Bioterrorismo y armas biológicas: caracterización y respuesta frente a las amenazas actuales / Bioterrorism and biological weapons: characterization and response to current threats

El uso de agentes biológicos con fines terroristas constituye una amenaza singular. Aunque poco probable, su materialización puede ser difícilmente evitable en el futuro. Este artículo revisa el fenómeno del bioterrorismo, examinando los posibles riesgos y vulnerabilidades, los mecanismos de respuesta y las nuevas amenazas para la bioseguridad. (AU)

The use of biological agents for terrorist purposes is a unique threat. Although unlikely, it may be difficult to prevent in the future. This article provides an overview of the phenomenon of bioterrorism, examining potential risks and vulnerabilities, response mechanisms and emerging threats to biosecurity. (AU)

COVID-19, SARS-CoV-2, and Export Controls.

Export controls are intended to prevent the proliferation of materials that could be misused to make biological weapons. They are not intended to stifle critical research and development in the midst of a pandemic. This article explores how and why export controls might apply to severe acute respiratory syndrome coronavirus 2, the virus that causes coronavirus disease 2019. It outlines the taxonomic and genetic factors associated with the current approach to export control lists and discusses how they lead to unnecessary ambiguity. The authors describe ways in which the current export control systems might be revised in the short, medium, and long term, including sequence, disease, and function-based approaches.

Who Should Be Driving US Science Policy?

Transparency was not always a desired aspect of medicine or STEM (science, technology, engineering, and math) research. In the late 1940s, the Nuremberg Code heralded a new era of informed patient consent, research subject protection, and the view that the public had a stake in emerging technology and should have some knowledge and input into the directions of scientific research. This understanding intensified in the United States with the very public discussions leading to the promulgation of the NIH Guidelines for Recombinant DNA Research in the 1970s. The way in which oversight of recombinant DNA research was handled is still the exception rather than the rule. Starting in the 1990s, various terror incidents led to the enactment of statutes and issuance of regulations that undermined the ability of scientists and research institutions to self-regulate and in some cases to disseminate information freely. This essay explores how the scientific community got to this status quo, and how it could regain some measure of control despite competing needs for transparency and security, so that research critical to biosecurity is supported rather than impeded.

Public Health and Law Enforcement Joint Investigation of Unknown Suspicious Substances and Potential Threat Evaluations, Minnesota, 2007-2016.

From the Field is a semi-regular column that explores what it means to be a local health professional on the front lines of an emergency. Typically, National Association of County and City Health Officials (NACCHO) members share their stories of preparing for and responding to disasters, epidemics, and other major health issues. This month's column features a submission from a state health department that describes their experience in investigating white powder incidents. Through exploring the analysis of the challenges faced and the solutions developed, readers can learn how these public health champions keep their communities safe even in extreme situations. Readers may submit topics of interest to the column's editor, Meghan McGinty, PhD, MPH, MBA, at mmcginty@naccho.org.

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)

Synthetic biology and biosecurity

This article discusses the conflict fields and legal questions of synthetic biology, esp. concerning biosecurity. A respective jurisprudential discussion has not taken place yet in Germany apart trom few statements and recommendations. But in Germany, Europe and the USA, it is generally accepted that a broad discussion is necessary. This is esp. true for the question of biosecurity and the possible dangers arising from Synthetic Biology (AU)

Este artículo aborda las campos de conflicto y las cuestiones legales de la biología sintética, especialmente lo relativo a la bioseguridad. La pertinente discusión jurisprudencial no ha tenido lugar aún en Alemania, al margen de algunas declaraciones y recomendaciones. Pero en Alemania, en Europa y en los Estados Unidos, es generalmente aceptada la necesidad de un debate respecto de este asunto. Esto es especialmente válido para la cuestión de la bioseguridad y de los posibles peligros derivados de la biología sintética (AU)

Negative impact of laws regarding biosecurity and bioterrorism on real diseases.

Research on highly pathogenic microorganisms in biosafety level 3 and 4 laboratories is very important for human public health, as it provides opportunities for the development of vaccines and novel therapeutics as well as diagnostic methods to prevent epidemics. However, in recent years, after the anthrax and World Trade Center attacks in 2001 in the USA, the threat of bioterrorism has grown for both the public and the authorities. As a result, technical and physical containment measures and biosafety and biosecurity practices have been implemented in laboratories handling these dangerous pathogens. Working with selected biological agents and toxins is now highly regulated, owing to their potential to pose a threat to public health and safety, despite the fact that the anthrax attack was found to be the result of a lack of security at a US Army laboratory. Thus, these added regulations have been associated with a large amount of fruitless investment. Herein, we describe the limitations of research in these facilities, and the multiple consequences of the increased regulations. These limitations have seriously negatively impacted on the number of collaborations, the size of research projects, and, more generally, scientific research on microbial pathogens. Clearly, the actual number of known victims and fatalities caused by the intentional use of microorganisms has been negligible as compared with those caused by naturally acquired human infections.

State-of-the-art in biosafety and biosecurity in European countries.

The terms biosafety and biosecurity are widely used in different concepts and refer not only to protection of human beings and their surrounding environment against hazardous biological agent, but also to global disarmament of weapons of mass destruction. As a result, the biosafety and biosecurity issues should be considered interdisciplinary based on multilateral agreements against proliferation of biological weapons, public health and environmental protection. This publication presents information on both, international and national biosafety and biosecurity legislation. Status of national implementation of the Biological and Toxin Weapons Convention, penalization issues and measures to account for and secure production, use, storage of particularly dangerous pathogens or activities involving humans, plants and animals where infection may pose a risk have been analyzed. Safety and security measures in laboratories have been studied. Moreover, dual-use technology and measures of secure transport of biohazard materials have been also taken into account. In addition, genetic engineering regulations, biosecurity activities in laboratories and code of conducts have been investigated, as well.

Preventing biological weapon development through the governance of life science research.

The dual-use dilemma in the life sciences-that illicit applications draw on the same science and technology base as legitimate applications-makes it inherently difficult to control one without inhibiting the other. Since before the September 11 attacks, the science and security communities in the United States have struggled to develop governance processes that can simultaneously minimize the risk of misuse of the life sciences, promote their beneficial applications, and protect the public trust. What has become clear over that time is that while procedural steps can be specified for assessing and managing dual-use risks in the review of research proposals, oversight of ongoing research, and communication of research results, the actions or decisions to be taken at each of these steps to mitigate dual-use risk defy codification. Yet the stakes are too high to do nothing, or to be seen as doing nothing. The U.S. government should therefore adopt an oversight framework largely along the lines recommended by the National Science Advisory Board for Biosecurity almost 5 years ago-one that builds on existing processes, can gain buy-in from the scientific community, and can be implemented at modest cost (both direct and opportunity), while providing assurance that a considered and independent examination of dual-use risks is being applied. Without extraordinary visibility into the actions of those who would misuse biology, it may be impossible to know how well such an oversight system will actually succeed at mitigating misuse. But maintaining the public trust will require a system to be established in which reasonably foreseeable dual-use consequences of life science research are anticipated, evaluated, and addressed.

From biodefence to biosecurity: the Obama administration's strategy for countering biological threats.

The Seventh Review Conference of the Biological Weapons Convention (BWC), the first international treaty to outlaw an entire class of weapons, was held in Geneva in December 2011. On 7 December, Secretary of State Hillary Clinton became the highest-ranking US government official to address a BWC meeting. Secretary Clinton told the assembled delegation that 'we view the risk of bioweapons attack as both a serious national security challenge and a foreign policy priority'. At the same time, she warned that a large-scale disease outbreak 'could cripple an already fragile global economy'. Secretary Clinton's speech reflected a new understanding that the range of biological threats to international security has expanded from state-sponsored biological warfare programmes to include biological terrorism, dual-use research and naturally occurring infectious diseases such as pandemics. Recognizing these changes, President Barack Obama released a new national strategy for countering biological threats in 2009. This strategy represents a shift in thinking away from the George W. Bush administration's focus on biodefence, which emphasized preparing for and responding to biological weapon attacks, to the concept of biosecurity, which includes measures to prevent, prepare for and respond to naturally occurring and man-made biological threats. The Obama administration's biosecurity strategy seeks to reduce the global risk of naturally occurring and deliberate disease outbreaks through prevention, international cooperation, and maximizing synergies between health and security. The biosecurity strategy is closely aligned with the Obama administration's broader approach to foreign policy, which emphasizes the pragmatic use of smart power, multilateralism and engagement to further the national interest. This article describes the Obama administration's biosecurity strategy; highlights elements of continuity and change from the policies of the Bush administration; discusses how it fits into Obama's broader foreign policy agenda; and analyses critical issues that will have to be addressed in order to implement the strategy successfully.

Biologists napping while work militarized.

As researchers discover more agents that alter mental states, the Chemical Weapons Convention needs modification to help ensure that the life sciences are not used for hostile purposes, says Malcolm Dando.