Editing Genetic engineering (section)

==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="BergBaltimoreBrennerRoblinSinger1975"/> 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 | bibcode = 2008PBioJ...6....2M }}</ref> which assigned regulatory approval of GM food to the USDA, FDA and EPA.<ref name="CoordinatedFrameworkForRegulationOfBiotechnology1986">{{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 |publisher=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=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|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="european_regulatory_system_genetic_engineering">[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="CoordinatedFrameworkForRegulationOfBiotechnology1986" />
|
|-
|Europe
|[[European Food Safety Authority]]<ref name="european_regulatory_system_genetic_engineering" />
|
|-
|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|access-date=3 May 2017|archive-date=22 April 2011|archive-url=https://web.archive.org/web/20110422171028/http://www.inspection.gc.ca/english/sci/biotech/bioteche.shtml|url-status=dead}}</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="Nature2010">{{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="Nature2010" />
|-
|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| bibcode = 2010PlnSc.178...94D }}</ref>