National Industrial Chemicals Notification and Assessment Scheme
ANNUAL REPORT 2013–14
NIC
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NICNAS I ANNUAL REPORT 2013–14
NICNASNational Industrial Chemicals Notification and Assessment Scheme
ANNUAL REPORT 2013–14
2
NICNAS I ANNUAL REPORT 2013–14
National Industrial Chemicals Notification and Assessment Scheme
Annual Report 2013–14
The operation of the Industrial Chemicals (Notification and Assessment) Act 1989
National Industrial Chemicals Notification and Assessment Scheme
Annual Report 2013–14
ISSN: 1037 - 6909
Print ISBN: 978-1-74186-215-7
Online ISBN: 978-1-74186-216-4
Publications approval number: 10868
Paper-based publications
© Commonwealth of Australia 2014
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© Commonwealth of Australia 2014
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NICNAS I ANNUAL REPORT 2013–14
Transmittal letter
Senator the Hon Fiona Nash
Assistant Minister for Health
Parliament House
Canberra ACT 2600
Dear Assistant Minister
I have pleasure in submitting to you, for presentation to the Parliament, the Annual Report of
the operation of the Industrial Chemicals (Notification and Assessment) Act 1989
(the ICNA Act) for the year ending 30 June 2014. 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 2013 to 30 June 2014. I am pleased to
report that, for this period, NICNAS met all of its performance targets, and efficiently operated
within its available resources.
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 Annual Report 2013–14, reflecting administrative arrangements for 2013–14.
Yours sincerely
Dr Brian Richards
Director, NICNAS
1 October 2014
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NICNAS I ANNUAL REPORT 2013–14
NICNAS contacts
GPO Box 58
Sydney NSW 2001
Australia
T + 61 2 8577 8800
F + 61 2 8577 8888
Freecall: 1800 638 528
www.nicnas.gov.au
Annual Report webpage:
www.nicnas.gov.au/Publications/Annual_Reports.asp
For further information, please contact
Communications Manager, NICNAS
at the above address
T + 61 2 8577 8819
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NICNAS I ANNUAL REPORT 2013–14
Contents
Page
3 Letter of transmittal
4 Contacts
6 Director’s report
8 Role, governance and structure
14 Operations
15 Chemicals assessment
21 Harmonisation
22 Compliance and outreach
23 Administering the scheme
28 Appendices
64 Glossary, acronyms and abbreviations
69 Index
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NICNAS I ANNUAL REPORT 2013–14
Director’s reportThe National Industrial Chemicals Notification and
Assessment Scheme (NICNAS) aids in the protection
of the Australian people (both the general public and
workers) and the environment by assessing the risks
of industrial chemicals and providing information to
promote their safe use. This annual report provides an
overview of NICNAS operations in 2013–14.
A statement of expectations for the performance of
the scheme was issued by the Minister for Health, the
Hon Peter Dutton MP (see Appendix 02), to highlight
the Government’s commitment to reducing the
burden of regulation. The Minister communicated the
Government’s expectation for the scheme to operate in an accountable and transparent
manner, and to target compliance and enforcement activities toward businesses presenting
a higher risk.
As the statutory office-holder accountable for the administration of the scheme, I am
committed to reducing unnecessary burden on businesses, the community, and individuals,
while delivering appropriate and proportionate regulation that upholds the public health
and safety protections set out in the Industrial Chemicals (Notification and Assessment) Act 1989.
NICNAS cooperates with other government agencies, the chemicals industry and
community groups to promote the safe use of industrial chemicals through the uptake of risk
management recommendations that arise from NICNAS assessments.
In 2013–14, pre-market assessments were undertaken for 327 new industrial chemicals, and
post-market reviews of the risks of 1,089 industrial chemicals already approved for use in
Australia were also conducted. Assessment of the health and environmental impacts of
industrial chemicals used in hydraulic fracturing for extracting natural gas from coal seams,
as well as the hazards of chemicals used in oil dispersants, continued during 2013–14.
The Inventory Multi-tiered Assessment and Prioritisation (IMAP) Framework, an innovative tool
for efficiently assessing the risks to human health and the environment of existing chemicals
identified because of their high volume of use, specific risk management requirements
in countries comparable to Australia, or their reported detection in human cord blood,
provides an excellent example of a targeted, proportionate approach to regulation.
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NICNAS I ANNUAL REPORT 2013–14
As part of ongoing efforts to streamline and harmonise international data requirements
for assessing chemicals, NICNAS staff participated in a range of tasks conducted under
the auspices of the Organisation for Economic Co-operation and Development (OECD),
including developing assessment methodologies for industrial chemicals that reduce
the need for animal testing, and harmonising requirements for polymers of low concern
and nanomaterials.
NICNAS enforcement and compliance activities focused on the registration of companies
introducing industrial chemicals in Australia and, in particular, on reminding companies of
their legal obligations regarding the introduction of new industrial chemicals.
In November 2013, a survey of NICNAS stakeholders was conducted to assess their
awareness and experience of the scheme. Information from this survey is being used to
inform continuous improvement in all areas of the administration of the scheme, including
assessment, communication and compliance activities.
Throughout 2013-14, NICNAS staff have continued to contribute technical information to
assist the policy review of NICNAS being conducted by the Department of Health. I look
forward to working with all staff and stakeholders in implementing recommendations arising
from this review that are agreed by the Australian Government.
Finally, I would like to thank all who have supported NICNAS in the activities outlined in this
report, including members of NICNAS consultative committees and working groups.
In particular, I would like to acknowledge the commitment of the highly skilled and
dedicated staff who work on the scheme in both the Department of Health and the
Department of the Environment.
Dr Brian Richards Director, NICNAS
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NICNAS I ANNUAL REPORT 2013–14
Role, governance and structure
Role, functions, structure and linkagesThe National Industrial Chemicals Notification and Assessment Scheme (NICNAS) was
established in July 1990 under the Industrial Chemicals (Notification and Assessment) Act 1989 (the ICNA Act) and operates according to the ICNA Act.
The objects of the ICNA Act are:
‘to provide for:
(a) a national system of notification and assessment of industrial chemicals for the
purposes of:
(i) aiding in the protection of the Australian people and the environment by
finding out the risks to occupational health and safety, to public health and to
the environment that could be associated with the importation, manufacture
or use of the chemicals; and
(ii) providing information, and making recommendations, about the chemicals
to Commonwealth, State and Territory bodies with responsibilities for the
regulation of industrial chemicals; and
(iii) giving effect to Australia’s obligations under international agreements relating
to the regulation of chemicals; and
(iv) collecting statistics in relation to the chemicals;
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.’
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:
• a national system of notification and assessment of industrial chemicals (chemical
substances, not products);
• the Australian Inventory of Chemical Substances (AICS); and
• a register of persons introducing industrial chemicals.
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NICNAS I ANNUAL REPORT 2013–14
Our role in chemical safety in AustraliaA number of Australian Government as well as state and territory government agencies
share responsibility for chemical safety in Australia. Each chemical is regulated according to
its use.
An industrial chemical is any chemical not falling into one of the other categories1. Industrial
chemicals include: chemicals used in solvents, adhesives, plastics, paints, inks, fuels, or
laboratory reagents, as well as in refrigeration, cosmetics and household cleaning products.
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.
NICNAS operates within the Australian Government Department of Health to promote
the safe use of industrial chemicals by providing information about the chemicals and
recommendations to other regulators, state and territory governments, industry and to the
public to manage identified risks.
Under NICNAS:
The Australian Inventory of Chemical Substances (AICS) lists around 40,000 ‘existing’
industrial chemicals that may be used in Australia without notifying NICNAS.
Any company / person proposing to introduce (import and / or manufacture) a new
industrial chemical (i.e. a chemical not listed on the AICS) in Australia must notify NICNAS,
unless the chemical is exempt from assessment under the ICNA Act.
Once a chemical has been assessed for its human health, worker safety and environmental
risks, a risk assessment report is published on the NICNAS website (www.nicnas.gov.au),
which can include recommendations for further regulatory control of the chemical (such as
by poisons scheduling, worker health and safety regulation, or environmental controls).
A certificate or permit is issued to the introducer of a new chemical, who must report to
NICNAS any new information that becomes available about the chemical, or any changes
to the circumstances of the assessment.
An assessed chemical can be authorised for wider use by being listed on AICS after five
years—or earlier if requested by the notifier. Most of the chemicals on AICS were listed
without assessment when the scheme started, on the basis of their historical use.
1 Food and food additives; pesticides and veterinary medicines; medicines and medical devices
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NICNAS I ANNUAL REPORT 2013–14
Industrial chemicals already in use in Australia can be assessed for their human health,
worker safety and environmental risks. For a chemical that has previously been assessed
by NICNAS, new information about the chemical, or a significant change in its introduction
into Australia, might require certain aspects of the chemical to be reassessed (a secondary
notification assessment). An AICS-listed chemical can be identified as requiring Priority
Existing Chemical (PEC) assessment if the Minister agrees that its manufacturing, handling,
storing, usage or disposal gives rise to a risk of adverse health and / or environmental effects.
Since July 2012, the IMAP Framework has been used to review the risks of 3,000 chemicals
already listed on the AICS, which were prioritised through a consultation process. Following
completion of an existing chemical assessment, NICNAS publishes the outcome of a high
throughput screening process (IMAP Tier I) or chemical-by-chemical assessment report
(IMAP Tier II), for human health and environmental risks. Tier II assessment reports can
recommend further regulatory measures to mitigate any identified risks.
Regulatory planThe Health 2013–14 regulatory plan—as well as information about it and what it does
(and does not) include—is available on the Health website (www.health.gov.au). It covers
regulatory activities planned by Health, including those under NICNAS. The 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.
Cooperative arrangementsStaff employed by the Department of Health (Health) undertake public health and worker
health and safety assessments for chemicals regulated by NICNAS.
Staff employed by the Department of the Environment (Environment) conduct
complementary environmental assessments for NICNAS, and provide scientific, technical
and regulatory advice on environmental protection in relation to chemical safety.
In addition:
The Office of Chemical Safety (OCS)—also located within Health—is responsible for public
health policy in relation to industrial chemicals.
The Environmental Health Standing Committee (enHealth—a committee of the Australian
Health Protection Principal Committee of the Australian Health Ministers’ Advisory Committee
(AHMAC))—coordinates state and territory input into NICNAS’s public health assessments
and recommendations.
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NICNAS I ANNUAL REPORT 2013–14
The Advisory Committee on Chemicals Scheduling (ACCS), established under the
Therapeutic Goods Act 1989, provides advice to the Secretary of the Department of Health
(or delegate) who reviews NICNAS’s recommendations for scheduling of chemicals for
inclusion in the relevant legislation of states and territories, by reference to the Standard for
the Uniform Scheduling of Medicines and Poisons (SUSMP—Poisons Standard).
The Australian Competition and Consumer Commission (ACCC)—responsible for the safety
of products—receives NICNAS’s technical advice and recommendations concerning
chemicals in consumer products.
The Standing Committee on Chemicals (SCOC—operating within the Department
of Industry)—works to achieve, through reforms agreed by the Council of Australian
Governments, an effective and efficient system of chemicals and plastics regulation.
In 2013–14 NICNAS continued to work with other Australian Government departments
including:
• Australian Customs and Border Protection Service (reviewing industrial
chemical importation)
• Department of Foreign Affairs and Trade (in relation to international agreements)
• Attorney-General’s Department (regarding chemicals of security concern), and
• Safe Work Australia in the Department of Employment (managing risks arising from
industrial chemicals).
Recommendations arising from NICNAS assessment reports are directed to relevant
Australian Government agencies as well as state and territory public health, worker health
and safety and environmental, transport and consumer product safety agencies.
NICNAS also provides technical assessment services to assist with national standard
setting, implementation and enforcement activities and directly interacts with all Australian
Government chemical regulators through the Regulators’ Forum.
Details of other Australian Government departments involved in chemicals regulation are
presented on the NICNAS website: Chemicals in Australia—who’s who.2
StructureNICNAS is a statutory scheme established within Health. The Director of NICNAS is a
statutory office holder with specific functions and powers under the Industrial Chemicals (Notification and Assessment) Act 1989, who reports to Parliament through the Assistant
Minister for Health.
2 See: About NICNAS / Regulatory partners
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NICNAS I ANNUAL REPORT 2013–14
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
ICNA Act. The Secretary, Environment also provides staff to the Director to conduct assessments.
Figure 01 depicts the organisational structure of NICNAS in 2013–14.
Figure 01: NICNAS organisational programme structure at 30 June 2014*
* The Regulatory Strategy and Business Management & Communications programmes were
combined as the Corporate and Regulatory Strategy programme, during June 2014.
DIRECTORPrincipal Scientists
Existing Chemicals Programme
Corporate and
Regulatory Strategy
Programme
Compliance & Enforcement
Programme
New Chemicals Programme
Targeted Assessment Programme
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NICNAS I ANNUAL REPORT 2013–14
Advisory group governance: community, industry and government NICNAS commenced a review of stakeholder engagement arrangements (as represented
in Figure 02) during 2013–14. The review aims to deliver improvements to the efficiency and
effectiveness of NICNAS’s engagement mechanisms, and the outcome of the review will be
presented to the Assistant Minister for Health in 2014–15 (see Appendix 07).
In 2013–14, three non-statutory committees provided strategic advice to NICNAS:
1. Industry Government Consultative Committee (IGCC)
2. Community Engagement Forum (CEF), and
3. States and Territories Memorandum of Understanding (MoU) Group.
Another group which met during the year—the Industry Engagement Group (IEG)—
supports strategy implementation. Members of the Nanotechnology Advisory Group (NAG)
were available to provide advice (until March 2014).
Figure 02: NICNAS committee structure, 2013–14
All committees and groups were under review during 2013–14. Not all of them continued to
meet while the review was being conducted.3
3 Details of membership and meetings of each committee and group are provided at Appendix 07.
Assistant Minister for
Health
Director of NICNAS
Industry Government Consultative
Committee (IGCC)
Nanotechnology Advisory Group
(NAG)—includes strategy
development
Community Engagement Forum
(CEF)
Industry Engagement Group (IEG)
States and Territories Memorandum of Understanding
Group (MoU) Group
Strategy development Strategy implementation
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NICNAS I ANNUAL REPORT 2013–14
OperationsThis section provides information about NICNAS during 2013–14, including performance
against the deliverables and key performance indicators (KPIs) outlined in the Department
of Health Portfolio Budget Statements4 under sub-programme 1.4.35; operations under the
ICNA Act and their outcomes; and corporate operational activities.
Table 01: NICNAS performance measurement targets, 2013–14678
Deliverable / KPI Reference point or target Result
Qualitative deliverables
Scientifically robust assessments of new and existing industrial chemicals
Peer review and stakeholder feedback supports assessment outcomes
Met
High quality assessment outcomes are produced through effective use of the IMAP Framework
Stakeholder engagement and communication strategies effectively communicate assessment outcomes
Met
Contribution to the international harmonisation of regulatory approaches and methodologies for assessing industrial chemicals by reviewing Australian processes
Review international regulatory approaches and methodologies from three key sub-committees of the OECD Chemicals Committee for their application to NICNAS assessments of industrial chemicals
Met
All introducers of industrial chemicals are aware of their legal obligations
Register identified introducers and provide regular information updates
Met
Qualitative indicator
Effective use of international information
For new chemicals: incorporate available international hazard assessment information into assessments
Met
For existing chemicals: provide guidance and training on the use of international information to assessors implementing the IMAP Framework
Met
4 See: www.health.gov.au5 Sub-programme 1.4.3 aims to ensure uses of industrial chemicals are safe for human health and the environment,
and to further improve efficiency of the regulatory framework, for industry and the community.6 Calculations based on inclusion of 241 chemicals that—despite not having been included in the initial IMAP Stage
One list of 3,000 chemicals—are members of groups of chemicals being assessed in Stage One, whose inclusion brings further efficiencies to the IMAP implementation.
7 Chemicals identified on the basis of characteristics agreed by stakeholders as priorities for early consideration.8 Since its inception, NICNAS has completed 2,408 assessments for a total of 1,808 chemicals under the IMAP
Framework.
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NICNAS I ANNUAL REPORT 2013–14
Deliverable / KPI Reference point or target Result
Quantitative indicators
Target Actual, by quarter
1 2 3 4
Percentage of new chemical assessments completed within legislated timeframes
96% 100% 97% 99% 98% Met
Cumulative percentage6 of Stage One chemicals7 assessed through effective application of IMAP Framework
50% by 30 June 2014
28.5% 32.5% 37.4% 55.8%8 Met
Percentage of those introducing over $500,000 of industrial chemicals assessed for compliance with new chemicals obligations
35% 35% Met
Chemicals assessment
DeliverableScientifically robust assessments of new and existing industrial chemicals
Reference point / targetPeer review and stakeholder feedback supports assessment outcomes
New chemicals
NICNAS published 179 public reports for new chemicals during the year, in the Chemical Gazette. All reports were peer reviewed. Three hundred and twenty-seven new chemical
certificate and permit assessments were completed, with 322 (98.5%) of these completed
within legislated timeframes (see Appendix 04).
There were no applications for review of these decisions by the Administrative Appeals
Tribunal (AAT).
Existing chemicals
NICNAS published three Priority Existing Chemical (PEC) final reports: Dibutyl phthalate
(DBP) in November 2013, Dimethyl phthalate (DMP) in January 2014 and Di (methoxyethyl)
phthalate (DMEP) in May 2014.
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NICNAS I ANNUAL REPORT 2013–14
During 2013–14, 38 inquiries were received concerning potential secondary notifications9.
Secondary notification assessments were determined to be not required for 24 chemicals
and (at the end of June 2014) a further 14 chemicals remained under consideration.
A secondary notification assessment report was published in January 2014 on
Phoslock™ (Lanthanum Modified Clay), following a review by the AAT. The health and
environmental risks of the perfluorinated chemical (PFC) Fluorosurfactant FC-4430 are
currently under review.
The IMAP Framework was used to conduct 1,425 assessments for a total of 1,085 chemicals,
for public comment on the NICNAS website. This included 850 Tier II assessments.10
DeliverableHigh quality assessment outcomes are produced through effective use of the IMAP Framework
Reference point / targetStakeholder engagement and communication strategies effectively communicate assessment outcomes
As part of implementing the IMAP Framework, staff from NICNAS continue to engage
with stakeholders and meet with key Australian risk management agencies to promote
the uptake of recommendations (see Table 02). All information supplied by introducers
and users of Stage One chemicals—as well as by industry bodies—is considered. The
opportunity for stakeholders to provide data to inform assessments, the use of internal and
external peer review, and the availability of a public comment period on draft assessments
and recommendations are all important components of the IMAP Framework, which add
significant value to the final assessment. All public comments—and NICNAS responses—are
summarised on the NICNAS website11.
Communicating all assessment findings is crucial to the success of the IMAP programme,
and NICNAS uses various tools to communicate with stakeholders about ‘tranches’—the
periodic release of a group of assessments. News of each tranche is disseminated by
directly liaising with interested national and international companies and peak stakeholder
organisations, and each tranche is publicised through NICNAS’s Chemical Gazette, NICNAS Matters and website homepage.
9 Reassessment of previously assessed (existing) chemicals.10 Tier II assessments evaluate risk on a substance-by-substance or chemical category-by-category basis.11 See: Chemical information / IMAP assessments
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NICNAS I ANNUAL REPORT 2013–14
From IMAP’s inception in July 2012 to the end of 2013–14, NICNAS staff had conducted
2,408 human health and / or environment IMAP assessments for a total of 1,808 unique
chemicals (including 241 supernumerary chemicals) in nine tranches. In addition, 1,308
recommendations have been made for a total of 984 unique chemicals in relation to risks
and concerns.
Table 02: Nature of recommendations made under IMAP, 2012–1412
Nature of recommendation Agency 2012–13 2013–14 Total
Worker health and safety Safe Work Australia 188 741 929
Public health Scheduling12 56 153 209
Product safety Australian Competition and Consumer Commission
11 73 84
Environment Department of the Environment
0 8 8
Further assessment at Tier III
NICNAS 13 65 78
Total 268 1,040 1,308
Note: More than one recommendation was made for risk management of some chemicals.
12 National classification system for controlling how medicines and chemicals are made available to the public in Australia, by classifying them into Schedules according to level of regulatory control over availability, to protect public health and safety.
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NICNAS I ANNUAL REPORT 2013–14
IMAP case studies:
1. Metal assessments and industry engagement
Prior to starting to assess metal compounds including nickel, cobalt, cadmium, beryllium and molybdenum, NICNAS sought to engage with industry metal associations and consortia. Early engagement—between industry representatives and NICNAS scientific experts—identified methods for assessing metal compounds, current scientific literature, relevant industry information and overseas risk assessments. The industry engagement enabled appropriate chemical groupings to be established (leading to increased assessment efficiency), based on the ‘bio-accessibility’ of metal complexes in different biological fluids. Industry also provided ‘use’, ‘volume’ and ‘hazard’ data for various chemicals processed both in Australia and internationally.
This early engagement with industry added significant value to the assessments through securing accurate, up-to-date data—as well as confirming shared goals for protecting human health and minimising environmental impact.
2. Filling data gaps using international assessments
The assessment of 158 petroleum chemicals under the IMAP Framework was completed in a very short timeframe by adapting different components from a number of international assessments, for the Australian context. These reports provided useful information on chemical composition and hazard data, exposure scenarios and risk characterisation, or references to other data sources.
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NICNAS I ANNUAL REPORT 2013–14
Deliverable Services to other Australian Government departments / agencies
NICNAS assesses chemicals on behalf of other agencies, as required, under its Targeted
Assessment programme. During 2013–14, the Australian Maritime Services Authority (AMSA)
contracted NICNAS to screen chemicals used in oil dispersant products and identify
those of low human health concern. The dispersants are chemical mixtures of surface active
agents used to manage oil spills. They combine with large floating masses of oil and help
break it into small microscopic droplets that can disperse throughout the water column. An
adaptation of the IMAP Framework—which includes a method of identifying chemicals of
low concern for human health rapidly—was used to identify such oil dispersant chemicals,
and provide a draft report to AMSA.
NICNAS drafted advice to the Department of the Environment13 on the chemicals used in coal
seam gas extraction in Australia, a literature review report and a report on chemicals of low
concern for human health. These reports were undergoing peer review at the end of the year.
Qualitative KPI Effective use of international information
Reference point / targets
New chemicals Incorporate available international hazard assessment information into assessments
Existing chemicals
Provide guidance and training on the use of international information to assessors implementing the IMAP Framework
NICNAS’s scientific assessors have effectively used international information, in line with
NICNAS’s Science Strategy, which outlines key priorities for building and maintaining
scientific capacity. As in previous years, scientific assessors working on NICNAS assessments
accessed professional development opportunities provided by visiting national and
international experts. These are listed at Appendix 08.
13 for the Office of Water Science
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NICNAS I ANNUAL REPORT 2013–14
• Incorporate available international hazard assessment information into new chemicals assessments
In 2013–14, NICNAS received submissions based on three Approved Foreign Scheme
assessments and nine comparable agency assessments—three from the US and six
from Canada.
The arrangement to share these assessment reports with the United States Environmental
Protection Agency (US EPA) and Environment Canada resulted in relevant international
hazard assessment information being made available, and incorporated into the NICNAS
assessments, resulting in cost-savings for the industry notifiers and a reduced assessment
effort by NICNAS.
• Provide guidance and training on the use of international information to existing chemicals assessors implementing the IMAP Framework
Engagement with international regulatory agencies and expanded connections with global
industry associations provided NICNAS with access to international information for the
existing chemicals programme, including both IMAP and PEC assessments.
Sharing information with international regulatory organisations assisted in peer reviewing
assessment reports, and helped validate IMAP assessment outcomes during the public
comment phase. Liaison with international industry associations assisted in verifying
assessment methodologies and gaining access to industry-held data where appropriate.
Guidance materials, information management systems, advanced training, knowledge
sharing, and the promotion of the use of international information in IMAP assessments, built
assessors’ capabilities in applying the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) United Nations 2009.
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NICNAS I ANNUAL REPORT 2013–14
Harmonisation
Deliverable
Contribution to the international harmonisation of regulatory approaches and methodologies for assessing industrial chemicals by reviewing Australian processes
Reference point / target
Review international regulatory approaches and methodologies from three key sub committees of the OECD Chemicals Committee for their application to NICNAS assessments of industrial chemicals
NICNAS was represented as a member of the Australian delegation to the Organisation
for Economic Co-operation and Development (OECD) Chemicals Committee and its key
chemical sub-committees. These include the Task Force on Hazard Assessment, the Task
Force on Exposure Assessment, the Cooperative Chemicals Assessment Programme, the
New Chemicals Clearing House, the Working Party on Manufactured Nanomaterials, and
the OECD / United Nations Environmental Programme (UNEP) Global PFC Steering Group.
International engagement helps NICNAS to ensure that multilateral initiatives are in step
with Australia’s needs in areas such as the concept of chemical categorisation, developing
and applying other integrated testing and assessment approaches, and characterising
chemicals of Unknown Variable Composition and Biologicals (UVCBs). It also enables
access to information to ensure that NICNAS assessments are scientifically robust and that
international experience is applied to improve Australian regulatory systems.
NICNAS contributed to the OECD’s ‘avoiding duplication’ project—which aims to avoid
duplication by sharing assessment schedules of different regulatory schemes on the
eChemPortal—by providing a schedule of NICNAS’s current existing chemical assessments.
NICNAS also represented Australia at the Asia-Pacific Economic Cooperation (APEC)
Chemicals Dialogue, and participated in the APEC Regulators Forum. NICNAS contributed
to the APEC work programme by developing a submission for funding a metals risk
assessment workshop.
NICNAS staff participated in bilateral information exchanges (via teleconference) on
several technical topics with the European Chemicals Agency (ECHA) and with Health and
Environment Canada.
NICNAS processes are benchmarked against the latest international developments concerning
alternative testing methods (including a review of OECD guidance on assessment of categories
and OECD guidelines relating to alternatives to animal testing methods).
Additional information about meetings in which NICNAS was involved is available
at Appendix 08.
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NICNAS I ANNUAL REPORT 2013–14
Compliance and outreach
DeliverableAll introducers of industrial chemicals are aware of their legal obligations
Reference point / targetRegister identified introducers and provide regular information updates
Register identified introducers
Registration renewal packages were sent to over 5,300 registrants in July 2013 with an on-
time response rate of 84%. As at the end of the year, 99.87% of identified introducers were
registered with NICNAS with debt recovery activities initiated for the remaining 0.13%
(see Appendix 05).
The total number of registered introducers for the year was 5,465 at 30 June 2014,
representing the second highest total number of registrants since NICNAS registration was
introduced (and the highest number of total registrants since 2005–06).
During the year, introducers paid a total of 236 late penalties for renewing their registration
after the legislated deadline of 31 August 2013. Two late penalties remained unpaid at the
end of the year.
Through desktop audits, NICNAS identified 108 previously unknown introducers who were
introducing above the current monitoring threshold for relevant industrial chemicals.
Dedicated compliance activities were conducted for these introducers and—as a result—84
have since registered with NICNAS. A further 23 provided evidence to NICNAS that they are
not required to be registered. Registration of the one remaining introducer was expected
early in 2014–15.
In response to reassessments during 2013–14 against relevant registration levels for the
2012–13 year, 174 introducers adjusted their level in accordance with the issued notice; just
one registration adjustment remained outstanding at the end of the financial year.
NICNAS delivered 10 information sessions (to over 300 attendees) in major capital cities and
other areas where significant numbers of NICNAS registrants are based. Five sessions tailored
to the needs of accredited customs brokers were also held; over 200 brokers attended.
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NICNAS I ANNUAL REPORT 2013–14
Deliverable
Percentage of those companies introducing over $500,000 of industrial chemicals assessed for compliance with new chemicals obligations
Reference point / target 35%
In 2013–14, a sample of NICNAS registrants introducing above $500,000 worth of relevant
industrial chemicals was audited for evidence of compliance with new chemicals obligations.
As a result of the screening of 435 (35% of the total 1,241) high level 2012–13 registrants, 103
organisations were selected for further investigation.
Information regarding compliance with the new chemicals obligations of the ICNA Act was
sought from these companies, and 53 companies were asked to provide further evidence of
compliance with their new chemical obligations. At the end of the year, 46 companies had
responded to NICNAS’s request for evidence and 23 (50%) of these respondents were found
to be fully compliant with their new chemicals obligations.
The audit has, to date, identified nine non-compliant companies (potentially in breach of
obligations) introducing new industrial chemicals. NICNAS continues to work with these
companies—and those yet to provide the requested information—to achieve compliance
with the Act.
Administering the scheme
Managing financial performance
Compared with last year, total revenue and expenses have increased by $1.015m and
$0.832m, respectively.
Industry cost recovered revenue was $12.819m, which is $1.730m higher than the previous
year as a result of the changes to registration levies, fees and charges (in accordance with
the NICNAS Cost Recovery Impact Statement—CRIS) and a higher than expected number
of new chemicals notifications.
Net revenue from other sources was $2.094m, which is $0.715m lower than the previous
year, due to timing of the deliverables for the CSG assessment ($0.771m decrease) and an
interest equivalency payment ($0.056m increase).
Total expenses were $13.906m, which is $0.832m higher than the previous year, in line with
the increased level of revenue-generating activities.
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NICNAS I ANNUAL REPORT 2013–14
The table below provides a five-year comparison of NICNAS revenue and expenses.
Table 03: Five-year comparison of NICNAS revenue and expenses
2009–10 $’000
2010–11 $’000
2011–12 $’000
2012–13 $’000
2013–14 $’000
Industry cost-recovered revenue
7,956 8,586 9,014 11,089 12,819
Other revenue 787 809 836 2,809 2,094
Total revenue 8,743 9,395 9,850 13,898 14,913
Total expenses 8,748 9,259 10,004 13,074 13,906
Operating surplus / (deficit)
(5) 136 (154) 824 1,007
The NICNAS final net result for 2013–14 was a surplus of $1.007m. This is primarily attributable
to delays in recruitment due to APS-wide staff mobilisation policies and resultant reduced
expenses, re-scoping of—and delays in—IT projects outside NICNAS’s direct control, and the
increase in the NICNAS reserve by the amount of the interest equivalency payment and the
(net) late penalty payments, consistent with the NICNAS CRIS.
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 03.
Communicating about NICNAS
The new NICNAS website went ‘live’ on 1 July 2013, to improve access to information and
other resources. Further improvements to the website will continue into 2014–15.
The cosmetics pages on the NICNAS website were revised to provide better guidance and
clarity to stakeholders on the Australian regulation of chemicals used in these products.
The Chemical Gazette was published on the NICNAS website on the first Tuesday of each
month; three issues of NICNAS Matters were published in 2013–1414 (September and
December 2013 and March 2014).
In November 2013, NICNAS conducted a stakeholder survey and approximately 1,000
participated—see Appendix 10 for details. Information from this survey is contributing to
continuous quality improvement of NICNAS services.
Information sheets were published concurrently with the release of each of the three
PEC reports.
14 June / July 2014 issue was published in early July 2014.
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NICNAS I ANNUAL REPORT 2013–14
Staffing
All staff working on NICNAS uphold the Australian Public Service (APS) values and code
of conduct, and are impartial, committed to service, accountable, respectful and ethical
in all their work. Members of staff meet accountability obligations and are encouraged
to take a reasonable amount of risk. Performance is reviewed twice yearly under the
department’s Performance Development Scheme. In 2013–14, nine staff shared
performance pay totalling $64,991.
This year NICNAS staff were again encouraged to balance the demands of their work and
private lives; a ‘Healthy Team’ stepping competition was one of several activities run.
Data and further information about the NICNAS workforce are available at Appendix 09.
For information on the impact and features of enterprise or collective agreements, individual
flexibility arrangements (IFAs), determinations, common law contracts and Australian
Workplace Agreements (AWAs), enterprise or collective agreements, please refer to the
Department of Health Annual Report 2013–14.
A core number of permanent (ongoing) APS staff is engaged to administer NICNAS.
Medium-term increases in workload are managed by engaging non-ongoing APS staff,
and short-term peaks in workload are managed by the engagement of contractors. Staff
engaged to administer NICNAS comply with departmental policies and procedures.
In accordance with worker health and safety requirements, two workplace inspections were
conducted during the year. Workstation assessments are regularly conducted.
Manage media inquiries, complaints, FOI requests and similar matters
NICNAS manages all media inquiries in accordance with departmental policies and
procedures. The subjects of the main media inquiries in 2013–14 are listed at Appendix 06.
NICNAS engaged in a review of procedures used in dealing with complaints. Staff
performance against service charter customer service standards was assessed through the
November 2013 stakeholder survey. Overall results of the survey are available at Appendix 10.
Details of NICNAS’s information publication scheme and Freedom of Information (FOI) log
are available on the NICNAS website15. NICNAS received one request under the FOI Act, but
it was refused on the grounds that the requested document did not exist.
15 See: About NICNAS / Freedom of information
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NICNAS I ANNUAL REPORT 2013–14
Management of assets, fraud control, auditing and scrutiny
Under the guidance of—and as part of the service level agreement with—Health, NICNAS:
• complies with the Commonwealth Fraud Control Guidelines16
• effectively manages all Commonwealth resources
• complies with all other requirements in meeting Auditor-General, Parliamentary
Committee and Commonwealth Ombudsman expectations.
NICNAS has a risk management strategy that outlines all internal audit arrangements,
including the approach to identifying, addressing and managing areas of significant
financial or operational risk.
In 2013–14, NICNAS received no judicial decisions or findings by the Australian Information
Commissioner.
Resources
The following table provides a brief summary of NICNAS outputs and resources in 2013–14,
by programme area.
16 See Department of Health Annual Report 2013–14
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NICNAS I ANNUAL REPORT 2013–14
Table 04: NICNAS outputs, outcomes and resources—consolidated summary
Programme Examples of outputs Number in 2013–14
Assessment activities
New Chemicals
Certificate and permit assessments completed
327
Percentage of certificate and permit assessments completed on time
98%
Reports published on the website 179
Existing Chemicals
IMAP assessments completed 1,425
Chemicals assessed under IMAP 1,085
PEC and other assessments completed 3
Secondary notifications completed 1
Targeted Assessments
CSG chemicals reports To draft stage
AMSA chemical reports To draft stage
Inventory (AICS) management Immediate AICS listing 147
Confidential AICS search requests 346
Number of chemicals searched c. 1,000
Compliance and Enforcement Level A registrants 2,862
Level B registrants 1,356
Level C registrants 910
Level D registrants 337
Information sessions 10
Corporate and Regulatory Strategy
Website visitors 862,963
Website hits 1,113,067
Responses to media inquiries c. 50
Information sheets, newsletters etc c. 20
Resource $’000 13,906
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NICNAS I ANNUAL REPORT 2013–14
Appendices
Page Appendix
29 01. Abstracts from NICNAS financial statements
33 02. Reducing regulatory burden
35 03. Consultancies
36 04. New Chemicals data
40 05. Compliance data
42 06. Communications and media
45 07. Advisory groups: community, industry, government
50 08. Links: national and international
55 09. Staff profile, training, development
58 10. Stakeholder survey update
60 11. Compliance with mandatory reporting requirements
64 Glossary, acronyms and abbreviations
69 Index
29
NICNAS I ANNUAL REPORT 2013–14
Appendix 01—Abstracts from NICNAS financial statementsNICNAS’s 2013–14 financial statements were audited by the Australian National Audit Office
as part of its audit of the consolidated financial statements of the Department of Health.
Presented below are NICNAS’s income statement, balance sheet, cash flow statement and
statement of changes in equity which have been extracted from the Department’s audited
consolidated statements.
Table 05: Statement of comprehensive income for the period ended 30 June 201417
2014 2013$'000 $'000
EXPENSES
Employee benefits 8,614 7,386
Supplier 4,737 5,328
Depreciation and amortisation 266 207
Write-down and impairment of assets 241 153
Other expenses 48 -
Total expenses 13,906 13,074
LESS:
OWN-SOURCE INCOME
Own-source revenue
Sale of goods and rendering of services 14,477 13,518
Total own-source revenue 14,477 13,518
Net contribution by (cost of) services 571 444
Revenue from Government 436 380
Surplus attributable to the Australian Government 1,007 824
OTHER COMPREHENSIVE INCOME
Items not subject to subsequent reclassification to profit or loss
Changes in asset revaluation surplus - -
Total other comprehensive income - -
Total comprehensive surplus attributable to the Australian Government 1,007 824
17 Statements should generally be read in conjunction with accompanying notes. However no notes accompany the four tables published in this appendix.
30
NICNAS I ANNUAL REPORT 2013–14
Table 06: Balance sheet as at 30 June 2014
2014 2013$'000 $'000
ASSETSFinancial assetsCash and cash equivalents 11,059 10,292
Trade and other receivables 257 59
Other financial assets - -
Total financial assets 11,316 10,351
Non-financial assetsLand and buildings 1,205 1,364
Property, plant and equipment 64 89
Intangibles 154 237
Inventories - -
Other non-financial assets 54 40
Total non-financial assets 1,477 1,730
Total assets 12,793 12,081
LIABILITIESPayablesSupplier payables (1,867) (1,323)
Other payables (3,114) (4,129)
Total payables (4,981) (5,452)
Provisions Employee provisions (2,167) (1,991)
Other provisions (130) (130)
Total provisions (2,297) (2,121)
Total liabilities (7,278) (7,573)
Net assets 5,515 4,508
EQUITYContributed equity - -
Reserves 169 169
Accumulated surplus 5,346 4,339
Total entity interest 5,515 4,508
Total equity 5,515 4,508
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NICNAS I ANNUAL REPORT 2013–14
Table 07: Cash flow statement for the period ended 30 June 2014
2014 2013$'000 $'000
OPERATING ACTIVITIES
Cash received
Goods and services 14, 022 17, 590
Net GST received 101 189
Appropriations 7,346 18, 632
Other - -
Total cash received 21, 469 36, 411
Cash used
Employees (8,404) (7,136)
Suppliers (5, 340) (7, 665)
Cash to the Official Public Account (6,910) (11,500)
Other (48) -
Total cash used (20, 702) (26, 301)
Net cash from operating activities 767 10,110
INVESTING ACTIVITIES
Cash received
Proceeds from sales of property, plant and equipment - -
Total cash received - -
Cash used
Purchase of property, plant, equipment and intangibles - (151)
Total cash used - (151)
Net cash used by investing activities - (151)
FINANCING ACTIVITIES
Cash received
Appropriations—Equity injection - -
Appropriations—Departmental capital budget - -
Total cash received - -
Cash used
Other - -
Total cash used - -
Net cash received from financing activities - -
Net increase / (decrease) in cash held 767 9, 959
Cash and cash equivalents at the beginning of the reporting period 10,292 333
Cash and cash equivalents at the end of the reporting period 11,059 10,292
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NICNAS I ANNUAL REPORT 2013–14
Table 08: Statement of changes in equity for the period ended 30 June 2014
Retained earnings
Asset revaluation
surplus
Contributed equity / capital
Total equity
2014 2013 2014 2013 2014 2013 2014 2013
$'000 $'000 $'000 $'000 $'000 $'000 $'000 $'000
Opening balance
Balance carried forward from previous period 4,339 3,515 169 169 - - 4,508 3,684
Adjusted opening balance 4,339 3,515 169 169 - - 4,508 3,684
Comprehensive income
Other comprehensive income - - - - - - - -
Surplus / deficit for the period 1,007 824 - - - - 1,007 824
Total comprehensive income 1,007 824 - - - - 1,007 824
Closing balance as at 30 June 5,346 4,339 169 169 - - 5,515 4,508
Closing balance attributable to the Australian Government 5,346 4,339 169 169 - - 5,515 4,508
33
NICNAS I ANNUAL REPORT 2013–14
Appendix 02—Reducing regulatory burdenThe Hon Peter Dutton MP, Minister for Health, has outlined his expectations for the
performance of the scheme in a letter to the Director of NICNAS, Dr Brian Richards, who
affirms his intention to meet these expectations in his ‘Director’s report’ on pages 6-7 of this
annual report.
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NICNAS I ANNUAL REPORT 2013–14
Appendix 03—Consultancies
Table 09: New and active consultancies 1 July 2013 to 30 June 2014
Name of consultant Description
Date
Procurement method
Value (to nearest dollar)
Start End ContractGoods
receipted 2013–14
Oasis LMC-Ltd / Professor Ovanes Mekenyan
Provision of training and expert advice on computational modelling
2 February 2014
30 June 2014
Direct source $25,000 $25,000
Environmental Risk Sciences Pty Ltd
Develop and design a toxicology training package
13 June 2014
26 September 2014
Open / panel
$48,400 $40,000
Note: Information on the value of contracts and consultancies is available on the AusTender website: www.tenders.gov.au
36
NICNAS I ANNUAL REPORT 2013–14
Appendix 04—New chemicals dataData provided in this appendix relate to new chemicals certificates and permits issued.
In previous years, comparable tables provided details of applications for new chemicals
certificates and permits.
Figure 03: Number of new chemicals certificates issued by category in 2013-14
Note: In 2013–14, NICNAS issued no new chemicals certificates in the SANHP (Self-Assessment for Non-Hazardous Polymer notification), SANHC (Self-Assessment for Non-Hazardous Chemical notification) or SN (Secondary Notification) categories.
Certificate categories
STD (Standard) 26%
LTD (Limited) 33%
PLC (Polymer of Low Concern) 30.5%
SAPLC (Self-Assessment for Polymer of Low Concern notification) 7.5%
EXT (Extension of Assessment Certificate) 3%
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NICNAS I ANNUAL REPORT 2013–14
Figure 04: Number of new chemicals permits issued by category in 2013-14
Note: In 2013–14, NICNAS issued no new chemicals permits in either the Controlled Use Permit (CUP), CUPR (renewal), or Export Only Permit (EOP) categories.
Permit categories
CEC (Commercial Evaluation Chemical) 8%
CECR (Commercial Evaluation Chemical Renewal) 1.5%
LVC (Low Volume Chemical) 33%
LVCR (Low Volume Chemical Permit Renewal) 13%
EIP (Early Introduction Permit) 44%
EOPR (Export Only Permit Renewal) 0.5%
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NICNAS I ANNUAL REPORT 2013–14
Figure 05: Industry sectors for chemicals notified under the assessment certificate category18 in 2013-14
Note: In 2013-14, NICNAS received no chemical notifications under the assessment certificate category from the following industry sectors: Education, research and development, Electrical / electronic, Photographic, Textile.
18 The total number of assessment certificates by ‘Use category’ does not include extension certificates and some chemicals are assessed for use in more than one category.
Use category
Engineering 8%
Cosmetics / Personal 16%
Domestic / Cleaning 6%
Fuel and oil 10%
Leather processing 1%
Manufacturing other chemicals 2%
Mining and metal extraction 6%
Office supplies 1%
Packaging, paper and pulp 1%
Plastics 6%
Printing industry 8%
Refrigeration 1%
Surface coatings 31%
Water treatment 1%
Other 2%
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NICNAS I ANNUAL REPORT 2013–14
Table 10: New chemical reports in 2013–14
Category No. of reports of new chemicals (for each category)
<1 per cent cosmetic exemption 52
<100 kg cosmetic exemption 91
<100 kg non cosmetic exemption 91
<100 kg R&D exemption 29
Permits 301
Table 11: New chemicals exempt from notification in 2013–14, by quarter19
Quarter 1 Quarter 2 Quarter 3 Quarter 4 Total
Cosmetic chemicals
21 59 20 47 147
Non-cosmetic chemicals
16 10 9 10 45
Total 37 69 29 57 192
19 Exemption advice forms for cosmetic and non-cosmetic chemicals being introduced under the exemption provi-sions of subsection 21(4) of the legislation acknowledged by NICNAS during 2013–14.
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NICNAS I ANNUAL REPORT 2013–14
Appendix 05—Compliance data
Table 12: NICNAS registrations by tier, over three years and in each quarter 2013–14
Total registrants as at:
Tiers* 30 June 2012
30 June 2013
Levels* 30 Sept 2013
31 Dec 2013
31 March 2014
30 June 2014
Tier 1 3,766 4,048 Level A 2,415 2,558 2,728 2,862
Level B 1,188 1,268 1,332 1,356
Tier 2 873 890 Level C 843 879 904 910
Tier 3 363 350 Level D 322 329 333 337
TOTAL 5,002 5,288 4,768 5,034 5,297 5,465
* From 1 September 2013, Registration charges (based on the value of chemicals
introduced) changed from three ‘tier’ categories to four ‘level’ categories:
• Level A (introduction value $1–$99,999) and Level B (introduction value $100,000–
$499,999) replaced Tier 1 (introduction value $1–$499,999)
• Level C (introduction value $500,000–$4,999,999) replaced Tier 2 (same
introduction value)
• Level D (introduction value $5,000,000 and above) replaced Tier 3 (same
introduction value)
Table 13: NICNAS non-renewed registrations over three years
Non-renewals as:
at 30 June 2012 at 30 June 2013 at 30 June 2014
TOTAL 520 591 487
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NICNAS I ANNUAL REPORT 2013–14
Table 14: Cases managed by NICNAS compliance and enforcement programme 2013–14
Cases: Chemical Registration Cosmetic Other
Cases managed in 2013–14 149 22 9 2
Active cases at 30 June 2014 82 2 4 0
Table 15: Rotterdam Convention processed 2013–14
Category Numbers processed
PIC annual authorisation 12
NICNAS advice on export notification 64
Table 16: NICNAS registration audit activities in 2013–14, by quarter
Quarter 1 Quarter 2 Quarter 3 Quarter 4 Total for 2013–14
On-time renewal rate 84%
Late penalty issued 17 115 42 62 236
Note: All payments recovered or otherwise written off or cancelled in line with internal debt management procedures and / or the Financial Management Act (FMA)20.
Table 17: NICNAS registration level re-assessments in 2013–14
Quarters 1–4
Number of companies audited 223
Number resolved 222
As a percentage 99.6%
20 Changes to the FMA to be implemented in 2014–15 are outlined on the Department of Finance website.
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NICNAS I ANNUAL REPORT 2013–14
Appendix 06—Communications and media
Table 18: New and revised publications—an overview212223
Category Items added in 2013–14
Total
2013–14 Total number
Assessment reports
New chemicals All reports available at: www.nicnas.gov.au/chemical-information/new-chemical-assessments
179 c. 3,200
Priority Existing Chemicals (PECs)
Dibutyl phthalate (DBP), Di(methoxyethyl) phthalate (DMEP), Dimethyl phthalate (DMP)
3 38
Other existing chemicals21
Phoslock™ (Lanthanum Modified Clay)— secondary notification
1 23
IMAP assessment reports / outcomes
All reports available in Excel file at http://www.nicnas.gov.au/chemical-information/imap-assessments.
Number of assessment reports
1,42522 2,408
Total number of chemicals assessed
1,085 1,808
Newsletters, factsheets and other publications
Newsletters Chemical Gazette 1323 c. 185
NICNAS Matters 4 42
Factsheets Specific chemicals Phthalates: DBP, DMEP, DMP
3 52
General, issue-based & IMAP No new titles though several revised c. 10
Other publications
NICNAS website Website regularly updated as required, with frequently asked questions, adjustments to details, fees etc.
c. 8,000 pages
Corporate Annual Report 2012–13 1
Consultations Revised guidelines for (AICS) confidential listing applications 2
Voluntary provision of information / public comment on Stage One chemicals—in 2013: Tranche 4 (T4)—July; T5—Sept; T6—Nov; in 2014: T7—Feb; T8—April
5
Handbook for notifiers (website)
Updated as required during the course of the year c. 323 pages
Note: All publications are available in electronic format on the NICNAS website
21 Mostly secondary notification assessment reports.22 Figure includes assessments completed in 2013–14 and published as Tranche 9 in the week beginning 30
June 2014.23 A special gazette was issued 19 August 2013 for release of the PEC assessment report on DBP, for public comment.
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NICNAS I ANNUAL REPORT 2013–14
Table 19: Visits to the NICNAS website (www.nicnas.gov.au) in 2013–1424
Quarter 1 Quarter 2 Quarter 3 Quarter 4 Total
2012–13 2013–14
Visitors 38,946 254,120 276,108 293,789 1,164,734 862,963
Hits to website
49,935 329,360 359,436 374,336 35,233,606 1,113,06724
Note: Web analytics available from 18 September 2013 only
Table 20: Top ten most viewed web pages in 2013–14
Title of NICNAS web page Number of hits Number of visits
AICS search page 447,797 338,995
NICNAS homepage 67,380 54,806
AICS listing 57,005 47,150
Australian Inventory of Chemicals Substances (AICS) 39,333 30,283
Search 31,956 26,780
Cosmetics 30,560 24,659
New Chemical assessments 23,617 15,818
Registration 20,288 16,362
NICNAS Handbook for Notifiers 13,378 9,496
Inventory Multi-tiered Assessment and Prioritisation (IMAP) 12,990 9,724
24 The tool for counting ‘hits’ has been refined to more accurately indicate actual number.
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NICNAS I ANNUAL REPORT 2013–14
Principal media topics, 2013–14
Major topics / issues raised:
• chemicals such as lead, p-phenylenediamine (PPD), iodopropynyl butylcarbamate
(IPBC) and triclosan in products including household cleaners, paints and inks,
tattoo inks, baby wipes and cosmetics (nail varnishes, hair dyes, teeth whiteners
and soap);
• azo dyes, formaldehyde, phthalates and flame retardants in a variety of
consumer products;
• toxic waste, asbestos, chemicals used in association with coal seam gas
extraction; and
• chemical exposure during pregnancy, the use of neurotoxicity measures
in assessments, the use of data from animal testing.
Table 21: 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
$7,213
Note: NICNAS did not conduct any advertising campaigns in 2013–14.
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NICNAS I ANNUAL REPORT 2013–14
Appendix 07—Advisory groups: community, industry, governmentNICNAS’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.
During the year, NICNAS instituted a review of its stakeholder engagement arrangements—
with the aim of improving the efficiency and effectiveness of consultative and engagement
mechanisms25.
The advisory groups for 2013–14 are listed in alphabetical order.
Community Engagement ForumMembers of the Community Engagement Forum (CEF) provide advice to NICNAS for the
worker health and safety, public health and the environment sectors, and help NICNAS
address aspects of the community’s information requirements by developing strategies to
improve access to health and safety and environmental information on industrial chemicals.
The CEF comprises the Chair and seven member positions: Director NICNAS, two community
members representing the interests of the environment, two representing public health,
as well as two non-government members representing the interests of worker health and
safety. However, the CEF met once only (by teleconference): CEF32 on 21 Aug 2013, as it was
inquorate for most of the year pending the review of consultative arrangements.
25 Proposal for revised NICNAS consultative arrangements (discussion paper) is available on the NICNAS website .
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NICNAS I ANNUAL REPORT 2013–14
CEF membership at 30 June 2014
NICNAS: Chair (vacant)
Dr Brian Richards (Director, NICNAS)
Mr Justin Roberts (Secretariat)
Representing: Environment: Ms Jo Immig, one vacancy
Worker health and safety: two vacancies
Public health: Dr Liz Hanna, one vacancy
Industry Engagement GroupThree meetings of the NICNAS Industry Engagement Group (IEG) were held in 2013–14:
IEG12 on 28 Oct 2013, IEG13 on 27 Feb 2014 and IEG14 on 26 June 2014.
The group was established to provide a forum for considering and advising on practical
(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:
• specific technical matters such as review of guidance materials;
• avenues to enhance the arrangements for acceptance of assessments under
international arrangements;
• industry issues / concerns, as appropriate;
• current industry operations and practice; and
• planned outreach activities such as training programmes.
Industry members of the IEG represent a broad range of sectors, including paper products,
consumer cosmetics, household products, paints, plastics and petroleum.
Agenda items included: the NICNAS Handbook / website, draft guidelines for confidential
listing / exempt information applications, topics for notifier training, and new chemicals
operational improvements (including an updated early introduction permit form with
flowchart and new polymer of low concern flowchart).
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NICNAS I ANNUAL REPORT 2013–14
IEG membership in 2013–14
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, DuPont, Minerals Council of Australia, Plastics and Chemicals Industries
Association (PACIA), Packer Leather Pty Ltd, Unilever Australasia.
Industry Government Consultative CommitteeThe Industry Government Consultative Committee (IGCC) reviews the use of resources
against NICNAS objectives; reviews the performance of NICNAS against agreed
performance indicators (including those established in the NICNAS Service Charter and
Business Plan), and in particular the impact on industry and the protection of human health
and the environment; develops strategies for improving the efficiency and effectiveness
of NICNAS operations within the context of (i) established goals and objectives and (ii)
developing and emerging issues; and develops compliance strategies and monitors the
effectiveness of these strategies in promoting compliance with NICNAS.
The IGCC has eight members, including four industry representatives and four
from government.
IGCC membership in 2013–14
Representing:
Industry: Australian Chamber of Commerce and Industry (ACCI): Ms Carolyn Davis
Accord Australasia: Ms Bronwyn Capanna
APMF: Mr Richard Phillips
PACIA: Mr Ben Stapley
Government: NICNAS: Dr Brian Richards (Chair), Mr Nick Miller (Secretariat)
Department of Employment: Mr Henry Carr
Department of the Environment: Mr Andrew McNee
Department of Industry: Ms Ann Bray
Department of Health is an ex-officio member: Mr Neil Ellis
The IGCC held three meetings during the year (with both face-to-face and by-video-
conference attendance): IGCC46 on 20 Aug 2013, IGCC47 on 3 Dec 2013 and IGCC48 on
25 March 2014.
At each meeting, the committee discussed NICNAS budget and performance issues,
provided feedback on compliance, AICS, IMAP, communications and similar matters, as well
as discussing the NICNAS review of stakeholder engagement / consultative arrangements.
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NICNAS I ANNUAL REPORT 2013–14
Nanotechnology Advisory GroupThe 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 NAG comprises three individuals representing the community, three representing
industry, one expert in nanoscience, one expert in toxicology, and a NICNAS representative.
The group did not meet face-to-face during 2013–14. The group’s tenure has been extended
twice; its third term ended in March 2014. Further extension will be considered when the
review of NICNAS consultative arrangements has been finalised.
NAG membership in 2013–14
NICNAS: Dr Roshini Jayewardene (Chair), Dr Matthew Gredley (member), Ms Nicola Hall (Secretariat)
Representing:
Community: Ms Renata Musolino (CEF)
Dr Rye Senjen (National Environment Consultative Forum—NECF)
Dr Sam Bruschi (CEF nominee)
Industry: Mr Geoff MacAlpine / Mr Ben Stapley (PACIA)
Mr Leo Hyde (APMF)
Mr Craig Brock (Accord Australasia)
Experts: Nanoscience: Prof. Colin Raston (Flinders University)
Toxicology: Dr Brian Priestly (Monash University)
States and Territories Memorandum of Understanding GroupThe States and Territories Memorandum of Understanding (MoU) group serves as a conduit
for the exchange of information and service delivery between NICNAS and the states 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 16 Oct 2013 and on 25 June 2014, and members
discussed recent PEC reports; IMAP programme; coal seam gas; review of NICNAS; azo dyes;
triclosan; and obligations under the Rotterdam Convention.
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MoU Group membership in 2013–14
NICNAS: Mr Lewis Norman (Chair), Dr Brian Richards (Director), Dr Trang Pham, Ms Louise Stedman, Mr Ambrose Sharp (Secretariat)
Members: Ms Anita Aiezza (Victoria)
Mr Ian Graham (Tasmania)
Ms Caroline Topping (Queensland)
Ms Mary Kary (Australian Capital Territory)
Ms Sally North (Western Australia)
Mr Mahinda Seneviratne (New South Wales)
Ms Shelley Rowett, Mr Chor Wong (South Australia)
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Appendix 08—Links: national and international
Table 22: International and national presenters to staff information and training sessions in 2013–1426
Name and position From Topic
Dr Jan Hermann, Dr Victoria Coleman
National Measurement Institute Nanometrology at the National Measurement Institute
Mr F. Verdonck, Mr H. Waeterschoot et al
ARCHE and Eurometaux Hazard classification challenges for complex inorganic materials
Prof. Brian Priestly Chemicals delegate, Scheduling Secretariat
Scheduling of NICNAS chemicals in the SUSMP
Mr Peter Wallner, Mr Neville Matthews
ACCC ACCC product safety
Dr Klaus Koop Chief scientist, NSW EPA State-based regulatory science
Ms Jackie Randles Inspiring Australia Inspiring Australia’s aims and achievements
Mr Richard Greenwood Senior consultant, Hazardous Chemicals, Noel Arnold and Associates
Globally Harmonised System of Classification and Labelling of Chemicals (GHS) United Nations 2009 training
Ms Carolyn Vickers World Health Organisation Update on the WHO International Programme on Chemical Safety (IPCS)
Prof. Ovanes Mekenyan OASIS LMC Ltd OASIS human health pipeline computational modelling training (quantitative structure—activity relationship (QSAR) models)
Various OECD Review of OECD guidance on assessment of categories (alternative testing methods)—new information26
Note: This listing provides an overview, only, of the range of speakers and is not all-inclusive.
26 In response to this, test guidelines on matters including skin and eye corrosion / irritation and skin sensitisation were added to NICNAS’s internal database to facilitate easy access to current information.
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Attendance / presentation at Australian conferencesThis listing is not all-inclusive—it provides an overview of the range of events / topics only.
NICNAS provided inputs to meetings of the following agencies during 2013–14:
• Society for Risk Analysis, Australia and New Zealand (September 2013)
• Endocrine Disrupting Chemicals: Science and Regulation symposium
(October 2013)
• Australian Federal Police Chemical Diversion Workshop (November 2013)
• Australian Institute of Occupational Hygienists Annual Conference
(December 2013)
• National Measurement Institute seminar: predicting hazards and risks, engineered
nanomaterials (February 2014)
• Australian Microscopy and Microanalysis Society, Australian Nanotechnology
Network, 2014 International Conference (February 2014)
• Regulatory Science Workshop on communication (February 2014)
• Sixteenth International Workshop on Quantitative Structure Activity Relationships
(QSAR) in Environmental and Health Sciences (May 2014)
• Nanotechnology workshop, on regulatory co-operation (June 2014)
• Sixth International Workshop on Per- and Polyfluorinated Alkyl Substances (PFAS)
(June 2014)
Attendance / presentation at international conferencesThis listing provides an overview of the range of events / topics.
OECD Task Force on Exposure Assessment (TFEA)—Discussed potential activities of the
occupational exposure subgroup and shared experiences on exposure assessments
conducted by member agencies. Specific Consumer Exposure Determinants project activity
has the potential to provide useful exposure information for the IMAP programme.
NICNAS responded to a TFEA survey that aimed to identify guidance documents and
methods used by OECD member countries to assess combined exposures to multiple
chemicals. NICNAS phthalates assessments were used as examples of how guidance
documents identified by NICNAS were used, and could be developed as a case study on
combined exposures.
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Working Party on Manufactured Nanomaterials—NICNAS coordinated Australia’s support
for OECD council recommendation on safety testing and assessing of nanomaterials,
that ‘member countries apply existing international and national chemical regulatory
frameworks to manage the risks associated with nanomaterials’. NICNAS’s approach to
regulation and assessment of these substances is consistent with this recommendation.
Main outcomes from engagement in this working party in 2013–14 included:
• publishing outcomes from the OECD Sponsorship Programme (testing 13 specific
nanomaterials);
• revising existing OECD test guidelines on developing new guidelines suitable for
testing nanomaterials; commencing work on seven proposals and identifying a
further 10—for future work;
• six expert workshops on issues relevant to assessing specific hazard endpoints and
planning for two more expert workshops;
• three pilot projects relating to using interspecies variability, approaches to dealing
with nanoparticles dissolution and approaches for grouping, equivalence and
read-across; and
• three projects relating to exposure assessing nanomaterials: harmonised tiered
approach to measurement and assessing airborne nanomaterials, assessing bio-
durability of nanomaterials and a case study on occupational exposure to
nano gold.
OECD seminar: approaches for risk assessment and risk management of chemicals—NICNAS presented on ‘Australian regulation of industrial nanomaterials’ (June 2014).
51st joint meeting of OECD Chemicals Committee, Working Party on Chemicals, Pesticides and Biotechnology—The meeting:
• agreed that the Cooperative Chemical Assessment Programme (CoCAP) was a
success; supported a proposed new direction; and recommended that the work
programme requires further prioritisation and scoping;
• supported work towards a harmonised approach to the characterisation of UVCBs27
for hazard assessment for regulatory purposes;
• endorsed a project to develop a knowledge base (wiki) of adverse outcome
pathways to support an integrated approach to testing and assessment; noting
the need to coordinate work with other bodies, and ensure uncertainties relating
to gaps in scientific evidence are appropriately characterised (to support targeted
research);
27 Substances of unknown or variable composition, complex reaction products or biological materials
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• agreed on the terms of reference for the comparative analysis of risk reduction
approaches for per- and poly-fluorinated chemicals across the OECD, with a
primary focus on longer chain substances. Work is to be undertaken in cooperation
with UNEP; and
• supported a proposal for various work items proposed to be undertaken under the
auspices of three key sub-committees of the joint meeting.
NICNAS prepared briefing material for the Australian delegation on items relevant to
industrial chemicals. (February 2014).
ECHA Stakeholder Meeting, Helsinki Chemicals Forum—NICNAS presentation to ECHA
members (May 2014).
OECD Task Force on Hazard Assessment (TFHA)—At the task force meeting, NICNAS:
• participated in discussions on a proposed new programme to replace current
CoCAP;
• identified (consistent with focus on category assessments) priority activities:
expanding the concept of categories of chemicals; developing and applying other
integrated approaches to testing and assessment; and characterising UVCBs for
hazard assessment purposes; and
• provided initial comments on developing a draft OECD guidance document on
incorporating analysis of non-testing (QSAR) results in assessing carcinogenicity
endpoint—and will: continue to review this document to ensure usability in our
assessments; (potentially) contribute a case study.
The meeting agreed:
• that the activities of highest priority in the new cooperative assessment programme
would be the Integrated Approaches to Testing and Assessment (IATA) and novel
methods of assessments with a focus on combined risks from multiple exposures to
chemicals;
• to the development of assessment guidance for metals (and inorganics) salts and
organometallic and organic metal salt as a follow up from the workshop held in
September 2011 at the OECD in Paris on Metals Specificities in Environmental Risk
Assessment; and
• to continuing the development of guidance documents on characterising UVCB
substances for assessment purposes.
NICNAS staff attended the Molecular Screening and Toxico-genomics Advisory Group
meeting held back-to-back with the 7th Task Force on Hazard Assessment meeting. The work
of the Advisory Group feeds into the activities of the Task Force.
Information exchanges—ECHA and Canada—Teleconferences were conducted on
several technical topics during the year.
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OECD New Chemicals Clearing House—NICNAS shared information on Australia’s low
volume exemption categories with Japan. NICNAS, the US EPA, Environment Canada &
Health Canada (participants in the CHNC polyester project) signed modus operandi for
work-sharing arrangements (see OECD website). Signatories agreed on the approach to
assessments and assessment report template. Dossiers for eight new candidate nominations
were received from six companies—the assessments are to be completed by the end of
September 2014.
A proposal was finalised for an analogue workshop in 2014–15, with the following rationales:
improve efficiency of new chemicals (NC) programmes in member countries by sharing
scientific knowledge and approaches to identification, use and evaluation of analogues;
developing a toolbox of common approaches to identify appropriate substance analogues
and evaluate their suitability for NC assessment; provide an analogue evaluation framework
for CHNC member countries to use, and increase the potential use of shared information
across jurisdictions; and developing a framework for continuous member engagement. The
workshop planning committee is currently evaluating the logistics.
OECD / UNEP Global Perfluorinated chemicals (PFC) Steering Group—discussed
populating a PFC portal with information on short-chain PFCs. The general opinion was
that a balanced view of both the benefits and adverse effects of short-chain PFCs should
be presented on the portal, but there was a current lack of resources to achieve this.
Consultants could be used to initially populate the portal; group members’ resources will be
reviewed (three teleconferences).
Revised cooperative chemicals assessment activity—The group discussed future
cooperative work on the hazard assessment of chemicals, with the new programme to
replace the CoCAP; agreed that the main focus of new programme should be developing
and applying novel methods for assessing chemical hazards; and that countries with
limited resources would benefit from others contributing specific types of assessments to the
programme (two teleconferences).
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Appendix 09—Staff profile, training, development
Executive staff, NICNAS programmes at 30 June 201428
Director, NICNAS: Dr Brian Richards
Compliance and Enforcement Programme: Mr Lewis Norman (Head)
Corporate and Regulatory Strategy Programme: Dr Roshini Jayewardene (Head)
Existing Chemicals Programme: Ms Angela McKinnon (Head), Dr Kerry Nugent
(Principal Scientist)
New Chemicals Programme: Dr Sarah Rumble (Head), Dr Daniela Leonte (Principal Scientist)
Targeted Assessment Programme: Dr Sneha Satya (Head), Dr Matthew Gredley
(Principal Scientist)
All Executive staff members meet each week as the NICNAS Executive Team, to discuss and
respond to operational matters and issues.
28 From late June 2014, the functions of the Business Management and Communications and Regulatory Strategy programmes were combined as the Corporate and Regulatory Strategy programme. Prior to 4 June 2013, Heads of Programme were: Regulatory Strategy: Dr Roshini Jayewardene; Business Management and Communications: Mr Nick Miller.
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Table 23: NICNAS staff profile at 30 June 2014
Classification Female Male Total Total, as percentage
Holder of public office 0 1 1 1%
Executive Level 2 Officers 5 3 8 10%
Executive Level 1 Officers 14 7 21 25%
APS Level 6 16 13 29 35%
APS Level 5 5 1 6 7%
APS Level 4 9 0 9 11%
APS Level 3 7 1 8 10%
APS Level 2 1 0 1 1%
Total 57 26 83 100%
Table 24: Membership of Equal Employment Opportunity groups at 30 June 2014
Number As percentage of total headcount
Female 57 69%
Aboriginal and Torres Strait Islander 1 1%
NESB 1–2 14 17%
People with disability 3 4%
Table 25: Full time and part-time staff at 30 June 2014
Full time–Part time Headcount As percentage
Full-time 70 84%
Part-time 13 16%
Casual 0 0%
Total 83 100%
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Table 26: Summary of staff training, by total formal training29 days in 2013–14
All staff formal training Number of participants, e-Learning training 151
Number of participants, non e-Learning training 95
Total number of formal training courses (both e-Learning and non e-Learning) 246
Average number of courses per staff member 30 2.96
Note: NICNAS staff attended numerous ‘Tuesday tune-up’ and other scientific sessions (as summarised at Appendix 08). Some sessions were presented by international speakers, some by Australian experts and some by NICNAS staff.30
29 Includes eLearning which is classified as formal training.30 This figure does not include professional development training—including scientific training—opportunities, or
attendance at NICNAS’s ‘Tuesday tune-up’ and similar sessions. Average is based on total headcount as at 30 June 2014.
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Appendix 10—Stakeholder survey updateThe last NICNAS Stakeholder Survey of its customers was conducted in October / November
2013. It covered service in key areas. Around 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 programmes and
activities to improve outcomes.
Analysis across the range of areas upon which participants provided comments in the
survey is ongoing. It provides opportunities to identify key themes of interest and concern to
stakeholders.
The next survey is scheduled for 2015–16.
Table 27: Activity during 2013–14 on key outcomes from 2011–13 stakeholder survey (conducted October / November 2013)
Topic / finding Action proposed Status
Audit—67% of respondents agreed that audit activities should occur, with a focus on new chemicals, existing chemicals and compliance with registration requirements
Maintain audit programme Commenced and on-going
Communication—Opportunity to improve ratings across a range of communication types, particularly: new and emerging issues, reform implementation, compliance requirements for business, regulatory changes, application requirements, NICNAS scope
Review all communication activities with focus on specified topic areas, especially with material offered via Chemical Gazette and NICNAS Matters
Commenced and on-going
Training—60% of participants showed strong interest in participation in consultations, workshops and training, especially:
• Registration processes and process updates
• New and emerging technologies
• Regulatory reform
• Navigating the broader system of
chemicals regulation
17% of respondents felt that NICNAS was not meeting expectations in the area of training, with particularly strong demand among industry stakeholders
Improved / increased opportunities for training for industry, especially notifiers, across Australia
More training opportunities offered in 2013–14 and planned for 2014–15
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Topic / finding Action proposed Status
Website—The 40% of participants who used the new website generally gave positive feedback:
Conduct full review of new website, using survey findings, other data
Proposal to conduct website review approved and review to be conducted in 2014–15Good / Very
Good Poor / Very Poor
‘Look and feel’ 66% 7%
Navigation 58% 13%
Accuracy 71% 5%
Quality and readability of information 66% 8%
Ability to easily identify information being searched for
58% 15%
Scheme performance—NICNAS’s performance strongly met expectations in:
On-going focus on improving performance in all areas
Commenced and on-going
Satisfied Dissatisfied
Core business areas:
Registration services 62% 8%
New Chemicals assessments 52% 11%
Existing chemicals assessments 56% 12%
Checking compliance with regulations 50% 12%
Service satisfaction / staff performance:
Staff helpfulness 54% 4%
Staff courtesy 58% 2%
Staff knowledge 54% 4%
Ability to contact NICNAS 58% 4%
Timeliness of responses 44% 5%
Scientific approach to assessments 41% 5%
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Appendix 11—Compliance with mandatory reporting requirements
Mandatory requirements under the Act
In addition to the requirement to produce an annual report to Parliament on the operations
of the ICNA Act and other external scrutiny such as through the NICNAS IGCC, the Act also
prescribes additional mandatory reporting requirements.
Table 28: Compliance with mandatory reporting requirements under the ICNA Act
Requirement 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 30 September 2013—published in the October 2013 Chemical Gazette.
Number of LVC permits issued 2013–14: 65 comprising 47 LVCs and 18 LVC renewals.
A list of both current chemicals and those that have previously been Priority Existing Chemicals (PECS) is to be published annually in the Chemical Gazette. [section 54(1) and 54(2)]
A list of current and completed PECs was published in the August 2013 Chemical Gazette, with an updated list to be published in the August 2014 Chemical Gazette.
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 September 2013 edition of the Chemical Gazette.
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 in 2013–14 to the Office of Gene Technology Regulator for advice
Annual publication in Chemical Gazette of a summary of the information given to the Director with respect to new chemicals eligible for introduction without notification (section 21AB)
The summary of chemicals reported during 2013–14 is to be published in the August 2014 Chemical Gazette.
Annual publication in Chemical Gazette of chemicals in respect of which controlled use permits are in force (section 22N)
The controlled use permit list—listing those in force at 31 October 2013—was published in the 5 November 2013 Chemical Gazette
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Table 29: Compliance with mandatory reporting requirements for 2013–14 by the Department of Prime Minister and Cabinet
Description Page
Letter of transmittal 3
Table of contents 5
Index 69
Glossary 64
Contact officer(s) 4
Internet home page address and Internet address for report 4
Review by Secretary
Summary of significant issues and developments 6 - 7
Overview of department’s performance and financial results 14 - 27
Departmental overview
Role and functions 8 - 10
Organisational structure 12
Outcome and programme structure 14 - 27
Report on performance
Review of performance during the year in relation to programmes and contribution to outcomes
14 - 27
Actual performance in relation to deliverables and KPIs set out in PB Statements / PAES or other portfolio statements
14 - 15
Narrative discussion and analysis of performance 14 - 26
Trend information 14 - 26
Contribution of risk management in achieving objectives 26
Performance against service charter / customer service standards, complaints data, and the department’s response to complaints
25, 58 - 60
Discussion and analysis of the department’s financial performance 23 -24
Discussion of any significant changes in financial results from the prior year, from budget, or anticipated to have a significant impact on future operations.
23 - 24
Agency resource statement and summary resource tables by outcomes 27
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Description Page
Corporate governance
Statement of the main corporate governance practices in place 13
Names of the senior executive and their responsibilities 55
Senior management committees and their roles 55
Corporate and operational plans and associated performance reporting and review
10 - 12, 47
Internal audit arrangements including approach adopted to identifying areas of significant financial or operational risk and arrangements to manage those risks
26
Policy and practices on the establishment and maintenance of appropriate ethical standards
8 - 13
External scrutiny
Significant developments in external scrutiny 26
Judicial decisions and decisions of administrative tribunals and by the Australian Information Commissioner
15-16, 26
Reports by the Auditor-General, a Parliamentary Committee, the Commonwealth Ombudsman or an agency capability review
26
Management of human resources
Assessment of effectiveness in managing and developing human resources to achieve departmental objectives
25
Workforce planning, staff retention and turnover 25, 56
Training and development undertaken and its impact 50, 57
Work health and safety performance 25
Statistics on staffing 55 - 57
Performance pay 25
Management of other resources
Assessment of assets management effectiveness 26
Assessment of purchasing against core policies and principles 23 - 24
Summary statement detailing number of new consultancy services contracts let during the year and related information
35
Financial statements 29 - 32
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Description Page
Other information
Work health and safety 25
Advertising and market research and statement on advertising campaigns 44
Ecologically sustainable development and environmental performance 10, 17
Grant programmes 23 - 24, 29 - 32
Information Publication Scheme statement 25
Agency Resource Statements and Resources for Outcomes 27
Note: For additional details and information and data related to other mandatory requirements
(including review by departmental secretary; outlook for 2014–15; certification of compliance with
‘Commonwealth Fraud Control Guidelines’; impact and features of enterprise or collective agreements,
individual flexibility arrangements (IFAs), determinations, common law contracts and Australian
Workplace Agreements (AWAs); absence of provisions in contracts allowing access by the Auditor-
General; details of variation and reasons for change (where outcome and programme structures differ
from PB Statements or other portfolio statements); factors, events or trends influencing departmental
performance; and disability reporting please see the Department of Health Annual Report 2013–14.
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Glossary, acronyms and abbreviationsGlossaryThe 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): the body that independently reviews administrative decisions made by the Australian Government and some non-government bodies
Australian High Volume Industrial Chemicals (AHVIC): the 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): the list of chemical identity data maintained by NICNAS; the legal device that distinguishes new from existing chemicals, commencing with a list of 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
Chemical Gazette: a 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 and territory Premiers and Chief Ministers and the President of the Australian Local Government Association. The Prime Minister chairs COAG
Director: Director of NICNAS
Existing chemical: an industrial chemical listed on the Australian Inventory of Chemical Substances (AICS)
Inventory Multi-tiered Assessment and Prioritisation (IMAP) Framework: assessment framework developed by NICNAS to help prioritise the assessment of chemicals of concern listed on the AICS, leading to enhancements in chemical safety information flow and chemicals management. The programme will run from 2012-13 to 2015-16
Industrial chemical: for registration and introduction purposes, a chemical with an application, purpose or use that is industrial (whether or not it also has non-industrial uses)
Industry Government Consultative Committee (IGCC): the 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 formerly-used ‘tiers’, 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
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Memorandum of Understanding (MoU): an 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 (Safe Work Australia) as well as with the European chemicals agency ECHA and the New Zealand EPA
New chemical: an industrial chemical (including a polymer) proposed for introduction in Australia that is not listed on the AICS
Organisation for Economic Co-operation and Development (OECD): a group of 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
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: a chemical which is known to be used in the manufacture of drugs and explosives
Priority Existing Chemical (PEC): a chemical declared by the Minister for assessment under the NICNAS Existing Chemicals programme because its manufacture, handling, storage, use or disposal gives rise, or could 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 a chemical that has been previously assessed by NICNAS and requires re-assessment based on new data becoming available that could change the risks identified in the earlier assessment
Service Charter: a 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
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 could lead to significant adverse human health and / or environmental effects that would warrant global action
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)
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Appendix 08—Links: national and international
Table 22: International and national presenters to staff information and training sessions in 2013–14
Name and position From Topic
Dr Jan Hermann, Dr Victoria Coleman
National Measurement Institute Nanometrology at the National Measurement Institute
Mr F. Verdonck, Mr H. Waeterschoot et al
ARCHE and Eurometaux Hazard classification challenges for complex inorganic materials
Prof. Brian Priestly Chemicals delegate, Scheduling Secretariat
Scheduling of NICNAS chemicals in the SUSMP
Mr Peter Wallner, Mr Neville Matthews
ACCC ACCC product safety
Dr Klaus Koop Chief scientist, NSW EPA State-based regulatory science
Ms Jackie Randles Inspiring Australia Inspiring Australia’s aims and achievements
Mr Richard Greenwood Senior consultant, Hazardous , Noel Arnold and Associates
Globally Harmonised System of Classification and Labelling of Chemicals (GHS) United Nations 2009 training
Ms Carolyn Vickers World Health Organisation Update on the WHO International Programme on Chemical Safety (IPCS)
Prof. Ovanes Mekenyan OASIS LMC Ltd OASIS human health pipeline computational modelling training (quantitative structure—activity relationship (QSAR) models)
Various OECD Review of OECD guidance on assessment of categories (alternative testing methods)—new information
Note: This listing provides an overview, only, of the range of speakers and is not all-inclusive.
Acronyms and abbreviationsAAT Administrative Appeals Tribunal
ACCC Australian Competition and Consumer Commission
ACCI Australian Chamber of Commerce and Industry
ACCS Advisory Committee on Chemicals Scheduling
ACTRA Australasian College of Toxicology and Risk Assessment
AGD Attorney-General’s Department
AHPC Australian Health Protection Committee (Health committee)
AICS Australian Inventory of Chemical Substances (see Glossary, above)
AIOH Australian Institute of Occupational Hygienists
AMSA Australian Maritime Services Authority
ANAO Australian National Audit Office
APEC Asia-Pacific Economic Co-operation
APMF Australian Paint Manufacturers Federation
APVMA Australian Pesticides and Veterinary Medicines Authority
ASCC Australian Safety and Compensation Council (Safe Work Australia)
ASCC Australian Society of Cosmetic Chemists
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)
CoCAP Cooperative Chemical Assessment Programme (OECD)
COAG Council of Australian Governments (see Glossary, above)
CRIS Cost Recovery Impact Statement
CSG coal seam gas – also known as natural gas from coal seams
CSIRO Commonwealth Scientific and Industrial Research Organisation
CWG Chemicals Working Group
DBP dibutyl phthalate
DEHP diethylhexyl phthalate
DEP diethyl phthalate
DMEP di(methoxyethyl) phthalate
DMP dimethyl phthalate
ECHA European Chemicals Agency
EIP Early Introduction Permit (NICNAS)
enHealth Environmental Health Committee–subcommittee of Health’s AHPC
EOP (controlled use) Export Only Permit (NICNAS)
EPHC Environment Protection and Heritage Council
EU European Union
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FMA Financial Management and Accountability Act 1997
FO Freedom of Information Act 1982
FSANZ Food Standards Australia New Zealand
GHS Globally Harmonized System of Classification and Labelling of chemicals (United Nations)
HAZMAT Hazardous materials
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)
IPBC iodopropynyl butylcarbamate
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
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
PACIA Plastics and Chemicals Industries Association
PEC Priority Existing Chemicals
PFC Perfluorinated chemicals
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 Chemical substances
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
SCOC Standing Committee on Chemicals
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STD Standard notification category (NICNAS)
SUSMP Standard for the Uniform Scheduling of Medicines and Poisons (see Poisons Standard, Glossary, above)
SWA Safe Work Australia
TFEA Task Force on Exposure Assessment (OECD)
TFHA Task Force on Hazard Assessment (OECD)
TGA Therapeutic Goods Administration
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
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Indexabbreviations and acronyms (NICNAS), 66-68
Administrative Appeals Tribunal (AAT), 15, 16
advertising (NICNAS), 44
advice – technical and other (NICNAS), 10–11
Advisory Committee on Chemicals Scheduling (ACCS), see chemicals (industrial) scheduling
advisory groups (NICNAS), 13, 45–9
AICS, see Australian Inventory of Chemical Substances,
Animal testing (alternatives to), 7, 21, 44
APEC chemical dialogue and regulators forum, 21
assessment/s, (NICNAS)
chemicals, 9, 15–20
chemicals used in coal seam gas extraction, 7, 17, 19, 48
chemicals used in oil dispersant products, 19
existing chemicals, 15–20, 60
international, 18
multi-tiered assessment and prioritisation of chemicals on the AICS inventory (IMAP) — project and framework (NICNAS), 6, 10, 14, 15–20, 42
of metals (IMAP), 18
new chemicals, 8, 15–20, 36–39, 60
reports (numbers), 42
Attorney-General’s Department (security chemicals framework programme), 11
audits / auditing, and investigation / monitoring (NICNAS), 22, 23, 26, 29, 41, 58
Australia-Canada Bilateral Agreement, see international harmonisation
Australian Competition and Consumer Commission (ACCC), 11, 50
Australian Government Attorney-General’s Department, see Attorney-General’s Department
Australian Government Department of Health (Health), 6, 9
portfolio budget statement (PBS), 14
regulatory plan, 10
Australian Government Department of Industry (Industry), 47
Australian Government Department of the Environment (Environment), 7, 10, 12
Australian Inventory of Chemical Substances (AICS), 8, 9, 10
assessment and prioritisation of chemicals, see inventory multi-tiered assessment and prioritisation (IMAP),
listings and search requests, 27, 43
Bilateral arrangements (NICNAS), see international harmonisation
Canada, bilateral agreement, see international harmonisation
case studies (IMAP), 18
certificate (assessment) applications, 15, 36-8
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chemicals (industrial),
cooperative assessment programme (OECD), 52
exempt from notification, 9, 39
regulation, 10
safety, 9–10
scheduling, 11, 17
security concern (report), see Attorney-General’s Department
see also existing chemicals assessment
see also new chemicals assessment
Clearing House (new chemicals) OECD, see new chemicals
Coal seam gas (CSG) chemicals, see assessment/s, chemicals used in coal seam gas extraction
committees (NICNAS), see advisory groups
communication/s (NICNAS), 24, 42–4
Community Engagement Forum (NICNAS), 13, 45–6,
complaints (NICNAS), 25
compliance (NICNAS),
and enforcement programme activities , 22
and outreach activities, 22, 59
mandatory reporting requirements,60–6
training for industry, 22–3
with Health regulatory requirements (NICNAS), 10
conferences, workshops and meetings attended (NICNAS), 50–4
consultancy services let during the year (NICNAS), 35
consultations (NICNAS), 43
cooperative arrangements, 10
contact details (NICNAS), 4
corporate governance (NICNAS), 3
cosmetics (NICNAS), 8, 24, 43, 44
exemptions, 39
customer survey (NICNAS) see stakeholder survey
deliverables and KPIs (NICNAS), 14–15
Department of the Environment (Environment), see Australian Government Department of the Environment (Environment)
Department of Health (Health), see Australian Government Department of Health (Health)
Department of Industry (Industry), see Australian Government Department of Industry (Industry)
dibutyl phthalate – DBP (assessment), 15
dimethoxyethel phthalate – DMEP (assessment), 15
dimethyl phthalate – DMP (assessment), 15
Director’s report (NICNAS), 6–7
ECHA, see European Chemicals Agency
employees (NICNAS), see people
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enterprise agreement, staff (NICNAS) , 25
Environment Canada, 20
Environmental Health Standing Committee, 10
European chemicals agency, ((ECHA), see international harmonisation
Stakeholder meeting, 53
existing chemicals (NICNAS)
assessments, 15–20
priority (PEC) reports, 15, 24
secondary notifications, 16
see also assessments
see also international harmonisation
financial information (NICNAS),
performance (NICNAS), 23–4,
revenue and expenses, 24
statements (NICNAS), 29–32
Fluorosurfactant FC-4430 (review), 16
foreign scheme/s (approved), see international harmonisation
fracking chemicals, see assessment/s, chemical used in coal seam gas extraction
freedom of information (NICNAS), 25
functions (NICNAS), see role, governance and structure
Globally harmonised system for classification and labeling of chemicals (GHS) (United Nations), 20
Glossary, 64–5
governance (NICNAS), see corporate governance
harmonisation, see international harmonisation
Health Canada, see international harmonisation
health, safety and environment outcomes (NICNAS), 6–7, 8, 9–10, 11, 16–17, 45
human resources (NICNAS), see people
IGCC, see Industry Government Consultative Committee
IMAP framework (NICNAS), see assessment — multi-tiered 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 ICNA Act), 3, 8, 12, 60
Industry Engagement Group (IEG) (NICNAS), 13, 46–7
Industry Government Consultative Committee (IGCC) (NICNAS), 13, 47
industry sectors for new chemicals, 38
Information Publications Scheme, 25
international harmonisation / partnerships, 14, 21
and work sharing activities, 20
visitors to NICNAS,
Bilateral: arrangements with ECHA, Environment Canada, US EPA, 20, 21, 53
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Multilateral: with APEC, OECD agencies, UNEP, WHO, 7, 21
International treaties,
Rotterdam convention compliance and arrangements (data), 41
internet home page address and internet address for report (NICNAS), 4
inventory (NICNAS), see Australian Inventory of Chemical Substances,
inventory multi-tiered assessment and prioritisation (IMAP), see assessment/s
KPIs (NICNAS), see deliverables and KPIs
letter of transmittal, 3
links, national and international (NICNAS), 50–4
media inquiries (NICNAS), 25, 44
memorandum(s) of understanding
States and Territories MOU Group, 13, 48–9
with NZ EPA and ECHA, see international harmonisation,
MOUs see memorandum(s) of understanding
nanomaterials (industrial),
working party on manufactured (OECD), 52–3
Nanotechnology Advisory Group (NICNAS), 13, 48
new chemicals (NICNAS),
assessment, see assessment/s
Clearing House (OECD), 54
see also assessments
see also international harmonisation
occupational health and safety and assessments (NICNAS), see work health and safety assessments
see also people
Office of Chemical Safety (OCS), 10
Operations (NICNAS), 14–27
Organisation for Economic Cooperation and Development (OECD), 21, 7
Chemicals committee, 52–3
New Chemicals Clearing House, 54
Task Force on Exposure Assessment, 51
Task Force on Hazard Assessment, 53
UNEP Global PFC steering group, 54
Working Party on Manufactured Nanomaterials, 52
see international harmonisation
organisational structure / chart (NICNAS), 12
outreach, see training
people (NICNAS), 12, 25
executive staff, 55
occupational health and safety, see work health and safety assessments, staff
profile, 55–7
training and development, 19–20, 21, 50, 57
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perfluorinated chemical/s (PFCs), 16
performance (NICNAS),
measurement targets (NICNAS), 14–15
pay (bonuses), 25
permits, assessment (NICNAS), 15
PhoslockTM (assessment), 16, 42
portfolio budget statement (PBS) see Australian Government Department of Health (Health)
presentations (NICNAS), 51–4
Principal Scientists (NICNAS), 12, 55
prioritisation of chemicals on the inventory, see assessment/s, multi-tiered assessment and prioritisation of chemicals on the inventory
priority existing chemicals (PECs) (NICNAS), see existing chemicals assessment
programmes (NICNAS), 12, 27, 55
publications (NICNAS), 24, 42–3
Quantitative Structure Activity Relationship (QSAR), 50, 53
Recommendations, IMAP, 17
registration (NICNAS), 22–23
audits and cases managed, 41
data, 40–1
levels and tiers, 40
re-assessments, 41
regulation / regulatory approach, plan (NICNAS), 10
regulatory burden, reducing, 33–4
Regulators’ Forum, 11
Resources (NICNAS), summary, 26–7
revenue and expenses, see financial performance
review (of NICNAS stakeholder consultative arrangements), 13, 45–9
risk assessment and management
at NICNAS, 26
OECD seminar, 52
role, governance and structure (NICNAS), 8–13
Rotterdam Convention on Prior the Informed Consent Procedure on Certain Hazardous Chemicals and Pesticides in International Trade, see international treaties, Rotterdam
Safe Work Australia (Australian Government Department of Employment), 11
science strategy (NICNAS), 19
scientists, principal, see Principal Scientists
secondary notification assessments, see existing chemicals
security, chemicals of concern, see Attorney-General’s
senior executive (Heads of Programme) and responsibilities (NICNAS), 55
service charter (NICNAS), 25
staffing (NICNAS), see people
74
Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), see chemicals (industrial) scheduling
Standing Committee on Chemicals (SCOC), 11
states and territories, 10
Memorandum of Understanding Group (NICNAS), see memorandum/s of understanding
structure (NICNAS) see role, governance and structure
survey (stakeholder) (NICNAS), 7, 24, 58–9
training and development (NICNAS),
for industry/community, 22, 59
for staff, see people
treaties, see international treaties
United Nations Environmental Protection Agency (USEPA), 20
US (United States) see international harmonisation
website (NICNAS), 24, 59
visitors and most viewed pages (data), 43
work health and safety assessments, staff (NICNAS), 25