In recent years the term “Safety by Design” or “Safe-by-Design” (SbD) has gained a lot of attention in the nanotechnology universe, nationally and internationally. In Brazil, it is used without translation, which perhaps contributes to the strangeness and questions about its real meaning.
Another term that has been used for a few years, and it is widely used in the context of nanoHSE, is “nano risk governance”.
In this post, these terms will be defined and analyzed within the current situation in the area of health, safety, and the environment in nanotechnology.
What does Safe-by-Design (SbD) mean?
Safe-by-design is originally a concept that was developed and used by engineers, especially those working in the construction industry. It is applied in the context of incorporating safety considerations in the design, construction, and maintenance of engineering products and workplaces. The basic idea refers to the importance of considering and incorporating safety considerations during product development. The development path of nanoproducts is essentially an innovation path. Thus, Safe-by-Design within nanotechnology refers to the way of approach and how to proceed using these concepts. The chain of innovation, research, and development of innovative products is always a process that goes through questions and uncertainties. The safe-by-design is about including questions about occupational and environmental safety during this process. Thus, the nanoproduct can be ‘designed’ considering these aspects.
Uncertainties permeate the development process of nanoproducts
This is the principle of the term, therefore, it does not refer to a defined methodology or a legal demand. In nanotechnology, this term first emerged as an important concept in European projects NanoReg and ProSafe.
The practice ‘Safe-by-Design’ in nanotechnology
Thus, there is no recipe for bringing this security approach to nanotechnology processes. The implementation of this practice is anchored in the vision of the company that produces and manipulates the nano. Based on the company’s vision of sustainability and social and environmental responsibility this practice can be proactively used.
It may seem distant, but here in Brazil, aspects of this approach are executed within the scope of routine development of nanomaterials and nanoproducts in some projects within the University. In these projects, researchers are dedicated to the care of waste management, environmental and occupational monitoring processes. This can be considered a practical example of a ‘safe-by-design’ approach.
Also, the life cycle analysis of nanoproducts is an important tool that makes it possible to understand the environmental and human health impacts associated with a product, process, or material throughout its entire life cycle. From the extraction and processing of raw material until final disposal. For example, the execution of leaching tests, such as washing, is important for understanding the release of nanomaterials in situations of use. This can be classified as part of a ‘safe-by-design’ approach. However, it is worth noting that these actions must be procedural, not punctual within the development process. The key concept is the continuous implementation of this approach in parallel and throughout the development of nanoproducts.
So, we can say that the ‘safe-by-design’ approach in nanotechnology is about asking the right questions throughout the development stages. And the delivery of safety in these processes goes through these stages with an understanding of the risk aspects of the procedures performed at each stage.
Risk governance in nanotechnology
Risk governance is the architecture or framework in which risk management operates in an organization. So, it concerns the structuring of procedures that involve the mapping of hazards, exposure scenarios, and prioritization of risks. In nanotechnology and in processes that the degree of uncertainty is high, the precautionary principle determines decision making. One way to structure such actions is through the use of risk management tools, then, in a structured way, manage these risks.
Today there are several tools, developed specifically to analyze occupational and environmental risks of nanotechnology processes. Some examples are the SimpleBox4Nano, StoffenmanagerNano, and GuideNano tools, but there are several others. The European project Calibrate Nano Risk Governance developed a portal to support the execution of risk governance for researchers and companies working with nanotechnology.
In the vision of Nanos, risk governance can be performed in several ways, but initially, it can be understood as a practical way of executing a Safe-by-Design approach. At each stage of development of the nanoproduct, risk analyzes must be performed, because they will support the decisions about the development and they can help to find other ways throughout the process. It is through this risk report, executed among the professionals responsible for the development of the product itself that the area of health, safety, and environment, or nanoHSE, comes to support the sustainable and safe development of nanoproducts. Therefore, a clear understanding of the risks of different procedures can be transformed into opportunities for improvement. For example, developing new waste management processes or optimizing the use of nanomaterial in a matrix, which can decrease risks potential exposure for people, consumers, or workers.
So, apply risk governance in the development process enable the identification, evaluation, monitoring, and communication. This can lead to safer and more sustainable processes and procedures, thus resulting in nanoproducts safer-by-design.
Safe-by-design and risk governance in the context of nanotechnology regulation
Broadly, in the regulatory context, the chemical risk assessment framework is still used today: “the use of the risk assessment framework for nanomaterials was a logical step, given its use for products chemicals. ” (Best practices from nano-risk analysis relevant for other emerging technologies, 2019). Thus, the tools for risk analysis developed for nanomaterials are usually modifications of these tools already used for chemicals.
However, in a scenario of many uncertainties about the understanding of the specificities of nanoforms, unlike chemicals, the risk approach in the context of nanotechnology seems to be motivating the differentiation of regulatory processes.
In the European Union since January 2020, there is a specific rite for the registration of nanomaterials. Specific information regarding risks is requested. In Brazil, there is a Nanoproducts Certification Program in progress at INMETRO (The National Institute of Metrology, Standardization, and Industrial Quality). Possibly, it will result in protocols that will support various national regulatory agencies. Also, the Labor Public Prosecutor’s Office drafted a Term of Reference with recommendations on the inclusion of risk analysis tools to adapt work safety documents. All of these are reflections of advances in the nanoHSE area.
In a development context, risk governance must be a dynamic process and must allow adaptive responses in front of new information. Regardless of the structuring form of or the chosen tools, its continuous execution through the cooperation and incorporation of perspectives from all interested parties allows dealing directly with the risk uncertainty. Therefore, in the stage of development, new information on possible processes, waste management, and uses of these nanoproducts are presented and must be considered in the decision-making process.
These actions support the evolution of the nanotechnology regulation process and are executed proactively towards the responsible development of nanotechnology. The safe approach, safe by design, and risk governance in nano can also be seen as interesting tools in the process of regulating nanoproducts.
Bibliographic references
2019, Best practices from nano-risk analysis relevant for other emerging technologies. Available at: https://www.nature.com/articles/s41565-019-0572-1
- REFERENCE TERMS PRT3 / MPT NANOPARTICLES / RISK MANAGEMENT.
2017, NANoREG framework for the safety assessment of nanomaterials. Available at: https://ec.europa.eu/jrc/en/publication/eur-scientific-and-technical-research-reports/nanoreg-framework-safety-assessment-nanomaterials
2017, Safe-by-Design: from Safety to Responsibility. Available at: 10.1007/s11569-017-0301-x
Important recommendations and guides in the area of nanoHSE:
NIOSH: https://www.nano.gov/node/1164
WHO: https://apps.who.int/iris/bitstream/handle/10665/259671/9789241550048-eng.pdf?sequence=1
BAUA/NANOVALID: http://www.nanovalid.eu/nanoToGo/Brochure/Safe%20handling%20of%20nanomaterials%20and%20other%20advanced%20materials%20at%20workplaces_v1-0.pdf
CALIBRATE PROJECT: http://www.nanocalibrate.eu/tools
04/02/2021
Written by Camila de Oliveira Viana