Current guidance for the risk assessment of nanomaterials
Organisations involved in the manufacture, supply or use of any material carry a duty to understand the risks that the material may pose not just to the health of their workforce but also to their customers and to the environment, and to put in place such measures that are needed to manage these risks. This requires them to address the gaps in knowledge to gain a better understanding of the risks associated with these materials than they currently have, whether it is to comply with regulation, pre-empt potential regulation or demonstrate responsibility.
A number of general approaches to the risk assessment of nanomaterials have been published, including detailed methods. These most notably include the International Organization for Standardization (ISO) technical report on nanomaterial risk evaluation (ISO/TR 13121:2011
), and specific guidance on risk assessment for nanoscience and nanotechnologies in the food and feed chain (EFSA, 2011
), and for cosmetics (SCCS, 2012
). Moreover, recommendations for nanomaterials assessment under REACH have been adopted into a number of specific guidance documents published by the European Chemicals agency (ECHA) following the recommendations in the RIP-oN 2 and 3 projects
coordinated by SAFENANO.
As an example of how the principles of risk assessment advocated in the abovementioned guidance can be expressed, we provide an overview below from the open-access Nano Risk Framework developed by the Environmental Defense Fund and DuPont.
Principles of a risk framework
The Nano Risk Framework
, published in June 2007, is a joint effort by Environmental Defense Fund and DuPont to establish a process for ensuring the responsible development of nanoscale materials, which can then be widely used by companies and other organisations.
The document outlines a proposal for a comprehensive, practical, and flexible Nano Risk Framework to evaluate and address the potential risks of nanomaterials. The Framework intends to:
- offer guidance on the key questions an organisation should consider in developing applications of such materials, and on the critical information needed to make sound risk evaluations and risk management decisions;
- allow users to address areas of incomplete or uncertain information by using reasonable assumptions and appropriate risk management measures;
- describe a system to guide information generation and update assumptions, decisions, and practices with new information as it becomes available;
- offer guidance on how to communicate information and decisions to stakeholders.
The framework, which is designed for iterative use as development advances and new information becomes available, consists of six distinct steps:
- Step 1. Describe Material and Application - develop a general description of the nanomaterial and its intended uses;
- Step 2. Profile Lifecycle(s) - develop three sets of profiles, of the nanomaterial's properties, inherent hazards, and associated exposures throughout the material's lifecycle, from material sourcing, through production and use, to end-of-life disposal or recycling;
- Step 3. Evaluate Risks – review profiled information in order to identify and characterise the nature, magnitude, and probability of risks presented by this particular nanomaterial and its anticipated application;
- Step 4. Assess Risk Management - evaluate the available options for managing the identified risks and recommend risk management measures;
- Step 5. Decide, Document, and Act - decide whether or in what capacity to continue development and production, share appropriate information with the relevant stakeholders, and consider future revision of the risk evaluation and risk-management decisions;
- Step 6. Review and Adapt - update and re-execute the risk evaluation, ensure risk-management systems are working as expected, adapt systems in the face of new information or conditions.
Through these six steps, the framework seeks to guide a process for risk evaluation and management that is practical, comprehensive, transparent, and flexible.
More recently, a Risk Assessment Strategy has been developed by the 'Managing Risks of Nanomaterials' (MARINA
) project, to meet the challenges involved in efficient information-gathering for risk assessment of engineered nanomaterials and in the risk assessment process itself. The basic process of this exposure-driven strategy consists of two phases: a problem framing phase and an iterative risk assessment phase. Whilst the framework has been published
, further developments are acknowledged as being needed to make the strategy operational, including the provision of essential guidance and tools for information-gathering and risk characterisation as well as for the decision-making moments.
Published guidance and examples
A number of examples have been published in which the Nano Risk Framework, or a similar approach, has been applied to a variety of nanomaterials, which serve as a useful reference.
Key guidance resources for the risk assessment of nanomaterials are summarised below.
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