Evaluation of protein safety in the context of agricultural biotechnology

被引：123

作者：

Delaney, Bryan ^{[10
]}

Astwood, James D. ^{[8
]}

Cunny, Helen ^{[9
]}

Conn, Robin Eichen ^{[7
]}

Herouet-Guicheney, Corinne ^{[6
]}

MacIntosh, Susan ^{[5
]}

Meyer, Linda S. ^{[4
]}

Privalle, Laura ^{[3
]}

Gao, Yong ^{[2
]}

Mattsson, Joel ^{[2
]}

Levine, Marci ^{[1
]}

机构：

[1] Int Life Sci Inst, Washington, DC USA

[2] Dow AgroSci, Indianapolis, IN USA

[3] BASF, Res Triangle Pk, NC USA

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

[5] MacIntosh & Associates, St Paul, MN USA

[6] Bayer CropSci, Sophia Antipolis, France

[7] Cargill Inc, Wayzata, MN USA

[8] Monsanto Co, St Louis, MO USA

[9] Bayer CropSci LP, Res Triangle Pk, NC USA

[10] Pioneer HiBred Int Inc, Johnston, IA USA

来源：

FOOD AND CHEMICAL TOXICOLOGY | 2008年 / 46卷

关键词：

novel protein; biotechnology; GM; safety assessment; hazard; case study;

D O I：

10.1016/j.fct.2008.01.045

中图分类号：

TS2 [食品工业];

学科分类号：

0832 ;

摘要：

One component of the safety assessment of agricultural products produced through biotechnology is evaluation of the safety of newly expressed proteins. The ILSI International Food Biotechnology Committee has developed a scientifically based two-tiered, weight-of-evidence strategy to assess the safety of novel proteins used in the context of agricultural biotechnology. Recommendations draw upon knowledge of the biological and chemical characteristics of proteins and testing methods for evaluating potential intrinsic hazards of chemicals. Tier I (potential hazard identification) includes an assessment of the biological function or mode of action and intended application of the protein, history of safe use, comparison of the amino acid sequence of the protein to other proteins, as well as the biochemical and physico-chemical properties of the proteins. Studies outlined in Tier II (hazard characterization) are conducted when the results from Tier I are not sufficient to allow a determination of safety (reasonable certainty of no harm) on a case-by-case basis. These studies may include acute and repeated dose toxicology studies and hypothesis-based testing. The application of these guidelines is presented using examples of transgenic proteins applied for agricultural input and output traits in genetically modified crops along with recommendations for future research considerations related to protein safety assessment. (C) 2008 ILSI. Published by Elsevier Ltd. All rights reserved.

引用

页码：S71 / S97

页数：27

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