Presentation at the Controlling Dangerous Pathogens Project Regional Workshop on Dual-Use Research, Teresopolis, Brazi

Fernandez, Roberto J.

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Biosafety and Dual-Use Scientific Research.Dr.Roberto J. Fernandez, MDChief DSOHChief of Biosafety.IPK.Dual-UseAlready precisely defined?Where are the limits?Risk and Perception.Risk increases with:-development in biotechnology.-lack or insuficient control.Risk perception influenced by:-education/culture.-specific knowledge about Biosafety.-media.There are differences betweendeveloped and underdevelopedcountries.Different positions regarding thisitem.Biosafety in Cuba.Biosafety in Cuba. Particular issues.All research facilities belong to government.Biosecurity is included in Biosafety.Biological agents comprises those relatedwith human, animal and plant health.Deals with traditional and GMO’s organisms.Protects laboratory workers, community & environment.Definición de Bioseguridad. CUBA.Conjunto de medidas científico-organizativas y técnico-ingenieras.Destinadas a proteger: trabajador de la instalación, la comunidad y el ambiente.De: los riesgos que entraña el trabajo con agentes biológicos o la liberación de organismos al ambiente (OGM o exóticos).Para: prevenir daños y disminuir efectos y eliminar consecuencias en caso de contaminación, efectos adversos, escapes o pérdidas.Background.Isolated scientific leaders.Concern about occupationalbiological hazards.Safety empirical measures to protect theirown laboratory workers.[Not complete or organized actions].Middle 60’s and during 70’sHospitals increased in number and variety ofservices.Public Health Laboratory Network grew.New research centers were created.Set up a growing biotechnological andpharmaceutical industry.In the 80’s.The Scientific Pole of Western Havana wasfounded.Biosafety Commission of the CubanAcademy of Sciences (ACC) was establish.Assesment the design of new facilities orremodeling existing ones.Between 1991 and 1996.Specialist working in this field increase in number and diversity, creating trulyinterdisciplinary groups.Nexus with activities of the Biological andToxin Weapons Convention (BTWC). Annual reports and Conferences.Biosafety courses were done on annualbasis.In the last decade.Approval of national laws and regulations.Growing relationships with otherorganizations.Biosafety start putting attention to issuesrelated to biodiversity, quality control, medical care and others activities related tothe economic and social life in the country.In 1996 was created tha NationalCenter for Biological Safety (CNSB).Main structure:Departament of Inspection and activitiesrelated to BTWC.Departament of Safety Analisis (RiskAssesment).Departament of Teaching and Development.Subordination.Ministry of Science, Technology andEnvironment (CITMA).Office of Environmental Regulation andNuclear Security (ORASEN).CEANPAQ     CICA     CNSN    CNSBCNSBCNSBNational Relationships of CNSB.CNSB                   Metod. Adv.                 OACE(Ministries)Specialists Metod. Adv.                ProvincialTerritorial Deleg.                                    Adm.CITMA (14 Prov.+ Special Mun.)International Relationships of CNSB.Secretaria del Convenio de Diversidad Biológica.Departamento de Desarme de Naciones Unidas.Proyecto del Fondo Mundial para el Medio Ambiente (PNUMA).Laws & RegulationsBackground:1. Ley 13/77 de Prot. e Higiene del Trabajo.Basic legal documents:1. Res. 67/96 CITMA: Creation of the CNSB.2. Ley 81/97: Environmental Law.Specific legal documents:1. Decreto-Ley 190/99 About Biological Safety. *It is the top specific document.Complimentary Regulations (1).1.Res. 42/99. Res.38/06 (update): List of biologicalagents.2. Res. 8/00: General Regulations of BS.3. Res. 76/00: Autorizations (licenses).4. Res 103/02: Requirements and Procedures in Fac.Complimentary Regulations (2).5. Acuerdo 4728/03: Appoint the National Autority forthe BTWC.6. Res. 112/03: BS Requirements for working withPlants and Animals.7. Res. 2/04: Accountability and Control.Others.Decreto-Ley 200: De las Contravenciones en Materia de Medio Ambiente.Technical Committee for Standards No. 94 / Biological Safety. National Office forStandardisation.Some Interesting Activities.Visits of the Center for Defense Information(USA) to research center in Cuba.IAP. Codes of Conduct for BiologicalScientists. Cuban Academy Workshop: Scientist Point of View. 2005.WHA.58.29 Enhancement of LaboratoryBiosafety. PAHO efforts/ Regional meetingsSP 2005; Guatemala 2006.IHR 2005.Some Challenges.Developing a “culture” of Biosafety.What to control and how without limitingdevelopment.Harmonization (in spite of many differences).To consider also animals and plants.Biosafety (and Biosecurity) is not an option. It is a crucial need for the development of biological sciences that can not be postponed.Thanks!

Biosafety and Dual-Use Scientific Research

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Biosafety and Dual-Use Scientific Research

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