StarLink corn recall

The StarLink corn recalls occurred in the autumn of 2000, when over 300 food products were found to contain a genetically modified corn that had not been approved for human consumption.[1] It was the first-ever recall of a genetically modified food. The anti-GMO activist coalition Genetically Engineered Food Alert, which detected and first reported the contamination, was critical of the FDA for not doing its job. The recall of Taco Bell-branded taco shells, manufactured by Kraft Foods and sold in supermarkets, was the most publicized of the recalls. One settlement resulted in $60 million going to Taco Bell franchisees for lost sales due to the damage to the Taco Bell brand.

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Genetic engineering
 
Genetically modified organisms
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StarLink is a genetically modified maize, containing two modifications: a gene for resistance to glufosinate, and a variant of the bacillus thuringiensis (Bt) protein called Cry9C.[2] Cry9C had not been used in a GM crop prior to StarLink, causing heightened regulatory scrutiny.[3] StarLink's creator, Plant Genetic Systems, which later became Aventis CropScience during the time of the incident,[4]:15–16 had applied to the US Environmental Protection Agency (EPA) to market StarLink for use in animal feed and in the human food supply.[4]:14 However, because the Cry9C protein lingers in the digestive system before breaking down, the EPA had concerns about its allergenicity, and PGS did not provide sufficient data to prove that Cry9C was not allergenic.[5]:3 As a result, PGS split its application into separate permits for use in food and use in animal feed only.[3][6] StarLink was approved by the EPA for use in animal feed only in May 1998. After the incident the company at first tried to get the application for human consumption approved, and then withdrew the product entirely from the market.[4]:15

The Garst Seed Company (part of the Advanta group) was licensed by Aventis to produce and sell StarLink seed in the US.[7]:8

Product recalls
A taco with a hard taco shell

In 2000, Genetically Engineered Food Alert was launched by seven organizations (Center for Food Safety, Friends of the Earth, Institute for Agriculture and Trade Policy, National Environmental Trust, Organic Consumers Association, Pesticide Action Network North America, and The State PIRGs) to lobby the FDA, Congress and companies to ban or stop using GMOs.[8][9][10] One of their activities was testing food for the presence of GMOs via a lab called Genetic ID, the vice president of which was Jeffrey M. Smith.[11][12]

On September 18, 2000, Genetically Engineered Food Alert released a statement that Genetic ID had conducted tests on "Taco Bell Home Originals" brand taco shells, made by Kraft Foods that had been purchased in a grocery store near Washington, DC, and had detected StarLink;[13] the story was reported on by The Washington Post.[4]:15[12] Kraft distributed the Taco Bell-branded taco shells under a 1996 license agreement with Taco Bell.[14]:54

Kraft had bought the shells from a Sabritas plant in Mexicali which used flour supplied from an Azteca mill plant in Plainview, Texas. The Texas mill used flour from six states supplied by elevators that did not segregate their genetically modified and conventionally-grown corn at the time. Kraft also suspended production of the recalled products.[15][16][17] "All of us — government, industry and the scientific community — need to work on ways to prevent this kind of situation from ever happening again," said Betsy Holden, Kraft's chief executive in September 2000. She also stated that food safety and legal compliance were Kraft's main priority.[18]

Safeway later announced it would recall its store brand taco shells at the recommendation of a consumer group on October 12, 2000. This was done as a precaution, and no StarLink was confirmed to be found in any of the products[19] On October 13 and 14, Mission Foods voluntary recalled about 300 products.[20][21] On October 22, 2000 it was reported that Kellogg's had shut down a plant as a precaution because they couldn't guarantee that StarLink corn flour had not been supplied to the plant.[22]

On October 26, 2000 StarLink corn was reported to be found in Japan and South Korea.[4]:20–21 The market and distribution network for corn in the US was thrown into disarray through 2001, as there were no existing means to segregate the grain;[23][24] the disarray eventually eased due to the Aventis' testing and buyback program discussed below.[25]

Aventis recall/buyback

In January 2001 under a written agreement with 17 US states,[26] Aventis initiated a program called the StarLink Enhanced Stewardship (SES) program, under which StarLink corn, buffer corn, and any corn stored in grain elevators that had become mixed with StarLink, would be bought by Aventis and directed to animal feed and non-food industrial use (e.g. ethanol production); the program included free kits to test for StarLink, and covered costs of cleaning equipment, transport, and storage facilities, as well as increased transportation costs.[27]:193–95 Aventis estimated the cost would be between $100 million to $1 billion.[28][29][30]

It was estimated that due to grain mixing StarLink corn could have existed in more than 50% of the US corn supply[2] and that overall, the StarLink incident depressed the price of US corn about 7% for about a year.[31]:533

Aftermath

Following the recalls, 51 people reported adverse effects to the FDA; these reports were reviewed by the US Centers for Disease Control (CDC), which determined that 28 of them were possibly related to StarLink.[32] The CDC studied the blood of these 28 individuals and concluded there was no evidence the reactions these people experienced were associated with hypersensitivity to the StarLink Bt protein.[33]

The EPA was criticized by Joseph Mendelson III of the Center for Food Safety, who said "Clearly they didn't do anything here until they became embarrassed."[34] The EPA and Aventis were also criticized for statements at the time of the recall that indicated they had no idea such a thing would happen.[35] "If there has been a violation of our licensing process, then we would have a very great concern," was attributed to Stephen Johnson of the EPA. Margaret Gadsby of Aventis was quoted with her earlier statement "We have difficulty imagining how our corn could end up in the human food supply."

The registration for the StarLink varieties was voluntarily withdrawn by Aventis in October 2000.[36]:7 In February 2001, it was announced that the president, general counsel, and vice president of market development for Aventis CropScience (US), had been fired in response to the recall.[37]

In June 2001 Tricon Global Restaurants, 20% owners of Taco Bell at the time, announced a $60 million settlement with some of the suppliers of the supermarket taco shells; under the terms of the settlement they could not disclose the identity of suppliers.[38] Tricon stated that the settlement would go to Taco Bell franchisees and Tricon would not receive any of it. Tricon also announced that it, along with the suppliers and franchisees, would initiate litigation against the parties responsible for StarLink entering the food chain.

In September 2001, a group of about 5,000 Taco Bell franchisees and a handful of taco shell suppliers brought a class-action lawsuit against Aventis, Garst Seed Co.; Gruma Corp., ("the largest producer and distributor of corn flour and tortillas in the United States) and Azteca Milling seeking damages.[39] This suit was voluntarily dismissed in December 2001.[40]:65

In 2002, Aventis, Garst, Kraft Foods, Azteca Foods, Azteca Milling, and Mission Foods settled a lawsuit brought by two people, and the grandmother of a third, who claimed to have had allergic reactions to StarLink, for $9 million.[41]

In 2002, nongovernmental organizations claimed that 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.[42]:96

In 2003, farmers who did not plant StarLink who had suffered economic losses due to depressed corn prices following the StarLink recalls settled a class-action lawsuit against Aventis and Advanta for $100 million.[43]

GeneWatch UK and Greenpeace International set up the GM Contamination Register in 2005 citing these recalls as one of the "highlights" of the register.[44]

The US corn supply was monitored by the Federal Grain Inspection Service for the presence of the StarLink Bt proteins from 2001 until 2010.[45][46]

Later incidents

In August 2013, StarLink corn was reported to be found again contaminating some foods in Saudi Arabia.[47]

See also

References
  1. Andrew Pollack for the New York Times. September 23, 2000 Kraft Recalls Taco Shells With Bioengineered Corn
  2. Staff, Cornell Cooperative Extension, 2002. Genetically Engineered Foods: StarLink Corn in Taco Shells
  3. Michael R. Taylor and Jody S. Tick of Resources for the Future, Pew Initiative on Food and Biotechnology. The StarLink Case: Issues for the Future Archived 2013-09-21 at the Wayback Machine
  4. "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." Staff, EPA. November 2000 Executive Summary: EPA Preliminary Evaluation of Information Contained in the October 25, 2000 Submission from Aventis Cropscience
  5. Plant Genetic Systems (America) Inc.: PP 7G4921 Federal Register Vol. 62, No. 228, November 26, 1997 pp 63169 bottom of middle column - 63170 right column; see especially p63169 top of right column
  6. Marion Nestle. Safe Food: The Politics of Food Safety University of California Press, 2010
  7. Internet Archive capture of Genetically Engineered Food Alert webpage, August 17, 2000
  8. Margot Roosevelt for Time Magazine. Monday, Jul. 31, 2000 Inside The Protests: Taking It To Main Street
  9. Staff, The Progress Report. New Coalition Acts Against GM Food Dangers
  10. Andrew Pollack for the New York Times. October 12, 2000 Safeway Recalls Taco Shells After Test Questions Corn Origin
  11. Marc Kaufman for the Washington Post. September 18, 2000 Biotech Critics Cite Unapproved Corn in Taco Shells; Gene-Modified Variety Allowed Only for Animal Feed Because of Allergy Concerns
  12. Press Release Contaminant found in Taco Bell taco shells. Food safety coalition demands recall (press release) Washington, DC: Friends of the Earth, 2000. Available: 3 November 2001.
  13. "Management Communication - A Case Analysis Approach, 5th Ed, James S. O'Rourke, IV" (PDF).
  14. Kraft Foods Press Release September 25, 2000 Press Release: USA: Kraft Foods announces voluntary recall of all Taco Bell Taco Shell products from grocery stores
  15. Fulmer, M. (September 23, 2000). "Taco Bell Recalls Shells That Used Bioengineered Corn". The Los Angeles Times. Retrieved August 3, 2013.
  16. Staff, CNN October 18, 2000 ConAgra stops producing corn flour at Kansas mill as precaution against genetically modified grain
  17. Philip Brasher for ABC News. September 23, 2000. Kraft Recalls Biotech Taco Shells
  18. Staff, CNN. October 12, 2000 Safeway recalls its taco shells
  19. Staff, CNN. November 1, 2000 Scope of biotech corn product recall revealed: More than 300 items on FDA list
  20. Staff, CNN. November 1, 2000 FDA list of recalled products for "Tortillas, Shells, Tostadas, and Chips Recall #F-023/026-1"
  21. Staff, CNN October 22, 2000. Kellogg's plant stops production after engineered-corn scare
  22. David Barboza for the New York Times. December 11, 2000 Gene-Altered Corn Changes Dynamics Of Grain Industrypagewanted=all&src=pm
  23. WIlliam Lin, Gregory K. Price, and Edward Allen. StarLink: Impacts on the U.S. Corn Market and World Trade (2001). pp 46-54 in Feed Situation and Outlook Yearbook, April 2001 by United States Dept. of Agriculture Economic Research Service
  24. William Lin, Gregory K. Price, Edward W. Allen StarLink: Impacts on the U.S. corn market and world trade (2003) Agribusiness 01/2003; 19(4):473-488.
  25. Michael Howie for Feedstuffs. January 29, 2001 Aventis, states reach agreement over StarLink corn
  26. D. L. Uchtmann. StarLink: A Case Study of Agricultural Biotechnology regulation Drake Journal of Agricultural Law Vol. 7, 2002: 159-211
  27. Philip Brasher for ABC News. September 29, 2000. Biotech Company to Reimburse Farmers for Banned Corn
  28. Sarah Lueck, Amy Merrick, Joel Millman And Stephen D. Moore for the Wall Street Journal. November 3, 2000. Corn-Recall Cost Could Reach Into the Hundreds of Millions
  29. Note: Despite long searching, as of October 2013 editors could find no reliable source reporting on the actual cost of the StarLink buyback to Aventis. The task is complicated due to the sale of Aventis CropScience to Bayer in October 2001, in which Aventis agreed to retain liability for matters related to StarLink (CNN News, October 2, 2001), the subsequent merger of Sanofi and Aventis in 2004 (Sanofi company history, Official site), and the fact that Aventis and Sanofi are not US companies and their regulatory filings are not in English. In a financial regulatory filing submitted to the US Securities and Exchange Commission in March 2003, in which Aventis provided consolidated financial reporting for the years 2000-2002, Aventis described the sale of Aventis CropScience to Bayer and communicated that it had indemnified Bayer for all matters related to StarLink and other environmental liabilities and that the sale had netted Aventis €4.2B, and "This sale resulted in a gain for Aventis of €2.07 billion after provisions for indemnification related to the StarLink litigation, as well as environmental, tax, and product liability indemnification as stipulated in the Share Purchase Agreement between Aventis and Bayer."(Aventis Form F-20 for calendar years 2000-2002, F-43) Therefore Aventis seems to have reserved about €2.1B euros in 2003, which at that time was US$2.3B.
  30. Colin A. Carter and Aaron Smith Estimating the Market Effect of a Food Scare: The Case of Genetically Modified StarLink Corn. The Review of Economics and Statistics Aug., 2007 Vol. 89(3): 522-533
  31. Staff, EPA review committee. LLP Incidents
  32. "Health Studies: Cry9c Report: Home | CDC HSB". www.cdc.gov.
  33. Pollack, Andrew (September 4, 2001), "Altered Corn Surfaced Earlier", New York Times, New York, p. 1, retrieved August 7, 2013
  34. Pollack, Andrew (September 4, 2001), "Altered Corn Surfaced Earlier", New York Times, New York, p. 2, retrieved August 7, 2013
  35. Janet E. Carpenter and Leonard P. Gianessi, US National Center for Food and Agricultural Policy. 2001. Agricultural Biotechnology: Updated Benefit Estimates,
  36. Clark, A.; Martinson, J. (February 12, 2001). "Aventis chiefs in GM blunder sacked". The Guardian. Retrieved August 7, 2013.
  37. Taco Bell Rings up $60 Million for StarLink-Contaminated Shells, Louisville, KY: Virgo Publishing, June 12, 2001, archived from the original on October 20, 2013, retrieved August 7, 2013
  38. Associated Press, September 19, 2001. Taco Bell Sues Over StarLink Corn Fiasco
  39. Gruma Gruma Annual Report for the fiscal year ended December 31, 2002, Form 20-F
  40. Staff, Livestock Weekly. March 14, 2002 Judge Okays $9 Million Payoff In Lawsuit Over StarLink Corn
  41. Jennifer Clapp. Hunger in the Balance: The New Politics of International Food Aid. Cornell University Press, 2012 ISBN 9780801464409
  42. Staff, Farm and Dairy News. March 27, 2003 StarLink in class action settlement
  43. "First on-line worldwide register of GM contamination incidents launched today". genewatch.org. Retrieved 23 September 2013.
  44. "StarLink Corn Regulatory Information". Environmental Protection Agency (EPA). April 2008.
  46. Elsanhoty, R. M.; Al-Turki, A. I.; Ramadan, M. F. (2013). "Prevalence of Genetically Modified Rice, Maize, and Soy in Saudi Food Products". Applied Biochemistry and Biotechnology. 171 (4): 883–99. doi:10.1007/s12010-013-0405-x. PMID 23904260. S2CID 28533048.
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