Small is Different: A Science Perspective on the Regulatory Challenges of the Nanoscale

Publication Date : 2008
Code : 145
2,083 Visited Entry Date : 2017/11/20


Volume 152 Pages
Document type Report
Subject Regulatory & Legal Aspect

This report summarizes the work of the Expert Panel on Nanotechnology (the panel) established by the Council of Canadian Academies (the Council), to assess 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.

This study by the Expert Panel on Nanotechnology (the panel) represents a comprehensive effort to address the current state of scientific knowledge regarding nanomaterials, and how that should guide the approach taken to steward the process through which nanomaterials are responsibly introduced into Canadian trade and commerce.

This report focuses on the scientific and technological considerations (interpreted broadly) that in part define and can help to meet the challenge of developing an appropriate regulatory regime for engineered nanomaterials. A substantial part of the report is therefore devoted to assessing what is known, and not known, about the health and environmental risks of nanomaterials. Moreover, the report will offer an account of the unique regulatory challenges presented by nanotechnologies in light of findings about the nature and behaviour of nanoscale materials more generally. The report includes discussion of some of the reasons why there are gaps in our knowledge - e.g., the lack of fully developed measurement tools, test methods and material characterizations - and thus indicates where to give priority in order to develop a more comprehensive account of the potential health and environmental risks of nanomaterials. Finally, given that regulatory approaches to nanomaterials will be needed in the short- to medium-term, the report assesses a number of other factors - including science and technology priorities, public awareness and engagement, and regulatory management - which could provide a firmer basis on which government and the public could generate policies and approaches to the regulation of nanomaterials.

The sponsors of this assessment requested that the focus of the report be on the scientific knowledge that would inform regulatory perspectives on those engineered nanomaterials that are already in the marketplace in one form or another, or whose entry into trade and commerce could occur over the next several years.

The unique contribution of this report is its clear focus on assessing the state of scientific knowledge concerning engineered nanomaterials from the perspective of risk assessment and regulation. In this regard, it is designed to assist the Government of Canada in developing a robust regulatory approach to these materials, a task that is urgent and time sensitive. This report therefore provides an overview of what we know generally about nanomaterials, their properties, and how they differ from more conventional materials. It then discusses the current state of the science with regard to the risks associated with exposure to these materials, and identifies specific findings with regard to the nature of the regulatory approach that would most effectively address the issues presented by nanomaterials and products that make use of them.




1. Chapter I – Introduction

   Charge to the Expert Panel

   Objectives and Scope of the Report



2.Chapter II – A Primer on “Nano”

   Some Basic Terms and Concepts

   Glossary of Key Terms

   What is Fundamentally Different About “Nano?”

      The Physical Aspects

      The Biological Aspects

      The Ecological and Environmental Aspects

      Convergent Technologies

   The Importance of Nanomaterials

      Potential Benefits

   Public Knowledge and Concerns

   Summary of Chapter II Findings


3.Chapter III – A Science Perspective on Nanomaterial Risk

   Risk and Risk Assessment

   Risk Assessment Frameworks

      The Components of a Risk Framework

   Hazard Identification

      Hazard Identification on Nanomaterials

      Metrology of Nanomaterials

      Physical versus Molecular Properties

      Nanomaterials Characterization

      Considerations and Implications for Toxicity Studies on Nanomaterials

   Hazard Characterization

      Dose-Response Assessment with Nanomaterials

      Overall Assessment of Toxicity

   Exposure Assessment

      Performing Exposure Assessment on Nanomaterials

      Routes of Exposure – A Life-Cycle Approach

      Risk Characterization

      Risk Characterization with Nanomaterials

      Strategic Risk Research

   Summary of Chapter III Findings


4. Chapter IV – underpinning Regulatory Perspectives on Nanomaterials

   A Precautionary Approach to Risk Assessment

      Precaution in Regulation

      Burden of Proof

   Determination of “Acceptable” Risk

      Precaution in the Face of Uncertainty

      The Role of Public Participation in Governance of Nanotechnology

   Using Foresight to “Fill in the Gaps”

      Science-centred Regulatory Challenges

      Management-centred Regulatory Challenges

      Filling in the Knowledge Gaps

   Summary of Chapter IV Findings Epilogue








Appendix A – List of Respondents to Public Call for Evidence.
  • Council of Canadian Academies Published by
Related Document