Nanotechnologies: evidence-based regulation: Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02260 | Published on: 20/02/2024
Autor(a) principal: | |
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Data de Publicação: | 2024 |
Outros Autores: | |
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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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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