The Plant Product Life-Cycle
The Research and Discovery stage includes activities to identify and evaluate the specific genes and other elements that may be used to produce or construct a new plant product through biotechnology. Stewardship for this stage of the product life cycle includes assuring that the processes for design and construction result in the intended product and that plant product integrity is maintained.
The Product Development stage includes activities that occur before a biotechnology-derived plant product can be commercialized. These activities include plant transformation and regeneration, event selection in contained facilities or confined field trials, and event evaluation to determine suitability for intended use and to generate data for regulatory submissions. Stewardship for this stage of the life cycle includes assuring that systems are in place to maintain plant product integrity, achieve regulatory compliance, manage product launch, and plan for effective and proper product use to sustain its value.
The Seed or Plant Production stage includes activities designed to ensure that plant products are grown according to defined standards to meet product specifications for purity and performance.
The Marketing and Distribution stage includes activities related to the distribution of product through both the internal supply chain and the external distribution chains to customers. Prior to the commercial sale of any biotechnology-derived seed or plant product, the product developer or its licensee should have secured all necessary regulatory authorizations in the country of launch as well as in key import markets.
The Crop Production stage includes activities involved in the cultivation for harvest of an authorized, commercially available biotechnology-derived seed or plant.
The Crop Utilization stage includes the use of biotechnology-derived plant products for food, feed, fiber or other purposes (e.g., biofuels, industrial applications).
The Product Discontinuation stage includes activities involving products that were authorized for commercial use, but have since reached the end of their commercial life cycle. This activity is a planned part of the product life cycle and is separate and distinct from product withdrawals and recalls. Discontinuation of a product is a business decision, and takes into account many factors. These include prevailing regulatory requirements, market forces and product replacement. Discontinuation is recognized by the industry as a normal part of the product life cycle.