37
Views
6
CrossRef citations to date
0
Altmetric
Research Articles

Assessing Risk of Unintended Antigen Occurrence in Food: A Case Instance for Maize-Expressed LT-B

, &
Pages 856-870 | Received 07 Nov 2005, Accepted 14 Dec 2005, Published online: 18 Jan 2007

REFERENCES

  • AgMRC (Agricultural Marketing Resource Center) . 2003 . The U.S. Corn Masa Industry: Structure and Implications for the Great Plains Region , Manhattan, KS, , USA : Prepared for AgMARC by Sparks Companies, Inc., Department of Agricultural Economics, Kansas State University .
  • Bannon , G , Fu , T-J Kimber , I . 2003 . Protein digestibility and relevance to allergenicity . Environ Health Persp , 111 : 1122 – 4 . [CSA]
  • Bucchini , L and Goldman , L R . 2002 . Starlink maize: A risk analysis . Environ Health Persp , 110 : 5 – 13 . [CSA]
  • Cheng , E , Cárdenas-Freytag , L and Clements , J D . 2000 . The role of cAMP in mucosal adjuvanticity of Escherichia coli heat-labile enterotoxin (LT) . Vaccine , 18 : 38 – 49 . [CROSSREF] [CSA]
  • Chikwamba , R K , McMurray , J Shou , H . 2002 . Expression of a synthetic E. coli heat-labile enterotoxin B sub-unit (LT-B) in maize . Molec Breed , 10 : 253 – 65 . [CROSSREF] [CSA]
  • Chikwamba , R K , Scott , M P Meja , L B . 2003 . Localization of a bacterial protein in starch granules of transgenic maize kernels . Proc Nat Acad Sci USA , 100 : 11127 – 32 . [INFOTRIEVE] [CROSSREF] [CSA]
  • Christensen , P , Misra , M K Rai , S . 2005 . “ Confined Production Processes for Non-Food Corn ” . In Biosafety Institute for Genetically Modified Agricultural Products , Ames, IA, , USA : Iowa State University .
  • Dickinson , B L and Clements , J D . 1996 . “ Use of Escherichia coli heat-labile enterotoxin as an oral adjuvant ” . In Mucosal Vaccines , Edited by: Kiyono , H , Ogra , P L and McGhee , J R . 73 – 87 . San Diego, CA, , USA : Academic Press, Inc. .
  • EC (European Commission) . 2000 . “ Report of the Scientific Steering Committee's Working Group on Harmonisation of Risk Assessment Procedures in the Scientific Committees advising the European Commission in the area of human and environmental health—26–27 October 2000 ” . Brussels, , Belgium : European Commission Directorate-General Health & Consumer Protection .
  • EFSA (European Food Safety Authority) . 2004 . Draft Guidance Document for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed , Brussels, , Belgium : European Food Safety Authority . April 2004
  • FAO (Food and Agriculture Organization) . 2001 . Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology, 2001 , Rome, , Italy : FAO/WHO . Evaluation of allergenicity of genetically modified foods. 22–25 Jan 2001
  • Gendel , S . 1998 . The use of amino acid sequence alignments to assess potential allergenicity of proteins used in genetically modified foods . Adv Food Nutr Res , 42 : 45 – 62 . [INFOTRIEVE] [CSA]
  • Guidry , J J , Cardenas , L Cheng , E . 1997 . Role of receptor binding in toxicity, immunogenicity, and adjuvanticity of E. coli heat labile enterotoxin . Infect Immun , 65 : 4943 – 50 . [INFOTRIEVE] [CSA]
  • HNRC (Human Nutrition Research Center) . 1998 . “ Continuing Survey of Food Intakes by Individuals (CSFII) 1994–96, 1998 Data File ” . Beltsville, Maryland, , USA : USDA Agricultural Research Service . NTIS PB2000-500027
  • Howard , J A and Donnelly , K C . 2004 . A quantitative safety assessment model for transgenic protein products produced in agricultural crops . J Agric Environ Ethics , 17 : 545 – 58 . [CROSSREF] [CSA]
  • IHC (International Conference on Harmonisation) . 1997 . Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals , ICH Harmonised Tripartite Guideline S6 Geneva, , Switzerland : ICH Secretariat . 16 July 1997
  • Kodell , R L and Gaylor , D W . 1999 . Combining uncertainty factors in deriving human exposure levels of noncarcinogenic toxicants . Annals NY Acad Sci , 895 : 188 – 95 . [CROSSREF] [CSA]
  • Lamphear , B J , Streatfield , S J Jilka , J M . 2002 . Delivery of subunit vaccines in maize seed . J Controlled Release , 85 : 169 – 80 . [CROSSREF] [CSA]
  • Ma , J K-C , Drake , P MW and Christou , P . 2003 . The production of recombinant pharmaceutical protein in plants . Nature Reviews Genetics , 4 : 794 – 805 . [INFOTRIEVE] [CROSSREF] [CSA]
  • Macilwain , C . 2005 . US launches probe into sales of unapproved transgenic corn . Nature , 434 : 423 [INFOTRIEVE] [CROSSREF] [CSA]
  • Millar , G G , Hirst , T R and Snider , D P . 2001 . Escherichia coli heat-labile enterotoxin B subunit is a more potent mucosal adjuvant than its closely related homologue, the B subunit of cholera toxin . Infection Immun , 69 : 3476 – 82 . [CROSSREF] [CSA]
  • NASS (National Agricultural Statistics Service) . 2005 . Crop Production Acreage Supplement 30 June 2005. Available at http://usda.mannlib.cornell.edu/reports/nassr/field/pcp-bba/acrg0605.txt,
  • Petersen , B J , Rachman , N J and Watters , J L . 2001 . “ Estimated Potential Dietary Intake of Cry9c Protein Based on Measurements of Cry9c In Processed Foods Made from 100% Starlink Corn ” . Available at http://www.epa.gov/pesticides/biopesticides/pips/old/stlink/starlink_01-01_86-5_report_final.pdf
  • Peterson , R KD and Arntzen , C J . 2004 . On risk and plant-based biopharmaceuticals . Trends Biotechnol , 22 : 64 – 6 . [INFOTRIEVE] [CROSSREF] [CSA]
  • Samyn-Petit , B , Gruber , V Flahaut , C . 2001 . N-glycosylation potential of maize: The human lactoferrin used as a model . Glycoconjugate J , 18 : 519 – 27 . [CROSSREF] [CSA]
  • SOT (Society of Toxicology) . 2002 . Proceedings of the Workshop on Non-clinical Safety Evaluation of Preventive Vaccines: Recent Advances and Regulatory Considerations Available at http://www.toxicology.org/ai/meet/cct-vaccines.asp
  • Streatfield , S J , Mayor , J M Barker , D K . 2002 . Development of an edible subunit vaccine in corn against enterogenic strains of Eschericia coli . In Vitro Cell Dev—Plant , 38 : 11 – 17 . [CROSSREF] [CSA]
  • Tacket , C O , Mason , H S Losonsky , G . 1998 . Immunogenicity in humans of a recombinant bacterial antigen delivered in a transgenic potato . Nature Medicine , 4 : 607 – 9 . [INFOTRIEVE] [CROSSREF] [CSA]
  • Takeda , Y , Honda , T Taga , S . 1981 . In vitro formation of hybrid toxins between subunits of Escherichia coli heat-labile enterotoxin and those of cholera enterotoxin . Infection Immun , 34 : 341 – 6 . [CSA]
  • USDA (United States Department of Agriculture) . 2002 . USDA investigates biotech company for possible permit violations Available at http://www.aphis.usda.gov/lpa/news/2002/11/prodigene.html
  • USEPA (United States Environmental Protection Agency) . 1998 . Bacillus thuringiensis Subspecies tolworthi Cry9C Protein and the Genetic Material Necessary for its Production in Corn; Exemption from the Requirement of a Tolerance Related Material . Federal Register , 63 : 28258 – 61 . [CSA]
  • USEPA (US Environmental Protection Agency) . 2001a . “ Pesticide Fact Sheet: Bacillus thuringiensis subspecies Cry1F Protein and the Genetic Material Necessary for Its Production (Plasmid Insert PHI 8999) in Corn ” . Washington, DC, , USA : EPA Office of Prevention, Pesticides, and Toxic Substances .
  • USEPA (US Environmental Protection Agency) . 2001b . Biopesticides Registration Action Document—Bacillus thuringiensis Plant-Incorporated Protectants , Washington, DC, , USA : EPA Office of Prevention, Pesticides, and Toxic Substances .
  • USEPA (US Environmental Protection Agency) . 2003 . CSFII Analysis of Food Intake Distributions , Washington, DC, , USA : EPA Risk Assessment Forum . EPA/600/R-03/029
  • USFDA (US Food and Drug Administration) . 2003 . Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals, Draft Guidance , Washington, DC, , USA : FDA Center for Biologics Evaluation and Research .
  • Wang , K , Chikwamba , R and Cunnick , J . 2004 . “ Plant-based oral vaccines ” . In Novel Vaccination Strategies , Edited by: Kaufmann , S HE . Weinheim, , Germany : Wiley-VCH Verlag . Ch. 18
  • Williams , N A . 2000 . Immune modulation by the cholera-like enterotoxin B-subunits: From adjuvant to immunotherapeutic . Intl J Med Microbiol , 290 : 447 – 53 . [CSA]
  • Wolt , J D and Peterson , R KD . 2000 . Agricultural biotechnology and societal decision-making: The role of risk analysis . AgBioForum , 3 : 291 – 8 . [CSA]
  • Wolt , J D , Shyy , Y-Y Christensen , P . 2004 . Quantitative exposure assessment for confinement of maize biogenic systems . Environ Biosafety Res , 3 : 183 – 96 . [INFOTRIEVE] [CROSSREF] [CSA]

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.