GOVERNANCE AND SANDBOX: BUILDING SELF-REGULATION MODELS FOR NANOTECHNOLOGIES

Wilson Engelmann

doi:10.29073/jer.v1i1.7

Authors

Wilson Engelmann JUSNANO and UNISINOS https://orcid.org/0000-0002-0012-3559

DOI:

https://doi.org/10.29073/jer.v1i1.7

Keywords:

Agile Regulation, Governance, Nanotechnologies, Principles, Regulatory Sandbox, Regulated Self-Regulation

Abstract

The 21^st 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.

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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. (2022). Commission Recommendation of 10.6.2022 on the definition of nanomaterial. Retrieved from 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

Doménech-Pascual, G. (2021). Thought experiments in Law. In Special issue experimental legislation in times of crisis. Sofia Ranchordás; Bart van Klink (eds.). Law and Method. Doi: 10.5553/REM/.000053.

Engelmann, W. (2001). Crítica ao Positivismo Jurídico: princípios, regras e o conceito de Direito. Porto Alegre: Sérgio Antonio Fabris Editor.

Engelmann, W. (2022). Percursos para inovar a Teoria Geral das Fontes do Direito: modelos de autorregulação regulada para as nanotecnologias, sandbox regulatório e princípios. Constituição, Sistemas Sociais e Hermenêutica [recurso eletrônico]: Anuário do Programa de Pós-Graduação em Direito da Unisinos, n. 18. Organizadores: Vichinkeski Teixeira, Lenio Luiz Streck, Leonel Severo Rocha. Blumenau, SC: Editora Dom Modesto, 327–341.

Engelmann, W. (2018). Nanotecnologia e direitos humanos. Cadernos de Dereito Actual, Santiago de Compostela, Espanha, n. 9. Núm. Ordinario, 441–487. Retrieved from http://www.cadernosdedereitoactual.es/ojs/index.php/cadernos/article/view/325/201.

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 (pp. 81–94). Editorial Comares: Granada.

Franzius, C. (2015). Autorregulación regulada como estrategia de coordenación. In 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. (Eds.), 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 nanomaterials and nanoforms (1.0). Retrieved from https://doi.org/10.5281/zenodo.5534466

Li, M., Liu, D., Chen, X., 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). Retrieved from http://www.centerforfoodsafety.org/files/final-pdf-principles-for-oversight-of-nanotechnologies_80684.pdf

Ruggie, J. G. (2011, March 21). Report of the Special Representative of the Secretary-General on the issue of human rights and transnational corporations and other business enterprises. Human Rights Council Seventeenth Session; Agenda item 3: Promotion and protection of all human rights, civil, political, economic, social and cultural rights, including the right to development. Retrieved from https://www.right-docs.org/download/7325/.

Schwab, K. (2016). A quarta revolução industrial. Tradução Daniel Moreira Miranda. São Paulo: EDIPRO.

Schwab, K. (2018). Aplicando a quarta revolução industrial. Tradução Daniel Moreira Miranda. São Paulo: EDIPRO.

StatNano (2023, July 13). Nanotechnology Products Database. Retrieved from https://product.statnano.com/

Turns, A. (2022, April 25). Forget microplastics: we may have a much smaller problem. The Guardian. Retrieved from https://www.theguardian.com/environment/2022/apr/25/nano-state-tiny-and-now-everywhere-how-big-a-problem-are-nanoparticles

OECD. (2022). Recommendation of the Council for Agile Regulatory Governance to harness innovation, OECD/LEGAL/0464. Retrieved from https://legalinstruments.oecd.org/en/instruments/OECD-LEGAL-0464.

Zwanenberg, P. v., Ely, A., & 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. Retrieved from https://www3.weforum.org/docs/WEF_Agile_Regulation_for_the_Fourth_Industrial_Revolution_2020.pdf