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Regulating Nanomaterials under CEPA

CIELAP Workshop

February 22, 2008

Bernard Madé, New Substances ProgramEnvironment Canada

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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

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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)

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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)

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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

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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.

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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

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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

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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

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Anticipated timelines

Milestone Target DatePre-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

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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

Alignment with Other Countries

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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

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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

Research and Other Scientific/Technical Activities

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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.

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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

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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

Questions?

Supplemental Slides

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OECD Working Party on Manufactured Nanomaterials

Eight Steering Groups working on specific issues:

SG1: OECD database on EHS Research

SG2: EHS Research strategies on Manufactured Nanomaterials

SG3: Safety testing of a representative set of Manufactured Nanomaterials

SG4: Manufactured Nanomaterials and Test Guidelines

SG5: Co-operation on Voluntary Schemes and Regulatory Programs

SG6: Co-operation on Risk Assessment

SG7: Role of Alternative Methods in Nano Toxicology

SG8: Exposure Measurement and Exposure Mitigation

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OECD representative nanomaterials

• Fullerenes (C60)• SWCNTs• MWCNTs• Silver nanoparticles• Iron nanoparticles• Carbon black• Titanium dioxide

• Aluminum dioxide• Cerium oxide• Zinc oxide• Silicon dioxide• Polystyrene• Dendrimers• Nanoclays