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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

House Panel Explores DoD Anthrax Shipments

July 31, 2015 —The House Energy and Commerce Subcommittee on Oversight and Investigations July 28 held a hearing entitled, “Continuing Concerns with the Federal Select Agent Program: Department of Defense Shipments of Live Anthrax.” The hearing focused on shipments of live anthrax from a Department of Defense (DoD) laboratory at the Dugway Proving Grounds in Utah that occurred over nearly a 10-year period.

Subcommittee Chair Tim Murphy (R-Pa.) opened the hearing describing what he called “a pattern of recurring issues of complacency and a lax culture of safety.”

He said, “And despite the growing number of red flags, these incidents keep happening…. Apparently Dugway's process to inactivate anthrax spores was not fully effective. And the sterility testing used to validate and ensure that the anthrax spores were inactivated failed to detect the live anthrax spores. What's most troubling, however, is that Dugway used this potentially deadly process for years.”

“[T]his is completely unacceptable,” the chairman said, adding, “These dangerous safety lapses at our high-containment labs are threatening our nation's security and public health.”

Rep. Frank Pallone (D-N.J.), the ranking member on the full committee, said that “incidents in the past year involving anthrax, Ebola, and highly-pathogenic avian flu raise questions about whether we need to strengthen our federal oversight of labs that are working with dangerous pathogens.”

Reiterating a question posed by other subcommittee members, Ranking Member Rep. Diana DeGette (D-Colo.), asked, “Do we need to have 200 labs working with anthrax, or is it possible that we could limit the number of labs and therefore limit the risk while still being able to do this important research?” She urged the chairman to hold another hearing in the fall after the agencies have figured out what improvements in standardization and oversight are going to occur.

Department of Defense Deputy Assistant Secretary of Defense for Chemical and Biological Defense David Hassell told the subcommittee the recently completed comprehensive review of the causes of the incident found “the primary systemic issue is the lack of specific validated standards to guide the development of protocols, processes and quality assurance measures.” He acknowledged during questioning that “different chains of command has been one of the fundamental problems here, because each laboratory reports up to a different chain.”

Centers for Disease Control (CDC) Deputy Director of the Office of Public Health Preparedness and Response Daniel Sosin, M.D., M.P.H, testified, “The Federal Select Agent Program relies primarily on sterility testing to assure that a select agent can no longer grow. We remain unsure whether there was a problem with the execution of this testing at Dugway, or if the biology of spores as not sufficiently understood to make the procedure reliable.”

He said CDC is “maintaining a moratorium on the use and transfer of inactivated anthrax spores until we have an acceptable and credible approach to increasing safety and security, and we are developing a research agenda on spore biology to answer questions about inactivation and sterility, and we will help to conduct some of that research.”

Health and Human Services (HHS) Office of Inspector General (OIG) Chief Counsel to the Inspector General Greg Demske told the subcommittee that OIG is expanding its audits and evaluations of Select Agent management, and will focus on CDC’s oversight of the Select Agent Program and on the operation of HHS laboratories that handle select agents.

Government Accountability Office (GAO) Healthcare Director Marcia Crosse, Ph.D., testified that “the incidents you are examining today are part of a long series of safety lapses. Since 2007, GAO has reported on these issues and has made multiple recommendations to improve federal oversight of high-containment laboratories.”

Dr. Crosse noted the federal departments “have not implemented our key recommendation to establish a single federal entity with responsibility for oversight of all high-containment laboratories.” She added that “the lapses we've seen are indicative of failures in a system that is supposed to have multiple levels of control, including cross checks, inspections, training, procedures, and validated protocols that should prevent such accidents from occurring, and certainly should prevent such incidents from recurring.”

Asked to expand on GAO’s oversight recommendation Dr. Crosse continued, “I think that we're concerned that there hasn't been kind of a consistent set of standards in place, a consistent understanding of what the needs are, a consistent plan developed for where these laboratories ought to be built and maintained, and what the costs are going to be over the long-term for maintaining this kind of infrastructure, and whether it is in line with the needs.”

Contact:

Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559
Email: dbmoore@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org