NANOTECHNOLOGY WORKSHOP

4 July 2012

WELCOME

Adrian O’Connell

General Manager

Standards Australia

4 July 2012

INTRODUCTIONS AND FORUM OBJECTIVES

Damian Fisher

Senior National Sector Manager

Operations – Health & ICT

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

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)

Agenda

continued

Workshop – Breakout Groups

Open forum discussion

Feedback from Breakout Group Leaders

Panel discussion

Summary, Next steps and close

Principal

objectives of

today’s

workshop

meeting…

Up-date stakeholders on the important standards

development work that is happening

internationally in ISO/TC 229 - 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

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

THANK YOU

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

A Not-For-Profit Company – Membership based; Government, Industry & Community

Standards

Australia

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

Australia’s

National

Standards Body

Member of ISO

and IEC

Multi-discipline and cross-sector, including

conformity assessment

Electro-technology, including medical

devices

Our Key

Activities

Standards Development

Accreditation of SDO Organisations

Design Assessment & Promotion

National and International Standards Co-ordination

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.

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.

International standards development

Recognised as a major contributor to ISO / IEC & regional bodies

A leading standards body in the Asia Pacific region

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

www.iso.org

ISO’s structure

Notes 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

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

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

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

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

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 229 - 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)

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

Request for a

new project Preliminary Draft Development and

Acceptance of

Committee Draft

Draft International

Standard (DIS)

Consideration of

Voting (66%)

Final Draft

International

Standard (FDIS) Publication of ISO

International

Standard

Working Group or Subcommittee

Proposal Stage

Committee Stage

Send to Central Secretariat

Send to Central Secretariat

Circulated to Member Bodies for voting

HOW A STANDARD IS DEVELOPED

Preparatory stage

Enquiry Stage

Approval Stage

Publication Stage

Consideration of

Voting (66%)

ISO Project

Stages

Preliminary stage Preliminary work item (project) PWI

Proposal stage New proposal for a work item NP

Preparatory stage Working draft WD

Committee stage Committee draft CD

Enquiry stage Draft International Standards DIS

Approval Stage Final Draft International standards FDIS

Publication Stage International Standards IS

• 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

Copyright © 2010 Standards Australia Limited

ISO Project

Tracks

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

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

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.

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…

THANK YOU

Leveraging the use of International Nanotechnology Standards in Australia

Mr Damian Fisher

Senior National Sector Manager

Operations – Health & ICT

4 July 2012

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

Quality

Value

Strategic Engagement

Time and Costs

Principles of

Standardisation Neutrality and Independence Neutrality and Independence

Consensus Consensus

Balanced Representation Balanced Representation

Consultation Consultation

Transparency Transparency

International Alignment International Alignment

National Compatibility National Compatibility

TR

US

T A

ND

AU

TH

OR

ITY

All project proposals assessed and approved by the Board

-Standards Development Sub-Committee

Approved projects commence with kick off meeting &

project management plan

Standards

Development

Process

Committee

Review

Public

Comment

Committee

BallotPublication

Working

Draft

Should take no more than 24 months. Goal is 12 months or less.

Timeframes also pathway related

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

Standards

Development

Pathways

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

Prioritisation

Process for

Standards

Australia

Resourced

Pathway

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…

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

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)

Proposals to develop or revise a standard or engage in

international standardisation activity are made via a

Project Proposal Form

» www.standards.org.au

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?

Project Proposal

and Net Benefit

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

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.

Net Benefit Test

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

Stakeholder

Engagement is

Critical

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

THANK YOU