governance and sandbox: building self-regulation models for nanotechnologies
Keywords:
Regulatory sandbox, Governance, Principles, Nanotechnologies, Agile regulation, Regulated self-regulationAbstract
The 21st century is marked by the emergence of a new Industrial Revolution, the fourth, which is characterized by speed, systemic impact, in addition to breadth and depth. Nanotechnologies are born from the human possibilities of accessing the so-called nano scale: the scale that is equivalent to a billionth of a meter. When it comes to nanotechnologies and products generated from this scale, there is something new in research and production, which can generate effects that are still little known by human beings, especially through the interfaces with the human body and the environment. There is an openness to formulating regulatory environments, structured from a varied set of principles and designing agile, flexible and adequate “regulated self-regulation” models. The choice of the structuring principles of these directives must take into account the guidelines of ethics and be enriched with dimensions coming from the environment where these scientific-technological innovations. The governance of the various stakeholders in nanoscale regulation and the combination of principles, to be tested in Regulatory Sandbox, as real laboratories for improvements in normative models that are structured from principles sought in national and international organizations.
Downloads
References
Berger Filho, A. G. (2018). Regulação e governança dos riscos das nanotecnologias. Belo Horizonte: Arraes Editores.
Collingridge, D. (1980). The social control of technology. Nova York: St. Martin’s Press.
Comissão Europeia. Commission Recommendation of 10.6.2022 on the definition of nanomaterial. https://ec.europa.eu/environment/chemicals/nanotech/pdf/C_2022_3689_1_EN_ACT_part1_v6.pdf
Cooper, R. G. (2017). Idea-to-Launch Gating Systems: Better, Faster, and More Agile. Research-Technology Management, 60 (1), 48-52. http://dx.doi.org/10.1080/08956308.2017.1255057
Cooper, R. G.; Sommer, A. F. (2018). Agile-Stage-Gate for Manufacturers. Research- Technology Management, 61 (2), 17-26. https://doi.org/10.1080/08956308.2018.1421380
Engelmann, W. (2001). Crítica ao Positivismo Jurídico: princípios, regras e o conceito de Direito. Porto Alegre: Sérgio Antonio Fabris Editor.
Esteve Pardo, J.; Tejada Palacios, J. (2013). Ciencia y Derecho: la nueva división de poderes. Madrid: Fundación Coloquio Jurídico Europeo.
Esteve Pardo, J. (2016). Tecnologías convergentes y principio de precaución. In Romeo Casabona, Carlos María (Ed.). Tecnologías convergentes: desafíos éticos y jurídicos. Editorial Comares: Granada, 81-94.
Franzius, C. (2015). Autorregulación regulada como estrategia de coordenación. Darnaculleta I G., M. Mercê; Esteve Pardo, J.; Spiecker Gen. Döhmann, I. (eds.). Estrategias del derecho ante la incertidumbre y la globalización. Madrid: Marcial Pons.
Herberg, M. (2008). Global legal pluralism and interlegality: environmental self- regulation in multinational enterprises as global law-making. In Dilling, O.; Herberg, M.; Winter, G. (Edit.). Responsible business: self-governance and law in transnational economic transactions. Oxford: Hart Publishing.
Hunt, N. (2021). Guidance on the GRACIOUS Framework for grouping and read- across of nanomaterialsBand nanoforms (1.0). Https://doi.org/10.5281/zenodo.5534466
Li, Mengqiao; Liu, Dairong; Chen, Xing et al. (2021). Radical-driven decomposition of graphitic carbon nitride nanosheets: light exposure matters. Environ. Sci. Technol, 55, (18), 12414-12423. https://doi.org/10.1021/acs.est.1c03804
NanoAction. (2007). The International Center for Technology Assessment. Principles for the Oversight of Nanotechnologies and Nanomaterials. Washington: NanoAction, (NanoAction Project). http://www.centerforfoodsafety.org/files/final-pdf-principles-for-oversight-of-nanotechnologies_80684.pdf
Schwab, K. (2016). A quarta revolução industrial. Tradução Daniel Moreira Miranda. São Paulo: EDIPRO.
Turns, A. (2022). Forget microplastics: we may have a much smaller problem. The Guardian de 25 abril 2022.
Zwanenberg, P. v.; Ely, A. and Smith, A. (2011). Regulating technology: international harmonization and local realities. London: Earthscan.
World Economic Forum - WEF. (2020). Agile regulation for the Fourth Industrial Revolution: a toolkit for regulators. https://www3.weforum.org/docs/WEF_Agile_Regulation_for_the_Fourth_Industrial_R evolution_2020.pdf
