Regulating transgenic crops: a comparative analysis of different regulatory processes

Transgenic Res. 2004 Feb;13(1):5-19. doi: 10.1023/b:trag.0000017198.80801.fb.


Transgenic crops have the potential to benefit both developed and developing countries. To ensure safe crops to humans and the environment, a strong, but not stifling, regulatory system needs to be established and properly implemented. This paper explores some essential components of a strong regulatory structure for transgenic crops. First, five different regulatory systems for transgenic crops--the United States, the European Union, South Africa, Taiwan, and Argentina--are described and explained. The major components of those systems are then compared to components necessary to a regulatory system that ensures safe products and engenders public trust. The key components discussed include: (1) mandatory pre-market approval; (2) established safety standards; (3) transparency; (4) public participation; (5) use of outside scientists for expert scientific advice; (6) independent agency decisions; (7) post-approval activities; and (8) enforcement authority and resources. Although no one of the existing systems analyzed adequately achieves all the necessary components of a strong regulatory system, those systems serve as models for deciding which regulatory procedures should be emulated and which should be avoided. A mandatory pre-market approval system that applies established safety standards in procedures that are transparent and allows for public participation with no pre-conceived notions or biases will best achieve both safe products and consumer trust.

Publication types

  • Comparative Study
  • Review

MeSH terms

  • Argentina
  • Consumer Product Safety
  • Crops, Agricultural / genetics*
  • European Union
  • Legislation, Food / standards*
  • Legislation, Food / trends
  • Plants, Genetically Modified*
  • South Africa
  • Taiwan
  • United States