RCC Nanotechnology Initiative

Transcription

1 RCC Nanotechnology Initiative Presentation to RCC Stakeholder Dialogue Session June 20, 2013 Environment Canada David Morin US Environmental Protection Agency Jeff Morris 1.

2 Content 1. Overview of the initiative 2. Progress update 3. Milestones and next steps 4. Key issues and linkages to other international work 5. Questions 6. Annexes 2.

3 RCC Nanotechnology Initiative Nanotechnology Work Plan Outcome: Share information and develop common approaches on foundational regulatory elements. Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US Available online at: Contributing Agencies: US Office of Management and Budget (OMB) US Environmental Protection Agency (EPA) Canadian Privy Council Office (PCO) Environment Canada (EC) Health Canada (HC) 3.

4 RCC Nanotechnology Work Plan Elements and Progress to Date 1. Principles: Identification of common principles for the regulation of nanomaterials to help ensure consistency for industry and consumers in both countries Progress: Canadian Policy Principles have been developed, consistent with the US Policy Principles, and have been issued for public comment until July 17 th, Priority-Setting: Identification of common criteria for determining characteristics of industrial nanomaterials of concern/no-concern Progress: A classification scheme based on common characteristics for nanomaterials has been developed to help in regulatory decision making 3. Risk Assessment/Management (RA/RM): Sharing of best practices for assessing and managing the risks of industrial nanomaterials Progress: A comparative analysis on the two regulatory programs and a case-study risk assessment have been completed to inform best practices of RA/RM 4.

5 RCC Nanotechnology Work Plan Elements and Progress to Date 4. Commercial Information: Characterization of existing commercial activities and identification of gaps and priorities for future knowledge gathering for industrial nanomaterials Progress: Information on existing commercial activities has been collected and is currently being shared with stakeholders to identify gaps and priorities 5. Regulatory Cooperation in Areas of Emerging Technologies: Development of a model framework providing key elements and approaches to regulating products and applications of emerging technologies with respect to potential impacts on the environment, human health, food or agriculture Progress: A draft framework has been developed 5.

6 Milestones and Next Steps May, 2012: Publication of the RCC Joint Nanotechnology Work Plan November 28, 2012: Stakeholder Webinar providing background information and updates on ongoing activities under the RCC Nanotechnology Work Plan March 20, 2013: Stakeholder Workshop to provide an opportunity for informed stakeholders to engage in focused discussions on several technical aspects of the RCC Nanotechnology Work Plan End of May 2013: Circulation of final workshop report to participants Spring and Summer 2013: Technical Team discussions and report development May July 17 th 2013: Consultation on RCC Nanotechnology Policy Principles ( Late Fall, 2013: Final Stakeholder Workshop and finalization of reports If you would like more information or to become involved in the work of the RCC Nanotechnology Initiative, contact: 6.

7 Stakeholder Engagement Stakeholders from Canada and the US have been well engaged throughout the RCC Nanotechnology Work Plan, including: launch through initial webinar active involvement at the March Workshop specific technical discussions comment on principles Feedback from Industry has been positive throughout. 7.

8 Key Issues and Linkages to International Work RCC Nanotechnology work is both informed by, and will inform, international work on nanotechnology: Nomenclature ISO TC 229 was established in 2005 to develop standards related to nanomaterials, including terminology and nomenclature A joint ISO TC 229-IUPAC project is currently underway targeting the development of a nomenclature system for nanomaterials Science to Support Risk Assessment The OECD Working Party on Manufactured Nanomaterials (WPMN) was established in 2006 to address the Environment, Health and Safety (EHS) implications of manufactured nanomaterials The primary activity has been a sponsored research program involving the generation and collection of information on a representative set of 13 different types of nanomaterials to build a foundational dataset to inform regulatory decision making 8.

9 Questions Moving forward, what opportunities do you see for further Canada-US regulatory alignment in the chemicals sector, or in other areas of emerging technologies? 9.

10 Annex Regulatory Context for Nanomaterials No single regulatory definition for nanomaterials in Canada or the US Generally recognized as materials having 1 or more dimensions in the nanoscale (typically 1-100nm); or with dimensions above or below 1-100nm exhibiting nanoscale phenomena May exhibit novel properties due to their nanoscale size as compared to their non-nanoscale counterparts Used in a broad range of applications and sectors Existing regulatory frameworks for chemicals applicable (i.e. CEPA/TSCA) No nanomaterial specific regulations in Canada and the US 10.

11 Annex RCC Nanotechnology Work Plan Timelines Common Principles for Regulation Canadian feedback on US Policy Principles Draft Common Principles Final Common Principles Priority-Setting of Industrial Nanos Share Info re: Characteristics Analysis of Characteristics Determining Characteristics of Classes Summary Report on Characteristics of Classes Risk Assessment/ Risk Management for Industrial Nanos Share approaches Data Needs to Reduce Uncertainty Analysis of Current Approaches, Best Practices Summary Report on Current Approaches, Best Practices Commercial Information for Industrial Nanos Share lessons learned on data gathering activities Share Non-CBI Marketplace Info and ID Gaps Analysis of Uses Industrial nano in Canada/US Summary Report on Industrial Uses in Canada/US Regulatory Cooperation in Emerging Technologies Scoping of Models/Frameworks to Support Int l Cooperation for Emerging Technologies Draft Report including Lessons Learned to Date Summary Report on Approaches and Considerations for Regulatory Alignment Stakeholder Engagement Webinar on Results to Date Workshop on Results to Date Technical Team Discussions Final Workshop 18 Months 11.

12 Annex RCC Nanotechnology Policy Principles Summary: Base decisions on the best available scientific evidence Seek and develop information with respect to the potential effects of nanomaterials on human health and the environment in an open and transparent manner Communicate information to the public regarding the potential benefits and risks associated with specific uses of nanomaterials Consider the potential benefits and costs of regulation and oversight Provide flexibility in oversight and regulation to accommodate new evidence and learning on nanomaterials Mandate risk management actions appropriate to, and commensurate with, the degree of risk identified in an assessment Strive to reach an appropriate level of consistency in risk assessment and risk management across the Government of Canada Coordinate with the international community 12.

13 Annex Proposed Groupings of Industrial Nanomaterials 13.