Biosafety and Biosecurity Overview : Brazil. Leila Macedo, Ph.D. President of ANBio www.anbio.org.br. Biosafety Regulatory Basis Law 8.974/ 1995 Law 11.105/2005- Applied only to DNA technology Establishes the National authorities – CTNBio (MS&T), CNBS Decree 5.591/05 - PowerPoint PPT Presentation
Text of Biosafety and Biosecurity Overview : Brazil
Biosafety and Biosecurity Overview : Brazil
Leila Macedo, Ph.D.President of ANBiowww.anbio.org.br
Biosafety Regulatory Basis
Law 8.974/ 1995Law 11.105/2005- Applied only to DNA technologyEstablishes the National authorities CTNBio (MS&T), CNBSDecree 5.591/05Cartagena Biosafety Protocol ( enforcement required)
Health Biosafety Committee (CBS)Established by Rule GM/MH 1.683, August 28th, 2003 Coordination under Secretary of Science and Technology from the Ministry of Health- Responsible to establish procedures for human infectious agents. (procedures are voluntary) Biosafety of Infectious Agents
CBS - The Health Biosafety Committee Ministry of Health: Publications:Risk Classification of Biological Agents General Procedures to work with Biological Agents.http://bvsms.saude.gov.br/bvs/publicacoes/
CBS - The Health Biosafety Committee Ministry of Health
Publications (cont.): 3) Health Biosafety: Priorities and a Strategic Plan4) Regulatory Framework .
Biosecurity Measures2004- National Program for Sensible Goods (PRONABENS)- Ministry of Science and TechnologyResolution 10/March 2008- List of select agents- voluntary notificationOn site visit to identify select agents in the labs- more than 400 visitsTraining on identification of select agents and biosecurity measuresANBios training on Biosafety since 1999 and on Biosecurity since 2007 (BEP support)-BSL3 / 2
Different levels of quality Maintenance, certification, waste management and a global inventory of samples are the main gaps
Survey of BSL3 LabsFigure 1. The results of a survey conducted by ANBio about the state of biosafety and biosecurity in biological research institutions across Brazil (including two from Peru and Equator). The survey took place from May 2008 to February 2009, and 237 questionnaires were received.
The Road aheadBiosecurity is a new issueA complete inventory of Biological Agents in the LabsHow many Labs are there in the country (universities)?What are the Biosafety conditions of the facilities?Where are they in the country?What are the Biosafety procedures?What are the purposes of the work?Destruction of samples (polio post eradication)Personnel reliability and commitmentContinuous Biosafety and Biosecurity plan- Training, training, training..
Lessons LearnedThe Biosafety Societies are key to push Biosafety/ Biosecurity developments in the countriesLong Term Biosafety Projects are neededCoordination and Governance are crucialConstruction and commissioning of new labs, BUT, LONG TERM MAINTENANCE PLAN MUST BE REQUIRED.