Biotechnological research on the most dangerous pathogens: Challenges for risk governance and safety management

Biotechnological research on the deadliest pathogens has rapidly grown into a vast enterprise in the United States. With over $50 billion from federal agencies, thousands of projects are conducted at hundreds of university laboratories and other facilities in a national effort to gain the knowledge and methods for preventing the natural occurrence of pathogenic disease and protecting against bioterrorism. This paper describes this enterprise, defines several risk scenarios unrelated to terrorism which threaten lab workers and the public with lethal and contagious pathogenic disease, and evaluates the official policy framework for decision-making with regard to preventing and responding to the risk scenarios. It finds that the framework emphasizes physical security and secrecy to prevent terrorist exploitation of the enterprise, but fails to sufficiently address prevention of lab mishaps, accidental releases, and other incidents during the routine conduct of research which would expose workers and the public to the lethal pathogens. Nor does the framework effectively provide for the emergency response measures needed to prevent an accidental release of the more highly contagious pathogens from spiraling into a local or larger scale disease epidemic. These findings, supported by the growing number of near misses and small-scale incidents and lawsuits, point to major weaknesses in federal oversight and regulation, official disregard for siting criteria, inadequate self-regulation and management of lab safety practices, breakdowns in reporting systems, and obstacles to organizational learning and emergency response created by secrecy and security policies. Recommendations are made regarding these inadequacies of the federal framework and urge application of lessons learned from safety science experience with other hazardous technologies where increasing attention is being given to safety culture initiatives.