Nanotechnologies: evidence-based regulation: Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02260 | Published on: 20/02/2024

Detalhes bibliográficos
Autor(a) principal: Binsfeld, Pedro Canisio
Data de Publicação: 2024
Outros Autores: Mauro Granjeiro, José
Tipo de documento: Artigo
Idioma: por
Título da fonte: Vigilância Sanitária em Debate
Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2260
Resumo: The debate on best practices for the regulation of nanotechnologies needs to be deepened and still represents a challenge for Brazilian society, political authorities, and regulatory bodies. In recent years, there has been much discussion about the regulation of nanotechnologies; however, as a disruptive technology due to its complexity, limitations in the validation of analysis methodologies, and the scarcity of references on nanoparticles and nanomaterials, significant asymmetries and difficulties in understanding of best regulatory practices persist. Due to the limited technical and scientifically validated evidence, regulatory models known as “command and control” and the precautionary principle are used to prevent concrete/abstract but plausible dangers. As an alternative to the current regulatory model, this paper discusses the regulatory model considered the best global regulatory practice, which relies on regulatory science and evidence-based regulation. There is growing global acceptance of using technically and scientifically validated evidence to assist political and regulatory authorities in developing guidelines and regulatory standards that can protect public interests and maximize new technologies’ economic and social benefits.  Furthermore, evidence allows for anticipating potential risks and enables proactive approaches to the regulation of nanotechnologies. When considering this perspective, it is essential to emphasize that implementing an evidence-based regulatory model requires political, scientific, technical, and regulatory maturity to ensure that the benefits are harnessed to provide prosperity, safety, and sustainability through the use of disruptive technologies.
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spelling Nanotechnologies: evidence-based regulation: Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02260 | Published on: 20/02/2024NANOTECNOLOGÍAS: REGULACIÓN BASADA EN EVIDENCIA: NANOTECNOLOGÍAS: REGULACIÓN BASADA EN EVIDENCIANanotecnologias: regulação baseada em evidências: Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02260| Publicado em: 20/02/2024NanopartículasNanomateriaisNanossegurançaCiência RegulatóriaNanoparticlesNanomaterialNanosafetyRegulatory ScienceNanopartículasnanomaterialesnanoseguridadciencia regulatoriaThe debate on best practices for the regulation of nanotechnologies needs to be deepened and still represents a challenge for Brazilian society, political authorities, and regulatory bodies. In recent years, there has been much discussion about the regulation of nanotechnologies; however, as a disruptive technology due to its complexity, limitations in the validation of analysis methodologies, and the scarcity of references on nanoparticles and nanomaterials, significant asymmetries and difficulties in understanding of best regulatory practices persist. Due to the limited technical and scientifically validated evidence, regulatory models known as “command and control” and the precautionary principle are used to prevent concrete/abstract but plausible dangers. As an alternative to the current regulatory model, this paper discusses the regulatory model considered the best global regulatory practice, which relies on regulatory science and evidence-based regulation. There is growing global acceptance of using technically and scientifically validated evidence to assist political and regulatory authorities in developing guidelines and regulatory standards that can protect public interests and maximize new technologies’ economic and social benefits.  Furthermore, evidence allows for anticipating potential risks and enables proactive approaches to the regulation of nanotechnologies. When considering this perspective, it is essential to emphasize that implementing an evidence-based regulatory model requires political, scientific, technical, and regulatory maturity to ensure that the benefits are harnessed to provide prosperity, safety, and sustainability through the use of disruptive technologies.El debate sobre las mejores prácticas para la regulación de la nanotecnología necesita ser profundizado y todavía representa un desafío para la sociedad, las autoridades políticas y regulatorias brasileñas. En los últimos años se ha hablado mucho de la regulación de las nanotecnologías, sin embargo, como una tecnología disruptiva, debido a la complejidad, limitaciones en la validación de metodologías de análisis y escasas referencias sobre nanopartículas y nanomateriales, aún persisten importantes asimetrías y comprensión de las mejores prácticas regulatorias. . Actualmente, debido a la aún limitada evidencia técnica y científica validada, se utilizan modelos regulatorios llamados comando y control y el principio de precaución como medio para evitar peligros concretos/abstractos, pero cuya ocurrencia es probable. Como alternativa al modelo regulatorio actual, este texto analiza el modelo regulatorio que se trata como la mejor práctica regulatoria global y que utiliza la ciencia regulatoria y la regulación basada en evidencia. A nivel mundial, está creciendo la aceptación del uso de evidencia técnica y científica validada para ayudar a las autoridades políticas y regulatorias en el desarrollo de directrices y estándares regulatorios que puedan proteger los intereses públicos y maximizar los beneficios económicos y sociales de las nuevas tecnologías. Además, la evidencia nos permite anticipar posibles riesgos y permitir enfoques proactivos para la regulación de las nanotecnologías. Y al considerar esta perspectiva, es importante enfatizar que la implementación de un modelo regulatorio basado en evidencia requiere madurez política, científica, técnica y regulatoria, de modo que los beneficios se aprovechen para brindar prosperidad, seguridad y sostenibilidad a través del uso de tecnologías disruptivas.O debate quanto às melhores práticas da regulação das nanotecnologias precisa ser aprofundado, pois ainda representa um desafio para a sociedade brasileira, autoridades políticas e regulatórias. Nos últimos anos, muito se fala na regulação das nanotecnologias, porém, como tecnologia disruptiva, pela complexidade, limitações na validação de metodologias de análise e escassas referências sobre nanopartículas e nanomateriais, ainda persistem expressivas assimetrias e dificuldades de compreensão sobre as melhores práticas regulatórias. Atualmente, pelas ainda limitadas evidências técnicas e científicas validadas, utilizam-se os modelos de regulação denominados de comando e controle e o princípio da precaução como meio de evitar o perigo concreto/abstrato, mas cuja ocorrência seja verossímil. Como alternativa ao atual modelo regulatório, no presente texto, discorre-se sobre o modelo regulatório, tratado como a melhor prática regulatória global e que se vale da ciência regulatória e da regulação baseada em evidências. Globalmente cresce a aceitação do uso de evidências técnicas e científicas validadas para auxiliar autoridades políticas e regulatórias na elaboração de diretrizes e normas regulatórias que consigam proteger os interesses públicos e maximizar os benefícios econômicos e sociais das novas tecnologias. Para além disso, evidências permitem antecipar possíveis riscos e permitem abordagens proativas para a regulação das nanotecnologias. E ao considerar essa perspectiva, é importante enfatizar que a implementação de um modelo de regulação baseada em evidências requer maturidade política, científica, técnica e regulatória, para que os benefícios sejam aproveitados de maneira a prover prosperidade, segurança e sustentabilidade pelo uso de tecnologias disruptivas.Instituto Nacional de Controle de Qualidade em Saúde2024-02-20info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/226010.22239/2317-269x.02260Health Surveillance under Debate: Society, Science & Technology ; v. 12 (2024) | Continuous publication; 1-8Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; v. 12 (2024) | Publicación continua; 1-8Vigil Sanit Debate, Rio de Janeiro; v. 12 (2024) | Publicação contínua; 1-82317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2260/1611Copyright (c) 2024 Pedro Canisio Binsfeld, José Mauro Granjeiro (Autor)https://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessBinsfeld, Pedro CanisioMauro Granjeiro, José2024-03-15T19:23:30Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/2260Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2024-03-15T19:23:30Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Nanotechnologies: evidence-based regulation: Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02260 | Published on: 20/02/2024
NANOTECNOLOGÍAS: REGULACIÓN BASADA EN EVIDENCIA: NANOTECNOLOGÍAS: REGULACIÓN BASADA EN EVIDENCIA
Nanotecnologias: regulação baseada em evidências: Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02260| Publicado em: 20/02/2024
title Nanotechnologies: evidence-based regulation: Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02260 | Published on: 20/02/2024
spellingShingle Nanotechnologies: evidence-based regulation: Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02260 | Published on: 20/02/2024
Binsfeld, Pedro Canisio
Nanopartículas
Nanomateriais
Nanossegurança
Ciência Regulatória
Nanoparticles
Nanomaterial
Nanosafety
Regulatory Science
Nanopartículas
nanomateriales
nanoseguridad
ciencia regulatoria
title_short Nanotechnologies: evidence-based regulation: Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02260 | Published on: 20/02/2024
title_full Nanotechnologies: evidence-based regulation: Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02260 | Published on: 20/02/2024
title_fullStr Nanotechnologies: evidence-based regulation: Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02260 | Published on: 20/02/2024
title_full_unstemmed Nanotechnologies: evidence-based regulation: Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02260 | Published on: 20/02/2024
title_sort Nanotechnologies: evidence-based regulation: Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02260 | Published on: 20/02/2024
author Binsfeld, Pedro Canisio
author_facet Binsfeld, Pedro Canisio
Mauro Granjeiro, José
author_role author
author2 Mauro Granjeiro, José
author2_role author
dc.contributor.author.fl_str_mv Binsfeld, Pedro Canisio
Mauro Granjeiro, José
dc.subject.por.fl_str_mv Nanopartículas
Nanomateriais
Nanossegurança
Ciência Regulatória
Nanoparticles
Nanomaterial
Nanosafety
Regulatory Science
Nanopartículas
nanomateriales
nanoseguridad
ciencia regulatoria
topic Nanopartículas
Nanomateriais
Nanossegurança
Ciência Regulatória
Nanoparticles
Nanomaterial
Nanosafety
Regulatory Science
Nanopartículas
nanomateriales
nanoseguridad
ciencia regulatoria
description The debate on best practices for the regulation of nanotechnologies needs to be deepened and still represents a challenge for Brazilian society, political authorities, and regulatory bodies. In recent years, there has been much discussion about the regulation of nanotechnologies; however, as a disruptive technology due to its complexity, limitations in the validation of analysis methodologies, and the scarcity of references on nanoparticles and nanomaterials, significant asymmetries and difficulties in understanding of best regulatory practices persist. Due to the limited technical and scientifically validated evidence, regulatory models known as “command and control” and the precautionary principle are used to prevent concrete/abstract but plausible dangers. As an alternative to the current regulatory model, this paper discusses the regulatory model considered the best global regulatory practice, which relies on regulatory science and evidence-based regulation. There is growing global acceptance of using technically and scientifically validated evidence to assist political and regulatory authorities in developing guidelines and regulatory standards that can protect public interests and maximize new technologies’ economic and social benefits.  Furthermore, evidence allows for anticipating potential risks and enables proactive approaches to the regulation of nanotechnologies. When considering this perspective, it is essential to emphasize that implementing an evidence-based regulatory model requires political, scientific, technical, and regulatory maturity to ensure that the benefits are harnessed to provide prosperity, safety, and sustainability through the use of disruptive technologies.
publishDate 2024
dc.date.none.fl_str_mv 2024-02-20
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
"Peer-reviewed article"
"Artículo revisado por pares"
"Artigo avaliado pelos pares"
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2260
10.22239/2317-269x.02260
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2260
identifier_str_mv 10.22239/2317-269x.02260
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2260/1611
dc.rights.driver.fl_str_mv Copyright (c) 2024 Pedro Canisio Binsfeld, José Mauro Granjeiro (Autor)
https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2024 Pedro Canisio Binsfeld, José Mauro Granjeiro (Autor)
https://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
dc.source.none.fl_str_mv Health Surveillance under Debate: Society, Science & Technology ; v. 12 (2024) | Continuous publication; 1-8
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; v. 12 (2024) | Publicación continua; 1-8
Vigil Sanit Debate, Rio de Janeiro; v. 12 (2024) | Publicação contínua; 1-8
2317-269X
reponame:Vigilância Sanitária em Debate
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Vigilância Sanitária em Debate
collection Vigilância Sanitária em Debate
repository.name.fl_str_mv Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br
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