810 x NK603, has three stacked traits. It is resistant to an
herbicide and to two different kinds of insect pests. Some combined testing methods could
give results that would triple the actual GM content of a sample containing this GMO.

Detecting unknown GMOs

Almost all transgenic plants contain a few common building blocks that make unknown
GMOs easier to find. Even though detecting a novel gene in a GMO can be like finding a
needle in a haystack, the fact that the needles are usually similar makes it much easier. To
trigger gene expression, scientists couple the gene they want to add with what is known as a
transcription promoter. The high-performing 35S promoter is a common feature to many
GMOs. In addition, the stop signal for gene transcription in most GMOs is often the same:
the NOS terminator. Researchers now compile a set of genetic sequences characteristic of
GMOs. After genetic elements characteristic of GMOs are selected, methods and tools are
developed for detecting them in test samples. Approaches being considered include
microarrays and anchor PCR profiling.

Near infrared fluorescence (NIR)

Near infrared fluorescence (NIR) detection is a method that can reveal what kinds of
chemicals are present in a sample based on their physical properties. By hitting a sample with
near infrared light, chemical bonds in the sample vibrate and re-release the light energy at a
wavelength characteristic for a specific molecule or chemical bond. It is not yet known if the
differences between GMOs and conventional plants are large enough to detect with NIR
imaging. Although the technique would require advanced machinery and data processing
tools, a non-chemical approach could have some advantages such as lower costs and
enhanced speed and mobility.
 CONCLUSION

 Genetically-modified foods have the potential to solve many of the world's hunger
and malnutrition problems, and to help protect and preserve the environment by
increasing yield and reducing reliance upon chemical pesticides and herbicides.

 Yet there are many challenges ahead for governments, especially in the areas of safety
testing, regulation, international policy and food labeling. Many people feel that
genetic engineering is the inevitable wave of the future and that we cannot afford to
ignore a technology that has such enormous potential benefits.

 However, we must proceed with caution to avoid causing unintended harm to human
health and the environment as a result of our enthusiasm for this powerful technology.