Characteristics and safety assessment of intractable proteins in genetically modified crops

被引：33

作者：

Bushey, Dean F. ^{[1
]}

Bannon, Gary A. ^{[2
]}

Delaney, Bryan F. ^{[3
]}

Graser, Gerson ^{[4
]}

Hefford, Mary ^{[5
]}

Jiang, Xiaoxu ^{[6
]}

Lee, Thomas C. ^{[2
]}

Madduri, Krishna M. ^{[7
]}

Pariza, Michael ^{[8
]}

Privalle, Laura S. ^{[6
]}

Ranjan, Rakesh ^{[1
]}

Saab-Rincon, Gloria ^{[9
]}

Schafer, Barry W. ^{[7
]}

Thelen, Jay J. ^{[10
]}

Zhang, John X. Q. ^{[3
]}

Harper, Marc S. ^{[3
]}

机构：

[1] Bayer CropSci, Res Triangle Pk, NC 27709 USA

[2] Monsanto Co, Global Regulatory, St Louis, MO 63167 USA

[3] DuPont Pioneer, Johnston, IA 50131 USA

[4] Syngenta Biotechnol Inc, Res Triangle Pk, NC 27709 USA

[5] Sir Frederick G Banting Res Ctr, Biol Res Ctr, Ottawa, ON K1A 0K9, Canada

[6] BASF Plant Sci LP, Res Triangle Pk, NC 27709 USA

[7] Dow AgroSci, Indianapolis, IN 46268 USA

[8] Univ Wisconsin, Dept Food Sci, Madison, WI 53706 USA

[9] Univ Nacl Autonoma Mexico, Inst Biotecnol, Dept Ingn Celular & Biocatalisis, Cuernavaca 62250, Morelos, Mexico

[10] Univ Missouri, Div Biochem, Christopher S Bond Life Sci Ctr, Columbia, MO 65211 USA

来源：

REGULATORY TOXICOLOGY AND PHARMACOLOGY | 2014年 / 69卷 / 02期

关键词：

Genetically modified (GM) crops; Intractable proteins; Food safety; Membrane proteins; Signaling proteins; Transcription factors; N-glycosylated proteins; Resistance proteins; Weight-of-evidence approach; ALPHA-AMYLASE INHIBITORS; PHASEOLUS-VULGARIS LECTINS; RESISTANCE GENE-PRODUCT; MEMBRANE-PROTEIN; DIACYLGLYCEROL ACYLTRANSFERASE; TRANSCRIPTION-FACTOR; N-GLYCOSYLATION; PHOSPHOENOLPYRUVATE CARBOXYLASE; ARABIDOPSIS-THALIANA; DISEASE RESISTANCE;

D O I：

10.1016/j.yrtph.2014.03.003

中图分类号：

DF [法律]; D9 [法律]; R [医药、卫生];

学科分类号：

0301 ; 10 ;

摘要：

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. (C) 2014 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license.

引用

页码：154 / 170

页数：17

共 148 条

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