Oversight of High-Containment Biological Laboratories: Issues for Congress

The federal government responded to the September 11, 2001, terrorist attacks and the subsequent anthrax attacks with increased focus on and funding for biodefense. A key consideration in this response was addressing shortages in diagnostic, clinical, and research laboratory capacity.

Several departments and agencies have increased or are in the process of increasing their laboratory capacity. High-containment laboratories play a critical role in the biodefense effort, offering the hope of better responses to an attack and a better understanding of the threat posed by bioterrorism. However, they also could increase the risk of a biological attack by serving as a potential source of materials or training. Indeed, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism recommends tightening government oversight of high-containment laboratories.

Policymakers have become increasingly interested in the oversight of these facilities following reports of accidents, regulatory noncompliance, and community resistance. The increase in highcontainment laboratory capacity has raised new policy questions and emphasized existing ones. How much laboratory capacity is enough? What is the necessary federal investment? Should laboratories be consolidated or dispersed? What plans exist to coordinate multiple agency efforts to expand high-containment laboratory capacity? Does increasing laboratory capacity increase the risk of accidents and the opportunity for purposeful misuse? What is an acceptable balance between the benefits these laboratories provide and the risks they pose? Interested Members of Congress might take action to address some or all of these concerns.

Alternatively, they might defer action until efforts currently under way assess and make recommendations regarding the existing regulatory structure. If Congress chooses to enhance oversight, it might require a survey of existing facilities and their use and a national needs assessment, perhaps barring further construction until these are complete. Stakeholders could focus on enhancing self-regulatory activities such as improving or standardizing laboratory worker training or building a mechanism for sharing lessons learned. Rather than relying on selfregulation,
policymakers might enhance oversight through additional regulation of ighcontainment facilities, requiring laboratory or personnel certification, or by broadening the Select Agent Program. Which agencies should implement any new mandates remains an open question.

Biocontainment technologies are widely used by scientists around the world. Efforts to increase control of U.S. high-containment laboratories may put domestic industry at a competitive disadvantage and inhibit international academic collaboration. Absent international harmonization, the United States can only partially address the threat of a high-containment laboratory being the source of a bioterror weapon.

A key task for policymakers is to define their goals for enhancing oversight of high-containment laboratories. The focus of the oversight effort may affect which policy issues are addressed. For example, focusing on a registry of existing high- containment laboratory capacity may improve planning, coordination, and efficiency of use but provide relatively limited security benefits.

Similarly, a rigorous oversight program including facility and personnel licensure, mandatory training, and restricted construction of new facilities may provide security benefits at the cost of regulatory burden, increased federal expenditures, and impeded scientific progress in countermeasure research, bioforensics, and public health. When weighing options to address these complex policy issues, policymakers may have to reconcile many competing and potentially conflicting national needs.

Frank Gottron
Specialist in Science and Technology Policy

Dana A. Shea
Specialist in Science and Technology Policy

May 4, 2009