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Testing for adventitious presence of transgenic material in conventional seed or grain lots using quantitative laboratory methods: statistical procedures and their implementation

Published online by Cambridge University Press:  22 February 2007

Jean-Louis Laffont
Affiliation:
Pioneer Génétique, Chemin de l'Enseigure, 31840, Aussonne, France
Kirk M. Remund*
Affiliation:
Monsanto Company, 800 North Lindbergh Blvd., St. Louis, Missouri, 63167, USA
Deanne Wright
Affiliation:
Pioneer Hi-Bred International Inc., 7300 N.W. 62nd Avenue, Johnston, Iowa, 50131-1004, USA
Robert D. Simpson
Affiliation:
Monsanto Company, 800 North Lindbergh Blvd., St. Louis, Missouri, 63167, USA
Sylvain Grégoire
Affiliation:
GEVES, La Minière, 78 285 Guyancourt, Cedex, France
*
*Correspondence: Fax: +1 314 693 6673, Email: kirk.m.remund@monsanto.com
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Abstract

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When the laboratory methods employed are qualitative, the statistical methodologies used in testing for the adventitious presence (AP) of transgenic material in conventional seed and grain lots are well defined. However, when the response from the method used by the laboratory is quantitative (e.g. percent transgenic DNA), the statistical methodologies developed for qualitative laboratory methods are not fully appropriate. In this paper, we present the details of procedures specific to quantitative laboratory methods. In particular we consider: (1) the assessment of quantitative laboratory method errors using linear modelling; and (2) the process of deciding whether or not a lot meets pre-specified purity standards, including the development of probability calculations needed to develop operating characteristic curves and estimate consumer and producer risks for a given lower quality limit (LQL), acceptable quality limit (AQL) and testing plan. We also describe implementation of this approach in a useful spreadsheet application.

Information

Type
Research Article
Copyright
Copyright © Cambridge University Press 2005