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{{Short description|Manipulation of an organism's genome}}
{{About||a non-technical introduction to the topic of genetics|Introduction to genetics|the song by Orchestral Manoeuvres in the Dark|Genetic Engineering (song)|the Montreal hardcore band|Genetic Control}}
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{{Genetic engineering sidebar}}
'''Genetic engineering''', also called '''genetic modification''' or '''genetic manipulation''', is the modification and  manipulation of an organism's [[gene]]s using [[technology]]. It is a set of [[Genetic engineering techniques|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 [[Artificial gene synthesis|artificially synthesising]] the DNA. A [[Vector (molecular biology)|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 phage|lambda virus]]. As well as inserting [[gene]]s, the process can be used to remove, or "[[Gene knockout|knock out]]", genes. The new DNA can be inserted randomly, or [[Gene targeting|targeted]] to a specific part of the [[genome]].<ref>{{Cite web|title=Genetic Engineering|url=https://www.genome.gov/genetics-glossary/Genetic-Engineering|access-date=2022-02-20|website=Genome.gov|language=en}}</ref>

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 [[Genetically modified bacterium|bacterium]] generated by [[Herbert Boyer]] and [[Stanley Norman Cohen|Stanley Cohen]] in 1973. [[Rudolf Jaenisch]] created the first GM animal when he inserted foreign DNA into a [[Genetically modified mouse|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 [[AquAdvantage salmon|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 [[Model organism|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]].[[Chinese hamster ovary cell|Chinese hamster ovary (CHO) cells]] are used in industrial genetic engineering. Additionally [[MRNA vaccine|mRNA vaccines]] are made through genetic engineering to treat viruses such as [[COVID-19 vaccine|COVID-19]]. 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 [[Genetically modified food controversies|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, critics consider GM food safety a leading concern. [[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.

{{Quote box
| title = [[International Union of Pure and Applied Chemistry|IUPAC]] definition
| quote = '''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.

''Note'': Adapted from ref.<ref>{{cite web|website=U.S. Environmental Protection Agency online|title=Terms and Acronyms|url=http://www.epa.gov/OCEPAterms/gterms.html|access-date= 16 July 2015}}</ref><ref>{{cite journal | vauthors = Vert M, Doi Y, Hellwich KH, Hess M, Hodge P, Kubisa P, Rinaudo M, Schué F |title=Terminology for biorelated polymers and applications (IUPAC Recommendations 2012) |journal=[[Pure and Applied Chemistry]] |year=2012 |volume=84 |issue=2 |pages=377–410 |doi=10.1351/PAC-REC-10-12-04 |s2cid=98107080 |doi-access=free }}</ref>
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==Overview==

[[File:Breeding transgenesis cisgenesis.svg|thumb|Comparison of conventional plant breeding with [[transgenic]] and [[cisgenic]] genetic modification|upright=1.7]]

Genetic engineering is a process that alters the genetic structure of an organism by either removing or introducing [[DNA]], or modifying existing genetic material in situ. Unlike traditional [[animal breeding|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 [[Domain (biology)|domains]]) and prevents other undesirable genes from also being added.<ref>{{Cite web|url=https://royalsociety.org/topics-policy/projects/gm-plants/how-does-gm-differ-from-conventional-plant-breeding/|title=How does GM differ from conventional plant breeding?|website=royalsociety.org|language=en-gb|access-date=2017-11-14}}</ref>

Genetic engineering could potentially fix severe [[genetic disorder]]s in humans by replacing the defective gene with a functioning one.<ref>{{Cite book|title=Ethical Issues in Scientific Research: An Anthology |last1=Erwin |first1=Edward |last2=Gendin |first2=Sidney |last3=Kleiman |first3=Lowell | name-list-style = vanc |date=2015-12-22 |publisher=Routledge |isbn=978-1-134-81774-0 |page=338 }}</ref> It is an important tool in research that allows the function of specific genes to be studied.<ref>{{cite journal | vauthors = Alexander DR | title = Uses and abuses of genetic engineering | journal = Postgraduate Medical Journal | volume = 79 | issue = 931 | pages = 249–51 | date = May 2003 | pmid = 12782769 | pmc = 1742694 | doi = 10.1136/pmj.79.931.249 }}</ref> Drugs, vaccines and other products have been harvested from organisms engineered to produce them.<ref>{{cite journal | vauthors = Nielsen J | title = Production of biopharmaceutical proteins by yeast: advances through metabolic engineering | journal = Bioengineered | volume = 4 | issue = 4 | pages = 207–11 | date = 2013-07-01 | pmid = 23147168 | pmc = 3728191 | doi = 10.4161/bioe.22856 }}</ref> [[List of genetically modified crops|Crops]] have been developed that aid [[food security]] by increasing yield, nutritional value and tolerance to environmental stresses.<ref>{{cite journal | vauthors = Qaim M, Kouser S | title = Genetically modified crops and food security | journal = PLOS ONE | volume = 8 | issue = 6 | pages = e64879 | date = 2013-06-05 | pmid = 23755155 | pmc = 3674000 | doi = 10.1371/journal.pone.0064879 | bibcode = 2013PLoSO...864879Q | doi-access = free }}</ref>

The DNA can be introduced directly into the [[host organism]] or into a cell that is then [[Cell fusion|fused]] or [[Hybrid (biology)|hybridised]] with the host.<ref name="EU17">{{Cite periodical |title=Directive on the release of genetically modified organisms (GMOs) Directive 2001/18/EC ANNEX I A|periodical=Official Journal of the European Communities|date=12 March 2001|author=The European Parliament and the council of the European Union|url=https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32001L0018}}</ref> This relies on [[Recombinant DNA|recombinant nucleic acid]] techniques to form new combinations of heritable genetic material followed by the incorporation of that material either indirectly through a [[Vector (molecular biology)|vector]] system or directly through [[microinjection|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 acid|nucleic acids]] or a [[genetically modified organism]] in the process.<ref name="EU17" /> However, some broad definitions of genetic engineering include [[selective breeding]].<ref name=":2">{{cite web|url=http://ec.europa.eu/agriculture/publi/gmo/gmo.pdf |title=Economic Impacts of Genetically Modified Crops on the Agri-Food Sector; p. 42 Glossary – Term and Definitions |archive-url=https://web.archive.org/web/20130514202621/http://ec.europa.eu/agriculture/publi/gmo/gmo.pdf |archive-date=14 May 2013 |website=The European Commission Directorate-General for Agriculture |quote=Genetic engineering: The manipulation of an organism's genetic endowment by introducing or eliminating specific genes through modern molecular biology techniques. A broad definition of genetic engineering also includes selective breeding and other means of artificial selection}}</ref> [[Cloning]] and [[stem cell]] research, although not considered genetic engineering,<ref>{{cite web|title=Is Livestock Cloning Another Form of Genetic Engineering? |last=Van Eenennaam |first=Alison | name-list-style = vanc |publisher=agbiotech |url=http://agribiotech.info/details/Alison%20-%20cloning%20March%208%20-%2003.pdf |archive-url=https://web.archive.org/web/20110511121055/http://agribiotech.info/details/Alison%20-%20cloning%20March%208%20-%2003.pdf |archive-date=11 May 2011 }}</ref> are closely related and genetic engineering can be used within them.<ref>{{cite journal | vauthors = Suter DM, Dubois-Dauphin M, Krause KH | title = Genetic engineering of embryonic stem cells | journal = Swiss Medical Weekly | volume = 136 | issue = 27–28 | pages = 413–5 | date = July 2006 | doi = 10.4414/smw.2006.11406 | pmid = 16897894 | s2cid = 4945176 | url = http://www.smw.ch/docs/pdf200x/2006/27/smw-11406.PDF | archive-url = https://web.archive.org/web/20110707003215/http://www.smw.ch/docs/pdf200x/2006/27/smw-11406.PDF | archive-date = 7 July 2011 }}</ref> [[Synthetic biology]] is an emerging discipline that takes genetic engineering a step further by introducing artificially synthesised material into an organism.<ref>{{cite journal | vauthors = Andrianantoandro E, Basu S, Karig DK, Weiss R | title = Synthetic biology: new engineering rules for an emerging discipline | journal = Molecular Systems Biology | volume = 2 | issue = 2006.0028 | pages = 2006.0028 | date = 16 May 2006 | pmid = 16738572 | pmc = 1681505 | doi = 10.1038/msb4100073  }}</ref>

Plants, animals or microorganisms that have been changed through genetic engineering are termed [[genetically modified organism]]s or GMOs.<ref>{{cite web|url=http://www.csiro.au/Outcomes/Food-and-Agriculture/WhatIsGM.aspx|title=What is genetic modification (GM)?|publisher=[[CSIRO]]}}</ref> 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]].<ref>{{cite journal |doi=10.1007/s11540-008-9097-y |title=Cisgenesis, a New Tool for Traditional Plant Breeding, Should be Exempted from the Regulation on Genetically Modified Organisms in a Step by Step Approach |year=2008 | vauthors = Jacobsen E, Schouten HJ |journal=Potato Research |volume=51 |pages=75–88|s2cid=38742532 |url=http://library.wur.nl/WebQuery/wurpubs/fulltext/44813 }}</ref> If genetic engineering is used to remove genetic material from the target organism the resulting organism is termed a [[gene knockout|knockout]] organism.<ref>{{cite journal | vauthors = Capecchi MR | title = Generating mice with targeted mutations | journal = Nature Medicine | volume = 7 | issue = 10 | pages = 1086–90 | date = October 2001 | pmid = 11590420 | doi = 10.1038/nm1001-1086 | s2cid = 14710881 }}</ref> 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.<ref>Staff [http://www.usda.gov/wps/portal/usda/usdahome?contentid=BiotechnologyGlosary.xml&navid= Biotechnology – Glossary of Agricultural Biotechnology Terms] {{webarchive|url=https://web.archive.org/web/20140830102928/http://www.usda.gov/wps/portal/usda/usdahome?contentid=BiotechnologyGlosary.xml&navid= |date=30 August 2014 }} United States Department of Agriculture, "Genetic modification: The production of heritable improvements in plants or animals for specific uses, via either genetic engineering or other more traditional methods. Some countries other than the United States use this term to refer specifically to genetic engineering.", Retrieved 5 November 2012</ref><ref>{{cite web|title=Genetically Engineered Foods|first=James H. |last=Maryanski | name-list-style = vanc |publisher=Center for Food Safety and Applied Nutrition at the [[Food and Drug Administration]]|date=19 October 1999|url=https://www.fda.gov/NewsEvents/Testimony/ucm115032.htm}}</ref><ref>Staff (28 November 2005) [http://www.hc-sc.gc.ca/sr-sr/pubs/biotech/reg_gen_mod-eng.php Health Canada – The Regulation of Genetically Modified Food] {{Webarchive|url=https://web.archive.org/web/20170610170104/http://www.hc-sc.gc.ca/sr-sr/pubs/biotech/reg_gen_mod-eng.php |date=10 June 2017 }} Glossary definition of Genetically Modified: "An organism, such as a plant, animal or bacterium, is considered genetically modified if its genetic material has been altered through any method, including conventional breeding. A 'GMO' is a genetically modified organism.", Retrieved 5 November 2012</ref>

==History==
{{main|History of genetic engineering}}

Humans have altered the genomes of species for thousands of years through [[selective breeding]], or artificial selection<ref name=Root>{{cite book|title=Domestication|url={{google books |plainurl=y |id=WGDYHvOHwmwC}}|first=Clive |last=Root| name-list-style = vanc |year=2007|publisher=Greenwood Publishing Groups}}</ref>{{rp|1}}<ref name=Zohary>{{cite book |title=Domestication of Plants in the Old World: The origin and spread of plants in the old world|url={{google books |plainurl=y |id=tc6vr0qzk_4C}}|first1=Daniel |last1=Zohary |first2=Maria |last2=Hopf |first3=Ehud |last3=Weiss | name-list-style = vanc |year=2012|publisher=Oxford University Press}}</ref>{{rp|1}} 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 coined by the Russian-born geneticist [[Nikolay Timofeev-Ressovsky]] in his 1934 paper "The Experimental Production of Mutations", published in the British journal Biological Reviews.<ref>{{cite journal | vauthors = Timofeev-Ressovsky NW | title = The Experimental Production of Mutations | journal = Biological Reviews | volume = 9 | issue = 4 | pages = 411–457 | date = October 1934 | doi = 10.1111/j.1469-185X.1934.tb01255.x | s2cid = 86396986 | url = https://archive.org/details/in.ernet.dli.2015.26044/page/n449}}</ref> [[Jack Williamson]] used the term in his science fiction novel Dragon's Island, published in 1951<ref>{{cite book|last=Stableford|first=Brian M.| name-list-style = vanc |title=Historical dictionary of science fiction literature|page=133|year=2004|publisher=Scarecrow Press |isbn=978-0-8108-4938-9|url={{google books |plainurl=y |id=nzmIPZg5xicC|page=9}}}}</ref> – one year before DNA's role in [[heredity]] was confirmed by [[Alfred Hershey]] and [[Martha Chase]],<ref>{{cite journal | vauthors = Hershey AD, Chase M | title = Independent functions of viral protein and nucleic acid in growth of bacteriophage | journal = The Journal of General Physiology | volume = 36 | issue = 1 | pages = 39–56 | date = May 1952 | pmid = 12981234 | pmc = 2147348 | doi = 10.1085/jgp.36.1.39 }}</ref> and two years before [[James D. Watson|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''.<ref>{{cite encyclopedia|url=http://www.sf-encyclopedia.com/entry/genetic_engineering|title=Genetic Engineering|date=2 April 2015|encyclopedia=Encyclopedia of Science Fiction}}</ref><ref>{{Cite book|url=https://books.google.com/books?id=WJrvj0pOJx0C&pg=PA164 |title=Modern Concepts in Nanotechnology, Volume 5|year=2008|isbn=978-81-8356-296-6|publisher=Discovery Publishing House |author=Shiv Kant Prasad |author2=Ajay Dash}}</ref>

[[File:Jaenisch 2003 by Sam Ogden.jpg|thumb|upright|In 1974 [[Rudolf Jaenisch]] created a [[genetically modified mouse]], the first GM animal.]]

In 1972, [[Paul Berg]] created the first [[recombinant DNA]] molecules by combining DNA from the monkey virus [[SV40]] with that of the [[Lambda phage|lambda virus]].<ref>{{cite journal | vauthors = Jackson DA, Symons RH, Berg P | title = Biochemical method for inserting new genetic information into DNA of Simian Virus 40: circular SV40 DNA molecules containing lambda phage genes and the galactose operon of Escherichia coli | journal = Proceedings of the National Academy of Sciences of the United States of America | volume = 69 | issue = 10 | pages = 2904–9 | date = October 1972 | pmid = 4342968 | pmc = 389671 | doi = 10.1073/pnas.69.10.2904 | first8 = David A. Jackson Robert H. Symons and Paul Berg | bibcode = 1972PNAS...69.2904J | doi-access = free }}</ref> In 1973 [[Herbert Boyer]] and [[Stanley Norman Cohen|Stanley Cohen]] created the first [[transgenic organism]] by inserting [[Antibiotic resistance#Applications|antibiotic resistance genes]] into the [[plasmid]] of an ''[[Escherichia coli]]'' bacterium.<ref>{{cite web|title=History of Genetics: Genetic Engineering Timeline|last=Arnold|first=Paul| name-list-style = vanc |year=2009|url=http://www.brighthub.com/science/genetics/articles/21983.aspx}}</ref><ref>{{cite journal | vauthors = Gutschi S, Hermann W, Stenzl W, Tscheliessnigg KH | title = [Displacement of electrodes in pacemaker patients (author's transl)] | journal = Zentralblatt für Chirurgie | volume = 104 | issue = 2 | pages = 100–4 | date = 1 May 1973  | pmid = 433482}}</ref> A year later [[Rudolf Jaenisch]] created a [[transgenic mouse]] by introducing foreign DNA into its embryo, making it the world's first [[transgenic animal]]<ref name="pmid4364530">{{cite journal | vauthors = Jaenisch R, Mintz B | title = Simian virus 40 DNA sequences in DNA of healthy adult mice derived from preimplantation blastocysts injected with viral DNA | journal = Proceedings of the National Academy of Sciences of the United States of America | volume = 71 | issue = 4 | pages = 1250–4 | date = April 1974 | pmid = 4364530 | pmc = 388203 | doi = 10.1073/pnas.71.4.1250| bibcode = 1974PNAS...71.1250J | doi-access = free }}</ref> 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 on Recombinant DNA|Asilomar Conference]] in 1975. One of the main recommendations from this meeting was that government oversight of recombinant DNA research should be established until the technology was deemed safe.<ref name="ReferenceA">{{cite journal | vauthors = Berg P, Baltimore D, Brenner S, Roblin RO, Singer MF | title = Summary statement of the Asilomar conference on recombinant DNA molecules | journal = Proceedings of the National Academy of Sciences of the United States of America | volume = 72 | issue = 6 | pages = 1981–4 | date = June 1975 | pmid = 806076 | pmc = 432675 | doi = 10.1073/pnas.72.6.1981 | bibcode = 1975PNAS...72.1981B | doi-access = free }}</ref><ref>{{cite web | title = NIH Guidelines for research involving recombinant DNA molecules | work = Office of Biotechnology Activities | publisher = U.S. Department of Health and Human Services | url = http://oba.od.nih.gov/rdna/nih_guidelines_oba.html | archive-url = https://web.archive.org/web/20120910070047/http://oba.od.nih.gov/rdna/nih_guidelines_oba.html | archive-date = 10 September 2012 }}</ref>

In 1976 Genentech, the first genetic engineering company, was founded by Herbert Boyer and [[Robert A. Swanson|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.<ref name=":0">{{cite journal | vauthors = Goeddel DV, Kleid DG, Bolivar F, Heyneker HL, Yansura DG, Crea R, Hirose T, Kraszewski A, Itakura K, Riggs AD | title = Expression in Escherichia coli of chemically synthesized genes for human insulin | journal = Proceedings of the National Academy of Sciences of the United States of America | volume = 76 | issue = 1 | pages = 106–10 | date = January 1979 | pmid = 85300 | pmc = 382885 | doi = 10.1073/pnas.76.1.106 | bibcode = 1979PNAS...76..106G | doi-access = free }}</ref> In 1980, the [[U.S. Supreme Court]] in the ''[[Diamond v. Chakrabarty]]'' case ruled that genetically altered life could be patented.<ref>{{cite web |url=http://supreme.justia.com/us/447/303/case.html |title=Diamond V Chakrabarty|volume=447|author=US Supreme Court Cases from Justia & Oyez|website=Justia |date=16 June 1980 |access-date=17 July 2010 |issue=303}}</ref> The [[Insulin (medication)|insulin]] produced by bacteria was approved for release by the [[Food and Drug Administration]] (FDA) in 1982.<ref>{{cite magazine|url=http://www.time.com/time/magazine/article/0,9171,949646-1,00.html |archive-url=https://web.archive.org/web/20111027011602/http://www.time.com/time/magazine/article/0,9171,949646-1,00.html |archive-date=27 October 2011 |title=Artificial Genes |magazine=[[Time (magazine)|Time]] |date=15 November 1982 |access-date=17 July 2010}}</ref>

In 1983, a biotech company, Advanced Genetic Sciences (AGS) applied for U.S. government authorisation to perform field tests with the [[Ice-minus bacteria|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.<ref>{{cite journal | last1 = Bratspies | first1 = Rebecca | name-list-style = vanc | year = 2007 | title = Some Thoughts on the American Approach to Regulating Genetically Modified Organisms | ssrn = 1017832 | journal = Kansas Journal of Law & Public Policy | volume = 16 | issue = 3 | pages = 101–31 }}</ref> In 1987, the ice-minus strain of ''P. syringae'' became the first [[genetically modified organism]] (GMO) to be released into the environment<ref name=BBC2002>{{Cite news|date=2002-06-14|title=GM crops: A bitter harvest?|language=en-GB|url=http://news.bbc.co.uk/2/hi/science/nature/2045286.stm|access-date=2023-03-30}}</ref> when a strawberry field and a potato field in California were sprayed with it.<ref>{{cite news |last=Maugh |first=Thomas H. II |date=9 June 1987 |url=http://articles.latimes.com/1987-06-09/news/mn-6024_1_frost-damage |title=Altered Bacterium Does Its Job: Frost Failed to Damage Sprayed Test Crop, Company Says |work=[[Los Angeles Times]]}}</ref> 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".<ref name=BBC2002 />

The first field trials of [[transgenic plants|genetically engineered plants]] occurred in France and the US in 1986, tobacco plants were engineered to be resistant to [[herbicide]]s.<ref>{{cite web |last=James |first=Clive | name-list-style = vanc |title=Global Review of the Field Testing and Commercialization of Transgenic Plants: 1986 to 1995 |url=http://www.isaaa.org/kc/Publications/pdfs/isaaabriefs/Briefs%201.pdf |archive-url=https://web.archive.org/web/20100616175626/http://isaaa.org/kc/Publications/pdfs/isaaabriefs/Briefs%201.pdf |archive-date=2010-06-16 |url-status=live |publisher=The International Service for the Acquisition of Agri-biotech Applications|access-date=17 July 2010 |year=1996}}</ref> The People's Republic of China was the first country to commercialise transgenic plants, introducing a virus-resistant tobacco in 1992.<ref name="James1997">{{cite journal|last=James |first=Clive | name-list-style = vanc |year=1997 |title=Global Status of Transgenic Crops in 1997 |journal=ISAAA Briefs No. 5. |page=31 |url=http://www.isaaa.org/resources/publications/briefs/05/download/isaaa-brief-05-1997.pdf |archive-url=https://web.archive.org/web/20090116155014/http://www.isaaa.org/Resources/Publications/briefs/05/download/isaaa-brief-05-1997.pdf |archive-date=2009-01-16 |url-status=live}}</ref> In 1994 [[Monsanto#Spin-offs and mergers|Calgene]] attained approval to commercially release the first [[genetically modified food]], the [[Flavr Savr]], a tomato engineered to have a longer shelf life.<ref>{{cite journal |doi=10.3733/ca.v054n04p6 |title=The case of the FLAVR SAVR tomato |year=2000 | vauthors = Bruening G, Lyons JM |journal=California Agriculture |volume=54 |issue=4 |pages=6–7|doi-access=free }}</ref> 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.<ref>{{cite magazine|title=Transgenic tobacco is European first|date=18 June 1994 |last=MacKenzie |first=Debora | name-list-style = vanc |url=https://www.newscientist.com/article/mg14219301.100-transgenic-tobacco-is-european-first.html|magazine=[[New Scientist]]}}</ref> In 1995, [[Genetically modified potato#NewLeaf|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.<ref>{{Cite web|title=Lawrence Journal-World - Google News Archive Search|url=https://news.google.com/newspapers?nid=2199&dat=19950506&id=A0YyAAAAIBAJ&sjid=jOYFAAAAIBAJ&pg=4631,1776980&hl=en|access-date=2023-03-30|website=news.google.com}}</ref> 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.<ref>{{Cite web|title=Executive Summary: Global Status of Commercialized Biotech/GM Crops: 2009 - ISAAA Brief 41-2009 &#124; ISAAA.org|url=https://www.isaaa.org/resources/publications/briefs/41/executivesummary/default.asp|access-date=2023-03-30|website=www.isaaa.org}}</ref>

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 (biology)|replicate]] and produce proteins.<ref>{{cite journal | vauthors = Pennisi E | author-link = Elizabeth Pennisi | title = Genomics. Synthetic genome brings new life to bacterium | journal = Science | volume = 328 | issue = 5981 | pages = 958–9 | date = May 2010 | pmid = 20488994 | doi = 10.1126/science.328.5981.958 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Gibson DG, Glass JI, Lartigue C, Noskov VN, Chuang RY, Algire MA, Benders GA, Montague MG, Ma L, Moodie MM, Merryman C, Vashee S, Krishnakumar R, Assad-Garcia N, Andrews-Pfannkoch C, Denisova EA, Young L, Qi ZQ, Segall-Shapiro TH, Calvey CH, Parmar PP, Hutchison CA, Smith HO, Venter JC | display-authors = 6 | title = Creation of a bacterial cell controlled by a chemically synthesized genome | journal = Science | volume = 329 | issue = 5987 | pages = 52–6 | date = July 2010 | pmid = 20488990 | doi = 10.1126/science.1190719 | bibcode = 2010Sci...329...52G | citeseerx = 10.1.1.167.1455 | s2cid = 7320517 }}</ref> 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.<ref>{{cite journal | vauthors = Malyshev DA, Dhami K, Lavergne T, Chen T, Dai N, Foster JM, Corrêa IR, Romesberg FE | title = A semi-synthetic organism with an expanded genetic alphabet | journal = Nature | volume = 509 | issue = 7500 | pages = 385–8 | date = May 2014 | pmid = 24805238 | pmc = 4058825 | doi = 10.1038/nature13314 | bibcode = 2014Natur.509..385M }}</ref><ref>{{cite journal | vauthors = Thyer R, Ellefson J | s2cid = 4399670 | title = Synthetic biology: New letters for life's alphabet | journal = Nature | volume = 509 | issue = 7500 | pages = 291–2 | date = May 2014 | pmid = 24805244 | doi = 10.1038/nature13335 | bibcode = 2014Natur.509..291T | doi-access = free }}</ref> In 2012, [[Jennifer Doudna]] and [[Emmanuelle Charpentier]] collaborated to develop the [[CRISPR|CRISPR/Cas9]] system,<ref>{{Cite news |url=https://www.nytimes.com/2015/05/12/science/jennifer-doudna-crispr-cas9-genetic-engineering.html |archive-url=https://ghostarchive.org/archive/20220102/https://www.nytimes.com/2015/05/12/science/jennifer-doudna-crispr-cas9-genetic-engineering.html |archive-date=2022-01-02 |url-access=limited |url-status=live |title=Jennifer Doudna, a Pioneer Who Helped Simplify Genome Editing|last=Pollack|first=Andrew | name-list-style = vanc |date=2015-05-11 |work=[[The New York Times]] |access-date=2017-11-15}}{{cbignore}}</ref><ref>{{cite journal | vauthors = Jinek M, Chylinski K, Fonfara I, Hauer M, Doudna JA, Charpentier E | title = A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity | journal = Science | volume = 337 | issue = 6096 | pages = 816–21 | date = August 2012 | pmid = 22745249 | pmc = 6286148 | doi = 10.1126/science.1225829 | bibcode = 2012Sci...337..816J }}</ref> a technique which can be used to easily and specifically alter the genome of almost any organism.<ref>{{cite journal | vauthors = Ledford H | title = CRISPR: gene editing is just the beginning | journal = Nature | volume = 531 | issue = 7593 | pages = 156–9 | date = March 2016 | pmid = 26961639 | doi = 10.1038/531156a | bibcode = 2016Natur.531..156L | doi-access = free }}</ref>

==Process==
{{main|Genetic engineering techniques}}
[[File:Master Mix with Primers form PCR.jpg|thumb|upright|[[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 screen]]s can be carried out to determine potential genes and further tests then used to identify the best candidates. The development of [[DNA microarray|microarrays]], [[transcriptomics]] and [[Whole genome sequencing|genome sequencing]] has made it much easier to find suitable genes.<ref>{{Cite book|url=https://books.google.com/books?id=jWJ1CgAAQBAJ&pg=PA242|title=Current Technologies in Plant Molecular Breeding: A Guide Book of Plant Molecular Breeding for Researchers|last1=Koh|first1=Hee-Jong|last2=Kwon|first2=Suk-Yoon|last3=Thomson|first3=Michael| name-list-style = vanc |date=2015-08-26|publisher=Springer|isbn=978-94-017-9996-6|page=242|language=en}}</ref> Luck also plays its part; the [[Roundup Ready]] gene was discovered after scientists noticed a bacterium thriving in the presence of the herbicide.<ref>{{Cite news|url=http://sitn.hms.harvard.edu/flash/2015/how-to-make-a-gmo/|title=How to Make a GMO|date=2015-08-09|work=Science in the News|access-date=2017-04-29|language=en-US}}</ref>

=== Gene isolation and cloning ===
{{Main|Molecular cloning}}
The next step is to isolate the candidate gene. The [[Cell (biology)|cell]] containing the gene is opened and the DNA is purified.<ref>{{Cite book|url=https://books.google.com/books?id=g1v6WMHVkTgC|title=An Introduction to Genetic Engineering|last=Nicholl|first=Desmond S.T.|date=2008-05-29|publisher=Cambridge University Press|isbn=978-1-139-47178-7|page=34|language=en}}</ref> The gene is separated by using [[restriction enzymes]] to cut the DNA into fragments<ref>{{cite book |vauthors=Alberts B, Johnson A, Lewis J, etal |chapter= Isolating, Cloning, and Sequencing DNA |title=Molecular Biology of the Cell |edition= 4th |location=New York|publisher=Garland Science|year= 2002 |chapter-url=https://www.ncbi.nlm.nih.gov/books/NBK26837/ |isbn=0-8153-3218-1}}</ref> or [[polymerase chain reaction]] (PCR) to amplify up the gene segment.<ref>{{cite journal | vauthors = Kaufman RI, Nixon BT | title = Use of PCR to isolate genes encoding sigma54-dependent activators from diverse bacteria | journal = Journal of Bacteriology | volume = 178 | issue = 13 | pages = 3967–70 | date = July 1996 | pmid = 8682806 | pmc = 232662 | doi = 10.1128/jb.178.13.3967-3970.1996 }}</ref> 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 [[Library (biology)|genetic library]]. If the [[DNA sequence]] is known, but no copies of the gene are available, it can also be [[Gene synthesis|artificially synthesised]].<ref>{{cite journal | vauthors = Liang J, Luo Y, Zhao H | title = Synthetic biology: putting synthesis into biology | journal = Wiley Interdisciplinary Reviews: Systems Biology and Medicine | volume = 3 | issue = 1 | pages = 7–20 | year = 2011 | pmid = 21064036 | pmc = 3057768 | doi = 10.1002/wsbm.104 }}</ref> Once isolated the gene is [[Ligation (molecular biology)|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.<ref>{{Cite web|url=http://www.fao.org/docrep/006/y4955e/y4955e06.htm|title=5. The Process of Genetic Modification|website=www.fao.org|access-date=2017-04-29}}</ref> The [[RK2 plasmid]] is notable for its ability to replicate in a wide variety of [[single-celled organism]]s, which makes it suitable as a genetic engineering tool.<ref>J M Blatny, T Brautaset, C H Winther-Larsen, K Haugan and S Valla: "Construction and use of a versatile set of broad-host-range cloning and expression vectors based on the RK2 replicon", ''Appl. Environ. Microbiol.'' 1997, Volume 63, Issue 2, p. 370</ref>

Before the gene is inserted into the target organism it must be combined with other genetic elements. These include a [[Promoter (biology)|promoter]] and [[Terminator (genetics)|terminator]] region, which initiate and end [[Transcription (genetics)|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 digest]]s, ligations and molecular cloning.<ref>{{cite journal | vauthors = Berg P, Mertz JE | title = Personal reflections on the origins and emergence of recombinant DNA technology | journal = Genetics | volume = 184 | issue = 1 | pages = 9–17 | date = January 2010 | pmid = 20061565 | pmc = 2815933 | doi = 10.1534/genetics.109.112144 }}</ref>

===Inserting DNA into the host genome===
{{Main|Gene delivery}}
[[File:Genegun.jpg|left|thumb|upright|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 [[Competence (biology)|take up foreign DNA]]. This ability can be induced in other bacteria via stress (e.g. [[heat shock|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 [[Cell nucleus|nucleus]], or through the use of [[viral vectors]].<ref>{{cite journal | vauthors = Chen I, Dubnau D | title = DNA uptake during bacterial transformation | journal = Nature Reviews. Microbiology | volume = 2 | issue = 3 | pages = 241–9 | date = March 2004 | pmid = 15083159 | doi = 10.1038/nrmicro844 | s2cid = 205499369 }}</ref>

Plant genomes can be engineered by physical methods or by use of ''[[Agrobacterium]]'' for the delivery of sequences hosted in [[Transfer DNA binary system|T-DNA binary vectors]]. In plants the DNA is often inserted using [[Agrobacterium#Uses in biotechnology|''Agrobacterium''-mediated transformation]],<ref>{{Cite book|url=https://www.ncbi.nlm.nih.gov/books/NBK215771/|title=Methods and Mechanisms for Genetic Manipulation of Plants, Animals, and Microorganisms| author =National Research Council (US) Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health |date=2004-01-01|publisher=National Academies Press (US)|language=en}}</ref> taking advantage of the ''Agrobacterium''s [[Transfer DNA|T-DNA]] sequence that allows natural insertion of genetic material into plant cells.<ref>{{cite journal | vauthors = Gelvin SB | title = Agrobacterium-mediated plant transformation: the biology behind the "gene-jockeying" tool | journal = Microbiology and Molecular Biology Reviews | volume = 67 | issue = 1 | pages = 16–37, table of contents | date = March 2003 | pmid = 12626681 | pmc = 150518 | doi = 10.1128/MMBR.67.1.16-37.2003 }}</ref> Other methods include [[biolistics]], where particles of gold or tungsten are coated with DNA and then shot into young plant cells,<ref>{{cite book |first1=Graham |last1=Head |last2=Hull |first2=Roger H |last3=Tzotzos |first3=George T. | name-list-style = vanc |title=Genetically Modified Plants: Assessing Safety and Managing Risk |url=https://archive.org/details/geneticallymodif00hull |url-access=limited |publisher=Academic Pr |location=London |year=2009 |page=[https://archive.org/details/geneticallymodif00hull/page/n254 244] |isbn=978-0-12-374106-6 }}</ref> 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 [[Regeneration (biology)|regenerated]] from that single cell. In plants this is accomplished through the use of [[Plant tissue culture|tissue culture]].<ref>{{cite journal | vauthors = Tuomela M, Stanescu I, Krohn K | title = Validation overview of bio-analytical methods | journal = Gene Therapy | volume = 12 Suppl 1 | issue = S1 | pages = S131-8 | date = October 2005 | pmid = 16231045 | doi = 10.1038/sj.gt.3302627 | s2cid = 23000818 | doi-access =  }}</ref><ref>{{Cite book|url=https://books.google.com/books?id=-M4lR-pxqJMC|title=Plant Cell and Tissue Culture|last=Narayanaswamy|first=S.|date=1994|publisher=Tata McGraw-Hill Education|isbn=978-0-07-460277-5|page=vi|language=en}}</ref> In animals it is necessary to ensure that the inserted DNA is present in the [[embryonic stem cells]].<ref>{{Cite book|url=https://www.ncbi.nlm.nih.gov/books/NBK215771/|title=Methods and Mechanisms for Genetic Manipulation of Plants, Animals, and Microorganisms| author =National Research Council (US) Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health |date=2004|publisher=National Academies Press (US)|language=en}}</ref> 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.<ref>{{cite journal | vauthors = Hohn B, Levy AA, Puchta H | title = Elimination of selection markers from transgenic plants | journal = Current Opinion in Biotechnology | volume = 12 | issue = 2 | pages = 139–43 | date = April 2001 | pmid = 11287227 | doi = 10.1016/S0958-1669(00)00188-9 }}</ref>

[[File:Agrobacterium-tumefaciens.png|thumb|upright|''[[A. tumefaciens]]'' attaching itself to a carrot cell]]

Further testing using PCR, [[Southern hybridization]], and [[DNA sequencing]] is conducted to confirm that an organism contains the new gene.<ref>{{Cite book|url=https://books.google.com/books?id=aGkXFmqOcyIC|title=Genetic Engineering: Principles and Methods|last=Setlow|first=Jane K. | name-list-style = vanc |date=2002-10-31|publisher=Springer Science & Business Media|isbn=978-0-306-47280-0|page=109|language=en}}</ref> 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 [[Gene expression|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 hybridization|northern hybridisation]], quantitative [[RT-PCR]], [[Western blot]], [[immunofluorescence]], [[ELISA]] and phenotypic analysis.<ref>{{cite journal | vauthors = Deepak S, Kottapalli K, Rakwal R, Oros G, Rangappa K, Iwahashi H, Masuo Y, Agrawal G | title = Real-Time PCR: Revolutionizing Detection and Expression Analysis of Genes | journal = Current Genomics | volume = 8 | issue = 4 | pages = 234–51 | date = June 2007 | pmid = 18645596 | pmc = 2430684 | doi = 10.2174/138920207781386960 }}</ref>

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 [[nuclease]]s that create specific [[double-strand breaks|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|nonhomologous end-joining]]. There are four families of engineered nucleases: [[meganuclease]]s,<ref>{{cite journal | vauthors = Grizot S, Smith J, Daboussi F, Prieto J, Redondo P, Merino N, Villate M, Thomas S, Lemaire L, Montoya G, Blanco FJ, Pâques F, Duchateau P | title = Efficient targeting of a SCID gene by an engineered single-chain homing endonuclease | journal = Nucleic Acids Research | volume = 37 | issue = 16 | pages = 5405–19 | date = September 2009 | pmid = 19584299 | pmc = 2760784 | doi = 10.1093/nar/gkp548 }}</ref><ref>{{cite journal | vauthors = Gao H, Smith J, Yang M, Jones S, Djukanovic V, Nicholson MG, West A, Bidney D, Falco SC, Jantz D, Lyznik LA | title = Heritable targeted mutagenesis in maize using a designed endonuclease | journal = The Plant Journal | volume = 61 | issue = 1 | pages = 176–87 | date = January 2010 | pmid = 19811621 | doi = 10.1111/j.1365-313X.2009.04041.x | doi-access =  }}</ref> [[zinc finger nuclease]]s,<ref>{{cite journal | vauthors = Townsend JA, Wright DA, Winfrey RJ, Fu F, Maeder ML, Joung JK, Voytas DF | title = High-frequency modification of plant genes using engineered zinc-finger nucleases | journal = Nature | volume = 459 | issue = 7245 | pages = 442–5 | date = May 2009 | pmid = 19404258 | pmc = 2743854 | doi = 10.1038/nature07845 | bibcode = 2009Natur.459..442T }}</ref><ref>{{cite journal | vauthors = Shukla VK, Doyon Y, Miller JC, DeKelver RC, Moehle EA, Worden SE, Mitchell JC, Arnold NL, Gopalan S, Meng X, Choi VM, Rock JM, Wu YY, Katibah GE, Zhifang G, McCaskill D, Simpson MA, Blakeslee B, Greenwalt SA, Butler HJ, Hinkley SJ, Zhang L, Rebar EJ, Gregory PD, Urnov FD | title = Precise genome modification in the crop species Zea mays using zinc-finger nucleases | journal = Nature | volume = 459 | issue = 7245 | pages = 437–41 | date = May 2009 | pmid = 19404259 | doi = 10.1038/nature07992 | bibcode = 2009Natur.459..437S | s2cid = 4323298 }}</ref> [[transcription activator-like effector nuclease]]s (TALENs),<ref>{{cite journal | vauthors = Christian M, Cermak T, Doyle EL, Schmidt C, Zhang F, Hummel A, Bogdanove AJ, Voytas DF | title = Targeting DNA double-strand breaks with TAL effector nucleases | journal = Genetics | volume = 186 | issue = 2 | pages = 757–61 | date = October 2010 | pmid = 20660643 | pmc = 2942870 | doi = 10.1534/genetics.110.120717 }}</ref><ref>{{cite journal | vauthors = Li T, Huang S, Jiang WZ, Wright D, Spalding MH, Weeks DP, Yang B | title = TAL nucleases (TALNs): hybrid proteins composed of TAL effectors and FokI DNA-cleavage domain | journal = Nucleic Acids Research | volume = 39 | issue = 1 | pages = 359–72 | date = January 2011 | pmid = 20699274 | pmc = 3017587 | doi = 10.1093/nar/gkq704 }}</ref> and the Cas9-guideRNA system (adapted from [[CRISPR gene editing|CRISPR]]).<ref>{{cite journal | vauthors = Esvelt KM, Wang HH | title = Genome-scale engineering for systems and synthetic biology | journal = Molecular Systems Biology | volume = 9 | page = 641 | year = 2013 | pmid = 23340847 | pmc = 3564264 | doi = 10.1038/msb.2012.66 }}</ref><ref>{{cite book | vauthors = Tan WS, Carlson DF, Walton MW, Fahrenkrug SC, Hackett PB | chapter = Precision editing of large animal genomes | volume = 80 | pages = 37–97 | year = 2012 | pmid = 23084873 | pmc = 3683964 | doi = 10.1016/B978-0-12-404742-6.00002-8 | isbn = 978-0-12-404742-6 | title = Advances in Genetics Volume 80 }}</ref> TALEN and CRISPR are the two most commonly used and each has its own advantages.<ref name=":5">{{cite journal | vauthors = Malzahn A, Lowder L, Qi Y | title = Plant genome editing with TALEN and CRISPR | journal = Cell & Bioscience | volume = 7 | page = 21 | date = 2017-04-24 | pmid = 28451378 | pmc = 5404292 | doi = 10.1186/s13578-017-0148-4 | doi-access = free }}</ref> TALENs have greater target specificity, while CRISPR is easier to design and more efficient.<ref name=":5" /> In addition to enhancing gene targeting, engineered nucleases can be used to introduce mutations at endogenous genes that generate a [[gene knockout]].<ref>{{cite journal | vauthors = Ekker SC | title = Zinc finger-based knockout punches for zebrafish genes | journal = Zebrafish | volume = 5 | issue = 2 | pages = 121–3 | year = 2008 | pmid = 18554175 | pmc = 2849655 | doi = 10.1089/zeb.2008.9988 }}</ref><ref>{{cite journal | vauthors = Geurts AM, Cost GJ, Freyvert Y, Zeitler B, Miller JC, Choi VM, Jenkins SS, Wood A, Cui X, Meng X, Vincent A, Lam S, Michalkiewicz M, Schilling R, Foeckler J, Kalloway S, Weiler H, Ménoret S, Anegon I, Davis GD, Zhang L, Rebar EJ, Gregory PD, Urnov FD, Jacob HJ, Buelow R | title = Knockout rats via embryo microinjection of zinc-finger nucleases | journal = Science | volume = 325 | issue = 5939 | page = 433 | date = July 2009 | pmid = 19628861 | pmc = 2831805 | doi = 10.1126/science.1172447 | bibcode = 2009Sci...325..433G }}</ref>

== 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 [[Enzyme substrate (biology)|substrates]].<ref>{{cite web|url=http://www.learner.org/courses/biology/textbook/gmo/gmo_2.html|title=Genetic Modification of Bacteria|publisher=[[Annenberg Foundation]]|access-date=4 October 2012|archive-date=24 December 2013|archive-url=https://web.archive.org/web/20131224110848/http://www.learner.org/courses/biology/textbook/gmo/gmo_2.html}}</ref><ref>Panesar, Pamit et al. (2010) "Enzymes in Food Processing: Fundamentals and Potential Applications", Chapter 10, I K International Publishing House, {{ISBN|978-93-80026-33-6}}</ref> Plants have been modified for insect protection, [[herbicide resistance]], virus resistance, enhanced nutrition, tolerance to environmental pressures and the production of [[edible vaccines]].<ref>{{cite web|url=http://www.isaaa.org/gmapprovaldatabase/gmtraitslist/default.asp|title=GM traits list|publisher=International Service for the Acquisition of Agri-Biotech Applications}}</ref> Most commercialised GMOs are insect resistant or herbicide tolerant crop plants.<ref>{{cite web|url=http://www.isaaa.org/resources/publications/briefs/43/executivesummary/default.asp|title=ISAAA Brief 43-2011: Executive Summary|publisher=International Service for the Acquisition of Agri-Biotech Applications}}</ref> 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 [[knock-out mice|genes knocked out]], [[oncomouse|increased susceptibility to disease]], hormones for extra growth and the ability to express proteins in their milk.<ref>{{cite news|url=https://www.independent.co.uk/news/science/the-mouse-that-shook-the-world-744870.html|title=The mouse that shook the world|last=Connor|first=Steve| name-list-style = vanc |date=2 November 2007|newspaper=The Independent}}</ref>

=== Medicine ===

Genetic engineering has many applications to medicine that include the manufacturing of drugs, creation of [[Model organism|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.<ref name=":0" /> This application has now been applied to human [[growth hormone]]s, [[Follicle-stimulating hormone|follicle stimulating hormones]] (for treating infertility), [[Albumin human|human albumin]], [[monoclonal antibodies]], [[antihemophilic factor]]s, [[vaccine]]s and many other drugs.<ref>{{cite book|url={{google books |plainurl=y |id=gR8cWf2-UY4C}}|title=The hope, hype & reality of genetic engineering: remarkable stories from agriculture, industry, medicine, and the environment|last=Avise|first=John C.| name-list-style = vanc |publisher=Oxford University Press US|year=2004|isbn=978-0-19-516950-8|page=22}}</ref><ref>{{cite news|date=10 December 2012|title=Engineering algae to make complex anti-cancer 'designer' drug|url=http://phys.org/news/2012-12-algae-complex-anti-cancer-drug.html|work=PhysOrg|access-date=15 April 2013}}</ref> Mouse [[Hybridoma technology|hybridomas]], cells fused together to create [[monoclonal antibodies]], have been adapted through genetic engineering to create human monoclonal antibodies.<ref>{{cite journal | vauthors = Roque AC, Lowe CR, Taipa MA | title = Antibodies and genetically engineered related molecules: production and purification | journal = Biotechnology Progress | volume = 20 | issue = 3 | pages = 639–54 | year = 2004 | pmid = 15176864 | doi = 10.1021/bp030070k | s2cid = 23142893 }}</ref> [[Genetically engineered virus]]es are being developed that can still confer immunity, but lack the [[Infectious Disease|infectious]] [[DNA sequence|sequences]].<ref>{{cite journal | vauthors = Rodriguez LL, Grubman MJ | title = Foot and mouth disease virus vaccines | journal = Vaccine | volume = 27 | pages = D90-4 | date = November 2009 | issue = Suppl 4 | pmid = 19837296 | doi = 10.1016/j.vaccine.2009.08.039 }}</ref>

Genetic engineering is also used to create animal models of human diseases. [[Genetically modified mouse|Genetically modified mice]] are the most common genetically engineered animal model.<ref>{{cite web|url=http://www.geneticsandsociety.org/article.php?id=386|title=Background: Cloned and Genetically Modified Animals|date=14 April 2005|publisher=Center for Genetics and Society|access-date=9 July 2010|archive-url=https://web.archive.org/web/20161123110939/http://geneticsandsociety.org/article.php?id=386|archive-date=23 November 2016}}</ref> They have been used to study and model cancer (the [[oncomouse]]), obesity, heart disease, diabetes, arthritis, substance abuse, anxiety, aging and Parkinson disease.<ref>{{cite web|url=http://www.genome.gov/12514551|title=Knockout Mice|year=2009|publisher=Nation Human Genome Research Institute}}</ref> Potential cures can be tested against these mouse models. 

Gene therapy is the [[Human genetic engineering|genetic engineering of humans]], generally by replacing defective genes with effective ones. [[Clinical research]] using [[Somatic (biology)|somatic]] gene therapy has been conducted with several diseases, including [[X-linked severe combined immunodeficiency|X-linked SCID]],<ref>{{cite journal | vauthors = Fischer A, Hacein-Bey-Abina S, Cavazzana-Calvo M | title = 20 years of gene therapy for SCID | journal = Nature Immunology | volume = 11 | issue = 6 | pages = 457–60 | date = June 2010 | pmid = 20485269 | doi = 10.1038/ni0610-457 | s2cid = 11300348 }}</ref> [[chronic lymphocytic leukemia]] (CLL),<ref name="Porter">{{cite journal |doi=10.1038/news.2011.472 |title=Cell therapy fights leukaemia |year=2011 |last1=Ledford |first1=Heidi | name-list-style = vanc |journal=Nature }}</ref><ref>{{cite journal | vauthors = Brentjens RJ, Davila ML, Riviere I, Park J, Wang X, Cowell LG, Bartido S, Stefanski J, Taylor C, Olszewska M, Borquez-Ojeda O, Qu J, Wasielewska T, He Q, Bernal Y, Rijo IV, Hedvat C, Kobos R, Curran K, Steinherz P, Jurcic J, Rosenblat T, Maslak P, Frattini M, Sadelain M | display-authors = 6 | title = CD19-targeted T cells rapidly induce molecular remissions in adults with chemotherapy-refractory acute lymphoblastic leukemia | journal = Science Translational Medicine | volume = 5 | issue = 177 | pages = 177ra38 | date = March 2013 | pmid = 23515080 | pmc = 3742551 | doi = 10.1126/scitranslmed.3005930 }}</ref> and [[Parkinson's disease]].<ref>{{cite journal | vauthors = LeWitt PA, Rezai AR, Leehey MA, Ojemann SG, Flaherty AW, Eskandar EN, Kostyk SK, Thomas K, Sarkar A, Siddiqui MS, Tatter SB, Schwalb JM, Poston KL, Henderson JM, Kurlan RM, Richard IH, Van Meter L, Sapan CV, During MJ, Kaplitt MG, Feigin A | display-authors = 6 | title = AAV2-GAD gene therapy for advanced Parkinson's disease: a double-blind, sham-surgery controlled, randomised trial | journal = The Lancet. Neurology | volume = 10 | issue = 4 | pages = 309–19 | date = April 2011 | pmid = 21419704 | doi = 10.1016/S1474-4422(11)70039-4 | s2cid = 37154043 }}</ref> In 2012, [[Alipogene tiparvovec]] became the first gene therapy treatment to be approved for clinical use.<ref name="Gallagher">{{Cite news|date=2012-11-02|title=Gene therapy: Glybera approved by European Commission|language=en-GB|work=BBC News|url=https://www.bbc.com/news/health-20179561|access-date=2023-03-30}}</ref><ref name="Richards2012">{{cite web|last=Richards|first=Sabrina| name-list-style = vanc |title=Gene Therapy Arrives in Europe|url=http://www.the-scientist.com/?articles.view/articleNo/33166/title/Gene-Therapy-Arrives-in-Europe/|publisher=The Scientist|access-date=16 November 2012}}</ref> 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.<ref>{{Cite news|url=https://www.npr.org/2017/11/08/562647401/genetically-altered-skin-saves-a-boy-dying-of-a-rare-disease?sc=tw|title=Genetically Altered Skin Saves A Boy Dying of a Rare Disease|work=NPR.org|access-date=2017-11-15|language=en}}</ref>

[[Germline]] gene therapy would result in any change being inheritable, which has raised concerns within the scientific community.<ref>{{cite web|url=http://www.cioms.ch/frame_1990_texts_of_guidelines.htm |title=1990 The Declaration of Inuyama |date=5 August 2001 |url-status=bot: unknown |archive-url=https://web.archive.org/web/20010805085535/http://www.cioms.ch/frame_1990_texts_of_guidelines.htm |archive-date=5 August 2001 }}</ref><ref>{{cite journal | vauthors = Smith KR, Chan S, Harris J | title = Human germline genetic modification: scientific and bioethical perspectives | journal = Archives of Medical Research | volume = 43 | issue = 7 | pages = 491–513 | date = October 2012 | pmid = 23072719 | doi = 10.1016/j.arcmed.2012.09.003 }}</ref> In 2015, CRISPR was used to edit the DNA of non-viable [[human embryos]],<ref name="NYT-20150423">{{cite news |last=Kolata |first=Gina | name-list-style = vanc |title=Chinese Scientists Edit Genes of Human Embryos, Raising Concerns |url=https://www.nytimes.com/2015/04/24/health/chinese-scientists-edit-genes-of-human-embryos-raising-concerns.html |archive-url=https://ghostarchive.org/archive/20220102/https://www.nytimes.com/2015/04/24/health/chinese-scientists-edit-genes-of-human-embryos-raising-concerns.html |archive-date=2022-01-02 |url-access=limited |url-status=live |date=23 April 2015 |work=The New York Times |access-date=24 April 2015 }}{{cbignore}}</ref><ref name="PC-20150418">{{cite journal | vauthors = Liang P, Xu Y, Zhang X, Ding C, Huang R, Zhang Z, Lv J, Xie X, Chen Y, Li Y, Sun Y, Bai Y, Songyang Z, Ma W, Zhou C, Huang J | display-authors = 6 | title = CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes | journal = Protein & Cell | volume = 6 | issue = 5 | pages = 363–372 | date = May 2015 | pmid = 25894090 | pmc = 4417674 | doi = 10.1007/s13238-015-0153-5 }}</ref> leading scientists of major world academies to call for a moratorium on inheritable human genome edits.<ref name="NYT-20151203-nw">{{cite news |last=Wade |first=Nicholas | name-list-style = vanc |author-link=Nicholas Wade |title=Scientists Place Moratorium on Edits to Human Genome That Could Be Inherited |url=https://www.nytimes.com/2015/12/04/science/crispr-cas9-human-genome-editing-moratorium.html |archive-url=https://ghostarchive.org/archive/20220102/https://www.nytimes.com/2015/12/04/science/crispr-cas9-human-genome-editing-moratorium.html |archive-date=2022-01-02 |url-access=limited |url-status=live |date=3 December 2015 |work=The New York Times |access-date=3 December 2015 }}{{cbignore}}</ref> 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.<ref>{{cite web|title=The Ethics of Gene Therapy|first=Emilie R. |last=Bergeson| name-list-style = vanc |year=1997|url=http://www.ndsu.edu/pubweb/~mcclean/plsc431/students/bergeson.htm}}</ref> The distinction between cure and enhancement can also be difficult to establish.<ref>{{cite web|first=Kathi E. |last=Hanna| name-list-style = vanc |url=http://www.genome.gov/10004767|publisher=National Human Genome Research Institute|title=Genetic Enhancement}}</ref> In November 2018, [[He Jiankui]] announced that he had [[Genome editing|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. The work was widely condemned as unethical, dangerous, and premature.<ref>{{cite news |last1=Begley |first1=Sharon | name-list-style = vanc |title=Amid uproar, Chinese scientist defends creating gene-edited babies – STAT |url=https://www.statnews.com/2018/11/28/chinese-scientist-defends-creating-gene-edited-babies/ |work=STAT |date=28 November 2018}}</ref> 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.<ref>{{cite journal |last1=Li |first1=Emily |title=Diagnostic Value of Spiral CT Chest Enhanced Scan |journal=Journal of Clinical and Nursing Research |date=July 31, 2020 |url=http://scholar.googleusercontent.com/scholar?q=cache:h6ILNa11QgIJ:scholar.google.com/+%E2%80%8BLi,+E.+(2020).+Risks+of+CRISPR+Gene+Editing+and+An+Answer+to+Them.+%E2%80%8BJournal+of+Clinical+and+Nursing+Research,%E2%80%8B+%E2%80%8B4(%E2%80%8B+4).&hl=en&as_sdt=0,21}}</ref>

Researchers are altering the genome of pigs to induce the growth of human organs, with the aim of increasing the success of [[Xenotransplantation|pig to human organ transplantation]].<ref name="Medical News Today">{{cite news|date=21 September 2003|title=GM pigs best bet for organ transplant|work=Medical News Today|url=http://www.medicalnewstoday.com/articles/4344.php|access-date=9 July 2010|archive-date=10 May 2011|archive-url=https://web.archive.org/web/20110510121726/http://www.medicalnewstoday.com/articles/4344.php}}</ref> 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.<ref>{{Cite news|url=https://www.nytimes.com/2015/11/27/us/2015-11-27-us-animal-gene-editing.html |archive-url=https://ghostarchive.org/archive/20220102/https://www.nytimes.com/2015/11/27/us/2015-11-27-us-animal-gene-editing.html |archive-date=2022-01-02 |url-access=limited |url-status=live|title=Open Season Is Seen in Gene Editing of Animals|last=Harmon|first=Amy| name-list-style = vanc |date=2015-11-26|work=The New York Times|access-date=2017-09-27|language=en-US|issn=0362-4331}}{{cbignore}}</ref>

=== Research ===

[[File:PCWmice1.jpg|thumb|[[Knockout mouse|Knockout mice]]]]

[[File:Expression of Human Wild-Type and P239S Mutant Palladin.png|thumb|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.<ref>{{cite book | vauthors = Praitis V, Maduro MF | title = Caenorhabditis elegans: Molecular Genetics and Development | chapter = Transgenesis in C. elegans | series = Methods in Cell Biology | volume = 106 | pages = 161–85 | date = 2011 | pmid = 22118277 | doi = 10.1016/B978-0-12-544172-8.00006-2 | isbn = 978-0-12-544172-8 }}</ref> 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, [[Clone (cell biology)|clonal]], multiply quickly, relatively easy to transform and can be stored at -80&nbsp;°C almost indefinitely. Once a gene is isolated it can be stored inside the bacteria providing an unlimited supply for research.<ref>{{Cite web|url=https://www.learner.org/courses/biology/textbook/gmo/gmo_2.html|title=Rediscovering Biology – Online Textbook: Unit 13 Genetically Modified Organisms|website=www.learner.org|access-date=2017-08-18|archive-date=3 December 2019|archive-url=https://web.archive.org/web/20191203123559/http://www.learner.org/courses/biology/textbook/gmo/gmo_2.html}}</ref>

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 [[blastocyst]]s, 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]].<ref name=":3">{{Cite book |last1=Alberts |first1=Bruce |last2=Johnson |first2=Alexander |last3=Lewis |first3=Julian |last4=Raff |first4=Martin |last5=Roberts |first5=Keith |last6=Walter |first6=Peter | name-list-style =  vanc |date=2002 |chapter=Studying Gene Expression and Function|url=https://www.ncbi.nlm.nih.gov/books/NBK26818/ |title=Molecular Biology of the Cell |edition=4th |location=New York|publisher=Garland Science |isbn=0-8153-3218-1}}</ref> 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]].<ref>{{Cite book|url=https://books.google.com/books?id=ycVoWFqDTmAC&pg=PA94|title=Protein Engineering and Design|last1=Park|first1=Sheldon J.|last2=Cochran|first2=Jennifer R.| name-list-style = vanc |date=2009-09-25|publisher=CRC Press|isbn=978-1-4200-7659-2|language=en}}</ref>
* '''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 is required, especially when dealing with genetic or functional redundancy.<ref name=":3" />
* '''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.<ref name=":3" />
* '''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 (biology)|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]].<ref>{{Cite book|url=https://books.google.com/books?id=ed4_CQAAQBAJ&pg=PA114 |title=Techniques in Genetic Engineering|last=Kurnaz|first=Isil Aksan| name-list-style = vanc |date=2015-05-08|publisher=CRC Press|isbn=978-1-4822-6090-8 }}</ref>

=== Industrial ===
{{Main|Industrial microbiology}}
[[File:Applications of combinatorial gene circuit optimization strategies.svg|thumb|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 [[Protein expression (biotechnology)|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 [[Protein purification|purifying]] the protein.<ref>{{cite web|title=Applications of Genetic Engineering |publisher=Microbiologyprocedure |url=http://www.microbiologyprocedure.com/microbial-genetics/applications-of-genetic-engineering.htm |access-date=9 July 2010 |archive-url=https://web.archive.org/web/20110714085807/http://www.microbiologyprocedure.com/microbial-genetics/applications-of-genetic-engineering.htm |archive-date=14 July 2011 }}</ref> Some genes do not work well in bacteria, so yeast, insect cells or mammalian cells can also be used.<ref>{{cite web|title=Biotech: What are transgenic organisms? |publisher=Easyscience |year=2002 |url=http://www.easyscience.co.nz/ubbiology/biotech/lesson4.htm |access-date=9 July 2010 |archive-url=https://web.archive.org/web/20100527060202/http://www.easyscience.co.nz/ubbiology/biotech/lesson4.htm |archive-date=27 May 2010 }}</ref> These techniques are used to produce medicines such as [[insulin]], [[human growth hormone]], and [[vaccine]]s, supplements such as [[tryptophan]], aid in the production of food ([[chymosin]] in cheese making) and fuels.<ref>{{cite magazine|title=Making Gasoline from Bacteria: A biotech startup wants to coax fuels from engineered microbes|first=Neil|last=Savage|name-list-style=vanc|date=1 August 2007|url=http://www.technologyreview.com/biztech/19128/|magazine=[[MIT Technology Review]]|access-date=16 July 2015|archive-date=9 April 2020|archive-url=https://web.archive.org/web/20200409015344/https://www.technologyreview.com/biztech/19128/}}</ref> Other applications with genetically engineered bacteria could involve making them perform tasks outside their natural cycle, such as making [[biofuel]]s,<ref>{{cite web | last = Summers | first = Rebecca | name-list-style = vanc | date = 24 April 2013 | url = https://www.newscientist.com/article/dn23431-bacteria-churn-out-first-ever-petrollike-biofuel.html | title = Bacteria churn out first ever petrol-like biofuel | work = New Scientist | access-date = 27 April 2013 }}</ref> cleaning up oil spills, carbon and other toxic waste<ref>{{cite web|title=Applications of Some Genetically Engineered Bacteria |url=http://www.molecular-plant-biotechnology.info/use-of-microbes-in-industry-and-agriculture/applications-of-genetically-engineered-bacteria.htm |access-date=9 July 2010 |archive-url=https://web.archive.org/web/20101127053814/http://molecular-plant-biotechnology.info/use-of-microbes-in-industry-and-agriculture/applications-of-genetically-engineered-bacteria.htm |archive-date=27 November 2010 }}</ref> and detecting arsenic in drinking water.<ref>{{cite web | last = Sanderson | first = Katherine | name-list-style = vanc | date = 24 February 2012 | url = http://cen.acs.org/articles/90/web/2012/02/New-Portable-Kit-Detects-Arsenic.html | title = New Portable Kit Detects Arsenic in Wells | work = Chemical and Engineering News | access-date = 23 January 2013 }}</ref> 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.<ref>{{Cite book|title = Campbell Biology Ninth Edition|last1 = Reece|first1 = Jane B.|first2 = Lisa A.|last2 = Urry|last3 = Cain|first3 = Michael L.|last4 = Wasserman|first4 = Steven A.|last5 = Minorsky|first5 = Peter V.|last6 = Jackson|first6 = Robert B.|name-list-style = vanc|publisher = Pearson Benjamin Cummings|year = 2011|isbn = 978-0-321-55823-7|location = San Francisco|page = [https://archive.org/details/campbellbiologyj00reec/page/421 421]|url = https://archive.org/details/campbellbiologyj00reec/page/421}}</ref>

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]].<ref>{{cite web|url=http://web.mit.edu/newsoffice/2009/virus-battery-0402.html |title= New virus-built battery could power cars, electronic devices |publisher=Web.mit.edu |date=2 April 2009 |access-date=17 July 2010}}</ref><ref>{{cite news|url=https://www.npr.org/templates/story/story.php?storyId=102647672 |title=Hidden Ingredient in New, Greener Battery: A Virus |newspaper=Npr.org |access-date=17 July 2010}}</ref> Bacteria have also been engineered to function as sensors by expressing a fluorescent protein under certain environmental conditions.<ref>{{cite web|title=Researchers Synchronize Blinking 'Genetic Clocks' – Genetically Engineered Bacteria That Keep Track of Time|website=ScienceDaily|date=24 January 2010|url=https://www.sciencedaily.com/releases/2010/01/100120131157.htm}}</ref>

===Agriculture===

{{Main|Genetically modified crops|Genetically modified food}}

[[File:Bt plants.png|thumb|upright|Bt-toxins present in [[peanut]] leaves (bottom image) protect it from extensive damage caused by [[lesser cornstalk borer]] [[larva]]e (top image).<ref>{{cite web |last=Suszkiw |first=Jan | name-list-style = vanc |url=http://ars.usda.gov/is/ar/archive/nov99/pest1199.htm |title=Tifton, Georgia: A Peanut Pest Showdown |access-date=23 November 2008 |work= [[Agricultural Research Service|Agricultural Research]] |date=November 1999}}</ref>]]

One of the best-known and [[Genetically modified food controversies|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 stress]]es, alter the composition of the food, or to produce novel products.<ref>{{cite journal | vauthors = Magaña-Gómez JA, de la Barca AM | title = Risk assessment of genetically modified crops for nutrition and health | journal = Nutrition Reviews | volume = 67 | issue = 1 | pages = 1–16 | date = January 2009 | pmid = 19146501 | doi = 10.1111/j.1753-4887.2008.00130.x | doi-access = free }}</ref>

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.<ref>{{cite journal |doi=10.3329/ptcb.v16i2.1113 |title=Fungus Resistant Transgenic Plants: Strategies, Progress and Lessons Learnt |year=2008 |last1=Islam |first1=Aparna | name-list-style = vanc |journal=Plant Tissue Culture and Biotechnology |volume=16 |issue=2 |pages=117–38|doi-access=free }}</ref><ref>{{cite web|title=Disease resistant crops|publisher=GMO Compass|url=http://www.gmo-compass.org/eng/agri_biotechnology/breeding_aims/148.disease_resistant_crops.html|archive-url=https://web.archive.org/web/20100603215011/http://www.gmo-compass.org/eng/agri_biotechnology/breeding_aims/148.disease_resistant_crops.html|archive-date=3 June 2010}}</ref> This makes the insect and weed management of crops easier and can indirectly increase crop yield.<ref>{{cite journal |doi=10.1111/j.1744-7348.2004.tb00376.x |title=First impact of biotechnology in the EU: Bt maize adoption in Spain |year=2004 | vauthors = Demont M, Tollens E |journal=Annals of Applied Biology |volume=145 |issue=2 |pages=197–207}}</ref><ref name="Biodiversity">{{cite book |url=https://archive.org/details/sustaininglifeho00eric|title=Sustaining Life |last1=Chivian|first1=Eric|last2=Bernstein|first2=Aaron | name-list-style = vanc |publisher=Oxford University Press, Inc|year=2008|isbn=978-0-19-517509-7 |url-access=registration}}<!--|access-date=12 September 2009 --></ref> 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.<ref name="Deborah B. Whitman 2000" /> In 2016 [[AquAdvantage salmon|Salmon]] have been genetically modified with growth hormones to reach normal adult size much faster.<ref name="Genetically Engineered Salmon">{{cite news|url=https://www.nytimes.com/2015/11/20/business/genetically-engineered-salmon-approved-for-consumption.html?_r=0|title=Genetically Engineered Salmon Approved for Consumption|date=19 November 2015|work=The New York Times|last1=Pollack|first1=Andrew| name-list-style = vanc |access-date=21 April 2016}}</ref>

GMOs have been developed that modify the quality of produce by increasing the nutritional value or providing more industrially useful qualities or quantities.<ref name="Deborah B. Whitman 2000">{{cite web|title=Genetically Modified Foods: Harmful or Helpful?|year=2000|first=Deborah B.|last=Whitman|name-list-style=vanc|url=http://www.csa.com/discoveryguides/gmfood/overview.php|access-date=9 July 2010|archive-date=16 February 2015|archive-url=https://web.archive.org/web/20150216145707/http://www.csa.com/discoveryguides/gmfood/overview.php}}</ref> The [[Amflora]] potato produces a more industrially useful blend of starches. [[Genetically modified soybean|Soybeans]] and [[Genetically modified canola|canola]] have been genetically modified to produce more healthy oils.<ref>Rapeseed (canola) has been genetically engineered to modify its oil content with a gene encoding a "12:0 thioesterase" (TE) enzyme from the California bay plant ([[Umbellularia californica]]) to increase medium length fatty acids, see: [http://www.geo-pie.cornell.edu/traits/altoil.html Geo-pie.cornell.edu] {{webarchive|url=https://web.archive.org/web/20090705230132/http://www.geo-pie.cornell.edu/traits/altoil.html |date=5 July 2009 }}</ref><ref>{{cite journal | vauthors = Bomgardner MM | year = 2012 | title = Replacing Trans Fat: New crops from Dow Chemical and DuPont target food makers looking for stable, heart-healthy oils | url = http://cen.acs.org/articles/90/i11/Replacing-Trans-Fat.html | journal = Chemical and Engineering News | volume = 90 | issue = 11| pages = 30–32 | doi = 10.1021/cen-09011-bus1 }}</ref> The first commercialised GM food was a [[Flavr Savr|tomato]] that had delayed ripening, increasing its [[shelf life]].<ref>{{Cite journal|last1=Kramer|first1=Matthew G.|last2=Redenbaugh|first2=Keith| name-list-style = vanc |date=1994-01-01|title=Commercialization of a tomato with an antisense polygalacturonase gene: The FLAVR SAVR™ tomato story|journal=Euphytica|language=en|volume=79|issue=3|pages=293–97|doi=10.1007/BF00022530|s2cid=45071333|issn=0014-2336}}</ref>

Plants and animals have been engineered to produce materials they do not normally make.  [[Pharming (genetics)|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.<ref>{{cite journal |doi=10.1051/agro:2007050 |title=Pharmaceutical crops in California, benefits and risks. A review |year=2008 |last1=Marvier |first1=Michelle | name-list-style = vanc |journal=Agronomy for Sustainable Development |volume=28 |issue=1 |pages=1–9|s2cid=29538486 |url=https://hal.archives-ouvertes.fr/hal-00886450/file/hal-00886450.pdf |archive-url=https://web.archive.org/web/20180719040330/https://hal.archives-ouvertes.fr/hal-00886450/file/hal-00886450.pdf |archive-date=2018-07-19 |url-status=live }}</ref> 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.<ref>{{cite web|url=https://www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm190728.htm|title=FDA Approves First Human Biologic Produced by GE Animals|publisher=US Food and Drug Administration}}</ref><ref>{{cite web|title=GM cow milk 'could provide treatment for blood disease'|first=Paulo |last=Rebêlo| name-list-style = vanc |date=15 July 2004|publisher=SciDev|url=http://www.scidev.net/en/news/gm-cow-milk-could-provide-treatment-for-blood-dis.html}}</ref>

=== Other applications ===
Genetic engineering has potential applications in conservation and natural area management. Gene transfer through [[viral vector]]s has been proposed as a means of controlling invasive species as well as vaccinating threatened fauna from disease.<ref>{{cite journal | vauthors = Angulo E, Cooke B | title = First synthesize new viruses then regulate their release? The case of the wild rabbit | journal = Molecular Ecology | volume = 11 | issue = 12 | pages = 2703–9 | date = December 2002 | pmid = 12453252 | doi = 10.1046/j.1365-294X.2002.01635.x | bibcode = 2002MolEc..11.2703A | hdl = 10261/45541 | s2cid = 23916432 | hdl-access = free }}</ref> Transgenic trees have been suggested as a way to confer resistance to pathogens in wild populations.<ref>{{Cite journal| vauthors = Adams JM, Piovesan G, Strauss S, Brown S |date=2 August 2002|title=The Case for Genetic Engineering of Native and Landscape Trees against Introduced Pests and Diseases |journal=Conservation Biology |volume=16 |issue=4|pages=874–79|doi=10.1046/j.1523-1739.2002.00523.x  |bibcode=2002ConBi..16..874A |s2cid=86697592}}</ref> 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.<ref>{{cite journal | vauthors = Thomas MA, Roemer GW, Donlan CJ, Dickson BG, Matocq M, Malaney J | title = Ecology: Gene tweaking for conservation | journal = Nature | volume = 501 | issue = 7468 | pages = 485–6 | date = September 2013 | pmid = 24073449 | doi = 10.1038/501485a | doi-access = free }}</ref> 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]].<ref>{{cite web|title=Bio-artists bridge gap between arts, sciences: Use of living organisms is attracting attention and controversy|first=Jessica M. |last=Pasko| name-list-style = vanc |publisher=msnbc|url=http://www.nbcnews.com/id/17387568|date=2007-03-04}}</ref> Some bacteria have been genetically engineered to create black and white photographs.<ref>{{cite web|title=Genetically Modified Bacteria Produce Living Photographs|first=Joab |last=Jackson| name-list-style = vanc |publisher=National Geographic News|date=6 December 2005|url=http://news.nationalgeographic.com/news/2005/12/1206_051206_bacteria_photos.html|archive-url=https://web.archive.org/web/20051216101532/http://news.nationalgeographic.com/news/2005/12/1206_051206_bacteria_photos.html|url-status=dead|archive-date=16 December 2005}}</ref> Novelty items such as lavender-colored [[Dianthus caryophyllus#Colors|carnations]],<ref name="physorg">{{Cite web|title=Plant gene replacement results in the world's only blue rose|url=https://phys.org/news/2005-04-gene-results-world-blue-rose.html|access-date=2023-03-30|website=phys.org|language=en}}</ref> [[blue rose]]s,<ref>{{cite journal | vauthors = Katsumoto Y, Fukuchi-Mizutani M, Fukui Y, Brugliera F, Holton TA, Karan M, Nakamura N, Yonekura-Sakakibara K, Togami J, Pigeaire A, Tao GQ, Nehra NS, Lu CY, Dyson BK, Tsuda S, Ashikari T, Kusumi T, Mason JG, Tanaka Y | title = Engineering of the rose flavonoid biosynthetic pathway successfully generated blue-hued flowers accumulating delphinidin | journal = Plant & Cell Physiology | volume = 48 | issue = 11 | pages = 1589–600 | date = November 2007 | pmid = 17925311 | doi = 10.1093/pcp/pcm131 | citeseerx = 10.1.1.319.8365 }}</ref> and [[GloFish|glowing fish]]<ref>{{Cite web|title=WIPO - Search International and National Patent Collections|url=https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2000049150|access-date=2023-03-30|website=patentscope.wipo.int}}</ref><ref>{{cite journal | vauthors = Stewart CN | title = Go with the glow: fluorescent proteins to light transgenic organisms | journal = Trends in Biotechnology | volume = 24 | issue = 4 | pages = 155–62 | date = April 2006 | pmid = 16488034 | doi = 10.1016/j.tibtech.2006.02.002 | url = http://plantsciences.utk.edu/pdf/stewart-TIBTECH-FPs-2006.pdf | access-date = 25 October 2017 | archive-date = 3 July 2010 | archive-url = https://web.archive.org/web/20100703194009/http://plantsciences.utk.edu/pdf/stewart-TIBTECH-FPs-2006.pdf }}</ref> have also been produced through genetic engineering.

==Regulation==

{{main|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 Conference Grounds|Asilomar]], California.<ref>{{cite journal | vauthors = Berg P, Baltimore D, Boyer HW, Cohen SN, Davis RW, Hogness DS, Nathans D, Roblin R, Watson JD, Weissman S, Zinder ND | title = Letter: Potential biohazards of recombinant DNA molecules | journal = Science | volume = 185 | issue = 4148 | page = 303 | date = July 1974 | pmid = 4600381 | pmc = 388511 | doi = 10.1126/science.185.4148.303 | url = http://beck2.med.harvard.edu/week13/The%20Science%20Letter.pdf | bibcode = 1974Sci...185..303B | access-date = 3 May 2017 | archive-date = 12 August 2011 | archive-url = https://web.archive.org/web/20110812073943/http://beck2.med.harvard.edu/week13/The%20Science%20Letter.pdf | url-status = dead }}</ref> The [[Asilomar conference on recombinant DNA|Asilomar meeting]] recommended a set of voluntary guidelines regarding the use of recombinant technology.<ref name="ReferenceA"/> As the technology improved the US established a committee at the [[Office of Science and Technology Policy|Office of Science and Technology]],<ref name="McHughen2007">{{cite journal | vauthors = McHughen A, Smyth S | title = US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars | journal = Plant Biotechnology Journal | volume = 6 | issue = 1 | pages = 2–12 | date = January 2008 | pmid = 17956539 | doi = 10.1111/j.1467-7652.2007.00300.x | doi-access = free }}</ref> which assigned regulatory approval of GM food to the USDA, FDA and EPA.<ref name=":7">{{cite journal | title = Coordinated framework for regulation of biotechnology; announcement of policy; notice for public comment |journal=Federal Register | date = June 1986 | pmid = 11655807 | url = http://usbiotechreg.nbii.gov/CoordinatedFrameworkForRegulationOfBiotechnology1986.pdf | archive-url = https://web.archive.org/web/20110516173328/http://usbiotechreg.nbii.gov/CoordinatedFrameworkForRegulationOfBiotechnology1986.pdf | archive-date = 16 May 2011 |author1=U.S. Office of Science and Technology Policy |volume=51 |issue=123 |pages=23302–23350 }}</ref> The [[Cartagena Protocol on Biosafety]], an international treaty that governs the transfer, handling, and use of GMOs,<ref>{{cite journal|author=Redick, T.P.|year=2007|title=The Cartagena Protocol on biosafety: Precautionary priority in biotech crop approvals and containment of commodities shipments, 2007|journal=Colorado Journal of International Environmental Law and Policy|volume=18|pages=51–116}}</ref> was adopted on 29 January 2000.<ref>{{cite web|url=http://bch.cbd.int/protocol/background/|title=About the Protocol|work=The Biosafety Clearing-House (BCH)|date=29 May 2012}}</ref> One hundred and fifty-seven countries are members of the Protocol, and many use it as a reference point for their own regulations.<ref name="Kimani">{{cite web|url=http://www.agbioforum.org/v13n3/v13n3a02-gruere.htm#R13|title=AgBioForum 13(3): Implications of Import Regulations and Information Requirements under the Cartagena Protocol on Biosafety for GM Commodities in Kenya|date=28 October 2010|access-date=3 May 2017|archive-date=4 March 2016|archive-url=https://web.archive.org/web/20160304190534/http://www.agbioforum.org/v13n3/v13n3a02-gruere.htm#R13}}</ref>

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.<ref>[https://tile.loc.gov/storage-services/service/ll/llglrd/2014427358/2014427358.pdf ''Restrictions on Genetically Modified Organisms.''] Library of Congress, March 2014 (LL File No. 2013-009894). Summary about a number of countries. [https://www.loc.gov/item/2014427358/ via]</ref><ref>{{Cite web|url=http://www.americanbar.org/content/newsletter/publications/aba_health_esource_home/aba_health_law_esource_1302_bashshur.html|title=FDA and Regulation of GMOs|last=Bashshur|first=Ramona|name-list-style=vanc|date=February 2013|publisher=American Bar Association|access-date=24 February 2016|archive-date=29 September 2016|archive-url=https://web.archive.org/web/20160929163558/http://www.americanbar.org/content/newsletter/publications/aba_health_esource_home/aba_health_law_esource_1302_bashshur.html|url-status=dead}}</ref><ref>{{Cite magazine|last=Sifferlin|first=Alexandra| name-list-style = vanc |date=3 October 2015|title=Over Half of E.U. Countries Are Opting Out of GMOs|url=http://time.com/4060476/eu-gmo-crops-european-union-opt-out/|magazine=Time}}</ref><ref>{{Cite web|url=http://www.cfr.org/agricultural-policy/regulation-gmos-europe-united-states-case-study-contemporary-european-regulatory-politics/p8688|title=The Regulation of GMOs in Europe and the United States: A Case-Study of Contemporary European Regulatory Politics|first1=Diahanna|last1=Lynch|last2=Vogel|first2=David|name-list-style=vanc|date=5 April 2001|publisher=Council on Foreign Relations|access-date=24 February 2016|archive-url=https://web.archive.org/web/20160929200540/http://www.cfr.org/agricultural-policy/regulation-gmos-europe-united-states-case-study-contemporary-european-regulatory-politics/p8688|archive-date=29 September 2016}}</ref> 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.<ref>{{cite web|url=https://www.loc.gov/law/help/restrictions-on-gmos/|title=Restrictions on Genetically Modified Organisms - Law Library of Congress|website=[[Library of Congress]]|date=22 January 2017}}</ref> Some of the most marked differences occur 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]].<ref name="Marsen">{{cite journal |title=Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture |last=Marden |first=Emily |date=1 May 2003 |journal=Boston College Law Review |volume=44 |number=3 |page=733 |url=https://lira.bc.edu/work/ns/d6fc0184-cdee-497d-add0-56ab2c374b25}}</ref> The [[European Union]] by contrast has possibly the most stringent GMO regulations in the world.<ref name="Davison2010" /> 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".<ref name=":8">[http://www.gmo-compass.org/eng/regulation/regulatory_process/156.european_regulatory_system_genetic_engineering.html GMO Compass: The European Regulatory System.] {{webarchive|url=https://web.archive.org/web/20120814025652/http://www.gmo-compass.org/eng/regulation/regulatory_process/156.european_regulatory_system_genetic_engineering.html |date=14 August 2012 }} Retrieved 28 July 2012.</ref> The level of regulation in other countries that cultivate GMOs lie in between Europe and the United States.

{| class="wikitable"
|+Regulatory agencies by geographical region
!Region
!Regulators
!Notes
|-
|US
|[[United States Department of Agriculture|USDA]], [[Food and Drug Administration|FDA]] and [[United States Environmental Protection Agency|EPA]]<ref name=":7" />
|
|-
|Europe
|[[European Food Safety Authority]]<ref name=":8" />
|
|-
|Canada
|[[Health Canada]] and the [[Canadian Food Inspection Agency]]<ref>{{cite web|url=http://www.inspection.gc.ca/english/sci/biotech/bioteche.shtml|title=Information for the general public| author =Government of Canada, Canadian Food Inspection Agency |website=www.inspection.gc.ca|date=20 March 2015}}</ref><ref>{{cite encyclopedia | url=http://www.thecanadianencyclopedia.com/articles/genetically-modified-foods | title=Genetically Modified Foods | first=Cecil W. | last=Forsberg | date=23 April 2013 | encyclopedia=The Canadian Encyclopedia | access-date=4 October 2017 | archive-date=18 September 2013 | archive-url=https://web.archive.org/web/20130918203331/http://www.thecanadianencyclopedia.com/articles/genetically-modified-foods }}</ref>
|Regulated products with novel features regardless of method of origin<ref>Evans, Brent and Lupescu, Mihai (15 July 2012) [http://gain.fas.usda.gov/Recent%20GAIN%20Publications/Agricultural%20Biotechnology%20Annual_Ottawa_Canada_07-20-2012.pdf Canada – Agricultural Biotechnology Annual – 2012] {{Webarchive|url=https://web.archive.org/web/20131215160309/http://gain.fas.usda.gov/Recent%20GAIN%20Publications/Agricultural%20Biotechnology%20Annual_Ottawa_Canada_07-20-2012.pdf |date=15 December 2013 }} GAIN (Global Agricultural Information Network) report CA12029, United States Department of Agriculture, Foreifn Agricultural Service, Retrieved 5 November 2012</ref><ref>{{cite book|title=Pandora's Picnic Basket|last=McHugen|first=Alan|name-list-style=vanc|date=14 September 2000|publisher=Oxford University Press|isbn=978-0-19-850674-4|chapter=Chapter 1: Hors-d'oeuvres and entrees/What is genetic modification? What are GMOs?|chapter-url=https://archive.org/details/pandoraspicnicba00mchu}}</ref>
|-
|Africa
|[[Common Market for Eastern and Southern Africa]]<ref name=":4">{{cite journal | doi = 10.1038/467633b | volume=467 | title=Editorial: Transgenic harvest | year=2010 | journal=Nature | issue=7316 | pages=633–634| pmid=20930796 | doi-access=free | bibcode=2010Natur.467R.633. }}</ref>
|Final decision lies with each individual country.<ref name=":4" />
|-
|China
|Office of Agricultural Genetic Engineering Biosafety Administration<ref>{{cite web|url=http://www.agbioforum.org/v5n4/v5n4a01-huang.htm|title=AgBioForum 5(4): Agricultural Biotechnology Development and Policy in China|date=5 September 2003|access-date=3 May 2017|archive-date=25 July 2016|archive-url=https://web.archive.org/web/20160725141840/http://www.agbioforum.org/v5n4/v5n4a01-huang.htm}}</ref>
|
|-
|India
|Institutional Biosafety Committee, Review Committee on Genetic Manipulation and Genetic Engineering Approval Committee<ref>{{Cite web|url=https://agritech.tnau.ac.in/bio-tech/biotech_gmcrop_gmregulation.html|title=TNAU Agritech Portal :: Bio Technology|website=agritech.tnau.ac.in}}</ref>
|
|-
|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)<ref name="BASFppt">{{cite web|url=http://www.eurofins.com/media/11753/dcontri.pdf|title=BASF presentation|archive-url=https://web.archive.org/web/20110928104527/http://www.eurofins.com/media/11753/dcontri.pdf|archive-date=28 September 2011}}</ref>
|Final decision made by the Secretariat of Agriculture, Livestock, Fishery and Food.<ref name="BASFppt" />
|-
|Brazil
|National Biosafety Technical Commission (environmental and food safety) and the Council of Ministers (commercial and economical issues)<ref name="BASFppt" />
|
|-
|Australia
|[[Office of the Gene Technology Regulator]] (oversees all GM products), [[Therapeutic Goods Administration]] (GM medicines) and [[Food Standards Australia New Zealand]] (GM food).<ref name="VIC ag">[http://www.new.dpi.vic.gov.au/agriculture/science-and-research/biotechnology/genetically-modified-crops/federal-and-state-responsibilities Agriculture – Department of Primary Industries] {{webarchive|url=https://web.archive.org/web/20110329120907/http://new.dpi.vic.gov.au/agriculture/science-and-research/biotechnology/genetically-modified-crops/federal-and-state-responsibilities |date=29 March 2011 }}</ref><ref name="OTRWebsite">{{cite web|url=http://www.ogtr.gov.au/|title=Welcome to the Office of the Gene Technology Regulator Website|publisher=Office of the Gene Technology Regulator|access-date=25 March 2011}}</ref>
|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.<ref name="OTRWebsite" />
|}
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]]<ref name="EC1">{{cite web | agency = The European Parliament and the Council of the European Union | date = 2003 | url = http://ec.europa.eu/food/food/animalnutrition/labelling/Reg_1829_2003_en.pdf | title = Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 On Genetically Modified Food And Feed | work = Official Journal of the European Union | volume = L 268/3 (21) | quote = 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 detectability of 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. | archive-url = https://web.archive.org/web/20140120113714/http://ec.europa.eu/food/food/animalnutrition/labelling/Reg_1829_2003_en.pdf | archive-date = 20 January 2014 }}</ref> and facilitate the withdrawal of products if adverse effects on health or the environment are discovered.<ref name="EC2">{{cite web | publisher = The European Parliament and the Council of the European Union | date = 2003 | url = http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32003R1830 | title = 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 |  work = Official Journal L 268|pages=24–28 | quote = (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. }}</ref> The [[American Medical Association]]<ref name="AMA">{{cite web | publisher = American Medical Association | date = 2012 | url = http://www.ama-assn.org/resources/doc/csaph/a12-csaph2-bioengineeredfoods.pdf | archive-url = https://web.archive.org/web/20120907023039/http://www.ama-assn.org/resources/doc/csaph/a12-csaph2-bioengineeredfoods.pdf | archive-date = 7 September 2012  | title = Report 2 of the Council on Science and Public Health: Labeling of Bioengineered Foods}}</ref> and the [[American Association for the Advancement of Science]]<ref name="AAAS">American Association for the Advancement of Science (AAAS), Board of Directors (2012). [http://www.aaas.org/sites/default/files/AAAS_GM_statement.pdf Statement by the AAAS Board of Directors On Labeling of Genetically Modified Foods], and associated [http://www.aaas.org/news/releases/2012/1025gm_statement.shtml Press release: Legally Mandating GM Food Labels Could Mislead and Falsely Alarm Consumers] {{Webarchive|url=https://web.archive.org/web/20131104063411/http://www.aaas.org/news/releases/2012/1025gm_statement.shtml |date=4 November 2013 }}</ref> say that absent scientific evidence of harm even voluntary labeling is [[Fear, uncertainty and doubt|misleading]] and will falsely alarm consumers. Labeling of GMO products in the marketplace is required in 64 countries.<ref name="Burlington-2014">{{cite news |last=Hallenbeck |first=Terri | name-list-style = vanc |url=http://www.burlingtonfreepress.com/story/news/politics/2014/04/27/gmo-labeling-came-pass-vermont/8166519/ |title=How GMO labeling came to pass in Vermont |work=Burlington Free Press |date=2014-04-27 |access-date=2014-05-28 }}</ref> 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,<ref name="RegGMFood">{{cite web|url=http://www.hc-sc.gc.ca/sr-sr/pubs/biotech/reg_gen_mod-eng.php|title=The Regulation of Genetically Modified Foods|access-date=5 November 2012|archive-url=https://web.archive.org/web/20170610170104/http://www.hc-sc.gc.ca/sr-sr/pubs/biotech/reg_gen_mod-eng.php|archive-date=10 June 2017}}</ref> while in Europe all food (including [[processed food]]) or [[Compound feed|feed]] which contains greater than 0.9% of approved GMOs must be labelled.<ref name="Davison2010">{{cite journal | last1 = Davison | first1 = John | name-list-style = vanc | year = 2010 | title = GM plants: Science, politics and EC regulations | journal = Plant Science | volume = 178 | issue = 2| pages = 94–98 | doi=10.1016/j.plantsci.2009.12.005}}</ref>

==Controversy==

{{Main|Genetically modified food controversies|}}

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.<ref>{{Cite journal|last=Sheldon|first=Ian M.| name-list-style = vanc |date=2002-03-01|title=Regulation of biotechnology: will we ever 'freely' trade GMOs?|journal=European Review of Agricultural Economics|volume=29|issue=1|pages=155–76|doi=10.1093/erae/29.1.155|issn=0165-1587|citeseerx=10.1.1.596.7670}}</ref>

Accusations that scientists are "[[Playing God (ethics)|playing God]]" and other [[Religious views on genetically modified foods|religious issues]] have been ascribed to the technology from the beginning.<ref>{{cite journal | vauthors = Dabrock P | title = Playing God? Synthetic biology as a theological and ethical challenge | journal = Systems and Synthetic Biology | volume = 3 | issue = 1–4 | pages = 47–54 | date = December 2009 | pmid = 19816799 | pmc = 2759421 | doi = 10.1007/s11693-009-9028-5 }}</ref> Other ethical issues raised include the [[Biological patent|patenting of life]],<ref>{{cite journal | vauthors = Brown C | title = Patenting life: genetically altered mice an invention, court declares | journal = CMAJ | volume = 163 | issue = 7 | pages = 867–8 | date = October 2000 | pmid = 11033718 | pmc = 80518 }}</ref> the use of [[intellectual property]] rights,<ref>{{Cite news|url=http://sitn.hms.harvard.edu/flash/2015/the-patent-landscape-of-genetically-modified-organisms/|title=The Patent Landscape of Genetically Modified Organisms |last=Zhou|first=Wen| name-list-style = vanc |date=2015-08-10|work=Science in the News|access-date=2017-05-05}}</ref> the level of labeling on products,<ref>{{Cite web|url=http://www.huffingtonpost.com/teen-vogue/why-the-new-gmo-foodlabel_b_9738698.html|title=Why The New GMO Food-Labeling Law Is So Controversial|last=Puckett|first=Lily| name-list-style = vanc |date=2016-04-20|website=Huffington Post|access-date=2017-05-05}}</ref><ref>{{Cite news|url=http://www.latimes.com/opinion/op-ed/la-oe-0412-miller-gmo-labels-unscientific-20160412-story.html|title=GMO food labels are meaningless|last=Miller|first=Henry| name-list-style = vanc |date=2016-04-12|work=Los Angeles Times|access-date=2017-05-05|issn=0458-3035}}</ref> control of the food supply<ref>{{Cite news|url=https://www.forbes.com/sites/stevensavage/2015/06/26/who-controls-the-food-supply/#449914fe2f9d|title=Who Controls The Food Supply?|last=Savage|first=Steven| name-list-style = vanc |work=Forbes|access-date=2017-05-05}}</ref> and the objectivity of the regulatory process.<ref>{{Cite book|url=https://books.google.com/books?id=jGD7CwAAQBAJ&pg=PA156|title=Science, Risk, and Policy|last=Knight|first=Andrew J.| name-list-style = vanc |date=2016-04-14|publisher=Routledge|isbn=978-1-317-28081-1|page=156}}</ref> Although doubts have been raised,<ref>{{Cite news|url=https://www.nytimes.com/2016/10/30/business/gmo-promise-falls-short.html |archive-url=https://ghostarchive.org/archive/20220102/https://www.nytimes.com/2016/10/30/business/gmo-promise-falls-short.html |archive-date=2022-01-02 |url-access=limited |url-status=live|title=Doubts About the Promised Bounty of Genetically Modified Crops|last=Hakim|first=Danny| name-list-style = vanc |date=2016-10-29|work=The New York Times|access-date=2017-05-05|issn=0362-4331}}{{cbignore}}</ref> economically most studies have found growing GM crops to be beneficial to farmers.<ref>{{Cite journal| vauthors = Areal FJ, Riesgo L, Rodríguez-Cerezo E |date=2013-02-01|title=Economic and agronomic impact of commercialized GM crops: a meta-analysis|journal=The Journal of Agricultural Science|volume=151|issue=1|pages=7–33|doi=10.1017/S0021859612000111 |s2cid=85891950}}</ref><ref>{{Cite journal |last1=Finger |first1=Robert |last2=El Benni |first2=Nadja |last3=Kaphengst |first3=Timo |last4=Evans |first4=Clive |last5=Herbert |first5=Sophie |last6=Lehmann |first6=Bernard |last7=Morse |first7=Stephen |last8=Stupak |first8=Nataliya| name-list-style = vanc |date=2011-05-10|title=A Meta Analysis on Farm-Level Costs and Benefits of GM Crops  |journal=Sustainability|volume=3|issue=5|pages=743–62|doi=10.3390/su3050743|url=https://www.research-collection.ethz.ch/bitstream/20.500.11850/42242/1/sustainability-03-00743.pdf |archive-url=https://web.archive.org/web/20180719124037/https://www.research-collection.ethz.ch/bitstream/20.500.11850/42242/1/sustainability-03-00743.pdf |archive-date=2018-07-19 |url-status=live |doi-access=free }}</ref><ref>{{cite journal | vauthors = Klümper W, Qaim M | title = A meta-analysis of the impacts of genetically modified crops | journal = PLOS ONE | volume = 9 | issue = 11 | pages = e111629 | date = 2014-11-03 | pmid = 25365303 | pmc = 4218791 | doi = 10.1371/journal.pone.0111629 | bibcode = 2014PLoSO...9k1629K | doi-access = free }}</ref>

[[Gene flow]] between GM crops and compatible plants, along with increased use of selective [[herbicide]]s, can increase the risk of "[[superweeds]]" developing.<ref>{{Cite journal|last=Qiu|first=Jane|author-link=Jane Qiu| name-list-style = vanc |title=Genetically modified crops pass benefits to weeds|url=http://www.nature.com/news/genetically-modified-crops-pass-benefits-to-weeds-1.13517|journal=Nature|doi=10.1038/nature.2013.13517|year=2013|s2cid=87415065|doi-access=free}}</ref> Other environmental concerns involve potential impacts on non-target organisms, including [[soil microbes]],<ref name=":1">{{Cite web |url= http://www.fao.org/docrep/003/X9602E/x9602e07.htm |title=GMOs and the environment |website=www.fao.org|access-date=2017-05-07}}</ref> and an increase in secondary and resistant insect pests.<ref>{{cite journal | vauthors = Dively GP, Venugopal PD, Finkenbinder C | title = Field-Evolved Resistance in Corn Earworm to Cry Proteins Expressed by Transgenic Sweet Corn | journal = PLOS ONE | volume = 11 | issue = 12 | pages = e0169115 | date = 2016-12-30 | pmid = 28036388 | pmc = 5201267 | doi = 10.1371/journal.pone.0169115 | bibcode = 2016PLoSO..1169115D | doi-access = free }}</ref><ref>{{Cite journal|last=Qiu|first=Jane|date=2010-05-13|title=GM crop use makes minor pests major problem |journal=Nature News|doi=10.1038/news.2010.242|citeseerx=10.1.1.464.7885}}</ref> Many of the environmental impacts regarding GM crops may take many years to be understood and are also evident in conventional agriculture practices.<ref name=":1" /><ref>{{cite journal | vauthors = Gilbert N | title = Case studies: A hard look at GM crops | journal = Nature | volume = 497 | issue = 7447 | pages = 24–6 | date = May 2013 | pmid = 23636378 | doi = 10.1038/497024a | bibcode = 2013Natur.497...24G | s2cid = 4417399 | doi-access =  }}</ref> With the commercialisation of [[genetically modified fish]] there are concerns over what the environmental consequences will be if they escape.<ref>{{Cite web|url=https://www.nature.com/scitable/blog/accumulating-glitches/are_gmo_fish_safe_for|title=Are GMO Fish Safe for the Environment? {{!}} Accumulating Glitches {{!}} Learn Science at Scitable|website=www.nature.com|access-date=2017-05-07}}</ref>

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 [[Outcrossing|outcross]] to other crops.<ref>{{Cite web|url=https://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/|title=Q&A: genetically modified food|website=World Health Organization|access-date=2017-05-07}}</ref> There is a [[scientific consensus]]<ref>{{cite journal | vauthors = Nicolia A, Manzo A, Veronesi F, Rosellini D | title = An overview of the last 10 years of genetically engineered crop safety research | journal = Critical Reviews in Biotechnology | volume = 34 | issue = 1 | pages = 77–88 | date = March 2014 | pmid = 24041244 | doi = 10.3109/07388551.2013.823595 | s2cid = 9836802 | quote = 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 GM crops. 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. }}</ref><ref>{{Cite web|url=http://www.fao.org/docrep/006/Y5160E/y5160e10.htm#P3_1651The|title=State of Food and Agriculture 2003–2004. Agricultural Biotechnology: Meeting the Needs of the Poor. Health and environmental impacts of transgenic crops|publisher=Food and Agriculture Organization of the United Nations|quote=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).|access-date=8 February 2016}}</ref><ref>{{cite journal | vauthors = Ronald P | title = Plant genetics, sustainable agriculture and global food security | journal = Genetics | volume = 188 | issue = 1 | pages = 11–20 | date = May 2011 | pmid = 21546547 | pmc = 3120150 | doi = 10.1534/genetics.111.128553 | quote = "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 on Agriculture and Natural Resources, Committee on Environmental Impacts Associated with Commercialization of Transgenic Plants, 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 Council 2004; 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 2010)." }}</ref><ref>But see also:

{{cite journal | vauthors = Domingo JL, Giné Bordonaba J | title = A literature review on the safety assessment of genetically modified plants | journal = Environment International | volume = 37 | issue = 4 | pages = 734–42 | date = May 2011 | pmid = 21296423 | doi = 10.1016/j.envint.2011.01.003 | quote = 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. }}

{{Cite journal|last=Krimsky|first=Sheldon|name-list-style=vanc|date=2015|title=An Illusory Consensus behind GMO Health Assessment|url=http://www.tufts.edu/~skrimsky/PDF/Illusory%20Consensus%20GMOs.PDF|journal=Science, Technology, & Human Values|volume=40|issue=6|pages=883–914|doi=10.1177/0162243915598381|s2cid=40855100|quote=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.|access-date=30 October 2016|archive-url=https://web.archive.org/web/20160207171524/http://www.tufts.edu/~skrimsky/PDF/Illusory%20Consensus%20GMOs.PDF|archive-date=7 February 2016}}

And contrast:

{{cite journal | vauthors = Panchin AY, Tuzhikov AI | title = Published GMO studies find no evidence of harm when corrected for multiple comparisons | journal = Critical Reviews in Biotechnology | volume = 37 | issue = 2 | pages = 213–217 | date = March 2017 | pmid = 26767435 | doi = 10.3109/07388551.2015.1130684 | s2cid = 11786594 | quote = 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

{{cite journal | vauthors = Yang YT, Chen B | title = Governing GMOs in the USA: science, law and public health | journal = Journal of the Science of Food and Agriculture | volume = 96 | issue = 6 | pages = 1851–5 | date = April 2016 | pmid = 26536836 | doi = 10.1002/jsfa.7523 | bibcode = 2016JSFA...96.1851Y | quote = "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." }}</ref> that currently available food derived from GM crops poses no greater risk to human health than conventional food,<ref>{{Cite web|url=http://www.aaas.org/sites/default/files/AAAS_GM_statement.pdf|title=Statement by the AAAS Board of Directors on Labeling of Genetically Modified Foods|date=20 October 2012|publisher=American Association for the Advancement of Science|quote="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."|access-date=8 February 2016}}{{Cite web|url=http://www.aaas.org/news/aaas-board-directors-legally-mandating-gm-food-labels-could-%E2%80%9Cmislead-and-falsely-alarm|title=AAAS Board of Directors: Legally Mandating GM Food Labels Could "Mislead and Falsely Alarm Consumers"|last=Pinholster|first=Ginger| name-list-style = vanc |date=25 October 2012|publisher=American Association for the Advancement of Science|access-date=8 February 2016}}
</ref><ref>{{Cite book|url=http://ec.europa.eu/research/biosociety/pdf/a_decade_of_eu-funded_gmo_research.pdf |archive-url=https://web.archive.org/web/20101224152216/http://ec.europa.eu/research/biosociety/pdf/a_decade_of_eu-funded_gmo_research.pdf |archive-date=2010-12-24 |url-status=live|title=A decade of EU-funded GMO research (2001–2010)|date=2010|publisher=Directorate-General for Research and Innovation. Biotechnologies, Agriculture, Food. European Commission, European Union.|doi=10.2777/97784|isbn=978-92-79-16344-9|access-date=8 February 2016|author1=European Commission. Directorate-General for Research}}</ref><ref>{{Cite web|url=https://www.isaaa.org/kc/Publications/htm/articles/Position/ama.htm|title=AMA Report on Genetically Modified Crops and Foods (online summary)|date=January 2001|publisher=American Medical Association|quote="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 [[International Service for the Acquisition of Agri-biotech Applications|ISAAA]])''" "Crops and foods produced using recombinant DNA techniques 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."|access-date=19 March 2016}}{{Cite web|url=http://www.ama-assn.org/resources/doc/csaph/a12-csaph2-bioengineeredfoods.pdf|title=Report 2 of the Council on Science and Public Health (A-12): Labeling of Bioengineered Foods|date=2012|publisher=American Medical Association|quote=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.|access-date=19 March 2016|url-status=bot: unknown|archive-url=https://web.archive.org/web/20120907023039/http://www.ama-assn.org/resources/doc/csaph/a12-csaph2-bioengineeredfoods.pdf|archive-date=7 September 2012}}
</ref><ref>{{Cite web|url=https://www.loc.gov/law/help/restrictions-on-gmos/usa.php#Opinion|title=Restrictions on Genetically Modified Organisms: United States. Public and Scholarly Opinion|date=9 June 2015|publisher=Library of Congress|quote="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."|access-date=8 February 2016}}</ref><ref>{{Cite book|url=http://www.nap.edu/read/23395/chapter/7#149|title=Genetically Engineered Crops: Experiences and Prospects|date=2016|publisher=The National Academies of Sciences, Engineering, and Medicine (US)|page=149|quote="''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."|access-date=19 May 2016|doi=10.17226/23395|pmid=28230933|isbn=978-0-309-43738-7|last1=National Academies of Sciences|first1=Engineering|author2=Division on Earth Life Studies|author3=Board on Agriculture Natural Resources|author4=Committee on Genetically Engineered Crops: Past Experience Future Prospects}}</ref> but that each GM food needs to be tested on a case-by-case basis before introduction.<ref>{{Cite web|url=https://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/|title=Frequently asked questions on genetically modified foods|publisher=World Health Organization|quote=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.|access-date=8 February 2016}}</ref><ref>{{cite journal | vauthors = Haslberger AG | title = Codex guidelines for GM foods include the analysis of unintended effects | journal = Nature Biotechnology | volume = 21 | issue = 7 | pages = 739–41 | date = July 2003 | pmid = 12833088 | doi = 10.1038/nbt0703-739 | s2cid = 2533628 | quote = These principles dictate a case-by-case premarket assessment that includes an evaluation of both direct and unintended effects. }}</ref><ref>Some medical organizations, including the [[British Medical Association]], advocate further caution based upon the [[precautionary principle]]:{{Cite web|url=http://www.argenbio.org/adc/uploads/pdf/bma.pdf |archive-url=https://web.archive.org/web/20140322224425/http://www.argenbio.org/adc/uploads/pdf/bma.pdf |archive-date=2014-03-22 |url-status=live|title=Genetically modified foods and health: a second interim statement|date=March 2004|publisher=British Medical Association|quote=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 currently available. 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 basis. 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 effects. 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 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.|access-date=21 March 2016}}</ref> Nonetheless, members of the public are less likely than scientists to perceive GM foods as safe.<ref>{{Cite web |first1=Cary |last1=Funk |last2=Rainie |first2=Lee| name-list-style = vanc |url= http://www.pewinternet.org/2015/01/29/public-and-scientists-views-on-science-and-society/ |title=Public and Scientists' Views on Science and Society|date=29 January 2015|publisher=Pew Research Center|quote=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. |access-date=24 February 2016}}</ref><ref>{{cite journal | vauthors = Marris C | title = Public views on GMOs: deconstructing the myths. Stakeholders in the GMO debate often describe public opinion as irrational. But do they really understand the public? | journal = EMBO Reports | volume = 2 | issue = 7 | pages = 545–8 | date = July 2001 | pmid = 11463731 | pmc = 1083956 | doi = 10.1093/embo-reports/kve142 }}</ref><ref>{{Cite web|url=http://csec.lancs.ac.uk/archive/pabe/docs/pabe_finalreport.doc|title=Public Perceptions of Agricultural Biotechnologies in Europe|date=December 2001|publisher=Commission of European Communities|author=Final Report of the PABE research project|access-date=24 February 2016}}</ref><ref>{{cite journal | vauthors = Scott SE, Inbar Y, Rozin P | s2cid = 261060 | title = Evidence for Absolute Moral Opposition to Genetically Modified Food in the United States | journal = Perspectives on Psychological Science | volume = 11 | issue = 3 | pages = 315–324 | date = May 2016 | pmid = 27217243 | doi = 10.1177/1745691615621275 }}</ref>

==In popular culture==
{{Main|Genetics in fiction#Genetic engineering}}
Genetic engineering features in many [[science fiction]] stories.<ref name="SFE">{{cite web |title=Genetic Engineering |url=http://www.sf-encyclopedia.com/entry/genetic_engineering |website=The Encyclopedia of Science Fiction |access-date=19 July 2018 |date=15 May 2017 }}</ref> [[Frank Herbert]]'s novel ''[[The White Plague]]'' describes the deliberate use of genetic engineering to create a [[pathogen]] which specifically kills women.<ref name="SFE" /> Another of Herbert's creations, the ''[[Dune (franchise)|Dune]]'' series of novels, uses genetic engineering to create the powerful [[Tleilaxu]].<ref>{{cite web|url=https://www.outerplaces.com/science/item/16677-genetics-science-fiction-future|title=The Science of Sci-Fi: How Science Fiction Predicted the Future of Genetics|last1=Koboldt|first1=Daniel| name-list-style = vanc |date=29 August 2017|website=Outer Places|archive-url=https://web.archive.org/web/20180719233445/https://www.outerplaces.com/science/item/16677-genetics-science-fiction-future|archive-date=19 July 2018|url-status=live|access-date=19 July 2018}}</ref> Few films have informed audiences about genetic engineering, with the exception of the 1978 ''[[The Boys from Brazil (film)|The Boys from Brazil]]'' and the 1993 ''[[Jurassic Park (film)|Jurassic Park]]'', both of which make use of a lesson, a demonstration, and a clip of scientific film.<ref name="Moraga2">{{cite journal|last=Moraga|first=Roger| name-list-style = vanc |date=November 2009|title=Modern Genetics in the World of Fiction|url=http://clarkesworldmagazine.com/moraga_11_09/|url-status=live|journal=[[Clarkesworld Magazine]]|issue=38|archive-url=https://web.archive.org/web/20180719114128/http://clarkesworldmagazine.com/moraga_11_09/|archive-date=19 July 2018}}</ref><ref name=Wellcome>{{cite web |last=Clark |first=Michael | name-list-style = vanc |title=Genetic themes in fiction films: Genetics meets Hollywood |url=http://genome.wellcome.ac.uk/doc_WTD023539.html |publisher=[[The Wellcome Trust]] |access-date=19 July 2018 |archive-url=https://web.archive.org/web/20120518055848/http://genome.wellcome.ac.uk/doc_WTD023539.html |archive-date=18 May 2012}}</ref> 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"<ref name="Wellcome" /> 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.<ref name="Wellcome" /> 

In the 2007 video game, ''[[BioShock]]'', genetic engineering plays an important role in the central storyline and universe. The game takes place in the fictional underwater dystopia [[Rapture (BioShock)|Rapture]], in which its inhabitants possess genetic superhuman abilities after injecting themselves with "plasmids", a serum which grants such powers. Also in the city of Rapture are "Little Sisters", little girls who are generically engineered, as well as a side-plot in which a cabaret singer sells her foetus to genetic scientists who implant false memories into the newborn and genetically engineer it to grow into an adult.

== See also ==
* [[Biological engineering]]
* [[Modifications (genetics)]]
* [[RNA editing#Therapeutic mRNA Editing]]
* [[Semi-synthetic organisms]]
* [[Mutagenesis (molecular biology technique)]]

== References ==
{{Reflist}}

== Further reading ==
{{refbegin}}
* {{cite book | author=British Medical Association | author-link=British Medical Association | title=The Impact of Genetic Modification on Agriculture, Food and Health | publisher=BMJ Books | year=1999 | isbn=0-7279-1431-6}}
* {{cite book | author=Donnellan, Craig | title=Genetic Modification (Issues) | publisher=Independence Educational Publishers | year=2004 | isbn=1-86168-288-3}}
* {{cite book|first=Sally |last=Morgan| name-list-style = vanc |title=Superfoods: Genetic Modification of Foods|url={{google books |plainurl=y |id=48QpTA2P6O0C}}|date=1 January 2009|publisher=Heinemann Library|isbn=978-1-4329-2455-3}}
* {{cite book | author=Smiley, Sophie | title=Genetic Modification: Study Guide (Exploring the Issues) | publisher=Independence Educational Publishers | year=2005 | isbn=1-86168-307-3}}
* {{cite book |last=Watson |first=James D. |author-link=James D. Watson | name-list-style = vanc |title=Recombinant DNA: Genes and Genomes: A Short Course |publisher=W.H. Freeman |location=San Francisco |year=2007 |isbn=978-0-7167-2866-5 }}
* {{Cite report| last1 = Weaver| first1 = Sean|first2=Morris |last2=Michael | name-list-style = vanc | title = An Annotated Bibliography of Scientific Publications on the Risks Associated with Genetic Modification | publisher = Victoria University | location = Wellington, NZ| year = 2003| url = http://researcharchive.vuw.ac.nz/handle/10063/3}}
* {{cite book | vauthors = Zaid A, Hughes HG, Porceddu E, Nicholas F |title= Glossary of Biotechnology for Food and Agriculture – A Revised and Augmented Edition of the Glossary of Biotechnology and Genetic Engineering |url=http://www.fao.org/docrep/004/y2775e/y2775e00.htm|year=2001 |publisher=[[FAO]] |location= Rome, Italy |isbn= 92-5-104683-2}}
{{refend}}

== External links ==
{{Library resources box
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{{Commons category}}
{{Wikiquote}}
* [https://web.archive.org/web/20061213064401/http://www.gmo-safety.eu/en/ GMO Safety - Information about research projects on the biological safety of genetically modified plants.]
* [https://web.archive.org/web/20080719170701/http://www.gmo-compass.org/. GMO-compass, news on GMO en EU]

{{Engineering fields}}
{{Genetics}}
{{Medical ethics}}
{{Biotechnology}}
{{emerging technologies|topics=yes|biomed=yes}}
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[[Category:Genetic engineering| ]]
[[Category:1950s neologisms]]
[[Category:1972 introductions]]

[[Category:Biological engineering]]
[[Category:Biotechnology]]
[[Category:Molecular biology]]
[[Category:Molecular genetics]]
[[Category:Engineering disciplines]]