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)

Biodefense Policy Analysis-A Systems-based Approach.

Understanding the overall biosecurity and biodefense policy landscape, the relationships between policies and their effects on each other, and the mechanisms for leveraging advances in science and technology to enhance defensive capabilities is crucial for ensuring that policy strategies address long-standing gaps and challenges. To date, policy analyses have been conducted primarily on single issues, which limits analyses of broader effects of policies, particularly after implementation. Here we describe the first-ever systems-based analysis of the US biosecurity and biodefense policy landscape to analyze functional relationships between policies, including examination of the unintended positive or negative consequences of policy actions. This analysis revealed a striking bifurcation of the US policy landscape for countering biological threats, with one grouping of policies focused on prevention of theft, diversion, or deliberate malicious use of biological sciences knowledge, skills, materials, and technologies (ie, biosecurity) and a second grouping on development of capabilities and knowledge to assess, detect, monitor, respond to, and attribute biological threats (ie, biodefense). An analysis of indirect effects demonstrated that policies within groups may result in mutual benefit, but policies in different groups may counteract each other, limiting achievement of the policy objectives in either group. The current policy landscape predominantly focuses on pathogens and toxins, having limited focus on rapidly changing biotechnologies with potential to positively contribute to biodefense capabilities or introduce unknown and/or unacceptable security risk. Based on our analyses, we present actions for implementing biosecurity and biodefense policy in the United States that intends to harness the benefits of science and technology while also minimizing potential risks. This article synthesizes and highlights the major findings and conclusions from the detailed analyses, which can be found in the full report ( http://www.gryphonscientific.com/biosecurity-policy/ ).

Dual use issues in research - A subject of increasing concern?

Dual use is defined as the application of materials, knowledge or technologies for military or terrorist purposes, as well as for good. In biological science, it is considered to be a growing threat as the genetics of pathogenicity traits and toxins are becoming on one hand elucidated in a detail that was not anticipated 20years ago and on the other hand technological advances in genetic engineering and synthetic biology are continually enabling easier access to these technologies. On a theoretical and policy level, much has happened over the past decade, but translating these policies and concepts to operational level awareness and robust processes requires more attention. Where the research is conducted, scientists have to make ethical judgements and account for their data sharing and publication policies. How can we ensure the requirement for dual use review is taken on board, but is not skewing research detrimentally and imposing a disproportionate burden?

Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements. Final rule.

In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. Following the review, HHS has decided: Not to finalize the proposed changes to the list of select agents and toxins at this time; to finalize provisions to address toxin permissible limits and the inactivation of select agents; to finalize specific provisions to the section of the regulations addressing biosafety; and to clarify regulatory language concerning security, training, incident response, and records. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) has made parallel regulatory changes.

Possession, Use, and Transfer of Select Agents and Toxins-- Addition of Bacillus Cereus Biovar Anthracis to the HHS List of Select Agents and Toxins. Interim final rule and request for comments.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is adding Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. We are taking this action to regulate this agent that is similar to B. anthracis to prevent its misuse, which could cause a biological threat to public health and/or national security.

Review of Restricted Experiment Requests, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 2006-2013.

The Centers for Disease Control and Prevention (CDC) Division of Select Agents and Toxins (DSAT) regulates laboratories that possess, use, or transfer select agents and toxins in the United States. DSAT also mitigates biosafety risks through the review of "restricted experiments," which under the select agent regulations are experiments that pose heightened biosafety risks. From January 2006 through December 2013, DSAT received 618 requests from 109 entities to perform potentially restricted experiments. Of these requests, 85% were determined not to meet the regulatory definition of a restricted experiment, while 15% of the requests met the definition of a restricted experiment. Of the 91 restricted experiments proposed, DSAT approved 31 (34%) requests because the biosafety conditions proposed were commensurate with the experiments' biosafety risk. All 31 approved restricted experiments were for work with select toxins. DSAT did not approve 60 restricted experiment requests due to potentially serious biosafety risks to public health and safety. All 60 denied restricted experiments proposed inserting drug resistance traits into select agents that could compromise the control of disease. The select agents and toxins associated most frequently with requests that met the regulatory definition of a restricted experiment are Shiga toxin (n = 16), Burkholderia mallei (n = 15), Botulinum neurotoxin (n = 14), and Brucella abortus (n = 14). In general, all restricted experiment decisions are determined on a case-by-case basis. This article describes the trends and characteristics of the data associated with restricted experiment requests among select agents that have an impact on public health and safety (HHS only agents) or both public health and safety and animal health or products (overlap agents). The information presented here, coupled with the information published in the restricted experiment guidance document ( www.selectagents.gov ), is intended to promote awareness among the research community of the type of experiments that meet the regulatory definition of a restricted experiment as well as to provide a greater understanding of the restricted experiment review process.

Transfer of Select Agents and Toxins: 2003-2013.

The Federal Select Agent Program, which is composed of the Centers for Disease Control and Prevention Division of Select Agents and Toxins and the Animal and Plant Health Inspection Service Agricultural Select Agent Services, regulates entities that possess, use, or transfer biological select agents and toxins in the United States and must preapprove all transfers within or into the US. The requirement to preapprove transfers allows the Federal Select Agent Program to monitor and track shipments to receive alerts of theft, loss, or release during shipment, thereby protecting public health and safety. As part of the program, the Division of Select Agents and Toxins regulates biological select agents and toxins that have been identified by the US government as posing a severe threat to public health and safety. The division analyzed 4,402 transfers that occurred between March 2003 and December 2013 to identify frequently transferred biological select agents and toxins and the types of entities involved in transfers. During the study period, 1 package was lost during shipment and it was determined not to pose a threat to public health. The Federal Bureau of Investigation investigated the loss and concluded that the package was most likely damaged by the commercial carrier and discarded. Further, there were no reports of theft or release associated with biological select agents and toxins shipments. This report represents the first in-depth review of biological select agent and toxin transfers that were approved by the Division of Select Agents and Toxins.

Poxvirus countermeasures during an emergency in the United States.

Although smallpox was eradicated worldwide by 1980, national security experts remain concerned that it could be used in a deliberate attack. The United States and other governments have given priority to developing and stockpiling vaccines and antivirals to protect their populations from the potential reintroduction of this deadly disease. Public health officials are also concerned about the spread of related zoonotic orthopoxviruses such as monkeypox and cowpox, against which smallpox vaccine provides protection. This report analyzes how medical countermeasures available in the US Strategic National Stockpile will be given priority and used in the event of an intentional or accidental release of smallpox in the United States.

Legal and regulatory capacity to support the global health security agenda.

On February 13, 2014, 27 nations, along with 3 international organizations, launched the Global Health Security Agenda (GHSA). The intent of GHSA is to accelerate progress in enabling countries around the world to prevent, detect, and respond to public health emergencies-capacities to be achieved through 9 core objectives. Building national, regional, and international capacity includes creating strong legal and regulatory regimes to support national and international capacities to prevent, detect, and respond to public health emergencies. Accordingly, establishing and reinforcing international and national-level legal preparedness is central to advancing elements of each of the 9 objectives of the GHSA.

Strengthening global health security by developing capacities to deploy medical countermeasures internationally.

In 2014, the United States in partnership with international organizations and nearly 30 partner countries launched the Global Health Security Agenda (GHSA) to accelerate progress to improve prevention, detection, and response capabilities for infectious disease outbreaks that can cause public health emergencies. Objective 9 of the GHSA calls for improved global access to medical countermeasures and establishes as a target the development of national policy frameworks for sending and receiving medical countermeasures from and to international partners during public health emergencies. The term medical countermeasures refers to vaccines, antimicrobials, therapeutics, and diagnostics that address the public health and medical consequences of chemical, biological, radiological, and nuclear events; pandemic influenza; and emerging infectious diseases. They are stockpiled by a few countries to protect their own populations and by international organizations, such as the World Health Organization (WHO), for the international community, typically for recipients with limited resources. However, as observed during the 2009 H1N1 influenza pandemic, legal, regulatory, logistical, and funding barriers slowed the ability of WHO and countries to quickly deploy or receive vaccine. Had the 2009 H1N1 influenza pandemic been more severe, the world would have been ill prepared to cope with the global demand for rapid access to medical countermeasures. This article summarizes the US government efforts to develop a national framework to deploy medical countermeasures internationally and a number of engagements to develop regional and international mechanisms, thus increasing global capacity to respond to public health emergencies.

John Bartlett and bioterrorism.

Until 1997, the subject of bioterrorism was not discussed within the medical community and deliberately ignored in national planning efforts. Biological weapons were regarded as "morally repulsive." This complacency stemmed from a 1972 Biological Weapons Convention where all countries agreed to cease offensive biological weapons research. In the 1990s, however, the Soviet Union was discovered to have an extensive bioweapons program and a Japanese religious cult sought to launch an anthrax attack on Tokyo. Biological weapons such as smallpox and anthrax had the potential to cause a national catastrophe. However, little was done until John Bartlett in 1997 led a symposium and program to educate the medical community and the country of the need for definitive bioweapons programs. It was highly persuasive and received a final stimulus when the anthrax attack occurred in the United States in 2001.

Syndromic surveillance in an ICD-10 world.

The Centers for Disease Control and Prevention's BioSense program is an integrated national public health surveillance system that uses electronic medical record (EMR) data to provide situational awareness for all-hazard health-related events. Because the system leverages International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) coded data from EMRs for syndromic surveillance, the upcoming Health and Human Services-mandated transition from ICD-9-CM to ICD-10-CM will have a significant impact. To translate across the two encoding systems, we developed a Mapping Reference Table (MRT) for the ICD-9/10 transition. We extracted ICD-9-CM codes binned to predefined syndromes and mapped each to its corresponding ICD-10-CM code(s). Then, we translated the output ICD-10-CM codes back to ICD-9-CM through a reverse translation validation process. Throughout the translation process, we examined outputs manually and incorporated annotated results into the MRT. The resulting MRT can be used to refine and update each existing syndromic surveillance definition in BioSense to be compatible with ICD-10-CM and consistently classify or bin any given emergency department visit into the correct syndrome regardless of coding system.

The insider threat--a new aspect of biosecurity.

The need for those responsible for security at hospital research centers to take steps to counter insider threats to use biomedical and microbiological research and for perverted purposes is real, says the author. He spells out what the threats consist of suspicious behaviors to be aware of and reporting procedures for effective resolution that will enable life science researchers and law enforcement to successfully work together to thwart such threats.

Impacts of dual-use research on life science researchers including veterinarians.

Since the September 11, 2001, terrorist attacks, concern for the future direction of biological research has expanded to include not only issues involving the welfare of mankind, but also the more immediate and personal concern of individual scientists in the life sciences community. For many investigators in the life sciences, the remainder of their careers will be impacted by concerns about bioterrorism and issues associated with dual-use research. Awareness of these issues will be critical for all professional groups and affiliated organizations as they navigate the growing call for more federal rules and regulations. Veterinarians are not immune to the coming changes in science; all researchers risk criminal sanctions if they violate the USA Patriot Act or the Bioterrorism Act of 2002. Compliance with these regulations will be necessary, not just because of the potential legal ramifications, but because establishing and maintaining public trust is a never-ending requirement for the future of scientific research.

[Safe from biothreats? Legislation protects you and society]. / Biouhilta turvassa?--Säädökset suojaavat työntekijää ja yhteiskuntaa.

The 9/11 terror attacks, followed by mailing of letters containing anthrax spores, changed our comprehension on threats towards modern society. Finland is committed by international treaties to develop biosafety and biosecurity legislation, and general awareness of the legislation. However, the rapidly developing field of biosciences cannot be extensively regulated by legislation. Awareness of the risks and challenges involved in handling of biological agents is an important tool in threat prevention. Despite active efforts to update the legislation by government authorities, currently the sustenance and development of biosecurity are primarily in the hands of individual researchers and the scientific community.