1. Page 1 Regulating Nanomaterials under CEPA CIELAP Workshop February 22, 2008 Bernard Madé, New Substances Program Environment Canada

2. Page 2 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

3. Page 3 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)

4. Page 4 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)

5. Page 5 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

6. Page 6 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.

7. Page 7 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

8. Page 8 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

9. Page 9 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

10. Page 10 Anticipated timelines MilestoneTarget Date Pre-testingApril 2008 Information sessionSeptember 2008 Publication of section 71 notice in Canada Gazette for three months September 2008 End of response periodDecember 2008

11. Page 11 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

12. Alignment with Other Countries

13. Page 13 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

14. Page 14 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

15. Research and Other Scientific/Technical Activities

16. Page 16 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.

17. Page 17 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

18. Page 18 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

19. Questions?

20. Supplemental Slides

21. Page 21 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

22. Page 22 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