Characterization of Departures from Regulatory Requirements Identified During Inspections Conducted by the US Federal Select Agent Program, 2014-15.

We studied departures from regulatory requirements identified on US Federal Select Agent Program (FSAP) inspections to increase transparency regarding biosafety and security risk at FSAP-regulated entities and identify areas for programmatic improvement. Regulatory departures from inspections led by Centers for Disease Control and Prevention inspectors during 2014-15 were grouped into "biosafety," "security," and "other" observation categories and assigned a risk level and score reflecting perceived severity. The resulting 2,267 biosafety (n = 1,153) and security (n = 1,114) observations from 296 inspections were analyzed by frequency and risk across entity and inspection characteristics. The greatest proportion of biosafety observations involved equipment and facilities (28%), and the greatest proportion of security observations involved access restrictions (33%). The greatest proportion of higher-risk observations for biosafety were containment issues and for security were inventory discrepancies. Commercial entities had the highest median cumulative risk score per inspection (17), followed by private (13), academic (10), federal government (10), and nonfederal government (8). Maximum containment (BSL-4) inspections had higher median biosafety risk per inspection (13) than other inspections (5) and lower security risk (0 vs 4). Unannounced inspections had proportionally more upper risk level observations than announced (biosafety, 21% vs 12%; security, 18% vs 7%). Possessors of select agents had higher median biosafety risk per inspection (6) than nonpossessors (4) and more upper risk level security observations (10% vs 0%). Programmatic changes to balance resources according to entity risk may strengthen FSAP oversight. Varying inspection methods by select agent possession and entity type, and conducting more unannounced inspections, may be beneficial.

Abordando la problemática de las armas biológicas en el siglo XXI: el papel de una red de prevención 2.0 / No disponible

El uso estratégico de la enfermedad en la guerra ha demostrado ser una amenaza para la humanidad desde hace mucho tiempo; sin embargo, la naturaleza cambiante tanto de la ciencia como de Ia seguridad tiene, al combinarse, el potencial idóneo para estimular la adopción de nuevas (y clásicas) armas biológicas. Este breve artículo se inicia con la descripcion de algunos de estos cambios antes de considerar los medios y las medidas establecidas para hacer frente al desafío de las armas biológicas. Posteriormente, se procederá a delinear una red de prevención 2.0, compuesta por hebras que se refuerzan mutuamente, con la que se pretende formar un marco para un enfoque más holistico que sirva para hacer frente al desafío de las armas biológicas en el siglo XXI (AU)

The strategic use of disease in Warfare has long proven a menace to humankind; however, the changing nature of both science and security has the potential to encourage the assimilation of new (and old) biological weapons. This short article begins by outlining some of these changes before considering the means and measures in place to deal with the challenge of biological weapons. It proceeds to outline a Web of Prevention 2.0, comprised of mutually reinforcing strands that are intended to form a framework for a more holistic approach to dealing with the challenge of biological Weapons around the globe ln the 21st century (AU)

A question of control.

Scientists must address the ethics of using neuroactive compounds to quash domestic crises.

Protección sanitaria biológica: aspectos generales / No disponible

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