Annual Report 2012-13
National Industrial Chemicals Notification and Assessment Scheme
Annual Report 2012–13
ISSN: 1037 - 6909
Print ISBN: 978-1-74186-051-1
Online ISBN: 978-1-74186-052-8
Publications approval number:10463
© Commonwealth of Australia 2013
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The Hon. Peter Dutton MP
Minister for Health
Minister for Sport
Canberra ACT 2600
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 2013. 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 Notifications and Assessment Scheme (NICNAS) against outcome and output measures as detailed in the Portfolio Budget Statements for the period 1 July 2012 to 30 June 2013.
An abstract of financial information for NICNAS is included in this report. Further financial information for NICNAS can be found in the Australian Government Department of Health and Ageing Annual Report 2012–13, reflecting administrative arrangements for 2012–13.
Dr Brian Richards
2 October 2013
Machinery of Government changes
On 18 September 2013 the Prime Minister announced changes to the 'Machinery of Government'.
A key change to the Department of Health and Ageing was that the department's name was changed to the Department of Health.
Details of further changes to the department's responsibilities and legislation administered by the department are included in the Administrative Arrangements Order issued by the Governor-General on 18 September 2013.
This annual report is for the 2012-13 financial year and is based on the structure of the National Industrial Chemicals Notification and Assessment Scheme within the Department of Health and Ageing at 30 June 2013. It reports on the Scheme's activities during 2012–13.
GPO Box 58
Sydney NSW 2001
T + 61 2 8577 8800
F + 61 2 8577 8888
Freecall: 1800 638 528
Annual Report webpage:
For further information, please contact
Communications Manager, NICNAS
at the above address
T + 61 2 8577 8819
This report provides an overview of the operations of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) in 2012–13.
NICNAS aids in the protection of the Australian people and the environment by assessing the risks of industrial chemicals and providing information to promote their safe use.
Key achievements in 2012–13 were the completion of 281 pre-market assessments of new industrial chemicals and the assessment of 723 industrial chemicals already in use (using the Inventory Multi-tiered Assessment and Prioritisation [IMAP] Framework or as Priority Existing Chemicals).
To promote the safe use of chemicals, NICNAS continued to engage with its key stakeholders—the chemical industry, the community (including employees who work with chemicals), the Australian Government and state and territory governments—through national networks, advisory committees and information-sharing activities.
I thank all who have supported NICNAS in the activities outlined in this report.
I particularly wish to thank Dr Roshini Jayewardene, Head of our Regulatory Strategy program, who served as Director, NICNAS from 27 June to 26 September 2012, prior to my appointment.
being a system under which information about the properties and effects of the chemicals is obtained from importers and manufacturers of the chemicals; and
b. national standards for cosmetics imported into, or manufactured in, Australia and the enforcement of those standards."1
NICNAS assesses information provided by importers and/or manufacturers relevant to each chemical's human health (public health and occupational health and safety) and environmental risks. NICNAS encompasses:
1Industrial Chemicals (Notification and Assessment) Act 1989 ( www.comlaw.gov.au/Details/C2012C00811), p.1.
Our role in chemical regulation in Australia
A range of state, territory and Commonwealth government agencies share responsibility for chemical safety in Australia. Each chemical is regulated according to its use. 2 Industrial chemicals include any chemical not falling into one of the other categories, such as chemicals used in solvents, adhesives, plastics, paints, inks, fuels, or laboratory reagents, as well as in refrigeration, cosmetics and household cleaning.
NICNAS helps to protect the Australian people and environment by detecting risks associated with manufacturing, importing or using industrial chemicals, and by maintaining a national standard for cosmetic products.
During 2012–13, NICNAS operated within the Australian Government Department of Health and Ageing (DoHA) now Department of Health (Health). It promotes the safe use of industrial chemicals by providing information and recommendations to other regulators, industry and to the public.
Any company/person proposing to introduce (import and/or manufacture) a new industrial chemical in Australia must notify NICNAS. Once NICNAS has assessed a chemical for its human health, worker safety and environmental risks, it publishes an assessment report that may include recommendations for further regulatory control of the chemical (such as by poisons scheduling, worker health and safety or environmental controls). NICNAS also issues
a certificate or permit to the introducer, who must report any new information that becomes available about the chemical.
After five years, NICNAS may authorise a chemical for wider use by listing it on the AICS, which currently includes about 40,000 industrial chemicals that may be used without notifying NICNAS. Many of these were listed without assessment when the scheme started, on the basis of their historical use.
In July 2012, NICNAS started using the Inventory Multi-tiered Assessment and Prioritisation (IMAP) Framework to review the risks of 3,000 chemicals already listed on the AICS, which were prioritised through a consultation process. Once an IMAP assessment is completed, NICNAS publishes an IMAP assessment report that may recommend further regulatory controls (as for new chemicals).
NICNAS's regulatory plan covers business regulation, including primary legislation, subordinate legislation, quasi-regulation or treaties that directly affect business, have a significant indirect effect on business, or restrict competition.
A statement about information that the regulatory plan does (and does not) include, as well as the regulatory plan itself (covering all business regulation activities planned by Health, including those under NICNAS) for 2013–14 and preceding years is available on the Health website3.
2 Four schemes make up the Australian Government's regulatory framework for chemicals: NICNAS (industrial chemicals); Food Standards Australia New Zealand (food and food additives); Australian Pesticides and Veterinary Medicines Authority (pesticides and veterinary medicines); Therapeutic Goods Administration (medicines and medical devices).
Staff employed by the Department of Health perform public health and occupational health and safety assessments related to industrial chemicals for NICNAS.
Staff employed by the Department of the Environment (Environment)4 conduct complementary environmental assessments for NICNAS, and provide scientific, technical and regulatory advice on environmental protection in relation to chemical safety.
The Office of Chemical Safety (OCS)—like NICNAS, located within Health—applies public health policy to assessment outcomes.
The Environmental Health Committee (enHealth—a subcommittee of the Australian Health Protection Committee) coordinates state and territory input into NICNAS public health assessments and recommendations.
The Therapeutic Goods Administration's (TGA) Advisory Committee on Chemicals Scheduling (ACCS) reviews NICNAS recommendations for scheduling of chemicals, for inclusion in the relevant legislation of states and territories, with reference to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP—Poisons Standard).
The Standing Committee on Chemicals (SCOC)—responsible to the Council of Australian Governments (COAG)—aims to achieve an effective and efficient system of chemicals and plastics regulation.
The Standing Council on Environment and Water (SCEW)5 promotes the protection of the environment and water under
a certificate or permit to the introducer, who must report any new information that becomes available about the chemical.
COAG, providing a forum for the Australian Government, states and territories to address related broad national and reform issues. It also provides input into some NICNAS environmental risk management recommendations.
The Australian Competition and Consumer Commission (ACCC)—which is responsible for the safety of products—receives NICNAS's technical advice and recommendations concerning chemicals in consumer products.
NICNAS uses Model Work Health and Safety (WHS) Regulations in reviewing occupational health and safety assessments and recommendations in relation to the national occupational health and safety framework. This includes hazard classifications and applying labelling requirements and Safety Data Sheet (SDS) Codes of Practice to all industrial chemicals used in workplaces.
Details of other Australian Government departments involved in chemicals regulation are presented on the NICNAS website: Chemicals in Australia—who's who. NICNAS participates in the Regulators' Forum with all Australian Government regulators of chemicals, and also on its advisory committees.
4 In 2012–13, Department of Sustainability, Environment, Water, Population and Communities (DSEWPaC)
5 SCEW, which incorporates the National Environment Protection Council (NEPC), was established by COAG in 2010.
The United Nations (UN) Globally Harmonised System (GHS) of Classification and Labelling of Chemicals guides NICNAS in classifying chemicals.
NICNAS is a statutory scheme established within Health. The Act establishes the Director, NICNAS as a statutory office holder with specific functions and powers with direct responsibilities to the Minister for Health6. The Secretary, Health makes available the services of employees of the department to
the Director, for the purposes of assessing chemicals and assisting in the administration of the Act. The Secretary, Department of the Environment (Environment—in 2012–13. DSEWPaC) also provides staff to the Director to conduct assessments.
The following figure depicts NICNAS's organisational structure for 2012–13. Details of work performed in each of the six programs are provided under Core activities.
6 In 2012–13 and previously through the Parliamentary Secretary for Health and Ageing.
Governance through community, industry and government advisory groups
Three non-statutory committees provide strategic development advice to NICNAS: the Community Engagement Forum (CEF), the Industry Government Consultative Committee (IGCC) and the States and Territories Memorandum of Understanding (MoU) Group.
The Nanotechnology Advisory Group (NAG) also provides strategic development advice and—along with the Cosmetic Advisory Group and Industry Engagement Group—supports NICNAS in implementing strategies. NICNAS also occasionally receives advice from groups formed for specific projects. Details of these groups and the subjects of their meetings are provided at Appendix 07.
This chapter outlines NICNAS operations and outcomes under the Act during 2012–13. It includes progress in NICNAS's five priority projects as detailed in NICNAS's Business Plan 2012–13 (the business plan). For business plan targets, see Appendix 08.
Information about our 2012–13 performance against agreed deliverables and key performance indicators (KPIs) can also be found in the Department of Health and Ageing Annual Report 2012–13 under Sub- program 1.4.3: Industrial Chemicals.
Departmental staff assess chemicals and carry out related activities for NICNAS. In 2012–13 this work was performed by staff in seven programs (see Figure 01, above).
In NICNAS's chemical assessment programs, staff employed by DoHA (now Health) conduct human health (public health and worker health and safety) assessments while Environment staff carry out the environmental components of assessments.
New chemicals assessment
In 2012–13, NICNAS issued 162 certificates and 119 permits7. We met approximately 95 per cent of statutory timelines in this work. Figurative tables providing data about the types of new chemical notifications we received are at Appendix 03.
Milestone: In March 2013, NICNAS completed its 3,000th new chemical assessment report.
Enhance New Chemicals operations8
With the aim of improving the efficiency and effectiveness of our new chemicals notification program, we continued compiling common inquiries and categorising decisions in our internal decision repository. We included several 'decisions' and 'chemical scenarios' in the repository and in the log of exposure scenarios.
We developed generic exposure scenarios for chemicals used in automotive paints for after-market applications (including repackaging and reformulation activities) and members of our Industry Engagement Group (IEG) reviewed and supported the scenarios (which provided options based on the mode of import of a notified chemical/polymer). Decisions were prepared in a question and answer (Q&A) format for publishing on the NICNAS website.
Implement approach for
7 Factors such as type of chemical, amount introduced, proposed use, planned period of use and company's business needs/commitments determine whether notifiers apply for a permit or certificate.
8 Priority Project 5 in the business plan, Appendix 08.
9 Group of compounds—used to make everyday products resist stains and grease, or as wetting agents—some of which are of concern because they do not break down in the environment and can persist and accumulate to levels that can harm living systems.
shorter chain perfluorinated chemicals (proposed as substitutes for long chain perfluorinated chemicals that are known to accumulate in the environment). The assessments included a hazard assessment of perfluorohexanoic acid (PFHxA), the ultimate degradation product of the proposed shorter chain substitutes.
Offer industry options to introduce
Milestone: In the first half of the year, we conducted 129 chemical assessments11 at Tier I12 and eight at Tier II13 for human health. In the second half of 2012–13 we conducted even more assessments: 330 (for human health) and 302 (for environment) at Tier I, and we carried out a further 215 assessments at Tier II (human health).
Implement IMAP Framework14
At the stakeholder forum15 we held on 19 July 2012, we announced that we were starting to use the IMAP Framework for assessing existing chemicals. The forum increased stakeholder understanding of IMAP and explored opportunities for greater national and international collaboration.
We had spent several years carefully preparing and planning for IMAP, through consultations—such as those on potential sources of Australian exposure information to be used in assessing chemicals listed on the AICS—and the consultation process continued during the first year of operation. For example, we explored ways to identify chemicals (including polymers) of low concern to human health, and Australian scientific experts independently validated this process.
In December 2012 we advertised the publication of the first tranche of IMAP assessments through our consultative
committees, the NICNAS website, the Chemical Gazette and targeted e-mails, and invited stakeholders to comment on the reports. We also published the IMAP Framework, pilot evaluation papers, four factsheets and answers to frequently asked questions (FAQs) on our website. These gave the public and the chemical industry information about the methodologies we use for conducting risk assessments.
We continued to implement the framework and engage with stakeholders, inviting public comment on three further tranches of chemical assessments during 2012–13.
Assess Stage One chemicals by
We assessed 24 per cent of all Stage One chemicals in 2012–13, exceeding our 20 per cent target.
Altogether, we used the IMAP Framework to complete 984 assessments for a total of 72316 chemicals (261 were assessed for both human health and environmental impacts).
We demonstrated the effective operation of the framework when we recommended additional regulatory controls and/or further assessments of a significant number of chemicals to relevant Australian Government and state and territory agencies.
11 We assessed some chemicals in more than one category.
12 High throughput assessment against criteria, for chemicals not considered to pose unreasonable risk to the health of workers, public health and the environment.
13 Chemical-by-chemical evaluation against criteria.
14 Full details of IMAP are available under 'Chemical information' on the NICNAS website at: www.nicnas.gov.au/chemical-information/imap-assessments.
15 Some details of the forum program are at Appendix 09.
16 This includes 20 chemicals that were not included in the initial IMAP Stage One list of 3,000 chemicals. They are members of groups of chemicals already being assessed in Stage One and have been added to gain further efficiencies in the implementation of the IMAP Framework.
From July to December 2012, we:
From January to June 2013, we published three further tranches of IMAP assessments for public comment—including: 330 Tier I (human health) and 302 (environment) assessments—and 215 Tier II human health assessments.
During the year we recommended 201 chemicals for referral:
Note: some chemicals had more than one recommendation for risk management.
In addition, the Tier II assessments contained information on the GHS17 classifications for the 223 chemicals.
Address specific health and environmental concerns when assessing chemicals of concern
During the year we progressed our assessments of chemicals in the PEC and Secondary Notification categories. A list of all PEC assessments (past and current) is available at Appendix 04.
We published final reports for diisononyl phthalate (DINP—PEC) and polymer in Millifluid® (Secondary Notification). We also finalised the draft PEC report for dibutyl phthalate (DBP) for release to applicants and made significant progress drafting the dimethyl phthalate (DMP) and dimethoxyethyl phthalate (DMEP) reports for peer review.
We also considered several inquiries related to potential secondary notification assessments.
Use international information effectively
During the year we developed guidance material and training activities for staff undertaking IMAP assessments using information/knowledge sourced overseas. For example, we made extensive use of international information in completing the first tranche of IMAP assessments. We kept international regulatory agencies fully informed about the assessments and the timing for their release—and IMAP assessment reports indicate the use of
17 United Nations Globally Harmonised System of Classification and Labelling of Chemicals.
chemical information from international organisations.
Sharing information with these organisations also contributed to validating assessment outcomes during the IMAP public comment phase.
We engaged several international experts—including a Bulgarian specialist—who provided advanced training in assessment methodologies including Quantitative Structure Activity Relationship (QSAR) modeling software to staff. Such expertise made a significant contribution to the successful implementation of IMAP in its first year. A list of other international visitors who provided training is at Appendix 09.
Other assessment-related activities
NICNAS engages in many activities which complement and support chemical assessment work. In 2012–13 these were the responsibility of the Science Strategy and International (SS&I) and Reform programs.
Maintain chemical substances inventory
The Australian Inventory of Chemical Substances (AICS) was managed under the Reform program up to and including 2012–13. Each year it requires ongoing work to ensure its effectiveness and that users can access any information from it that they require.
In response to concerns and suggestions, we improved a number of the processes and procedures around the maintenance of the AICS—including those concerning
confidential listings—during the year.
Three major needs were dealt with:
These concerns were addressed (respectively) by:
Assess chemicals used in hydraulic fracturing
NICNAS is leading a national assessment—with the Commonwealth Scientific and Industrial Research Organisation (CSIRO), Environment and Geoscience Australia— to examine human health and environmental risks from chemicals used in drilling and hydraulic fracturing for coal seam gas (CSG)18 extraction in Australia.
18 Also known as: 'natural gas from coal seams'.
The assessment focuses on risks arising from surface handling of hydraulic fracturing and drilling chemicals at the well site, and surface handling of flow-back and produced waters that flow up well bores.
We identified chemicals associated with hydraulic fracturing in Australia through a voluntary industry survey (with input from government agencies, CSG companies and the industry association). It consisted of three separate surveys: for CSG companies, site operators and service providers. Based on survey responses, we drafted a report for the Office of Water Science.
We applied IMAP-developed criteria to determine which of the chemicals identified in the survey were of low concern for human health—in order to focus on those that needed further assessment. We conducted chemical-specific literature searches to assess the toxicity of the chemicals and used the resulting data to help establish the profiles we needed to comprehensively assess the hazards of the chemicals. This enabled us to start drafting hazard assessments of 12 CSG chemicals.
A paper we prepared on the methodology for occupational and public exposure estimation is to be further discussed at an exposure workshop later in 2013. We have also modified NICNAS's internal database of information on existing chemicals for functionalities specific to CSG chemicals assessment. We also participated in the NSW Government regulatory roundtable on unconventional gas, and provided input into the National Harmonised Regulatory Framework for CSG.
Report on chemicals of security concern
The public report on the NICNAS Voluntary Call for Information on the Attorney-General's Department (AGD) Chemicals of Security Concern project was published on the NICNAS website.
Improve scientific capabilities, enhance access to expertise
The SS&I program conducted a number of other activities which supported our commitment to 'continuous improvement' during the year. These included:
Collect statistics on chemicals
Continue review of NICNAS
A review of NICNAS continued during 2012–13, investigating how the regulatory settings could be improved to enhance both the competitiveness of Australia's chemical industry and public health and environmental outcomes.
NICNAS gave technical input to the concepts and draft framework for assessing new and existing industrial chemicals—including cosmetics and polymers—and into the draft regulatory impact statement prepared for stakeholder consultation.
Strengthen science strategy
Two Principal Scientists were part of NICNAS's executive team in 2012–13, for New Chemicals and Existing Chemicals. The scientists manage NICNAS's science strategy for all assessment and assessment-related work.
We managed activities under our science strategy to enhance staff access to expertise and contribute to advances in methodologies for chemical risk assessment, nationally and internationally.
19 Priority Project 2 in the business plan, Appendix 08.
The strategy encourages training by international scientific speakers to be made available for staff. Some of these sessions are listed at Appendix 09.
We finalised the NICNAS Science Strategy 2012–14, which outlines the approaches for enhancing staff skills and expertise.
Introduce revised sunscreen standard
We consulted on the proposed adoption by the Cosmetics Standard 2007 of the revised Australian/New Zealand Sunscreen Standard20 (the 2012 Sunscreen Standard) and published a regulatory impact statement about it.
The (then) Parliamentary Secretary for Health and Ageing approved this change, with adoption to commence in August 2013 with a five-year transition period during which businesses will be able to produce cosmetic sunscreen products complying with either the 1998 or the 2012 Sunscreen Standard.
Review annotation of lead in surface
Strengthen national and international links
NICNAS provided technical advice to national agencies (including Safe Work Australia and SCOC) for managing risks from industrial chemicals and determining Australia's position at international conventions and meetings such as those of the Stockholm and Rotterdam conventions.
Department of the Environment: NICNAS discussed issues of mutual interest with the (then) DSEWPaC, including the review of NICNAS; legislative changes to the Act; the assessment of persistent, bio-accumulative and toxic (PBT) and persistent organic pollutant (POP) chemicals; regulating chemicals in the Stockholm Convention; IMAP and the notification of CSG chemicals.
Safe Work Australia: NICNAS exchanged information with Safe Work Australia on activities relating to chemicals and the workplace.
Safe Work Australia provided updates on the model Work Health and Safety (WHS) Act and lowering the exposure standards for lead.
Standing Committee on Chemicals (SCOC): NICNAS participated in meetings of the Chemicals Working Group (that supports SCOC activities), attended SCOC meetings as an observer and provided input into the secretariat's business checklist and the review of SCOC.
Other national agencies: Assessment reports from IMAP tranches— where appropriate—referred to relevant national agencies including Safe Work Australia and the Scheduling Delegate for the Poisons Standard (SUSMP).
20 AS/NZS 2604:2012 Sunscreen products—Evaluation and classification.
Stockholm Convention21 We provided technical advice on industrial chemicals listed for discussion at the eighth review committee: draft risk profiles of hexachlorobutadiene (HCBD), polychlorinated naphthalenes (PCN) and short chain chlorinated paraffins. After review, both HCBD and PCN were determined to meet the review committee's criteria.
For the ninth review committee, NICNAS provided Australian use and volume information on pentachlorophenol and technical input into briefs on hexabromocyclododecane (HBCD) for discussion at the sixth meeting of the Conference of Parties (COP-6) and provided input into a Japanese government survey of the regulation, use, manufacture and export volumes of HBCD (and associated products) forwarded by the (then) DSEWPaC.
Rotterdam Convention22 We provided technical advice on commercial pentaBDE, commercial octaBDE and PFOS to the (then) DSEWPaC. These chemicals were listed for discussion at COP-6.
Contribute to international
international regulatory approaches.
This international engagement ensures that NICNAS assessments are scientifically robust and international experience is applied to improve our regulatory systems.
In 2012–13, NICNAS participated in:
OECD Clearing House on New Chemicals: We reviewed the list of low concern polyesters.
World Health Organization (WHO): We helped establish an international network of risk assessors, under the International Programme on Chemical Safety.
OECD Task Force on Hazard Assessment (TFHA): We provided input into the revised guidance on forming chemical categories to increase the efficiency of assessments— it assists in selecting appropriate analogue chemicals, which can provide useful information for assessing likely hazards of industrial chemicals. NICNAS also contributed to the 'avoiding duplication' project by sharing its current schedules for existing chemical assessments (PEC and IMAP) with other regulators. NICNAS contributed to the Cooperative Chemical Assessment Program by reviewing the dimethyl anilines24, a six-chemical category of interest to NICNAS.
OECD Working Party on Manufactured Nanomaterials (WPMN): Our WPMN participation ensured that Australian regulatory agencies' views were reflected in
21 Stockholm Convention on Persistent Organic Pollutants (POP).
22 Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
23 Harmonisation of international chemical assessments, regulatory approaches and methodologies with Australian industrial chemicals assessment and management systems.
24 A chemical group used in manufacturing dyes, pigments and photographic chemicals that are of concern for human health. Selected for review because six of the chemicals are on the IMAP Stage One chemicals list. The category approach is a major and critical aspect of IMAP.
the draft OECD Council recommendation (2013) that "approaches for the testing and assessment of traditional chemicals are in general appropriate for assessing the safety of nanomaterials, but may have to be adapted to the specificities of nanomaterials". WPMN participation also ensures that NICNAS's approach to hazard and risk assessment—and regulation of industrial nanomaterials—is science-based and internationally harmonised.
Asia-Pacific Economic Co-operation (APEC) Regulators Forum under the Chemical Dialogue: The chemical dialogue agreed to an Australian industry proposal to examine the need for training regulators in the risk assessment of metals and metal compounds. As a result we are facilitating industry to survey APEC economics during 2013–14 on the need for such training, with the intention to run a training workshop in 2014–15, if appropriate.
Continue bilateral activities
Canada cooperative arrangement: We continued liaising with Environment Canada about a confidentiality agreement (now submitted for signature) and reached agreement with both Health Canada and Environment Canada about the value of a multi-partite confidentiality agreement (that includes Health Canada and the then DSEWPaC) to be drawn up in 2013–14.
European Chemicals Agency (ECHA) MoU: We discussed efficient handling of inquiries and Helpdesk arrangements with ECHA, as
well as potential copyright issues arising from the use of data from the ECHA website and progress with IMAP assessments.
New Zealand EPA MoU: We met with NZ EPA so both parties could receive updates on activities of mutual interest—specifically existing substances, hazardous substances and reform.
US EPA cooperative arrangement: We exchanged information on inventories, existing chemicals and nanomaterials activities in each country—and discussed future information exchange. We also discussed the need to identify overlaps and raise awareness of assessment outcomes of common chemicals during the draft stage.
Manage strategy for industrial nanomaterials25
In 2012–13, we continued to regulate industrial nanomaterials. Our approach focused on:
25 Priority Project 1 in the business plan, Appendix 08.
Participate in NETS
We secured funding for the year from the National Enabling Technologies Strategy (NETS), administered by the (then) Australian Government Department of Industry, Innovation, Climate Change, Science, Research and Technical Education (previously DIISRTE)26 to support our technical, international and compliance work on industrial nanomaterials.
These funds supported NICNAS's participation and engagement with the OECD WPMN, outreach activities with universities and other research and development facilities and developing potential exposure scenarios for certain industrial nanomaterials.
compliance with the registration obligations of the Act, and achieved a level of 99.7 per cent compliance among known industrial chemical introducers. Registration numbers exceeded those of 2011–12 by almost 300, with around 700 introducers registering with NICNAS for the first time.
Auditing of new chemicals obligations led to the notification of four new industrial chemicals with a further 35 being advised or reported to the Director as meeting the criteria for introduction without notification.
We continued to focus on education and awareness raising activities with 11 training sessions being delivered to 380 participants (including customs brokers) in Adelaide, Ballarat, Brisbane, Melbourne, Newcastle and Sydney.
We monitored the introduction of new chemicals without notification to NICNAS and this led to us identifying three new chemicals which were found to be unsuitable for introduction under the exemption provisions of the Act.
The team achieved 100 per cent compliance by new chemical introducers with annual reporting obligations under section 21 AA of the Act, with 6,260 new chemicals being reported by 170 introducers.
In accordance with the administrative requirements of the Rotterdam Convention, we granted 15 annual export authorisations to companies exporting aviation gasoline—but processed no export notifications during the year. However we processed 67 in-bound export notifications (concerning export from
26 Now Department of Industry.
elsewhere to Australia) during the year, and subsequently advised the Australian designated national authority (then DSWEPaC) about the import of Rotterdam Convention Annex III listed chemicals into Australia.
Ensure introducers of industrial
Communication materials including Chemical Gazette notices, fact sheets, and materials for the website were prepared. As NICNAS is rolling out changes to registration levels (fees and charges) and other elements of the program in 2013–14, details of these were communicated towards the end of the year.
Table 01: Auditing of high level introducers against new chemicals obligations
|Desktop audits to identify high risk introducers for the purpose of the audit||374|
|On-site audits to determine compliance with new chemicals obligations||16|
|Closed audits where the company was able to demonstrate compliance with obligations||17|
|Continuing audits where the company agreed to provide evidence of compliance within agreed timeframe||5|
Improve Tier 2 and Tier 3 introducers' compliance with new chemicals obligations
NICNAS aimed to conduct audits of 30 per cent of Tier 2 and 3 introducers during the year, for their compliance with new chemicals obligations. We exceeded that target (30.3 per cent).
Business management, communications and corporate activities
Milestone: The new version of the NICNAS website was launched on 27 June 2013. It contained updated versions of most NICNAS materials including 50 revised chemical factsheets and the updated Handbook for Notifiers.
Manage financial performance
Compared with last year, both NICNAS's revenue and expenses increased. Revenue increased by 41 per cent ($4.058m) and expenses increased by 31 per cent ($3.070m), primarily due to new project activities including the accelerated assessment of existing chemicals under the IMAP Framework (IMAP assessments) and the national assessment of chemicals associated with CSG extraction in Australia (CSG assessment).
The total revenue cost-recovered from the regulated industry was $11.089m, which is 23 per cent higher than the previous year as a result of changes to registration levies (informed by the NICNAS cost recovery impact statement) to fund IMAP assessments, and as a result of changes to fees and charges for other activities.
Table 02: Four-year comparison of NICNAS revenue and expenses
|Industry cost recovered revenue||7,956||8,586||9,014||11,089|
The total revenue from sources other than the recovery of costs from industry was $2.089m, which is 236 per cent higher than the previous year due to the receipt of funds to conduct the CSG assessment.
Total expenses were $13.074m, which is 31 per cent higher than the previous year in line with the increase in activities.
The NICNAS final net result for 2012–13 was a surplus of $0.824m, which is primarily attributable to deferral of some assessment activities in the IMAP project, a decrease in the bond rate and subsequent reduction to total long service leave provisions, and delays in IT projects outside NICNAS's direct control.
Detailed abstracts of NICNAS's financial statements are provided at Appendix 01, and information about actual expenditure on contracts for consultancies is available at Appendix 02.
Meetings of NICNAS's two advisory committees and the States and Territories MoU Group were conducted in 2012–13 (see details at Appendix 07).
Manage communication and
The next stakeholder survey will be conducted in the second quarter of 2013–14. A report on progress in matters raised in the last survey is provided at Appendix 11.
Provide advice and raise awareness
The majority of inquiries received were handled within agreed timelines.
NICNAS staff provided education and training to registrants and potential registrants—see: Compliance and enforcement activities. The half-day sessions raised awareness of requirements for all NICNAS notification, with updates on such topics as AICS searching, cosmetics, nanomaterials and IMAP.
NICNAS staff also represented the scheme at conferences and other events. A number of these are listed at Appendix 09.
Provide staff and maintain their
NICNAS paid performance bonuses of $46,037 during 2012–13. This total was paid to seven staff.
Following recruitment to fill a number of vacancies, a NICNAS orientation program was formalised for all new staff.
For scientific staff, training in QSAR models by an international expert was offered, as well as in-house training on evaluation of repeated dose toxicology studies (attended by 15 assessment staff in November 2012) and regular Tuesday Tune-up sessions where issues of interest to both scientific and all other staff are discussed. A listing of presentations by overseas visitors is provided at Appendix 09.
NICNAS's staff performance is reviewed twice each year under the Personal Development Strategy.
Following the release of results of the (then) DoHA 2013 Staff Survey, key actions from it were incorporated into the NICNAS Business Plan 2013–14.
Workstation assessments were undertaken and all updates completed, as necessary, by the end of 2012–13.
Manage complaints, FOI requests
27 Available on the NICNAS website.
28 See: www.nicnas.gov.au/about-nicnas/information-publication-scheme.
29 Priority Project 4 in the business plan, Appendix 08.
Figure 03: NICNAS website progress by quarter in 2012–13
|Quarter||Focus / developments|
|1||Redevelopment of NICNAS website|
|2||Presentations to CEF and IGCC November meetings on progress to date; website build almost completed pending content migration|
|3||Ongoing work on IMAP database; content migration of new website progressed with user acceptance testing (UAT)|
|4||Website build and content migration continues, and website goes live on 27 June 2013|
The aim of each project in Figure 03 was to improve the efficiency and effectiveness of NICNAS's business systems. This is available on the NICNAS website.
Appendix 01—Abstracts from NICNAS financial statements
NICNAS's 2012–13 financial statements were audited by the Australian National Audit Office as part of its audit of the consolidated financial statements of the Department of Health and Ageing. Presented below are NICNAS'S income statement, balance sheet, cash flow statement and statement of changes in equity which have been extracted from the Department's audited consolidated statements
Table 03: Statement30 of comprehensive income for the period ended 30 June 2013
|Depreciation and amortisation||207||181|
|Write down and impairment of assets||153||81|
|Sale of goods and rendering of services||13,518||9,423|
|Total own-source revenue||13,518||9,423|
|Sales of assets||-||-|
|Total own-source income||13,518||9,423|
|Net cost of services||(444)||581|
|Revenue from Government||380||427|
|Surplus/(deficit) attributable to the Australia Government||824||(154)|
|OTHER COMPREHENSIVE INCOME|
|Items not subject to subsequent reclassification to profit or loss|
|Changes in asset revaluation surplus||-||89|
|Total other comprehensive income||-||89|
|Total comprehensive surplus/(loss) attributable to the|
30 Statements should be read in conjunction with accompanying notes. However no notes accompany the four tables published in this appendix.
Table 04: Balance sheet as at 30 June 2013
|Cash and cash equivalents||336||333|
|Trade and other receivables||10,015||11,053|
|Other financial assets||-||-|
|Total financial assets||10,351||11,386|
|Land and buildings||1,364||1,524|
|Property, plant and equipment||89||97|
|Other non-financial assets||40||28|
|Total non-financial assets||1,730||1,773|
|Total entity interest||4,508||3,684|
Table 05: Cash flow statement for the period ended 30 June 2013
|Goods and services||17,590||8,299|
|Net GST received||189||783|
|Total cash received||26,455||10,714|
|Net GST paid||-||-31|
|Cash to the official Public Account||(11,500)||(1,205)|
|Total cash used||(26,301)||(10,436)|
|Net cash from operating activities||154||278|
|Proceeds from sales of property, plant and equipment||-||-|
|Total cash received||-||-|
|Purchase of property, equipment and intangibles||(151)||(224)|
|Total cash used||(151)||(224)|
|Net cash used by investing activities||(151)||(224)|
|Appropriations—Department capital budget||-||-|
|Total cash received||-||-|
|Total cash used||-||-|
|Net cash received from financing activities||-||-|
|Net increase/(decrease) in cash held||3||54|
|Cash and cash equivalents at the beginning of reporti ng period||333||279|
|Cash and cash equivalents at the end of reporting period||336||333|
31 For consolidated statements, GST was grossed up in supplier payments in 2011–12.
Table 06: Statement of changes in equity for the period ended 30 June 2013
|Retained earnings||Asset revaluation surplus||Contributed equity/capital||Total Equity|
|$' 000||$' 000||$' 000||$' 000||$' 000||$' 000||$' 000||$' 000|
|Balance carried forward from previous period||3,515||3,669||169||80||-||-||3,684||3,749|
|Adjusted opening balance||3,515||3,669||169||80||-||-||3,684||3,749|
|Other comprehensive income||-||-||-||89||-||-||-||89|
|Surplus/deficit for the period||824||(154)||-||-||-||-||824||(154)|
|Contributions by owners|
|Return of capital:|
|Reduction in equity appropriation32||-||-||-||-||-||-||-||-|
|Departmental capital budget||-||-||-||-||-||-||-||-|
|Sub-total transactions with owners||-||-||-||-||-||-||-||-|
|Closing balance as at 30 June||4,339||3,515||169||169||-||-||4,508||3,684|
|Closing balance attributable to the Australian Government||4,339||3,515||169||169||-||-||4,508||3,684|
32 Return of prior year appropriation relating to Appropriation Bill (No 2) 2010–11.
Table 07: New and active consultancies 1 July 2012 to 30 June 2013
|Category||No. of reports of new|
|Value (to nearest dollar)|
|Provide advice and|
assistance in relation
to legislative changes
|30 Jun 2013||Open/panel||$4,900||$2,80033|
|UXC Consulting Pty Ltd||IT strategy consultant|
to provide a review
and analysis of the
existing NICNAS IT
|23 Jul 2012||30 Jun 2013||Open/panel||$31,581||$31,581|
|Tetra Tech Australia||Provide services|
relating to data
on nanoforms of certain chemicals,
|31 Dec 2012||Open/ panel||$40,093||$40,092|
|Tetra Tech Australia||Provide services|
relating to data
on nanoforms of
|16 Nov 2012||30 Jun 2013||Open/panel||$19,761||nil34|
Note: Information on the value of contracts and consultancies is available on the AusTender website: www.tenders.gov.au
33 NICNAS accrued $19,761 at the end of the financial year for work performed but not yet invoiced.
34 Contract now closed—no further expenses.
Appendix 03—New Chemicals assessment program
Data provided in this appendix relate to new chemicals certificates and permits issued. In previous years, comparable tables provided details of new chemicals certificates and permits applied for.
35 The total of assessment certificates by use category does not include extension certificates and some chemicals are assessed for use in more than one category.
Table 08: New chemical reports in 2012-13 under sections 21AA and 40N
Each report can comprise numerous chemicals.
|Category||No. of reports of new chemicals|
for each category
|<1 per cent cosmetic exemption||52|
|<100 kg cosmetic exemption||89|
|<100 kg non cosmetic exemption||79|
|<100 kg R&D exemption||25|
Table 09: New chemicals exempt from notification in 2012–13, by quarter36
|Quarter 1||Quarter 2||Quarter 3||Quarter 4||Total|
Appendix 04—Existing Chemicals program
Under sections 54(1) and 54(2) of the Act, the Director of NICNAS is required to maintain a list of priority existing chemicals (PECs) and a list of chemicals that have been PECs, and under section 54(3). These lists are to be published once a year.
The following tables detail the nature of the assessment (full or preliminary). Assessments are conducted to determine the potential risks to the public, worker health and environment associated with all uses of the chemical in Australia, unless indicated otherwise. Assessments maybe conducted for several chemicals as a group, and these are indicated by the title of the assessment.
More information on current PECs is available from the NICNAS website.
Table 11 indicates the publication date of the assessment reports for which the declaration of the PEC was revoked. All published PEC reports are available from NICNAS. Electronic copies are available from the NICNAS website.
36 Exemption advice forms for cosmetic and non-cosmetic chemicals being introduced under the exemption provisions of subsection 21(4) of the legislation were acknowledged by NICNAS during 2012–13.
Table 10: Current Priority Existing Chemicals
|Chemical||CAS number||Status||Declaration date|
|Full risk assessments|
|Bis(2-methoxyethyl) phthalate 37(DMEP)||117-82-8||Commenced||March 2006|
|Butylbenzyl phthalate 37(BBP)||85-68-7||Commenced||March 2006|
|Dibutyl phthalate 37(DBP)||84-74-2||Public comment||March 2006|
|Diisodecyl phthalate 37(DIDP)||26761-40-0,|
|Not commenced||March 2006|
|Dimethyl phthalate 37(DMP)||131-11-3||Commenced||March 2006|
|Di-n-octyl phthalate 37(DnOP)||117-84-0||Not commenced||March 2006|
|Decabromodiphenyl ether||1163-19-5||Commenced||June 2005|
|Pentabromodiphenyl ether||32534-81-9||Commenced||January 2006|
|Tetrabromobisphenol A||79-94-7||Commenced||June 2005|
Table 11: Chemicals that have been Priority Existing Chemicals
|Chemical||CAS number||Status||Publication date|
|Full risk assessments|
|2-butoxyethanol in cleaning products||111-76-2||Completed||October 1996|
|Alkyl phosphate anti-valve|
seat recession additive
|Ammonium, potassium and|
sodium persulfate in hairdressing38
|7727-54-0; 7727-21-1; 7775-27-1||Completed||June 2001|
|Chrysotile (asbestos)||12001-29-5||Completed||February 1999|
|Diethyl phthalate37(DEP)||84-66-2||Completed||November 2011|
|Diethylhexyl phthalate37(DEHP)||117-81-7||Completed||July 2010|
|Diisononyl phthalate37(DINP)||28553-12-0, 68515-48-0||Completed||September 2012|
|Hexabromocyclododecane (HBCD)||25637-99-4; 3194-55-6||Completed||June 2012|
|Lead compounds used in|
industrial surface coatings and inks40
|N-vinyl-2-pyrrolidone (NVP)||88-12-0||Completed||February 2000|
|Octabromodiphenyl ether39||32536-52-0||Completed||February 2007|
|Savinase – Proteolytic enzymes|
|Sodium alkylbenzene sulfonate|
anti-valve seat recession additive
|Sodium cyanide41||143-33-9||Completed||February 2010|
|Sodium ethyl xanthate||140-90-9||Completed||May 1995|
|Triglycidylisocyanurate (TGIC)||2451-62-9||Completed||April 1994|
|Tris(2,3-dibromopropyl) phosphate (TBPP)||126-72-7||Completed||November 2005|
|Glycolic acid in cosmetics40||79-14-1||Completed||April 2000|
|Hydrofluoric acid (HF)||7664-39-3||Completed||June 2001|
|Polybrominated flame retardants||Various38||Completed||June 2001|
|Short chain chlorinated paraffins (SCCPs)||Various38||Completed||June 2001|
37 Assessment restricted to public health risk from use in cosmetics, children's toys and childcare articles
38 Group assessments. Refer to PEC Report for CAS numbers.
39 No applications were received for assessment, and therefore, the chemical was removed from the AICS.
40 Assessment restricted to health risk.
41 Assessment restricted to environmental risk.
Table 12: Scorecard of progress with implementation of recommendations from the Existing Chemicals Program Review, as at 30 June 2013
The scorecard of progress with implementation of Existing Chemicals Review recommendations has been published annually. Activities reported as 'completed' in NICNAS Annual Report 2011–12 are not included.
|Implementation Stream 1: Communications|
Chapter 3 recommendations: Better engagement and communication
|3.1 42||Promote community awareness of, education about, and participation in Existing Chemicals (Assessment) Program.||Ongoing(focus of IMAP communications)|
|Chapter 5 recommendation: Improve efficiency|
|5.1||Develop, modify and publish process to filter out and redirect matters not relevant to NICNAS and determine level of response and/or assessment required.||Ongoing 43|
|Implementation Stream 2: Screening, prioritisation, assessment products|
Chapter 4 recommendations: Enhance mechanisms to identify chemicals of concern: new screening processes
|4.2||Screen AICS-listed chemicals for hazard and/or risk indicators elements.||Ongoing|
|Chapter 5 recommendations: Improve efficiency|
|5.3||Publish the prioritisation process and recommendations.||Ongoing|
|5.4||Streamline the Secondary Notification process for existing chemicals originally assessed as new chemicals.||In progress 44|
|Chapter 6 recommendations: Broaden assessment options|
|6.1||Develop new types of assessment products based on intended outputs and purposes.||Partially completed 45|
|6.2||Develop information requirements for each new assessment type.||Ongoing|
|Implementation Stream 3: Monitoring|
Chapter 4 recommendation: Enhance mechanisms to identify chemicals of concern: new screening processes
|4.3||Examine feasibility of nationally coordinated system of surveillance monitoring and post-market reporting.||In progress 46|
|Implementation Stream 4: Consultation|
Chapter 5 recommendations: Improving efficiency
|5.5||Explore with states and territories improved processes for coordination and cooperation, including use of NICNAS MoU group.||Ongoing|
|Implementation Stream 6: Currently improve practice|
|5.6||Continue to participate in chemicals management forums to ensure harmonised and streamlined regulation of industrial chemicals at a national level.||Ongoing|
42 NICNAS promotes community awareness and participation by using targeted, plain-English information for the community, separate from more technical, and industry specific information.
43 This work continues; the Who's Who Guide effectively filters out non-NICNAS inquiries.
44 Implementation requires legislative change to the Act; depends on outcome of the review of NICNAS.
45 Subsumed into the Tier III process of IMAP Framework. Implementation options depend on outcome of review of NICNAS.
46 Being considered as part of review of NICNAS.
Appendix 05—Compliance program
Table 13: NICNAS registrations by tier, over three years and in each quarter 2012–13
|Total registrants as at:|
|30 June 2011||30 June 2012||30 September 2012||31 December 2012||31 March 2013||30 June 2013|
Table 14: NICNAS non-renewed registrations over three years
|at 30 June 2011||at 30 June 2012||at 30 June 2013|
Table 15: Cases managed by NICNAS compliance and enforcement program 2012–13
|Cases managed in 2012–13||53||25||22||2|
|Active cases at 30 June 2013||25||4||5||0|
Table 16: Rotterdam Convention processed 2012–13
|PIC annual authorisation||15|
|NICNAS advice on export notification||69|
Table 17: NICNAS registration audit activities in 2012–13, by quarter
|Quarter 1||Quarter 2||Quarter 3||Quarter 4||2012–13|
|On-time renewal rate||84%|
|Late penalty issued||115||107||0||0||222|
|Late penalty recovered|
Table 18: NICNAS registration level reassessments
|Quarter 1||Quarter 2||Quarter 3||Quarter 4|
|Number of companies audited||181|
|As a percentage||92%||97%||100%|
Appendix 06—Communications and media
Table 19: New and revised publications
|Quarters 1 and 2 (2012)||Quarters 3 and 4 (2013)||Total|
|Revised versions of: About NICNAS, NICNAS Registrationand NICNAS Service Charterpublished and available on new website. New brochure: The role of NICNAS in regulating cosmeticsalso published.|
|Community engagement bulletin||Publication cancelled. Community Engagement Forum matters incorporated in NICNAS Matters|
|Planning documents, reports and factsheets|
|Corporate||Annual Report 2011–12||1|
|Business plan 2012–13||1|
|New chemicals||3,000th report published during second half||3,008+ reports available|
|Existing chemicals||Diisononyl phthalate (DINP) PEC report (public health risk from use in cosmetics, children's toys and childcare articles)PhoslockTM Secondary Notification (draft)||Diisononyl phthalate (DINP) PEC report (public health risk from use in cosmetics, children's toys and childcare articles)PhoslockTM Secondary Notification (draft)||2 published2 drafted|
|IMAP assessment outcomes||129 at Tier I, eight at Tier II published||330 Tier I (human health), 302 Tier I (environment) and 215 Tier II (human health) published||984 assessments, covering|
|IMAP documents||Factsheets: Overview, Stage 1 implementation, Better chemical information, Leveraging international information||IMAP Framework document—chemicals of low concern, polymers of low concernPilot evaluation of IMAP Framework||6|
|Nanomaterials||Factsheets and technical information sheets: nano titanium dioxide, nano silver||2+2|
|Website||New website launched50||Approximately 7,000 web pages|
|Handbook for notifiers||Revised version launched on new website, 27 June 2013|
|Main chapters||77 webpages|
|Chemical fact sheets||Revised version of all current/relevant fact sheets launched on new website, 27 June 2013||50|
Note: Overall NICNAS inquiry statistics are no longer recorded.
47 Includes special Gazettes for the release of report on PhoslockTM, 22 January and 19 March 2013.
48 July 2012: HBCD PEC report/information sheet, IMAP Stage One chemicals assessments/IMAP factsheets; October 2012: New Director, transfer of cosmetic ingredients from TGA, Nanotechnology, Legislative amendments, AICS changes; December 2012: Release of first IMAP assessments, Priority projects, consultations.
49 April 2013: 3,000 new chemicals assessments, Consultations, Legislative amendments, CSG, committee reports.
50 At the end of 2012–13, new NICNAS website—a platform for improved communication—launched.
Table 20: Visits to the NICNAS website (www.nicnas.gov.au) in 2012–13
|Quarter 1||Quarter 2||Quarter 3||Quarter 4||Total|
|Hits to website||11,764,479||8,098,913||7,746,336||7,623,878||35,233,606||57,764,089|
Table 21: Top ten most viewed web pages in 2012–13
|Title of web page||Number of hits||Number of visits|
|2. AICS/Search.asp doc||130,884||2,047|
|3. AICS Search||116,924||21,187|
|4. Chemicals in Australia||19,215||808|
|5. Current issues/Cosmetics||18,951||1,640|
|7. About NICNAS||15,612||736|
|9. CAR (chemical assessment reports)||13,701||2,709|
|10. Chemical Gazette||12,743||2,842|
Note: The most popular days of the week are: Wednesday and Tuesday.
- Topics/issues raised included lead, anti-ageing cosmetic claims, banned chemicals and labelling, IMAP and the assessment of chemicals on the AICS, formaldehyde, chemicals in cleaning products, use of phthalates in cosmetics and hydraulic fracturing chemicals.
Table 22: Media advertising organisations engaged by NICNAS
|Organisation||Service provided||Paid $ (GST inclusive)|
|Adcorp||Advertising in professional magazines, directories and journals regarding NICNAS general awareness and registration||$16,357|
Appendix 07—Advisory groups: community, industry, government
NICNAS's formal consultation mechanisms include advisory groups drawn from community, industry and other government agency stakeholders to provide advice on its regulatory activities and strategies.
Note: 2012–13 advisory groups are listed in alphabetical order.
Community Engagement Forum
Members of the Community Engagement Forum (CEF) provide advice to NICNAS for the worker health and safety, public health and the environment sectors. They help it address the community's information requirements by developing strategies to improve public access to health and safety and environmental information on industrial chemicals. The CEF continued to work on improving ways for NICNAS to engage with stakeholders, and produced two issues of NICNAS's Community Engagement Bulletin, which were distributed to interested organisations and individuals and published on the NICNAS website.
The Forum comprised the Chair and seven members: Director/Acting Director NICNAS, two community members representing the interests of the environment, two representing public health, as well as two nongovernment members representing the interests of worker health and safety.
CEF membership at 30 June 2013
Worker health and safety: Ms Renata Musolino, Ms Pamela Grassick (to February 2013)
Public health: Dr Liz Hanna, Dr David Oakenfull The forum met three times in 2012–13:
CEF 29 (13 August 2012): discussed NICNAS performance update, CEF Work Plan 2012–13, topics for September Community Engagement Bulletin. At joint CEF/IGCC meeting on 14 August members updated the (then) Parliamentary Secretary for Health and Ageing on current key issues and discussed the NICNAS Strategic Plan for 2012–14 with IGCC members, NICNAS.
and IEG11 on 13 May 2013).
The group was established to provide a forum for considering and advising on technical issues relating to the regulation of industrial chemicals and to provide technical input towards the development of relevant documents and proposals prior to wider consultations.
Under its terms of reference, NICNAS is committed to working in collaboration with the group on specific matters, with the group providing advice to the Director on:
Industry members of the IEG represent a broad range of sectors, including those for paper products, consumer cosmetics, household products, paints, plastics and petroleum.
Agenda items included: discussion of exposure scenarios for new chemicals notifications, ideas for operational improvements (listed on the IEG ideas 'hopper' list), the prioritisation and assessment of chemicals on the AICS (IMAP), and new chemicals operational improvements (including a revised screening framework, the smart forms project and the decision repository).
A notable outcome of the IEG was its role in finalising the review of the NICNAS Handbook for Notifiers in readiness for its publication on the NICNAS website.
IEG membership in 2012–13 represented:
NICNAS (Chair and Secretariat), 3M Australia Pty Ltd, Accord Australasia, Australian Plantation Products and Paper Industry Council, Aerosol Association of Australia Inc, Australian Food and Grocery Council, Australian Institute of Petroleum, Albright & Wilson (Australia) Ltd, Australian Paint Manufacturers Association (APMF), Australian Society of Cosmetic Chemists, Minerals Council of Australia, Plastics and Chemicals Industries Association (PACIA), Packer Leather Pty Ltd, Unilever Australasia.
IGCC 43 (14 August 2012): Members focused on reviewing NICNAS's 2011–12 financial year operational and financial performance, as well as the committee's 2012–13 work plan and priorities, within the budget established through the NICNAS cost recovery impact statement (CRIS) in line with the NICNAS planning cycle. At a joint CEF/IGCC meeting the same day IGCC members updated the (then) Parliamentary Secretary for Health and Ageing on their current key issues and discussed the NICNAS Strategic Plan for 2012–14.
IGCC 44 (27 November 2012): Members focused on: budget and performance positions, compliance strategies, and 2013–14 high-level revenue projections and key priorities. They supported NICNAS's compliance approach and noted that the indicative 2013–14 budget is based on the 2012–16 cost recovery impact statement (CRIS). They received an update on the new NICNAS website.
IGCC 45 (26 March 2013): Members focused on NICNAS's budget and performance positions, in line with the IGCC's terms of reference, and considered the handling of strategic issues in 2013–14 and beyond. The meeting supported arrangements to include additional chemicals to the Stage One list for the IMAP Framework. Members provided useful feedback on implementing revised arrangements for NICNAS registration in 2013–14.
Nanotechnology Advisory Group
The Nanotechnology Advisory Group (NAG) was established to advise NICNAS on regulatory and technical matters to ensure its regulations can manage any risks arising from industrial nanomaterials.
The group's tenure was extended twice. While the group did not meet face to face during 2012–13, it provided out-of-session advice to NICNAS on new nanotechnology publications. Its term is currently due to end in March 2014.
The NAG comprises three individuals representing the community, three representing industry, one expert in nanoscience, one expert in toxicology, and a NICNAS representative.
NAG membership in 2012–13:
NICNAS: Dr Roshini Jayewardene (Chair), Dr Matthew Gredley (member) , Ms Nicola Hall/Dr Stephen Zaluzny (Secretariat)
CEF 30 (30 November 2012): discussed NICNAS performance update, formaldehyde, new website, LRCC reform, inputs to CEF Work Plan 2012–13 and NICNAS stakeholder survey.
CEF 31 (15 March 2013): discussed Coal Seam Gas (CSG) with presentations on scope of national assessment of chemicals associated with CSG extraction project from the (then) DSEWPaC and NICNAS, NICNAS performance updates and CEF Work Plan 2012–13 and stakeholder survey.
Terms of reference for—and other details about—the forum are available on the Community page of the NICNAS website.
Cosmetics Advisory Group
The group was chaired by NICNAS and comprised one NICNAS representative, two Australian Government representatives, three industry representatives, three community representatives, one health expert and one formulation expert.
CAG membership in 2012–13:
Independent experts: Prof. Mike Roberts, Mr Ric Williams
Community: Dr Rye Senjen (National Environmental Consultative Forum—NECF), Ms Robyn Easton (Consumers Federation of Australia), Mr Craig Sinclair (Cancer Council Australia)
Industry: Dr Kerryn Greive/Ms Catherine Gwynne (Australian Self Medication Industry), Ms Dusanka Sabic and Dr Graeme Haley (Accord Australasia)
Government: Dr Raymond Wilson (TGA), Mr Peter Wallner (ACCC)
Industry Engagement Group
Two meetings of the NICNAS Industry Engagement Group (IEG) were held in 2012–13 (IEG10 on 22 October 2012
Industry Government Consultative Committee
The Industry Government Consultative Committee (IGCC):
reviews the use of resources against NICNAS objectives;
IGCC membership during 2012–13:
Australian Chamber of Commerce and Industry (ACCI): Ms Carolyn Davis
A representative of DoHA (now Health) is an ex-officio member: Ms Megan Morris (First Assistant Secretary), Mr John Barbeler (Chief Financial Officer), Mr Graeme Barden
The IGCC held three face-to-face meetings during the year:
Industry: Mr Geoff MacAlpine (PACIA), Mr Leo Hyde (APMF), Mr Craig Brock (Accord Australasia)
States and Territories Memorandum of Understanding Group
The States and Territories Memorandum of Understanding (MoU) group serves as a conduit for the exchange of information and service delivery between NICNAS and the state and territories, concerning occupational health and safety, public health and environmental protection, relating to the use of industrial chemicals in Australia.
The group met by teleconference on 30 January 2013 and members discussed the following items:
MoU Group membership:
NICNAS: Mr Lewis Norman (Chair), Dr Brian Richards (Director), Dr Trang Pham, Ms Louise Stedman, Dr Adrienne Adams (Secretariat)
Victoria: Ms Anita Aiezza, Mr Halil Ahmet
Tasmania: Mr Ian Graham, Mr Daryl Langerak
Queensland: Mr David Grantham, Ms Caroline Topping
Western Australia: Ms Sally North, Mr Mark Lewis
New South Wales: Dr Usha St George
South Australia: Mr Chor Wong, Ms Shelley Rowett
Technical Advisory Group
This group did not convene in 2012–13 and is not continuing.
Appendix 08—performance: government expectations
Sub-Program 1.4.3: Industrial Chemicals
Sub-Program 1.4.3 aims to ensure that uses of industrial chemicals are safe for human health and the environment, and to further improve the efficiency of the regulatory framework, for industry and the community.
Table 23: NICNAS's performance results against PBS deliverables and KPIs in 2012–13
|2012–13 NICNAS PRIORITY PROJECTS|
|1. Strategy for industrial nanomaterials||Address uncertainty surrounding the risk and appropriateness of current assessment protocols and regulatory requirements for nano-forms of existing chemicals||Substantially met—|
see p. 16-17
|2. Cost recovery impact statement||Implement outcomes of review of cost recovery arrangements||Completed—see p.13|
|3. Completion of cosmetic reforms||Safe use of UV filters in products transferred from therapeutic to industrial chemicals regime||Deferred pending review|
|4. IT strategic program, with focus on integrated system||Improve efficiency and effectiveness of business systems||Substantially met, and ongoing—see p. 21-22|
|5. Enhancements to new chemicals operations||More efficient and effective new chemicals notification program and increased use of safer chemicals||Substantially met—see p.7|
|2012–13 PERFORMANCE MEASUREMENT TARGETS FOR QUARTERLY REPORTING|
|Deliverable/KPI||2012–13 reference point/target||Result51|
|Implement IMAP framework||IMAP Framework governance arrangements in place; ongoing stakeholder engagement and communication strategies are effectively implemented||Met|
|Implement approach for introducing substitutes for perfluorinated chemicals||Framework for the assessment of new perfluorinated chemicals implemented||Met|
|Contribute to international harmonisation of assessments, regulatory approaches and methodologies by adjusting, as appropriate, Australian industrial chemicals assessment and management systems||Review international assessments, regulatory approaches and methodologies for their application to NICNAS risk assessments from three key sub committees of the OECD Chemicals Committee||Met|
|Introducers of industrial chemicals aware of their obligations through NICNAS Registration||Registration of all identified introducers||Met|
|KPI: Effective use of international information||A. For new chemicals: finalise lessons learnt from US EPA bilateral agreement and explore options for further developing arrangements B. For existing chemicals: through implementing the IMAP Framework, developing guidance and training on the use of international information||Met|
|KPI: Percentage uptake by industry of options to introduce new chemicals that are a lower risk to human health or the environment||Target: 20%; Actual: 24%||Met|
|KPI: Percentage of Stage One chemicals assessed through effective application of IMAP Framework||Target: 80%; Actual: 80%||Met|
|KPI: Percentage of those introducing over $500,000 of industrial chemicals assessed for compliance with new chemicals obligations||Target: 30%; Actual: 30.34%||Met|
|Other targets:||2012–13 target||2012–13 actual|
|Percentage of variance between actual and budgeted expenses.||≤0.5%||— 7.2%||Met|
|Percentage of NICNAS PEC recommendations developed in consultation with relevant stakeholders||100%||100%||Met|
|Percentage of reports on assessed chemicals posted to the NICNAS website New chemicals:|
|All recent reports are available. Uploading all 3,000+ reports is in progress|
|Percentage of inquiries to NICNAS responded to within 24 hours||95%||Statistics for inquiries no longer gathered|
|Percentage of new chemical assessments completed within legislated timeframes||96%||95%||Met|
|Percentage of legislated timeframes adhered to for assessment of existing chemicals||100%||100%||Met|
|Percentage of AICS searches completed within five working days||95%||97%||Met|
|KPI: Percentage of known industrial chemical introducers registered and compliant||95%||99.7%||Met|
|KPI: Percentage of customers satisfied with NICNAS training||95%||95%||Met|
|KPI: Percentage increase in visitor sessions to NICNAS website||5%||— 18% (decrease)||Not met|
|KPI: Percentage uptake of options to introduce low risk new chemicals||80%||80%||Met|
51 For commentary, see Department of Health and Ageing Annual Report 2012–13,
Sub-program 1.4.3: Industrial chemicals.
Appendix 09—Links: national and international
Table 24: International and national presenters to staff information and training sessions in 2012–13
Note: This listing provides an overview, only, of the range of speakers and is not all-inclusive.
|Name and position||From||Topic|
|Geert Dancet||European Chemicals Agency (ECHA)||EU REACH regulation, at forum to launch IMAP|
|Dr Robert Kavlock||US EPA Office of Research and Development||Computational methodologies,|
|Hitoshi Nanimoto||Ministry of Economy, Trade and Industry, Japan||Stepwise assessment scheme,|
|Dr Bette Meek||University of Ottawa, Canada||Canadian prioritisation program and beyond, at forum|
|Rob Forlong||New Zealand EPA||International information flows in risk management, at forum|
|Dr Simon Apte|
Ms Sarah Court
Dr Marion Healy
Dr Stephen Healy
Prof. Ian Rae
University of Melbourne
|Various topics, at forum|
|Prof David Berube,|
|North Carolina State University, USA||Communicating risk in the 21st century|
|Michael Borowick||ACTU||Tuesday tune-up: Chemicals regulation|
|Speaker from Black dog institute||Mindfulness|
|Dr Joe Schwarcz||McGill University, Canada||Better living through chemistry|
|Prof Arie Freiberg||Monash University||Tune-up: Regulation|
|Dr Rhian Cope||Staff training: Toxicology|
|Michael Frost||COAG Reform Council||Tune-up: COAG Reform Council and Reform|
|Prof. Ovanes Mekenyan||Laboratory of Mathematical Chemistry, Bulgaria||Staff training: use of OASIS TIMES and OECD Toolbox|
|Dr Roger Klein||University of Cambridge, UK||Fluorochemicals—emerging contaminants of concern|
|Ms Francine Lamoriello||US Personal Care Products Council||Cosmetics and toxicology testing|
|Speaker from Safe Work Australia||Tune-up: WHS regulations, exposure standards and health surveillance|
|Speakers from PACIA, ACCI, APMF||Tune-up: The business of chemistry; About ACCI; About the APMF|
|Ms Sue Sinclair||Cancer Australia||Tuesday tune-up: Cancer control|
|Alec Johnston||Trainer||Tune-up: The business of chemistry; About ACCI; About the APMF|
Table 25: Additional international activity
NICNAS provided inputs to meetings of the following agencies during 2012–13
|APEC||See Scientific, regulatory and reform activities for details.|
|Chemicals Evaluation and Research Institute (CERI), Japan||Provided additional information on chemical regulation in Australia to Japan's CERI in response to their inquiries received during the year.|
|International Conference on Chemicals Management||Provided technical advice briefs on emerging issues related to chemicals in products, perfluorinated chemicals, nanomaterials, and endocrine disruption.|
|OECD/UNEP Global Perfluorinated Chemicals Group||Compared domestic PFC uses and volumes with data in a synthesis paper drafted by the Fluoro Council for the Global PFC Group, to be released on the OECD portal on perfluorinated chemicals, and observed that all Australian uses had been captured except as a mist suppressant in metal plating.|
|OECD Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology||Drafted/coordinated briefs on eChemPortal, managing safety of manufactured nanomaterials, hydraulic fracturing chemicals, integrated approaches to testing and assessment, work plan for substitution of hazardous chemicals, policy drivers influencing chemicals management decision-making, QSAR Toolbox, survey on PFCs.|
|OECD Working Party on Manufactured Nanomaterials||See Scientific, regulatory and reform activities for details. Involved in sponsorship program on safety testing of representative set of manufactured nanomaterials.|
Table 26: NICNAS presentations at Australian conferences
Note: This listing provides an overview, only, of the range of events/topics. It is not all-inclusive.
|Standards Australia||Workshop on|
|Dr Matt Gredley, Dr Kerry|
|World Congress on Risk||Risk||Several NICNAS staff|
|WHO combined exposure|
|Exposure||Dr Sneha Satya|
|Dioxins conference||Perfluorinated chemicals||Dr Sneha Satya||August|
|AIOH seminar||Toxicological basis of|
|Dr Jackie Kitching||September|
|Accord Australasia||Regulation of chemicals|
|Dr Roshini Jayewardene||October|
|Customs broker and|
|NICNAS requirements||Lewis Norman|
network and forum
|NICNAS new chemicals||Dr Brian Richards,|
Dr Daniela Leonte
|AFP Australian chemical|
|Chemical security||Dr Sneha Satya||December|
|ACTRA annual scientific|
|Dr Daniela Leonte,||March|
|HAZMAT 2013||Various topics (IMAP etc)||Several staff||May|
Appendix 10—Staff profile, training, development
Executive staff, NICNAS programs at 30 June 2013
Director, NICNAS: Dr Brian Richards
Regulatory Strategy: Dr Roshini Jayewardene (Head)
New Chemicals: Dr Kate Liddell (acting Head), Dr Daniela Leonte (Principal Scientist)
Existing Chemicals: Ms Angela McKinnon (Head), Dr Kerry Nugent (Principal Scientist)
Science Strategy and International: Dr Sneha Satya (Head)
Reform: Dr Matthew Gredley (Head)
Compliance and Enforcement: Mr Lewis Norman (Head)
Business Management and Communications: Mr Nick Miller (Head)
Table 27: NICNAS staff profile at 30 June 2013 (Health employees)
|Classification||Male||Female||Total||Total, as percentage|
|Holder of public office||1||-||1||1.3|
|Executive Level 2 Officers||5||6||11||13.9|
|Executive Level 1 Officers||9||17||26||32.9|
|APS Level 6||13||6||19||24.1|
|APS Level 5||-||6||6||7.6|
|APS Level 4||-||5||5||6,3|
|APS Level 3||3||7||10||12.6|
|APS Level 2||-||1||1||1.3|
Table 28: Membership of Equal Employment Opportunity groups at 30 June 2013 (Health employees)
|Number||As percentage of total|
|Aboriginal and Torres Strait Islander||1||1.3|
|People with disability||3||3.8|
Table 29: Full time and part-time staff at 30 June 2013 (Health employees)
|Full time—Part time||Headcount||Headcount|
Table 30: Summary of staff training, by total formal training days in 2012–13 (Health employees)
|All staff formal|
|Number of participants, e-Learning training||185|
|Number of participants, non e-Learning training||69|
|Total number of formal training courses (both e-Learning and non e-Learning)||254|
|Average number of courses per staff member||3.2|
Note: In October 2012, the inaugural NICNAS staff-members-coordinated Staff Orientation Day was held for a large number of newly-recruited NICNAS staff.
In addition, NICNAS staff attended numerous 'Tuesday tune-up' and other scientific sessions (as detailed at Appendix 09). Some were presented by international speakers, some by Australian experts and some by NICNAS staff.
Appendix 11—Update: stakeholder survey
The last NICNAS Stakeholder Survey of its customers was conducted in August 2010. It covered service in key areas but also NICNAS's CRIS and other specific activities. More than 1,000 responses were received from registrants, peak bodies, government organisations and interest groups.
The survey—which confirmed that NICNAS stakeholders generally view the organisation positively—provided NICNAS with valuable data on which to build programs and activities to improve outcomes.
The next survey is scheduled for later in 2013.
Table 31: Activity during 2012–13 on key outcomes from 2009–10 stakeholder survey
Opportunities to improve user experiences of the confidential AICS process appear to be related to the timeliness of feedback, the user friendliness of the application form, channels to seek further information and overall clarity of the process for confidential listings.
|Improve timeliness of NICNAS processes Clarify grounds for stopping assessment when information: inadequate Transparency of decision-making||Completed—see: Other assessment-related activities|
|Improved clarity of AICS search page (including pointers on nil results page)||Completed|
Communications, workshops and training
Engagement with Tier 1 registrants (particularly those dealing with very low values of chemicals), as well as those in less regular contact … and specific stakeholder segments (such as those dealing with cosmetics) … on rationale for fees and charges, scope of scheme, compliance requirements and implementation of reforms.
|Improve website Enhance chemical safety information Target Tier 1||Completed|
There is a clear demand for NICNAS training, workshops and consultations across all stakeholder segments … this is likely to include structuring courses to meet the needs of small business users of chemicals, larger operators … and specific user segments— (e.g. cosmetics)
|Targeted training||Ongoing improvements to delivery—see Appendixes 09 and 10|
Staff performance was viewed positively
|Continue to promote NICNAS service culture through measures in place||Track progress in 2013 stakeholder survey|
Appendix 12—Ecologically sustainable development
The Act administered by NICNAS provides for a national notification and risk assessment scheme for industrial chemicals. NICNAS assessment reports provide information and recommendations to regulators (including the Commonwealth, states and territories), industry and the general public.
NICNAS's risk assessment activities involve assessing the health and environmental risks of new industrial chemicals entering Australia for the first time (by manufacture/import) before their use and subsequent release to the environment. NICNAS also assesses chemicals already in commerce, based on environmental and/or health concerns.
All chemical risk assessment activities undertaken by NICNAS are within an internationally-agreed policy framework that is consistent with the principles of ecologically sustainable development (ESD) that comprises a hazard assessment, dose-response relationships, exposure assessment and risk assessment, including risk management options.
NICNAS environmental risk assessments are conducted through a cooperative partnership arrangement with DSEWPaC (now Environment). NICNAS's activities are aligned with a series of ESD principles. Decision-making processes effectively integrate both long-term and short-term environmental, social and equity-supporting considerations.
NICNAS operates within an agreed framework for chemical management that is consistent with the National Strategy for ESD, its principles and policies. This framework aligns with the UN Conference on Environment and Development (UNCED) Agenda 21 (Rio Declaration), of which Chapter 19 relates to the environmentally-sound management of toxic chemicals.
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 determined for each chemical, based on its known or anticipated use pattern. Risk assessment integrates both the hazard and exposure assessment to create a risk estimate and determination of whether or not the risk is acceptable. If the risk is considered unacceptable, recommendations for action are provided to the relevant agency.
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 guides health and environmental risk assessments and forms the basis of 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 (the precautionary approach).
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 the conservation of biological diversity and ecological integrity should be a fundamental consideration in decision-making.
NICNAS's risk assessments aim to preserve the integrity of the environment and its biodiversity. The known or anticipated use pattern of each chemical is characterised within the context of the risk assessment, taking into account Australia's demography and ecosystems. The outcome of the NICNAS assessment provides the information necessary for informed, objective and transparent decision-making, including 'trade-offs' between competing objectives of current utility and future adverse environmental effects.
Improved valuation pricing and incentive mechanisms continue to be promoted, and NICNAS's Low Regulatory Concern Chemical (LRCC) reforms continued to be implemented in 2012–13. As in previous years, they included strategies that encourage the introduction of less hazardous chemicals that pose a lower risk to the environment. The proportion of safer chemicals assessed—based on their hazard and risk profile—was 74 per cent in 2010–11, 77 per cent in 2011–12 and 80 per cent in 2012–13.
Promoting new technologies through direct financial incentives (for chemicals that pose a lower regulatory risk) will result in a more sustainable overall regulatory framework, as well as a more sustainable chemical industry in Australia.
How outcomes relate to ESD
Chapter 19 of UNCED Agenda 21—while 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:
1. a lack of sufficient scientific information for the assessment of risks entailed by the use of a great number of chemicals; and
2. a lack of resources for assessment of chemicals for which data are available.
|Chapter 19 concentrates on generating, harmonising and disseminating chemical data and strengthening capacity for chemical management. 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').|
Appendix 13—Compliance with mandatory
Mandatory 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 IGCC, the Act also prescribes additional mandatory reporting requirements.
Table 32: Compliance with mandatory reporting requirements under the Act, including last/next publishing date.
Last published / Next published
Annual publication in the Chemical Gazette of the list of chemicals that are the subject of low volume chemical permits [subsection 21ZA(2)].
List of low volume chemical permits in force at
Number of LVC permits issued 2012–13: 36 comprising
Annual publication in the Chemical Gazette of a list of current and previous Priority Existing Chemicals
A list of current and previous PECs is published on the NICNAS website. This list is also available at Appendix 04 .
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].
All assessments undertaken and published by NICNAS are subject to secondary notification provisions. Secondary notifications are published individually in the Chemical Gazette . The list was published in the October 2102 edition of the Chemical Gazette, with an updated list published in the gazette in September 2013.
A list of the chemicals undergoing secondary notification and no longer requiring secondary notification will be published in the Chemical Gazette in the second quarter of 2013–14.
Written notice to the Gene Technology Regulator when a genetically modified (GM) product is regulated by NICNAS [section 10A].
No genetically modified chemicals were referred to the Office of the Gene Technology Regulator for advice during 2012 –13
Annual publication in Chemical Gazette of chemicals in respect of which controlled use permits are in force (section 22N)
This list will be published in the November 2013 Chemical Gazette
Table 33: Compliance with mandatory reporting requirements by the Department of
Prime Minister and Cabinet, 2012–13
Letter of transmittal
Table of contents
Internet home page address and address for report
Review by NICNAS Director
Overview of NICNAS's performance and financial results
See DoHA Annual Report
Role and functions
2 – 3
Outcome and program structure
Where outcome and program structures differ from Portfolio Budget Statements (PBS), details of variation and reasons for change
Report on performance
Review of performance during the year in relation to programs and contribution to outcomes
See DoHA Annual Report
Actual performance in relation to deliverables and KPIs set out in PBS
Where performance targets differ from the PBS, details of former and new targets, and reasons for the change
Narrative discussion and analysis of performance
Performance against service charter customer service standards, complaints data, and department's response to complaints
Discussion and analysis of department's financial performance
Discussion of any significant changes from prior year, from budget or anticipated to have a significant impact on future operations.
Agency resource statement and summary resource tables by outcomes
Management and accountability
Director's certification that the agency complies with Commonwealth Fraud Control Guidelines.
See DoHA Annual Report
Statement of the main corporate governance practices
6, 39 –40
Names of the senior executive and their responsibilities
Senior management committees and their roles
Significant developments in external scrutiny
Judicial decisions and decisions of administrative tribunals
Reports by the Auditor-General, Parliamentary Committee or
Management of human resources
Assessment of effectiveness in managing and developing human resources to achieve objectives
Workforce planning, staff turnover and retention
20 –21; 46
Training and development undertaken and impact
Work health and safety performance
Statistics on staffing
Enterprise or collective agreements, IFAs, determinations, common law contracts and AWAs
See DoHA Annual Report
Assessment of effectiveness of assets management
13; See DoHA Annual Report
Assessment of purchasing against core policies and principles
13; See DoHA Annual Report
Statement detailing number of new consultancy services contracts let during the year.
Absence of provisions in contracts allowing access by the Auditor-General
See DoHA Annual Report
Contracts exempt from the AusTender
Other mandatory information
Work health and safety (Schedule 2, Part 4 of the Work Health and Safety Act 2011 )
Advertising and market research (section 311A of the Commonwealth Electoral Act 1918 ) and statement on advertising campaigns
Ecologically sustainable development and environmental performance (section 516A of the Environment Protection and Biodiversity Conservation Act 1999 )
Disability reporting—explicit and transparent reference to agency level information available through other reporting mechanisms
46; See DoHA Annual Report
Information publication scheme statement
Agency resource statements and resources for outcomes
List of requirements
The terms described in this 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 NICNAS is given in Part 1 section 5 of the Act.
The Act/ICNA Act the Commonwealth Industrial Chemicals (Notification and Assessment) Act 1989
Administrative Appeals Tribunal (AAT) body which provides independent review of administrative decisions made by the Australian Government and some non-government bodies
Australian High Volume Industrial Chemicals (AHVIC) list of information about chemicals manufactured in and/or imported into Australia in quantities greater than or equal to 1000 tonnes
Australian Inventory of Chemical Substances (AICS) 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 chemicals assessed since February 1990 and corrections as required
Business Plan for NICNAS document describing the performance measures and data for NICNAS and how these relate to the NICNAS Strategic Plan and Portfolio Budget Statements
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
Community Engagement Forum (CEF) NICNAS's consultative group that identifies community concerns about the effects of industrial chemicals on the environment, public health and/or worker health and safety
Council of Australian Governments (COAG) the peak intergovernmental forum in Australia, comprising the Prime Minister, state premiers, Territory chief ministers and the President of the Australian Local Government Association (ALGA).
Director Director of NICNAS
Ecologically sustainable development (ESD) 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
Existing chemical an industrial chemical other than a new industrial chemical—see entry for Australian Inventory of Chemical Substances (AICS)
Inventory Multi-tiered Assessment and Prioritisation (IMAP) Framework framework developed by NICNAS to assist in the prioritisation and assessment of chemicals of concern on the AICS, leading to enhancements to chemical safety information flow and chemicals management, 2012–15
Industrial chemical a chemical with an application, purpose or use that is industrial for registration and introduction purposes (whether or not it also has non-industrial uses)
Industry Government Consultative Committee (IGCC) primary consultative body for industry and government on NICNAS matters. Among other things, it reviews the use of resources against NICNAS objectives under terms of reference set by the Minister
Level A, Level B, Level C, Level D NICNAS registration levels replacing tiers (see below), 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, commencing 1 September 2013
Low regulatory concern chemicals (LRCC) industrial chemicals which could qualify for reduced regulation on the basis of a definition of low risk, or where regulatory input from elsewhere is sufficient to meet Australian requirements
Memorandum of Understanding (MoU) agreement between parties that details mutual obligations relating to services and/or the exchange of information (relating to industrial chemicals). NICNAS has a States and Territories Group (MoU) and an MoU with the Australian Customs and Border Protection Service, the Australian Taxation Office and the Office of the Australian Safety and Compensation Council, as well as with the European chemicals agency ECHA and the New Zealand EPA
New chemical an industrial chemical (including a polymer) not listed on the AICS
Organisation for Economic Co-operation and Development (OECD) 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. Its work covers economic and social issues from macroeconomics, to trade, education, development and science and innovation
Outcome in the context of the Portfolio Budget Statements (PBS) (see below): the results, impacts or consequences of actions by the Australian Government on the Australian community; a stated goal for achievement by an organisation
Output in the context of the PBS (see below): the goods or services produced by agencies on behalf of the Australian Government for external organisations or individuals; a set of activities and products that contribute to the achievement of a stated goal of an organisation (outcome) subject to performance standards
Parallel process refers to a company notifying in multiple jurisdictions and authorising participating governments to share information when conducting their reviews of new chemicals
Performance measures provide information on administered items and departmental outputs in terms of quality, quantity and efficiency
Poisons Standard (SUSMP) a legislative instrument that consists of decisions regarding the classification of medicines and poisons into schedules for inclusion in legislation of the states and territories; it includes model provisions about containers and labels, a list of products recommended to be exempt from these provisions, and recommendations about other controls on drugs and poisons
Portfolio Budget Statements (PBS) statements prepared by portfolios to explain budget appropriations in terms of outcomes and outputs
Precursor chemical chemical which is known to be used in the manufacture of drugs and explosives
Priority Existing Chemical (PEC) 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
Rotterdam Convention the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for Certain Severely Restricted or Banned Hazardous Chemicals and Pesticides in International Trade. Ratified by Australia on 20 May 2004.
It ensures that certain hazardous industrial chemicals comply with national and international import and export controls
Secondary notification assessment assessment of chemical/s that has been previously assessed by NICNAS and requires re-assessment based on new data becoming available, that may change the risks identified in the earlier assessment
Service Charter for NICNAS document that spells out the types, levels and standards of service NICNAS clients can expect from the organisation, including details of complaint resolution procedures
SIDS Initial Assessment Report (SIAR) OECD Chemicals Programme report of hazards of a specific industrial chemical based upon an evaluation of an OECD Screening Information Data Set
Stockholm Convention the Stockholm Convention on Persistent Organic Pollutants (POPs), ratified by Australia on
20 May 2004. Its review committee examines risk profiles of nominated chemicals to determine whether they may lead to significant adverse human health and/or environmental effects that would warrant global action
Tier 1, Tier 2, Tier 3 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. New registration levels (see above) introduced 1 September 2013 replace tiers
Tier I, Tier II, Tier III IMAP assessment levels for unassessed industrial chemicals: high throughput assessment against criteria (Tier I), chemical-by-chemical evaluation against criteria (Tier II), in-depth chemical assessment (Tier III)
Acronyms and abbreviations
|AAT||Administrative Appeals Tribunal|
|ACCC||Australian Competition and Consumer Commission|
|ACCI||Australian Chamber of Commerce and Industry|
|Accord||national industry association for the Australasian consumer, cosmetic, hygiene and|
specialty products industry
|ACCS||Advisory Committee on Chemicals Scheduling|
|ACTRA||Australasian College of Toxicology and Risk Assessment|
|AICS||Australian Inventory of Chemical Substances (see Glossary, above)|
|AIOH||Australian Institute of Occupational Hygienists|
|ANAO||Australian National Audit Office|
|APEC||Asia-Pacific Economic Co-operation|
|AHPC||Australian Health Protection Committee (Health committee)|
|APMF||Australian Paint Manufacturers Federation|
|APVMA||Australian Pesticides and Veterinary Medicines Authority|
|ASCC||Australian Safety and Compensation Council|
|ASCC||Australian Society of Cosmetic Chemists|
|BRMP||Better Regulation Ministerial Partnership (review of NICNAS)|
|CAG||Cosmetics Advisory Group (NICNAS committee)|
|CAS||Chemical Abstracts Service, a division of the American Chemical Society|
|CEC||Commercial Evaluation Category permit (NICNAS)|
|CECR||Commercial Evaluation Category Permit Renewal (NICNAS)|
|CEF||Community Engagement Forum (see Glossary, above)|
|CHNC||Clearing House on New Chemicals (OECD)|
|COAG||Council of Australian Governments (see Glossary, above)|
|CRIS||Cost Recovery Impact Statement|
|CSG||coal seam gas – also known as natural|
|CSIRO||Commonwealth Scientific and Industrial Research Organisation|
|CWG||Chemicals Working Group|
|DEEWR||Australian Government Department of Education, Employment and Workplace Relations|
|DIISRTE||Australian Government Department of Innovation, Industry, Science, Research and Tertiary Education – also|
known as DSIICCRTE (with inclusion of Climate Change in the portfolio)
|DMEP||bis (2-methoxyethyl) phthalate|
|DoFD||Australian Government Department of Finance and Deregulation|
|DoHA||Australian Government Department of Health and Ageing—now Department of Health (Health)|
|DSEWPaC||Australian Government Department of Sustainability, Environment, Water, Population and Communities|
|DWAIN||NICNAS's internal database|
|ECHA||European Chemicals Agency|
|EIMS||Electronic Information Management System (NICNAS–IMAP project)|
|EIP||Early Introduction Permit (NICNAS)|
|enHealth||Environmental Health Committee–subcommittee of Health's AHPC|
|Environment||Australian Government Department of the Environment (formerly DSEWPaC)|
|EOP||(controlled use) Export Only Permit (NICNAS)|
|EPHC||Environment Protection and Heritage Council|
|ERMA||New Zealand Environmental Risk Management Authority (now part of the New Zealand Environmental|
|ESD||Ecologically sustainable development|
|FSANZ||Food Standards Australia New Zealand|
|GHS||Globally Harmonised System of Classification and Labelling of chemicals (United Nations)|
|Health||Australian Government Department of Health|
|HPV||High Production Volume (chemicals)|
|HSIS||Hazardous Substances Information System|
|IARC||International Agency for Research on Cancer|
|IEG||Industry Engagement Group (NICNAS committee)|
|IGCC||Industry Government Consultative Committee (see Glossary, above)|
|IMAP||Inventory Multi-tiered Assessment and Prioritisation (NICNAS)|
|Industry||Australian Government Department of Industry (formerly DIISRTE / DSIICCRTE)|
|ISG||Implementation Steering Group (NICNAS committee)|
|LRCC||Low Regulatory Concern Chemicals (NICNAS)|
|LTD||Limited notification category (NICNAS)|
|LVC||Low Volume Chemical (NICNAS)|
|LVCR||Low Volume Chemical Permit Renewal (NICNAS)|
|MSDS||Material Safety Data Sheet|
|NAG||Nanotechnology Advisory Group (NICNAS committee)|
|NChEM||National Framework for Chemicals Environmental Management (EPHC committee)|
|NECF||National Environmental Consultative Forum|
|NETS||National Enabling Technology Strategy (DIISRTE program)|
|NZ EPA||New Zealand Environmental Protection Agency|
|OCS||Office of Chemical Safety|
|OECD||Organisation for Economic Co-operation and Development|
|OWS||Office of Water Science (DSEWPaC)|
|PACIA||Plastics and Chemicals Industries Association|
|PBT||persistent bioaccumulative and toxic (chemicals)|
|PEC||Priority Existing Chemicals|
|PFCA||perfluoroalkyl carboxylic acid|
|PIC||Prior Informed Consent (refers to Rotterdam Convention, see Glossary above)|
|PLC||Polymer of Low Concern category (NICNAS)|
|POP||Persistent Organic Pollutants (refers to Stockholm Convention see Glossary above)|
|POPRC||Persistent Organic Pollutants Review Committee|
|QSAR||Quantitative Structure Activity Relationship modeling software|
|REACH||European Community's legislation for Registration, Evaluation, Authorisation and Restriction of|
|SANHC||Self-assessment for Non-Hazardous Chemical notification (NICNAS)|
|SANHP||Self-assessment for Non-Hazardous Polymer notification (NICNAS)|
|SAPLC||Self-assessment for Polymer of Low Concern notification (NICNAS)|
|SCAA||Surface Coatings Association of Australia|
|SCEW||Standing Council on Environment and Water (COAG committee)|
|SCOC||Standing Committee on Chemicals|
|STD||Standard notification category (NICNAS)|
|SUSMP||Standard for the Uniform Scheduling of Medicines and Poisons (see Poisons Standard, Glossary, above)|
|SWA||Safe Work Australia|
|TAG||Technical Advisory Group (NICNAS)|
|TFHA||Task Force on Hazard Assessment|
|TGA||Therapeutic Goods Administration|
|UNCED||United Nations Conference on Environment and Development|
|UNEP||United Nations Environment Programme|
|US EPA||United States Environmental Protection Agency|
|UVCB||Unknown or Variable composition, Complex reaction products or Biological materials|
|WHO||World Health Organization|
|WHS||work health and safety|
|WPMN||Working Party on Manufactured Nanomaterials|
abbreviations and acronyms (NICNAS), 54
advertising (NICNAS), 37
advice – technical and other (NICNAS), 4-5, 44,
advisory groups (NICNAS), 6, 38-40
AICS, see Australian Inventory of Chemical Substances,
Animal testing (alternatives to), 12
annual reporting (NICNAS), 13, 30
APEC chemical dialogue and regulators forum, 16, 44
- and prioritisation of chemicals on the AICS inventory (IMAP) project (NICNAS), 8-11,
- chemicals used in coal seam gas extraction, 11-12
- existing chemicals, 10, 30-34
new chemicals, 7-8, 29-30
Attorney-General's security chemicals framework program, 12,
audits / auditing, and investigation / monitoring (NICNAS), 13, 18, 35-36,
- new chemicals, 13, 30
- registration, 17-19, 34-35
Australia-Canada Bilateral Agreement, see international harmonisation
Australian Competition and Consumer Commission (ACCC), 4, 10
Australian Government Department of Health (Health) and Ageing (DoHA), 3-4
- portfolio budget statement (PBS), 41-42
- regulatory plan, 3
Australian Government Department of Industry (Industry) and Innovation, Science, Research and Tertiary Educations (DIISRTE), 17,
Australian Government Department of the Environment (Environment) / Sustainability, Environment, Water, Population and Communities (DSEWPaC), 4, 5, 14, 17, 18
Australian Inventory of Chemical Substances (AICS), 2, 3,
- assessment and prioritisation of chemicals, see inventory multi-tiered assessment and prioritisation (IMAP), 9-11
- improvements, 11
- listings and search requests, 42
- Technical Advisory Group, 40
Australian Pesticides and Veterinary Medicines Authority (APVMA), 3
Better Regulation Ministerial Partnership (BRMP) review, 13
- management, 19-22,
- plan, 21
Canada, bilateral agreement, see international harmonisation
- certificate (assessment) applications, 7-8, 29-30
- certified agreement (NICNAS) see enterprise agreement (NICNAS)
- chemicals (industrial),
- cooperative assessment program (OECD), 15
- exempt from notification, 13, 29-10
- hydraulic fracturing, see hydraulic fracturing,
- low regulatory concern (LRCC), 8, 42
- regulation, 3
- safer, 8,
- security concern (report), see Attorney-General's
- see also existing chemicals assessment
- see also new chemicals assessment
Clearing House (new chemicals) OECD, see new chemicals
Coal seam gas (CSG) chemicals, see hydraulic fracturing, assessment/s, chemicals used in coal seam gas extraction
committees (NICNAS), 38-40
communication/s (NICNAS), 36-37
Community Engagement Forum (NICNAS), 38
complaints (NICNAS), 21
- and enforcement program activities (NICNAS), 17-19
- mandatory reporting requirements, 18-19
- training for industry, 17
- with DoHA regulatory requirements (NICNAS), 49
conferences, workshops and meetings attended (NICNAS), 43-44
consultancy services let during the year (NICNAS), 28
contact details (NICNAS), iv
core activities (NICNAS), 7-22
corporate governance (NICNAS), 2-6
cosmetics (NICNAS), 14
- advisory group (NICNAS), 38
- reform, 14
- ultraviolet (UV) filters, see sunscreens, data requirements
cost recovery impact statement (NICNAS), 13
- see also financial performance
customer survey (NICNAS) see stakeholder survey
Department of Health and Ageing (DoHA), see Australian Government Department of Health (Health) and Ageing
dibutyl phthalate (DBP), 10
diisononyl phthalate – DINP (assessment), 10
dimethoxyethel phthalate – DMEP (assessment), 10
dimethyl phthalate – DMP (assessment), 10
Director's report (NICNAS), 1
ecologically sustainable development (ESD), 48-49
employees (NICNAS), see people
endocrine disrupters, 12
engagement – stakeholder (NICNAS), 6, 9, 38
enterprise agreement, staff (NICNAS) , 20-21
environment, see ecologically sustainable development
European chemicals agency (ECHA), 16
existing chemicals (NICNAS), 8-11
- assessments, 8-11, 30-32
- priority (PEC) reports, 10, 30-32
- secondary notifications, 10
- see also assessments
- see also international harmonisation
Existing Chemicals Program Review / reform (NICNAS) scorecard, 8, 32
- performance (NICNAS), 19-20
- revenue (NICNAS), 19
- statements (NICNAS),24-27
Food Standards Australia New Zealand (FSANZ), 3
fracking chemicals, see assessment/s, chemical used in coal seam gas extraction, hydraulic fracturing
freedom of information (NICNAS), 21
functions (NICNAS), see role, governance and structure
Globally harmonised system for classification and labeling of chemicals (GHS) (United Nations), 5
governance (NICNAS), see corporate governance
Handbook for Notifiers (NICNAS), 36
harmonisation, see international harmonisation
hazardous substances Information system (HSIS), 10
health, safety and environment outcomes (NICNAS), 9-10
hexabromocyclododecane (HBCD), see flame retardants
human resources (NICNAS), see people
hydraulic fracturing, 11-12
IGCC, see Industry Government Consultative Committee
IMAP framework (NICNAS), see assessment and prioritisation of chemicals on the AICS inventory
industrial chemicals, see chemicals, industrial
industrial nanomaterials, see nanomaterials
Industrial Chemicals (Notification and Assessment) Act 1989 (the Act), 2,
Industry Engagement Group (IEG) (NICNAS), 38-39
Industry Government Consultative Committee (IGCC) (NICNAS), 38-39
industry sectors for new chemicals, 29
Information Publications Scheme, 21
information technology (IT) (NICNAS), 21-22
inquiries (NICNAS), 36, 42
international harmonisation / partnerships, 13-14, 43-45
- and work sharing activities, 8, 10-11,
- visitors to NICNAS, 43-44
- arrangement with Canada, ECHA, NZ EPA, US EPA, 16
- with APEC, OECD agencies, UNEP, WHO, 15-16, 44
- Rotterdam convention compliance and arrangements, 15, 35
- Stockholm convention compliance and arrangements, 15
internet home page address and internet address for report (NICNAS), iv
inventory (NICNAS), see Australian Inventory of Chemical Substances,
inventory multi-tiered assessment and prioritisation (IMAP),
- chemicals assessments, 9-11
- launch, 9, 43
lead compounds in inks and coatings, 14
legislative changes, 13, 14
letter of transmittal, iii
low regulatory concern chemicals (LRCC), see chemicals
media inquiries (NICNAS), 37
memorandum(s) of understanding
- States and Territories MOU Group, 6, 40
- with NZ EPA and ECHA, see international harmonisation,
Millfluid PC-51 (NICNAS assessment), 10
Model Work Health and Safety Regulations, see regulations
MOUs see memorandum(s) of understanding
nanomaterials (industrial),16-17, 36
- NICNAS regulatory activities, 16-17
- working party on manufactured (OECD), 16, 36, 44
Nanotechnology Advisory Group (NICNAS), 40
national enabling technologies strategy (NETS), 17
new chemicals (NICNAS), 7-8, 29-30
- assessment, see assessment/s
- Clearing House (OECD), 15
- enhancements (NICNAS), 7, 41
- see also assessments
- see also international harmonisation
occupational health and safety and assessments (NICNAS), see work health and safety assessments
- see also people
octabromodiphenyl ether (octaBDE), 15
Office of chemical safety (OCS), 4
Office of Water Science, 12
Organisation for Economic Cooperation and Development (OECD), 15, 16
- Working Party on Manufactured Nanomaterials, 16
- see also Rotterdam Convention
- see international harmonisation
organisational structure / chart (NICNAS), 5
outreach see training
pentabromodiphenyl ether (pentaBDE), 15
people (NICNAS), 20-21
- occupational health and safety, see work health and safety assessments, staff
- training and development, 46
perfluorinated chemicals (PFCs), 15, 44
- substitutes, 7-8
- against government expectations, 50-51
- pay (bonuses), 21
permits, assessment (NICNAS)
- applications, 29-30
persistent organic pollutants, see international treaties, Stockholm convention
PFOA, PFOS, see perfluorinated chemicals
- scheduling delegate (role/actions), 4, 10
polymer in Milifluid®, 10
portfolio budget statement (PBS) see Department of Health (Health) and Ageing (DoHA)
Principal Scientists (NICNAS), 13, 45
Prior Informed Consent (PIC), see international treaties, Rotterdam Convention
prioritisation of chemicals on the inventory, see assessment/s, and prioritisation of chemicals on the inventory
priority existing chemicals (PECs) (NICNAS), see existing chemicals assessment
priority projects (NICNAS), 7, 13, 14, 16-17, 21-22, 41
publications (NICNAS), 20-21, 36
Quantitative Structure Activity Relationship (QSAR), 12, 43, 44
- program (NICNAS), 5, 11-12
- initiatives (NICNAS), 13-14, 33
registration (NICNAS),17-19, 35-36
regulation / regulatory approach, 3,
- plan (NICNAS), 3
- requirements (DoH), NICNAS compliance with,
- strategy program (NICNAS), 13-17
revenue and expenses, see financial performance
role, governance and structure (NICNAS), 2-6
Rotterdam Convention on Prior the Informed Consent Procedure on Certain Hazardous Chemicals and Pesticides in International Trade, see international treaties, Rotterdam
Safe Work Australia, 4
safety data sheets, 4
- strategy (NICNAS), 13-14
- strategy and international (program), 11-13
scientists, principal, see Principal Scientists
secondary notification assessments, see existing chemicals
security, chemicals of concern, see Attorney-General's
senior executive (Heads of Program) and responsibilities (NICNAS), 45
service charter (NICNAS),
staff (NICNAS), see people
Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), see poisons scheduling
Standing Committee on Chemicals (SCOC), 4, 15,
Standing Council on Environment and Water (SCEW), 4
States and Territories Memorandum of Understanding Group (NICNAS), see memorandum/s of understanding
Stockholm Convention, see international treaties
structure (NICNAS) see role, governance and structure
- Revised Australian/New Zealand, 14
survey (stakeholder) (NICNAS), 47
Technical Advisory Group (TAG), see AICS
training and development (NICNAS),
- for industry/community,17
- for staff, 43-44, 46
treaties, see international treaties
United Nations Environment Program, see environment
US (United States) see international harmonisation
website (NICNAS), 21-22
- visitors, 37, 42
weight of evidence (approach to assessment), 12
work health and safety assessments, staff (NICNAS), 21