ABSTRACT

Regulations in the United States and in most other countries treat all plants produced using recombinant DNA methods (genetic engineering or genetic modi‰cation) as illegal for use in the environment or in commercial products until their safety and acceptability has been speci‰cally authorized. The costs of complying with regulations and the legal risks of not complying place severe constraints on the use of recombinant DNA breeding methods at both research and commercial phases. In particular, the limitations to gene release in the environment pose severe constraints for required ‰eld research, development, and commercial applications for most horticultural crops, a problem that is exacerbated in many cases by their incomplete

Need for Biotechnology Scientists to Be Informed and to Inform Regulations ....250 Consequences of Failure to Comply with Regulations Are Large ......................... 252 A Multitude of Regulations Exist at National and International Levels ................ 253 Regulatory Compliance Is Especially Problematic for Horticultural Crops .......... 253 Deregulated Horticultural Varieties Do Not Provide General Models ...................254 Causes of Our Stringent Regulatory System .........................................................254