Biological engineering,
bioengineering, or bio-engineering is the application of
principles of biology and the tools of engineering to create usable,
tangible, economically-viable products. Biological engineering employs knowledge and expertise from a number of pure and applied sciences, such as mass and heat transfer, kinetics, biocatalysts, biomechanics, bioinformatics, separation and purification processes, bioreactor design, surface science, fluid mechanics, thermodynamics,
and polymer science. It is used in the design of medical devices,
diagnostic equipment, biocompatible materials, renewable bioenergy,
ecological engineering, agricultural engineering, and other areas that
improve the living standards of societies. Examples of bioengineering
research include bacteria engineered to produce chemicals, new medical imaging technology, portable and rapid disease diagnostic devices, prosthetics, biopharmaceuticals, and tissue-engineered organs. Bioengineering overlaps substantially with biotechnology and the biomedical sciences in a way analogous to how various other forms of engineering and technology relate to various other sciences (such as aerospace engineering and other space technology to kinetics and astrophysics).
In general, biological engineers (or biomedical engineers)
attempt to either mimic biological systems to create products or modify
and control biological systems so that they can replace, augment,
sustain, or predict chemical and mechanical processes. Bioengineers can apply their expertise to other applications of engineering and biotechnology,
including genetic modification of plants and microorganisms, bioprocess
engineering, and biocatalysis. Working with doctors, clinicians, and
researchers, bioengineers use traditional engineering principles and
techniques and apply them to real-world biological and medical problems.
History
Biological engineering is a science-based discipline founded upon the biological sciences in the same way that chemical engineering, electrical engineering, and mechanical engineering can be based upon chemistry, electricity and magnetism, and classical mechanics, respectively. And it has the same fundamental attention to cost-effectiveness as all branches of engineering do.
Before WWII, biological engineering had just begun being
recognized as a branch of engineering, and was a very new concept to
people. Post-WWII, it started to grow more rapidly, partially due to the
term "bioengineering" being coined by British scientist and broadcaster
Heinz Wolff
in 1954 at the National Institute for Medical Research. Wolff graduated
that same year and became the director of the Division of Biological
Engineering at the university. This was the first time Bioengineering
was recognized as its own branch at a university. Electrical engineering
is considered to pioneer this engineering sector due to its work with
medical devices and machinery during this time.
When engineers and life scientists started working together, they
recognized the problem that the engineers didn't know enough about the
actual biology behind their work. To resolve this problem, engineers who
wanted to get into biological engineering devoted more of their time
and studies to the details and processes that go into fields such as
biology, psychology, and medicine.
The term biological engineering may also be applied to environmental
modifications such as surface soil protection, slope stabilization,
watercourse and shoreline protection, windbreaks, vegetation barriers
including noise barriers and visual screens, and the ecological
enhancement of an area. Because other engineering disciplines also
address living organisms, the term biological engineering can be applied more broadly to include agricultural engineering.
The first biological engineering program was created at University of California, San Diego in 1966, making it the first biological engineering curriculum in the United States. More recent programs have been launched at MIT and Utah State University. Many old agricultural engineering departments in universities over the world have re-branded themselves as agricultural and biological engineering or agricultural and biosystems engineering, due to biological engineering as a whole being a rapidly developing field with fluid categorization. According to Professor Doug Lauffenburger of MIT,
biological engineering has a broad base which applies engineering
principles to an enormous range of size and complexities of systems.
These systems range from the molecular level (molecular biology, biochemistry, microbiology, pharmacology, protein chemistry, cytology, immunology, neurobiology and neuroscience)
to cellular and tissue-based systems (including devices and sensors),
to whole macroscopic organisms (plants, animals), and can even range up
to entire ecosystems.
Education
The average length of study is three to five years, and the completed degree is signified as a bachelor of engineering (B.S.
in engineering). Fundamental courses include thermodynamics,
bio-mechanics, biology, genetic engineering, fluid and mechanical
dynamics, kinetics, electronics, and materials properties.
Sub-disciplines
Modeling of the spread of disease using Cellular Automata and Nearest Neighbor Interactions
Depending on the institution and particular definitional boundaries
employed, some major branches of bioengineering may be categorized as
(note these may overlap):
Biomedical engineering: application of engineering principles and design concepts to medicine and biology for healthcare purposes.
Biochemical engineering:
fermentation engineering, application of engineering principles to
microscopic biological systems that are used to create new products by
synthesis, including the production of protein from suitable raw
materials.
Biological systems engineering: application of engineering principles and design concepts to agriculture, food sciences, and ecosystems.
Environmental health engineering:
application of engineering principles to the control of the environment
for the health, comfort, and safety of human beings. It includes the
field of life-support systems for the exploration of outer space and the
ocean.
Human-factors engineering: application of engineering, physiology,
and psychology to the optimization of the human–machine relationship.
Biotechnology: the use of living systems and organisms to develop or make products. (Ex: pharmaceuticals).
Biomimetics:
the imitation of models, systems, and elements of nature for the
purpose of solving complex human problems. (Ex: velcro, designed after George de Mestral noticed how easily burs stuck to a dog's hair).
Accreditation Board for Engineering and Technology (ABET),
the U.S.-based accreditation board for engineering B.S. programs, makes
a distinction between biomedical engineering and biological
engineering, though there is much overlap (see above).
American Institute for Medical and Biological Engineering
(AIMBE) is made up of 1,500 members. Their main goal is to educate the
public about the value biological engineering has in our world, as well
as invest in research and other programs to advance the field. They give
out awards to those dedicated to innovation in the field, and awards of
achievement in the field. (They do not have a direct contribution to
biological engineering, they more recognize those who do and encourage
the public to continue that forward movement).
Institute of Biological Engineering
(IBE) is a non-profit organization, they run on donations alone. They
aim to encourage the public to learn and to continue advancements in
biological engineering. (Like AIMBE, they do not perform research
directly; however, they offer scholarships to students who show promise
in the field).
Society for Biological Engineering (SBE) is a technological community associated with the American Institute of Chemical Engineers
(AIChE). SBE hosts international conferences, and is a global
organization of leading engineers and scientists dedicated to advancing
the integration of biology with engineering.
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 DNA is 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 generated by 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 US and Europe.
Genetic engineering:
Process of inserting new genetic information into existing cells in
order to modify a specific organism for the purpose of changing its
characteristics.
Overview
Comparison of conventional plant breeding with transgenic and cisgenic genetic modification
Genetic engineering is a process that alters the genetic structure of an organism by either removing or introducing DNA. Unlike traditional 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 delivers it to 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.
The 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. Such synthetic DNA as Artificially Expanded Genetic Information System and Hachimoji DNA is made in this new field.
Plants, animals or microorganisms 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 methods.
History
Humans have altered the genomes of species for thousands of years through selective breeding, or artificial selection as contrasted with natural selection. More recently, mutation breeding
has used exposure to chemicals or radiation to produce a high frequency
of random mutations, for selective breeding purposes. Genetic
engineering as the direct manipulation of DNA by 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 and 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.
In 1976 Genentech, the first genetic engineering company, was founded by Herbert Boyer and Robert Swanson and a year later the company produced a human protein (somatostatin) in E.coli. Genentech announced the production of genetically engineered human insulin in 1978. In 1980, the U.S. Supreme Court in the 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 trasher".
The first field trials of genetically engineered plants occurred in France and the US 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, the 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 US.
In 2009 11 transgenic crops were grown commercially in 25 countries,
the largest of which by area grown were the US, Brazil, Argentina,
India, Canada, China, Paraguay and South Africa.
In 2010, scientists at the 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 a 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 and 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.
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, transcriptomics 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
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.
Inserting DNA into the host genome
A gene gun uses biolistics to insert DNA into plant tissue
There are a number of techniques used to insert genetic material 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; up-taken DNA can either integrate with the genome or exist as extrachromosomal DNA. 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 viral vectors.
Plant genomes can be engineered by physical methods or by use of Agrobacterium for the delivery of sequences hosted in T-DNA binary vectors. In plants the DNA is often inserted using Agrobacterium-mediated transformation, 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.
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 transgenic plant.
Further testing using PCR, Southern hybridization, and DNA sequencing 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 analysis.
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-guideRNA system (adapted from CRISPR). TALEN and CRISPR are the two most commonly used and each has its own advantages. TALENs have greater target specificity, while 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 knockout.
Applications
Genetic
engineering has applications in medicine, research, industry and
agriculture and can be used on a wide range of plants, animals and
microorganisms. 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 milk.
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 illness.
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 DNA of non-viable human embryos, leading scientists of major world academies to call 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. In November 2018, He Jiankui announced that he had edited the genomes of two human embryos, to attempt to disable the CCR5 gene, which codes for a receptor that HIV
uses to enter cells. He said that twin girls, Lulu and Nana, had been
born a few weeks earlier. He said that the girls still carried
functional copies of CCR5 along with disabled CCR5 (mosaicism) and were still vulnerable to HIV. The work was widely condemned as unethical, dangerous, and premature.
Currently, germline modification is banned in 40 countries. Scientists
that do this type of research will often let embryos grow for a few days
without allowing it to develop into a baby.
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 looking to spread the genetically altered mosquitoes
throughout the mosquito population in the hopes of eliminating the
disease.
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, with the creation of transgenic organisms one of the most important tools for analysis of gene function.
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 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
redundancy.
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.
Industrial
Products of genetic engineering
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 easily recoverable.
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.
Bacteria have also been engineered to function as sensors by expressing
a fluorescent protein under certain environmental conditions.
The first crops to be released commercially on a large scale provided protection from insect pests or tolerance to herbicides. Fungal and virus resistant crops have also been developed or are in development. This makes 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 faster.
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.
Other applications
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 into practice.
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.
Regulation
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 the US established a committee at the Office of Science and Technology, which assigned regulatory approval of GM food to the USDA, FDA and 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 own regulations.
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 even though no GM products are yet produced
(Japan, South Korea). Most countries that do not allow GMO cultivation
do permit research.
Some of the most marked differences occurring between the US 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. The 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.
Office of Agricultural Genetic Engineering Biosafety Administration
India
Institutional Biosafety Committee, Review Committee on Genetic Manipulation and Genetic Engineering Approval Committee
Argentina
National Agricultural 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.
Brazil
National Biosafety Technical Commission (environmental and food
safety) and the Council of Ministers (commercial and economical issues)
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 US 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 labelled.
Controversy
Critics have objected to the use of genetic engineering on several
grounds, including ethical, ecological and economic concerns. Many of
these concerns involve GM crops and whether food produced from them is
safe 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 and 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 less likely than scientists to perceive GM foods as safe.
In popular culture
Genetic engineering features in many science fiction stories. Frank Herbert's novel The White Plague described the deliberate use of genetic engineering to create a pathogen which specifically killed women.Another of Herbert's creations, the Dune series of novels, uses genetic engineering to create the powerful but despised Tleilaxu. Films such as The Island and Blade Runner
bring the engineered creature to confront the person who created it or
the being it was cloned from. Few films have informed audiences about
genetic engineering, with the exception of the 1978 The Boys from Brazil and the 1993 Jurassic Park, both of which made use of a lesson, a demonstration, and a clip of scientific film.
Genetic engineering methods are weakly represented in film; Michael Clark, writing for The Wellcome Trust, calls the portrayal of genetic engineering and biotechnology "seriously distorted" in films such as The 6th Day.
In Clark's view, the biotechnology is typically "given fantastic but
visually arresting forms" while the science is either relegated to the
background or fictionalised to suit a young audience.
