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Learning from the CDC's Biosafety Breaches

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The US Centers for Disease Control and Prevention (CDC) has come under fire this past month for a series of biosafety problems reported by the country’s top government labs. Last week, the CDC released a report reviewing an incident that occurred in early June that involved the unintentional exposure of CDC personnel to potentially viable anthrax. Additional biosafety violations were also disclosed, including the discovery of smallpox vials in a Food and Drug Administration lab and a transfer from a CDC lab to a US Department of Agriculture lab of an avian influenza cross-contaminated with a highly dangerous influenza strain, H5N1. As a result of these incidents, the CDC issued a moratorium on the transfer of biological specimens from the agency’s highest-level biosafety labs, the closure of the two labs involved in the recent breaches, and the appointment of a senior scientist to be the single point of responsibility for lab safety going forward. The CDC has also established an external advisory group to review the incidents and make recommendations for strengthening biosafety in its labs.
In a hearing before the Subcommittee on Oversight and Investigations on July 16th, CDC Director, Dr. Tom Frieden recognized the need to “greatly improve the culture of safety” at the agency. The major themes raised in the hearing included an overall lack of national strategy addressing the increasing number of labs and issues with the oversight of biosafety. Recommendations also included the need for a single, independent agency regulating the labs and their safety. Currently, US research on dangerous human pathogens must abide by safety guidelines issued by the CDC. Experts testified that it is extremely problematic that the CDC is performing and funding the same kind of lab work that it is responsible for regulating.
As the US reviews the recent CDC events and considers the recommendations to incorporate into nationwide regulatory activities, the international community should take heed. Labs that handle agents causing lethal disease are proliferating globally and many countries have few or no biosafety regulations. Although thankfully the CDC breaches were contained, escape of an agent such as H5N1 could be catastrophic and result in the worst pandemic in history. Let us hope that these recent biosafety concerns serve as a wake up call not only for the US but for research agencies across the world and spur them to evaluate and strengthen biosafety measures in their labs.

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The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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