Nanotechnology & Molecular Engineering (NME) Phase 2 Report

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Nanotechnology & Molecular Engineering (NME) Phase 2 Report Nanotechnology & Molecular Engineering (NME) Phase 2 Report November 15, 2013 Professional Engineers Ontario (PEO) Emerging Disciplines Task Force NME Group NME Chair: Argyrios Margaritis, PhD., P.Eng. NME Vice Chair: Yuri Kuzyk, P.Eng. Group members: Laura Deakin, PhD. Peter DeVita P.Eng. (EDTF Chair) Brian Haydon, P.Eng. Roger Jones, P.Eng. (EDTF Councillor Liaison) Observers: Alana Lavoie Corneliu Chisu, P.Eng. Staff Advisor: Jordan Max Nanotechnology & Molecular Engineering Phase 2 Report EDTF- NME Phase 2 Report Contents Executive Summary .......................................................................................................................................... 3 NME Scope of Practice Definition ................................................................................................................. 4 NME Developments Since Phase I Report ................................................................................................... 5 Summary Of NME Phase 2 Report Recommendations .................................................................................... 7 Rights to Practice Recommendations ........................................................................................................ 7 Registrar Recommendations ..................................................................................................................... 8 Admissions/Academic Recommendations – Enhancements to Phase 1 Report ...................................... 8 Other/Special Recommendations .............................................................................................................. 8 1 Introduction to Main Report .......................................................................................................................10 1.1 EDTF Current Mandate and Terms of Reference ............................................................................10 1.2 Canadian Law Perspectives .............................................................................................................10 1.3 Enforcement is the essence of licensure ..........................................................................................11 1.4 Some EDTF Background ..................................................................................................................12 1.5 Phase One and Phase Two Reports ................................................................................................12 1.6 NME ..................................................................................................................................................13 2 The “Public Interest” of NME .....................................................................................................................14 3 Profile of the NME Industry and Practitioners ...........................................................................................18 3.1 External Regulatory Landscape .......................................................................................................20 3.2 Nanotechnology and Provincial Regulatory Implications .................................................................22 3.3 Standards External to PEO ..............................................................................................................23 3.4 Activities outside of Canada .............................................................................................................25 3.5 Bioprocessing Regulations in the Biopharmaceutical industry .........................................................27 4 PEO Licensing Considerations .................................................................................................................31 4.1 Product Regulations vs. Licensure ...................................................................................................31 4.2 Accelerating Pace of Change ...........................................................................................................32 4.3 PEO Processes ................................................................................................................................32 4.4 Academic Requirements ..................................................................................................................33 4.5 Experience Requirements ................................................................................................................38 4.6 Professional Guidelines and Standards ...........................................................................................40 4.7 Compliance Considerations and Proposals .....................................................................................41 4.8 Stakeholder Feedback to the Phase 2 report ...................................................................................42 4.9 Communications and Public Education Plan ....................................................................................42 4.10 Establishing Rights to Practice .........................................................................................................43 5 Future Work...............................................................................................................................................48 Glossary ..........................................................................................................................................................51 Appendix A – NME Stakeholders consulted ...................................................................................................53 Appendix B – List of Ontario Industries/companies using NME .....................................................................54 Appendix C – List of Standards published by CSA, ISO/TC229, and IEC/TC113..........................................73 Appendix D - CEQB Draft Nanotechnology Examination Syllabus (May 2013) .............................................75 Appendix E - Target Domains .........................................................................................................................78 Appendix F – Information and Guidance for Practitioners ..............................................................................81 Appendix G - The Accelerating Pace of Change ............................................................................................83 Appendix H - NME Experience Requirements Criteria ...................................................................................86 P a g e 2 Nanotechnology & Molecular Engineering Phase 2 Report Executive Summary Nanotechnology and Molecular Engineering (NME) is a new discipline that is rapidly growing. NME is an enabling technology that has applications and uses in many industries. The global market for nanotechnology was valued at more than $20 billion in 2012. Total sales are expected to reach nearly $50 billion in 2017 for a five-year compounded annual growth rate of over 18%1. These statistics indicate the need and potential to serve the public interest through the practice of NME. PEO, a regulatory body established by statute and accountable to the people of Ontario, recognizes that the public interest can be served and protected by licensing NME within the practice of professional engineering. As is the case with all other engineering disciplines, NME shall be regulated in the public interest by PEO in Ontario. NME presents a challenge, as this field encompasses engineering work with materials in the nanoscale, but also overlaps with other traditional fields of engineering. This reflects the horizontal nature of this emerging discipline. The NME group issued its Phase 1 Report on March 24, 2010, which introduced and defined the discipline of Nanotechnology and Molecular Engineering. It identified the public safety risks arising from NME, applicable legislation and technical standards, and presented a draft Core Body of Knowledge (CBOK) for ethical NME practice, along with specific academic requirements and practical experience requirements for licensure as a Professional NME. The Phase 1 Report and its recommendations were approved by PEO Council on April 16, 2010 so that NME became a PEO recognized discipline of Professional Engineering. Since that time, the NME landscape continues to evolve. This includes the first graduating class from the University of Waterloo’s Nanoengineering program; PEO Council’s adoption of NME as a new engineering discipline; the IRSST’s research report on the occupational health and aspects of synthetic nanoparticles; Health Canada’s release of its Policy Statement on its Working Definition for Nanomaterials, and the new Canadian standard: Nanotechnologies — Exposure control program for engineered nanomaterials in occupational settings. New nanotechnology standards from CSA and ISO are listed in Appendix C. This Phase 2 report deals with the practice, regulatory and legislative issues required to create a fully licensed discipline in the practice of Professional Engineering. Section 3, 1 http://www.bccresearch.com/report/nanotechnology-market-applications-products-nan031e.html P a g e 3 Nanotechnology & Molecular Engineering Phase 2 Report Profile of the NME Industry and Practitioners, of this report provides the latest information on: public health and nanomaterials, a profile of NME industries, the role of research and industry in developing technical safety standards, the provincial and federal legislation nanomaterials landscape, and, bioprocessing regulations that might be
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