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PERSPECTIVES

Quality Control in the Development of Transgenic Crop Seed Products

^a GeneMax Services, 4002 Turnberry Drive, Champaign, IL 61822
^b DuPont Crop Genetics, Experiment Station, Room 402E/3224, Wilmington, DE 19880

* Corresponding author (rita.mumm{at}genemaxservices.com)

ABSTRACT

In light of (i) public concern with the safety of genetically modified crops, (ii) the issue of food labeling, and (iii) governmental regulation of transgenic plants, quality control (QC) monitoring of the process of Transgenic Seed Product Development (TSPD) is essential to protecting research investments, maintaining compliance with governmental regulations, and ensuring customer satisfaction. The primary goal of QC monitoring in TSPD is to ensure the authenticity (transgenic event identity and purity) of seed materials used in product testing, in the development of regulatory data packages for governmental review, and to develop seed volumes for commercial release. Monitoring is performed to confirm the presence of the presumed transgenic event(s) and the absence of all others. Sophisticated QC strategies formulated to monitor the product development process and to maintain quality standards in the manufacturing industry can serve as a foundation in devising efficient strategies tailored to meet needs in the seed industry. A number of considerations in the design of an optimized QC monitoring plan for TSPD are discussed, including: costs vs. economic benefits of developing and commercializing nondefective products; effective timing of inspections; joint scheduling of inspections with other genetic analyses; assay methods that maximize screening efficiency, flexibility, and accuracy; sampling vs. 100% assessment of transgenic populations; the ability to bulk samples to minimize data point requirements; and the need to minimize or eliminate inspection errors. An overview of the general process of TSPD and an example QC monitoring strategy for corn (Zea mays L.) are provided.

Abbreviations: BC1, generation resulting from the first backcross to the recurrent parent (BC2–BC6 follow the same convention with the specific generation designated) • EPA, Environmental Protection Agency • FDA, Food and Drug Administration • PCR, polymerase chain reaction • QC, quality control • R&D, research and development • S1, first generation after self-pollination (S2–S3 follow the same convention with the specific generation designated) • TSPD, Transgenic Seed Product Development • T0, generation resulting from regenerated transformed cells • T1, first generation after transformation • T2, second generation after transformation

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This issue in Crop science

Crop Science 2001 41: 1379-1380. [Full Text]  

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				R. H. Mumm Backcross versus Forward Breeding in the Development of Transgenic Maize Hybrids: Theory and Practice Crop Sci., December 18, 2007; 47(Supplement_3): S-164 - S-171. [Abstract] [Full Text] [PDF]