BioSafety Journal Pontificia Universidad Católica de Valparaíso ISSN: 1366 0233 Vol. 1, Num. 1, 1995

BIOSAFETY: an online journal
Volume 1, Paper 5 (BY95005), May 22nd 1995
Online Journal, URL - http://bioline.bdt.org.br/by 

The regulation of biosafety in Brazil

        
Fundacao Oswaldo Cruz, Rio de Janeiro, Av. Brazil 4365, 
21045-900 Rio de Janeiro, RJ, Brazil
Email: VALLE@dcc001.cict.fiocruz.br

Code Number: BY95005
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The rapid development of biotechnology since the 1970s continues to bring changes to our daily lives. Genetic manipulation techniques help us engender many processes and products that can change and interfere with the quality of life of people and animals, as well as the quality of the environment. The use of these new techniques is generating economic and social benefits for humanity, such as in the prevention and diagnosis of disease, production of medicines, and biological pest and vector control.

Biosafety regulations involving projects in genetic manipulation have become a world-wide concern for governments, companies, scientists and society at large. Major issues raised by discussions include the limits and rigor of regulations, product/process regulations and the scientific grounds for characterizing risk.

Alongside the advance of technologies and outlooks for new products, the advance of regulatory environments is often seen as a hindrance to investments in biotechnology projects. Such regulations find their justification in potential risks arising from experiences with biotechnology and in the need to set rules to control them. Regulations allow for the safe use of genetic engineering and a reduction of uncertainties.

Most developed countries have now established biosafety laws or standards, although following quite heterogeneous patterns in their regulations. Regulations in those countries have not held back growing investments in biotechnology. On the other hand, developing countries do not yet have either biosafety laws or a significant number of projects in the area of biotechnology. There are growing international pressures, however, in favor of a rapid implementation of standards.

In Brazil, following five years in Congress, and with minimal involvement of the scientific community, a Biosafety Act (No. 8.974) was passed into law on January 5, 1995. (1)

Following are some of the highlights in the new law:

     The Executive is authorized to create a National          
     Technical Commission on Biosafety (CTNBio);

     Activities involving genetically-modified organisms     
     (GMOs) can only be carried out by institutions with a     
     legal personality, not by individuals;

     Standards are set for the use of genetic engineering     
     techniques and for environmental releases of GMOs, with   
 
     the objective of protecting the health of people,     
     animals, plants and the environment;

     Regulations are established for teaching, research,     
     development and production activities involving GMOs;


     The National Technical Commission on Biosafety will issue 
     a Biosafety Quality Certificate to institutions working   
     with GMOs.

Infractions of standards set by the law will be subject to fines and will be considered crimes subject to a maximum of 20 years imprisonment, depending on the gravity of the infraction.

Activities involving GMOs which are prohibited by the law include:

     - the genetic manipulation of human germ cells;

     - the production, storage or manipulation of human
       embryos for use as biological material subject to
       manipulation with recombinant DNA technologies;

     - in vivo intervention in human genetic material, except  
       for the treatment of genetic defects;

     - in vivo intervention in animal genetic material, except 
       for cases involving significant scientific advances;    
       and

     - environmental releases of GMOs without the previous     
       authorization of the CTNBio.

Globalization of the economy has made well-defined regulations indispensable to affirm each country's intentions with regards to genetic manipulation, especially in countries still lacking educational programs aimed at informing society on genetic engineering's benefits and limitations, especially in ethical terms.

REFERENCE:

(1) Diario Oficial, Imprensa Nacional, Ano CXXXIII, No. 5, 6 de Janeiro 1995, Brasilia, D.F. Brasil.

Published by Bioline Publications and Science and Technology Letters.

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