International development of methods of analysis for the presence of products of modern biotechnology.

Abstract

Methods of analysis for products of modern biotechnology are required for national and international trade in seeds, grain and food in order to meet the labeling or import/export requirements of different nations and trading blocks. Although many methods were developed by the originators of transgenic events, governments, universities, and testing laboratories, trade is less complicated if there exists a set of international consensus-derived analytical standards. In any analytical situation, multiple methods may exist for testing for the same analyte. These methods may be supported by regional preferences and regulatory requirements. However, tests need to be sensitive enough to determine low levels of these traits in commodity grain for regulatory purposes and also to indicate purity of seeds containing these traits. The International Organization for Standardization (ISO) and its European counterpart have worked to produce a suite of standards through open, balanced and consensus-driven processes. Presently, these standards are approaching the time for their first review. In fact, ISO 21572, the "protein standard" has already been circulated for systematic review. In order to expedite the review and revision of the nucleic acid standards an ISO Technical Specification (ISO/TS 21098) was drafted to set the criteria for the inclusion of precision data from collaborative studies into the annexes of these standards.