July 16, 2008 — An expert panel appointed by the Council of Canadian Academies has concluded that too little is known to assess the overall human and environmental risks posed by the introduction nanomaterials and nanotechnology products into society. However, the panel did not identify any evidence that nano-based products currently on the market in Canada present risks that cannot be addressed through available risk management strategies.
“The panel sought to assemble the existing science, and understand what it implies about the hazards presented by nanomaterials, what risks they present to human health and our environment, and how we can best manage these risks given the current uncertainties and key gaps in knowledge,” said University of of Toronto professor Pekka Sinervo, chair of the expert panel.
The report, requested by Health Canada (in consultation with several other federal agencies), was prepared by a panel of 15 experts who are engaged in the creation and application of nanomaterials, assessment of the risks they may present, and public policy issues related to health and environmental regulation. The report was in response to the question, “What is the state of knowledge with respect to existing nanomaterial properties and their health and environmental risks, which could underpin regulatory perspectives on needs for research, risk assessment and surveillance?”
The report concluded that to date, there has been no identification of unique biological effects associated with exposure to nanomaterials, but there is still a poor understanding of the pathways by which these effects may occur.
The current risk assessment strategies that are used in health and environmental regulations in Canada comprise four steps: hazard identification, hazard characterization, exposure assessment and risk characterization. The application of these to nanomaterials will require new ways for measuring exposure, dose and response. The report concludes that there are, at present, inadequate data to inform quantitative risk assessments on nanomaterials. At most, only qualitative risk assessments are feasible. Moreover, changes in the potential for nanomaterials to cause harm at different stages — from production, through usage, to final disposal — implies the need for a full, life-cycle approach to risk assessment.
Uncertainties associated with risk assessment and risk management are typical in the introduction of new technologies and are not unique to nanomaterials. Such uncertainties have been managed within Canadian regulatory systems by taking a precautionary approach — giving priority to ensuring the safety of health and the environment. Since it is not possible, at present, to implement a robust and reliable “science-based” regulatory approach to nanoproducts, it is important that appropriate precautionary measures guide the scientific assessment of the risks and the selection of standards of safety. In so doing, a wide spectrum of stakeholders should be involved in determining the desired level of precaution when regulating the introduction of new nanomaterials and products to the market. The report finds that an adaptive management approach will be needed so that, as scientific research fills in our knowledge gaps, the decisions respecting the precautionary measures applied to nanoproducts can be revised.
While the panel was not asked to make specific recommendations, it identified the following as key steps towards filling in existing knowledge gaps.
– International efforts are currently underway to develop standardized definitions and nomenclatures for nanomaterials but the process may take upwards of 10 years to complete. In the meantime, interim terminology and classification are needed to help regulators oversee this emerging group of materials and products.
– In conjunction with classification, new tools and standards are needed to ensure that the exposure of both the public and workers to nanomaterials is consistently and reliably monitored.
– Current regulatory triggers (based on the amount and chemical structure of materials) will need to be revised in order to identify those nanomaterials entering the market that may require regulatory oversight.
– The diversity in both material type and usage of nanomaterials, the magnitude of scientific research that is needed, and the increasing presence of traded products that contain nanomaterials, will require governments to work collaboratively both within Canada and internationally.
The complete findings of the expert panel have been conveyed to Canada’s federal government and are available on the Council’s website.
Last summer, U.S.-based partners DuPont and Environmental Defense released the fruits of their partnership: The Nano Risk Framework.
Along similar lines, the Swiss company The Innovation Society and German partner TÜV SÜD last month introduced a tool, NanoRisk Check, to help small companies conduct nanotech safety and risk management tests.