Biosecurity as the third component of biorisk management focuses on securing biological materials. The current focus on biosecurity evolved from a series of events that made the need for more focus on security around laboratories clear.
In 1984, members of the Rajneeshee commune in The Dalles, Oregon, purchased a strain of Salmonella from a medical supply company in Seattle, Washington to contaminate ten local salad bars, sickening over 750 individuals. Although not immediately recognized as an attack, this incident was a clear indication of the potential impact of the misuse of biological agents.
In 2001, at least five envelopes containing Bacillus anthracis spores (the etiologic agent of the disease anthrax) were mailed to U.S. Senators and media organizations. At least 22 individuals contracted anthrax as a result of the mailings; five of the individuals died. After a nearly ten year investigation, known as Amerithrax, it was determined through genetic analysis that the spores in the letters were derived from a single spore-batch of Bacillus anthracis (Ames strain), isolated from a cow in Texas and distributed to a number of research laboratories, including the United States Army Medical Research Institute for Infectious Diseases (USAMRIID). On February 19, 2010, the Justice Department, the FBI, and the U.S. Postal Inspection Service formally concluded the investigation into the 2001 anthrax attacks, which determined that Dr. Bruce Ivins, a USAMRIID employee, acted along in planning and executing these attacks.
Events such as the 1984 Rajneeshee Salmonella incident and the 2001 anthrax mailings demonstrate vulnerabilities to acts of bioterrorism and the importance of biosecurity training and personnel reliability programs. Both incidents have led to policy changes intended to reduce the risk of future misuse of organisms intended for research and disease prevention.
In October 2003, a report from the National Research Council of the National Academies entitled, Biotechnology Research in an Age of Terrorism , often referred to as the “Fink Report” was released. This report called for more oversight from and self-policing by scientists in life sciences and recommended that the Department of Health and Human Services (HHS) set up a national board to offer guidance to funding agencies. In 2005, HHS established the National Science Advisory Board for Biosecurity (NSABB) to advise the Federal government on biosecurity issues and options for addressing them.
In 2009, Executive Order (EO) 13486, Strengthening Laboratory Biosecurity in the United States, was signed by the President. EO 13486 established the Working Group on Strengthening the Biosecurity of the United States and states that its scope of activities pertains to the United States’ policy which states: “…Facilities that possess biological select agents and toxins have appropriate security and personnel assurance practices to protect against theft, misuse, or diversion to unlawful activity of such agents and toxins.”
Although not the only biological incidents in U.S. history, these incidents have been very influential on the formation of U.S. policy for handling and storing biological agents. There have been many reports, committees, recommendations, and policies to address protecting biological agents and toxins from theft, loss, and misuse in the past 20 years. Each has made a unique contribution to the way the U.S. approaches protecting the biological sciences and future reports will continue to contribute to an ever evolving program.