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biosecurity

One more round

The Senate authorizes research with stem cells and reestablishes the powers of the CTNBio

ADVANCED CELL TECNOLOGYAfter some eight months of discussion, a wide ranging agreement among political leaders has guaranteed the approval by the Federal Senate by 52 votes in favor to 2 against, of the biosafety bill. A substituted item from Senator Ney Suassuna (PMDB-PB) modified the project approved by the Deputies Chamber and authorizes the use of embryo stem cells leftover from the processes of in vitro fertilization – assuming that they are unsuitable for implanting or have been frozen for three years or more -, but keeps the ban on therapeutic cloning. The changes oblige the project to be returned to the lower Chamber for a new vote before being sanctioned by President Luiz Inácio Lula da Silva. In the Chamber, the text cannot be changed. The deputies can only integrally approve of reject the alteration by Senator Suassuna. In the case of a rejection, the controversial project from Deputy Renildo Calheiros (PCdoB/PE), approved in February, will again become the proposal.

Scientists commemorated the Senate’s decision. “It is an excellent advance”, stated Patrícia Pranke, a specialist in umbilical stem cell research from the colleges of Pharmacy and Medicine of the Federal University of Rio Grande do Sul (UFRGS). They would have preferred if, as well, they had obtained authorization to advance in the investigation of therapeutic cloning. “But this is a procedure that will still require a lot of research and is coming up against some limitations”, accepts Mayana Zatz from the University of São Paulo (USP) and the coordinator of the Human Genome Studies Center, one of the Research, Innovation and Diffusion Centers (Cepid) maintained by FAPESP. Research with stem cells, on the other hand, is already well advanced, Mayana guarantees. She said that the scientists are willing to participate in public debate at the Chamber just as it was done in the Senate before voting the new law, to clarify any questions concerning the implications and benefits of research.

Technical commission
The bill pproved by the Senate also reestablishes part of the powers of the National Technical Commission on Bio-Security (CTNBio) withdrawn from the Chamber project. In the new text the CTNBio again has the power to approve not only research but also the commercial use of genetically modified organisms (GMOs). The National Health Surveillance Agency (Anvisa) and the Brazilian Environment and Renewable Natural Resources Institute (Ibama) could well contest the commission’s decision in what is referred to as food safety or on the impact on the environment brought about by the commercial planting of transgenics and to present resources to the National Bio-Security Council, composed of eleven ministers. “The text is better than the current legislation, Law 8,974 from 1995”, compares Reginaldo Minare, a lawyer and a specialist in bio-security.

In Manare’s evaluation, one of the main advances of the project lies in article 36, which changes the Environmental Law (6,938/81), eliminating the statement, which he considers to be “dogmatic”, that any introduction of a genetically modified species constitutes a potentially polluting activity, which demanded an environmental license and the study of the environmental impact before its commercial use.The project regulates the planting of transgenics in Brazil. However, the delay in the approval of the law has obliged the government to publish provisional measures allowing the planting and commercialization of the soybean crop for 2005. The text permits the sale of Soya until the 31st of January 2006.

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