Nuevas Fronteras en Bioseguridad y Biocustodia

La biotecnología tiene un gran potencial para contribuir al desarrollo sostenible. Durante los últimos 18 meses, ha permitido el rápido despliegue de métodos para detectar, tratar y proteger a las personas contra la infección por SARS-CoV-2. Además, la edición de genes promete revolucionar la medicina, la salud pública, la agricultura y la fabricación a través, entre otras cosas, del tratamiento de enfermedades hereditarias, el control de plagas agrícolas y vectores de patógenos humanos peligrosos, la mejora de cultivos para dietas más sanas y el ganado. para un mayor bienestar animal, y la producción de organismos para la biotecnología industrial que produzcan materias primas que puedan sustituir a los combustibles fósiles en la fabricación de numerosos productos.

Raybould, Alan. New Frontiers in Biosafety and Biosecurity. Frontiers in bioengineering and biotechnology vol. 9 727386. 21 Jul. 2021, doi:10.3389/fbioe.2021.727386

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Monitoring #SelectAgent Theft, Loss and Release Reports in USA

cdc.gov

The APHIS/CDC Form 3, Report of Theft, Loss or Release of Select Agents and Toxins (TLR incident report) is the mechanism by which the theft, loss or release of a biological select agent and toxin (BSAT) is reported to the United States Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS) or Health and Human Services (HHS)/ Center for Disease Control and Prevention (CDC). A total of seven hundred and twenty seven (727) TLR Incident Reports were received by CDC between 2004 and 2010.

REFERENCES:
Henkel RD, et al. Monitoring Select Agent Theft, Loss and Release Reports in the United States—2004-2010. Applied Biosafety Vol. 17, No. 4, 2012:171-180.
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Synthetic biology and biosecurity. From low levels of awareness to a comprehensive strategy

Photo: Mashable

Synthetic biology has become one of the most dynamic research fields in the life sciences. In reality, though, the term is used to cover a host of different approaches rather than a single defined discipline; these range from the large-scale assembly of DNA segments to the development of new tools and technology platforms, and to the search for the minimal cell and the origins of life. The evolution of the field has also been accompanied by the recognition that the concomitant shift in biology from a descriptive to a predictive science, and the technologies that will ensue, bring with them a range of potential societal implications and dangers.
REFERENCE:
Kelle A. Synthetic biology and biosecurity. From low levels of awareness to a comprehensive strategy. EMBO Rep. 2009 Aug;10 Suppl 1:S23-7.

Containing the accidental laboratory escape of potential pandemic influenza viruses.

Abstract
BACKGROUND:

The recent work on the modified H5N1 has stirred an intense debate on the risk associated with the accidental release from biosafety laboratory of potential pandemic pathogens. Here, we assess the risk that the accidental escape of a novel transmissible influenza strain would not be contained in the local community.
METHODS:
We develop here a detailed agent-based model that specifically considers laboratory workers and their contacts in microsimulations of the epidemic onset. We consider the following non-pharmaceutical interventions: isolation of the laboratory, laboratory workers' household quarantine, contact tracing of cases and subsequent household quarantine of identified secondary cases, and school and workplace closure both preventive and reactive.
RESULTS:
Model simulations suggest that there is a non-negligible probability (5% to 15%), strongly dependent on reproduction number and probability of developing clinical symptoms, that the escape event is not detected at all. We find that the containment depends on the timely implementation of non-pharmaceutical interventions and contact tracing and it may be effective (>90% probability per event) only for pathogens with moderate transmissibility (reproductive number no larger than R₀ = 1.5). Containment depends on population density and structure as well, with a probability of giving rise to a global event that is three to five times lower in rural areas.
CONCLUSIONS:
Results suggest that controllability of escape events is not guaranteed and, given the rapid increase of biosafety laboratories worldwide, this poses a serious threat to human health. Our findings may be relevant to policy makers when designing adequate preparedness plans and may have important implications for determining the location of new biosafety laboratories worldwide.

REFERENCE

1: Merler S, Ajelli M, Fumanelli L, Vespignani A. Containing the accidental laboratory escape of potential pandemic influenza viruses. BMC Med. 2013 Nov
28;11:252

Technologies to Enable Autonomous Detection for BioWatch

Technologies to Enable Autonomous Detection for BioWatch is the summary of a workshop hosted jointly by the Institute of Medicine and the National Research Council in June 2013 to explore alternative cost-effective systems that would meet the requirements for a BioWatch Generation 3.0 autonomous detection system, or autonomous detector, for aerosolized agents . The workshop discussions and presentations focused on examination of the use of four classes of technologies--nucleic acid signatures, protein signatures, genomic sequencing, and mass spectrometry--that could reach Technology Readiness Level (TRL) 6-plus in which the technology has been validated and is ready to be tested in a relevant environment over three different tiers of temporal timeframes: those technologies that could be TRL 6-plus ready as part of an integrated system by 2016, those that are likely to be ready in the period 2016 to 2020, and those are not likely to be ready until after 2020. Technologies to Enable Autonomous Detection for BioWatch discusses the history of the BioWatch program, the role of public health officials and laboratorians in the interpretation of BioWatch data and the information that is needed from a system for effective decision making, and the current state of the art of four families of technology for the BioWatch program. This report explores how the technologies discussed might be strategically combined or deployed to optimize their contributions to an effective environmental detection capability.

Paperback

300 pages | 6 x 9 

ISBN 978-0-309-29251-1

#ARTÍCULO: Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment

>>  COMPLETE TABLE  <<

Abstract:
We describe herein, limitations on research at biosafety level 4 (BSL-4) containment laboratories, with regard to biosecurity regulations, safety considerations, research space limitations, and physical constraints in executing experimental procedures. These limitations can severely impact the number of collaborations and size of research projects investigating microbial pathogens of biodefense concern. Acquisition, use, storage, and transfer of biological select agents and toxins (BSAT) are highly regulated due to their potential to pose a severe threat to public health and safety. All federal, state, city, and local regulations must be followed to obtain and maintain registration for the institution to conduct research involving BSAT. These include initial screening and continuous monitoring of personnel, controlled access to containment laboratories, accurate and current BSAT inventory records. Safety considerations are paramount in BSL-4 containment laboratories while considering the types of research tools, workflow and time required for conducting both in vivo and in vitro experiments in limited space. Required use of a positive-pressure encapsulating suit imposes tremendous physical limitations on the researcher. Successful mitigation of these constraints requires additional time, effort, good communication, and creative solutions. Test and evaluation of novel vaccines and therapeutics conducted under good laboratory practice (GLP) conditions for FDA approval are prioritized and frequently share the same physical space with important ongoing basic research studies. The possibilities and limitations of biomedical research involving microbial pathogens of biodefense concern in BSL-4 containment laboratories are explored in this review.
Referencia:
Shurtleff AC, et. al. Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment. Viruses. 2012 December; 4(12): 3932–3951.

BOOK: Preparing for bioterrorism #biosecurity #biosafety

First edition 
December 2012

Center for Biosecurity of UPMC

ISBN-13: 978-0615706825

ISBN-10: 0615706827 

LCCN: 2012918441

261 pages

New year, New book
DOWNLOAD PDF:
>> Preparing for Bioterrorism <<

By Gigi Kwik Gronvall 

Synopsis: With the 2001 anthrax attacks, the threat of bioterrorism became real to the nation. Before that, biological weapons were a known threat to warfighters, but after, the vulnerability of US civilians was clear. Only a handful of civilian experts were involved, and the Alfred P. Sloan Foundation was the only US philanthropy willing to commit resources to confront the challenges of preparing for bioterorism. When Sloan got involved in 2000, the professional field of biosecurity did not exist. There was little science or scholarship no guidelines or planning tools, and few policies or officials to direct civilian preparedness, planning, and response. Over ten years, the Sloan Foundation awarded more than $44 million in biosecurity grants and was instrumental in establishing the field and many of its most prominent leaders. That was money well-invested. The nation is now vastly better prepared for bioterrorism and other catastrophic threats to the public's health and national security. Author Gigi Kwik Gronvall chronicles the foundation's leadership in the field and the innovations that followed to show how the Sloan Foundation helped lay the groundwork on which US civilian biosecurity has been built.

Content (PDF by sections):

 Front matter: Cover, copyright page, title page, dedication, contents, Foreword, Preface, Acknowledgments 

 Foreword by D. A. Henderson

 Introduction: Finding A Sustainable Approach To Biosecurity

 CH 1: Building Civilian Preparedness and Readiness

 CH 2: Organizing to Counter Bioterrorism

 CH 3: Criminalizing Bioterrorism

 CH 4: Responsible Stewardship of Powerful Biotechnologies

 CH 5: Public Health Law for the 21st Century

 CH 6: Preparing Businesses for Terrorism and Other Emergencies

 CH 7: Making Buildings Safe

 CH 8: Using Disease Surveillance for Early Warning

 CH 9: Strengthening Preparedness for Pandemic Influenza

 CH 10: Preparing New Yorkers for Terrorism and Other Disasters

 Afterword by Tom Inglesby

 Back matter: Notes, Selected Bibliography, Appendix

Animal Disease Traceability

On Thursday, December 20th, the U.S. Department of Agriculture (USDA) announced a final rule establishing general regulations for improving the traceability of U.S. livestock moving interstate.

For more Info visit: TRACEABILITY

ONLINE COURSE: Build Security into Good Laboratory Practices #biosecurity #biocustodia

Curso Online Editado por el Centro de Control de Enfermedades. El curso contiene tres módulos:

• Bioseguridad y Biocustodia
• Evaluación de riesgo
• Desarrolla de un Plan de Biocustodia

Descripción del Curso

Este en curso contiene las claves principales para la seguridad de los agentes biológicos en laboratorios de investigación e instalaciones biomédicas, en los que el robo, pérdida, liberación o mal uso que los agentes pueden tener consecuencias económicas y en la salud pública. Este curso define el termino de biocustodia, marca las diferencias y similitudes entre bioseguridad y biocustodia, y discutes los componentes de un programa de biocustodia de laboratorio. Un programa exitoso de biocustodia debe tener apoyo completo de todos los niveles administrativos, debe ser específico al laboratorio, y estar basado en el entendimiento de las instalaciones y necesidades. Los programas de biocustodia deben aplicar las medidas de custodia correspondientes usando un enfoque clasificado para reducir los riesgos a un nivel aceptable.

ACCESO AL CURSO:
>>  Laboratory Biosecurity: Build Security into Good Laboratory Practices <<

VIDEO: BSL3 inspection for select agents #biosecurity #CDC

Este video, en inglés, sirve con fines educativos para instituciones o individuos quienes poseen, almacenan o transfieren microorganismos controlados (Select Agents) y toxinas en Estados Unidos. Este video puede ser utilizado en programas de entrenamiento para personal o como herramienta para programas de entrenamiento. Puedes ver y descargar este y otros videos en: SelectAgents.Gov

BSL3 Inspection

Toxins Inspection

Donación de un libro

Tenemos 3 copias duras (libros impresos) del libro "Challenges and Opportunities for Education About Dual Use Issues in the Life Sciences", donados por el National Research Council que pondremos obsequiar a las bibliotecas de 3 instituciones públicas, que tengan laboratorios de investigación biomédica. Para lo cual, solicitamos que nos envíen su solicitud, firmada y sellada, con el Vo.Bo. del bibliotecario de su institución al correo electrónico del blogbioseguridad@gmail.com.
Este libro se encuentra disponible también en formato PDF.
Les daremos prioridad a las instituciones mexicanas, pero podrá tomarse en consideración la solicitud de algun país de habla hispana que desee contar con el libro.
Si quieres apoyar el programa "Dona un libro", por favor revisa las instrucciones.
El libro se enviará por correo regular, por lo que el libro lo recibirán a finales de Noviembre.

Establishing a laboratory network of influenza diagnosis in Indonesia

topnews.in

Abstract
Indonesia has been part of the global influenza surveillance since the establishment of a National Influenza Center (NIC) at the National Institute of Health Research and Development (NIHRD) by the Indonesian Ministry of Health in 1975. When the outbreak of avian influenza A (H5N1) occurred, the NIC and US Naval Medical Research Unit 2 were the only diagnostic laboratories equipped for etiology confirmation. The large geographical area of the Republic of Indonesia poses a real challenge to provide prompt and accurate diagnosis nationally. This was the main reason to establish a laboratory network for H5N1 diagnosis in Indonesia. Currently, 44 laboratories have been included in the network capable of performing polymerase chain reaction testing for influenza A. Diagnostic equipment and standard procedures of biosafety and biosecurity of handling specimens have been adopted largely from World Health Organization recommendations.
Reference:

Setiawaty V, Pangesti KN, Sampurno OD. Establishing a laboratory network of influenza diagnosis in Indonesia: an experience from the avian flu (H5N1) outbreak. Clin Epidemiol. 2012;4:209-12. Epub 2012 Aug 15.

Publica Science artículo de Fouchier sobre la transmisión de influenza H5N1

Ir al artículo original

Finalmente la revista Science publica el controversial artículo original de Fouchier et al. sobre la transmisión de influenza H5N1 en mamíferos.

REFERENCIAS

• Comentario editorial por Bruce Alberts. >> H5N1 << 
• Herfst et al. Airborne Transmission of Influenza A/H5N1 Virus Between Ferrets. Science 22 June 2012: Vol. 336 no. 6088 pp. 1534-1541. Artículo original
• Anthony S. Fauci and Francis S. Collins. Benefits and Risks of Influenza Research: Lessons Learned. Science 22 June 2012: 1522-1523.
• Mark S. Frankel. Regulating the Boundaries of Dual-Use Research. Science 22 June 2012: 1523-1525.
• Carrie D. Wolinetz. Implementing the New U.S. Dual-Use Policy. Science 22 June 2012: 1525-1527.

ABSTRACT
Highly pathogenic avian influenza A/H5N1 virus can cause morbidity and mortality in humans but thus far has not acquired the ability to be transmitted by aerosol or respiratory droplet (“airborne transmission”) between humans. To address the concern that the virus could acquire this ability under natural conditions, we genetically modified A/H5N1 virus by site-directed mutagenesis and subsequent serial passage in ferrets. The genetically modified A/H5N1 virus acquired mutations during passage in ferrets, ultimately becoming airborne transmissible in ferrets. None of the recipient ferrets died after airborne infection with the mutant A/H5N1 viruses. Four amino acid substitutions in the host receptor-binding protein hemagglutinin, and one in the polymerase complex protein basic polymerase 2, were consistently present in airborne-transmitted viruses. The transmissible viruses were sensitive to the antiviral drug oseltamivir and reacted well with antisera raised against H5 influenza vaccine strains. Thus, avian A/H5N1 influenza viruses can acquire the capacity for airborne transmission between mammals without recombination in an intermediate host and therefore constitute a risk for human pandemic influenza.

Screening category A and B priority #pathogens

Abstract. One of the objectives of the National Institutes of Allergy and Infectious Diseases (NIAID) Biodefense Program is to identify or develop broad-spectrum antimicrobials for use against bioterrorism pathogens and emerging infectious agents. As a part of that program, our institution has screened the 10 000-compound MyriaScreen Diversity Collection of high-purity druglike compounds against three NIAID category A and one category B priority pathogens in an effort to identify potential compound classes for further drug development. The effective use of a Clinical and Laboratory Standards Institutebased high-throughput screening (HTS) 96-wellbased format allowed for the identification of 49 compounds that had in vitro activity against all four pathogens with minimum inhibitory concentration values of 16 g/mL. Adaptation of the HTS process was necessary to conduct the work in higher-level containment, in this case, biosafety level 3. Examination of chemical scaffolds shared by some of the 49 compounds and assessment of available chemical databases indicates that several may represent broad-spectrum antimicrobials whose activity is based on novel mechanisms of action. 


References
Barrow EW, et.al. High-Throughput Screening of a Diversity Collection Using Biodefense Category A and B Priority Pathogens. J Biomol Screen. 2012 May 31. 

NIAID Category A, B, and C Priority Pathogens. NIAID’s pathogen priority list is periodically reviewed and is subject to revision in conjunction with our federal partners, including the Department of Homeland Security, which determines threat assessments, and the Centers for Disease Control and Prevention (CDC), which is responsible for responding to emerging pathogen threats in the United States. 

Biorisk Assessment Models (#BioRAMs)

The biorisk assessment models were designed for use by biorisk officers at laboratories and provide visualization of the relative risks, and help to identify risk mitigation measures. These models have incorporated IBTR and international biorisk officer experience in drafting sets of criteria, prioritizing the criteria, and outlining scoring functions for the criteria. The main objective of these models is to help strengthen risk governance in the laboratories by providing assessment methods that are is standardized, systematic, and repeatable. Biorisk subject matter expertise was critical in the development of these models, as there currently is no straight imperial data for laboratory biorisks.

1. Biorisk Assessment Models (BioRAMs) (Intro)
2. Biosafety Risk Assessment Methodology
3. Strengthening Risk Governance in Bioscience Laboratories
4. BioRAM (Biosafety and Biosecurity) Software: (You can obtain a link to download the software via email)

Biosafety concerns for labs in the developing world

As report reveals lax standards in Asia-Pacific, researchers debate how to enforce rules.

By Ewen Callaway

22 May 2012

Biocontainment labs across the Asia-Pacific region all too often fail to live up to the term. An inspection of dozens of labs has found that nearly one-third of the biosafety hoods intended to protect workers from deadly pathogens did not work properly — an offence for which a Western lab could be shut down. In one facility, only a shower curtain enclosed a table on which the brains of rabid dogs were routinely dissected. Such deficiencies are symptomatic of a biosafety crisis in many of the laboratories that diagnose and study infectious agents in developing countries, say biorisk experts who attended a meeting at London’s Chatham House on 17 May, where the results of the inspection were presented.

Please see article at:     >> Nature News <<

VIDEO: The Intersection of Science and Security: a Case Study Approach

Continuing the global dialogue with the scientific and science policy community: focus on Asia and the Western Pacific.

On December 9, 2011 the United States Government sponsored a workshop, The Intersection of Science and Security: a Case Study Approach, Continuing the global dialogue with the scientific and science policy community: focus on Asia and the Western Pacific. The purpose of this workshop was to give attendees a greater understanding of dual use research, including an awareness of strategies for managing dual use research of concern and an appreciation of how these issues are being addressed around the globe. The workshop utilized published articles as case studies, involving Mousepox and a SARS-like virus, as examples of dual use research of concern that highlight issues which investigators, institutions, journal editors, governments, and the scientific and security policy communities need to consider. In addition to presentations of the case studies, there were discussions among all panelists and attendees on global science and security issues as well as those of special interest within Asia and the Western Pacific, including information on training and education resources currently available.

Agenda, Meeting Materials and Participant Biographies available at: http://oba.od.nih.gov/biosecurity/meetings/Dec2011/Asia_Agenda_11-29-11.pdf

Archived Video Available at: http://www.youtube.com/playlist?list=PLDB3BA8B0B3D32989

#H5N1 research: #biosafety, #biosecurity and #bioethics, en Londres (Reino Unido)

Fuente: Cordis

Los días 3 y 4 de abril de 2012 se celebrará en Londres (Reino Unido) el evento «H5N1 research: biosafety, biosecurity and bioethics» («Investigación sobre el H5N1: seguridad, protección y ética biológica») El subtipo H5N1 del virus de la gripe A, que también se conoce como gripe aviar, es capaz de provocar enfermedad en humanos y en muchos otros animales, como lo demuestran los brotes del mismo detectados en todo el mundo. La investigación en este campo no se detiene y entre sus prácticas se incluye la creación de virus de H5N1 modificados en un entorno de laboratorio. Las condiciones de seguridad y protección biológica en las que se desarrolla este tipo de investigaciones han sido motivo reciente de una enorme preocupación. Un virus de H5N1 en condiciones de provocar un contagio podría causar estragos y lo cierto es que el riesgo de liberación accidental es importante. No obstante, el conocimiento científico presente y futuro obtenido en condiciones de protección adecuadas generará un conocimiento básico sobre la transmisión y la virulencia de la gripe. El evento reunirá a investigadores y estudiantes para debatir sobre la práctica de la investigación sobre el H5N1 y las políticas al respecto. Para más información, consulte: http://royalsociety.org/events/2012/viruses/
Categoría: Eventos
Fuente: The Royal Society
Documento de Referencia: Basado en un anuncio del evento
Códigos de Clasificación por Materias: Biotecnología; Biotecnología médica ; Medicina, Sanidad; Investigación científica; Ciencias veterinarias y de los animales

Leyes Mexicanas relacionadas a la importación de productos biológicos #bioseguridad

• Ley Federal de Sanidad Animal

• REGLAMENTO de Insumos para la Salud.

• REGLAMENTO en Materia de Registros, Autorizaciones de Importación y Exportación y Certificados de Exportación de Plaguicidas, Nutrientes Vegetales y Sustancias y Materiales Tóxicos o Peligrosos

• Ley General de Impuestos de Importación y Exportación

• Reglamento de la Ley General de Salud en Materia de Investigación para la Salud

• Reglamento de la Ley General de Salud en Materia de Sanidad Internacional

• Requisitos zoosanitarios para la importación de animales o bienes de origen animal

• Importación de productos agropecuarios

• ACUERDO mediante el cual se enlistan las enfermedades y plagas de los animales, exóticas y endémicas denotificación obligatoria en los Estados Unidos Mexicanos

OTras leyes y reglamentos

Case studies un Dual Use Biological Research

>> IR AL SITIO <<

Technical advances in modern molecular biology have increased the risk that research could be used against us by those with malicious intent. It is important that biologists increase their awareness of biosecurity issues and learn to assess their research in terms of modern security concerns to minimize that possibility. The case studies presented here will help define the issues associated with “dual-use” research and security in the research lab. They include interviews with researchers whose legitimate scientific work could potentially be used for questionable or harmful endeavors, as well as a historical perspective on their research, bioterrorism, and research regulations. We have included primary scientific research papers and discussion questions that are meant to raise awareness about the importance of responsible biological research.

Case studies un Dual Use Biological Research
Federation of American Scientists