A Biosafety Agenda to Spur Biotechnology Development and Prevent Accidents

B iosafety—keeping laboratory workers, the community, and the environment safe—is a crosscutting need for all research activities, as well as an important research and policy area with medical, political, and security consequences. As such, it requires a dedicated plan for the US government. One reason biosafety is attracting more attention now is because it may be a limiting factor in the development of advanced biotechnologies. Many potential new biotechnology applications with biomedical and economic implications are intended to be used outside the laboratory and released into the environment, so their safety cannot rely on traditional laboratory containment. They are meant to be ‘‘outside.’’ Applications such as mosquito control, agriculture, pollution remediation, mining, biofuels, medications that use synthetic organisms to treat gastrointestinal diseases, or even the recreation of extinct animals require synthetic organisms to be in the environment, where they can interact with other living things. These applications may be tremendously beneficial and may spur economic development, but if biosafety risks are not addressed and carefully thought through, they could yield unintended and accidental consequences. Biosafety has become more politically important in recent times as well, particularly after multiple highprofile safety failures at federal and military laboratories involving smallpox, anthrax, and flu. In 2014, decades-old glass vials containing live variola (smallpox) virus were discovered at the US Food and Drug Administration (FDA). Smallpox was declared eradicated in 1980 and is supposed to be held only under tightly controlled conditions at the Centers for Disease Control and Prevention (CDC) and a designated Russian laboratory. Given that decades have passed and the samples were not either transferred or disposed of, this incident was indicative of poor inventory management. In 2015, it was discovered that the US Army Dugway Proving Ground had shipped samples containing live anthrax to centers not registered to work with it. These samples were incompletely irradiated, and some vials still had live anthrax spores. Additional potential exposures of anthrax and noncirculating influenza at the CDC occurred as well. A series of comprehensive reforms affecting biosafety have already begun under the Obama Administration. Reform was motivated by laboratory incidents, but also by mounting concerns about the increased power and democratization of biotechnology: Consequential bio-errors may occur more frequently if more people are able to work on infectious diseases. If a laboratory accident occurs with a transmissible pathogen, the consequences could spread well beyond the laboratory—and beyond national borders. Many of these much-needed government reforms to biosafety are still in the process of being implemented. Yet, there are additional, new opportunities that will be important to pursue to increase safety in the coming years, including dedicating research funds to biosafety; expanding biosafety training into new environments, to reach the growing populations of people who are performing biological work; and leading the world to develop international biosafety norms.