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- Cartagena Biosafety Protocol ( enforcement required)

Health Biosafety Committee (CBS)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 AgentsBiosafety of Infectious Agents

CBS - The Health Biosafety Committee – Ministry of HealthCBS - The Health Biosafety Committee – Ministry of Health

: Publications:

1) Risk Classification of Biological Agents

2) General Procedures to work with Biological Agents.

http://bvsms.saude.gov.br/bvs/publicacoes/

CBS - The Health Biosafety Committee – Ministry of HealthCBS - The Health Biosafety Committee – Ministry of Health

Publications (cont.):

3) Health Biosafety: Priorities and a Strategic Plan

4) Regulatory Framework .

Biosecurity Measures

• 2004- National Program for Sensible Goods (PRONABENS)- Ministry of Science and Technology

• Resolution 10/March 2008- List of select agents- voluntary notification– On site visit to identify select agents in the labs-

more than 400 visits– Training on identification of select agents and

biosecurity measures– ANBio’s 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 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.

The Road ahead…The Road ahead…

• Biosecurity is a new issueBiosecurity is a new issue

• A complete inventory of Biological Agents in the LabsA complete inventory of Biological Agents in the Labs

• How many Labs are there in the country (universities)?How many Labs are there in the country (universities)?

• What are the Biosafety conditions of the facilities?What are the Biosafety conditions of the facilities?

• Where are they in the country?Where are they in the country?

• What are the Biosafety procedures?What are the Biosafety procedures?

• What are the purposes of the work?What are the purposes of the work?

• Destruction of samples (polio post eradication)Destruction of samples (polio post eradication)

• Personnel reliability and commitmentPersonnel reliability and commitment

• Continuous Biosafety and Biosecurity plan- Continuous Biosafety and Biosecurity plan- Training, Training,

training, training…..training, training…..

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.

Thank You!

Be Safe! Be Safe!

Be Safe!