NANOTECHNOLOGY WORKSHOP

Transcription

1 NANOTECHNOLOGY WORKSHOP 4 July 2012

2 WELCOME Adrian O Connell General Manager Standards Australia 4 July 2012

3 INTRODUCTIONS AND FORUM OBJECTIVES Damian Fisher Senior National Sector Manager Operations Health & ICT

4 Agenda Nanotechnology Workshop Welcome Mr Adrian O Connell, General Manager, Operations - Standards Australia Introductions and workshop objectives Speaker 1- Mr Damian Fisher (SA) Standards development processes & use of international standards in Australia Speaker 2- Mr Howard Morris (Chair of NT-001) Background to NT-001 & ISO Nanotechnologies Technical Committee TC 229 Facilitator Dr John Miles Development and application of Nanotechnologies including consideration of international definitions

5 Agenda Nanotechnologies Workshop Consumer Perspective - Ms Elaine Attwood (Consumer Federation of Australia) and Ms Georgia Miller (Friends of the Earth Australia) Industry Perspective, Mr Ken King (Micronisers) Unions Perspective, Ms Renata Musolino (Victorian Trade Hall Council) Regulator s Perspective, Ms Kerry Nugent (NICNAS) Scientific Communities Perspective, Associate Professor Paul Wright (RMIT University) Metrology Perspective, Dr Jan Hermann (National Measurement Institute)

6 Agenda continued Workshop Breakout Groups Open forum discussion Feedback from Breakout Group Leaders Panel discussion Summary, Next steps and close

7 Principal objectives of today s workshop meeting Up-date stakeholders on the important standards development work that is happening internationally in ISO/TC Nanotechnologies Seek feedback from stakeholders on key ISO nanotechnology definitions and nomenclature projects Explore current issues and identify needs of stakeholders that could be addressed by adopting new International Standards or developing Australian Standards Answer the key question of how you can get involved? Agree on the need for and structure of future Nanotechnology workshops that can help inform the work of Standards Australia and our technical committees

8 Stakeholder Engagement is Critical to Success Sector and Issue Forums are key to Standards Development In 2011 SA organised 20 forums with 450+ participants Aligning SA with emerging issues and market needs Facilitating strategic engagement Engaging new stakeholders De-risking new projects

9 THANK YOU

10 An Introduction to Standards Australia and the Standards Development Process Mr Damian Fisher Senior National Sector Manager, Operations Health & ICT Nanotechnologies Workshop 4 July 2012

11 Standards Australia A Not-For-Profit Company Membership based; Government, Industry & Community

12 Australia s National Standards Body Recognised as Australia s National Standards Body by the Australian Government

13 Member of ISO and IEC Multi-discipline and cross-sector, including conformity assessment Electro-technology, including medical devices

14 Our Key Activities Standards Development National and International Standards Co-ordination Accreditation of SDO Organisations Design Assessment & Promotion One of the world s leading standards organisations Standards Development developing internationally harmonised Australian Standards and other normative technical documents through expert Technical Committees. National and International Standards Information and Co-ordination coordinating representation of Australian input into international standards development and adoption, promoting information exchange and knowledge management. Accrediting Standards Development Organisations (SDOs) through the Accreditation Board for Standards Development Organisations (ABSDO). Design Assessment and Promotion Principal Sponsor of the Australian International Design Awards. More than 50 years experience of benchmarking excellence in fostering design and innovation. A leading standards body in the Asia Pacific region International standards development Recognised as a major contributor to ISO / IEC & regional bodies

15 The International Organization for Standardization (ISO) is the world's largest developer and publisher of International Standards ISO, which is based in Geneva, was founded in 1946 by delegates from 25 countries and started operations in 1947 ISO is now a network of the national standards bodies of 163 countries, (one member per country) Between 1947 and the present day, ISO has published more than 18,000 International Standards, ranging from standards for activities from agriculture and construction, through to mechanical engineering and medical devices, to the newest information technology developments

16 ISO s structure Notes Members from 163 countries, covering 98% of world GNI and 97% of world population Over 18,000 international standards based on consensus 195 active technical committees with 3,238 technical groups, 50,000 experts Central Secretariat in Geneva with 153 FTE staff

17 The ISO committee structure The technical work is carried out under the overall management of the Technical Management Board (TMB) It is responsible for setting up the various technical committees, appointing a TC Chairperson and monitoring the progress of the technical work It is also responsible for the Directives, which are essentially the rules for the development of International Standards

18 The ISO committee structure Technical Committees (TC) are established by the Technical Management Board to serve specific industries or generic subjects, in order to develop International Standards or other ISO publications appropriate to the needs of that sector Subcommittees (SC) to focus on specific parts of the overall standards requirement Working Groups (WG) to focus on specific tasks within the overall programme

19 Technical Barriers to Trade Background The Agreement on Technical Barriers to Trade (also known as the TBT Agreement) is an international treaty of the World Trade Organization The policy of Standards Australia is to base Australian Standards on International Standards to the maximum extent feasible Standards Australia have accepted the Code of Good Practice For The Preparation, Adoption And Application Of Standards set out in Annex 3 WTO TBT Agreement

20 Levels of participation in International standardisation All national bodies have the right to participate in the work of technical committees and subcommittees Standards Australia is the official Australian representative to ISO/TC Nanotechnologies In order to achieve maximum efficiency and the necessary discipline in the work, each national body is required to clearly indicate whether it intends to participate (P) or act as an observer (O) To participate actively in the work, with an obligation to vote on all questions formally submitted for voting within the technical committee or subcommittee, on new work item proposals, enquiry drafts and final draft International Standards, and to contribute to meetings (P-members)

21 Levels of participation To follow the work as an observer, and therefore to receive committee documents and to have the right to submit comments and to attend meetings (O-members) A national body may choose to be either a P- member or an O-member of a given committee or subcommittee All national bodies irrespective of their status within a technical committee or subcommittee, have the right to submit comments and vote on enquiry drafts and on final draft International Standards National bodies have the responsibility to organise their national input in an efficient and timely manner, taking account of all relevant interests at their national level

22 HOW A STANDARD IS DEVELOPED Proposal Stage Preparatory stage Request for a new project Preliminary Draft Working Group or Subcommittee Committee Stage Development and Acceptance of Committee Draft Consideration of Voting (66%) Enquiry Stage Draft International Standard (DIS) Send to Central Secretariat Approval Stage Final Draft International Standard (FDIS) Send to Central Secretariat Circulated to Member Bodies for voting Consideration of Voting (66%) Publication Stage Publication of ISO International Standard

23 ISO Project Stages ISO s deliverables are developed through a sequence of project stages Each stage has its name, but very often the stages are identified by using the acronyms that are associated with each stage Preliminary stage Preliminary work item (project) PWI Proposal stage New proposal for a work item NP Preparatory stage Working draft Committee stage Committee draft WD CD Enquiry stage Draft International Standards DIS Approval Stage Final Draft International standards FDIS Publication Stage International Standards IS

24 ISO Project Tracks Copyright 2010 Standards Australia Limited

25 Service Offering to Support Australian Mirror Committees Receive committee documents (such as ballots, comments, agendas, reports, etc.) from ISO or IEC Secretariat and distribute them to Australian mirror group as appropriate Distribute draft documents to the Australian mirror group within adequate timeframes to allow for consideration and formation of an Australian position Facilitate the endorsement of AU delegates by the mirror group to attend ISO/TC 229 meetings overseas Collate ballots and comments on various draft stages including working drafts, committee drafts, DIS (CDV) or FDIS documents from ISO or IEC committees and send to ISO/IEC TC or SC Secretariat

26 Service Offering to Support Australian Mirror Committees Facilitate an Australian position (yes/no/abstain) on systematic reviews, new work item proposals, CD, DIS or FDIS documents requiring a vote Administrate the vote from the national member body (SA) into the international arena in the manner required according to the international directives National Sector Managers provide consultation on new fields of work (TC/SC), new work item proposals for ISO or IEC and activities undertaken in support of existing Australian mirror groups including NT-001 Nanotechnologies

27 International Standards - Australian Mirror Committees Key principles: Member organisations have a broad national base of constituents; Transparent process; Consensus & Balance of interests Typical sectors of interest may include: Consumer/community groups; Employer bodies; Government: Federal, state and local; Industry, professional and technical bodies; Manufacturers/suppliers; Regulatory and controlling bodies; Researchers, academics and testing organisations; Unions/employees; and User and purchasing bodies.

28 Benefits Realisation for Active Participation Strategic engagement with NT-001 gives stakeholders with an interest in Nanotechnologies early access to information that could shape the market in the future Gives your organisation a key voice and role in the development of standards Helps contribute to keep market access open and ensures a focus on providing consensus based solutions to address health, safety and environmental concerns Fosters communication and collaboration in R&D and business. Getting involved in international standards development brings Australia s concerns and needs to bear on a process that will affect you now and in the future

29 THANK YOU

30 Leveraging the use of International Nanotechnology Standards in Australia Mr Damian Fisher Senior National Sector Manager Operations Health & ICT 4 July 2012

31 Standards Development Objective To excel in the provision of contemporary, internationally aligned standards and related services for the benefit of Australia Related services Forums; Seminars; Scoping Studies; International services and Training Speed to Market Time and Costs Quality Value Strategic Engagement

32 TRUST AND AUTHORITY Principles of Standardisation Neutrality and Independence Consensus Balanced Representation Consultation Transparency International Alignment National Compatibility

33 Standards Development Process All project proposals assessed and approved by the Board -Standards Development Sub-Committee Approved projects commence with kick off meeting & project management plan Working Draft Committee Review Public Comment Committee Ballot Publication Should take no more than 24 months. Goal is 12 months or less. Timeframes also pathway related

34 Standards Development Pathways Stakeholders have pathway options Standards Australia Resourced Committee Driven Externally Funded Difference between pathways is resource contribution and responsibility allocation Driver is control over work priorities and timeframes

35 Prioritisation Process for Standards Australia Resourced Pathway Purpose Fair, equitable and sustainable allocation of SA s standards development resources Criteria and Process Net benefit Stakeholder support Two Rounds per year May and November

36 Challenges 1. There are finite Standards Australia and stakeholder resources 2. The increasing demand for standardisation particularly in nanotechnologies 3. The need to maximise the effectiveness of the limited resources for optimal benefit 4. How to equitably allocate available SA resources across multiple sectors and industries

37 Benefits 1. Clarity Volume of work Scope of individual projects Intended outcome and benefits 2. Scheduled timeframes for submission and assessment of proposals 3. Equitable and transparent criteria and prioritisation process 4. Expectations are managed for all project participants

38 Proposal Forms 1. New or revised Australian Standard and lower consensus documents 2. AS or joint AS/NZS Australian identical adoption of published International Standard (ISO, IEC, ISO/IEC) 3. Australian participation in International Standardisation committees (ISO, IEC, ISO/IEC)

39 Project Proposal and Net Benefit Proposals to develop or revise a standard or engage in international standardisation activity are made via a Project Proposal Form» All proposals need to demonstrate Net Benefit, stakeholder support and to avoid duplication of international standards Net Benefit case answers the question - will the Standard have an overall positive impact on relevant communities?

40 Assessment 1. NSMs review proposals in their sectors for: Quality and completeness of proposal Evidence of Stakeholder consultation and support Prima facie Net Benefit 2. Assessors review in-depth all proposals received, and identify: Net Benefit Legislative reference (primary and secondary) International alignment

41 Net Benefit Test Methodology introduced in 2008 Net Benefit takes into account the costs and benefits related to the following criteria: Public health and safety; Social and community impact; Environmental impact; Competition; and Economic impact. These measures align with Australian Government Office of Best Practice Regulation (OBPR) and provide a level playing field for all proposals for Standards development projects.

42 Stakeholder Engagement is Critical Dedicated National Sector Managers work across 12 sectors; including the health sector Aligning Standards Australia with emerging needs and issues Refrigeration of vaccines A new AS in colour coding and positioning of disinfection solutions in sinks in relation to health care settings Sunscreens: 50+ SPF Traditional Chinese Medicine, Sterile acupuncture needles for single use Health Informatics /PCEHR, and much more Facilitating strategic engagement Nanotechnology website, forums & NWIP Engaging new stakeholders

43 Engaging Internationally is a Strategic Imperative Involvement in International Standards setting is a strategic asset for Australia It serves the national interest Participating internationally gives Australia the opportunity to define and shape international standards development solutions and outcomes It is a key enabler for driving positive change based on shared solutions underpinned by consensus, transparency and balanced interests Increasing use of standards helps to protect communities against safety, health and environmental issues Participating internationally opens up markets and reduces barriers to trade

44 THANK YOU