Biotechnology and Social Control

Biotechnology is rapidly progressing from laboratory research to the development, testing, marketing and use of a multitude of new products and methods in health care and agriculture. Promoted by substantial investment and incentives for societal benefits and financial gain, this progression has been relatively unimpeded by stringent regulation or other restrictive social controls. However, applications of biotechnology are stimulating deep moral concerns and producing growing evidence of potential harms to health, safety, and environment. As a result, public pressures have intensified for restrictive policies and regulations, and federal officials in the United States are now deliberating the steps to take. The paper surveys the main features and causes of this rapid progression, and the emerging patchwork of social controls, focusing on the safety of new gene therapies in health care and modified crops in agriculture. It finds that use of an organizational learning model to protect patient safety in clinical testing of new gene therapies has failed for several reasons, and that performance requirements for the approval of new crops have been too permissive and lack public credibility. It concludes with the perception that proposed regulatory reforms will in the aggregate, ultimately require health care and agricultural organizations to develop and implement safety management systems for more effective self-regulation. This poses a major challenge for these organizations, but raises the possibility that experience gained in managing the safety of other technologies may be of considerable value in achieving more effective social control of biotechnology