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Characteristics and safety assessment of intractable proteins in genetically modified crops.
Bushey, Dean F; Bannon, Gary A; Delaney, Bryan F; Graser, Gerson; Hefford, Mary; Jiang, Xiaoxu; Lee, Thomas C; Madduri, Krishna M; Pariza, Michael; Privalle, Laura S; Ranjan, Rakesh; Saab-Rincon, Gloria; Schafer, Barry W; Thelen, Jay J; Zhang, John X Q; Harper, Marc S.
Afiliación
  • Bushey DF; Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709-2014, USA. Electronic address: dean.bushey@bayer.com.
  • Bannon GA; Monsanto Company, Global Regulatory, 800 North Lindbergh Boulevard, St. Louis, MO 63167, USA.
  • Delaney BF; DuPont Pioneer, 7300 NW 62nd Avenue, P.O. Box 1004, Johnston, IA 50131, USA.
  • Graser G; Syngenta Biotechnology, Inc., P.O. Box 12257, 3054 East Cornwallis Road, Research Triangle Park, NC 27709-2257, USA.
  • Hefford M; Centre for Biologics Research, Sir Frederick G. Banting Research Centre, 251 Promenade Sir Frederick Banting Driveway, Ottawa, Ontario K1A 0K9, Canada.
  • Jiang X; BASF Plant Science, L.P., Regulatory Science, 26 Davis Drive, Research Triangle Park, NC 27709-3528, USA.
  • Lee TC; Monsanto Company, Global Regulatory, 800 North Lindbergh Boulevard, St. Louis, MO 63167, USA.
  • Madduri KM; Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN 46268, USA.
  • Pariza M; Department of Food Science, University of Wisconsin-Madison, 1550 Linden Drive, Madison, WI 53706, USA.
  • Privalle LS; BASF Plant Science, L.P., Regulatory Science, 26 Davis Drive, Research Triangle Park, NC 27709-3528, USA.
  • Ranjan R; Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709-2014, USA.
  • Saab-Rincon G; Departamento de Ingeniería Celular y Biocatálisis, Instituto de Biotecnología, Universidad Nacional Autónoma de México, AP 510-3, CP 62250 Cuernavaca, Morelos, Mexico.
  • Schafer BW; Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN 46268, USA.
  • Thelen JJ; University of Missouri, Division of Biochemistry, Christopher S. Bond Life Sciences Center, Columbia, MO 65211, USA.
  • Zhang JX; DuPont Pioneer, 7300 NW 62nd Avenue, P.O. Box 1004, Johnston, IA 50131, USA.
  • Harper MS; DuPont Pioneer, 7300 NW 62nd Avenue, P.O. Box 1004, Johnston, IA 50131, USA.
Regul Toxicol Pharmacol ; 69(2): 154-70, 2014 Jul.
Article en En | MEDLINE | ID: mdl-24662477
Genetically modified (GM) crops may contain newly expressed proteins that are described as "intractable". Safety assessment of these proteins may require some adaptations to the current assessment procedures. Intractable proteins are defined here as those proteins with properties that make it extremely difficult or impossible with current methods to express in heterologous systems; isolate, purify, or concentrate; quantify (due to low levels); demonstrate biological activity; or prove equivalency with plant proteins. Five classes of intractable proteins are discussed here: (1) membrane proteins, (2) signaling proteins, (3) transcription factors, (4) N-glycosylated proteins, and (5) resistance proteins (R-proteins, plant pathogen recognition proteins that activate innate immune responses). While the basic tiered weight-of-evidence approach for assessing the safety of GM crops proposed by the International Life Sciences Institute (ILSI) in 2008 is applicable to intractable proteins, new or modified methods may be required. For example, the first two steps in Tier I (hazard identification) analysis, gathering of applicable history of safe use (HOSU) information and bioinformatics analysis, do not require protein isolation. The extremely low level of expression of most intractable proteins should be taken into account while assessing safety of the intractable protein in GM crops. If Tier II (hazard characterization) analyses requiring animal feeding are judged to be necessary, alternatives to feeding high doses of pure protein may be needed. These alternatives are discussed here.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas de Plantas / Seguridad / Plantas Modificadas Genéticamente / Productos Agrícolas / Alimentos Modificados Genéticamente Tipo de estudio: Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Animals Idioma: En Revista: Regul Toxicol Pharmacol Año: 2014 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
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XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas de Plantas / Seguridad / Plantas Modificadas Genéticamente / Productos Agrícolas / Alimentos Modificados Genéticamente Tipo de estudio: Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Animals Idioma: En Revista: Regul Toxicol Pharmacol Año: 2014 Tipo del documento: Article Pais de publicación: Países Bajos