An Uncertain Partnership

Research conducted at U.S. universities has contributed significantly to improvements in public health and national security. Currently, university scientists are diligently working to modify standard laboratory operating procedures to comply with regulations imposed under two new federal antiterrorism laws passed last year: the Public Health Security and Bioterrorism Preparedness and Response Act and the Agricultural Bioterrorism Protection Act. The new regulations are intended to protect against potential terrorist threats posed by what are considered "select agents": dozens of pathogens and toxins, including anthrax, influenza virus, and botulinum toxin, used in many laboratories.

Although U.S. universities are accustomed to providing safe environments for working with these materials, we acknowledge the emergence of new threats in the world and accept responsibility for contributing to improved national security. Encouraged by language in the laws promising a cooperative partnership with the federal agencies given oversight for the new regulations [the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service], academic institutions have launched ambitious efforts to comply. These include facility renovations and background screens of many individuals. However, this fledgling government-university counterterrorism partnership may be heading for the rocks, set adrift by poor communication, lack of coordination among the responsible federal agencies, and a numbing backlog of federal approvals. These realities are creating a perfect storm of confusion and frustration among universities and scientists who are doing their level best to comply.

Consider the following situation at the University of Wisconsin-Madison. Despite submission of required registration material by the 12 March 2003 deadline, we have yet to receive approval or even a status update. Nor have we received feedback (April and June responses were promised) on the fate of any of our 150+ administrators and research personnel (those who survived the required Justice Department background checks). Nearly 60% of our submitted security risk assessment forms have been reported missing by the Federal Bureau of Investigation, and our proposed security plans, submitted for a 12 June 2003 deadline for implementation by 12 September, have gone unanswered.

A recent letter to Secretary of Agriculture Ann Veneman and Secretary of Health and Human Services Tommy Thompson, co-signed by the Association of American Universities, the Association of American Medical Colleges, the Council on Governmental Relations, and the National Association of State Universities and Land- Grant Colleges, expresses concern about the inability of the federal agencies to act promptly and further requests extension of the 12 November deadline for full compliance to avoid some serious potential consequences, including suspended research, attrition of scientists, and public health and agriculture crises (see www.aau.edu/resources/ltr10.15.03.html). We have already seen such consequences in the ability of the Wisconsin State Laboratory of Hygiene (WSLH) to cope with the recent monkeypox outbreak this year. Clinical specimens could not legally be transferred to the WSLH from the clinic in Marshfield, Wisconsin, where the virus was first isolated, because monkeypox was not included in WSLH's original select agent registration. As a result, the specimen had to be transferred directly to CDC, thereby circumventing utilization of the state's Laboratory Response Network, delaying definitive specimen identification, and prolonging response time. Such an incident leaves us wondering how a serious health crisis involving a select agent such as anthrax might evolve in the current regulatory environment.

All is not lost. With some relatively minor midcourse corrections, the partnership could be guided to safe harbor. Appointment of an interagency implementation team, including representatives from the university community, would encourage improved cooperation and enhance communication among the regulators and the regulated. This team could also work on streamlining the various approval processes and identifying needless duplication, with a view from both federal and university perspectives. The 3 November announcement of an extension of the 12 November deadline for personnel approvals has helped restore some faith in the partnership. Additional progress is required, however, for full restoration.

The federal decision to regulate research involving select agents that might be exploited by terrorists is reasonable, but a continued uncoordinated application of these regulations may threaten research and put the public at further risk. That outcome seems more certain than the possibilities that motivated the new laws in the first place.