Commercialization requires significant effort in several areas:
- Scientific capability: Is it possible to develop the crop⁄trait combination to yield the desired result?
- Intellectual property: Does the developer have the freedom to use the transformation method, and can the developer establish and maintain intellectual property on the invention or crop?
- Market realities: Is there a market for the crop?
- Regulations: Can the developer afford the costs associated with the various governmental regulatory requirements and can these be achieved?
To be commercialized and grown without restrictions, GE crops must go through an extensive food, feed, and environmental safety assessment process to prove that they are “substantially equivalent” to comparable non-GE crops.
SUBSTANTIAL EQUIVALENCE requires a prohibitive amount of data, some of which may duplicate existing data.
Estimates of the cost of meeting regulatory requirements (deregulation cost) for GE crops range from $20–30 million to over $100 million per new GM event.
- Phase 1. Construct optimization, use in target crop
- Phase 2. Trait development, preregulatory data, large-scale transformation
- Phase 3. Trait integration, field testing, regulatory data generation (if applicable)
- Phase 4. Regulatory submission (if applicable), seed bulk-up, pre-marketing
5.5 years to generate the data required for a regulatory dossier
Prohibitive costs limit commercial viability to high-value traits and crops.