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Biosafety and Biosecurity Overview : Brazil

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

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Biosafety and Biosecurity Overview : Brazil

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  1. BiosafetyandBiosecurity Overview : Brazil Leila Macedo, Ph.D. PresidentofANBio www.anbio.org.br

  2. BiosafetyRegulatoryBasis • Law 8.974/ 1995 • Law 11.105/2005- Appliedonlyto DNA technology • Establishes the National authorities – CTNBio (MS&T), CNBS • Decree 5.591/05 • Cartagena BiosafetyProtocol ( enforcementrequired)

  3. Health Biosafety Committee (CBS) BiosafetyofInfectiousAgents Established by RuleGM/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)

  4. : Publications: Risk Classification of Biological Agents General Procedures to work with Biological Agents. CBS - The Health Biosafety Committee – Ministry of Health http://bvsms.saude.gov.br/bvs/publicacoes/

  5. Publications (cont.): 3) Health Biosafety: Priorities and a Strategic Plan 4) Regulatory Framework . CBS - The Health Biosafety Committee – Ministry of Health

  6. BiosecurityMeasures • 2004- NationalProgram for SensibleGoods (PRONABENS)- Ministryof Science and Technology • Resolution 10/March 2008- Listofselectagents- voluntarynotification • On site visittoidentifyselectagents in thelabs- more than 400 visits • Training onidentificationofselectagentsandbiosecuritymeasures • ANBio’s training onBiosafetysince 1999 andonBiosecuritysince 2007 (BEP support)-BSL3 / 2

  7. Differentlevelsofquality Maintenance, certification, waste management and a global inventoryofsamples are themain gaps

  8. Surveyof BSL3 Labs Figure 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.

  9. The Road ahead… • Biosecurity is a new issue • A complete inventory of Biological Agents in the Labs • How 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 commitment • Continuous Biosafety and Biosecurity plan- Training, training, training…..

  10. Lessons Learned • The Biosafety Societies are key to push Biosafety/ Biosecurity developments in the countries • Long Term Biosafety Projects are needed • Coordination and Governance are crucial • Construction and commissioning of new labs, BUT, LONG TERM MAINTENANCE PLAN MUST BE REQUIRED.

  11. ThankYou! Be Safe! Be Safe! Be Safe!

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