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Bernard Courtney, the NBACC's former scientific director, described oversight, mentioning that frequent independent reviews over particular experiments occur. These reviews are operated by a group of up to four scientists on a case-by-case scenario. [13] Additionally, research at the labs is overseen by the Institutional Biosafety Committee.
DSAT investigates incidents related to the laboratory use of select agents and toxins and refers cases to the FBI and HHS Office of Inspector General when necessary. [2] They also review experiments that are deemed "restricted experiments" because of their increased risk. [3] Samuel S. Edwin became the director of the division in 2016. [4]
The CDC has regulated the laboratories which may possess, use, or transfer select agents within the United States under the SAP since 2001. The SAP was established to satisfy requirements of the USA PATRIOT Act of 2001 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which were enacted in the wake of the September 11, 2001 attacks and the subsequent 2001 ...
Since 1997, United States law has declared a list of bio-agents designated by the U.S. Department of Health and Human Services or the U.S. Department of Agriculture that have the "potential to pose a severe threat to public health and safety" to be officially defined as "select agents" and possession or transportation of them are tightly controlled as such. [5]
According to the 2008 report by the U.S. Congressional Research Service, "Developments in biotechnology, including genetic engineering, may produce a wide variety of live agents and toxins that are difficult to detect and counter; and new chemical warfare agents and mixtures of chemical weapons and biowarfare agents are being developed ...
Not all select agents require BSL-4 handling, namely select bacteria and toxins, but most select agent viruses do (with the notable exception of SARS-CoV-1 which can be handled in BSL3). Many non-select agent viruses are often handled in BSL-4 according to facility SOPs or when dealing with new viruses closely related to viruses that require BSL-4.
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The Biomedical Advanced Research and Development Authority (BARDA) is a center within the Administration for Strategic Preparedness and Response [1] (ASPR) located within the U.S. Department of Health and Human Services (HHS) responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear ...