Cambio de Consejo Directivo y Comisiones 2013-2014, www.amexbio.org

www.AMEXBIO.org

REGISTRE SU ASISTENCIA EN:
http://www.amexbio.wildapricot.org

Laboratorios de Bioseguridad Nivel 4 en Europa

Tabla 1. Instalaciones para diagnóstico e investigación en operación
en la Unión  Europea. Red Europea de Laboratorios de
Bioseguridad Nivel 4.

Un artículo publicado en Plos Pathogens, que habla acerca de la red de laboratorios BSL-4 europeo.  El artículo discute las características de la red y los laboratorios, así como las perspectivas y potenciales áreas de crecimiento. En esta red, se manejan microorganismos del grupo de riesgo 4, como son Arenaviridae, Bunyaviridae, Filoviridae, and Paramyxoviridae.


Referencia:
Nisii C., et al. Biosafety Level-4 Laboratories in Europe: Opportunities for Public Health, Diagnostics, and Research. PLoS Pathog 9(1): e1003105. doi:10.1371/journal.ppat.1003105

NOM Criterios para proyectos de investigación para la salud en seres humanos.

DOWNLOAD PDF

El día 4 de Enero de 2013 se publicó en el Diario Oficial de la Federación, la NOM que establece los criterios para la ejecución de proyectos de investigación para la salud en seres humanos.

1. Objetivo
Esta norma establece los criterios normativos de carácter administrativo, ético y metodológico, que en correspondencia con la Ley General de Salud y el Reglamento en materia de investigación para la salud, son de observancia obligatoria para solicitar la autorización de proyectos o protocolos con fines de investigación, para el empleo en seres humanos de medicamentos o materiales, respecto de los cuales aún no se tenga evidencia científica suficiente de su eficacia terapéutica o rehabilitatoria o se pretenda la modificación de las indicaciones terapéuticas de productos ya conocidos, así como para la ejecución y seguimiento de dichos proyectos.

2. Campo de aplicación
Esta norma es de observancia obligatoria, para todo profesional de la salud, institución o establecimiento para la atención médica de los sectores público, social y privado, que pretendan llevar a cabo o realicen actividades de investigación para la salud en seres humanos, con las características señaladas en el objetivo de la presente norma.

REFERENCIA:
DOF: 04/01/2013
NORMA Oficial Mexicana NOM-012-SSA3-2012, Que establece los criterios para la ejecución de proyectos de investigación para la salud en seres humanos.
http://dof.gob.mx/nota_detalle.php?codigo=5284148&fecha=04/01/2013

NOTA (15/01/2013):  El apartado 9, habla de la constitución, inscripción y funcionamiento de los Comités de Investigación, Etica en la Investigación y Bioseguridad.

How to survive a plague #Oscar Nominee

Información de la película:

Géneros:

Documental

Idioma:

Inglés

Duración:

1:49:35

Clasificación del partner:

SIN CLASIFICACIÓN 

Fecha de estreno:

21/09/2012

>>  Fully available in USA  <<

Vaya, es fecha de presentar los premios de la Academia Americana a las mejores películas. Y vaya sorpresa, "How to survive a plague", del director David France, está nominada a mejor documental.
Esta película relata la historia de los primeros años durante el despertar de la epidemia de VIH/SIDA y de como la convirtieron en una enfermedad manejable. De cómo lucharon por acelerar la búsqueda de nuevos compuestos en tiempo récord, ayudando a terminar los días mas oscuros de esta epidemia.
El NY Times hace una entrevista al respecto. Lo interesante, es que es una gran colección de video tomado por activistas durante los 80´s, y muchas entrevistas a oficiales de salud de E.E.U.U. Ojalá podamos verla pronto.

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

Infección ocupacional adquirida de Leishmaniasis cutánea,

Artículo completo

Abstract: En éste artículo se reportan dos casos de Leishmaniasis cutánea americana: Una autoinoculación con aguja contaminada durante el manejo de muestras, y una adquirida durante el trabajo de campo sobre biología de aves.

ENGLISH
We report two occupationally acquired cases of American cutaneous leishmaniasis (ACL): one accidental laboratory autoinoculation by contaminated needlestick while handling an ACL lesion sample, and one acquired during field studies on bird biology. Polymerase chain reaction (PCR) assays of patient lesions were positive for Leishmania, subgenus Viannia. One isolate was obtained by culture (from patient 2 biopsy samples) and characterized as Leishmania (Viannia) naiffi through an indirect immunofluorescence assay (IFA) with species-specific monoclonal antibodies (mAbs) and by multilocus enzyme electrophoresis (MLEE). Patients were successfully treated with N-methyl-glucamine. These two cases highlight the potential risks of laboratory and field work and the need to comply with strict biosafety procedures in daily routines. The swab collection method, coupled with PCR detection, has greatly improved ACL laboratory diagnosis.

Reference:
Felinto de Brito ME, et al. Occupationally acquired american cutaneous leishmaniasis. Case Rep Dermatol Med. 2012;2012:279517. doi: 10.1155/2012/279517.

Felices fiestas!!!

Feliz Navidad y Próspero 2013

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

USDA #Biosafety Symposium: Agricultural Research and Response for Field and Lab

USDA ARS 2nd International Biosafety and 

Biocontainment Symposium:

"Agricultural Research and Response 

for Field and Lab"

February 4-7, 2013

Hilton Alexandria Mark Center

Alexandria, Virginia

ABSA is the managing partner of the USDA Agricultural Research Service (ARS) 2nd International Biosafety & Biocontainment Symposium - Agriculture Research and Response for Field and Lab. The symposium will include ten pre-symposium courses and 2½ days of scientific presentations. There will also be exhibits showcasing the latest agricultural biosafety and biocontainment products and services. Registration, program, sponsors, and details for the symposium are available at http://arssymposium.absa.org.

Pre-Symposium Courses: (4 hours each)

Monday February 4, 2013

• Plant Pathology 101: Introduction of Principles of Plant Pathology
• Plant Research in Greenhouses and Other Specialized Containment Facilities
• APHIS Regulatory Oversight: Plant Pests, Diseases, and Imported Soil
• APHIS Permitting
• Integrated Pest Management & Biological Control
• Agrodefense and Beyond: Laboratory Response Networks
• Bioterrorism Awareness for the Animal Health Community
• GMO - International Perspective on Biological Safety in Agriculture
• Biocontainment Techniques Beyond the Biosafety Cabinet
• Food Defense from Farm to Fork

 The symposium will consist of sessions covering a variety of topics addressing national and international issues including GMOs, and agroterrorism. There will be roundtable discussions on the culture of responsibility and security, LAIs and breach in containment, and an interactive session where attendees will chose the topics of discussion. Keynote speakers will open the program on Tuesday and Wednesday.

In addition to the valuable courses and sessions, you will have the opportunity to network with professionals from the biosafety and scientific research industries, organizations, and agencies.

Register soon for this dynamic program at http://arssymposium.absa.org  

Safe Injection Practices & Bloodborne pathogens training

The One & Only Campaign is a public health campaign, led by the Centers for Disease Control and Prevention (CDC) and the Safe Injection Practices Coalition (SIPC), to raise awareness among patients and healthcare providers about safe injection practices. The campaign aims to eradicate outbreaks resulting from unsafe injection practices. 

 >> BLOODBORNE PATHOGENS TRAINING <<

REFERENCES:

1. Overcoming Education Gaps and Denial: CDC and SIPC Release New Tools to Help Clinicians Ensure Every Injection is Safe 
2. http://www.oneandonlycampaign.org/ 
3. BLOODBORNE PATHOGENS TRAINING

Meeting report: 15 th Annual Conference of the European BioSafety Association 2012

Almost 300 people participated in the latest annual conference of the European BioSafety Association (EBSA). This year’s EBSA conference, the 15th ofthe series, took place on June 12–13, 2012 in Manchester, UK. It was preceded by eight full-day courses with almost 200 participants in total. 

       The conference consisted of seven sessions with 16 lectures and started with the opening by the President of the society, Patrick Rüdelsheim (Perseus, Belgium), who presented the evolution of biosafety: starting from an intuitive approach followed by an evidence-based to the current performance-based approach. The welcome address by a representative of the host, the University of Manchester, Nalin Thakker, stressed the historical importance of the  location: first railway station, first telephone exchange and now the role of graphene. A video teleconference call by David Heymann on an armchair (literally) tour of the world of biosecurity addressed the historical approach to Ebola virus in Africa, the origin of HIV, certification of small pox eradication in 1980, SARS in 2003, and the consequences of Hepatitis C in Egypt on workers in Saudi Arabia. The conclusion was: laboratory and health workers are at great risk of infection.

This year's annual meeting of the European BioSafety Association, the 15^th of the series, took place on June 12–13, 2012 in Manchester, United Kingdom. Dr. Benedictus Verduin (BioRiskManagement, Wageningen, The Netherlands), President of EBSA 2007–2008, reports the proceedings of the meeting in this concise forum article. 

REFERENCIA:
Verduin BJM. Meeting report: 15th Annual Conference of the European BioSafety Association 2012. Biotechnology Journal 2012. 7(12):1427–1428. DOI: 10.1002/biot.201200302

Feliz cumpleaños querido blog!

Pasan muchas cosas hoy además de los cambios políticos en México. Pues hoy es 1° de Diciembre, y no lo quiero dejar pasar, porque hoy este blog cumple 5 años!! Wow!! Si alguien nos hubiera dicho que cumpliríamos 5 años, quizá no lo creeríamos. Pero gracias al interés de las personas que leen este blog y que nos envían sus preguntas, es que aprendemos todos, porque si alguna respuesta no se tiene, se busca, se comenta, y se pone en la mesa. Muchas de esas preguntas llegan de personal de laboratorio interesado, por diversas vías. Pero en todos los casos aportan a hacer crecer este blog. Gracias a todos por su apoyo!!

Felicitamos a los químicos hoy también en su día.

Y hoy también es el Día Internacional de la lucha contra el SIDA!

>250,00 visitas!!

Poster sobre uso de Equipo de Protección Personal #EPP

Prepared by the Academy for Educational Development for the USAID Avian Infl uenza Program

Pueden descargarla:

>> HOW TO WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE) <<
Pueden recibir gratuitamente 3 copias impresas tamaño poster, que serán enviadas por correo regular. Para lo cual, solicitamos que nos envíen su solicitud firmada al correo electrónico del blogbioseguridad@gmail.com.

VIDEO: Biosecurity Research Institute, Kansas State University #BRI

A continuación encontrarán una serie de 9 videos (total de 20 minutos) del Biosecurity Research Institute, Kansas State University. Una mirada a los programas de bioseguridad de esta universidad.

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 <<

Cabinas de Seguridad Biológica #WHO #CDC

Tengo aquí, tres documentos relacionados al uso de cabinas de seguridad biológica. El primero "Cabinas de seguridad biológica: uso, desinfección y mantenimiento" de la Organización Mundial de la Salud, es un libro muy completo que habla acerca de las características y buen uso de las cabinas. Después tengo el "Apéndice A" del Manual de Laboratorios Microbiológicos del CDC (BMBL5), y que complementa dicho manual. Finalmente, un pequeño texto sobre las recomendaciones para la "Colocación de Cabinas de Seguridad Biológicas en Laboratorios" y que puede ser de utilidad.

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

#WHO Laboratory Assesment Tool

El "Laboratory Assessment Tool.zip" ofrece una guía para evaluar laboratorios y sistemas nacionales. La audiencia blanco es cualquier persona que evalúa laboratorios: autoridades nacionales de salud, agencias multilaterales, organizaciones no gubernamentales (NGO´s), resposables de laboratorio, etc. Este documento describe los procesos generales para evaluar laboratorios y proporciona dos cuestionarios que ayudan a evaluar los sistemas de laboratorios nacionales (anexo 1) y laboratorios individuales (anexo 2). Los evaluadores pueden utilizar los cuestionarios tal y como se presentan o acondicionar los materiales disponibles para que cumplan con requerimientos locales o específicos y adecuarlos mejor al contexto de evaluación. Los cuestionarios se encuentran en formato PDF y pueden ser fácilmente impresos, y en archivos Excel que permiten calculos matemáticos automáticos de indicadores cuando se responde a las preguntas y el análisis de datos. Pueden descargar el Archivo ZIP o descargar los archivos individuales.
Publication details:
Number of pages: 35
Publication date: 2012
Languages: English
WHO reference number: WHO/HSE/GCR/LYO/2012.2

Microbial aerosol generation during laboratory accidents

Aim: To quantify microbial aerosols generated by a series of laboratory accidents and to use these data in risk assessment.
Methods and Results: A series of laboratory accident scenarios have been devised and the microbial aerosol generated by them has been measured using a range of microbial air samplers. The accident scenarios generating the highest aerosol concentrations were, dropping a fungal plate, dropping a large bottle, centrifuge rotor leaks and a blocked syringe filter. Many of these accidents generated low particle size aerosols, which would be inhaled into the lungs of any exposed laboratory staff. Spray factors (SFs) have been calculated using the results of these experiments as an indicator of the potential for accidents to generate microbial aerosols. Model risk assessments have been described using the SF data.
Conclusions: Quantitative risk assessment of laboratory accidents can provide data that can aid the design of containment laboratories and the response to laboratory accidents.
Significance and Impact of the Study: A methodology has been described and supporting data provided to allow microbiological safety officers to carry out quantitative risk assessment of laboratory accidents.

Reference:
A. Bennett & S. Parks. Microbial aerosol generation during laboratory accidents and subsequent risk assessment. Journal of Applied Microbiology 100 (2006) 658–663.

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.

Biocontainment in Gain-of-Function Infectious Disease Research

The discussion of H5N1 influenza virus gain-of-function research has focused chiefly on its risk-to-benefit ratio. Another key component of risk is the level of containment employed. Work is more expensive and less efficient when pursued at biosafety level 4 (BSL-4) than at BSL-3 or at BSL-3 as modified for work with agricultural pathogens (BSL-3-Ag). However, here too a risk-to-benefit ratio analysis is applicable. BSL-4 procedures mandate daily inspection of facilities and equipment, monitoring of personnel for signs and symptoms of disease, and logs of dates and times that personnel, equipment, supplies, and samples enter and exit containment. These measures are not required at BSL-3 or BSL-3-Ag. Given the implications of inadvertent or deliberate release of high-threat pathogens with pandemic potential, it is imperative that the World Health Organization establish strict criteria for biocontainment that can be fairly applied in the developing world, as well as in more economically developed countries.
Referencia
Lipkin WI. Biocontainment in Gain-of-Function Infectious Disease Research. MBio. 2012 Oct 9;3(5). pii: e00290-12. doi: 10.1128/mBio.00290-12. PMID: 23047747

Rethinking biosafety in research on potential pandemic pathogens

If accidentally released, mammalian-transmissible influenza A/H5N1 viruses could pose a greater threat to public health than possibly any other infectious agent currently under study in laboratories, because of such viruses' likely combination of transmissibility and virulence to humans. We advocate explicit risk-benefit assessments before work on such pathogens is permitted or funded, improvement of biosafety practices and enforcement, and harmonization of criteria for permitting such experiments across government agencies, as well as internationally. Such potential pandemic pathogens, as they have been called, jeopardize not only laboratory workers and their contacts, but also the wider population, who should be involved in assessments of when such risks are acceptable in the service of scientific knowledge that may itself bear major public health benefits.
Referencia:
Lipsitch M, Bloom BR. Rethinking biosafety in research on potential pandemic pathogens. MBio. 2012 Oct 9;3(5). pii: e00360-12. doi: 10.1128/mBio.00360-12. PMID: 23047752

NOM-007-SSA3-2011

El 27/03/2012 se publicó en el Diario Oficial de la Federación la nueva NOM-007-SSA3-2011, Para la organización y funcionamiento de los laboratorios clínicos
Para quienes no la han revisado, pueden verla en:
http://dof.gob.mx/nota_detalle.php?codigo=5240925&fecha=27/03/2012

Trends Relevant to the Biological Weapons Convention

Excerpt

The potential dual use of life sciences knowledge, tools, and techniques reinforces the need for the scientific community to be aware of the norms of responsible and appropriate scientific conduct, as well as international and national legal requirements. Over the past decade, national and international scientific organizations having become increasingly engaged in issues related to the responsibilities of the scientific community to help reduce the risks of misuse of life sciences research (Bowman et al., 2011; IAP, 2005; NRC, 2004, 2006a, 2009a, c, 2011a; OECD, 2004; Royal Society and Wellcome Trust, 2004; WHO, 2005, 2007a). Scientists can also play a useful role in communicating with policy makers and civil society to help them understand the nature, applications, and potential positive and negative implications of developments in their field. Perspectives from the scientific community can contribute to discussions of how to create the best mix of policies and practices to achieve safety and security without unduly hampering global scientific progress for beneficial applications. This is the motivation and foundation for the workshop and the committee's report.

Trends Relevant to the Biological Weapons Convention    PDF
National Research Council (US) Committee on Trends in Science and Technology Relevant to the Biological Weapons Convention: An International Workshop.
Washington (DC): National Academies Press (US); 2011.
ISBN-13: 978-0-309-21071-3
ISBN-10: 0-309-21071-2

EuroNHID Survey: Capabilities in 48 isolation facilities

BACKGROUND: Highly infectious diseases (HIDs) are defined as being transmissible from person to person, causing life-threatening illnesses and presenting a serious public health hazard. The sampling, handling and transport of specimens from patients with HIDs present specific bio-safety concerns.
FINDINGS: The European Network for HID project aimed to record, in a cross-sectional study, the infection control capabilities of referral centers for HIDs across Europe and assesses the level of achievement to previously published guidelines. In this paper, we report the current diagnostic capabilities and bio-safety measures applied to diagnostic procedures in these referral centers. Overall, 48 isolation facilities in 16 European countries were evaluated. Although 81% of these referral centers are located near a biosafety level 3 laboratory, 11% and 31% of them still performed their microbiological and routine diagnostic analyses, respectively, without bio-safety measures.
CONCLUSIONS: The discrepancies among the referral centers surveyed between the level of practices and the European Network of Infectious Diseases (EUNID) recommendations have multiple reasons of which the interest of the individuals in charge and the investment they put in preparedness to emerging outbreaks. Despite the fact that the less prepared centers can improve by just updating their practice and policies any support to help them to achieve an acceptable level of biosecurity is welcome.
PMID: 23009598
REFERENCE: Thiberville SD, et. al. Diagnostic issues and capabilities in 48 isolation facilities in 16 European countries: data from EuroNHID surveys. BMC Res Notes. 2012 Sep 25;5(1):527.