|
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
Claudia Ines Chamas, Maria Celeste Emerick and Silvio Valle
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
Size of Files:
Text: 7K
Graphics: No associated graphics files
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.
The law sets forth the responsibilities of enforcement
authorities in the areas of health, agriculture and the
environment, as well as the powers of the Internal Biosafety
Commissions (CIBio) to be created in 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.
We believe that the regulations are beneficial to all, and
that the clear and objective discussion of possible risks has
a positive impact on innovation by legitimizing the technology
employed to achieve it.
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.
Copyright is held by the authors.
Editorial Office: biosafe @biostrat.demon.co.uk
|