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
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