Canada/Australia Issues being faced in the regulation of nano-materials

1. Canada/AustraliaIssues being faced in the regulation of nano-materials Deborah Willcocks – Department of Health and Ageing, Government of Australia Anne-Marie Pelletier – New Substances Branch, Environment Canada

2. Australian and Canadian Approach to Regulating Chemicals • Both countries: • established informal interdepartmental nanotech networks • maintain watching briefs on international activities • Recent review by scientific committee reporting to Australian Prime Minister identified need to address: • Emerging safety implications • Development of a comprehensive impact and risk analysis framework

3. Australian and Canadian Approach to Regulating Chemicals (cont.) • Australia and Canada have similar risk assessment programs for industrial chemicals: • Identify substance by CAS #, and name • Require tests of properties, toxicity, description of use and exposure • KEY ISSUES: • Require globally harmonized definition of nano-materials • How different are nano-materials from ‘ordinary’ chemicals? Is the current regulatory approach adequate?

4. Nano-materials: Regulation and Notification Issues • Regulatory definition / Substance identification • Require internationally accepted definition of a nano-materials • Measurement standards: particles, tubes and “wires”, nanolayers and nanopores • Analytical methods and techniques - from all media including tissue • Nomenclature - standard chemical nomenclature adequate? • Regulatory system based on CAS # - nano-material may be built from existing chemical? Same CAS # - different substance, properties, hazard and use. • Product Classification • When is a nanomaterial an article? • Regulatory Framework • Analysis of current regulations needed - are existing regulatory frameworks suitable?

5. Nano-materials: Regulation and Notification Issuescont. • Current notification volume limits appropriate for nanoscale? • Some nanomaterials likely require lower volume limits given low anticipated manufacture, import and use volumes. • Current notification information requirements adequate? • Identification, properties, toxicity, etc • Based on hazard and exposure findings - should the requirements be modifiedfor nanomaterials? • Test methods – evaluation & development • If tests and test methods inadequate – Development of new methods • Toxicity tests requirements • Physchem property determination • Are current predictive tools adequate? • Labelling • Voluntary or mandatory labelling to identify nanosubstances for consumer goods?

6. Nano-materials: Assessment Issues & Knowledge Gaps • Technical capacity of assessors • Must be acquired to effectively assess and regulate • Exposure assessment • Lifecycle exposure – determine release during manufacturing, processing, transportation, use & disposal/recycling. • Can exposure be adequately modelled? • Monitoring data available? • Environmental Fate • Bioaccumulation and biomagnification potential • Persistence • Environmental partitioning • Transformation products – identification and fate • Effects • Human and environmental hazards - chronic and acute effects? • Human health – dermal, inhalation and oral exposure • Metabolic processes and fate • Can toxicity be modelled?

7. Nano-materials: Risk Management Issues • Precautionary principle? • Voluntary measures? • Government/Industry co-operation? • No Action?

8. Stakeholder Involvement & Communications • Government must be seen to be proactively addressing nanotechnology • Public must be informed and consulted – perception is everything • Society needs to understand hazard and exposure issues, if any exist • Industry, academia & other researchers involvement • NGO involvement – ETC, Greenpeace, etc. • All levels of government involvement

9. Conclusion • Many unanswered questions • Globally at initial stages of regulation • Good opportunities for international cooperation and work sharing • Definition • Science • Regulatory framework development • Need to set priorities and focus effort