1. Canada/Australia Issues 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 Issues cont. 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 modified for 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