The Operation of the Industrial Chemicals (Notification & Assessment) Act 1989 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT

SCHEME

The Hon Christopher Pyne MP Parliamentary Secretary to the Minister for Health and Ageing Parliament House Canberra ACT 2600

Dear Parliamentary Secretary I have pleasure in submitting to you for presentation to the Parliament, the Annual Report of the Operation of the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act), for the year ending 30 June 2005. The Annual Report has been prepared in accordance with Section 108 of the Act. The Annual Report details the performance of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) against outcome and output measures as detailed in the Portfolio Budget Statements for the period 1 July 2004 to 30 June 2005. A summary of financial information for NICNAS is included in this report. Audited financial statements for NICNAS can be found in the Australian Government Department of Health and Ageing Annual Report 2004-05, reflecting administrative arrangements for 2004-05. Yours sincerely

© Commonwealth of Australia 2005 This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney General's Department, Robert Garran Offices, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/cca ISSN 1037-6909 Designed by Ident Pty Ltd for the National Industrial Chemicals Notification and Assessment Scheme

Dr Margaret Hartley Director NICNAS 20 September 2005

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National Industrial Chemicals Notification and Assessment Scheme GPO Box 58 Sydney NSW 2001 Australia T +61-2-8577 8800 F +61-2-8577 8888 Freecall: 1800 638 528 www.nicnas.gov.au Annual Report web page: www.nicnas.gov.au/publications/annualreports/2004-05/

Page 3 4 7 8 16 22 30 40 48 52 53 54 56 56 65 71 74 89 95 96 146 Letter to the Minister Contact Details List of Appendices Glossary, Acronyms and Abbreviations Director's Overview Corporate Overview Management and Accountability Reform Initiatives International Treaties Operational Performance Performance Measurement Framework Consolidated Summary of Outputs/Resources Assessment – New Chemicals – Existing Chemicals Harmonisation Activities Compliance Communication and Services Compliance with Annual Report guidelines Appendices Index

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Page

Appendix

97 98 104 106 108 109 111 113 118 123 124 129 130 133 134

01 02 03 04 05 06 07 08 09 10 11 12 13 14 15

Compliance with Mandatory Reporting Requirements Under The Act External Accountability Arrangements Organisational Chart, Staff Profile, Training and Development Activities Consultancies Commissioned Media Advertising Organisations Engaged by NICNAS 2004-05 Ecologically Sustainable Development (ESD) Scorecard - Implementation of Low Regulatory Concern Chemicals Reform Recommendations Types and Categories of NICNAS Assessments New Chemicals Notification and Assessment Statistics Confidential Listing of Chemicals on the Australian Inventory of Chemical Substances Summary of Existing Chemicals Assessment Activity Partnership Agency Assessment Performance List of Chemicals that had Agreed International Assessments Inquiry Statistics Presentations, Conferences, Harmonisation and International Meetings and Site Visits undertaken by NICNAS NICNAS New and Revised Publications and Media Coverage NICNAS Web Site Usage Statistics

142 144

16 17

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Glossary
This glossary contains a brief description of terms relevant to an understanding of the NICNAS Annual Report for 2004-05. The terms described in the glossary do not substitute for definitions contained in the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act). An interpretation of terms relevant to the operation of the Industrial Chemicals Notification and Assessment Scheme is given in Part 1 Section 5 of the Act.
the Act

Community Engagement Forum

NICNAS's consultative group that identifies community concerns about the impact of industrial chemicals on the environment, public health and/or worker health and safety a business entity which has one or more potential contraventions of the Act concise, informative document published under the IPCS that provides a summary of the relevant scientific information concerning the potential effects of a chemical on human health and/or the environment procurement of external specialists to provide advice and services where NICNAS staff either do not have the expertise or have overriding obligations Director of NICNAS level of judgement, care, prudence, determination and activity with which a person would reasonably be expected to perform under particular circumstances using, conserving and enhancing the community's resources so that ecological processes, on which life depends, are maintained and the total quality of life, now and in the future, can be enhanced industrial chemicals other than new industrial chemicals chemical that has an industrial use (whether or not it also has other non-industrial uses) primary consultative body for industry and government on NICNAS matters; among other things, reviews the utilisation of resources against NICNAS objectives under terms of reference set by the Minister co-operative venture of the World Health Organisation, International Labour Organisation and United Nations Environmental Programme formed with the objective of establishing the scientific basis for the assessment of the risk to human health and the environment from exposure to chemicals and to provide technical assistance to strengthen national capacities for the sound management of chemicals Commonwealth Industrial Chemicals (Notification and Assessment) Amendment (Low Regulatory Concern Chemicals) Act 2004 industrial chemicals which could qualify for reduced regulatory input on the basis of a definition of low risk or where regulatory input from elsewhere is sufficient to meet Australian requirements

Compliance case Concise International Chemical Assessment Document (CICAD) Consultancy

Commonwealth Industrial Chemicals (Notification and Assessment) Act1989 body which provides independent review of a wide range of administrative decisions made by the Australian Government and some non-government bodies formal review of procedures and practices in relation to obligations under the Act list of information about chemicals manufactured in and/or imported into Australia in quantities greater than or equal to 1000 tonnes

Administrative Appeals Tribunal (AAT)

Director Due diligence

Audit

Australian High Volume Industrial Chemicals (HVIC) list Australian Inventory of Chemical Substances (AICS)

Ecologically sustainable development (ESD) Existing chemicals Industrial chemical

list of chemical identity data maintained by NICNAS; legal device that distinguishes new from existing chemicals and lists all industrial chemicals in use in Australia between 1 January 1977 and 28 February 1990; includes new assessed chemicals since February 1990 and corrections as required articulated in section 10(1) of the Public Service Act 1999; provide the real basis and integrating element to the Australian Public Service, its professionalism, its integrity and its impartial and responsive service to the government of the day document describing the performance measures and data for NICNAS and how these relate to the NICNAS Strategic Plan list of chemicals selected for possible priority assessment, following a screening process, from chemicals nominated to NICNAS by industry, unions, the public and government

Australian Public Service (APS) Values

Industry Government Consultative Committee (IGCC) International Program on Chemical Safety (IPCS)

Business Plan for NICNAS Candidate list

the LRCC Act Chemical Gazette

government publication, published by NICNAS, under its Act, on the first Tuesday of each month, containing information regarding changes to NICNAS legislation, newly assessed chemicals and the Register of Chemical Introducers

Low regulatory concern chemicals (LRCC)

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Material Safety Data Sheet (MSDS)

document that describes the properties and uses of a substance, ie identity, chemical and physical properties, health hazard information, precautions for use and safe handling information agreement between parties that details mutual obligations in relation to services and/or the exchange of information (relating to industrial chemicals) industrial chemicals (including polymers) not listed on the Australian Inventory of Chemical Substances general area of concern in employment which spans the physiological and psychological needs and well-being of persons engaged in occupations, work-related trauma and death, the prevention of work-related trauma and death, the protection from, or from risk of, work-related trauma and death, and the rehabilitation and retraining of persons who have suffered workrelated trauma (CCH Occupational Health and Safety: Glossary, CCH International, 1992) part of the TGA Group of Regulators in the Australian Government Department of Health and Ageing and comprises NICNAS; public health risk assessment for veterinary chemicals, pesticides and other environmental chemicals; establishment of public health controls and standards, and the secretariat for, poisons scheduling; and compliance and monitoring of narcotics and other prohibited goods under UN Treaties and the Customs Act groups 30 member countries sharing a commitment to democratic government and the market economy; plays a prominent role in fostering good governance in the public service and in corporate activity; work covers economic and social issues from macroeconomics, to trade, education, development and science and innovation in the context of the PBS, a stated goal for achievement by an organisation in the context of the PBS, a set of activities and products that contribute to the achievement of a stated goal of an organisation (outcome); subject to performance standards document that details proposed allocation of resources to government outcomes by agencies within a portfolio; facilitates understanding of the proposed appropriations in Appropriation Bills and provides sufficient information, explanation and justification to enable parliament to understand the purpose of each outcome proposed in the Bills

Precursor chemicals

chemicals which are known to be used in the manufacture of illicit drugs chemical declared by the Minister for assessment under the NICNAS Existing Chemicals Program because its manufacture, handling, storage, use or disposal gives rise or may give rise to an adverse risk to human health and/or the environment the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, ratified by Australia on 20 May 2004 agreed minimal data set as determined by the OECD that allows for the establishment of the hazards of a specific industrial chemical document that spells out the types, levels and standards of service NICNAS clients can expect from the organisation, including details of complaint resolution procedures OECD Existing Chemicals Programme report of hazards of a specific industrial chemical based upon an evaluation of an OECD Screening Information Data Set the Stockholm Convention on Persistent Organic Pollutants (POPs), ratified by Australia on 20 May 2004 document that details the strategies NICNAS uses to achieve its stated goals and values for the three years 2002-05 is a unit of the Australian Department of Health and Ageing

Memorandum of Understanding (MOU) New chemicals

Priority existing chemical (PEC)

Rotterdam Convention

Occupational health and safety (OHS)

Screening Information Data Set (SIDS) Service Charter for NICNAS

Office of Chemical Safety (OCS)

SIDS Initial Assessment Report (SIAR) Stockholm Convention Strategic Plan for NICNAS Therapeutic Goods Administration (TGA) Tier 1, Tier 2, Tier 3

Organisation for Economic Cooperation and Development (OECD)

Outcome Output

NICNAS Registration levels, each relating to a range of total values for industrial chemicals introduced in a registration year (1 September – 31 August of following year), used in assessing registration charges

Portfolio Budget Statement (PBS)

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Acronyms and abbreviations
ACC ACCC ACCI ACCORD

DITR DPP EEO EIP EPA EPHC FOI FSANZ FTE HPV HSNO ICMM ILO INC IPCS LTD LVC MAN MSDS NAMW NDPSC NEPC NEPM

Australian Government Department of Industry, Tourism and Resources Director of Public Prosecutions Equal employment opportunity Early Introduction Permit (NICNAS) Environmental Protection Agency (US) Environment Protection and Heritage Council Freedom of Information Food Standards Australia New Zealand Full time equivalent High production volume (chemicals) (NICNAS) Hazardous Substances and New Organisms International Council on Mining and Metals International Labour Organisation Intergovernmental Negotiating Committee International Programme on Chemical Safety Limited notification category (NICNAS) Low Volume Chemical (NICNAS) Mutual Acceptance of Notification Material Safety Data Sheet Number-average molecular weight National Drugs and Poisons Schedule Committee National Environment Protection Council National Environment Protection Measures

Australian Crime Commission Australian Competition and Consumer Commission Australian Chamber of Commerce and Industry ACCORD Australasia - previously ACSPA, the Australian Consumer and Speciality Products Association Attorney General's Department Australian Harmonised Export Commodity Classification Australian Inventory of Chemical Substances Australian Institute of Occupational Hygienists Australian Paint Manufacturers' Federation Australian Pesticides and Veterinary Medicines Authority Australian Standard Chemical Abstracts Service Commercial Evaluation Category Community Engagement Forum Concise International Chemical Assessment Document Council of Australian Governments Chemicals and Plastics Leadership Group Chemicals Standards Sub-Committee of the NOHSC Database @ NICNAS Australian Government Department of the Environment and Heritage Australian Government Department of Health and Ageing

AGD AHECC AICS AIOH APMF APVMA AS CAS CEC CEF CICAD COAG CPLG CSSC DAN/D@N DEH DoHA

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NOHSC NOTS NZ ERMA OECD OGTR OHS PACIA PBFR PBDE PEC PFAS PFOA PFOS PIC

National Occupational Health and Safety Commission Notified Toxic Substances New Zealand Environmental Risk Management Authority Organisation for Economic Cooperation and Development Office of Gene Technology Regulator Occupational Health and Safety Plastics and Chemicals Industries Association Polybrominated Flame Retardant Polybrominated diphenylether Priority Existing Chemicals Perfluoroalkyl sulfonate Perfluorooctanoic acid Perfluorooctane sulfonate Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazadous Chemicals and Pesticides in International Trade Polymer of Low Concern notification (NICNAS) Privacy Officer Network Stockholm Convention on Persistent Organic Pollutants Royal Australian Chemical Institute Research, development or analytical (RD&A purposes) Review Steering Committee for NICNAS Existing Chemicals Program Surface Coatings Association of Australia SIDS Initial Assessment Meeting of the OECD

SIAR SIDS SLA STD SUSDP TAG TTMRA UNCED UNEP WHO

SIDS Initial Assessment Report of the OECD Screening Information Data Set Service level agreement Standard notification category (NICNAS) Standard for the Uniform Scheduling of Drugs and Poisons Technical Advisory Group Trans-Tasman Mutual Recognition Arrangement United Nations Conference on Environment and Development United Nations Environment Programme World Health Organisation

PLC PON POPs RACI RD&A RSC SCAA SIAM

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This year NICNAS has successfully implemented a raft of important reforms to the regulation of industrial chemicals which have led to significant benefits including reduced regulatory ‘red-tape’ and costs, better stakeholder engagement and enhanced confidence that best regulatory practice is in place. These achievements complement the significant performance achievement we delivered in virtually all the operational areas within NICNAS. However our high performance would not have been possible if it were not for the professional and committed staff at NICNAS and the contribution of our many partner agencies, stakeholders and individuals who worked with us. I greatly appreciate their input, their support, and their willingness to assist us in our regulatory and reform work. As part of our innovative Low Regulatory Concern Chemicals (LRCC) reform agenda, we fully implemented some 73 per cent of the key recommendations for regulatory reform initiatives. Importantly this saw the registration of all persons who introduce industrial chemicals into Australia, lifting the number of registered companies from previous years to 4505 (a 477 per cent increase). The introduction of a new Tier 1 NICNAS Registration was a considerable undertaking, involving NICNAS contacting a potential 16,000 persons who may import and/or manufacture industrial chemicals for commercial purposes. It is a testament to our open consultative processes and administrative efficiency that we achieved such high compliance levels and managed to respond quickly and effectively to nearly 9000 client enquiries on the matter. In addition we received very few (0.3 per cent of all people contacted) complaints about the regulatory costs. We also moved closer to achieving complete self-assessment by introducers in those categories identified as being of low regulatory concern. In particular the introduction of audited self-assessment for polymers of low concern and non-hazardous chemicals saw an impressive take up by industry heralding the more rapid introduction of safer chemicals with less cost and time for industry. Importantly, all audits of our self-assessment applications found industry to be in full compliance with the legislative requirements. This builds further confidence that we can successfully apply other LRCC reform concepts such as low hazard and low risk into the scheme next year. As part of the LRCC reform initiative we also introduced enhancements to the cooperative frameworks that are needed for the safe use of chemicals in Australia. Importantly, based on expert advice from our Community Engagement Forum, we developed the NICNAS Community Engagement Charter which outlines the policy and protocols that NICNAS commits to following when engaging all stakeholders.

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The Charter is a first for a chemical regulatory agency in Australia and will effectively guide NICNAS stakeholder engagement activities and provide a consistent and open framework to deliver our commitment to community right to know principles. The Charter was implemented in draft form to guide the review of the existing chemicals assessment program at NICNAS. This year we increasingly operated in wider cooperation with other agencies, as part of our commitment to a whole-of-government approach to industrial chemicals regulatory matters. With NICNAS being located in the Office of Chemical Safety within the Department of Health and Ageing, we have cooperated to deliver a ‘one-stop shop’ for the human health assessment and management of chemical safety in Australia. This year we have worked with the various areas of the Office of Chemical Safety to improve human health risk assessments and provide toxicological advice to other regulatory authorities on public health issues relating to a the broad range of industrial chemicals. In particular, together we provided technical policy advice on national and international chemicals negotiations and treaties. When the Rotterdam Convention came into force for Australia on 18 August 2004, NICNAS implemented new regulations and established an export control system for Australian industry trading in industrial chemicals listed within the Rotterdam Convention. This guarantees Australia continues to meet its chemical safety commitments internationally and supports industry in its compliance obligations. In this as in all our work, the protection of human health and the environment from potential harm from industrial chemicals – and the commitment to contribute to the environmentally sound use of such substances – has been foremost. Important emerging issues, including security aspects of chemicals and how best to assess the safety of nanotechnology, provided challenges in determining best regulatory control practices which still encourage innovation and legitimate use while protecting all Australians. I am pleased that we had the opportunity to participate as an equal, credible contributor to dialogue on these and other issues working on a whole-ofgovernment level. It is through such processes that best regulatory policy and practice can be achieved.

Future directions
The coming year will present a number of new challenges that we will meet with a growing team of expert staff and the strong networks we have built with other agencies and departments across government, industry and the wider community. Our focus during 2005-06 will continue to be to build better outcomes through enhanced engagement. NICNAS will continue to deliver its reform agenda in 2005-06 including finalising LRCC implementation, completing and implementing the recommendations relating to improvements in our existing chemicals assessment activities and enhancing our bilateral relationships with Canada and the USA. The reform initiative for all chemical importers and/or manufacturers to register with NICNAS has, for the first time, enabled all legitimate players in the Australian chemical industry to be identified. This is expected to provide essential information as well as potential control mechanisms for the Government’s counter terrorism activities. In addition, NICNAS’s information gathering and dissemination role will be utilised as part of ensuring a whole-of-government approach to the control and monitoring of chemicals that are precursors for illegal drug manufacture. This will provide intelligence for law enforcement agencies and a potential national access control mechanism. Key activities will include: • Implementation of the remaining 27 per cent of recommendations arising from the Low Regulatory Concern Chemicals initiative • Finalisation and implementation of the recommendations of the Existing Chemicals Review • Design and building of a tracking system for precursor chemicals that have the potential to be diverted for the manufacture of illicit drugs under contract for the Attorney General’s Department • Completion of a compendium of hazard profiles and rapid risk assessments for some 25 phthalates of concern • Implementation of online facility/functionality for NICNAS Registration • Implementation of online facility/functionality for NICNAS Annual Reporting • Enhancement of availability of Compliance systems training for Tier 1 registrants • Dissemination of the NICNAS Community Engagement Charter and Community Engagement Forum resources • Launch of an updated, streamlined new NICNAS website In July 2005, NICNAS will celebrate its fifteenth year of operation.

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Key achievements 2004-05
Assessment
• Timeframe targets for issuing certificate assessments and permits exceeded: - 200 assessment certificates completed, 98 per cent within timeframe (target: 95 per cent) - 106 permits completed, 100 per cent within timeframe (target: 95 per cent) No appeals NICNAS’s recommendations for 196 of 200 (98 per cent) New Chemicals assessments (target 95 per cent) accepted in full by industry 100 per cent of NICNAS’s recommendations for hazard classification accepted by NOHSC Eight chemicals declared for priority review Draft risk assessment reports published to time, quality and to target: - Two Priority Existing Chemicals (formaldehyde and tris 2,3 dibromopropyl phosphate) - One Secondary Notification Assessment (Polymer in E 7581) 40 other assessments completed (target: 10) including: - Hazard assessments on 25 phthalates - Information sheets (Options for Disposal of Perfluorooctane Sulfonate – PFOS, Short-Chain Chlorinated Paraffins in Metal Working Fluids, Current Australian Use and Regulatory Activities on Polybrominated Flame Retardants) - One update and one alert (Perfluorooctanoic Acid and its Derivatives) - Five public health assessments for poison scheduling 59 international chemical assessments peer reviewed and 102 assessments agreed to, as part contribution to international harmonisation commitment

Treaties
• Rotterdam Convention and Stockholm Convention came into force for Australia on 18 August 2004

Compliance
• • • • • No appeals lodged against any decisions of the Director, NICNAS 22 finalised investigations of breaches relating to the introduction of industrial chemicals 251 finalised investigations relating to breaches of Registration requirements NICNAS enforcement policy guidance published Tier 1 registrants, customs brokers and industry training

• • • • •

Communication
• • Establishing a Case for Confidential Listing of Chemicals on the Australian Inventory of Chemical Substances guidelines finalised Publications released included: - 3 NICNAS Matters - 13 Chemical Gazettes - 234 Chemical assessments - 6 Information sheets/alerts 594,614 user sessions hosted on NICNAS website (compared to 445,619 in 2003-04 – an increase of 34 per cent) Service Charter performance targets achieved, with high industry client satisfaction

• •

Reform
• Key regulatory reform initiatives implemented: - 73 per cent of LRCC recommendations implemented - Full implementation of Tier 1 - New exemptions, Self-assessment provisions and AICS annotation - Auditing, annual reporting Existing Chemicals Program Review recommenced OECD New Chemicals Task Force pilot phase for the Parallel Process begins

• •

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Role and functions
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) aids in the protection of workers, the public and the environment from the harmful effects of a wide range of industrial chemicals including plastics, paints, inks, surface coatings, cosmetics and other consumer chemicals. NICNAS was established in July 1990 under Australian Government legislation - the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act). The Scheme aims to ensure the safe use of chemicals by making risk assessment and safety information on chemicals and their potential occupational health and safety (OHS), public health and/or environmental risks widely available to workers, the public, industry and other state, territory and Australian Government agencies. NICNAS scientific risk assessments support the wide range of chemicals management legislation for the protection of human health and the environment from the adverse effects of chemicals. NICNAS assesses industrial chemicals that are new to Australia for their health and environmental effects before they are used or released to the environment. NICNAS also assesses those chemicals that are already in use in Australia (known as 'existing chemicals') on a priority basis in response to specific concerns about potential health and/or environmental effects.

Organisational structure
Figure 1 provides an overview of the organisational structure of NICNAS. NICNAS is a statutory scheme. The Director, NICNAS is a statutory office holder and has specific functions and powers under the Act. In the exercise of these functions, the Director is directly responsible to the Minister through the Parliamentary Secretary to the Minister for Health and Ageing. NICNAS is located within the Office of Chemical Safety (OCS) in the Therapeutic Goods Administration (TGA) Group of Regulators of the Australian Government Department of Health and Ageing (DoHA). NICNAS's location provides for an ongoing, consistent approach to the protection of human health from the effects of industrial chemicals. In 2004-05 NICNAS continued to build on its team-based organisational structure within the OCS, further utilising the considerable synergies that co-location with other chemical regulatory functions within DoHA has brought.

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Figure 1 NICNAS Organisational Chart

Regulatory framework linkages and cooperative arrangements
NICNAS operates within a whole-of-government framework for the regulation of chemicals. This framework consists of five assessment/ registration schemes that regulate industrial chemicals, medicines and medical devices, food and food additives, gene technology and pesticides and veterinary medicines with the scope of each scheme defined by legislation. To minimise duplication of regulatory effort and unnecessary regulatory burdens on industry, these schemes operate in a complementary manner to deliver the health and safety of the Australian people and their environment from the use of chemicals. NICNAS regulates industrial chemicals, including cosmetics and domestic chemicals and its risk assessments are undertaken in partnership with the Australian Government Department of the Environment and Heritage (DEH). Assessment comprises a human health and environmental risk assessment and, where relevant, recommendations for risk mitigation. To avoid duplication of assessment activities, NICNAS assessments are available to other Australian Government and state/territory public health, OHS and environmental agencies. NICNAS also provides technical services to other Australian Government departments. The Office of Chemical Safety provides a ’one-stop shop‘ for human health risk assessment for chemicals at the Australian Government level. The NICNAS human health assessment includes a public health assessment and an occupational health and safety assessment. Public safety is achieved in part through the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), adopted by state/territory public health legislation. The secretariat for the National Drugs and Poison Scheduling Committee is located within the OCS, further enhancing regulatory linkages. Occupational health and safety assessment and ensuing recommendations are consistent with the national OHS framework, namely the National Occupational Health and Safety Commission (NOHSC) Model Regulations for the Control of Workplace Hazardous Substances. This includes the application of the NOHSC hazard classification and labelling and Material Safety Data Sheet (MSDS) codes to all NICNAS assessments. Additionally, NICNAS classifies chemicals in accordance with the United Nations Globally Harmonised System of Classification and Labelling of Chemicals (GHS) as part of contributing to the National Situational Analysis, in preparing for the Australian Government's decision on how it will implement the GHS.

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State/territory laws govern the supply and downstream control of industrial chemical use. Health policy and practice is applied through the location of NICNAS within the Department of Health and Ageing. The NICNAS-NOHSC Memorandum of Understanding facilitates the application of OHS policy to NICNAS assessments. Environmental policy is applied to industrial chemicals assessments through the partnership arrangement with the DEH that allows for the provision of scientific/technical and policy advice on environmental protection in relation to chemical safety. NICNAS is linked to several activities of national significance including the Chemicals and Plastics Action Agenda, the Environment Protection Heritage Council's (EPHC) development of a National Environmental Risk Management Framework for Chemicals and the Australian Crime Commission's monitoring program for precursor chemicals associated with illicit drug manufacture, as well as providing technical support for certain counter-terrorism activities. NICNAS contracted corporate services on a fee-for-service basis from both the TGA and the DoHA in 2004-05. In addition, library services were purchased on a fee-for-service basis from NOHSC.

Figure 2 NICNAS outcome/output statements

Outcome and output framework
NICNAS's mission is to be recognised as the leading national authority for the scientific assessment and management of risks to people and the environment associated with the use of industrial chemicals. NICNAS works to encourage the safe and sustainable use of industrial chemicals. NICNAS pursues its goal of safe and sustainable chemical use through the scientific assessment of chemical risk and by making recommendations for controlling these risks. NICNAS assessment information is made widely available and assists state and territory OHS, public health and environmental agencies in regulating the sale, control of use, release and disposal of industrial chemicals. NICNAS assessments also provide risk and safety information to industry, workers and the public to promote greater awareness of the dangers of chemicals and how to use them safely. NICNAS's activities are presented in Outcome 1 within the DoHA Portfolio Budget Statement (PBS) outcome/output structure for 2004-05. The relationship between the NICNAS Outcome and contributing Output is shown in Figure 2. The performance measures used for accounting against outputs and outcomes are shown in Table 1. Total Price of Outputs:

Estimate ($m)
$6.218

Actual ($m)
$5.498 $5.378

Departmental Outputs Appropriation: $6.098

Note: The above appropriation is cost recovered funds. The additional funds associated with the total price come from the Australian Government and are applied specifically to cover 50 per cent of the costs of NICNAS's compliance program.

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Table 1 NICNAS performance information against output
OUTPUT PBS PERFORMANCE MEASURES

Effective Regulation through:
• pre-introduction assessment of new industrial chemicals and review of priority existing chemicals (including for OHS and Public health and environmental risk); and

Quality:
• evaluations and appeals of decisions of applications for industrial chemicals are made within legislative and other agreed timeframes • number of NICNAS recommendations adopted

Quantity:
• timely production of quarterly and annual reports • number of assessments for new chemicals • number of existing chemical reviews (contributing to a target rate of 50 chemicals over a 3-year period) • provision of information.

Quality: • high level stakeholder
satisfaction with relevance, quality and timeliness of information and education services

Quantity:
• number of publications circulated including 3 issues NICNAS matters, 12 issues NICNAS Chemical Gazette • number of chemical assessments (new and existing chemicals) • growth in internet site user sessions

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Corporate governance
The Director is accountable for the overall legal and financial performance of the Scheme and ensures that the objectives of the Act are met. The Secretary of the Department of Health and Ageing (DoHA) provides staff to the Director, NICNAS to carry out the functions of the Act under Section 91(3) of the Act. The employment framework for NICNAS staff is the Public Service Act 1999. The DoHA Certified Agreement 2004-07 and the Department's governance policies and practices cover staff. These include the establishment and maintenance of appropriate ethical standards under the Australian Public Service (APS) Values and Code of Conduct, compliance with Australian Government Freedom of Information (FOI), Privacy and Occupational Health and Safety legislation, the Australian Government Disability Strategy and workplace diversity policy. The operations of the Scheme are governed by the Industrial Chemicals (Notification and Assessment ) Act 1989 (the Act) and a number of corporate documents that facilitate transparent, sustainable and open delivery of the regulation of industrial chemicals. NICNAS's cost recovery arrangements and performance targets are detailed in the DoHA PBS. The NICNAS PBS are supported by the NICNAS Strategic Corporate Plan 2002-05, the NICNAS Operational Plan 2004-05 and the NICNAS Service Charter 2002-05. The Act stipulates mandatory performance standards such as assessment timeframes, public reporting of prescribed information and annual reporting requirements. Performance reporting against the Act, corporate plan and operational plan is undertaken quarterly and is detailed in the Operational Performance section of this report, as is the outcome of the annual customer survey of key stakeholders. Compliance with mandatory reporting requirements under the Act is detailed at Appendix 01. The financial framework for the governance of NICNAS is established in the Financial Management and Accountability Act 1997 (the FMA Act). Integrity in financial reporting is through internal audit arrangements via a Service Level Agreement (SLA) with the DoHA. These are reported in the DoHA Annual Report 2004-05 where NICNAS's performance against governance policies and practices can also be found. NICNAS internal policies and practices also cover the physical security and protection of commercial-in-confidence information it receives from industry in support of chemical notifications.

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In 2004-05, NICNAS received two formal complaints on its operations as compared to two in 2003-04, one in 2002-03, seven in 2001-02 and two in 2000-01. One complaint related to the publication of a report on the NICNAS website that contained reference to confidential business information. The other related to the provision of an assessment report containing third party data to the notifier. NICNAS engaged the services of an independent consultant, Tress Cox Lawyers, to investigate the first complaint and a breach was found to have occurred. As a result we have made significant changes and improvements to NICNAS's internal procedures that were recommended. The second complaint was found to be baseless. However as part of the investigation of the matter, a number of procedural improvements were identified and implemented. Both complaints were resolved to the satisfaction of the complainants. Three non-statutory bodies provide advice to the Director on the NICNAS budgetary process, community information needs and the operation of the Scheme. These are: the NICNAS Industry Government Consultative Committee (IGCC), the NICNAS Community Engagement Forum (CEF) and the NICNAS/States and Territories Memorandum of Understanding (MOU) Group. These bodies remained critical to NICNAS's success in continuing to build effective partnerships to deliver whole-of-government achievement. By having well informed and actively engaged stakeholders, NICNAS was greatly assisted in meeting all its key targets in 2004-05.

Industry Government Consultative Committee
Industry Government Consultative Committee Seated (L to R): Mr Nick Munafo (PACIA), Ms Sylvia Kidziak AM (ACCI), Mr Tom Fisher (NOHSC) Standing (L to R): Mr Nick Miller (Secretariat, NICNAS), Mr Mark Hyman (DEH), Mr Geoff MacAlpine (ACCORD), Dr Margaret Hartley (Chair, NICNAS), Mr Wil Antioch (DITR), Ms Bronwyn Capanna (ACCORD), Mr Michael Hambrook (APMF), Ms Margaret Donnan (PACIA) Absent: Mr Shane Baker (DITR), Mr Terry Slater (TGA)

Appointed by the Minister, the IGCC oversees the efficient and effective utilisation of NICNAS resources and the Scheme's operational performance. IGCC membership, terms of reference and meeting details for 2004-05 are at Appendix 02. The IGCC met two times during 2004-05 with the focus of activities on the implementation of key reform initiatives, detailed in the Reform Initiatives section of this report. The Committee also determined the level of NICNAS fees and charges for 2005-06 and endorsed the NICNAS Operational Plan 2005-06 and NICNAS 2005-06 Budget. Other key outcomes from the IGCC meetings in 2004-05 were: • the establishment of a NICNAS-Industry Working Group to consider and report to the Director, NICNAS on the re-engineering of certain New Chemicals administrative and other processes to address the trend noted by NICNAS of a reduced application quality by industry • a report on the substantial progress being made in the review of the Existing Chemicals Program, and • the sustained high-level of performance as noted in quarterly performance reports for NICNAS, where overall performance targets were reported to have been met or exceeded. IGCC members evaluated the efficiency and performance of the IGCC process and feedback indicated that papers were well prepared and received on time, and that the meetings were well focused, with plenty of time for discussion and listening, leading to workable solutions.

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Community Engagement Forum
Community Engagement Forum (L to R): Dr Bro SheffieldBrotherton (environmental interests), Ms Pamela Grassick and Ms Renata Musolino (worker health and safety interests), Assoc Prof Christopher Winder (public health interests), Dr Wafa El-Adhami (Acting Director, NICNAS), Mr Griffin D'Costa (Secretariat, NICNAS), Ms Liz Hanna (public health interests) Absent: Ms Jane Bremmer (environmental interests), Dr Margaret Hartley (Chair - Director, NICNAS) States and Territories MOU Group (L to R): Mr Greg Balka (Victoria), Mr Bob Graf (NICNAS), Dr Joe Crea (South Australia), Mr Ian Graham (Tasmania), Dr Usha St George (New South Wales), Dr Jeff Langley (Western Australia), Dr Roshini Jayewardene (Chair, NICNAS), Dr David Grantham (Queensland), Mr Peter Haynes (representing NOHSC observer), Lewis Norman (Secretariat, NICNAS).

States and Territories Memorandum of Understanding Group

The establishment of the Community Engagement Forum (CEF) arose from NICNAS's low regulatory concern chemicals (LRCC) reform initiative. The LRCC Task Force recognised the advantages to NICNAS of maintaining an ongoing dialogue with the public through the establishment of a formal consultative mechanism and recommended the establishment of a community-based forum. The Forum was established to assist the NICNAS office improve public access to chemical safety information, address aspects of the community's right to know in relation to the control and use of industrial chemicals and to enable interested people, organisations and key stakeholders to have input into policy and decision-making processes. The Parliamentary Secretary appoints members to the CEF. Full membership lists, terms of reference and meeting details for 2004-05 are at Appendix 02. The focus of activities this year was on finalising the Community Engagement Charter. The CEF also supported NICNAS in a range of initiatives including reviewing LRCC implementation issues, the review of the Existing Chemical Program, and providing membership to technical working groups for review and reform programs.

Absent: Steve Caldwell (NT), Mark Brown (ACT), Dr Wafa El-Adhami (OCS Observer), Dr Graeme Barden (DEH - Observer).

The NICNAS States and Territories Memorandum of Understanding (MOU) Group was established to facilitate the exchange of important information relating to chemical safety and management in Australia between the various levels of government. In 2004-05 the MOU group continued to exemplify the ongoing cooperation that exists between NICNAS and other government agencies, and it remains a key strategic alliance through which enhanced compliance is achieved. The MOU provides an effective interface through which compliance related concerns are communicated and workshopped. Representatives from the states and territories liase with other agencies in their respective jurisdictions to assist in the integration of NICNAS recommendations into health, safety and environmental controls applying to chemical usage. The group also provides a mechanism to ensure NICNAS responds to the needs of state and territory agencies responsible for the control of industrial chemicals. The issue of exchanging confidential/exempt information between NICNAS and the Australian Government, state and territory authorities was addressed during 2004-05 as part of the review of the MOU group's efficiency and effectiveness. In response, NICNAS drafted Guidelines for the exchange of confidential/exempt information between NICNAS and the States and Territories. These guidelines outline appropriate arrangements between the parties in relation to the exchange of exempt and confidential information under the Act, and the storage and maintenance of the information. The guidelines will be finalised in 2005-06.

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The MOU group also provided a forum for consultation on reform programs and other NICNAS activities, and in 2004-05 provided initial comments on NICNAS initiatives such as the implementation of the Rotterdam Convention, amendments to the Industrial Chemicals (Notification and Assessment) Act 1989, and the Review of the Existing Chemicals Program. Details of the group's two meetings for 2004-05, membership (which includes representatives drawn from the OHS authorities of the various states and territories, NOHSC, DEH, OCS and NICNAS) and terms of reference are at Appendix 02.

Safety at work, our first priority and OHS Legislation for Commonwealth Employees (see Appendix 15 for details). OHS information – comprising a short OHS presentation followed by a tour of the premises – was provided to ten new staff members during the year. All staff ergonomic requirements were met, including adjustments to chair and monitor heights and distances, the supply of wrist rests, eye tests and other OHS needs.

Equity performance
NICNAS's mandate - to provide a national notification and assessment scheme to protect the health of the public, workers and the environment from the harmful effect of industrial chemicals - includes provision of information on chemicals to workers, industry, the community and other regulatory agencies. Chemical safety is promoted through a variety of information items available free of charge from NICNAS and also available on the website. The Act requires the Director to publish all assessment reports prepared by NICNAS, which also publishes brochures, safety information sheets, chemical alerts and guidance notes on industrial chemicals. These publications generally target the needs of the end user. Public information on industrial chemicals introduced into Australia is provided through the annual publication of specific information as required under the Act. This includes new chemicals introduced under exemption categories, current and previous Priority Existing Chemicals, chemicals that require secondary notification and those that are the subject of low volume permits. NICNAS was fully compliant with the Act in providing public information in 2004-05. The Industrial Chemicals (Notification and Assessment) Amendment (Low Regulatory Concern Chemicals) Act 2004 introduced several mechanisms through which information on industrial chemicals and their introducers will be made public. For the first time since the inception of the Scheme, the regulator will engage with the broader industrial chemicals sector via mandatory NICNAS Registration of all introducers. In addition, all new industrial chemicals introduced under exemptions must be reported to NICNAS annually. This will become operational next year, with the first reports due on 28 September 2005. Publication of statistics on this information further enhances the transparency of industrial chemicals regulation.

External scrutiny
Administrative Appeals Tribunal
The Act specifies those decisions of the Minister or the Director, NICNAS that may be taken before the Administrative Appeals Tribunal (AAT). Appealable matters include decisions on confidentiality, inventory listing, new and existing chemicals assessments and NICNAS Registration decisions. No applications were made to the AAT during 2004-05 (as in 2003-04 and 2002-03, and compared to four in 2001-02). The total number of appeals against the Director's decisions since the introduction of the Scheme in 1990 is seven, with five withdrawn and two found in favour of NICNAS.

Management of Human Resources
At 30 June 2005, NICNAS employed 42 full-time equivalent (FTE) staff. Of these, 30 are permanent employees and 12 are non-ongoing staff. The staffing profile for NICNAS is shown at Appendix 03, where training and development activities for NICNAS staff are also reported. A total of 171.25 days of formal training (approximately 4.7 days for each person, compared to 6.0 in 2003-04) were undertaken in the year, including orientation and induction training for new staff. Compulsory training in awareness of Australian Public Service (APS) values continued for all new staff and was offered to all existing staff. New staff also undertook compulsory customer service training. NICNAS conducted four 'in house' seminars during 2004-05.

Occupational Health and Safety (OHS)
Three OHS inspections were undertaken at the Marrickville office during 2004-05, with no major health or safety issues identified within the premises. Two OHS seminars were presented to staff during the year:

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NICNAS utilises its existing advisory committee structure as a conduit for information dissemination to the chemicals industry, the community and Australian Government and state/territory agencies. In addition, NICNAS routinely liaises with industry and industry associations, employer and worker representatives and the public through the assessment process. Extensive public consultation is undertaken on changes affecting the Scheme. Anyone (including the public) can nominate existing chemicals of health and/or environmental concern to NICNAS for priority review. Any member of industry or the community can appeal the Director's decisions under the Act through the AAT process.

Table 2 NICNAS financial accrual overview 2004-05
REVENUE $'000

Assessments NICNAS Registration Publication sales, industry education & research projects Interest Government subsidy
Expenditure

1,795 4,836 50 132 120

Financial performance
NICNAS operates on a cost recovery basis. Cost recovery is achieved in two ways: NICNAS Registration charges and fees, and fees and administrative charges for new chemical assessments. In 2004-05 NICNAS Registration monies funded the assessment of existing chemicals, client awareness and education activities, 78 per cent of the costs of compliance activities and the administration of Registration itself. The remaining 22 per cent of compliance activities were funded by an appropriation from the Australian Government under cost recovery policy arrangements. NICNAS's financial services are purchased through a service level agreement from the TGA. These administrative arrangements include the provision of fraud control measures, disability and purchasing strategies, and the management of human resources. Total funds cost recovered from industry in 2004-05 were $6,812,744. At 30 June 2005, the cash at bank total of $1,461,734 resulting from cost recovered funds was available for carryover into 2005-06. The net surplus this year mainly resulted from a significant increase in the number of NICNAS registrations following the introduction of Tier 1 Registration in September 2004. Additionally, cost savings were achieved by efficiently managing the implementation of Tier 1 Registration. The surplus was discussed with the Ministerial appointed NICNAS IGCC who noted that the majority of these funds are committed to ensure the wide range of legislated amendments to the Act can be fully implemented in 2005-06 without increasing NICNAS Registration fees and charges. Table 2 provides a summary of NICNAS's financial performance (accrual) for the year. Auditing of NICNAS's financial performance is undertaken as part of the TGA-wide auditing process, and is included in the financial performance reporting in the DoHA Annual Report 2004-05.

Salaries Administration Indirect overheads
Surplus / (Deficit)

3,137 749 1,612
1,435

Ecologically Sustainable Development and Environmental Performance
NICNAS operates its chemical risk assessment activities to be consistent with the Government's policy parameters of ecologically sustainable development (ESD) as outlined in section 3A of the Environment Protection and Biodiversity Conservation Act 1999. NICNAS ensures that ESD policy is applied consistently in the assessment of environmental risk for individual chemicals through cooperative partnership arrangements with the DEH, who apply scientific principles and related ESD policy in environmental risk assessment activities. Details of how the principles and practices of ESD are applied to NICNAS risk assessment practice are found at Appendix 06.

NICNAS Registration
Please see Reform Initiatives section of this report.

Consultancies, Commissions and Discretionary Grants
NICNAS did not make any discretionary grants for 2004-05. Please see Appendix 04 for consultancies commissioned.

Advertising and market research
Media advertising organisations used by NICNAS in 2004-05 are listed at Appendix 05.

Freedom of information
NICNAS received no Freedom of Information requests in 2004-05.

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NICNAS Registration
Since 1 September 2004, legislation under the Industrial Chemicals (Notification and Assessment) Amendment (Low Regulatory Concern Chemicals) Act 2004 (the LRCC Act) has required all importers and manufacturers of industrial chemicals for commercial purposes (including those who introduce chemicals valued at between $1 and $499,999) in Australia to register with NICNAS. The Registration Year continues to run from 1 September to 31 August the following year. The rollout of the new NICNAS Registration regime commenced early in the 2004-05 year with the mail out of letters to over 16,000 companies whose names were obtained from data held by the Australia Taxation Office (ATO) and/or the Australian Customs Service and/or NICNAS. As a direct result of the mail out and the subsequent period of interaction, 4505 companies were listed in the Register of Industrial Chemical Introducers at 30 June 2005. This represents a 477 per cent increase in registered companies from 2003-04, an increase resulting directly from the introduction of the Tier 1 Registration level under the LRCC Act. Table 3 provides the numbers of registrants at each of the three NICNAS Registration Tier levels in 2004-05, while Figure 3 shows the number of registrants by level over the seven years that NICNAS has been operating the company registration system.

Table 3 Number of registrants by Tier level in 2004-05
TIER LEVEL VALUE OF INDUSTRIAL CHEMICALS INTRODUCED NUMBER OF COMPANIES REGISTERED PROPORTION OF ALL NICNAS REGISTRATIONS
(AS PERCENTAGE)

Tier 1 Tier 2 Tier 3
Total

between $1 and $4,999,999 between $500,000 and $5,000,000 more than $5,000,000

3492 729 284
4505

77.5% 16.2% 6.3%

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Figure 3 Number of registrants by level over the seven years since the registration system was introduced

Figure 4 Number of NICNAS Registration enquiries

One spin-off from the intensive rollout of the Tier 1 Registration awareness program was a marked (29.3 per cent compared to 2003-04) increase in the number of Tier 2 and Tier 3 registrants. NICNAS's enhanced compliance audit program (reported in the Compliance section of this report) also contributed to this increase. Following the initial mail out, NICNAS provided an industry training program in each capital city for small to medium enterprises who had registered at Tier 1. Training for customs brokers who assist industry in both the import and export of materials including industrial chemicals, was also conducted. As part of the introduction of Tier 1 Registration, NICNAS used a call centre facility to handle anticipated follow-up enquiries. These, and the number of written enquiries, are detailed in Figure 4.

Seven letters to the Minister and 44 letters of complaint to the Director, NICNAS were received in relation to the introduction of Tier 1 Registration. Most of this correspondence related to the costs associated with registration at Tier 1 ($353). Late in the year, a Registration Performance Survey was initiated to measure the performance of NICNAS's implementation of Tier 1 Registration. Four hundred organisations which had little or no previous contact with NICNAS prior to 2004-05, were surveyed. For the purposes of this survey, industry contact with NICNAS was defined as registering as a Tier 1 organisation and/or clarifying registration related issues in the period 1 July 2004 to 30 June 2005. One hundred and forty organisations responded to the survey: • 26 per cent of respondents indicated they had further contact with NICNAS since the initial mail-out informing them of their potential need for registration • only 16 per cent of respondents had used the website, however 58 per cent indicated a desire to complete NICNAS Registration online with a further 24 per cent uncertain, and • 93 per cent of respondents were satisfied that NICNAS had fulfilled its obligations under the NICNAS Service Charter.

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Overall, the survey gave positive feedback about the professionalism with which NICNAS staff interacted with industry clients. The survey responses also provided useful suggestions for further improvement, which will be implemented by NICNAS in the coming year. Further details of NICNAS's Registration compliance program and audits of companies registered with NICNAS, are given in the Compliance section of this report.

Audited self-assessment of non-hazardous chemicals
Interim arrangements for the audited self-assessment of Polymers of Low Concern (SAPLCs) were extended to other non-hazardous chemicals, including an audited self-assessed assessment certificate for non-hazardous chemicals and polymers notified as a standard or limited notification. New fees for self-assessment applications were introduced in December 2004 with a 40 per cent reduction in fees operating in all self-assessment categories. Further, self-assessed PLCs now have a 28-day completion timeframe compared with the 90-day time period previously. In 2004-05 a total of 52 PLC self-assessment applications were received by NICNAS, of which six were not accepted for self-assessment, and the applicant withdrew another. The successful application of 39 SAPLCs represented savings to industry of $49,000 in application fees alone. Two standard certificate self-assessment applications were submitted to NICNAS, however they were not accepted as they failed to meet the criteria. Further savings occur with the reduced assessment timeframe, with industry's time to market enhanced by two thirds.

Implementation of other initiatives for chemicals of low regulatory concern
The LRCC Act came into effect on 9 August 2004, introducing a variety of measures aimed at providing more options for introducers of new industrial chemicals while including safeguards to maintain health and environmental standards. The specific measures implemented during 2004-05 are detailed below with a scorecard of the LRCC implementation timetable detailed at Appendix 07.

A new range of exemptions
New LRCC exemptions introduced in 2004-05 include: • a transhipment exemption for chemicals off-loaded and unopened at an Australian port or airport for a short period (30 days) and kept in control of Customs before leaving Australia • an increase in the volume to 100 kg per year (formerly 10 kg per year) for the exemption of low risk chemicals • an exemption for non-hazardous cosmetic ingredients introduced in products at one (1) per cent or less, and • an increase in the volume to 100 kg per year (formerly 50 kg per year) for the exemption of chemicals introduced for research, development and analysis. The extent of industry use of these exemptions will be measured when mandatory annual reporting becomes operational on 28 September 2005.

Electronic templates for notifiers
By developing electronic templates for use by industry, NICNAS passed savings of about $55,000 directly to industry for 2004-05. Self-assessment templates and guidance material developed for PLCs and non-hazardous chemicals as part of the LRCC reform initiative are now available on the NICNAS website. Rebates are available to applicants who submit their notification of a new chemical electronically using these templates. During the year, 43 STD and LTD notifications were submitted using the electronic template, leading to significant timesaving in NICNAS's assessment process.

Existing Chemicals Program Review
NICNAS's Existing Chemicals Program is being reviewed to enhance its flexibility and responsiveness to the needs and concerns of all stakeholders. The review was initially deferred to allow development of a community right-to-know charter with the CEF to guide NICNAS's review processes. The review recommenced in December 2004 when the NICNAS Community Engagement Charter was complete.

AICS amendments
The Director, NICNAS can now put the particulars of a chemical, including any conditions to which it is subject, on AICS, making these conditions enforceable under the Act. Furthermore, applicants of new industrial chemicals under an assessment certificate may now request that the chemical be added to AICS immediately after the assessment certificate is received from NICNAS. In 2004-05, 16 chemicals were immediately added to the AICS under this new provision.

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The 10-member Existing Chemicals Program Review Steering Committee (RSC) includes representatives from the community, worker safety, industry and government, and has a role to set a framework for the review and oversees its activities. Details of the committee are given at Appendix 02. It included three technical working groups to deal with specific aspects of the review. The groups meet sequentially with the following tasks: • Group 1: detection and identification of hazards, risks and concerns • Group 2: processes to address detected/identified hazards, risks and concerns • Group 3: development of regulatory framework to ensure best practice regulation of existing chemicals, including national implementation of NICNAS guidance and advice on safe use, elimination and risk reduction. Focusing on the communication of chemical concerns to NICNAS and mechanisms available to the various stakeholders, Group 1 met three times and delivered its report - which included recommendations to the RSC and issues for consideration by the other groups - in May 2005. Group 2 is focusing on how NICNAS can best respond to chemical concerns raised by stakeholders. The review is expected to be completed in March 2006 and will be fully implemented in 2006-07.

Permit amendments
The LRCC Act provides for new permit categories for low hazard and low risk chemicals, including a controlled use permit for chemicals used in a highly controlled environment. Technical working parties began developing low hazard and low risk criteria to give effect to the new range of permits in 2005-06. Permits can be renewed at a reduced price provided the circumstances of introduction and use are maintained. The global restriction on low volume (LVC) permits was also removed, allowing two or more companies to import the same chemical under permit, and a total of 30 LVC permit amendments were issued in 2004-05, five of which were joint permits issued to two or more companies.

Science Forum
Science Forum III The Practice of Human Health Risk Assessment in Australia was held in Canberra in July 2004. Established as part of the response to the Chemicals and Plastics Action Agenda call for enhanced mechanisms for best practice risk assessment, the Forum focuses on the human health risk assessment of chemicals. Approximately 100 people (including 30 NICNAS staff) attended the Forum, which was sponsored by the Population Health Division within the DoHA.

New definitions
Definitions have been updated to accommodate amendments and maintain consistency with other legislation. Notably, the definition of 'cosmetic' was amended to align it with the definition of 'cosmetic product' in the Trade Practices (Consumer Product Information Standards) (Cosmetic) Regulations 1991.

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Australia ratified two international conventions on 20 May 2004: the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, and the Stockholm Convention on Persistent Organic Pollutants (POPs). NICNAS undertook implementation activity to ensure Australia met its obligations under both treaties in 2004-05.

Rotterdam Convention
The Rotterdam Convention's objective is to promote shared responsibility and cooperative efforts among Parties in the international trade of certain hazardous pesticides and industrial chemicals in order to protect human health and the environment from potential harm and to contribute to their environmentally sound use, by facilitating information exchange about their characteristics. The obligations of the Convention entered into force for Australia on 18 August 2004, and as a Party to the Convention, Australia has to take administrative or legislative measures to implement its obligations. In order to implement the obligations of the Convention for the eleven industrial chemicals listed in Annex III of the Convention, Regulation 11C of the Industrial Chemicals (Notification and Assessment) Regulations was introduced effective from 5 August 2004. Regulation 11C controls the import and export of PIC listed industrial chemicals. Two additional industrial chemicals, tetra ethyl and tetra methyl lead, were added to the Convention this year, effective 1 February 2005. Measures were taken by NICNAS to ensure that the chemicals are not exported by Australian industry to countries that do not wish to receive them. Australia also has to provide an importing country response for these two chemicals. Australia had notified chrysotile to the Convention in January 2004 using the NICNAS Priority Existing Chemical Assessment for chrysotile (1999) as the documented risk assessment. At its first meeting in February 2005, the PIC Chemical Review Committee considered the Australian notification of chrysotile. The notification was accepted as meeting the criteria set out under the Convention. Processes will continue under the Convention to list chrysotile in 2006.

Monitoring Rotterdam Convention compliance
During the year NICNAS put in place administrative and legislative measures to ensure that Australia meets its obligation under the Convention including amendments to the Industrial Chemicals (Notification and Assessment) Regulations 1990. The amendments ensured controls for the importation of hexabromobiphenyl and the export of PIC listed industrial chemicals: hexabromobiphenyl, octabromobiphenyl, decabromobiphenyl,

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polychlorinated biphenyl and polychlorinated terphenyl. Octabromobiphenyl, decabromobiphenyl and tris (2,3- dibromopropyl) phosphate had been declared as priority existing chemicals on 6 July 2004. Industry web guidance and export forms for issuing export authorisation were developed and published on the NICNAS website. No export applications were submitted to NICNAS during 2004-05. The border control system has proven to be effective as NICNAS received 45 export advices from the Australian Customs Service during the year which were checked and cleared as the goods were not related to the PIC listed chemicals. Five PIC chemicals are included in the current monitoring regime. Required preliminary research and analysis work based on export and import data for those new PIC chemicals under relevant Australian Harmonised Export Commodity Classification (AHECC) codes was conducted.

The Convention covers control measures on 12 POPs identified for international action because of their persistence, bioaccumulation, longrange dispersion and toxicity. As a Party to the Convention, Australia has to ensure that when conducting assessment of new and existing industrial chemicals, criteria listed in the Convention are taken into consideration. Chemical companies may have to provide additional data to NICNAS to enable screening of industrial chemicals new to Australia with POPs characteristics.

Monitoring Stockholm Convention compliance
NICNAS has put additional screening measures in the assessment activity to identify potential POPs chemicals. Additional data in accordance with the Information Requirements and Screening Criteria of Annex D of the Convention may be requested, in particular, information relating to persistence, bioaccumulation and toxicity ie half-life of the chemical in both water and in soil, or other evidence of its persistence. Given that a POP must satisfy all three of these criteria it is envisaged that a tiered screening approach would be implemented, whereby only if a chemical meets one POPs criterion would information have to be provided to screen for other criteria. Guidance to industry on how to comply with the data requirements on persistent chemicals is available on the NICNAS website.

Communication and stakeholder engagement
Using import and export data extracted for Customs classifications relevant to industrial chemicals listed in Annex III of the Convention, about 160 advisory letters were sent by NICNAS to importers and exporters informing them of their obligations under the Convention. As part of the current arrangement under the MOU with the states and territories, letters and information papers were sent by the Director, NICNAS to heads of departments advising them of the administrative and legislative arrangements NICNAS has put in place.

Stockholm Convention
The Stockholm Convention's objective is to protect human health and the environment from the effects of persistent organic pollutants (POPs). The Convention sets out a range of control measures to reduce and, where feasible, eliminate POPs releases, including emissions of by-product POPs. The Convention also aims to ensure sound management of stockpiles and waste that contains POPs. The Convention focuses on three broad areas: intentionally produced and used POPs, unintentionally produced or by-product POPs and POPs in stockpiles and waste.

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Performance Measurement Framework
NICNAS contributes to the safe use of chemicals by providing information to its stakeholders on the hazards and risks posed by chemicals to workers, the community and the environment. This information takes the form of high quality scientific assessments of the risks posed from the import, manufacture, handling, use, storage and/or disposal of chemicals. Importantly, NICNAS assessments recommend ways of addressing these risks. The key NICNAS output is effective, accessible and reliable scientific information for other chemical control frameworks, workers, industry and other interested parties to implement controls as required to ensure the safe use of chemicals. The Scheme ensures this by also contributing outputs in the areas of compliance, customer service, community engagement and education and awareness-raising activities. Output performance measures as they relate to all Scheme activities are summarised in Table 4 and are reported against the performance targets identified in this section of the report.

Table 4 Summary of Output Performance Measures for the Scheme
TYPE PERFORMANCE MEASURE

Quantity Quantity Quality

Number of outputs (assessments, compliance investigations, audits, site visits, guidance notes, publications, etc) against agreed targets Number of outputs to appropriate benchmark/target used:
Assessments

Timeliness

Efficiency

• Timeliness • Effectiveness, eg acceptable to international scientific assessment standards and implementation within national control framework • Efficiency
Technical Guidance/Compliance/Service/Outreach

Effectiveness Price Price

• Timeliness • Effectiveness, acceptable standards as defined by Service Charter and/or published guidelines and/or legislation Cost recovery targets Contained and/or reduced assessment costs through utilisation of overseas reports Contained and/or reduced administrative and other Scheme costs
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52 NICNAS ANNUAL REPORT 2004-05

Consolidated summary of outputs/resources
An overview summary of key outputs against resources for each main output category is shown at Table 5.

OUTPUTS

RESOURCE $'000

Compliance1 including

New cases Investigations completed Number of companies in company registration audit Chemical notifications arising Number of prosecutions

25 22 226 12 0 163 2909 257 23 11 13 73 2 3492
1767

Table 5 Key NICNAS outputs and resources for each output category
OUTPUTS RESOURCE $'000

New Chemicals

Certificate applications received Certificates issued Permit applications received Permits issued Active submissions at 30 June 2005 MSDSs assessed (approx) LVC Exemptions

213 200 105 106 193 400 155 23 5 43 8 80
1591 Reform activities 2140 Communication including

AICS searches Enquiries Publications/assessments Presentations Conferences International meetings Percentage of reforms implemented Treaties ratified Tier 1 Registrations

ASSESSMENT

Consultations Site visits
Existing chemicals including

PEC/Screening/other assessments completed PECs declared Assessment modules completed PEC & other assessment reports published/completed Overseas assessments reviewed Overseas assessments agreed Site visits Number of appeals

1 Compliance was 78% funded through cost recovery and 22% funded through Australian Government appropriation.

59 102 6 0

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ASSESSMENT
The various types of assessments undertaken by NICNAS are described at Appendix 08. be linked to any particular industry sector. The fall in permits in 2004-05 is due mainly to a fall in Low Volume Chemical (LVC) applications, given the change in the level for which exemption from notification can be applied for (from 10 kg to 100 kg per annum) for chemicals which do not pose an unreasonable risk to health or the environment. The high level of Standard (STD) notifications received in 2003-04 was maintained this year with a slight decrease in Limited (LTD) notifications, and a slight increase in Polymer of Low Concern (PLC) notifications. The number of Extension of Assessment certificates (EXT) was almost double that of 2003-04 but still remains an option under-utilised by industry. The reduction in the number of Commercial Evaluation Category (CEC) permits issued in 2003-04 compared to 2002-03 reversed somewhat in 2004-05. A summary of applications for each notification category in terms of the number of certificates or permits received over a four-year period is illustrated in Figure 6 below.

New Chemicals
Detailed statistics of new chemicals assessment activity are provided at Appendix 09.

Quantity
In 2004-05, a total of 318 notifications were received and accepted, comprising 213 applications for certificates and 105 for permits, representing an increase of two percent and a decrease of 43 per cent, respectively, from 2003-04. NICNAS issued 200 assessment certificates and published assessment reports for each chemical, an increase of 11 per cent from the previous year and 60 per cent from 2002-03. A total of 106 new chemical permits were issued, a decrease of 35 per cent from the previous year. Trend analysis of assessments completed over the past 12 years is provided in Figure 5. The data demonstrate a sudden increase in completed certificate assessments and a decline in permit assessments reflecting the significant drop in permit applications in 2004-05.

Figure 6 Four-year trend data for New Chemicals assessments by category - certificates/permits received

Figure 5 Trend analysis for completed certificate and permit applications

* 52 were self-assessments, two of which were under the interim arrangement (ie arrived before 9 August 2004) and 7 of which did not meet criteria and were not progressed ** EIP not included in total Please see Appendix 08 for a description of each notification assessment type.

A cyclical fluctuation has been observed with certificate applications, reflecting general business environments over the past decade. To a certain extent this is also the case for permits, with a trend to lower overall numbers from 1999 onwards. NICNAS covers a wide variety of industries that manufacture and import industrial chemicals and the fluctuations cannot

Forty-nine Early Introduction Permits (EIP) were issued in 2004-05, a reduction from 60 issued the previous year. These account for 25 per cent of the certificate notifications received (excluding extensions). This type of permit enables chemicals that are not hazardous substances or dangerous goods, and which meet certain environmental criteria, to be introduced and used while the assessment is being undertaken by NICNAS.

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The issue of EIPs facilitated the introduction of 'safer' chemicals whose entry into the marketplace would otherwise have been delayed until completion of the full assessment. Five-year trend data for industry utilisation of EIPs are shown in Figure 7 and demonstrate a sustained trend of about one third of certificate assessments preceded by an EIP up to 2004-05 where the ratio was approximately one in eight. However there is a remarkable increase in the number of new chemicals notified as PLCs indicating that there has been an increase in the level of safer technology, most likely encouraged by the incentives under the self-assessment system.

The number of assessment certificates issued (either STD, LTD or PLC categories) since 2002-03 is represented under various industrial use categories in Table 6. As reflected in the three-year trend data shown in the Table, surface coatings and printing/photocopying maintained a high level of notifications. Chemicals used in cosmetics, fuel and oil and photographic chemicals were strong contributors to the use pattern of newly notified chemicals.

Table 6 Industrial uses of assessed chemicals (standard, limited and PLC) over the period July 2002 to June 2005
USE CATEGORY 2002-03 2003-04 2004-05

Figure 7 Trend analysis of assessment certificates preceded by EIP

Adhesives Building/Construction Cosmetics Domestic use Electrical Explosives Fuel and oil Leather processing Mining Packaging

7 4 25 4 0 0 11 2 0 4 2 0 10 20 0 35 1 3 7

5 1 29 6 0 0 13 0 0 0 1 0 15 37 0 56 3 4 19

5 1 25 9 0 0 17 0 2 0 2 18 11 39 1 39 5 0 6

Two applications for secondary notifications were received during 2004-05. The changes introduced to the Act with respect to new chemicals imported and/or manufactured under the non-cosmetic and cosmetic exemption provisions have offered more flexibility to industry with the volume of introduction increased to 100 kg per annum. However introduction of these chemicals may not pose an unreasonable risk to health or the environment. Fifty-one introducers of new chemicals under the non-cosmetic exemption chose to submit a notification advice during 2004-05, and 104 cosmetic exemption notifications were received during the year, compared to 396 for 2003-04 and 388 for 2002-03. This change reflects the fact that increased volumes for exemption categories were introduced under LRCC. The full scale of industry's utilisation of the new LRCC exemption categories will be measured through the annual reporting to be introduced on 28 September 2005.

Paper and pulp Photographic Plastics Printing/Photocopying Refrigeration Surface Coatings Textile processing Water treatment Other

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In 2004-05 NICNAS considered 10 applications for listing on the confidential section of the Australian Inventory of Chemical Substances (AICS), a decrease of 33.3 per cent from the previous year. In considering the case for confidential listing, the Director must weigh the commercial interest against the public interest. NICNAS has a small group of technical experts, the Technical Advisory Group, to provide advice in this process (see Appendix 10). The Director granted confidential listing for seven chemicals. There are three pending applications. The three-year trend in outcomes for confidential listing applications is shown in Figure 8.

Figure 9 Three-year trend analysis of timeliness (per cent of timeframes met) for certificate categories over three years

Figure 8 Three-year trend data: Outcome of decisions for confidential listing on AICS

An analysis of the four assessment reports which did not meet the performance standard revealed that all were completed within 92 days. Complex classification issues delayed two, one was delayed due to late input by the notifier on the final report and one as a result of time management issues. DEH performance for environmental assessments is summarised at Appendices 11 and 12. The timeframe performances for permits exceeded the 95 per cent target with 100 per cent of permits being issued within the agreed statutory and non-statutory timeframes. Figure 10 shows the trend data for timeliness for permits over a three-year period.

Timeliness
New chemical assessment output performance against target timeframes is detailed at Appendix 09. Ninety-eight per cent of total certificate assessment reports (164) were provided to notifiers within statutory timeframes (90 days), above the agreed target of 95 per cent. Figure 9 shows the trend data for timeliness for assessment certificates (90 days) over three years.

Figure 10 Three-year trend analysis of timeliness (per cent of timeframes met) for permit categories over three years

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Both NICNAS and industry have statutory responsibilities to publish assessment reports. Applicants may vary the assessment report and have a 14-day timeframe to lodge an application for variation, outlining the reasons for change. Twelve applications for variations of the assessment reports were received during the year, of which one was pending at 30 June 2005. All other variations were resolved satisfactorily between NICNAS and the applicant, with no appeals made by notifiers. Applicants may also provide written consent to publish the reports, withdraw the application or simply allow the publication process to proceed. If 28 days have elapsed since NICNAS provided the assessment reports to the notifier and no response has been received, NICNAS can publish the assessment reports. Industry performance over time against this timeframe is shown in Figure 11.

Efficiency
At the end of the 2004-05 financial year, the new chemical assessment output was slightly less than input. NICNAS received 213 notifications in the certificate categories and issued 200 certificates in 2004-05, a result due to the increased number of certificate notifications in the latter part of the year. For permits, 105 were received and 106 issued so input and output were balanced. Table 7 details input and output for certificate and permit categories for the past four years.

Table 7 Input and output data for certificate and permit categories for years 2001-02 to 2004-05
2001-02 2002-03 2003-04 2004-05

Certificates

Figure 11 Three-year trend data for percentage of companies responding within timeframes from provision of report to written consent to publish (calendar days)

Input Output Input Output

168 164 120 119

179 125 165 151

208 189 184 162

213 200 105 106

Permits

Effectiveness
Chemical notifiers and/or their consultants met with NICNAS staff on 23 separate occasions during the year to take advantage of NICNAS's free pre-notification consultancy service. Such consultations are part of our ongoing commitment to improve the quality of applications, the relationship between NICNAS and our clients, as well as optimising assessment timeframes through the lodgement of more complete notifications. NICNAS encourages notifiers to meet with staff at any time during the assessment process to discuss issues arising. Numerous other consultations were conducted by telephone or electronically. Approximately 67 per cent of notifiers responded within the 14-day timeframe, a significant increase from the previous year. A further 18 per cent responded prior to the 28-day deadline for publication, with less than 15 per cent not responding to NICNAS, triggering the publication process to proceed after the 28-day deadline. NICNAS issued 99 per cent of certificates within the 7-day statutory timeframe. Three certificates did not meet this timeframe. Two certificates were issued two days late, one due to agency delay. A third certificate was late due to non-response from the notifier. No trend was determined on the basis of the small number of late certificates. Of the applications for certificates received in 2004-05, assessment commenced on the day of receipt for approximately 29 per cent of certificate notifications, reflecting either a complete data package or one where only minor deficiencies were identified. NICNAS can only start the assessment process once the application is basically complete. Of the remaining applications, the clock was not activated on receipt of application and/or the ’90-day clock‘ was stopped part way through the assessment process and re-started. Flow through times, given in Table 8, indicate the EXT and LTD notification categories to be most successful (with 50 and 43 per cent respectively) in meeting data requirements, beginning on the date of receipt. CEC permit and STD notification categories were the most deficient with only 15 and

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nine per cent, respectively, commencing on the date of receipt. These data will allow better-targeted training programs for industry in an effort to improve quality of applications overall. During 2005-06 attention will be focussed on streamlining screening activity.

to NICNAS. The continued increase in PLC applications and, in particular, self-assessments, reflects the expansion in introduction of low hazard and low concern chemicals. The potential for non-hazardous polymers to be notified at a lower cost also delivers the benefit of introducing safer chemicals into use in Australia.

Table 8 Clock start times for assessments - all categories in 2004-05
NOT STARTED % CLOCK STARTED ON DATE OF RECEIPT % CLOCK STARTED CLOCK STARTED CLOCK STARTED UP TO 28 DAYS BETWEEN 28 AND MORE THAN 90 AFTER DATE OF 90 DAYS AFTER DAYS AFTER DATE RECEIPT % RECEIPT % OF RECEIPT %

Existing Chemicals Quantity
NICNAS undertakes assessments of chemicals already in use in Australia under the Existing Chemicals program. Appendix 08 details the types of assessments undertaken in the program. During 2004-05, full risk assessments for two chemicals under review as Priority Existing Chemicals (PECs) and one chemical being assessed under the provisions for secondary notification, were completed to public consultation stage. In addition to the three full risk assessments, hazard assessments for 25 phthalate chemicals were completed. The phthalates were assessed as a result of concerns raised overseas and in Australia regarding potential health effects from their use as plastic softeners in consumer products such as cosmetics and children's toys. In 2005-06, these assessments will be utilised to compile a comparative hazard compendium of important toxicological endpoints. Also completed in 2005-05 were four Information Sheets, one NICNAS alert, two screening assessments, six assessments examining poisons scheduling, and one health effects assessment. These are detailed in Table 9, and at Appendix 11.

STD LTD PLC EXT CEC LVC EIP SN

17 5 26 0 12 15 33 100

29 41 17 50 16 21 34 0

8 11 18 20 44 36 26 0

23 23 26 25 28 24 7 0

23 21 14 5 0 3 0 0

The assessment of Material Safety Data Sheets (MSDS) for notified chemicals and the products containing the chemical remain an important part of the assessment process for all categories. In 2004-05 over 400 MSDS were assessed by NICNAS on behalf of the chemical industry to ensure accurate and relevant information is available to workers, consumers and the community. No new chemicals assessment decisions were appealed in 2004-05.

Price
A minimum of 155 chemicals was notified by industry under the low volume exemptions in 2004-05. Before provisions for LVC exemptions were introduced in 1999, these chemicals required notification prior to their introduction. Estimates on the saving to industry in assessment fees in 2004-05, if priced as LVC permits, are approximately $400,000 (not including the savings related to data generation or industry administration costs). Overall, since introduction in 1997, the exemption (less than 10 kg) category alone has provided access to some 1923 chemicals over seven years at a minimum potential saving to industry of approximately $5.1 million. Chemicals introduced for non-cosmetic use and for research and development under the exemption category do not require notification

Table 9 List of Existing Chemical assessments in final consultation phase, published, or otherwise completed by NICNAS in 2004-05 Priority Existing Chemicals
Formaldehyde Tris(2,3-dibromopropyl) phosphate Secondary notification of Polymer in E7581 (NA/752)

Information sheets
Options for Disposal of Perfluorooctane Sulfonate (PFOS) Short-Chain Chlorinated Paraffins in Metal Working Fluids Current Activities on Polybrominated Flame Retardants (PFBRs) Current Australian Use and Regulatory Activities on Polybrominated Flame Retardants

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NICNAS Alerts
Perfluorooctanoic Acid and its Derivatives

Figure 12 Five-year trend data of Existing Chemical assessment outputs

Hazadous assessments
25 phthalates* Perfluoroalkyl sulfonate

Screening assessments
Polyvinyl acetate Iron Carbonyl

Poisons scheduling
Six chemical assessment submissions to the NDPSC

Health effects assessments
One chemical assessment for the TGA
* The names of the 25 phthalates are given at Appendix 11.

Timeliness
We have statutory timelines for PEC and secondary notification assessments. These include legislated deadlines mandated by the Act for applicant and public comment on draft reports, the Director's response to requests for variations to the draft report and for completion of an assessment. These timelines were all met in 2004-05.

A target of three full assessments and ten other assessments was set for 2004-05 to maintain an output target of 50 chemicals assessed over a three-year period. This target was met in the case of PECs and exceeded (by 400 per cent) in the case of other assessments. A list of chemicals that had agreed international assessments is provided at Appendix 13. Assessment outputs for 2004-05 are summarised in Table 10 compared with last year's activities, and presented over a five-year period in Figure 12.

Effectiveness
Strong partnerships with other government agencies involved with the protection of public health and safety through assessment and management of chemicals have continued to help the effectiveness of NICNAS. Examples of projects undertaken this year involving collaboration with other government regulatory agencies are detailed below.

Table 10 Output data for the Existing Chemical assessment types for 2003-04 and 2004-05
2003-04 2004-05

Review
Reviews by NICNAS of five industry submissions to the National Drugs and Poisons Schedule Committee (NDPSC) on cosmetic ingredients and one industry submission on a non-cosmetic chemical in regard to SUSDP scheduling, resulted in recommendations by NICNAS for consideration at three NDPSC meetings. These reviews covered a range of issues related to hazard and risks associated with specific uses of the chemicals. NICNAS also provided an update on a NICNAS preliminary review of chemicals in hair dyes at a NDPSC meeting.

Chemicals under assessment PECs declared for assessment (includes secondary notifications) Screening/other assessments commenced Assessment modules completed (PEC & Screening/Other) Assessments completed (PEC & Screening/Other) Chemicals subject to post-assessment activity

37 0 25 63 33 11

46 8 39 80 43 4

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Regulation
Regulatory activities related to polybrominated flame retardants (PBFRs) and phthalates, in an environment of increasing international concern over their wide usage and potential harmful effects. In 2001 NICNAS undertook a preliminary PBFR assessment and in 2004-05 conducted a survey of industry to update the 2001 collected data to help assess the need for further regulatory action. As a result, three PBFRs were declared PECs for full risk assessment in August 2004, and two information sheets were published in June 2005 to inform industry and the public of proposed regulatory activities. The DEH has commissioned studies to research levels of the chemicals in the Australian population, indoor air and in aquatic sediments. The findings of these studies are expected in late 2005 and will contribute to NICNAS risk assessments on these chemicals. Studies by Food Standards Australia New Zealand (FSANZ) on levels of polybrominated diphenylethers (PBDEs) in food, as part of the 22nd Australian Total Diet Survey, will also assist NICNAS in determining the dietary contribution of PBDEs. A committee comprising members of NICNAS, the DEH, FSANZ and the Australian Government Department of Industry, Tourism and Resources (DITR) provides a forum for communication on issues related to PBFRs.

The Information Sheet was distributed directly to industry as well as published on the website. Another Information Sheet on waste disposal options for perfluorooctane sulfonate (PFOS) was published on the NICNAS website in 2004-05 in response to public enquiries on the issue. An alert on PFOA and its derivatives, summarizing Australian data, national and international activities and providing advice on safe handling, was also published on the website.

Precursor information
NICNAS was commissioned by the Attorney-General's Department (AGD) during the year to work within the Act and under an MOU, to obtain and collate information on the introduction volumes and uses of 38 precursor chemicals. Working under the auspices of the National Working Group for the Prevention of the Diversion of Precursor Chemicals, the project aimed to explore the feasibility of monitoring the movement of - and build a central repository of information about - industrial chemicals which are known to be used in the manufacture of drug precursors. The project also aimed to determine the nature and extent of industry application of the precursor chemicals, thereby informing consideration of rescheduling or legislative amendments restricting the availability of these chemicals. A steering committee was established to identify stakeholders and issues and provide advice during the project, and NICNAS also analysed all information gained from industry, law enforcement and intelligence agencies and other government authorities. A report on the findings will be presented to the Australian Crime Commission (ACC) and AGD by 31 August 2005. It has been agreed that NICNAS will undertake further work on precursor chemicals.

Provision of expertise
NICNAS provided expertise - on behalf of the DoHA - on an EPHC working group established by the National Environment Protection Council, namely the Tier 2 Air Toxics Group. It is scoping which ambient air pollutants should be added to the existing Air Quality National Environment Protection Measure (NEPM) by designing a methodology to rank the relative risks associated with individual air pollutant chemicals. The Air Toxics Standard Setting Group is investigating how best to set health standards for air pollutant chemicals underlying NEPMs.

Uptake of recommendations
PEC reports make recommendations for the elimination or reduction of hazards and risks associated with chemical use. The number of recommendations made in PEC reports published to June 2005 is given in Table 11. NICNAS has continued to actively work with NOHSC on the take-up of recommendations made to that agency and consulted with NOHSC over the fast-tracking of exposure standards for 2-Butoxyethanol, 1,4-Dioxane, Trichloroethylene, Ortho-Dichlorobenzene, Ammonium Persulfate, Potassium Persulfate, and Sodium Persulfate in 2004-05. It is expected that these new exposure standards will be declared in late 2005.

Technical advice
NICNAS provided technical advice to NOHSC, to establish an exposure standard for the refrigerant chemical 2,2-dichloro-1,1,1-trifluoroethane (HCFC-123), and for the chemicals 2-butoxyethanol and 2-butoxyethanol acetate. In 2004-05, in addition to two Information Sheets published on the NICNAS website on the subject of Australian regulatory activities in regard to PBFRs, NICNAS issued an Information Sheet on Short Chain Chlorinated Paraffins in Metal Working Fluids, which summarises methods to minimize the environmental impact of metalworking fluids, in an easy-to-read format.

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HARMONISATION ACTIVITIES
TABLE 11 Number of recommendations in PEC reports by target area to June 2005
TARGET AREA FEB 93JUNE 02 OHS 2004-2005* PUBLIC HEALTH 2004-2005* FEB 93JUNE 02 ENVIRONMENT 2004-2005* FEB 93JUNE 02

Quantity OECD New Chemicals Task Force
NICNAS aims to reduce the regulatory burden on both industry and government through work sharing activities, leading to gains in efficiency, effectiveness and consistency with other national schemes. Work in 2004-05 focussed on developing the Parallel Process and Equivalence Framework, key concepts which arose out of a suggestion from NICNAS emphasising the achievability of significant work sharing opportunities. The Parallel Process primarily focuses on sharing hazard assessments using the Australian experience as a model. NICNAS attended a meeting of the OECD Steering Group formed to pilot the Parallel Process in Tokyo in March 2005 where procedures for the pilot phase were developed. Four chemicals are being assessed under the work sharing arrangements and NICNAS will prepare initial assessments for one of the chemicals in 2005-06.

2002-03

2003-04

2002-03

2003-04

2002-03

Peak bodies State & territory authorities Industry General public Total

63 10

1 0

0 0 5

5 2 9

21 2 6

1 1 3

0 0 1

6 1 3 1

1 1 6

0 0 1

0 0 0

2003-04

0 0 0 0

107 8

180 9

5 2

16 6

29 11

5 2

1 0.3

11 4

8 3

1 0.3

0 0

0 0

Percentage of 68 3 total recommendations

* Recommendations counted here are from 3 reports completed to consultation phase. These reports are expected to be published early 2005-06.

International Existing Chemicals
NICNAS participates in two international programs related to the safety assessment and risk management of existing chemicals. These are the International Programme on Chemical Safety (IPCS) Concise International Chemical Assessment Document (CICAD) activity, and the OECD's Screening Information Data Set (SIDS) Program. A description of these programs is provided at Appendix 08. One IPCS and two OECD SIDS meetings were attended by NICNAS during 2004-05. The number of chemical assessments presented at these forums, and the number approved following peer review of the assessments by member countries are shown in Table 13 along with four-year trend data.

An additional 35 recommendations were made in the other assessments completed in 2004-05. Target areas of the recommendations are shown in Table 12.

Table 12 Target areas of recommendations
TARGET AREA OHS PUBLIC HEALTH ENVIRONMENT

Peak bodies State and territory authorities Industry
Total

26

5

0 0

3
29 5

1
1

Percentage of total recommendations

83%

14%

3%

Price
The 43 assessments completed this year represent a 30 per cent increase over the number conducted in 2003-04 and a 400 per cent increase from the number required for performance targets to be achieved.

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Table 13 Four-year trend data for participation in international assessment activities for the Existing Chemical Program
2001-02 2002-03 2003-04 2004-05

Number of international assessment meetings attended Number of international assessments discussed at meetings

3 75

2 85 44 75

2 139 61 124

3 106 59 102

NICNAS commenced active consideration of nanomaterials and their regulation this year, and is a member of the OECD Steering Group for Nanotechnology. Australia made a joint presentation with Canada on issues being faced in the regulation of these materials to a Special Session on the Potential Implications of Manufactured Nanomaterials for the June 2005 OECD Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology

Number of international assessments 45 reviewed by NICNAS prior to the meetings Number of international assessments agreed at the meetings 72

Recognition of foreign schemes
NICNAS recognises chemical assessments conducted by other OECD countries and rebates of up to 40 per cent are available when foreign scheme assessment reports are provided. Most of these reports are from Canada, due to the Australia-Canada Bilateral Arrangement signed by both countries in 2002. The Arrangement, under which a free Early Introduction Permit (EIP) is also available for PLCs, is currently being renewed. Eleven applications under the Arrangement have been received this year, including two applications for a free EIP. In addition, four notifications based on previous assessments in the European Union were received. In 2004-05, the 15 applications under the foreign scheme provisions resulted in potential savings up to $78,000. Since 2000-01, a total of up to $230,000 was returned to industry as reduction in assessment fees for applications made under the foreign scheme arrangements. Through cooperative work in the OECD, NICNAS is progressing the development of a similar bilateral arrangement with the US Environmental Protection Agency (EPA). NICNAS also held preliminary discussions with the Japanese Government and industry in March 2005, with a view to developing similar cooperative arrangements.

NICNAS supports the use of these internationally agreed assessment reports in national assessment programs and provides links to the reports via the NICNAS website. NICNAS continued to play an active part in the ongoing cooperation on perfluorinated chemicals such as perfluorooctane sulfonate (PFOS), perfluoroalkyl sulfonate (PFAS), perfluorooctanoic acid (PFOA) and their related chemical substances being undertaken by the OECD, this year. Results of a questionnaire of OECD countries on the production and use of these chemicals conducted by Australia on behalf of the OECD were presented to the November 2004 Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology. To assist countries reporting in the next round of data collection, Australia also undertook to prepare comprehensive consolidated lists of PFOS, PFAS, PFOA and their related fluorinated chemicals. These lists were presented at the June 2005 Joint Meeting. The compilation of these lists was a complex task and OECD countries were highly complimentary of the work done by Australia.

Efficiency
Cooperative international activity on existing chemical assessment helps to avoid duplication of effort between countries in testing chemicals for the fulfilment of various national and regional requirements and international commitments. Where they are available, and as part of standard good practice, international assessments are consulted and utilised when they are relevant to NICNAS's chemical assessments. Participation in international assessment programs improves the effectiveness of our assessments by ensuring that they are of world standard, incorporating the latest scientific knowledge and developments in assessment methodology.

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COMPLIANCE
A range of innovations was introduced to NICNAS's Compliance area in 2004-05, designed to maintain the integrity of the Scheme and provide a firm, fair and consistent compliance function. The reporting method on compliance cases was reviewed during the year, and the following definitions now apply. In this report, ’compliance case‘ refers to a business entity which has one or more potential contraventions of the Act. A ’new chemical case‘ refers to a business entity which is introducing one or more new industrial chemicals, including potential contraventions of section 21 of the Act by introducing new chemicals without a valid assessment certificate, permit or grounds for exemption. For a new chemical case, the case is closed when an assessment certificate or permit is issued or the company is otherwise found to be compliant.

Table 15 Four-year trend in number of searches per AICS enquiry
2001-02
NO. (% TOTAL)

2002-03
NO. (% TOTAL)

2003-04
NO. (% TOTAL)

2004-05
NO. (% TOTAL)

1-10 11-20 21-50 >50

529 (89) 41 (7) 15 (3) 10 (2)

616 (92.5) 27 (4.1) 20 (3.0) 3 (0.1)

462 (91.2) 24 (4.7) 19 (3.8) 2 (0.4)

158 (96.9) 4(2.4) 1(0.7) -

Case management
NICNAS manages compliance cases from instigation to resolution or prosecution, and undertakes audits and inspections to ascertain compliance with the Act. During the year, the main activities of the compliance program included management of chemical cases, company audits and inspections and monitoring compliance with the Rotterdam Convention. A summary of all compliance cases involving potential or actual breaches related to industrial chemicals for 2004-05 is shown in Table 16.

Quantity Australian Inventory of Chemical Substances (AICS)
As in previous years, most searches in 2004-05 were for less than ten chemicals per enquiry (96.9 per cent, representing 158 out of 163). The remainder included four enquiries for between 11 and 20 chemicals, and one for between 21 and 50 chemicals. Since the non-confidential AICS was made publicly available on the NICNAS website, the number of non-confidential search requests has dramatically decreased and only one request was received in 2004-05. The three-year trend data for enquiries and searches are shown in Table 14, with three-year trend data for searches per enquiry shown in Table 15. This drop in search requests indicates industry is using the free online search facility offered on the NICNAS website.

Table 16 Summary of the number of compliance cases in 2004-05
ACTIVE CASES AS AT END OF 2003-04 NEW CASES REPORTED IN 2004-05 CASES CLOSED DURING 2004-05* ACTIVE CASES AS AT END OF 2004-05

New Chemicals cases Existing Chemicals Total Cases

17 1 18

25 0 25

21 1 22

21 0 21

*These are fully resolved cases, no further action required.

Table 14 Three-year trend data for AICS enquiries and searches
2002-03 2003-04 2004-05

Enquiries Searches

666 2683

507 2314

163 413

At the end of 2003-04, there were 18 active compliance cases including 17 new chemical cases and one existing chemical. The 17 new chemical cases included eight cases in which notifications were received during 2003-04 but assessments had not been finalised due to data deficiencies. In 200405, 25 cases, each relating to new industrial chemicals, were received. Of the 25 new chemical cases received during 2004-05, 22 cases related to industrial chemicals not covered by a certificate, permit or exemption, and three cases related to contravention of secondary notification or permit conditions.

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Figure 13 presents the trend in case categories over the last five years.

Industry profiles
In 2004-05, 43 compliance cases from a wide range of industry sectors were investigated (see Table 17).

Figure 13 Trend in case categories from 2000-01- 2004-05

Table 17 Break-down of compliance cases investigated in 2004-05 by industry sector
Chemicals – supply Plastics and resins Chemicals – manufacture Cosmetics Transport – cars and automotive components Specialty chemicals Pharmaceutical Paints and surface coatings A total of 22 cases relating to new and existing industrial chemicals were closed during 2004-05. The majority of these cases were resolved through informal compliance processes. There were 21 chemical cases active at the end of 2004-05, with 12 cases currently undergoing new chemical assessment. Recognising the importance of working with industry to develop agreed timetables to remedy breaches, the case management process was streamlined during the year. NICNAS's policy on negotiated timelines and outcomes with respect to self-reported chemical cases has been successful, resulting in 22 new chemical cases being closed. Office products – business machines and supplies Adhesives and sealants Petroleum/mineral products Paints/lacquers/varnishes Building and construction 10 7 7 4 2 2 2 2 2 2 1 1 1

The majority of cases came from chemical supply (23 per cent) followed by chemical manufacturing (16 per cent) and plastic and resins (16 per cent).

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Sources of cases
Compliance cases are generated through self-reporting, third party allegations from the public, industry or government agencies, and in-house investigations including desk auditing and on-site inspections or audits. Figure 14 presents four-year trend data for sources of compliance cases.

its recommendations have been accepted in full and are under active implementation.

Industry guidance
NICNAS is committed to establishing clear industry guidance on the regulatory requirements of the Act and so a number of guidance materials were developed and published during the year: • guidance notes on NICNAS Registration, to assist industry sectors in understanding NICNAS Registration requirements • other guidance material relating to NICNAS Registration including the NICNAS Registration brochure, Your simple guide to NICNAS, Which industrial chemicals are within the scope of NICNAS Registration? and Frequently Asked Questions • specific guidance notes for the cement, paint, ink and toner, plastics, and cosmetics and toiletries industries, designed to assist industry estimate the total value of introduction (ie import and/or manufacture) of industrial chemicals, and • several compliance guidance notes including Your obligations under the Act, Enforcement policy, Summary of enforcement provisions, Offences and penalties, Compliance Frequently Asked Questions, A compliance guide for introducers of industrial chemicals: a checklist approach and How to submit third party allegations. These publicly available materials are also accessible on the NICNAS website. Further guidance material will be developed and updated to assist industry in complying with their obligations under NICNAS.

Figure 14 Trends in the sources of compliance cases

All third party allegations are examined to determine whether a breach has occurred. This year NICNAS received seven third party allegations from industry participants. Three cases were found to be already compliant, one case was referred to a state government agency because it did not come under NICNAS's jurisdiction, and the remaining three are still under investigation.

Quality
Independent review of internal systems
NICNAS engaged the services of an independent consultant in October 2004 to review the Scheme's compliance program and procedures, and assess their appropriateness for the organisation's current and future requirements. In particular, the consultant was asked to consider whether: • the current risk approach to compliance was appropriate and soundly based • there were adequate resources to undertake the work necessary • the program was appropriate to cover the expected increase in the number of registered companies from 800 to between 6000 and 8000, and • adequate industry guidance material was in place. Through staff interviews and by reviewing files, documents and procedures, the consultant benchmarked the operations of NICNAS against the Australian Standard on Compliance: AS 3806. While the consultant noted 'the organisation is well run, efficient, and providing cost effective regulation', the report suggested action items to be implemented to improve compliance performance over forthcoming years. The report and

Monitoring compliance
During 2004-05, compliance monitoring activities included delivering training to industry on compliance, auditing self-assessed assessment certificates, outreach visits and on-site audits, as well as planning a comprehensive audit program for 2005-06 based on a risk assessment approach. The audit program for the year included self-assessed assessment certificate audits, which were primarily aimed at checking the data holding of notifiers and then verifying the authenticity of data. This program audited 32 self-assessed assessment certificates, which included 28 issued during the first quarter through to the third quarter of 2004-05, and four issued during the interim arrangement in the last quarter of 2003-04.

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Notifiers are not required to provide supporting data to NICNAS for PLC self-assessment. However, of the first 32 self-assessment notifications, 16 also included supporting data with the self-assessment submission. These data were checked to ensure correct transfer of information onto the PLC submission. The remaining 16 notifiers were offered two options: to submit the data for desk auditing or allow NICNAS inspectors to conduct on-site data verification audits. Two companies invited inspectors to conduct on-site audits while the rest provided data for desk auditing. The audit program successfully concluded all 32 self-assessments. The notifiers of self-assessments either hold relevant data on-site or third parties hold them on their behalf. Industry provided ready access to data and held, in the most part, comprehensive data sets as appropriate. Almost all notifiers cooperated to accomplish this task. During 2004-05, two on-site audits were undertaken in Melbourne for general compliance and educational purposes. Both companies were found to be compliant with regulatory requirements and were issued with Inspection Reports. Both companies were cooperative with NICNAS inspectors and demonstrated that they have adequate regulatory compliance systems to monitor introduction in accordance with permits/ certificates. NICNAS will prepare a comprehensive audit plan for 2005-06.

A further 18 registration cases were initiated through day-to-day compliance activities. These companies were investigated, and all were resolved. Seven registration cases were carried over from 2003-04 and resolved. Overall, registration compliance activities resulted in 183 additional registrations. Industry profiles for the new registrants are shown in Table 19 while Figure 15 shows the trend in the number of resolved registration investigations over 5 years.

Table18 Summary of NICNAS registration investigations 2004-05
ACTIVE NEW RESOLVED ACTIVE INVESTIGATIONS INVESTIGATIONS INVESTIGATIONS INVESTIGATIONS AT END OF REPORTED IN DURING AS AT END OF 2003-04 2004-05 2004-05 2004-05

Registration Audits Registration Cases Total

7 7

247 51 265*

226 47 251*

10 11 21

*Audits that were escalated to registration cases have only been counted as a single investigation (33) and resolution (22).

Table 19 Industry profiles of 2004-05 investigations by registration level
TIER 1 TIER 2 TIER 3 TOTAL

NICNAS Registration audits
NICNAS conducts registration audits as a routine function of its compliance program using import data based on the previous registration year (1 September 2003 to 31 August 2004) supplied by the Australian Customs Service. Registration audits that are not resolved become formal registration cases, which can also be generated from day-to-day compliance activities. A summary of NICNAS Registration compliance activities (ie registration audits and cases) is provided in Table 18. All activities reported for 2004-05 relate to Tier 2 and Tier 3 registrations. A review of the Customs data for 2003-04 identified 642 companies for prescreening, which in turn produced a list of 247 companies to be investigated through routine registration audit. These companies were informed of their potential registration liabilities for 2003-04 and/or 2004-05. Of the 247 audits, 204 were resolved at the audit stage. Of the remaining 43 audits, 33 were escalated to registration cases (of which 22 were resolved), and 21 remained active investigations (10 audits, 11 registration cases) at the end of the reporting year.

adhesives and sealants chemicals - manufacture chemicals - supply cleaning/household products cosmetics and toiletries machinery and equipment mining and mineral processing paints and coatings petroleum and mineral products plastics and resins printing and inks speciality chemicals unclassified
Total

0 0 0 0 4 0 0 3 1 0 1 0 11
20

2 8 5 1 24 4 5 15 3 11 11 1 62
152

0 0 0 0 3 0 0 1 3 0 0 0 4
11

2 8 5 1 31 4 5 19 7 11 12 1 77 183

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Figure 15 Resolved Registration investigations by year

NICNAS officers also made site visits in Perth to meet with industry for one-on-one discussions about the new registration requirements. In March 2005 NICNAS commenced the second round of information seminars to assist importers and manufacturers. At each seminar, an overview of NICNAS was presented. The program started with seminars in Melbourne (46 attendees), followed by Brisbane (30 attendees), then Adelaide (four attendees). Participant satisfaction with the sessions was high, based on the feedback received, with the most satisfied participants attending the Brisbane and Victorian sessions. Overall, most attendees requested more training seminars and expressed satisfaction with the course material. For the industry training program for small to medium enterprises (associated with Tier 1), NICNAS conducted all the seminars in Perth, but outsourced the sessions in other major capital cities and regional centres to Neill Buck & Associates Pty Ltd.

In 2004-05, 226 (91 per cent) of registration audits involving companies identified as potential registrants were resolved, based on audits of 2003-04 Customs data. In total, 47 (81 per cent) of 58 registration cases were resolved within the target, and a total of 251 registration compliance activities were resolved, resulting in 183 new registrations. At the end of the year, 21 investigations were outstanding. Nine registrants were referred to compliance for failing to renew their 200405 registration by 31 August 2004, and 10 for not paying the penalty fee for late renewal. Six non-renewals (which also attracted late penalty fees) and six late penalties were resolved; the remaining seven are outstanding.

Customs Broker training
Customs Broker training NICNAS conducted training for customs brokers.

Prosecutions
No prosecutions or penalties were applied by NICNAS in 2004-05. In accordance with prosecution guidelines developed by the Director of Public Prosecutions (DPP), an enforcement policy was finalised and published on the NICNAS website.

Industry training
In order to increase industry understanding of general obligations under the Act, NICNAS provided free information sessions for new registrants in 200405, and will continue to do so in future years. The first training, which covered registration, notification and record keeping requirements, took place in Perth (30 attendees), Adelaide (32 attendees), and Melbourne (69 attendees) in December 2004. The training was well received, gaining excellent feedback.

NICNAS also held free seminars in Sydney and Perth for customs brokers in November and December 2004. These seminars covered the new registration requirements for importers, as well as new requirements for exporters under the Rotterdam Convention. The Seminars also explained how NICNAS Registration operates, including the three Tier levels, and advised what customs brokers' clients need to do to ensure compliance with their obligations under NICNAS. Customs brokers commented that the sessions were very informative and more sessions are planned in other states.

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Outreach
The Compliance team's education and promotion strategy provides for outreach visits where first-time registrants are provided the opportunity to discuss their registration with NICNAS officers. Outreach participants can use this forum to discuss various NICNAS related issues such as determining if a chemical is listed on the AICS or calculating the registrable value of their imports. They can also seek advice on record keeping and compliance monitoring. In 2004-05, five organisations accepted NICNAS's offer to meet and discuss relevant issues and NICNAS will continue this initiative in forthcoming years.

Table 21 Trend in timeliness for searches of AICS for 2002-03 to 2004-05
RESPONSE TIME MET FOR AICS (%) NUMBER OF CHEMICALS PER ENQUIRY 1-10 11-20 21-50 >50

2002-03 2003-04 2004-05

91 88 92

96 84 100

100 100 100

100 100 -

Industry compliance with Registration renewal schedule
Industry compliance with the renewal deadline (31 August) stayed on par with last year in percentage total, even though the number of registrants increased. Figure 16 shows industry's timeliness pattern in relation to renewals over the past seven years.

Timeliness
Forty-three compliance cases were investigated during 2004-05, which included 25 cases received within the year and 18 cases carried forward from the previous year. Twenty two cases (51 per cent) were closed during the year. Twenty cases (91 per cent) were finalised within 100 days against a target of 95 per cent. Timely follow-up yielded 17 new chemicals notifications submitted within agreed timeframes.

Figure 16 Registrants' timeliness in NICNAS company registration renewals over the past seven years

AICS response
A summary of targets and performance for AICS searching is provided in Table 20. The time required to complete an AICS search varies considerably depending on the level of information provided for the search and the complexity of the chemical structure. The improvement in timeliness has also been achieved as a result of recent internal streamlining.

Table 20 Summary of timeliness for searches of AICS for 2004-05
1-10 11-20 21-50 >50

No. of enquiries by category Target for completion of search (days) Response time met (%)

158 2 92.4

4 7 100

1 14 100

28 -

The response time improved to those in 2003-04 as shown in Table 21.

Industry's rate of compliance with the renewal date has been consistently low. The renewal response rate for 2004-05 was similar to last year. Approximately 11 per cent of companies had still failed to renew by one month after renewal date. Regular debtors follow-up and compliance action to 30 June 2005 saw 17 companies still being investigated, pending renewal. Even though initial renewal of registration was higher than the past average rate, approximately 8 per cent of companies had still failed to renew by one month after renewal date. Regular debtors follow-up, and compliance action up to 30 June 2005 resulted in only three companies with pending renewal.

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Overall, late renewal penalties raised $50,628 from 123 companies during 2004-05, $29,640 raised from 24 upper (now Tier 3) level registrants and $20,988 from 99 lower (now Tier 2) level registrants. Penalties for late registration in Tier 1 will apply in 2005-06.

Figure 17 New chemical cases by notification category generated by compliance action

Effectiveness
The outcomes of the 22 compliance cases closed during the year are shown in Table 22.

Table 22 Outcomes of chemical case investigations in 2004-05
OUTCOME/RESULT NUMBER OF CASES (%) Notification categories: CEC-Commercial Evaluation Category; EIP-Early Introduction Permit; LVC- Low Volume Chemical; PLC- Polymer of Low Concern; STD- Standard; LTD- Limited; EXT- Extension to a Certificate.

Certificates/Permits issued Already compliant Written-off (no breach) Not a NICNAS matter (referred to other agencies) Resolved non compliance on interim basis

5 (23) 6 (27) 5 (23) 1 (4) 5 (14)

Enforcement tools
NICNAS's Enforcement Policy has been documented and published on the NICNAS website as part of our ongoing review of internal procedures and processes. It provides guidance to industry about our principles and approaches to enforcement and the tools available to NICNAS when enforcement action is required, and aims to provide a consistent and transparent framework to use when making decisions about noncompliance, for investigation and/or prosecution or other enforcement action.

Of the total number of cases closed during the year, 23 per cent were issued with certificates/permits, 27 per cent were found to be already compliant, 23 per cent of the cases were 'written off' as no breaches were identified, four per cent were referred to other organisations because the matters did not come under NICNAS jurisdiction and 14 per cent were resolved on an interim basis. A number of cases with notifications submitted remained under assessment at the end of 2004-05. During 2004-05, 17 new chemical notifications were received as a result of compliance action. Figure 17 presents the distribution of these across the notification categories. NICNAS policy on self-reported cases was tightened during 2004-05, requiring companies to enter into strictly monitored agreements on timeframes for submission of complete notifications that meet all assessment requirements. Industry welcomed NICNAS policy on self-reported cases, which allows them to continue trading while notifications and assessments are in progress. Tightened timeframes yielded timely submission of complete data for assessments. However this policy was implemented subject to case-by-case judgement of risk with regard to public health, safety and environmental impact. Non-compliance with a NICNAS agreement is considered a serious breach and can lead to an escalation of enforcement actions to prosecution.

Inspector training
Inspector training for all NICNAS compliance and assessment staff was provided in November 2004 and February 2005 resulting in 27 officers being appointed inspectors by the Director under section 84 of the Act. The training outlined auditing and inspection techniques used to monitor compliance with the Act based on best practice models adopted by other Australian Government regulators and relevant Australian Standards.

Strategic alliances States and Territories
In November 2004, NICNAS and the Victorian WorkCover Authority worked collaboratively on an issue relating to a PEC. Officers from both agencies jointly inspected an industrial chemical facility in Victoria to examine the OHS controls in place, and to determine the necessity for Secondary Notification for the chemical.

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COMMUNICATION & SERVICES
Another example of the cooperation between NICNAS and the states and territories involved follow-up to a compliance investigation by NICNAS in April 2005 regarding an imported product potentially containing new industrial chemicals. In addition to the possibility of containing unlisted chemicals, the product was found to be deficient with regard to Dangerous Goods and Hazardous Substances labelling. The allegation, and related information, was forwarded to the relevant WorkCover authority for further action. During 2004-05 enhanced public access to chemical safety information, and maintaining a customer and service delivery focus to meet Australian Government policy, ensured NICNAS had well informed and actively engaged stakeholders. Our communication strategies focus on targeted alliances to ensure the efficient distribution of information to increase knowledge and awareness on: • the work of NICNAS • existing and proposed regulatory requirements, and • the safe use of chemicals.

Australian Taxation Office
NICNAS via the DoHA has established an MOU with the Commissioner of Taxation, in his capacity as the Registrar of the Australian Business Register. The MOU has provided NICNAS with information not publicly available, which allows verification of an organisation's details and identifies the relevant industry category for industry profiling and targeted educational or awareness raising purposes.

Quantity
During 2004-05 NICNAS responded to 2909 (compared to 1510 in 2003-04) public enquiries, which took 1356 (487 in 2003-04) hours to handle. This was made up of 2029 telephone enquiries and 880 written enquiries. In addition, for the first year of NICNAS Tier 1 Registration, there were: • 7479 telephone enquiries (to the call centre and NICNAS, general and technical), and • 130 written and 1200 email enquiries all handled within Service Charter timeframes. The number of telephone enquiries rose significantly from previous years (1209 in 2003-04, 1446 in 2002-03, 1725 in 2001-02, 1752 in 2000-01, 1598 in 1999-2000) as did written enquiries (301 in 2003-04, 358 in 2002-03, 398 in 2001-02, 205 in 2000-01, 187 in 1999-2000). For full details on public enquiries to NICNAS see Appendix 14. NICNAS received 140 media enquiries during 2004-05 (154 in 2003-04, 150 in 2002-03). Key issues included polybrominated flame retardants (PBFRs), PFOA/Teflon, cosmetics, nanotechnology, household chemicals, sodium cyanide and NICNAS Tier 1 Registration. NICNAS received 171 email enquiries to our general email contact info@nicnas.gov.au. NICNAS staff were active in awareness raising and information exchange activities such as presentations (11), conferences (11), meetings for progressing international harmonisation activities (10), industry consultations (23) and site visits (11). These are detailed at Appendix 15.

Australian Customs Service
The Australian Customs Service continues to be a major partner agency involved in the monitoring of industrial chemical introduction into Australia. A 2004-05 MOU drafted between the two agencies facilitates the ongoing partnership. Data received from Australian Customs Service was instrumental in identifying potential registrants for Tier 1 Registration and this data continues to be an important tool in the detection of incorrectly registered or unregistered organisations. NICNAS also worked closely with Australian Customs Service leading up to the ratification of the Rotterdam Convention, to establish systems for the detection of PIC chemicals and consulted regularly to monitor the import/export of potential PIC listed items. The training in Sydney and Perth for customs brokers who manage imports/exports on behalf of other organisations (see above) was an extension of our work with this important sector as it raised awareness of NICNAS Registration and PIC requirements with them.

Price
NICNAS Registration cases, including newly identified registrants, registration compliance cases, renewals and upgrades have resulted in $614,739 in additional revenue to NICNAS as well as future income from ongoing registrations of these companies.

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NICNAS publications for 2004-05 are detailed at Appendix 16 and include 13 editions of the Chemical Gazette, the NICNAS Service Charter 2004-05, four Existing Chemicals Information Sheets and two NICNAS Alerts. A monthly summary of key issues at NICNAS - NICNAS NEWS - was sent with the monthly Chemical Gazette alerts. In addition, NICNAS published a total of 200 new chemical assessments on the web. NICNAS released three issues (December 2004, March 2005, June 2005) of its newsletter, NICNAS matters. NICNAS matters 11 (December 2004) featured articles on the Rotterdam Convention, NICNAS Registration, methylene chloride, phthalates, AICS and the third Science Forum. NICNAS matters 12 (March 2005) featured articles on NICNAS Registration, Guidelines for 'No Unreasonable Risk' - New Exemption Categories, the Community Engagement Forum, and PBFRs. NICNAS matters 13 (June 2005) featured articles on the New Reporting Requirements: Annual Reporting Requirements for Chemical Introducers, E-Notification of New Chemicals, the Australian High Volume Industrial Chemicals List, Changes to NICNAS fees and charges, formaldehyde, PBFRs, sodium cyanide and cosmetics. NICNAS advertisement activity is detailed at Appendix 05. In 2004-05 it focused on promoting new NICNAS Registration requirements. Website statistics for 2004-05 are detailed at Appendix 17. There were 594,614 user sessions on the NICNAS website in 2004-05 compared to 445,619 in 2003-04, a 34 per cent increase. Total hits for the year were over 10 million - equivalent to the total of the two previous years (six million in 2003-04 and four million in 2002-03).

The most requested web pages are shown in Table 23 below.

Table 23 Most requested website pages
RANK PAGE HITS

1 2 3 4 5 6 7 8 9 10

Home AICS Search Chemicals in Australia Publications News-Paraben Breast Cancer AICS News Publications-Handbook Obligations Forms

199,855 93,017 27,145 11,939 10,747 10,458 9,950 9,800 9,495 8,589

Timeliness
All NICNAS's timeframe targets for responsiveness to enquiries by telephone (94 per cent completed within 24 hours, against a target of 85 per cent, and the remainder within 28 days) and in writing (78 per cent finalised within 24 hours and 16 per cent in seven days, that is, 94 per cent within seven days, against a target of 85 per cent) were exceeded in 2004-05 (see Appendix 14). All media enquires were handled within agreed timelines. Twelve of the 13 issues of the Chemical Gazette were published within the statutory deadline, which is on the first Tuesday of each month. The remaining gazette was published as a special gazette detailing the legislative changes for LRCC as a reference document for industry.

Effectiveness
NICNAS continued to provide clear and accessible information on its website - www.nicnas.gov.au - during 2004-05 to assist importers and manufacturers of industrial chemicals in Australia in fulfilling their obligations, as well as the community to engage with NICNAS.

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The newsletter, NICNAS matters, is a central element to enhance access to chemical safety information by industry clients, the community, government agencies and the media. Printed copies of the December 2004, March and June 2005 issues were distributed to 5000 clients and stakeholders. NICNAS Matters was also available on the website. NICNAS's communication staff maintained an effective media management strategy and provided considerable assistance to media in accessing scientific information on chemical matters. In addition, NICNAS handled specific media enquiries resulting in print and television coverage, as detailed at Appendix 16.

• •

85 per cent found that NICNAS provided accurate and consistent information always or most of the time, the same as 2003-04 96 per cent of respondents were aware of the NICNAS website, the same as 2003-04. Of these, 76 per cent found the web site easy to navigate down from 96 per cent in 2003-04. The decrease from 96 per cent to 76 per cent is largely attributable to the number of no responses jumping from 2 per cent to 18 per cent 74 per cent of respondents were satisfied with NICNAS's regulatory efficiency strategy.

Customer surveys
The NICNAS Service Charter defines NICNAS's service standards, outlining the standards of service that the users of the Scheme and the public can expect. In 2004-05, two customer surveys were conducted on NICNAS's performance against its service standards: the first survey - the annual Service Charter Survey - targeted Tier 2 & Tier 3 registrants, while the second survey - the Registration Performance Survey - targeted Tier 1 registrants. Details of the findings from the latter survey are provided in the Reform section of this report.

The NICNAS website has been redesigned in response to comments made in our customer surveys, and to reflect the latest Internet requirements and trends. The new website goes live on 1 July 2005.

Efficiency
The NICNAS website received positive feedback in the Customer Survey with 76 per cent of respondents finding the website easy to navigate. Over 1500 chemical assessment reports on individual industrial chemicals are featured on the website. Users can conduct searches on assessment reports by: • chemical name • trade name • Chemical Abstracts Service (CAS) number • hazardous status, and • OECD industry use category. All material on the NICNAS website is freely available allowing greater access to chemical safety information by the public, government agencies and industry, which fulfils a key requirement of the Act. In line with Australian Government publishing guidelines, NICNAS maintains copies of printed information material and provides a print-on-demand service from its website. Electronic templates continue to reduce time and costs to small businesses in making applications for assessments.

Service Charter survey
Two hundred and three randomly selected organisations were canvassed by mail, most of whom had been in contact with NICNAS prior to 2004-05. Industry contact with NICNAS for the purposes of this survey is defined as contact through notification and assessment of new chemicals, review and treaties concerning existing chemicals and Priority Existing Chemicals (PEC), company registration with NICNAS, AICS searches, general enquiries and/or compliance activities for the period 1 April 2004 to March 31 2005. Ninety-eight organisations (48 per cent) responded to the survey. Overall, positive feedback was received indicating a good level of service in a number of key areas: • 88 per cent of respondents found staff to be helpful and courteous always, or most of the time compared to 94 per cent in 2003-04. The shortfall is mainly attributable to respondents selecting ‘not applicable’ or ‘no response’ • 85 per cent of respondents found their questions and enquiries answered within 28 days compared to 86 per cent in 2003-04 • 91 per cent of respondents found written explanations clear always, or most of the time, compared to 88 per cent in 2003-04

Database at NICNAS
The integrated information system, Database at NICNAS (D@N), continues to ensure efficiencies within the organisation. The database was built using web-based technology and during 2004-05 was upgraded to meet NICNAS's changing needs.

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Price
One copy of the Handbook for Notifiers and was sold in 2004-05 (three in 2003-04) reflecting the continued trend by customers of using electronic publications. All other NICNAS printed materials are available free-of-charge to industry. A total of 200 new chemicals reports completed by NICNAS in 2004-05 were made available to the public free-of-charge. Ongoing savings to industry are achieved by a focus on electronic publications. The move to place the Handbook for Notifiers and AICS online has led to savings to industry in the order of $20,000 over the past three years.

Compliance with Annual Report Guidelines
Page Item

39 31 39 4 5 31 22 16 38 39 39 37 36 38 38 39 8 36 145 3 30 36 53 38 54 104

Advertising and Market Research Certified Agreements and AWAs* Consultants Contact Details Contents Corporate Governance Corporate Overview Director's Overview Disability Strategy* Discretionary Grants Ecologically Sustainable Development and Environmental Performance Equity Performance External Scrutiny Financial Performance Fraud Measures* Freedom of Information* Glossary Human Resources Management Index Letter of Transmittal Management and Accountability Occupational Health and Safety* Performance Reports Purchasing* Resource Tables by Outcomes Staffing Statistics

* See also DoHA Annual Report 2004-05

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Compliance with Mandatory Reporting Requirements Under The Act
In addition to the requirement to produce an Annual Report to Parliament on the operations of the Act and other external scrutiny such as through the NICNAS Industry Government Consultative Committee (IGCC), the Act also prescribes additional mandatory reporting requirements. These are detailed in the following table along with information on the last/next publishing date.

REQUIREMENT

LAST PUBLISHED/NEXT PUBLISHED

Annual publication in the Chemical Gazette of the list of chemicals which are the subject of low volume chemical permits [Subsection 21ZA(2)]. Annual publication in the Chemical Gazette of a list of current and previous Priority Existing Chemicals (PECs) [Section 54]. Annual publication in the Chemical Gazette of a list of the chemicals requiring secondary notification and a list of those no longer requiring secondary notification [Section 71]. Written notice to the Gene Technology Regulator when a genetically modified (GM) product is regulated by NICNAS [Section 10A].

List of low volume chemical permits in force at 30 June 2005 published in October 2005 Chemical Gazette. Number of permits issued 2004-05: 106 A list of current and previous PECs will be published in the July 2005 Chemical Gazette. All assessments undertaken and published by NICNAS are subject to secondary provisions. These are published on our web site. A list of the chemicals no longer requiring secondary notification will be published in the October 2005 Chemical Gazette. Number of genetically modified chemicals referred to the Office of Gene Technology for advice: 0

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External Accountability Arrangements – NICNAS Committees/Forums
NICNAS Industry Government Consultative Committee (IGCC) Terms of Reference and Membership Terms of Reference
In March 1997, the Government agreed to amend the Industrial Chemicals (Notification and Assessment) Act 1989 to introduce new funding arrangements for NICNAS. Under these arrangements, the chemical industry will directly contribute to the operating costs of NICNAS. In order to ensure that industry has the opportunity to participate in the NICNAS budgetary process, a joint Industry Government Consultative Committee (IGCC) was established. The Committee meets at least twice a year. The Committee has eight members, including four industry representatives and four Government representatives. The membership consists of one representative from each of the following organisations:
MEMBER

The IGCC: (a) reviews the utilisation of resources against NICNAS objectives; (b) reviews the performance of NICNAS against agreed performance indicators (including those established in the NICNAS Service Charter and Corporate Plan), and in particular the impact on industry and the protection of human health and the environment; (c) develops strategies for improving the efficiency and effectiveness of NICNAS operations within the context of (i) established goals and objectives and (ii) developing and emerging issues; and (d) develops compliance strategies and monitors the effectiveness of these strategies in promoting compliance with the Scheme. The Chair of the Committee reported as necessary (at least every six months) to the Minister on the outcomes of the Committee.

IGCC Membership at 30 June 2005 and attendance at 2004-05 meetings
REPRESENTING 21ST MEETING 29 NOV 2004 22ND MEETING 18 MAY 2005

Industry
• • • • ACCORD Australasia Plastics and Chemicals Industries Association (PACIA) Australian Paint Manufacturers‘ Federation (APMF) Australian Chamber of Commerce and Industry (ACCI)

Dr Margaret Hartley (Chair) Ms Bronwyn Capanna Mr Nick Munafo Mr Michael Hambrook Ms Sylvia Kidziak AM

Director NICNAS ACCORD PACIA APMF ACCI NOHSC DITR DITR DEH TGA Secretariat

✔ ✔ ✔ ✔ ✔ ✔ ✔

✔ ✔ ✔ ✔ ✔ ✔ ✔

Government
• • • • NICNAS (Chair) National Occupational Health and Safety Commission (NOHSC) Australian Government Department of Industry, Tourism and Resources (DITR) Australian Government Department of Environment and Heritage (DEH)

Mr Tom Fisher Mr Shane Baker Mr Wilfred Antioch Mr Mark Hyman Mr Terry Slater Ex-officio

✔ ✔ ✔

✔ ✘ ✔

Given the integral relationship between the Director, NICNAS and the National Manager of the Therapeutic Goods Administration (TGA) Group of Regulators, the National Manager, TGA Group of Regulators, will be an exofficio member of the IGCC.

Mr Nick Miller

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NICNAS Community Engagement Forum (CEF) Terms of Reference and Membership
MEMBER

CEF Membership at 30 June 2005 and attendance at 2004-05 meetings
REPRESENTING MEETING 1 18 OCT 2004 MEETING 2 11 MAY 2005

Terms of Reference
The Terms of Reference for the Community Engagement Forum ensure that it will provide advice on: • strategies to improve public access to chemical health and safety and environmental standards; • community right to know issues including the development of a community right to know charter; • the development of NICNAS’s stakeholder engagement policies; • all NICNAS reform programs and participate where practicable; and • other issues, as required. The Community Engagement Forum consists of seven members and is chaired by the Director of NICNAS. Membership comprises of the: • Chair (Director NICNAS); • two community members representing the interests of the environment; • two community members representing the interests of public health; and • two non-government members representing the interests of worker safety. Nominations for membership were sought from peak national bodies recognised by Department of Health and Ageing as representing the interests of public health, environmental standards and worker health and safety. Members were chosen for their expertise in the following areas: • knowledge of industrial chemicals in a regulatory context; • ability to represent a broad cross section of community views; • understanding of community concerns related to the regulation of chemicals; and • knowledge of Government processes involving industrial chemicals regulation. While members have been nominated by specific organisations, they represent broad community interests in their respective areas and not simply the interests of their nominating or originating organisations. Members are appointed by the Parliamentary Secretary for a two year term. The CEF met formally twice in 2004-05. Dr Margaret Hartley (Chair) Ms Jane Bremmer Dr Bro Sheffield-Brotherton Ms Pamela Grassick Ms Renata Musolino3 Associate Professor Christopher Winder Ms Liz Hanna4 Ms Dusanka Sabic Mr Griffin D‘Costa
1 2 3

Director NICNAS Environmental Interests Environmental Interests Worker Health and Safety Interests Worker Health and Safety Interests Public Health Interests Public Health Interests Secretariat Secretariat

✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

✘1 ✔2 ✔ ✔ ✔ ✔ ✔ ✘ ✔

Dr Wafa El-Adhami, Acting Director NICNAS chaired meeting. By telephone. Ms Renata Musolino (representing worker health and safety interests) was appointed

to the CEF in August 2004 replacing Ms Sue Penniciuk who resigned her position on 27 August 2004
4

Ms Liz Hanna (representing public health) was appointed on 18th August 2004.

Teleconferences were held on 12 July 2004 and 10 March 2005, also, to discuss NICNAS‘s Community Engagement Charter.

NICNAS/States and Territories MOU Group – Terms of Reference and Membership Terms of Reference
The States and Territories MOU group exists as a conduit for the free flow of information and needs between the States and Territories and NICNAS on OHS, environmental and health matters relating to the use of chemicals in Australia.

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Each jurisdiction has a representative nominated as a member of the MOU. That person liaises with contacts from various departments with a role in chemical safety, such as environment, health, and Workcover within their State or Territory. This allows those regulating and controlling chemicals to raise issues of concern regarding chemicals with the Australian Government through their MOU representative and for NICNAS and its partner agencies to pass information to those involved in the day-to-day implementation of chemical regulation and policy. The MOU was signed in 1991 with the intention of formally recording arrangements to facilitate the operation of the Act, under which NICNAS was established, and States and Territories legislation relating to industrial chemicals. Under the MOU, each State and Territory is to consider and wherever possible implement each recommendation in an assessment report published by the Director, NICNAS and to inform the Director of any consequential action taken in respect of any recommendations. The agreement also provides mechanisms in relation to facilitating the operation of specific sections of the Act relating to new and existing chemicals.

Existing Chemicals Program Review Steering Committee
Planning for NICNAS to undertake a review of the Existing Chemicals Program, which has been in existence for five years, commenced during 2004-05. International changes to existing chemicals assessment programs mooted in Europe and elsewhere delayed the start of the review, which scheduled for two years ago. The aim is to review the current Program with a view to its: • Efficiency and effectiveness • Flexibility and responsiveness to stakeholder needs, and • Harmonisation with comparable schemes and reflecting international trends. The review will look at how to determine national priorities for assessment of existing chemicals, better utilise overseas testing and assessment program outputs, and address the needs of the community and industry regarding access to sound information on chemicals hazards and risks. The Steering Committee was established to assist the NICNAS office, and will be an expert group consisting of ten members, including an independent chair (Dr Wafa El-Adhami from the Office of Chemical Safety), three community representatives, three industry representatives and three government representatives. The Steering Committee will set a framework for the Review, and oversee its activities. It will be able to seek additional expert advice, for example from individuals, technical working groups or consultants as needed. The Committee will report to the Director, NICNAS. Draft Final Report and Recommendations on the future of the Existing Chemicals Program are to be presented to the Director, NICNAS by February 2006.

MOU Group Membership as at 30 June 2005 and attendance at 2004-05 meetings
MEMBERS REPRESENTING 3 SEPT 2004 18 FEB 2005

Ms Dusanka Sabic (Chair) Dr Roshini Jayewardene (Chair) Mr Steve Robbins Dr David Grantham Mr Erich Janssen Ms Mark Brown Mr Greg Balka Dr Jeff Langley Mr Joe Crea Mr Steve Caldwell Mr Ian Graham Mr Lewis Norman (Secretariat)

NICNAS NICNAS NSW QLD ACT ACT VIC WA SA NT TAS NICNAS

✔ ✘1 ✔ ✔ ✘ ✘
3

✘1 ✔ ✔2 ✔ ✘ ✘ ✔ ✔4 ✘ ✘ ✔ ✔
3

✔ ✔ ✔ ✘ ✔ ✔

1. Dr Jayewardene replaced Ms Sabic as the MOU chair in January 2005. 2. Mr Ted Szafraniec attended in Mr Robbins‘ place. 3. Mr Brown replaced Mr Janssen as the ACT representative in December 2005. 4. Mr David Torr attended in Dr Langley‘s place.

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Staff Profile and Training and Development Activities
There were 42 staff employed within NICNAS at 30 June 2005. Of these, 30 are permanent employees and 12 are non-ongoing staff. The staffing profile at 30 June 2005 by classification and membership of equal employment opportunity groups (EEO) are shown in the following tables.

Comparative summary of Staff Training by Category 2004-05 and 2003-04

2004–05 TOTAL NO. OF FORMAL TRAINING DAYS

2003–04

AVERAGE NO. OF TOTAL NO. AVERAGE NO. OF FORMAL TRAINING OF FORMAL FORMAL TRAINING DAYS PER STAFF TRAINING DAYS PER STAFF MEMBER DAYS MEMBER

NICNAS Staffing Profile at 30 June 2005
CLASSIFICATION MALE FEMALE TOTAL

All staff Scientific /Technical Related All staff Information Technology Related All staff Scheme Performance/Professional Development Related* New staff Orientation/ Induction Related
All staff total formal training+

37 10.5 119

1.0 0.3 3.3

95.5 13.5 96.0

2.7 0.4 2.6

Statutory Officers Executive Level 2 Officers Executive Level 1 Officers APS Level 5 and Level 6 Officers APS Level 1 – 4 Officers TOTAL

0 2 6 9 3 20

1 3 4 8 6 22

1 5 10 17 9 42

4.75
171.25

0.1
4.7

10.0
215.0

0.3
6.0

Membership of EEO Groups
EEO GROUP NO. OF STAFF % OF TOTAL STAFF

Women Aboriginal and Torres Strait Islander Staff Non-English Speaking Background People with Disabilities

22 1 15 1

52 2 36 2

* Formal training activities include customer service training, corporate governance activities, financial management, policy development, etc. + The total number of formal days training and the average number of formal training days for all staff members includes orientation and induction-related training for new staff members.

Occupational Health and Safety (OHS)
Accident incident reports for year 2004-05 Accidents* OOS** 2 2

* Both accidents occurred on the way to work. ** Occupational overuse syndrome

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Consultancies Commissioned
Details are provided below of: eight consultancies were commissioned by NICNAS during 2004-05, two consultancies commissioned and partly paid by NICNAS during 2004-05, and two consultancies commissioned by NICNAS during 2004-05 with payment expected in 2005-06. Consultancy services are contracted by NICNAS to ensure the achievement of high quality assessments of chemicals and more efficient and effective delivery of regulation and related outputs. The method of selection for each consultancy commissioned by NICNAS during 2004-05 was by direct engagement. They were chosen on the basis of pre-eminent expert advice, relevant to science expertise and direct knowledge of NICNAS organisational development programs for ongoing development resulting from staff surveys.

Prof David Coggon, MRC Environmental Epidemiology Unit, Southhampton General Hospital
Consultancy engaged for Formaldehyde assessment Total amount paid - $1,500

SAS Strategic Pty Ltd
Provide Team Structure training services for Review and Treaties and Rapid Risk Assessment Teams Total amount paid - $3,300

Tress Cox Lawyers
Consultancy to provide review and advice on various memoranda, legislation, policy and procedures for NICNAS Total amount paid - $28,214

Consultancies commissioned and partly paid during 2004-05 Australian Environment Agency Pty Ltd
Consultancy engaged for Development of Indirect Exposure Models for Australian Conditions Total amount paid - $14,412

Consultancies commissioned and paid during 2004-05 Australian Government Solicitors
Consultancy to provide legal advice on Rotterdam Convention implementation, on fertilisers, on execution of lease and on registration of importers/manufacturers of industrial chemicals Total amount paid - $23,321

Melbourne University Private Ltd
Consultancy to determine impact of LRCC annual reporting requirements Total amount paid - $11,000

Dr Rory Connolly, Center for Health Research, Chemical Industry Institute of Toxicology (CIIT), USA
Consultancy engaged for Formaldehyde assessment Total amount paid - $3,279 (US$2,500)

Consultancies commissioned during 2004-05 with payment expected in 2005-06 Australian Environment Agency Pty Ltd

Dr Malcolm Sim, Department of Epidemiology & Preventive Medicine, Monash University
Consultancy engaged for Formaldehyde assessment Total amount paid - $1,500

Consultancy engaged for management of the Priority Existing Chemical Assessment of Sodium Cyanide

National Research Centre for Environmental Toxicology, University of Queensland
Determination of Triclosan in the Australian population by analysis of human breast milk

Neill Buck & Associates Pty Ltd
Consultancy engaged to assist NICNAS by reviewing its risk based Compliance Program Total amount paid - $8,250

Consultancies commissioned during 2003-04 and paid in 2004-05
Nil
Note: All total amounts paid include GST.

OCS Canberra
Consultancy on SIDS Initial Assessment Reports (SIARs) of some of the chemicals that were discussed at the Twentieth OECD SIDS Initial Assessment Meeting (SIAM) Total amount paid - $13,424
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Media Advertising Organisations Engaged by NICNAS in 2004-05
ORGANISATION SERVICE PROVIDED COST ($)

Ecologically Sustainable Development (ESD)
Accordance of NICNAS activities with ESD principles
(a) decision-making processes should effectively integrate both long-term and short-term economic, environmental, social and equitable considerations. NICNAS operates within an agreed framework for the environmentally sound management of chemicals, consistent with the National Strategy for ESD and its principles and policies. This framework aligns with the United Nations Conference on Environment and Development (UNCED) Agenda 21 (Rio Declaration), of which Chapter 19 relates to the Environmentally Sound Management of Toxic Chemicals. All NICNAS risk assessments are undertaken within an internationally agreed policy framework that comprises a hazard assessment, dose-response relationships, exposure assessment and risk assessment including risk management options. The hazard assessment identifies the intrinsic ability of the chemical to cause harm to human health and/or the environment. The potential for exposure of human and environmental species is ascertained for each chemical based on its known or anticipated use pattern. The risk assessment integrates both the hazard assessment and exposure assessment to make a risk estimate and risk management strategies where unacceptable risks are identified. In recommending risk management strategies, economic and social benefit is balanced with the economic, political and social costs of implementing the strategies. Risk management also involves monitoring, evaluating and reviewing the strategies recommended. (b) if there are threats of serious or irreversible environmental damage, lack of full scientific certainty should not be used as a reason for postponing measures to prevent environmental degradation. The Precautionary Principle is the guiding principle for health and environmental risk assessments and forms the basis of the science-based risk assessment for industrial chemicals. This principle is applied in particular where international chemicals policy negotiations may need to rely on precaution. Caution is applied in line with the principles of ESD and the UNCED Agenda 21, Principle 15 (precautionary approach). (c) the principle of inter-generational equity - that the present generation should ensure that the health, diversity and productivity of the environment is maintained or enhanced for the benefit of future generations and (d) the conservation of biological diversity and ecological integrity should be a fundamental consideration in decision making. The aim of the NICNAS risk assessment aims to preserve the integrity of the environment and its biodiversity. The known or anticipated use pattern

HMA Blaze Pty Ltd

Advertisement in various newspapers and magazines regarding change to NICNAS registration requirements Recruitment advertisements in The Australian, 22 February 2005

$45,288

HMA Blaze Pty Ltd

$3,286

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NICNAS ANNUAL REPORT 2004-05 109

of the chemical is characterised within the context of the risk assessment taking into account Australia's demography, national ecosystems including fauna and flora. The outcome of the NICNAS assessment provides the information necessary for informed objective and transparent decisionmaking including trade-offs between competing objectives of current utility and future adverse environmental effects. (e) improved valuation pricing & incentive mechanisms should be promoted. NICNAS's Low Regulatory Concern Chemicals (LRCC) reform agenda introduces improved regulatory efficiency and provides positive incentives that will drive improvements in the safe and sustainable use of chemicals in Australia. These reforms offer an innovative and flexible approach to the regulation of industrial chemicals while improving health, safety and environmental standards & increased public access to chemical safety information.

Scorecard at a Glance
Report on progress with implementation of the LLRC reform recommendations at 30 June 2005
NO RECOMMENDATION COMPLETED BEING IMPLEMENTED 05/06 WORK PLAN

1

Audited self-assessment – legislative framework in place

1.1 1.2 1.3 1.4
2

Establish process for audited self-assessment Introduce permits for low hazard chemicals in low volumes Audit system in place Electronic tools developed
Modular assessment

✔ ✔ ✔ ✔ ✔

How Outcomes Relate to ESD
Chapter 19 of UNCED Agenda 21, whilst acknowledging that substantial use of chemicals is essential to meet the social and economic goals of the world community, identified two major problems, particularly in developing countries, namely (a) lack of sufficient scientific information for the assessment of risks entailed by the use of a great number of chemicals, and (b) lack of resources for assessment of chemicals for which data are at hand. Chapter 19 is focused on the generation, harmonization and dissemination of chemical data, and strengthening capacity for chemical management. To a The Agenda 21 programs and objectives for chemicals, to a large extent, reflect some important elements of the Rio Declaration including: Principle 9 (building capacity through developing and transferring scientific information), Principle 10 (the right of access to information or the ”right to know“ and the right to participate in decisions) and Principle 15 (the ”precautionary principle“). The risk assessment activities of NICNAS are fundamentally focussed on these principles. NICNAS assesses the health and environmental risks of new industrial chemicals entering Australia for the first time (by manufacture or import) before their use and subsequent release to the environment. NICNAS also assesses chemicals already in commerce based on environmental and/or health concerns. NICNAS assessment reports provide information and recommendations to regulators (including Commonwealth, States/Territories), industry and the general public. The development and operation of NICNAS represents significant capacity building in Australia for the management of chemicals.

2.1
3

Develop modular assessment fees
Exemptions – legislative framework in place – Record keeping and Annual reporting formats required

3.1 3.2 3.3 3.4 3.5
4

Transhipment Introduce exemption for low hazardous >100kg ’Without advice‘ cosmetics @ 1% or less Increase R&D to 100kg/12 months Increase low volumes for non-cosmetics to 100kg/12 months/introducer
Polymer regulation – legislative framework in place

✔ ✔ ✔ ✔ ✔

✔ ✔ ✔ ✔ ✔

4.1 4.2 4.3
5

Introduce legislative framework for audited self-assessment for PLCs Low hazard permit for polymers in low volume Introduce audited self-assessment for low regulatory concern polymers

✔ ✔ ✔

Cosmetic chemicals regulation – legislative framework in place

5.1 5.2 5.3

Self-assessment <10kg Advice for low hazard 10 to 100kg Amend definition of cosmetic to TPA Cosmetic/therapeutics interface

✔ ✔ ✔ ✔

The positive environmental effects of NICNAS assessment activities are outlined above.

5.4

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NICNAS ANNUAL REPORT 2004-05 111

NO

RECOMMENDATION

COMPLETED

BEING IMPLEMENTED

05/06 WORK PLAN

Types and Categories of NICNAS Assessments
New Chemicals: Industrial chemicals and polymers not listed in AICS New Chemicals
All new industrial chemicals must be notified to NICNAS, and an assessment certificate or permit obtained before they can be imported and/or manufactured in Australia. Certain new industrial chemicals are considered exempt from notifying to NICNAS but are subject to reporting requirements.

6

Controlled use – legislative framework in place

6.1 6.2
7

Introduce controlled use permits Export only
Incentives for the introduction of new and safer technologies – legislative framework in place

✔ ✔

7.1 7.2 7.3
8

Low hazard certificate Low volume/low risk category permits Low hazard permits for low volumes
International cooperation

✔ ✔ ✔ A new industrial chemical means an industrial chemical that is not a listed on the Australian Inventory of Chemical Substances (AICS). Some chemicals listed on the AICS may be subject to conditions of use. These chemicals are also defined as new industrial chemicals if their use is for other than that stated on AICS. A chemical that is a reaction intermediate or an incidentally produced chemical is not considered a new industrial chemical

8.1
9

Bilateral with Canada and the USA
Reducing the compliance burden – legislative framework in place

9.1 9.2 9.3
10

Administrative permit renewals Immediate AICS listing Guidance for definition of naturally occurring substance

✔ ✔ ✔

Certificates
New chemicals can only be introduced by the holder of an assessment certificate (unless the chemical is covered by a permit or under specific NICNAS exemptions). After five years and in some cases after assessment, the chemical is listed on AICS and is available for open use. The assessment report is provided to the notifier, who is able to use the report to support their responsibilities for control of the chemical, for example, State and Territory hazardous substances legislation, environmental legislation and Poisons Scheduling. The full public report, including recommendations on safe use, is available to the public on the NICNAS web site (www.nicnas.gov.au) and may be used by State and Territory agencies and in the workplace. Commercially sensitive information may be exempt from publication in the full public report, if the commercial interest outweighs the public interest. Summary reports of each assessment are published in the Commonwealth Chemical Gazette.

Safe use through compliance – legislative framework in place

10.1 10.2 10.3
11

Introduce mandatory registration Use of mandatory registration number Co-regulatory approach

✔ ✔ ✔

Access to chemical safety information – legislative framework in place

11.1
12

Update website/AICS annotation
Community participation

12.1 12.2 12.3

Establish community forum Develop a Community Right to Know Charter Develop a Community Engagement Strategy

✔ ✔ ✔

Standard Notification
Required for all new industrial chemicals and biopolymers where the volume of introduction is greater than 1,000 kg/year, and new polymers with a number-average molecular weight (NAMW) less than 1,000 daltons (except certain polyesters of low risk). This category requires the highest level of data including toxicological and ecotoxicological test data, chemical identity, physico-chemical properties, use pattern, occupational, environmental and public exposure information, environmental fate data, Material Safety Data Sheet (MSDS) and label.

Of 33 LRCC reform recommendations, nine only remain to be implemented. Seventy-three percent have been completed.

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NICNAS ANNUAL REPORT 2004-05 113

Limited Notification
These are required for all new industrial chemicals and biopolymers where the volume of introduction is less than 1,000 kg/year, and new polymers with a NAMW greater than 1,000 daltons. Standard data requirements are less than for a standard notification (includes chemical identity, physicochemical properties, use pattern, occupational, environmental and public exposure, MSDS and label), however, all available data must be provided.

Early Introduction Permit for Non - Hazardous Chemicals (EIP)
EIPs are available for the introduction of non-hazardous chemicals with respect to human health and the environment. Once an EIP is granted, the applicant may introduce the chemical according to permit conditions before the full assessment has been completed. Factors taken into account include reasonable protection of occupational health, public health and the environment.

Polymers of Low Concern (PLC)
These chemicals are defined by predetermined criteria to be of Concern (PLC) low hazard to humans and the environment. PLC can be introduced into Australia with reduced fees and reduced data requirements.

Research, development or analytical (RD&A) purposes
RD&A chemicals that are imported or manufactured in volumes not more than 100 kg/year do not require notification but are subject to annual reporting obligations*. At higher volumes, the same provisions apply as for other new chemicals and polymers. An exception applies in certain specific cases where an RD&A chemical is manufactured in Australia in situations where smaller volumes cannot be manufactured, for example, limitations on the size of equipment available for manufacture. In these cases, information must be provided to NICNAS on the type and location of the apparatus (a fixture), the program of work, type of chemical and procedures for safe disposal of the chemical and any hazardous degradation products.

Extension of original assessment certificate
The original assessment certificate can be extended to include other introducers, providing the original certificate holder agrees in writing. In addition to specific data requirements, new information on exposure or adverse health and environmental effects must also be provided.

Permits
Permits allow chemicals to be introduced conditionally, without a full assessment, providing certain information is provided on identity, hazard and exposure. MSDS and labels must also be provided. NICNAS assesses permit applications under shorter timeframes and reduced fees.

Self assessment
Audited self-assessment allows industry to self-assess low regulatory concern chemicals against specified criteria and provide an assessment report which is screened and adopted by NICNAS. This category is available for Polymer of Low Concern (PLC) and Non-hazardous chemicals and nonhazardous polymers other than PLC. The holder of a self assessment certificate must keep relevant records and report to the Director annually.

Commercial Evaluation Category (CEC)
Chemicals to be introduced solely for determination of their commercial potential are eligible for assessment as CECs. The application can be for introduction of up to 4,000 kg for up to two years provided that the quantity and timeframe requested by the notifier can be justified as necessary for commercial evaluation purposes. Data requirements include health and environmental effects information, chemical identity, use and distribution arrangements, volume and duration of introduction, occupational, environmental and public exposure, MSDS and label. Customer agreements must be provided for each proposed user of the chemical. Annual reporting obligations apply*.

Low volume exemptions
New industrial chemicals are exempt from notification if introduced: 1. at a port or airport in Australia, remains subject to the control of customs at the port or airport at all times and leaves Australia less than 30 days after the day of introduction. 2. in quantities of not more than 10 kg in a period of 12 months, is for cosmetic use, poses no unreasonable risk to occupational health, public health or the environment, and meets certain safeguards 3. in a cosmetic product at a concentration at 1% or less, and is non hazardous 4. in quantities not exceeding 100 kg in a period of 12 months, is for non-cosmetic use, and poses no unreasonable risk to occupational health, public health 5. in an amount that is greater than 10 kg but not exceeding 100kg in a period of 12 months, is for cosmetic use, and poses no unreasonable risk to occupational health, public health or the environment.

Low Volume Chemicals (LVC)
LVCs are available for chemicals introduced at 100 kg/year Data requirements include health and environmental effects information, chemical identity, use, volume and duration of introduction, occupational, environmental and public exposure, MSDS and label. The maximum LVC permit period is three years, with the provision for unlimited renewal. Annual reporting obligations apply*.

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NICNAS ANNUAL REPORT 2004-05 115

Note
Introducers under the low volume exemption category, self assessment, and certain permits must keep in writing, for 5 years after the introduction, all information available to the person about occupational health and safety, public health matters and the environmental effects of the chemical. In addition, introducers of chemicals in this category should complete an annual report form and return it to NICNAS before or on 28 September of the following registration year.

Sometimes related or similar chemicals are assessed as a group, and the assessment can focus on specific areas of concern. This flexibility in assessment ensures that NICNAS resources are targeted effectively to priority areas of concern.

Preliminary Assessments
Preliminary assessments are less detailed, tailored to the particular aspects that are the focus of the assessment. Preliminary assessments do not include a risk assessment. As with full assessments, preliminary assessments can apply to the chemical generally, or can focus on particular uses of the chemical, or on its manufacture, handling, storage or uses in a specified geographical area or in specified circumstances.

Existing Chemicals: Chemicals already in use in Australia Assessments
Assessments include screening assessments, PEC assessments (full, preliminary, and secondary), other assessments and international assessments. PEC assessments are comprised of assessment modules, with the modular make-up of each assessment varying depending on the scope of the assessment. The modules are: hazard assessment, exposure assessment, risk assessment/current controls, environment assessment, public health assessment, and recommendations/final draft report.

Secondary Assessments
Following the publication of a PEC assessment there may be changes in circumstances which necessitate a reassessment of particular aspects of the chemical. The secondary notification and assessment process is implemented when a new use of the chemical occurs or when significant new information about the health or environmental effects or circumstances of use of the chemical become available. Secondary assessments may also be required for new chemicals that have been assessed by NICNAS.

Screening Assessments
Chemicals to be considered for full or preliminary assessment are assessed by an expert agency panel against a set of criteria covering issues in public health, occupational health and safety and the environment. The data used for the screening comprise health and environmental hazard data plus exposure data submitted by industry in response to notice in the Chemical Gazette. Screening allows the chemicals to be included on the Candidate List on the basis of the perceived severity of the threat posed to human health or the environment. Results of screening assessments are made public.

International Assessment Programs - IPCS/CICADS; OECD/SIDS
There are two international assessment programs for existing chemicals under the auspices of the OECD and the IPCS. These programs coordinate international agreements on one assessment of a chemical, based on a draft assessment contributed by one of the participating countries, thereby avoiding duplication of the assessment by the other participating countries. The outcomes of international assessments are routinely considered by NICNAS. IPCS is a cooperative program of the World Health Organisation (WHO), the United Nations Environment Programme (UNEP) and the International Labour Organization (ILO). Concise CICADs are published under this program. They are summaries of relevant scientific information based on selected national or regional evaluation documents. The OECD SIDS program concentrates on the potential hazards of high production volume chemicals (HPV), which are defined as chemicals being produced in quantities of at least 1,000 tonnes per year in at least one OECD member country. In order to share the burden of testing and assessing these chemicals, member countries work together to cooperatively investigate HPV chemicals. Hazard assessment reports prepared by a country are available to all other member countries. The assessments are considered and member countries agree on conclusions about the hazards of the chemical and recommendations concerning the need for follow-up actions. The chemical industry plays a significant voluntary role in this program.

Other Assessments
This class of assessment provides for the fast collection and distribution of data on one or more aspects of a chemical that may be of concern, but which has not been declared a PEC. They serve the situation where there is an identified need for data on a chemical, but not necessarily for an evaluation of the data. Related or similar chemicals may be considered as a group. The draft reports are circulated for comment to interested parties before publication.

Full Assessments
Full assessments usually include information on chemical and physical properties, uses, exposure, kinetics and metabolism, effects on experimental animals and in vitro test systems, and human health effects. They include a hazard assessment and classification, a section on risk characterisation, risk management, and recommendations for safe use. Full assessments include an occupational, consumer and/or environmental risk assessment.

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New Chemicals Notification and Assessment Statistics
This appendix shows the number of new chemical submissions (total and assessment category) received and completed for 2004-05 (by quarter and total) and compares these to 2003-04 and 2002-03 figures. Data include our performance against statutory timeframes.

CERTIFICATE CATEGORY 1ST

2004-05 QUARTER 2ND 3RD 4TH

TOTAL 2004-05

TOTAL 2003-04

TOTAL 2002-03

Applications Received

STD LTD PLC Self Assessment PLC Extension

15 13 6 6
2

161 8 8 17 0
3

10 9 17 11 1
4

15 13 12 18 8
5

56 43 43 52
6

62 51 85 16
7

32 64 73 NA 10

10

19

10

TOTAL SUBMISSIONS 1ST

2004-05 QUARTER 2ND 3RD 4TH

TOTAL 2004-05

TOTAL 2003-04

TOTAL 2002-03

Certificates Issued

Applications Received - Certificates Applications Received - Permits Certificates Issued Permits Issued Total Certificates Active* (end of the final month) Total Permits Active* (end of the final month)
*

50 19 51 42 150 14

49 23 41 13 168 37

48 30 41 31 163 21

66 33 67
**

213 105 200 106 159 34

208 184 189 162 152 49

179 165 125 151 146
1

STD LTD PLC Self Assessment PLC Extension
2

16 17 8 7 3

8 10 11 8 4

11 8 6 13 3

21 16
8

66 51 41 39 13
3

31 54 93 4 11

18 45 54 NA 8

16 11 3

20 159 34

34

includes two secondary notification two notifications received under interim arrangements two notifications were not accepted as a self assessment PLC 4 three notifications were not accepted as a self assessment PLC and one notification was withdrawn 5 one notification was not accepted as a self assessment 6 only 45 accepted for assessment 7 received under the interim arrangement 8 includes two certificates issued without consent from notifier

Active includes all submissions accepted but not finalised (ie certificate or permit not signed). Active submissions may be in screening, under assessment, with the notifier for comment before publication of the final reports, or awaiting additional information from the notifier. ** Two certificates issued under section 38 (2) of the Act, without receipt of consent from notifier.

PERMIT CATEGORY 1ST

2004-05 QUARTER 2ND 3RD 4TH

TOTAL 2004-05

TOTAL 2003-04

TOTAL 2002-03

Applications Received

CEC LVC EIP
Permits Issued

8 5 6

5 6 12

4 8 18

9 11* 13

26 30 49

20 104 60

43 79 43

CEC LVC EIP
* includes 5 LVC permit renewal applications

6 27 9

6 2 5

17 9 5

5 8 7

34 46 26

13 88 61

51 61 39

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Assessment Performance Against Statutory Timeframes 2004-05 Including Comparison with 2003-04 and 2002-03
ALL ASSESSMENTS TARGET 1ST 2004-05 QUARTER 2ND 3RD 4TH 2004-05 TOTAL % 2003-04 % 2002-03 %

LIMITED NOTIFICATION

TARGET 1ST

2004-05 QUARTER 2ND 3RD 4TH

2004-05 TOTAL %

2003-04 %

2002-03 %

Certificates issued Reports to notifier within statutory timeframes 90 days 90 days not met; EIP issued prior 7 days

17
*

10

8 9/9 NA

16 9/10 NA

51 45/46 NA

-98 --

-78 --

-90 --

17 /17 10/10 NA NA

Certificates and permits issued Reports to notifier within statutory timeframes 90 days (all categories except Extension) 45 days (Extension) 90 days not met; EIP issued prior Certificates issued (upon receipt of notifier‘s reply to final reports) Permits issued within statutory/ non-statutory timeframes 7 days

93

54

72

87

306

--

-88

-94

44/44 32/32 38/38 46/50

160/164 98

5/5 NA

5/5 NA

1/1 NA

4/4 NA

15/15 NA

100 --

67 --

100 --

Certificates issued (upon receipt of notifier’s reply to final reports)

17/17 10/10

8/8

14/16**

49/51

96

89

96

NA – not applicable due to either (i) EIP not sought or (ii) 90 day statutory timeframe met. * included one secondary notification. ** included two certificates issued without consent from the notifier.

50/51 41/41 41/41 65/67

197/200 99

87

90
POLYMER OF LOW CONCERN TARGET 1ST 2004-05 QUARTER 2ND 3RD 4TH 2004-05 TOTAL % 2003-04 % 2002-03 %

14 days (CEC) 6/6 20 days (LVC) 27/27 28 days (EIP) 9/9

6/6 2/2 5/5

17/17 9/9 5/5

5/5 8/8 7/7

34/34 46/46 26/26

100 100 100

100 100 95

96 97 97

Certificates issued Reports to notifier within statutory timeframes 90 days 90 days not met; EIP issued prior 7 days

15

19

19

27

80 68/69 NA

-99 --

-95 --

-98 --

13/13 12/12 22/22 21/22 NA NA NA NA

NA – not applicable due to either (i) EIP not sought or (ii) 90 day statutory timeframe met. STANDARD NOTIFICATION TARGET 1ST 2004-05 QUARTER 2ND 3RD 4TH 2004-05 TOTAL % 2003-04 % 2002-03 %

Certificates issued Reports to notifier within statutory timeframes 90 days 90 days not met; EIP issued prior 7 days

16

8

11 7/7 NA

21 16/18 NA

56 47/49 NA

-96 --

-83 --

-94 --

14/14 10/10 NA NA

Certificates issued (upon receipt of notifier’s reply to final reports)

14/15 19/19 19/19 27/27

79/80

99

86

96

NA – not applicable due to either (i) EIP not sought or (ii) 90 day statutory timeframe met.

Certificates issued (upon receipt of notifier’s reply to final reports)

16/16

8/8

11/11 21/21

56/56

100

87

89

NA – not applicable due to either (i) EIP not sought or (ii) 90 day statutory timeframe met.

120 NICNAS ANNUAL REPORT 2004-05

NICNAS ANNUAL REPORT 2004-05 121

CERTIFICATE EXTENSION

TARGET 1ST

2004-05 QUARTER 2ND 3RD 4TH

2004-05 TOTAL %

2003-04 %

2002-03 %

Certificates issued Reports to notifier within statutory timeframes Certificates issued (upon receipt of notifier’s reply to final reports) 45 days

3 5/5

4 5/5

3 1/1

3 4/4

13 15/15

-100

-67

-100

Confidential Listing of Chemicals on the Australian Inventory of Chemical Substances
Technical Advisory Group (TAG) Terms of Reference and Membership
The Technical Advisory Group will: (a) taking into account the prepared guidance material, advise the Director during consideration of commercial and public interest in applications for continued confidential listing in respect of the AICS; (b) assist in reviewing the prepared guidance material for industry and the public outlining the information needed to accompany applications for continued confidentiality in respect of the AICS; (c) recognising the confidential nature of the proceedings, adopt a special role in identifying and assessing the public interest associated with reviewing applications for confidential listing on the AICS; (d) as required advise the Director on weighing of commercial interest and public interest; (e) have no decision making powers under the Industrial Chemicals (Notification and Assessment) Act 1989; and (f) be bound by prohibition of disclosure of confidentiality clauses within the Industrial Chemicals (Notification and Assessment) Act 1989.

7 days

3/3

4/4

3/3

3/3

13/13

100

82

25

COMMERCIAL EVALUATION CATEGORY

1ST

2004-05 QUARTER 2ND 3RD 4TH

2004-05 TOTAL %

2003-04 %

2002-03 %

Permits issued Permits issued within non-statutory timeframes (14 days)
LOW VOLUME CHEMICALS

6 6/6

6 6/6

17 17/17

5 5/5

34 34/34

-100

-100

-96

1ST

2004-05 QUARTER 2ND 3RD 4TH

2004-05 TOTAL %

2003-04 %

2002-03 %

TAG Membership
Professor Graham A R Johnston AM FRACI, FTSE (re-appointed October 2004) Professor of Pharmacology, University of Sydney Professor Ian Rae FRACI, FTSE (re-appointed October 2004)

Permits issued Permits issued within statutory timeframes (20 days)

27 27/27

2 2/2

9 9/9

8 8/8

46 46/46

-100

-100

-97

Department of History and Philosophy of Science, University of Melbourne
EARLY INTRODUCTION PERMIT 2004-05 QUARTER 2ND 3RD 4TH 2004-05 TOTAL % 2003-04 % 2002-03 %

Dr Mariann Lloyd-Smith (re-appointed October 2004) Co-ordinator,

1ST

National Toxics Network Canberra
Mr James Smith CEng, FIChemE, BCom (Melb) (re-appointed October 2004) Chemicals Advisor, Melbourne

Permits issued Permits issued within statutory timeframes (28 days)
<10KG PER YEAR EXEMPTION CATEGORY

9 9/9

5 5/5

5 5/5

7 7/7

26 26/26

-100

-95

-97

2004-05 meetings
2001-02 2002-03 2003-04 2004-05

Cosmetic Non-cosmetic Total

276 12 288

388 34 422

396 19 415

104 51 155

The Technical Advisory Group met three times in 2004-05. All three meetings were held at the NICNAS office. The TAG finalised 7 confidential chemical applications and Guidelines for "Establishing a Case for Confidential Listing of Chemicals on the Australian Inventory of Chemical Substances" and associated application form. The Final Guidelines for "Establishing a Case for Confidential Listing of Chemicals on the Australian Inventory of Chemical Substances" and associated application form were published on the NICNAS website in January 2005.

122 NICNAS ANNUAL REPORT 2004-05

NICNAS ANNUAL REPORT 2004-05 123

Summary of Existing Chemicals Assessment Activity
JUL-SEP 2004 OCT-DEC JAN-MAR APR-JUN 2004 2005 2005

Screening and Other Assessments
JUL-SEP 2004 OCT-DEC 2004 JAN-MAR 2005 APR-JUN 2005

New assessments commenced in quarter Number under review

0 1

5 1

3 1

32 26

New declarations in quarter Number under review/review published Data gathering phase Assessment phase • Uses • Hazard assessment completed • Exposure assessment completed • Risk assessment/current controls completed • Environment report completed by DEH • Recommendations/final draft report completed Consultation (corrections/variations) Appeals Publication phase Total Number published (and number within statutory deadline) No. PEC Safety Info Sheets published Data call-ins

3 4/0 2 4 1 0 0 0 0 0 0 0 0 0 0 2

1 4/0 2 4 2 0 0 0 2 1 0 0 0 0 0 2

1 5/0 2 5 0 1 1 1 1 0 0 0 0 0 0 2

3
Assessment phase

5/0 4 5 1 1 1 1 1 2 3 0 0 0 0 2

1st assessment module completed Recommendations/module completed No. of reports released for comments Total number published/completed

0 0 0 0

1 1 3 5

1 2 0 1

29 29 1 34

124 NICNAS ANNUAL REPORT 2004-05

NICNAS ANNUAL REPORT 2004-05 125

List of screening/other chemical assessments in publication phase, published or otherwise completed under the Existing Chemicals Program 2004-05
CHEMICAL CAS NO./ABBREV.

Candidate List of Chemicals
NICNAS undertakes a process of consultation with its stakeholders and the general public on chemicals to be assessed. At any time anyone may nominate a chemical for assessment, and from time to time NICNAS calls for nominations by advertisement in the press. Nominated chemicals are screened according to published criteria and are either selected for assessment and placed in the Candidate List, or not selected. A summary of the results of screening and reasons for not selecting a chemical are published in the Chemical Gazette. The Candidate List also includes a Standby Section containing chemicals with either international assessments currently underway, additional testing being conducted in other countries or with insufficient data. This list is reviewed annually against new published literature, chemical databases, and government/agency Internet sites for new information. As a result, chemicals are either moved into the main section of the Candidate List or removed from consideration. In the latter case, a summary of the results of screening and reasons for non-selection are published in the Chemical Gazette. From time to time chemicals are selected from the Candidate List for assessment, and recommended to The Minister for declaration following consultation with industry.

Options for Disposal of Perfluorooctane Sulfonate (PFOS) Perfluorooctanoic Acid and its Derivatives Short-Chain Chlorinated Paraffins in Metal Working Fluids Current Activities on Polybrominated Flame Retardants Current Australian Use and Regulatory Activities on Polybrominated Flame Retardants 6 NDPSC submissions assessed
Health effects profile of 1 chemical for TGA

Various 335-67-1 Various Various Various Various

25 phthalates: Diethylhexyl phthalate Diisodecyl phthalate Diisononyl phthalate Dibutyl phthalate Butylbenzyl phthalate Di-n-octyl phthalate Di-n-hexyl phthalate Diethyl phthalate Dimethyl terephthalate Diallyl phthalate Diisoundecyl phthalate Di-C7-9-phthalate Diundecyl phthalate Diisotridecyl phthalate Ditridecyl phthalate Di-C9-11-phthalate Diisoheptyl phthalate Dimethyl phthalate Diisobutyl phthalate Diisooctyl phthalate Diisohexyl phthalate Dicyclohexyl phthalate Dinonyl phthalate Di-C6-10-phthalate Bis (2-methoxyethy) phthalate Perfluoroalkyl sulfonate Polyvinyl acetate Iron Carbonyl
126 NICNAS ANNUAL REPORT 2004-05

DEHP DIDP DINP DBP BBP DnOP DnHP DEP DMT DAP DIUP di-C7-9 DUP DiTDP DTDP di-C9-11 DiHepP DMP DiBP DIOP DIHP DCHP DNP di-C6-10 DMEP 9003-20-7 13463-40-6

Candidate List of Chemicals
CHEMICAL CAS NO

Various Azo dyes Not assigned Alkyl phenol ethoxylates (including the specific chemicals listed): - Nonyl phenol ethoxylate 9016-45-9 - Nonyl phenol ethoxylate blend 63496-57-1 - Octylphenolethoxylate 9036-19-5 1,3 butadiene 106-99-0 Bismuth oxychloride 7787-59-9 t-butyl alcohol 75-65-0 Carbon disulphide 75-15-0 N,N-Dimethylformamide 68-12-2 Epichlorohydrin 106-89-8 Ethylene oxide 75-21-8 Di(2-ethylhexyl) adipate 103-23-1 Hydroquinone 123-31-9 Isocyanates (including the specific chemicals Listed): 2,4 TDI 584-84-9 2,4’-MDI 5873-54-1 2,6 -TDI 91-08-7 4,4’-MDI 101-68-8 Polymethylene polyphenylene isocyanate 9016-87-9 Isopropyl alcohol 67-63-0 Mercury compounds Methyl ethyl ketone peroxide 1338-23-4
NICNAS ANNUAL REPORT 2004-05 127

Methyl ethyl ketone Methyl methacrylate Methyl tert butyl ether Methylene chloride N-methyl pyrrolidone Naphthalene Peracetic acid Phenolphthalein Phthalates (including the specific chemicals listed): diethylhexyl phthalate (DEHP) Diethylphthalate (DEP) Dibutylphthalate di isodecyl phthalate (DIDP) di isononyl phthalate (DINP) butylbenzyl phthalate (BBP) dimethyl phthalate (DMP) dicyclohexyl phthalate di-n-hexyl phthalate di-n-pentyl phthalate di-n-propyl phthalate Polyvinyl acetate Sodium hydroxide Sodium hypochlorite Styrene 1,1,1,2-Tetrafluoroethane Tetrafluoroethylene Toluene Triethanolamine Triethylene tetramine Xylene – mixed isomers o – Xylene p – Xylene m - xylene

78-93-3 80-62-6 1634-04-4 75-09-2 872-50-4 91-20-3 79-21-0 77-09-8 117-81-7 84-66-2 84-74-2 26761-40-0 28553-12-0 85-68-7 131-11-3 84-61-7 84-75-3 131-18-0 131-16-8 9003-20-7 1310-73-2 7681-52-9 100-42-5 811-97-2 116-14-3 108-88-3 102-71-6 112-24-3 1330-20-7 95-47-6 106-42-3 108-38-3

Partnership Agency Assessment Performance
Australian Government Department of Environment and Heritage (DEH)
The DEH provides advice to NICNAS on the environmental implications of the importation, manufacture and use of new and existing industrial chemicals. The assessment reports submitted to NICNAS include an environmental hazard and risk assessment, including recommendations for the control measures necessary to minimise adverse environmental effects resulting from the stated use patterns of the chemicals. A summary of chemical assessment reports completed by DEH during 2004-05 is shown in the table below.

Assessments completed by DEH in 2004-05 compared with 2003-04
ASSESSMENT CATEGORY NUMBER OF ENVIRONMENT ASSESSMENT REPORTS SENT TO NICNAS 2003-04 2004-05

Standard Notification Limited Notification Polymer of Low Concern (PLC) Self Assessment Polymer of Low Concern Extensions/Secondary Notifications
Subtotal

35 66 99 NA 11
211

48 65 61 18 10
202

Commercial Evaluation Permit (CEC) Low Volume Chemical Permit (LVC) Early Introduction Permits (EIP)
Subtotal TOTAL New Chemicals

1 10 Not available*
11 222

2 7 Not available*
9 211

Table 2 Standby Section of Candidate List Chemical
Chromium (VI) compounds (including the specific chemicals listed): Lead chromate 7758-97-6 Lead sulphochromate 1344-37-2 Zinc chromate 13530-65-9 1-Napthalenamine 134-32-7 1-Napthalenamine, N-phenyl 90-30-2 2-Naphthalenamine 91-59-8 2-Naphthalenamine, N-phenyl 135-88-6 Tricresol phosphate 1330-78-5 Nickel 7440-02-0 Nickel oxide 1313-99-1 Nickel sulphate 7786-81-4

Priority Existing Chemical Reports
* See Appendix 8 for data on EIPs # Of these, two assessment reports were not finalised

-

-

128 NICNAS ANNUAL REPORT 2004-05

NICNAS ANNUAL REPORT 2004-05 129

List of Chemicals that had Agreed International Assessments
CHEMICAL NICNAS REVIEW

CHEMICAL

NICNAS REVIEW

SIAM 19
1

High Molecular Weight Phthalate Esters (HMWPE) 1,2-benzenedicarboxylic acid, di-2-propylheptyl ester Ditridecyl phthalate Di-undecyl phthalate Phthalic acid, di-C7-9-branched & linear esters Phthalic acid, di-C9-11-branched & linear alkyl esters Phthalic acid, di-C11-14-branched alkyl esters C13 rich Diundecyl phthalate, branched and linear esters Alkanes, C14-17, chloro Terephthalic acid, bis(2-ethylhexyl) ester 2-Hydroxy-3-naphthoic acid Phosphorous trichloride p-Phenylenediamine, N-phenyl2-Oxepanone Ethanol Monoethylene glycol ethers 2-Butoxyethyl acetate Ethanol, 2-(hexyloxy)Ethanol, 2-propoxy 2-Butoxyethanol Silane, trimethoxy(3-(oxiranylmethoxy)propyl)Sodium dithionite Methanol Higher Olefins 1-Octadecene Hexadecene Hexene Hepten Octene Dodecene Nonene -1Alkenes C10-13 Decene But-2-ene, 2-methyl Isobutanol Amorphous silica silicates Silica Silica amorphous fumed, crystalline-free Silica gel, precipitated, crystalline-free Silicic acid, aluminum sodium salt Silicic acid, calcium salt
1

Yes Yes Yes Yes Yes Yes Yes

Butenes 1-Butene Butene, mixed -1- and -2- isomers cis-2-Butene trans-2-Butene 2-Methylpropene Butene, mixed isomers Phosphoryl trichloride Diammonium sulfate Urea, N,N-(2-methylpropylidene)bis Naphthalene, 1,2,3,4-tetrahydro Choline, chloride Aniline, 2-methyl Diphenyl carbonate Diallyl phthalate Ethanol, 2,2'-thiodiEthanol, 2-tert-butoxyIron dichloride Phenol Thiophene,tetrahydro-, 1,1-dioxide
SIAM 20

Yes

Yes Yes

Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes Yes Yes Yes

SIDS (OECD Screening Information Data Set) Initial Assessment Meeting

Linear Alkylbenzene Sulfonates Benzenesulfonic acid, decyl-, Na salt Benzenesulfonic acid, dodecyl-, Na salt Benzenesulfonic acid, tridecyl-, Na salt Benzenesulfonic acid, undecyl-, Na salt Benzenesulfonic acid, mono-C10-16-alkyl Benzenesulfonic acid, C10-13-alkyl derives C10-14 Alkyl deriv benzene sulfonic acid, sodium salt Benzenesulfonic acid, mono-C10-14-alkyl Benzenesulfonic acid, mono-C10-13-alkyl derives., sodium salts 4-C10-13-sec Alkyl deriv benzene sulfonic acid, sodium salt Aniline, 3,4-dichloroEthanol, 2-mercapto2-Furanmethanol, tetrahydro3-Buten-2-one, 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)Toluene, 4-chloroTetrabromo bisphenol A Phthalimide 1,3-Isobenzofurandione isopropyl acetate Isobutyl isobutyrate Phthalic acid, bis(2-ethylhexyl) ester Isoprene Ethane, pentafluoro-

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes Yes Yes Yes

130 NICNAS ANNUAL REPORT 2004-05

NICNAS ANNUAL REPORT 2004-05 131

CHEMICAL

NICNAS REVIEW

Yes Yes Yes Yes Yes Yes Yes Yes Yes

186.40

314.10 672.70

125.85 683.03

227.3 3 5.35 11.35 14.05 11

181.5 82.40 7.5 4.8 0.5 28.6

40.1

13.25

2 3

Business Management & Commuication

Concise International Chemical Assessment Document

SUB TOTAL Business Management & Commuication

International Programme on Chemical Safety

132 NICNAS ANNUAL REPORT 2004-05

NICNAS ANNUAL REPORT 2004-05 133

*all handled within Servuce Charter timeframes

Yes Yes Yes Yes Yes

182 2029

212 880

TOTAL No. OF CALLS RECEIVED

2909 NICNAS Registration Tier 1

• NICANAS Reg. Tiers 2 & 3

• NICANAS Reg. Tiers 2 & 3

Existing Chemicals

273 205 17 16 1 45

679 25 16 138 53 38

447

88

451

23

Existing Chemicals

• New Chemicals • General NICNAS • Public • AICS • Registration • LRCC

• New Chemicals • AICS • LRCC • General NICNAS • Public • Registration

New Chemicals

New Chemicals

• General/Public

• General/Public

SUB TOTAL TOTAL

Compliance

Compliance

• PEC

• PEC

1355.73

TOTAL HOURS SPENT

WRITTEN

TELEPHONE

98.73

Yes

NICNAS Enquiries Yearly Summary July 2004 – June 2005

• Telephone (Call centre and NICNAS, general & technical) Total number of calls received 7479* • Written/Email Written 130* Email 1200*

Alkyl ketene dimers Fatty acids, tallow, hydrogenated, dimers, diketene derives 2-Oxetanone, 3-C12-16-alkyl-4-C13-17-alkylidene derivs Malonates Diethyl malonate Dimethyl malonate C.I. Pigment Green 7 Potassium sodium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino] -1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis (2-hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-, dipotassium salt Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis (2-hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-, disodium salt Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis (2-hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]Sodium nitrite Disodium sulfate Persulfates Dipotassium peroxydisulphate Diammonium peroxydisulfate Disodium peroxydisulfate Disodium carbonate, compound with hydrogen peroxide (2:3) 2-Hydroxyethyl acrylate Acrylic acid, monoester with 1,2-propanediol Cyclohexane, 1,1'-methylenebis[4-isocyanatotris-(2-Chloro-1-(chloromethyl)ethyl) phosphate Phosphoric acid, 2,2-bis(chloromethyl)-1,3-propanediyl tetrakis(2-chloroethyl) IPCS2 CICAD3 PROGRAM Brominated Phenols Heptachlor Tin and inorganic tin compounds Butyl acetates 2-Butoxyethanol

Inquiry Statistics
% GREATER THAN 28 DAYS NOT APPLICABLE

Yes Yes
%

27.3

8.8 3.9

2.7

4.3

1.9 6.9 4 61 25.0 15.6 53 137 73.1 77.5 155 682 2.2 1

2.2 4.9

Yes

FINALISED WITHIN 28 DAYS

4 16.0

NO.

24 8

24

12

1

2.7 33.3

%

5.3

6.8

20.9 7.8 5.9

0.7

13.0

6.3 8.0

0.9

9.3

ACKNOWLEDGED OR FINALISED WITHIN 7 DAYS

5 99

NO.

1

2

6

57 16 1

43 2

4

42

3

%

93.7 92.0 100.0 99.3 100.0 94.7

95.1 94.3

65.9

70.3 88.3 94.1 100.0 100.0 97.8

99.1

88.0

82.6

COMPLETED WITHIN 24 HOURS

NO.

173 1914

636 23 16 137 53 36

192 181 16 16 1 44

58

443

397

19

2596

89.2

236

8.1

77

2.6

Presentations, Conferences, Harmonisation and International Meetings and Site Visits undertaken by NICNAS
Presentations at Australian conferences
Deborah Willcocks Case study: HHRA of Benzene, Science Forum 3:

Presentations at overseas conferences
Bob Graf Chemicals Regulation in Australia, NICNAS and New Industrial Chemicals NICNAS - Reform Initiatives, Japan Chemical Industry, Tokyo, JAPAN, 7 March 2005 Deborah Willcocks Canada/Australia: Issues being faced in the regulation of

The Practice of Human Health Risk Assessment in Australia, Canberra, ACT, 30 July 2004
Deborah Willcocks Monitoring and Profiling Precursor Chemicals,

nanomaterials, OECD Special Session on the Potential Safety Implications of Nanomaterials, Paris, FRANCE, 7 June 2005

Presentations at training activities
Eighth National Chemical Division Conference, 19 October 2004
Margaret Hartley Overview of the Current Regulatory Landscape, Australian Consumer and Specialty Products Association (ACSPA) AGM and Industry Seminar, Sydney, NSW, 2 December 2004 Roshini Jayewardene Regulatory Issues with Novel Excipients, Australian Society of Cosmetics Chemists, Thirty ninth Annual Conference, Brisbane Convention Centre, QLD, 18 March 2005 Sneha Satya Review of Environmental Risk posed by Sodium Cyanide, Good Practice Cyanide Management in the Gold Industry, ACMER, 12 April 2005 Roshini Jayewardene The Journey so far… Review of products at the Hana Hamdan Customs Broker Training, NICNAS training seminar, Sydney, NSW, 24 November and 26 November 2004. Customs Broker Training also presented in Perth, WA, 13 December and 14 December 2004 Neil Buck & Associates Industry Information Sessions, NICNAS training

seminar, Adelaide, SA, 14 December 2004 Industry Information Sessions also presented in: • Melbourne, VIC, 15 December 2004 and 3 - 4 March 2005 • Brisbane, QLD, 8 March 2005 • Adelaide, SA, 10 March 2005
Bob Graf LRCC changes to the Act, PACIA, Sydney, NSW, 9 December 2004 Jane Weder Sources of Information in Toxicology, University of Sydney

cosmetic-therapeutic interface: Cosmetic or Medicine?, ACCORD seminar, Sydney, NSW, 18 April 2005. Also at Victorian Employers Chamber of Commerce and Industry, Melbourne, VIC, 19 April 2005
Deborah Willcocks Public and Occupational Risk Assessment - NICNAS,

School of Public Health (Short course on toxicology), Sydney NSW, 22 February 2005
Hana Hamdan, Bob Graf

NICNAS, New Chemicals and Reform Activities, June 2005

Clean Air Society, Australia, New Zealand Risk Assessment Workshop, Hobart, TAS, 3 May 2005
Bob Graf NICNAS Overview of Current Regulatory Landscape for Industrial

Internal training presentations
Sami Syed, Lewis Norman

Safety at work, our first priority, 17 August 2004,
Phil Burge

Chemicals, HAZMAT 2005, Sydney, NSW, 12 May 2005
Deborah Willcocks Nanotechnology and Nanomaterials, National Drugs and

OHS Legislation for Commonwealth Employees, 5 May 2005

Poisons Scheduling Committee meeting, Canberra, ACT, 23 June 2005

134 NICNAS ANNUAL REPORT 2004-05

NICNAS ANNUAL REPORT 2004-05 135

Conferences attended
30 July 2004 1 - 6 August 2004 Science Forum 3, Shine Dome, Canberra, ACT World Congress of Clinical Pharmacology and Therapeutics, Brisbane, QLD IPCS Uncertainty in Exposure Assessment meeting, Geneva, SWITZERLAND Seventeenth International Symposium on Epidemiology in Occupational Health, Melbourne, VIC The Safety Show Sydney 2004, Sydney, NSW Mineral Council of Australia: Inaugural Global Sustainable Development Conf. Melbourne, VIC Skin Science and Advances in Aesthetic Therapies Symposium, Brisbane, QLD Good Practice Cyanide Management in the Gold Industry, ACMER, Perth, WA CASANZ Risk Assessment Workshop, Hobart, TAS Seventeenth International Clean Air & Environment Conference, Hobart, TAS PACIA 2005 Conference, Sydney, NSW

26 November 2004

Interdepartmental meeting on Nanotechnology, Canberra, ACT NEPC Tier 2 Air Toxics Working Group Meeting, Melbourne, VIC DEH Indoor Air Quality Health Experts Workshop, Canberra, ACT Volatile Organic Compounds, DEH Indoor Air Quality Health Experts Workshop, Canberra, ACT EU Draft Chemicals Legislation Meeting of Australian Stakeholders, Canberra, ACT National Working Group on the Diversion of Chemical Precursors, Canberra, ACT Meeting to brief LRCC Cosmetic Working Group on the progress of the Interface project, Sydney, NSW Meeting with Fuel Quality Standards, DEH to discuss regulatory controls for tetraethyl lead (TEL), tetramethyl lead (TML), Canberra, ACT Inter-Departmental Meeting for a debrief of the Rotterdam Convention First Chemical Review Committee Meeting, Canberra, ACT Meeting with NATA, to discuss GLP requirements, Sydney, NSW Canada Bilateral, Teleconference Chemicals Clearing House Meeting, Canberra, ACT Meeting with International Zinc Association on the EU Risk Assessment of Zinc, Canberra, ACT Tier 2 Air Toxics Working Group meeting, Adelaide, SA University of Sydney External Advisory Committee, Sydney, NSW

30 Nov - 1 Dec 2004

19 - 20 August 2004

1 - 2 December 2004

13 - 16 October 2004

1 - 2 December 2004

15 October 2004 28 October 2004

28 January 2005

9 February 2005

16 March 2005

3 March 2005

12 - 13 April 2005

10 March 2005

3 May 2005 4 May 2005

10 March 2005

7 June 2005

15 March 2005

Other meetings in Australia
26 July 2004 NOHSC AD Hoc Working Group meeting to discuss exposure standards for certain chemicals, Melbourne, VIC Privacy Contact Officer Meeting, Canberra, ACT Inter-Departmental Meeting to discuss Poly Brominated Flame Retardants (PBFRs) Canberra, ACT NEPC Tier 2 Air Toxics Working Group Meeting, Adelaide, SA Twelfth NOHSC Chemical Standards Sub Committee Meeting, Canberra, ACT 15 March 2005 6 April 2005 7 April 2005

20 August 2004 21 October 2004

11 - 12 April 2005

28 October 2004

28 April 2005

23 November 2004.

136 NICNAS ANNUAL REPORT 2004-05

NICNAS ANNUAL REPORT 2004-05 137

5 May 2005

Chemicals Standards Sub Committee, Canberra, ACT Meeting with ERMA NZ, NICNAS, Sydney, NSW Teleconference with Fuel Quality Branch, DEH, Sydney, ACT Chemical Clearinghouse Meeting, Canberra, ACT Tier 2 Air Toxics Working Group meeting, Sydney, NSW Joint Standing Committee On Treaties Hearing regarding addition of TEL and TML to the Rotterdam Convention, Canberra, ACT Low Hazard Criteria for Low Volume Chemical Category Working Group Meeting, Sydney, NSW Low Risk Criteria for Controlled Use Permit Work Group Meeting, Sydney, NSW NSW PACIA meeting, Sydney NSW

Site Visits (not compliance-related)
25 August 2004 25 August 2004 26 August 2004 26 August 2004 Australian Automotive Air Pty Ltd, Croydon, VIC Henkel Australia Pty Ltd, Kilsyth, VIC Dulux Australia (Orica Australia Pty Ltd), Clayton, VIC PPG Industries Australia Pty Ltd at Toyota Painting Operations, Altona, VIC Hercules Polymers, Springvale, VIC Blue Scope Steel, Port Kembla, NSW SNF (Australia) Pty Ltd to discuss Acrylamide, Lara, VIC Nalco Australia Pty Ltd, Sydney, NSW Duromer Products Pty Ltd, Rhodes, NSW Sunrise Dam Gold Mine regarding the PEC assessment of sodium cyanide, between Laverton and Kalgoorlie, WA Granny Smith Gold Mine regarding the PEC assessment of sodium cyanide, between Laverton and Kalgoorlie, WA

11 May 2005 26 May 2005

27 May 2005 30 - 31 May 2005

30 August 2004 16 December 2004 3 February 2005

20 June 2005

27 June 2005

29 May 2005 28 June 2005 28 June 2005

27 June 2005

28 June 2005

Meetings for International Harmonisation
28 Sept - 1 Oct 2004 Twelfth Final Review Board Meeting on Concise International Chemical Assessment Documents (CICAD), Hanoi, VIETNAM (Deborah Willcocks)

29 June 2005

Industry consultations
14 February 2005 Teleconference with OECD Steering Group for Nanotechnology (Deborah Willcocks) OECD New Chemicals Task Force Steering Group Meeting, Tokyo, JAPAN (Bob Graf) Teleconference with OECD Steering Group for Nanotechnology (Deborah Willcocks) Teleconference with OECD Steering Group for Nanotechnology (Deborah Willcocks) OECD Twentieth SIDS Initial Assessment Meeting, Paris, FRANCE (Sneha Satya) 15 July 2004 11 Feb 2005 Meeting with ACSPA (now ACCORD) re Interface project Teleconferences with Industry Consortia and Soap and Detergents Association in US to discuss the joint assessment of Hydrotrope surfactants in the OECD SIDS Program Teleconferences with Industry Consortia and Soap and Detergents Association in US to discuss joint assessment of Hydrotrope surfactants Teleconference with Industry Consortia and Soap and Detergents Association in US to discuss hydrotrope surfactants assessment

8 - 9 March 2005

2 July 2004

11 March 2005

29 March 2005

19 - 21 April 2005

16 July 2004

138 NICNAS ANNUAL REPORT 2004-05

NICNAS ANNUAL REPORT 2004-05 139

29 July 2004

Meeting with Ciba Specialty Chemicals Pty Ltd to discuss issues relating to impurities in Triclosan, Sydney, NSW Meeting with Australian Wood Panel Association to discuss formaldehyde assessment, Sydney, NSW Meeting with Cosmetics, Toiletries and Fragrance Association regarding phthalates call for information/comments, Sydney, NSW Meeting with Plywood Association of Australasia to discuss formaldehyde assessment, Sydney, NSW Meeting with Australian Funeral Directors Association and Australian Institute of Embalming to formaldehyde assessment, Melbourne,VIC Meeting with Australian Wood Panel Association to discuss formaldehyde assessment, Sydney, NSW Meeting with 3M to discuss perfluorooctane sulfate (PFOS) waste disposal options, Sydney, NSW Teleconference with Industry Consortia and Soap and Detergents Association in US to discuss joint assessment of Hydrotrope surfactants, Sydney, NSW Meeting with Minerals Council Australia, Australian Gold Council, Newmont, Anglogold and Placer Dome Asia Pacific gold mines to discuss sodium cyanide assessment, Canberra, ACT Meeting with Australian Paint Manufacturers Federation to discuss biocides in paint and sensitisation potential, Sydney, NSW Teleconference with Industry Consortia and Soap and Detergents Association in US to discuss joint assessment of Hydrotrope surfactants, Sydney, NSW

24 February 2005

Teleconference with Industry Consortia and Soap and Detergents Association in US to discuss joint assessment of Hydrotrope surfactants, Sydney, NSW Meeting with Mr Leo Hyde, Mr David Bennie, DuPont Australia to discuss Teflon, Sydney, NSW Meeting with 3M to discuss perfluorooctane sulfonate (PFOS) and perfluoroalkyl sulfonate (PFAS), Sydney, NSW Meeting with Australian Paint Manufacturers Federation (APMF) to discuss Lead in Paints, Sydney, ACT Meeting with Afton Chemical on US Tier 2 testing of MMT, Sydney, NSW Meeting with Australian Gold Council, Minerals Council Australia and Anglogold, Newmont and Newcrest mines to discuss sodium cyanide assessment, Sydney, NSW Meeting with Australian Paint Manufacturers Federation (APMF) to discuss Lead in Paints, Sydney, NSW Meeting with stakeholders to present the findings of the formaldehyde risk assessment, Sydney, NSW and Melbourne, VIC

23 August 2004

28 February 2005

30 August 2004

11 March 2005

2 September 2004

12 May 2005

7 September 2004

24 May2005

15 September 2004 15 October 2004

10 June 2005

5 November 2004

30 June 2005

22 November 2004

20, 21 June 2005

7 December 2004

8 December 2004

140 NICNAS ANNUAL REPORT 2004-05

NICNAS ANNUAL REPORT 2004-05 141

NICNAS New and Revised Publications and Media Coverage
Information
NICNAS Annual Report 2003-04 NICNAS Operational Plan 2004-05 Chemical Gazette

NICNAS Media Coverage 2003-04: Highlights
Print
SMH Good Weekend 10 July 2004, pages 36-7, 'Something to sweat about?', article on parabens Chemistry in Australia July, 2004, p 38, 'LRCC reform initiative' Regulatory Rapporteur, Vol 1, No 7, July 2004, 'International Focus: Australia: Understanding chemicals regulation - the role of the Office of Chemical Safety' Sydney Morning Herald, health & science, 12 August 2004, p7, 'All in a lather' - article on sodium lauryl sulfate with quotes from Dr Jayewardene PACIA News, August 2004, pages 9-10, 'LRCC Bill 2004 Passed; Chemical Gazette' PACIA News, October 2004, page 11 'Latest NICNAS Gazette' PACIA News, November 2004, page 11, 'Latest NICNAS Gazette'

Format (web, print, etc.)
Available in PDF and on the web site, and in printed format. Available in both electronic and printed format. Available on the web site, in email alert subscription, and print on request. There is also the option of having the whole gazette emailed in a PDF file for those who only have email in their workplace, not internet access. Four information sheets are available on the web site and in print on request. All available for completion and printing from the website, or printed on request. Available in PDF on the web site. Print copies are available on request at a cost of $55 each.

Existing Chemical Info Sheets Forms Handbook for Notifiers

New Chemical Assessment Reports There are 234 new reports on the NICNAS web site. Hard copy provided to libraries (but numbers are limited). NICNAS Alerts NICNAS matters issues 11,12,13 NICNAS Registration Service Charter 2004-05 NICNAS Strategic Plan 2002-05 Two alerts are available on the web site and in print on request. Three issues of the NICNAS newsletter are available on the web site and in printed format. Brochure on new requirements for NICNAS Registration available in both electronic and printed format. Available in both electronic and printed format. Available on the web site and in printed format.

Sydney Morning Herald - Radar, 8 December 2004, page 6 Health - Toxic Shock with quotes from Dr Jayewardene ABC online, 28 June 2005, article on 'Flame retardants found in breast milk' Chemistry in Australia, July 2005, p 38, 'Common skin sensitisers hazard classification'

Television
Channel 7, Today-Tonight, 21 September 2004, 'Cosmetic industry not so pretty', including comments from Dr Hartley Channel 7, Today Tonight, 18 February 2005, 'Allergic to hair dye', including interview with Dr Hartley ABC TV, 7.30 Report, 12 April 2005, 'Polybrominated flame retardants', including interview with Dr Hartley Channel 7, Today Tonight, 25 May 2005 Adelaide, 27 May 2005 Perth, triclosan and toothpaste, reporter mentions NICNAS and PEC

142 NICNAS ANNUAL REPORT 2004-05

NICNAS ANNUAL REPORT 2004-05 143

NICNAS Website Usage Statistics
The charts in this appendix describe the successful hits on the NICNAS web site, the number of visitor sessions and their activity level during the week, as well as most requested Information Sheets and web site pages.

Activity
MONTH HITS VISITORS

July 2004 August 2004 September 2004 October 2004 November 2004 December 2004 January 2005 February 2005 March 2005 April 2005 May 2005 June 2005
Total
DAY OF THE WEEK

685,211 758,504 722,487 775,902 775,295 1,157,969 756,746 916,728 1,045,065 1,023,285 1,048,738 1,157,969
HITS

36,364 40,485 38,198 43,250 47,042 60,455 37,427 54,685 58,219 59,068 58,966 60,455
594,614
VISITORS

Sunday Monday Tuesday Wednesday Thursday Friday Saturday

537,072 1,326,216 1,669,401 1,657,001 1,518,175 1,669,319 912,569

51,585 74,792 89,768 89,017 88,926 80,374 57,370

Most requested Information Sheets
INFORMATION SHEET NUMBER OF D/L

12 15 04 20 18 10 02 21 01 08 19

Glycolic Acid Triglycidylisocyanurate (TGIC) Sodium Ethyl Xanthate (liquid) Hydrofluoric Acid For Hairdressers-Ammonium, Potassium & Sodium Persulfate Tricholoroethylene Glutaraldehyde Benzene Savinase Chrysotile Asbestos Tetrachloroethylene

3871 1854 1232 1209 1201 1178 1099 1093 891 875 865

abbreviations, 12 acronyms, 12 advertising, 108 AICS, see Australian Inventory of Chemical Substances Alerts, 66 assessments, types of, 113-117 see also existing chemicals assessment see also new chemicals assessment see also international harmonisation auditing, internal audit arrangements, 38 NICNAS/company registration compliance audits, 80-82 Australia-Canada Bilateral Agreement, see international harmonisation Australian Customs Service, 80, 88 Australian Government Department of the Environment and Heritage (DEH), 25 Australian Government Department of Health and Ageing (DoHA) service level agreement with NICNAS, 25 Australian Inventory of Chemical Substances (AICS) confidential listing, 60, 123 online, 74 timeliness, 84-85 trend data for inquiries and searches, 85 Australian Public Service, 31 Australian Taxation Office, 88 bilateral agreement with Canada, see international harmonisation candidate list (chemicals), 127-128 Canada, bilateral agreement, see international harmonisation Case management, see Compliance certified agreement, 31 Chemical Gazette, 90, 91 chemicals list of chemicals having internationally agreed assessments, 130-132 list of existing chemicals assessed, 126 public health and safety, 25-26 regulatory framework for, 25-26 see also existing chemicals assessment see also new chemicals assessment communication and services, 90-94 customer survey, 92 effectiveness, 91-93 efficiency, 93 enquiries, 43, 133 information sheets, 65

144 NICNAS ANNUAL REPORT 2004-05

NICNAS ANNUAL REPORT 2004-05 145

integrated database, 93 media - advertising, 108 media coverage, 144 media enquiries, 91 price, 94 publications, 90, 143 quantity, 94 registration performance survey, 43-44 timeliness, 91 web site, 90-91 see also conferences see also meetings see also presentations Community Engagement Charter, 34 Community Engagement Forum (CEF), 34, 100-101 complaints, 32 compliance, 74-89 and the Australian Inventory of Chemical Substances (AICS), 74 auditing, 79-81 case management, 75-76, 78 cases resolved, 86-87 effectiveness, 86-88 enforcement tools, 87 inspectors, 87 industry guidance, 79 quantity, 74-78 price, 88 site visits to check, 80 timeliness, 84 training, for industry and for NICNAS staff, 82-84 with annual report guidelines, 95 with mandatory registration, 80, 85-86 with mandatory reporting requirements, 80 Concise International Chemical Assessment Document (CICAD), see International Programme on Chemical Safety's (IPCS) conferences, 134-136 consultancies, 39, 106-107 contact details, 4 co-operative arrangements, see partnerships corporate governance, 31 corporate overview, 22-28 cosmetic chemicals, 46, 58 cost recovery, see financial performance customer survey, 92 customs brokers, 83

Department of the Environment and Heritage, see Australian Government Department of the Environment and Heritage (DEH) Department of Health and Ageing, see Australian Government Department of Health and Ageing (DoHA) Director's Overview, 16-18 disability strategy, 38 discretionary grants, 39 Ecologically Sustainable Development (ESD), 39, 109-110 electronic notification template, see template for new chemical notification employees, see staff enforcement, see compliance enquiries, 43, 133 equal employment opportunity (EEO), 104 equity, 37 existing chemicals assessment, 124-126 availability of publications, 65-66 candidate list, 127-128 effectiveness, 67 information sheets, 65, 68-69 harmonisation activities, 71 list of chemicals assessed, 126 price, 70 Priority Existing Chemicals (PEC), 65-67 Program review, 45, 46, 103 quantity, 65 summary of activities, 124-125 timeliness, 67 types of, 66 uptake of report recommendations, 69 use of international reports in, 71-73 see also international harmonisation, external scrutiny, 38 financial performance, 38-39 food standards, studies into PBDE levels in food, 68 foreign schemes, 73 fraud measures, 38 freedom on information, 39 glossary, 8 Handbook for Notifiers, 94 harmonisation, see international harmonisation human resources, see staff IGCC, see Industry Government Consultative Committee Industrial Chemicals (Notification and Assessment) Act 1989, 8, 23

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NICNAS ANNUAL REPORT 2004-05 147

Industrial Chemicals (Notification and Assessment) Amendment (Rotterdam Convention) Bill 2004, 49 industry training, 82 compliance with NICNAS registration renewals, 85-86 consultancy service for, 63 guidance, 79 profiles, 59, 77 see also Industry Government Consultative Committee Industry Government Consultative Committee (IGCC), 33 terms of reference, membership and meetings, 98-99 Information Sheets, 65 Inspectors, 87 interim arrangements for self-assessment certificates for polymers of low concern, 45 international harmonisation, 71-73 efficiency, 73 international assessment programs, 49 NICNAS-Canada bilateral, 73 NICNAS discussions with the US Environmental Protection Agency (EPA), 73 OECD New Chemicals Task Force, 71 OECD Screening Information Data Set (SIDS), 72 of existing chemicals assessment, 71-73 of new chemicals assessment, 71 International Programme on Chemical Safety's (IPCS) Concise International Chemical Assessment Document (CICAD), 71-72 letter of transmittal, 3 Low Regulatory Concern Chemicals (LRCC), 44 amendment to legislation, 37, 46 audited self-assessment of, 45 category, 44 exemptions, 44 implementation of new legislation, 46 international treaties on, 49 new range of exemptions, 44 range of new permits, 46 reforms, 17, 44-46 Rotterdam Convention, 49 Scorecard of reform implementation progress, 111-112 management and accountability, 30-39 management of human resources, 36 Material Safety Data Sheets (MSDS), 64 media, see communication and services meetings, 136-139 memorandum(s) of understanding, see National Industrial Chemicals Notification and Assessment Scheme
148 NICNAS ANNUAL REPORT 2004-05

methylene chloride, Nanomaterials, 73 National Drugs and Poisons Schedule Committee (NDPSC), National Environmental Protection Council, National Environmental Protection Measure Air toxics group National Industrial Chemicals Notification and Assessment Scheme (NICNAS) chemicals regulatory framework linkages, 25 corporate governance, 31-32 cost recovery, 38 definitions, 50, 74, 113-117 fees and charges, 39, 41 future directions, 19 financial performance, 38 media coverage, 144 memorandum of understanding with National Occupation Health and Safety Commission, 25 memorandum of understanding with states and territories Group, 35, 87, 101-102 memorandum of understanding with Australian Taxation Office, 88 organisational structure, 24 reform initiatives, 40-47 registration, 41-44, 80-82 review of existing chemicals program, 45 role and functions, 23 service level agreement with Australian Government Department of Health and Ageing, 25 Service Charter and customer survey, 92 summary of key achievements, 20-21 see also outcomes and outputs see also staff National Occupations Health and Safety Commission (NOHSC), memorandum of understanding with NICNAS, 25, 26 NOHSC Model regulations for the control of workplace Hazardous Substances, 25 new chemical assessment, 118-122 availability of reports, 62 Commercial Evaluation Permits, 61 consultancy service for industry, 63 Early Introduction Permits (EIP), 57 effectiveness, 63-64 efficiency, 63 exemption notifications, 58 fees and charges, 64

NICNAS ANNUAL REPORT 2004-05 149

industry compliance with statutory timeframes for publication of reports, 62 Low Regulatory Concern Chemicals (LRCC), 44-46 Material Safety Data Sheets (MSDS) and labels, 64 price, 64 quantity, 56 self-assessment, 45 statistics, 56-60 templates for notifiers, 45 timeliness, 60-62 trends analysis, 61-62 use categories, 113-116 use of foreign scheme assessments in, 73 see also assessments see also international harmonisation see also low regulatory concern category NICNAS, see National Industrial Chemicals Notification and Assessment Scheme 'NICNAS matters', 90-92 occupational health and safety (OHS), 36 see also National Occupational Health and Safety Commission Office of Chemical Safety (OCS), 18, 23 organisational chart, 24 Organisation of Economic Cooperation and Development (OECD), see international harmonisation outcomes and outputs framework, 26 performance measures for, 28 statement of, 27 summary against resources, 54-55 performance reports, 53 portfolio budget statement, 26 precursor chemicals information, 69 presentations, 134-135 Prior Informed Consent (PIC), see Rotterdam Convention priority existing chemicals (PEC), see existing chemicals assessment publications, 90, 143 purchasing, 38 reform initiatives, 40-47 Register of Industrial Chemicals Introducers, registration, see NICNAS registration resource tables by outcomes, 54

Rotterdam Convention on Prior the Informed Consent Procedure on Certain Hazardous Chemicals and Pesticides in International Trade, 49 Review Steering Committee (RSC), 45-46, 103 site visits, 139-140 self-assessment, 45 Science Forum, 47 Screening Information Data Sets (SIDS), 71 staff, certified agreement, 31 presentations, conferences and meetings attended by, 134-143 profile, 104-105 statistics, 104 training and development, 105 see also equal employment opportunity Stockholm Convention on Persistent Organic Pollutants (POPs) Treaty, 50 Technical Advisory Group (TAG), 123 template for new chemical notifications, 45 Therapeutic Goods Administration (TGA), 23 training, see industry, NICNAS staff web site, most requested pages, 91 usage, 145 effectiveness, 91-92

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152 NICNAS ANNUAL REPORT 2004-05

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