Transcript The “Purple” Team Existing Substances International

Regulating Nanomaterials under CEPA
CIELAP Workshop
February 22, 2008
Bernard Madé, New Substances Program
Environment Canada
Page 1
Objective of the Presentation
• To provide information on current thinking on
how to address nanomaterials under CEPA
1999
• Overview
– Background
– Current views in the following areas:
• Regulatory Aspects
• Alignment with Other Countries
• Research and Other Scientific/Technical Activities
– Conclusions
Page 2
Background
• Nanomaterials are being developed and are entering the
Canadian market
– Industry Canada indicates about 80 Canadian companies advertise
about 150 products containing 88 distinct nanomaterials
– Some nanomaterials have been on the market for a long time
• There is a concern that certain nanomaterials could have negative
impacts on human health or the environment as a result of their
new properties
• As part of their responsibilities under CEPA, EC and HC need to
ensure human health and environmental concerns are addressed
appropriately
– Need to explore concerns
– Need to determine if some nanomaterials present risks
– Need to address any significant risk (within CEPA jurisdiction)
Page 3
Substances Assessment and
Management under CEPA
• CEPA 1999, Part 5: Controlling Toxic Substances
– Assessments conducted jointly by Environment Canada (EC) and
Health Canada (HC) to determine if a substance is toxic or capable of
becoming toxic according to CEPA
– Toxic is defined by whether a substance constitutes or may pause a risk
to:
• The environment or biodiversity
• The environment upon which life depends
• Human life or health
– Risk Management:
• If there is a risk, how can risks be reduced or eliminated?
• Two programs: new and existing substances
– A “new” substance under CEPA is a substance not appearing on the
Domestic Substances List (DSL).
– All new substances must be notified to EC before the are
commercialized in Canada under the New Substances Notification
Regulations (NSNR)
Page 4
Some nanomaterials will be considered “new” and
others will be considered “existing” under CEPA
• Nanomaterials with unique structures and not
listed on the DSL are considered “new”
– New Substances regime apply
• Nanomaterials that have the same structure as
substances listed on the DSL are considered
“existing”
– Currently no special notification or assessment
scheme for these substances
Page 5
What have we done so far?
• In September 2007, EC and HC held a multistakeholder consultation
on a proposed regulatory framework
– Overall, stakeholders are supportive of efforts
– Interest is high and they want to be engaged in developing the specifics
• Our objective: Protect human health and the environment and
enhance public confidence by enabling the responsible introduction
and use of nanotechnology through a program that scientifically
assesses and appropriately manages the potential risks.
Page 6
Regulatory Challenges
• Ideally, all nanomaterials which exhibit new properties should be
assessed as new substances, However, at the moment it is not
the case
• There are important knowledge gaps on properties, fate, and
effects
– i.e., we may not know all we need to know to properly assess
and manage risks
• Current NSNR were not designed for nanomaterials
– Issues with notification triggers, information requirements
• Information on nanomaterials currently on the market is
incomplete
• There is a need to further inform manufacturers and importers
about current and future requirements
Page 7
Proposed Approach: Regulatory Aspects
• Phase 1 (Short term):
– Further inform companies of their obligations
under CEPA
– Gather information on materials already in
commerce through a CEPA, section 71 survey
and a voluntary challenge
– Consider whether changes to CEPA (and
NSNR) are needed
• Objective: ensure assessment of nanomaterials of interest
– Use Significant New Activity (SNAc)
provisions for new nanomaterials, where
applicable
Page 8
Information Gathering
• There is a need to gather information on all
current activities involving nanomaterials to
inform the implementation of a regulatory
framework:
– Which nanomaterials are currently being developed
or are on the market;
– In which quantities;
– For what applications;
– Have there been any toxicological studies done
Page 9
Anticipated timelines
Milestone
Target Date
Pre-testing
April 2008
Information session
September 2008
Publication of section 71 notice in
Canada Gazette for three months
September 2008
End of response period
December 2008
Page 10
Proposed Approach: Regulatory Aspects
(2)
• Phase 2 (Longer term)
– Consider more elaborate changes to NSNR to
ensure information requirements are sufficient
to assess and manage nanomaterials
– Consider using SNAc provisions for existing
nanomaterials
Page 11
Alignment with Other Countries
Current Status
• ISO has initiated work to develop standards for nanomaterials,
including in terminology and nomenclature
– A new nomenclature is likely necessary to provide a unique identifier for
each nanomaterial; an essential requirement for the appropriate
regulation of these substances.
– EC is chairing the Technical Committee sub-group on nomenclature
• Canada and the US are very active participants to the OECD
Working Party on Manufactured Nanomaterials
– This Working Party is developing a research strategy and testing
program to address the substantial science gaps associated with
nanomaterials
• High level of cooperation between EC, HC, and the US EPA
Page 13
Proposed Approach: Alignment with
Other Countries
• Support effort of the Canadian Standards Association
(CSA) in the development of standard nomenclature and
terminology through the ISO (2008-2010)
• Support the efforts of the OECD with regard to research
that will be done on nanomaterials identified as priorities
(2008-2012)
• Continue collaboration with US EPA
Page 14
Research and Other
Scientific/Technical Activities
Ecological Risk Assessment Needs
Need to develop an understanding of:
– properties and effects of NMs in the environment
– transformation characteristics of NMs in the environment.
– how does the size, shape and unique characteristics of these
materials effect bioavailability.
– the vector aspect of the nanomaterials wrt how NMs can
increase the toxicity of other organisms.
– the relationship between acute and chronic toxicity to aquatic
organisms
– the relationship between octanol water partition coefficient and
bioaccumulation for nanomaterials.
– baseline environmental levels and how to measure levels in the
environment.
Page 16
Proposed Approach: Research and
Other Scientific/Technical Activities
• Build up EC research capacity for NMs
• Involve research funding agencies
• Develop an EC research strategy which will
contribute to the OECD testing program
– Needs are beyond the scope of any one country’s research
capacity. Partnering with others is essential
• Consider compliance verification and monitoring
needs related to NMs
Page 17
Conclusions
• Concerns with regard to nanomaterials must be
addressed
• This will not be done overnight: some important
information needs to be developed in the coming
years to help us regulate these new materials
• EC and HC are taking steps to address
concerns and assess nanomaterials
Page 18
Questions?
Supplemental Slides
OECD Working Party on
Manufactured Nanomaterials
Eight Steering Groups working on specific issues:
SG1:
SG2:
SG3:
SG4:
SG5:
SG6:
SG7:
SG8:
OECD database on EHS Research
EHS Research strategies on Manufactured Nanomaterials
Safety testing of a representative set of Manufactured Nanomaterials
Manufactured Nanomaterials and Test Guidelines
Co-operation on Voluntary Schemes and Regulatory Programs
Co-operation on Risk Assessment
Role of Alternative Methods in Nano Toxicology
Exposure Measurement and Exposure Mitigation
Page 21
OECD representative nanomaterials
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Fullerenes (C60)
SWCNTs
MWCNTs
Silver nanoparticles
Iron nanoparticles
Carbon black
Titanium dioxide
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Aluminum dioxide
Cerium oxide
Zinc oxide
Silicon dioxide
Polystyrene
Dendrimers
Nanoclays
Page 22