Editing Genetically modified organism (section)

== Regulation ==
{{Main|Regulation of genetic engineering|}}
Genetically modified organisms are regulated by government agencies. This applies to research as well as the release of genetically modified organisms, including crops and food. The development of a regulatory framework concerning genetic engineering began in 1975, at [[Asilomar Conference Grounds|Asilomar]], California. The [[Asilomar conference on recombinant DNA|Asilomar meeting]] recommended a set of guidelines regarding the cautious use of recombinant technology and any products resulting from that technology.<ref>{{cite journal|vauthors=Berg P, Baltimore D, Brenner S, Roblin RO, Singer MF|date=June 1975|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|bibcode=1975PNAS...72.1981B|doi=10.1073/pnas.72.6.1981|pmc=432675|pmid=806076 |doi-access=free }}</ref> The [[Cartagena Protocol on Biosafety]] was adopted on 29 January 2000 and entered into force on 11 September 2003.<ref>{{cite web|url=http://bch.cbd.int/protocol/background/|title=About the Protocol|work=The Biosafety Clearing-House (BCH)|date=18 May 2021 }}</ref> It is an international treaty that governs the transfer, handling, and use of genetically modified organisms.<ref>{{cite journal|vauthors=Redick TP|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> 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 journal|vauthors=Kimani V, Gruère GP|title=Implications of import regulations and information requirements under the Cartagena Protocol on biosafety for GM commodities in Kenya.|url=http://www.agbioforum.org/v13n3/v13n3a02-gruere.htm#R13|journal=AgBioForum|volume=13|issue=3|page=article 2|access-date=18 February 2019|archive-date=4 March 2016|archive-url=https://web.archive.org/web/20160304190534/http://www.agbioforum.org/v13n3/v13n3a02-gruere.htm#R13|url-status=dead}}</ref>

Universities and research institutes generally have a special committee that is responsible for approving any experiments that involve genetic engineering. Many experiments also need permission from a national regulatory group or legislation. All staff must be trained in the use of GMOs and all laboratories must gain approval from their regulatory agency to work with GMOs.<ref name=":33">{{Cite book|title=Biotechnology: An Illustrated Primer| vauthors = Schmid RD, Schmidt-Dannert C |date=31 May 2016|publisher=John Wiley & Sons|isbn=978-3-527-33515-2|pages=332}}</ref> The legislation covering GMOs are often derived from regulations and guidelines in place for the non-GMO version of the organism, although they are more severe.<ref name=":52">{{cite journal | vauthors = Kimman TG, Smit E, Klein MR | title = Evidence-based biosafety: a review of the principles and effectiveness of microbiological containment measures | journal = Clinical Microbiology Reviews | volume = 21 | issue = 3 | pages = 403–25 | date = July 2008 | pmid = 18625678 | pmc = 2493080 | doi = 10.1128/CMR.00014-08 }}</ref> There is a near-universal system for assessing the relative risks associated with GMOs and other agents to laboratory staff and the community. They are assigned to one of four risk categories based on their virulence, the severity of the disease, the mode of transmission, and the availability of preventive measures or treatments. There are four [[biosafety level]]s that a laboratory can fall into, ranging from level 1 (which is suitable for working with agents not associated with disease) to level 4 (working with life-threatening agents). Different countries use different nomenclature to describe the levels and can have different requirements for what can be done at each level.<ref name=":52" />

[[File:NON GMO.jpg|thumb|upright|A label marking this peanut butter as being non-GMO|alt=]]
[[File:Époisses Gaugry - package with -sans OGM- label-9830.jpg|thumb|upright|Detail of a French cheese box declaring "GMO-free" production (i.e., below 0.9%)|alt=]]

There are differences in the regulation for the release of GMOs between countries, with some of the most marked differences occurring between the US and Europe.<ref>{{cite journal | vauthors = Gaskell G, Bauer MW, Durant J, Allum NC | title = Worlds apart? The reception of genetically modified foods in Europe and the U.S | journal = Science | volume = 285 | issue = 5426 | pages = 384–7 | date = July 1999 | pmid = 10411496 | doi = 10.1126/science.285.5426.384 }}{{Retracted|doi=10.1126/science.288.5472.1751a|pmid=10877693|intentional=yes}}</ref> Regulation varies in a given country depending on the intended use of the products of the genetic engineering. For example, a crop not intended for food use is generally not reviewed by authorities responsible for food safety.<ref name="PotatoPro2">{{cite web|url=http://www.potatopro.com/newsletters/20100310.htm|title=The History and Future of GM Potatoes|date=11 December 2013|website=PotatoPro.com|access-date=27 September 2012|archive-date=12 October 2013|archive-url=https://web.archive.org/web/20131012033805/http://www.potatopro.com/newsletters/20100310.htm|url-status=dead}}</ref> Some nations have banned the release of GMOs or restricted their use, and others permit them with widely differing degrees of regulation.<ref name="auto">{{Cite web|url=https://www.loc.gov/law/help/restrictions-on-gmos/|title=Restrictions on Genetically Modified Organisms|date=9 June 2015|publisher=Library of Congress|access-date=24 February 2016}}</ref><ref name="auto1">{{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|vauthors=Bashshur R|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 name="auto3">{{Cite magazine| vauthors = Sifferlin A |date=3 October 2015|title=Over Half of E.U. Countries Are Opting Out of GMOs|url=https://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| vauthors = Lynch D, Vogel D |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|url-status=dead}}</ref> In 2016, thirty eight countries officially ban or prohibit the cultivation of GMOs and nine (Algeria, Bhutan, Kenya, Kyrgyzstan, Madagascar, Peru, Russia, Venezuela and Zimbabwe) ban their importation.<ref>{{Cite web|url=https://gmo.geneticliteracyproject.org/FAQ/where-are-gmos-grown-and-banned/|title=Where are GMOs grown and banned?|date=7 February 2016|website=GMO FAQ|language=en-US|access-date=11 February 2019}}</ref> Most countries that do not allow GMO cultivation do permit research using GMOs.<ref name="auto2">{{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> Despite regulation, illegal releases have sometimes occurred, due to weakness of enforcement.<ref name="Freedman-2018" />

The European Union (EU) differentiates between approval for cultivation within the EU and approval for import and processing.<ref name="Purnhagen-2016">{{cite book | vauthors = Purnhagen K, Wesseler J | author-link1 = Kai Purnhagen | author-link2 = Justus Wesseler | chapter = The 'Honey' Judgment of Bablok and Others Versus Freistaat Bayern in the Court of Justice of the European Union: Implications for Co-existence. | title = The coexistence of genetically modified, organic and conventional foods | date = 2016 | pages = 149–165 | publisher = Springer | location = New York, NY. }}</ref> While only a few GMOs have been approved for cultivation in the EU a number of GMOs have been approved for import and processing.<ref name="Wesseler-2011">{{cite book | vauthors = Wesseler J, Purnhagen K | author-link2 = Kai Purnhagen | author-link1 = Justus Wesseler | chapter = Present and Future EU GMO policy | veditors =  Oskam A, Meesters G, Silvis H | title = EU Policy for Agriculture, Food and Rural Areas | edition = 2nd | location = Wageningen | publisher = Wageningen Academic Publishers | pages = 23–332 }}</ref> The cultivation of GMOs has triggered a debate about the market for GMOs in Europe.<ref name="Purnhagen-2016a">{{cite book | vauthors = Wesseler J, Purnhagen K  | author-link2 = Kai Purnhagen | author-link1 = Justus Wesseler  | date = 2016| chapter = Social, Economic and Legal Avenues | veditors = Kalaitzandonakes N, etal | title = The Coexistence of Genetically Modified, Organic and Conventional Foods | pages =  71–85 | location =  New York | publisher = Springer Science }}</ref> Depending on the coexistence regulations, incentives for cultivation of GM crops differ.<ref name="Beckman-2011">{{cite book | vauthors = Beckmann V, Soregaroli C, Wesseler J | chapter = Chapter 8: Coexistence of Genetically Modified (GM) and Non-Modified (non-GM) crops: Are the Two Main Property Rights Regimes Equivalent with Respect to the Coexistence Value? | title = Genetically modified food and global welfare | date = July 2011 | pages = 201–224 | veditors = Carter G, Moschini G, Sheldon I| location = Bingley, UK | publisher = Emerald Group Publishing | volume = 10 | series =  Frontiers of Economics and Globalization }}</ref> The US policy does not focus on the process as much as other countries, looks at verifiable scientific risks and uses the concept of [[substantial equivalence]].<ref name="Marsden">Emily Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture, 44 B.C.L. Rev. 733 (2003)[http://lawdigitalcommons.bc.edu/cgi/viewcontent.cgi?article=2236&context=bclr]</ref> Whether gene edited organisms should be regulated the same as genetically modified organism is debated. USA regulations sees them as separate and does not regulate them under the same conditions, while in Europe a GMO is any organism created using genetic engineering techniques.<ref name=":19">{{cite journal | title = A CRISPR definition of genetic modification | journal = Nature Plants | volume = 4 | issue = 5 | pages = 233 | date = May 2018 | pmid = 29725105 | doi = 10.1038/s41477-018-0158-1 | doi-access = free | bibcode = 2018NatPl...4..233. }}</ref>

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 |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 |date=2003|work=Official Journal of the European Union L 268/3 (21)|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 |url-status=dead |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. |agency=The European Parliament and the Council of the European Union}}</ref> and facilitate the withdrawal of products if adverse effects on health or the environment are discovered.<ref name="EC2">{{cite web|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|date=2003|work=Official Journal L 268|publisher=The European Parliament and the Council of the European Union|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="AMA2">{{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: Labeling of Bioengineered Foods|date=2012|publisher=American Medical Association|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|url-status=dead}}</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|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| vauthors = Hallenbeck T |date=27 April 2014|work=Burlington Free Press|access-date=28 May 2014}}</ref> Labeling can be mandatory up to a threshold GM content level (which varies between countries) or voluntary.  In the U.S., the National Bioengineered Food Disclosure Standard (Mandatory Compliance Date: January 1, 2022) requires labeling GM foods.<ref>{{cite web | url=https://www.federalregister.gov/documents/2018/12/21/2018-27283/national-bioengineered-food-disclosure-standard | title=National Bioengineered Food Disclosure Standard | date=21 December 2018 }}</ref> In Canada, 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=25 December 2018|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|url-status=dead}}</ref> while in Europe all food (including [[processed food]]) or [[Compound feed|feed]] which contains greater than 0.9% of approved GMOs must be labeled.<ref name="Davison20102">{{cite journal| vauthors = Davison J |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|bibcode=2010PlnSc.178...94D }}</ref> In 2014, sales of products that had been labeled as non-GMO grew 30 percent to $1.1 billion.<ref>{{cite web|url=http://www.smithsonianmag.com/smart-news/some-brands-are-labeling-products-gmo-free-even-if-they-dont-have-genes-180956421/|title=Some Brands Are Labeling Products 'GMO-free' Even if They Don't Have Genes|author=Smithsonian|year=2015}}</ref>