National Industrial Chemicals Notification and Assessment ... · 2 NICNAS I ANNUAL REPORT 2013–14...

National Industrial Chemicals Notification and Assessment Scheme

ANNUAL REPORT 2013–14

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NICNAS I ANNUAL REPORT 2013–14


NICNASNational Industrial Chemicals Notification and Assessment Scheme

ANNUAL REPORT 2013–14

2



Annual Report 2013–14

The operation of the Industrial Chemicals (Notification and Assessment) Act 1989


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

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3


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

4


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

E [email protected]

5


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

6


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.

7


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

8


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.

9


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

10


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.

11


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

12


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

13


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

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.

15


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.

16


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

17


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.

18


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.

19


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

20


• 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.

21


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.

22


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.

23


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.

24


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.

25


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

26


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

27


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

28


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


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


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

31


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

32


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


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.

34


35


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


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%

37


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%

38


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%

39


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.

40


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

41


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.

42


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.

43


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.

44


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.

45


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 .

46


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).

47


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.

48


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.

49


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)

50


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.

51


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.

52


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

53


• 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.

54


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).

55


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%

57


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.

58


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

59


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%

60


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

61


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.

64


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

65


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

70


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

71


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

72


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

73


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

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National Industrial Chemicals Notification and Assessment ... · 2 NICNAS I ANNUAL REPORT 2013–14...

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Transcript of National Industrial Chemicals Notification and Assessment ... · 2 NICNAS I ANNUAL REPORT 2013–14...