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.
Whilst a number of general approaches to the risk assessment of nanomaterials have been published, including detailed methods, currently there is no single piece of guidance which can provide a definitive, step-by-step approach to the risk assessment of nanomaterials. This is not surprising given the vast range of materials with widely different properties which may be included in the definition, and the current level of knowledge of their properties. We have not attempted to develop such a guide here, but instead provide an overview of one of the most well known approaches – the Nano Risk Framework developed by the Environmental Defense Fund and DuPont. This is further supplemented by outlining and providing links to examples of such a risk framework being applied.
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.
Published 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. These are outlined within the section below.
For further information and professional services which can support the development of appropriate risk assessment approaches, please visit
SAFENANO Scientific Services.
Collapse All Expand All
DuPont conducted three demonstration projects in order to evaluate the comprehensiveness, practicality, and flexibility of the Nano Risk Framework. The three nanomaterials considered - namely DuPont™ Light Stabilizer 210 (a surface-treated high-rutile phase titanium dioxide), carbon nanotubes, and nano-sized zero-valent iron (nano-Fe0) - differ in terms of composition, structure, intended application, stage of development, and DuPont's role in the development, evaluation, or potential use of the material.
Summaries of the case studies and output worksheets are freely available
here.
This report, which is available for
free download, investigates the suitability of REACH in ensuring the safety of nanomaterials by conducting a hypothetical registration under REACH of metallic silver, a substance that exists both in nanoform and in non-nanoform (i.e. bulk form).
The hypothetical registration includes a chemical safety assessment (CSA), in which the current REACH risk assessment process is applied. The report goes on to propose adaptations to the risk assessment framework for first generation nanomaterials under REACH, based on the information generated in the case study.
The New Energy and Industrial Technology Development Organization (NEDO) project on “Research and Development of Nanoparticle Characterization Methods”, is aiming to develop risk assessments of three different nano-objects. In 2009, NEDO published interim risk assessment reports for titanium dioxide, fullerene (C60) and carbon nanotubes, in addition to a brochure representing the concept of the assessment entitled “The principles and basic approach to risk assessment of manufactured nanomaterials”. In these interim reports, the procedures to establish a provisional value of an acceptable concentration in the occupational environmental are presented and a method is proposed to establish an acceptable exposure concentration in those situations with a limited number of inhalation exposure studies.
To access the reports online,
click here.