Editing Genetically modified maize (section)

=== Starlink corn recalls ===
{{main|Starlink corn recall}}

StarLink contains Cry9C, which had not previously been used in a GM crop.<ref name=ColStateExt-Starlink>{{cite web | work = Department of Soil and Crop Sciences at Colorado State University | date = 11 March 2004 | url = http://cls.casa.colostate.edu/transgeniccrops/hotstarlink.html | title = What is StarLink Corn | archive-url = https://web.archive.org/web/20060907235951/http://cls.casa.colostate.edu/transgeniccrops/hotstarlink.html | archive-date = 7 September 2006 }}</ref> Starlink's creator, [[Plant Genetic Systems]],  had applied to the US Environmental Protection Agency (EPA) to market Starlink for use in animal feed and in human food.<ref name=Pew>{{cite web | vauthors = Taylor MR, Tick JS | work = Resources for the Future, Pew Initiative on Food and Biotechnology | url = http://www.pewtrusts.org/~/media/legacy/uploadedfiles/wwwpewtrustsorg/reports/food_and_biotechnology/hhsbiotechstarcasepdf.pdf | title = The StarLink Case: Issues for the Future }}</ref>{{rp|14}} However, because the Cry9C protein lasts longer in the digestive system than other Bt proteins, the EPA had concerns about its allergenicity, and PGS did not provide sufficient data to prove that Cry9C was not allergenic.<ref>{{cite web | quote = While EPA had no specific data to indicate that Cry9C was an allergen, the protein expressed in StarLink corn did exhibit certain characteristics (i.e. relative heat stability and extended time to digestion) that were common to known food allergens such as those found in peanuts, eggs, etc. EPA's concern was that StarLink corn may be a human food allergen and in the absence of more definitive data, EPA has not made a decision whether or not to register the human food use. | author = Staff | work = U.S. Environmental Protection Agency | date = November 2000 | url = http://www.epa.gov/scipoly/sap/meetings/2000/november/prelim_eval_sub102500.pdf | title = Executive Summary: EPA Preliminary Evaluation of Information Contained in the October 25, 2000 Submission from Aventis Cropscience }}</ref>{{rp|3}} As a result, PGS split its application into separate permits for use in food and use in [[compound feed|animal feed]].<ref name="ColStateExt-Starlink"/><ref>{{cite journal | url = http://www.gpo.gov/fdsys/pkg/FR-1997-11-26/pdf/97-31131.pdf | title = Plant Genetic Systems (America) Inc.: PP 7G4921 | journal = Federal Register | volume = 62 | issue = 228 | date = 26 November 1997 | page = 63169 }} bottom of middle column - 63170 right column; see especially p63169 top of right column</ref> Starlink was approved by the EPA for use in animal feed only in May 1998.<ref name=Pew/>{{rp|15}}

StarLink corn was subsequently found in food destined for consumption by humans in the US, Japan, and South Korea.<ref name=Pew/>{{rp|20–21}} This corn became the subject of the widely publicized [[Starlink corn recall]], which started when [[Taco Bell]]-branded taco shells sold in supermarkets were found to contain the corn. Sales of StarLink seed were discontinued.<ref>{{cite web | vauthors = King D, Gordon A | collaboration = Genetically Engineered Food Alert Coalition | url = http://www.foe.org/act/getacobellpr.html | title = Contaminant found in Taco Bell taco shells. Food safety coalition demands recall | archive-url = https://web.archive.org/web/20001209004300/http://www.foe.org/act/getacobellpr.html | archive-date=9 December 2000 | location = Washington, DC | publisher = Friends of the Earth | date = 3 November 2001 }}</ref><ref>{{cite web | vauthors = Fuler M | date = 23 September 2000 |url= https://www.latimes.com/archives/la-xpm-2000-sep-23-mn-25314-story.html |title=Taco Bell Recalls Shells That Used Bioengineered Corn | work = The Los Angeles Times |access-date=31 December 2013}}</ref> The registration for Starlink varieties was voluntarily withdrawn by Aventis in October 2000. Pioneer had been bought by AgrEvo which then became Aventis CropScience at the time of the incident,<ref name=Pew/>{{rp|15–16}} which was later bought by [[Bayer CropScience|Bayer]].<ref>{{cite web | vauthors = Carpenter JE, Gianessi LP | title = Agricultural biotechnology: Updated benefit estimates. | location = Washington, DC | publisher = National Center for Food and Agricultural Policy | date = January 2001 | url = http://ucbiotech.org/biotech_info/PDFs/Carpenter_2001_Updated_Benefits.pdf }}</ref>

Fifty-one people reported adverse effects to the FDA; [[US Centers for Disease Control]] (CDC), which determined that 28 of them were possibly related to Starlink.<ref>{{cite web | author = Staff, EPA review committee. | url = http://www.usda.gov/documents/LLP%20Incidents%202.docx | title = LLP Incidents | work = U.S. Environmental Protection Agency }}</ref> However, the CDC studied the blood of these 28 individuals and concluded there was no evidence of hypersensitivity to the Starlink Bt protein.<ref>{{cite web |url=https://www.cdc.gov/nceh/ehhe/Cry9cReport/default.htm |title= Investigation of Human Health Effects Associated with Potential Exposure to Genetically Modified Corn | work = CDC, National Center for Environmental Health. A Report to the U.S. Food and Drug Administration from the Centers for Disease Control and Prevention. | location = Atlanta, GA | publisher = Centers for Disease Control and Prevention | date = 2001 |access-date=28 October 2014}}</ref>

A subsequent review of these tests by the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel points out that while "the negative results decrease the probability that the Cry9C protein is the cause of allergic symptoms in the individuals examined ... in the absence of a positive control and questions regarding the sensitivity and specificity of the assay, it is not possible to assign a negative predictive value to this."<ref>{{cite web|url=http://www.epa.gov/scipoly/SAP/meetings/2001/july/julyfinal.pdf |archive-url=https://ghostarchive.org/archive/20221009/http://www.epa.gov/scipoly/SAP/meetings/2001/july/julyfinal.pdf |archive-date=2022-10-09 |url-status=live|title=FIFRA Scientific Advisory Panel Report No. 2001-09, July 2001|website=epa.gov|access-date=8 April 2018}}</ref>

The US corn supply has been monitored for the presence of the Starlink Bt proteins since 2001.<ref>{{cite web|title=Starlink Corn Regulatory Information |url=http://www.epa.gov/oppbppd1/biopesticides/pips/starlink_corn.htm |date=April 2008 |publisher=Environmental Protection Agency (EPA) |url-status=dead |archive-url=https://web.archive.org/web/20130115215719/http://www.epa.gov/oppbppd1/biopesticides/pips/starlink_corn.htm |archive-date=15 January 2013 }}</ref>

In 2005, aid sent by the UN and the US to Central American nations also contained some StarLink corn. The nations involved, Nicaragua, Honduras, El Salvador and Guatemala refused to accept the aid.<ref>{{cite web | date = 16 February 2005 | work = Environment News Service |url=http://www.ens-newswire.com/ens/feb2005/2005-02-16-09.asp#anchor2 | archive-url = https://web.archive.org/web/20080905025904/http://www.ens-newswire.com/ens/feb2005/2005-02-16-09.asp | archive-date = 5 September 2008 |title=Banned as Human Food, StarLink Corn Found in Food Aid |publisher=Ens-newswire.com |access-date=31 December 2013}}</ref>