Quality control in the development of transgenic crop seed products
2001
Mumm, R.H. | Walters, D.S.
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.
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