A criticalpoint in regulating new technologies is the loss of focus on the product:many scientists, regulators and as expected the biotech opposition, insistin discussing and embedding the technology in the regulatory framework. Moreover,once the right focus is regained, we still have to keep clear in our minds thatregulations should be rooted on risk assessment (not on risk perception). Afundamental paper has just been published in Nature Botechnology:Conko G, KershenDL, Miller H, Parrott WA, 2016. A risk-based approach to the regulation of genetically engineeredorganisms. Nature Biotechnology 34: 493503 doi:10.1038/nbt.3568http://www.nature.com/nbt/journal/v34/n5/full/nbt.3568.htmlI suggestyou should take some time to read it. If you don t have access to the fullpaper, just send a note (andrade@ufpe.br).KindlyPaulo Paesde AndradeDepartmentof Genetics/ Federal University of Pernambuco RECIFE BrazilUm ponto critico na regulacao de novas tecnologias e a perdado foco, que deve ser no produto: muitos cientistas, reguladores e como esperado a oposicao a biotecnologia insistem em discutir e ancorar a tecnologia noarcabouco regulatorio. Alem disso, mesmo quando o foco correto e recuperado,ainda precisamos manter claro em nossa mente que a regulacao deve estar baseadana avaliacao de risco e nao na percepcao dos riscos. Um artigo fundamentalacaba de ser publicado na revista Nature Biotechnology:Conko G, KershenDL, Miller H, Parrott WA, 2016. A risk-based approach to the regulation of genetically engineeredorganisms. Nature Biotechnology 34: 493503 doi:10.1038/nbt.3568http://www.nature.com/nbt/journal/v34/n5/full/nbt.3568.htmlEu sugiro fortemente que voce reserve um tempo para ler oartigo. Se voce nao tiver acesso ao texto completo, basta me enviar umamensagem (andrade@ufpe.br).Gentilmente,Paulo Paes de AndradeDepartamento de Genetica/ UFPE RECIFE, Brasil DearreadersSuddenly astream of fresh air is flowing in the GMO risk assessment field: the oldparadigm of event-specific evaluation is being challenged. Moreover, respectedresearchers claim risk assessment must be directed to the product, not to thetechnology. And, finally, the same authors clarify that regulation must berisk-based. TheBrazilian GMO regulatory framework, established more than 10 years ago, requiresa case-by-case evaluation for all GMOs and regulates the technology, not theproduct. The strategy worked well for a while, but had a very high cost anddemanded a lot of time from CTNBio specialists to evaluate the large dossiersfor commercial release. Every genetic transformation, even if with the samegenes and the same host, was considered potentially different and was named anevent. The idea behind this approach was that the random gene insertion madeevery transformation very different from one anothe, even if the constructswere essentially the same. However, after 20 years of genetic engineering, itis clear that events harboring the same or similar genes behave in a verysimilar way, irrespective on how many copies they have and where they areinserted in the genome. It is clear now that the genomic intrincacies areirrelevant for risk assessment: the phenotypic changes are to be valued. Underthis new perspective, the event-based approach has no support. CTNBio hasalready recognized the limits of the event-based approach and issued anormative by which a recurrent construction used in a new event could beassessed in a more streamlined, fast systematics. But a list of safe eventswas never produced, even if this is a provision of the Cartagena Protocol, alsonever fulfilled. It is time to open the windows and reduce the burden on