Genetic engineering, also called genetic modification or genetic
manipulation, is the direct manipulation of an organism's genes using
biotechnology. It is a set of technologies used to change the genetic
makeup of cells, including the transfer of genes within and across
species boundaries to produce improved or novel organisms. New
obtained by either isolating and copying the genetic material of
interest using recombinant
DNA methods or by artificially synthesising
the DNA. A construct is usually created and used to insert this DNA
into the host organism. The first recombinant
DNA molecule was made by
Paul Berg in 1972 by combining
DNA from the monkey virus
SV40 with the
lambda virus. As well as inserting genes, the process can be used to
remove, or "knock out", genes. The new
DNA can be inserted randomly,
or targeted to a specific part of the genome.
An organism that is generated through genetic engineering is
considered to be genetically modified (GM) and the resulting entity is
a genetically modified organism (GMO). The first GMO was a bacterium
Herbert Boyer and Stanley Cohen in 1973. Rudolf Jaenisch
created the first GM animal when he inserted foreign
DNA into a mouse
in 1974. The first company to focus on genetic engineering, Genentech,
was founded in 1976 and started the production of human proteins.
Genetically engineered human insulin was produced in 1978 and
insulin-producing bacteria were commercialised in 1982. Genetically
modified food has been sold since 1994, with the release of the Flavr
Savr tomato. The
Flavr Savr was engineered to have a longer shelf
life, but most current GM crops are modified to increase resistance to
insects and herbicides. GloFish, the first GMO designed as a pet, was
sold in the United States in December 2003. In 2016 salmon modified
with a growth hormone were sold.
Genetic engineering has been applied in numerous fields including
research, medicine, industrial biotechnology and agriculture. In
research GMOs are used to study gene function and expression through
loss of function, gain of function, tracking and expression
experiments. By knocking out genes responsible for certain conditions
it is possible to create animal model organisms of human diseases. As
well as producing hormones, vaccines and other drugs genetic
engineering has the potential to cure genetic diseases through gene
therapy. The same techniques that are used to produce drugs can also
have industrial applications such as producing enzymes for laundry
detergent, cheeses and other products.
The rise of commercialised genetically modified crops has provided
economic benefit to farmers in many different countries, but has also
been the source of most of the controversy surrounding the technology.
This has been present since its early use, the first field trials were
destroyed by anti-GM activists. Although there is a scientific
consensus that currently available food derived from GM crops poses no
greater risk to human health than conventional food, GM food safety is
a leading concern with critics.
Gene flow, impact on non-target
organisms, control of the food supply and intellectual property rights
have also been raised as potential issues. These concerns have led to
the development of a regulatory framework, which started in 1975. It
has led to an international treaty, the Cartagena Protocol on
Biosafety, that was adopted in 2000. Individual countries have
developed their own regulatory systems regarding GMOs, with the most
marked differences occurring between the USA and Europe.
Gene isolation and cloning
DNA into the host genome
4.5 Other applications
7 See also
9 Further reading
10 External links
Comparison of conventional plant breeding with transgenic and cisgenic
Genetic engineering is a process that alters the genetic make-up of an
organism by either removing or introducing DNA. Unlike traditionally
animal and plant breeding, which involves doing multiple crosses and
then selecting for the organism with the desired phenotype, genetic
engineering takes the gene directly from one organism and inserts it
in the other. This is much faster, can be used to insert any genes
from any organism (even ones from different domains) and prevents
other undesirable genes from also being added.
Genetic engineering could potentially fix severe genetic disorders in
humans by replacing the defective gene with a functioning one. It
is an important tool in research that allows the function of specific
genes to be studied. Drugs, vaccines and other products have been
harvested from organisms engineered to produce them. Crops have
been developed that aid food security by increasing yield, nutritional
value and tolerance to environmental stresses.
DNA can be introduced directly into the host organism or into a
cell that is then fused or hybridised with the host. This relies on
recombinant nucleic acid techniques to form new combinations of
heritable genetic material followed by the incorporation of that
material either indirectly through a vector system or directly through
micro-injection, macro-injection or micro-encapsulation.
Genetic engineering does not normally include traditional breeding, in
vitro fertilisation, induction of polyploidy, mutagenesis and cell
fusion techniques that do not use recombinant nucleic acids or a
genetically modified organism in the process. However, some broad
definitions of genetic engineering include selective breeding.
Cloning and stem cell research, although not considered genetic
engineering, are closely related and genetic engineering can be
used within them.
Synthetic biology is an emerging discipline that
takes genetic engineering a step further by introducing artificially
synthesised material into an organism.
Plants, animals or micro organisms that have been changed through
genetic engineering are termed genetically modified organisms or
GMOs. If genetic material from another species is added to the
host, the resulting organism is called transgenic. If genetic material
from the same species or a species that can naturally breed with the
host is used the resulting organism is called cisgenic. If genetic
engineering is used to remove genetic material from the target
organism the resulting organism is termed a knockout organism. In
Europe genetic modification is synonymous with genetic engineering
while within the United States of America and Canada genetic
modification can also be used to refer to more conventional breeding
International Union of Pure and Applied Chemistry
International Union of Pure and Applied Chemistry definition of
Process of inserting new genetic information into existing cells in
order to modify a specific organism for the purpose of changing its
characteristics. Note: Adapted from ref.
Main article: History of genetic engineering
Humans have altered the genomes of species for thousands of years
through selective breeding, or artificial selection:1:1 as
contrasted with natural selection, and more recently through
Genetic engineering as the direct manipulation of
humans outside breeding and mutations has only existed since the
1970s. The term "genetic engineering" was first coined by Jack
Williamson in his science fiction novel Dragon's Island, published in
1951 – one year before DNA's role in heredity was confirmed by
Alfred Hershey and Martha Chase, and two years before James Watson
Francis Crick showed that the
DNA molecule has a double-helix
structure – though the general concept of direct genetic
manipulation was explored in rudimentary form in Stanley G. Weinbaum's
1936 science fiction story Proteus Island.
Rudolf Jaenisch created a genetically modified mouse, the
first GM animal.
Paul Berg created the first recombinant
DNA molecules by
DNA from the monkey virus
SV40 with that of the lambda
virus. In 1973
Herbert Boyer and Stanley Cohen created the first
transgenic organism by inserting antibiotic resistance genes into the
plasmid of an
Escherichia coli bacterium. A year later Rudolf
Jaenisch created a transgenic mouse by introducing foreign
its embryo, making it the world’s first transgenic animal. These
achievements 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
DNA research should be established until the technology
was deemed safe.
In 1976 Genentech, the first genetic engineering company, was founded
Herbert Boyer and Robert Swanson and a year later the company
produced a human protein (somatostatin) in E.coli.
the production of genetically engineered human insulin in 1978. In
U.S. Supreme Court
U.S. Supreme Court in the
Diamond v. Chakrabarty
Diamond v. Chakrabarty case ruled
that genetically altered life could be patented. The insulin
produced by bacteria was approved for release by the Food and Drug
Administration (FDA) in 1982.
In 1983, a biotech company, Advanced Genetic Sciences (AGS) applied
for U.S. government authorisation to perform field tests with the
ice-minus strain of
Pseudomonas syringae to protect crops from frost,
but environmental groups and protestors delayed the field tests for
four years with legal challenges. In 1987, the ice-minus strain of
P. syringae became the first genetically modified organism (GMO) to be
released into the environment when a strawberry field and a potato
field in California were sprayed with it. Both test fields were
attacked by activist groups the night before the tests occurred: "The
world's first trial site attracted the world's first field
The first field trials of genetically engineered plants occurred in
France and the USA in 1986, tobacco plants were engineered to be
resistant to herbicides. The People’s Republic of China was the
first country to commercialise transgenic plants, introducing a
virus-resistant tobacco in 1992. In 1994 Calgene attained approval
to commercially release the first genetically modified food, the Flavr
Savr, a tomato engineered to have a longer shelf life. In 1994,
European Union approved tobacco engineered to be resistant to the
herbicide bromoxynil, making it the first genetically engineered crop
commercialised in Europe. In 1995, Bt Potato was approved safe by
the Environmental Protection Agency, after having been approved by the
FDA, making it the first pesticide producing crop to be approved in
the USA. In 2009 11 transgenic crops were grown commercially in 25
countries, the largest of which by area grown were the USA, Brazil,
Argentina, India, Canada, China, Paraguay and South Africa.
In 2010, scientists at the
J. Craig Venter Institute
J. Craig Venter Institute created the first
synthetic genome and inserted it into an empty bacterial cell. The
resulting bacterium, named Mycoplasma laboratorium, could replicate
and produce proteins. Four years later this was taken a step
further when bacterium was developed that replicated a plasmid
containing a unique base pair, creating the first organism engineered
to use an expanded genetic alphabet. In 2012, Jennifer Doudna
Emmanuelle Charpentier collaborated to develop the CRISPR/Cas9
system, a technique which can be used to easily and
specifically alter the genome of almost any organism.
Genetic engineering techniques
Polymerase chain reaction
Polymerase chain reaction is a powerful tool used in molecular cloning
Creating a GMO is a multi-step process. Genetic engineers must first
choose what gene they wish to insert into the organism. This is driven
by what the aim is for the resultant organism and is built on earlier
research. Genetic screens can be carried out to determine potential
genes and further tests then used to identify the best candidates. The
development of microarrays, transcriptomes and genome sequencing has
made it much easier to find suitable genes. Luck also plays its
part; the round-up ready gene was discovered after scientists noticed
a bacterium thriving in the presence of the herbicide.
Gene isolation and cloning
Main article: Molecular cloning
The next step is to isolate the candidate gene. The cell containing
the gene is opened and the
DNA is purified. The gene is separated
by using restriction enzymes to cut the
DNA into fragments or
polymerase chain reaction (PCR) to amplify up the gene segment.
These segments can then be extracted through gel electrophoresis. If
the chosen gene or the donor organism's genome has been well studied
it may already be accessible from a genetic library. If the DNA
sequence is known, but no copies of the gene are available, it can
also be artificially synthesised. Once isolated the gene is
ligated into a plasmid that is then inserted into a bacterium. The
plasmid is replicated when the bacteria divide, ensuring unlimited
copies of the gene are available.
Before the gene is inserted into the target organism it must be
combined with other genetic elements. These include a promoter and
terminator region, which initiate and end transcription. A selectable
marker gene is added, which in most cases confers antibiotic
resistance, so researchers can easily determine which cells have been
successfully transformed. The gene can also be modified at this stage
for better expression or effectiveness. These manipulations are
carried out using recombinant
DNA techniques, such as restriction
digests, ligations and molecular cloning.
DNA into the host genome
See also: Transformation (genetics), Transfection, and Transduction
A gene gun uses biolistics to insert
DNA into plant tissue
There are a number of techniques available for inserting the gene into
the host genome. Some bacteria can naturally take up foreign DNA. This
ability can be induced in other bacteria via stress (e.g. thermal or
electric shock), which increases the cell membrane's permeability to
DNA can either integrate with the genome or exist as
DNA is generally inserted into animal cells
using microinjection, where it can be injected through the cell's
nuclear envelope directly into the nucleus, or through the use of
In plants the
DNA is often inserted using Agrobacterium-mediated
recombination, taking advantage of the Agrobacteriums T-DNA
sequence that allows natural insertion of genetic material into plant
cells. Other methods include biolistics, where particles of gold
or tungsten are coated with
DNA and then shot into young plant
cells, and electroporation, which involves using an electric shock
to make the cell membrane permeable to plasmid DNA. Due to the damage
caused to the cells and
DNA the transformation efficiency of
biolistics and electroporation is lower than agrobacterial
transformation and microinjection.
As only a single cell is transformed with genetic material, the
organism must be regenerated from that single cell. In plants this is
accomplished through the use of tissue culture. In animals it
is necessary to ensure that the inserted
DNA is present in the
embryonic stem cells.
Bacteria consist of a single cell and
reproduce clonally so regeneration is not necessary. Selectable
markers are used to easily differentiate transformed from
untransformed cells. These markers are usually present in the
transgenic organism, although a number of strategies have been
developed that can remove the selectable marker from the mature
A. tumefaciens attaching itself to a carrot cell
Further testing using PCR, Southern hybridization, and
is conducted to confirm that an organism contains the new gene.
These tests can also confirm the chromosomal location and copy number
of the inserted gene. The presence of the gene does not guarantee it
will be expressed at appropriate levels in the target tissue so
methods that look for and measure the gene products (
RNA and protein)
are also used. These include northern hybridisation, quantitative
RT-PCR, Western blot, immunofluorescence,
ELISA and phenotypic
The new genetic material can be inserted randomly within the host
genome or targeted to a specific location. The technique of gene
targeting uses homologous recombination to make desired changes to a
specific endogenous gene. This tends to occur at a relatively low
frequency in plants and animals and generally requires the use of
selectable markers. The frequency of gene targeting can be greatly
enhanced through genome editing.
Genome editing uses artificially
engineered nucleases that create specific double-stranded breaks at
desired locations in the genome, and use the cell’s endogenous
mechanisms to repair the induced break by the natural processes of
homologous recombination and nonhomologous end-joining. There are four
families of engineered nucleases: meganucleases, zinc finger
nucleases, transcription activator-like effector nucleases
(TALENs), and the Cas9-guide
RNA system (adapted from
CRISPR). TALEN and
CRISPR are the two most commonly used and
each has its own advantages. TALENs have greater target
CRISPR is easier to design and more efficient.
In addition to enhancing gene targeting, engineered nucleases can be
used to introduce mutations at endogenous genes that generate a gene
Genetic engineering has applications in medicine, research, industry
and agriculture and can be used on a wide range of plants, animals and
micro organisms. Bacteria, the first organisms to be genetically
modified, can have plasmid
DNA inserted containing new genes that code
for medicines or enzymes that process food and other
substrates. Plants have been modified for insect protection,
herbicide resistance, virus resistance, enhanced nutrition, tolerance
to environmental pressures and the production of edible vaccines.
Most commercialised GMOs are insect resistant or herbicide tolerant
crop plants. Genetically modified animals have been used for
research, model animals and the production of agricultural or
pharmaceutical products. The genetically modified animals include
animals with genes knocked out, increased susceptibility to disease,
hormones for extra growth and the ability to express proteins in their
Genetic engineering has many applications to medicine that include the
manufacturing of drugs, creation of model animals that mimic human
conditions and gene therapy. One of the earliest uses of genetic
engineering was to mass-produce human insulin in bacteria. This
application has now been applied to, human growth hormones, follicle
stimulating hormones (for treating infertility), human albumin,
monoclonal antibodies, antihemophilic factors, vaccines and many other
drugs. Mouse hybridomas, cells fused together to create
monoclonal antibodies, have been adapted through genetic engineering
to create human monoclonal antibodies. In 2017, genetic
engineering of chimeric antigen receptors on a patient's own T-cells
was approved by the U.S.
FDA as a treatment for the cancer acute
lymphoblastic leukemia. Genetically engineered viruses are being
developed that can still confer immunity, but lack the infectious
Genetic engineering is also used to create animal models of human
diseases. Genetically modified mice are the most common genetically
engineered animal model. They have been used to study and model
cancer (the oncomouse), obesity, heart disease, diabetes, arthritis,
substance abuse, anxiety, aging and Parkinson disease. Potential
cures can be tested against these mouse models. Also genetically
modified pigs have been bred with the aim of increasing the success of
pig to human organ transplantation.
Gene therapy is the genetic engineering of humans, generally by
replacing defective genes with effective ones.
Clinical research using
somatic gene therapy has been conducted with several diseases,
including X-linked SCID, chronic lymphocytic leukemia
(CLL), and Parkinson's disease. In 2012, Alipogene
tiparvovec became the first gene therapy treatment to be approved for
clinical use. In 2015 a virus was used to insert a healthy
gene into the skin cells of a boy suffering from a rare skin disease,
epidermolysis bullosa, in order to grow, and then graft healthy skin
onto 80 percent of the boy's body which was affected by the
Germline gene therapy would result in any change being
inheritable, which has raised concerns within the scientific
community. In 2015,
CRISPR was used to edit the
non-viable human embryos, leading scientists of major world
academies to called for a moratorium on inheritable human genome
edits. There are also concerns that the technology could be used
not just for treatment, but for enhancement, modification or
alteration of a human beings' appearance, adaptability, intelligence,
character or behavior. The distinction between cure and
enhancement can also be difficult to establish.
Researchers are altering the genome of pigs to induce the growth of
human organs to be used in transplants. Scientists are creating "gene
drives", changing the genomes of mosquitoes to make them immune to
malaria, and then spreading the genetically altered mosquitoes
throughout the mosquito population in the hopes of eliminating the
Human cells in which some proteins are fused with green fluorescent
protein to allow them to be visualised
Genetic engineering is an important tool for natural scientists. Genes
and other genetic information from a wide range of organisms can be
inserted into bacteria for storage and modification, creating
genetically modified bacteria in the process.
Bacteria are cheap, easy
to grow, clonal, multiply quickly, relatively easy to transform and
can be stored at -80 °C almost indefinitely. Once a gene is
isolated it can be stored inside the bacteria providing an unlimited
supply for research.
Organisms are genetically engineered to discover the functions of
certain genes. This could be the effect on the phenotype of the
organism, where the gene is expressed or what other genes it interacts
with. These experiments generally involve loss of function, gain of
function, tracking and expression.
Loss of function experiments, such as in a gene knockout experiment,
in which an organism is engineered to lack the activity of one or more
genes. In a simple knockout a copy of the desired gene has been
altered to make it non-functional.
Embryonic stem cells
Embryonic stem cells incorporate
the altered gene, which replaces the already present functional copy.
These stem cells are injected into blastocysts, which are implanted
into surrogate mothers. This allows the experimenter to analyse the
defects caused by this mutation and thereby determine the role of
particular genes. It is used especially frequently in developmental
biology. When this is done by creating a library of genes with
point mutations at every position in the area of interest, or even
every position in the whole gene, this is called "scanning
mutagenesis". The simplest method, and the first to be used, is
"alanine scanning", where every position in turn is mutated to the
unreactive amino acid alanine.
Gain of function experiments, the logical counterpart of knockouts.
These are sometimes performed in conjunction with knockout experiments
to more finely establish the function of the desired gene. The process
is much the same as that in knockout engineering, except that the
construct is designed to increase the function of the gene, usually by
providing extra copies of the gene or inducing synthesis of the
protein more frequently. Gain of function is used to tell whether or
not a protein is sufficient for a function, but does not always mean
it's required, especially when dealing with genetic or functional
Tracking experiments, which seek to gain information about the
localisation and interaction of the desired protein. One way to do
this is to replace the wild-type gene with a 'fusion' gene, which is a
juxtaposition of the wild-type gene with a reporting element such as
green fluorescent protein (GFP) that will allow easy visualisation of
the products of the genetic modification. While this is a useful
technique, the manipulation can destroy the function of the gene,
creating secondary effects and possibly calling into question the
results of the experiment. More sophisticated techniques are now in
development that can track protein products without mitigating their
function, such as the addition of small sequences that will serve as
binding motifs to monoclonal antibodies.
Expression studies aim to discover where and when specific proteins
are produced. In these experiments, the
DNA sequence before the DNA
that codes for a protein, known as a gene's promoter, is reintroduced
into an organism with the protein coding region replaced by a reporter
gene such as GFP or an enzyme that catalyses the production of a dye.
Thus the time and place where a particular protein is produced can be
observed. Expression studies can be taken a step further by altering
the promoter to find which pieces are crucial for the proper
expression of the gene and are actually bound by transcription factor
proteins; this process is known as promoter bashing.
Organisms can have their cells transformed with a gene coding for a
useful protein, such as an enzyme, so that they will overexpress the
desired protein. Mass quantities of the protein can then be
manufactured by growing the transformed organism in bioreactor
equipment using industrial fermentation, and then purifying the
protein. Some genes do not work well in bacteria, so yeast,
insect cells or mammalians cells can also be used. These
techniques are used to produce medicines such as insulin, human growth
hormone, and vaccines, supplements such as tryptophan, aid in the
production of food (chymosin in cheese making) and fuels. Other
applications with genetically engineered bacteria could involve making
them perform tasks outside their natural cycle, such as making
biofuels, cleaning up oil spills, carbon and other toxic
waste and detecting arsenic in drinking water. Certain
genetically modified microbes can also be used in biomining and
bioremediation, due to their ability to extract heavy metals from
their environment and incorporate them into compounds that are more
In materials science, a genetically modified virus has been used in a
research laboratory as a scaffold for assembling a more
environmentally friendly lithium-ion battery.
also been engineered to function as sensors by expressing a
fluorescent protein under certain environmental conditions.
Genetically modified crops
Genetically modified crops and Genetically modified
Bt-toxins present in peanut leaves (bottom image) protect it from
extensive damage caused by
European corn borer
European corn borer larvae (top
One of the best-known and controversial applications of genetic
engineering is the creation and use of genetically modified crops or
genetically modified livestock to produce genetically modified food.
Crops have been developed to increase production, increase tolerance
to abiotic stresses, alter the composition of the food, or to produce
The first crops to be realised commercially on a large scale provided
protection from insect pests or tolerance to herbicides. Fungal and
virus resistant crops have also being developed or are in
development. This make the insect and weed management of
crops easier and can indirectly increase crop yield. GM
crops that directly improve yield by accelerating growth or making the
plant more hardy (by improving salt, cold or drought tolerance) are
also under development. In 2016 Salmon have been genetically
modified with growth hormones to reach normal adult size much
GMOs have been developed that modify the quality of produce by
increasing the nutritional value or providing more industrially useful
qualities or quantities. The
Amflora potato produces a more
industrially useful blend of starches. Soybeans and canola have been
genetically modified to produce more healthy oils. The first
commercialised GM food was a tomato that had delayed ripening,
increasing its shelf life.
Plants and animals have been engineered to produce materials they do
not normally make. Pharming uses crops and animals as bioreactors to
produce vaccines, drug intermediates, or the drugs themselves; the
useful product is purified from the harvest and then used in the
standard pharmaceutical production process. Cows and goats have
been engineered to express drugs and other proteins in their milk, and
in 2009 the
FDA approved a drug produced in goat milk.
Genetic engineering has potential applications in conservation and
natural area management.
Gene transfer through viral vectors has been
proposed as a means of controlling invasive species as well as
vaccinating threatened fauna from disease.
Transgenic trees have
been suggested as a way to confer resistance to pathogens in wild
populations. With the increasing risks of maladaptation in
organisms as a result of climate change and other perturbations,
facilitated adaptation through gene tweaking could be one solution to
reducing extinction risks. Applications of genetic engineering in
conservation are thus far mostly theoretical and have yet to be put
Genetic engineering is also being used to create microbial art.
Some bacteria have been genetically engineered to create black and
white photographs. Novelty items such as lavender-colored
carnations, blue roses, and glowing fish have also
been produced through genetic engineering.
Main article: Regulation of genetic engineering
The regulation of genetic engineering concerns the approaches taken by
governments to assess and manage the risks associated with the
development and release of GMOs. The development of a regulatory
framework began in 1975, at Asilomar, California. The Asilomar
meeting recommended a set of voluntary guidelines regarding the use of
recombinant technology. As the technology improved USA
established a committee at the Office of Science and Technology,
which assigned regulatory approval of GM plants to the USDA,
EPA. The Cartagena Protocol on Biosafety, an international treaty
that governs the transfer, handling, and use of GMOs, was adopted
on 29 January 2000. One hundred and fifty-seven countries are
members of the Protocol and many use it as a reference point for their
The legal and regulatory status of GM foods varies by country, with
some nations banning or restricting them, and others permitting them
with widely differing degrees of regulation. Some
countries allow the import of GM food with authorisation, but either
do not allow its cultivation (Russia, Norway, Israel) or have
provisions for cultivation, but no GM products are yet produced
(Japan, South Korea). Most countries that do not allow for GMO
cultivation do permit research. Some of the most marked
differences occurring between the USA and Europe. The US policy
focuses on the product (not the process), only looks at verifiable
scientific risks and uses the concept of substantial equivalence.
European Union by contrast has possibly the most stringent GMO
regulations in the world. All GMOs, along with irradiated food,
are considered "new food" and subject to extensive, case-by-case,
science-based food evaluation by the European Food Safety Authority.
The criteria for authorisation fall in four broad categories:
"safety," "freedom of choice," "labelling," and "traceability."
The level of regulation in other countries that cultivate GMOs lie in
between Europe and the United States.
Regulatory agencies by geographical region
FDA and EPA
European Food Safety Authority
Health Canada and the Canadian Food Inspection Agency
Based on whether a product has novel features regardless of method of
Common Market for Eastern and Southern Africa
Final decision lies with each individual country.
Office of Agricultural Genetic
Institutional Biosafety Committee, Review Committee on Genetic
Manipulation and Genetic
Engineering Approval Committee
Biotechnology Advisory Committee (environmental
impact), the National Service of Health and Agrifood Quality (food
safety) and the National Agribusiness Direction (effect on trade)
Final decision made by the Secretariat of Agriculture, Livestock,
Fishery and Food.
National Biosafety Technical Commission (environmental and food
safety) and the Council of Ministers (commercial and economical
Office of the
Gene Technology Regulator (overseas all), Therapeutic
Goods Administration (GM medicines) and Food Standards Australia New
Zealand (GM food).
The individual state governments can then assess the impact of release
on markets and trade and apply further legislation to control approved
genetically modified products.
One of the key issues concerning regulators is whether GM products
should be labeled. The
European Commission says that mandatory
labeling and traceability are needed to allow for informed choice,
avoid potential false advertising and facilitate the withdrawal
of products if adverse effects on health or the environment are
discovered. The American Medical Association and the
American Association for the Advancement of Science say that
absent scientific evidence of harm even voluntary labeling is
misleading and will falsely alarm consumers". Labeling of GMO products
in the marketplace is required in 64 countries. Labeling can be
mandatory up to a threshold GM content level (which varies between
countries) or voluntary. In Canada and the USA labeling of GM food is
voluntary, while in Europe all food (including processed food) or
feed which contains greater than 0.9% of approved GMOs must be
Genetically modified food
Genetically modified food controversies
Critics have objected to the use of genetic engineering on several
grounds, that include ethical, ecological and economic concerns. Many
of these concerns involve GM crops and whether food produced from them
is safe, whether it should be labeled and what impact growing them
will have on the environment. These controversies have led to
litigation, international trade disputes, and protests, and to
restrictive regulation of commercial products in some countries.
Accusations that scientists are "playing God" and other religious
issues have been ascribed to the technology from the beginning.
Other ethical issues raised include the patenting of life, the
use of intellectual property rights, the level of labeling on
products, control of the food supply and the
objectivity of the regulatory process. Although doubts have been
raised, economically most studies have found growing GM crops to
be beneficial to farmers.
Gene flow between GM crops and compatible plants, along with increased
use of selective herbicides, can increase the risk of "superweeds"
developing. Other environmental concerns involve potential
impacts on non-target organisms, including soil microbes, and an
increase in secondary and resistant insect pests. Many of
the environmental impacts regarding GM crops may take many years to be
understood are also evident in conventional agriculture
practices. With the commercialisation of genetically
modified fish there are concerns over what the environmental
consequences will be if they escape.
There are three main concerns over the safety of genetically modified
food: whether they may provoke an allergic reaction; whether the genes
could transfer from the food into human cells; and whether the genes
not approved for human consumption could outcross to other crops.
There is a scientific consensus that currently
available food derived from GM crops poses no greater risk to human
health than conventional food, but that each
GM food needs to be tested on a case-by-case basis before
introduction. Nonetheless, members of the public are
much less likely than scientists to perceive GM foods as
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October 2010, doi:10.1038/467633b. Retrieved 9 November 2010
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Biotechnology Development and Policy
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28 September 2011.
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Council of 22 September 2003 On Genetically Modified Food And Feed"
(PDF). Official Journal of the European Union. The European Parliament
and the Council of the European Union. 2003. Archived from the
original (PDF) on 20 January 2014. The labeling should include
objective information to the effect that a food or feed consists of,
contains or is produced from GMOs. Clear labeling, irrespective of the
DNA or protein resulting from the genetic
modification in the final product, meets the demands expressed in
numerous surveys by a large majority of consumers, facilitates
informed choice and precludes potential misleading of consumers as
regards methods of manufacture or production.
^ "Regulation (EC) No 1830/2003 of the European Parliament and of the
Council of 22 September 2003 concerning the traceability and labeling
of genetically modified organisms and the traceability of food and
feed products produced from genetically modified organisms and
amending Directive 2001/18/EC". Official Journal L 268, 18/10/2003 P.
0024 - 0028. The European Parliament and the Council of the European
Union. 2003. (3) Traceability requirements for GMOs should facilitate
both the withdrawal of products where unforeseen adverse effects on
human health, animal health or the environment, including ecosystems,
are established, and the targeting of monitoring to examine potential
effects on, in particular, the environment. Traceability should also
facilitate the implementation of risk management measures in
accordance with the precautionary principle. (4) Traceability
requirements for food and feed produced from GMOs should be
established to facilitate accurate labeling of such products.
^ "Report 2 of the Council on Science and Public Health: Labeling of
Bioengineered Foods" (PDF). American Medical Association. 2012.
Archived from the original (PDF) on 7 September 2012.
American Association for the Advancement of Science
American Association for the Advancement of Science (AAAS), Board of
Directors (2012). Statement by the AAAS Board of Directors On Labeling
of Genetically Modified Foods, and associated Press release: Legally
Mandating GM Food Labels Could Mislead and Falsely Alarm Consumers
^ Hallenbeck, Terri (2014-04-27). "How GMO labeling came to pass in
Vermont". Burlington Free Press. Retrieved 2014-05-28.
^ "The Regulation of Genetically Modified Foods".
^ Sheldon, Ian M. (2002-03-01). "Regulation of biotechnology: will we
ever 'freely' trade GMOs?". European Review of Agricultural Economics.
29 (1): 155–176. CiteSeerX 10.1.1.596.7670 .
doi:10.1093/erae/29.1.155. ISSN 0165-1587.
^ Dabrock, Peter (2017-05-05). "Playing God?
Synthetic biology as a
theological and ethical challenge". Systems and Synthetic Biology. 3
(1–4): 47–54. doi:10.1007/s11693-009-9028-5. ISSN 1872-5325.
PMC 2759421 . PMID 19816799.
^ Brown, Carolyn (2000-10-03). "Patenting life: genetically altered
mice an invention, court declares". CMAJ: Canadian Medical Association
Journal. 163 (7): 867–868. ISSN 0820-3946. PMC 80518 .
^ Zhou, Wen (2015-08-10). "The Patent Landscape of Genetically
Organisms - Science in the News". Science in the News.
^ Puckett, Lily (2016-04-20). "Why The New GMO Food-Labeling Law Is So
Controversial". Huffington Post. Retrieved 2017-05-05.
^ Miller, Henry (2016-04-12). "GMO food labels are meaningless". Los
Angeles Times. ISSN 0458-3035. Retrieved 2017-05-05.
^ Savage, Steven. "Who Controls The Food Supply?". Forbes. Retrieved
^ Knight, Andrew J. (2016-04-14). Science, Risk, and Policy.
Routledge. p. 156. ISBN 9781317280811.
^ Hakim, Danny (2016-10-29). "Doubts About the Promised Bounty of
Genetically Modified Crops". The New York Times. ISSN 0362-4331.
^ Areal, F. J.; Riesgo, L.; Rodríguez-Cerezo, E. (2013-02-01).
"Economic and agronomic impact of commercialized GM crops: a
meta-analysis". The Journal of Agricultural Science. 151 (1): 7–33.
doi:10.1017/S0021859612000111. ISSN 0021-8596.
^ Finger, Robert; El Benni, Nadja; Kaphengst, Timo; Evans, Clive;
Herbert, Sophie; Lehmann, Bernard; Morse, Stephen; Stupak, Nataliya
(2011-05-10). "A Meta Analysis on Farm-Level Costs and Benefits of GM
Crops". Sustainability. 3 (5): 743–762. doi:10.3390/su3050743.
^ Klümper, Wilhelm; Qaim, Matin (2014-11-03). "A Meta-Analysis of the
Impacts of Genetically Modified Crops". PLOS ONE. 9 (11): e111629.
doi:10.1371/journal.pone.0111629. ISSN 1932-6203.
PMC 4218791 . PMID 25365303.
^ Qiu, Jane (2013). "
Genetically modified crops
Genetically modified crops pass benefits to
weeds". Nature. doi:10.1038/nature.2013.13517.
^ a b "GMOs and the environment". www.fao.org. Retrieved
^ Dively, Galen P.; Venugopal, P. Dilip; Finkenbinder, Chad
(2016-12-30). "Field-Evolved Resistance in Corn Earworm to Cry
Proteins Expressed by
Transgenic Sweet Corn". PLOS ONE. 11 (12):
e0169115. doi:10.1371/journal.pone.0169115. ISSN 1932-6203.
PMC 5201267 . PMID 28036388.
^ Qiu, Jane (2010-05-13). "GM crop use makes minor pests major
problem". Nature News. doi:10.1038/news.2010.242.
^ Gilbert, Natasha (2013-05-02). "Case studies: A hard look at GM
crops". Nature. 497 (7447): 24–26. doi:10.1038/497024a.
^ "Are GMO Fish Safe for the Environment? Accumulating Glitches
Learn Science at Scitable". www.nature.com. Retrieved
^ "Q&A: genetically modified food". World Health Organization.
^ Nicolia, Alessandro; Manzo, Alberto; Veronesi, Fabio; Rosellini,
Daniele (2013). "An overview of the last 10 years of genetically
engineered crop safety research" (PDF). Critical Reviews in
Biotechnology. 34: 1–12. doi:10.3109/07388551.2013.823595.
PMID 24041244. We have reviewed the scientific literature on GE
crop safety for the last 10 years that catches the scientific
consensus matured since GE plants became widely cultivated worldwide,
and we can conclude that the scientific research conducted so far has
not detected any significant hazard directly connected with the use of
The literature about Biodiversity and the GE food/feed consumption has
sometimes resulted in animated debate regarding the suitability of the
experimental designs, the choice of the statistical methods or the
public accessibility of data. Such debate, even if positive and part
of the natural process of review by the scientific community, has
frequently been distorted by the media and often used politically and
inappropriately in anti-GE crops campaigns.
^ "State of Food and
Agriculture 2003–2004. Agricultural
Biotechnology: Meeting the Needs of the Poor. Health and environmental
impacts of transgenic crops". Food and
Agriculture Organization of the
United Nations. Retrieved 8 February 2016. Currently available
transgenic crops and foods derived from them have been judged safe to
eat and the methods used to test their safety have been deemed
appropriate. These conclusions represent the consensus of the
scientific evidence surveyed by the ICSU (2003) and they are
consistent with the views of the World Health Organization (WHO,
2002). These foods have been assessed for increased risks to human
health by several national regulatory authorities (inter alia,
Argentina, Brazil, Canada, China, the United Kingdom and the United
States) using their national food safety procedures (ICSU). To date no
verifiable untoward toxic or nutritionally deleterious effects
resulting from the consumption of foods derived from genetically
modified crops have been discovered anywhere in the world (GM Science
Review Panel). Many millions of people have consumed foods derived
from GM plants - mainly maize, soybean and oilseed rape - without any
observed adverse effects (ICSU).
^ Ronald, Pamela (5 May 2011). "Plant Genetics, Sustainable
Agriculture and Global Food Security". Genetics. 188: 11–20.
doi:10.1534/genetics.111.128553. PMC 3120150 .
PMID 21546547. There is broad scientific consensus that
genetically engineered crops currently on the market are safe to eat.
After 14 years of cultivation and a cumulative total of 2 billion
acres planted, no adverse health or environmental effects have
resulted from commercialization of genetically engineered crops (Board
Agriculture and Natural Resources, Committee on Environmental
Impacts Associated with Commercialization of
National Research Council and Division on Earth and Life Studies
2002). Both the U.S. National Research Council and the Joint Research
Centre (the European Union's scientific and technical research
laboratory and an integral part of the European Commission) have
concluded that there is a comprehensive body of knowledge that
adequately addresses the food safety issue of genetically engineered
crops (Committee on Identifying and Assessing Unintended Effects of
Genetically Engineered Foods on Human Health and National Research
European Commission Joint Research Centre 2008). These
and other recent reports conclude that the processes of genetic
engineering and conventional breeding are no different in terms of
unintended consequences to human health and the environment (European
Commission Directorate-General for Research and Innovation
^ But see also: Domingo, José L.; Bordonaba, Jordi Giné (2011). "A
literature review on the safety assessment of genetically modified
plants" (PDF). Environment International. 37: 734–742.
doi:10.1016/j.envint.2011.01.003. PMID 21296423. In spite of
this, the number of studies specifically focused on safety assessment
of GM plants is still limited. However, it is important to remark that
for the first time, a certain equilibrium in the number of research
groups suggesting, on the basis of their studies, that a number of
varieties of GM products (mainly maize and soybeans) are as safe and
nutritious as the respective conventional non-GM plant, and those
raising still serious concerns, was observed. Moreover, it is worth
mentioning that most of the studies demonstrating that GM foods are as
nutritional and safe as those obtained by conventional breeding, have
been performed by biotechnology companies or associates, which are
also responsible of commercializing these GM plants. Anyhow, this
represents a notable advance in comparison with the lack of studies
published in recent years in scientific journals by those
companies. Krimsky, Sheldon (2015). "An Illusory Consensus
behind GMO Health Assessment" (PDF). Science, Technology, & Human
Values. 40: 1–32. doi:10.1177/0162243915598381. I began this article
with the testimonials from respected scientists that there is
literally no scientific controversy over the health effects of GMOs.
My investigation into the scientific literature tells another
story. And contrast:
Panchin, Alexander Y.; Tuzhikov, Alexander I. (14 January 2016).
"Published GMO studies find no evidence of harm when corrected for
multiple comparisons". Critical Reviews in Biotechnology: 1–5.
doi:10.3109/07388551.2015.1130684. ISSN 0738-8551.
PMID 26767435. Here, we show that a number of articles some of
which have strongly and negatively influenced the public opinion on GM
crops and even provoked political actions, such as GMO embargo, share
common flaws in the statistical evaluation of the data. Having
accounted for these flaws, we conclude that the data presented in
these articles does not provide any substantial evidence of GMO harm.
The presented articles suggesting possible harm of GMOs received high
public attention. However, despite their claims, they actually weaken
the evidence for the harm and lack of substantial equivalency of
studied GMOs. We emphasize that with over 1783 published articles on
GMOs over the last 10 years it is expected that some of them should
have reported undesired differences between GMOs and conventional
crops even if no such differences exist in reality. and
Yang, Y.T.; Chen, B. (2016). "Governing GMOs in the USA: science, law
and public health". Journal of the Science of Food and Agriculture.
96: 1851–1855. doi:10.1002/jsfa.7523. PMID 26536836. It is
therefore not surprising that efforts to require labeling and to ban
GMOs have been a growing political issue in the USA (citing Domingo
and Bordonaba, 2011).
Overall, a broad scientific consensus holds that currently marketed GM
food poses no greater risk than conventional food... Major national
and international science and medical associations have stated that no
adverse human health effects related to GMO food have been reported or
substantiated in peer-reviewed literature to date.
Despite various concerns, today, the American Association for the
Advancement of Science, the World Health Organization, and many
independent international science organizations agree that GMOs are
just as safe as other foods. Compared with conventional breeding
techniques, genetic engineering is far more precise and, in most
cases, less likely to create an unexpected outcome.
^ "Statement by the AAAS Board of Directors On Labeling of Genetically
Modified Foods" (PDF). American Association for the Advancement of
Science. 20 October 2012. Retrieved 8 February 2016. The EU, for
example, has invested more than €300 million in research on the
biosafety of GMOs. Its recent report states: "The main conclusion to
be drawn from the efforts of more than 130 research projects, covering
a period of more than 25 years of research and involving more than 500
independent research groups, is that biotechnology, and in particular
GMOs, are not per se more risky than e.g. conventional plant breeding
technologies." The World Health Organization, the American Medical
Association, the U.S. National Academy of Sciences, the British Royal
Society, and every other respected organization that has examined the
evidence has come to the same conclusion: consuming foods containing
ingredients derived from GM crops is no riskier than consuming the
same foods containing ingredients from crop plants modified by
conventional plant improvement techniques. Pinholster, Ginger (25
October 2012). "AAAS Board of Directors: Legally Mandating GM Food
Labels Could "Mislead and Falsely Alarm Consumers"". American
Association for the Advancement of Science. Retrieved 8 February
^ "A decade of EU-funded GMO research (2001–2010)" (PDF).
Directorate-General for Research and Innovation. Biotechnologies,
Agriculture, Food. European Commission, European Union. 2010.
doi:10.2777/97784. ISBN 978-92-79-16344-9. Retrieved 8 February
^ "AMA Report on Genetically Modified Crops and Foods (online
summary)". American Medical Association. January 2001. Retrieved 19
March 2016. A report issued by the scientific council of the American
Medical Association (AMA) says that no long-term health effects have
been detected from the use of transgenic crops and genetically
modified foods, and that these foods are substantially equivalent to
their conventional counterparts. (from online summary prepared by
ISAAA)" "Crops and foods produced using recombinant
have been available for fewer than 10 years and no long-term effects
have been detected to date. These foods are substantially equivalent
to their conventional counterparts. (from original report by AMA:
) "REPORT 2 OF THE COUNCIL ON SCIENCE AND PUBLIC HEALTH
(A-12): Labeling of Bioengineered Foods" (PDF). American Medical
Association. 2012. Archived from the original on 7 September 2012.
Retrieved 19 March 2016. Bioengineered foods have been consumed for
close to 20 years, and during that time, no overt consequences on
human health have been reported and/or substantiated in the
peer-reviewed literature. CS1 maint: BOT: original-url status
^ "Restrictions on Genetically Modified Organisms: United States.
Public and Scholarly Opinion". Library of Congress. 9 June 2015.
Retrieved 8 February 2016. Several scientific organizations in the US
have issued studies or statements regarding the safety of GMOs
indicating that there is no evidence that GMOs present unique safety
risks compared to conventionally bred products. These include the
National Research Council, the American Association for the
Advancement of Science, and the American Medical Association. Groups
in the US opposed to GMOs include some environmental organizations,
organic farming organizations, and consumer organizations. A
substantial number of legal academics have criticized the US's
approach to regulating GMOs.
^ "Genetically Engineered Crops: Experiences and Prospects". The
National Academies of Sciences, Engineering, and Medicine (US). 2016.
p. 149. Retrieved 19 May 2016. Overall finding on purported
adverse effects on human health of foods derived from GE crops: On the
basis of detailed examination of comparisons of currently
commercialized GE with non-GE foods in compositional analysis, acute
and chronic animal toxicity tests, long-term data on health of
livestock fed GE foods, and human epidemiological data, the committee
found no differences that implicate a higher risk to human health from
GE foods than from their non-GE counterparts.
^ "Frequently asked questions on genetically modified foods". World
Health Organization. Retrieved 8 February 2016. Different GM organisms
include different genes inserted in different ways. This means that
individual GM foods and their safety should be assessed on a
case-by-case basis and that it is not possible to make general
statements on the safety of all GM foods.
GM foods currently available on the international market have passed
safety assessments and are not likely to present risks for human
health. In addition, no effects on human health have been shown as a
result of the consumption of such foods by the general population in
the countries where they have been approved. Continuous application of
safety assessments based on the Codex Alimentarius principles and,
where appropriate, adequate post market monitoring, should form the
basis for ensuring the safety of GM foods.
^ Haslberger, Alexander G. (2003). "Codex guidelines for GM foods
include the analysis of unintended effects". Nature Biotechnology. 21:
739–741. doi:10.1038/nbt0703-739. PMID 12833088. These
principles dictate a case-by-case premarket assessment that includes
an evaluation of both direct and unintended effects.
^ Some medical organizations, including the British Medical
Association, advocate further caution based upon the precautionary
"Genetically modified foods and health: a second interim statement"
(PDF). British Medical Association. March 2004. Retrieved 21 March
2016. In our view, the potential for GM foods to cause harmful health
effects is very small and many of the concerns expressed apply with
equal vigour to conventionally derived foods. However, safety concerns
cannot, as yet, be dismissed completely on the basis of information
When seeking to optimise the balance between benefits and risks, it is
prudent to err on the side of caution and, above all, learn from
accumulating knowledge and experience. Any new technology such as
genetic modification must be examined for possible benefits and risks
to human health and the environment. As with all novel foods, safety
assessments in relation to GM foods must be made on a case-by-case
Members of the GM jury project were briefed on various aspects of
genetic modification by a diverse group of acknowledged experts in the
relevant subjects. The GM jury reached the conclusion that the sale of
GM foods currently available should be halted and the moratorium on
commercial growth of GM crops should be continued. These conclusions
were based on the precautionary principle and lack of evidence of any
benefit. The Jury expressed concern over the impact of GM crops on
farming, the environment, food safety and other potential health
The Royal Society review (2002) concluded that the risks to human
health associated with the use of specific viral
DNA sequences in GM
plants are negligible, and while calling for caution in the
introduction of potential allergens into food crops, stressed the
absence of evidence that commercially available GM foods cause
clinical allergic manifestations. The BMA shares the view that that
there is no robust evidence to prove that GM foods are unsafe but we
endorse the call for further research and surveillance to provide
convincing evidence of safety and benefit.
^ Funk, Cary; Rainie, Lee (29 January 2015). "Public and Scientists'
Views on Science and Society". Pew Research Center. Retrieved 24
February 2016. The largest differences between the public and the AAAS
scientists are found in beliefs about the safety of eating genetically
modified (GM) foods. Nearly nine-in-ten (88%) scientists say it is
generally safe to eat GM foods compared with 37% of the general
public, a difference of 51 percentage points.
^ Marris, Claire (2001). "Public views on GMOs: deconstructing the
myths". EMBO Reports. 2: 545–548. doi:10.1093/embo-reports/kve142.
PMC 1083956 . PMID 11463731.
^ Final Report of the PABE research project (December 2001). "Public
Perceptions of Agricultural Biotechnologies in Europe". Commission of
European Communities. Retrieved 24 February 2016.
^ Scott, Sydney E.; Inbar, Yoel; Rozin, Paul (2016). "Evidence for
Absolute Moral Opposition to Genetically Modified Food in the United
States" (PDF). Perspectives on Psychological Science. 11 (3):
315–324. doi:10.1177/1745691615621275. PMID 27217243.
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Morgan, Sally (1 January 2009). Superfoods: Genetic Modification of
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Smiley, Sophie (2005). Genetic Modification: Study Guide (Exploring
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Watson, James D. (2007). Recombinant DNA: Genes and Genomes: A Short
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