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National Industrial Chemicals Notification and Assessment Scheme

ANNUAL REPORT 2012–13

N I C N A S

ii

National Industrial Chemicals Notification and Assessment Scheme Annual Report 2011–12

ISSN: 1037 - 6909

Print ISBN: 978-1-74186-051-1

Online ISBN: 978-1-74186-052-8

Publications approval number:10463

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iii

NICNAS I Annual Report 2012–13

The Hon. Peter Dutton MP Minister for Health Minister for Sport Parliament House Canberra ACT 2600

Dear 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 Act)

for the year ending 30 June 2013. The Annual Report has been prepared in accordance with

section 108 of the Act.

The Annual Report details the performance of the National Industrial Chemicals Notifications

and Assessment Scheme (NICNAS) against outcome and output measures as detailed in the

Portfolio Budget Statements for the period 1 July 2012 to 30 June 2013.

An abstract of financial information for NICNAS is included in this report. Further financial

information for NICNAS can be found in the Australian Government Department of Health and

Ageing Annual Report 2012–13, reflecting administrative arrangements for 2012–13.

Yours sincerely

Dr Brian Richards

Director, NICNAS

2 October 2013

Machinery of Government changes

On 18 September 2013 the Prime Minister announced changes to the ‘Machinery of

Government’.

A key change to the Department of Health and Ageing was that the department’s name was

changed to the Department of Health.

Details of further changes to the department’s responsibilities and legislation administered

by the department are included in the Administrative Arrangements Order issued by the

Governor-General on 18 September 2013, available at: www.dpmc.gov.au/parliamentary/

This annual report is for the 2012-13 financial year and is based on the structure of the

National Industrial Chemicals Notification and Assessment Scheme within the Department of

Health and Ageing at 30 June 2013. It reports on the Scheme’s activities during 2012–13.

iv

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/communications/publications/annual-reporting

For further information, please contact

Communications Manager, NICNAS

at the above address

T + 61 2 8577 8819

E [email protected]

v


Contents

Page Appendix

iii Transmittal letter

iv NICNAS contacts

1 Director’s report

2 Role, governance and structure

7 Operations

7 New chemicals assessment

8 Existing chemicals assessment

11 Other assessment-related activities

13 Regulatory strategy, scientific and reform activities

17 Compliance and enforcement activities

19 Business management, communications and corporate activities

23 Appendices

52 Glossary, acronyms and abbreviations

58 Index

1


Director’s report This report provides an overview of the

operations of the National Industrial

Chemicals Notification and Assessment

Scheme (NICNAS) in 2012–13.

NICNAS aids in the protection of the

Australian people and the environment by

assessing the risks of industrial chemicals

and providing information to promote their

safe use.

Key achievements in 2012–13 were the

completion of 281 pre-market assessments

of new industrial chemicals and the

assessment of 723 industrial chemicals

already in use (using the Inventory Multi-

tiered Assessment and Prioritisation [IMAP]

Framework or as Priority Existing Chemicals).

To promote the safe use of chemicals,

NICNAS continued to engage with its key

stakeholders—the chemical industry, the

community (including employees who

work with chemicals), the Australian

Government and state and territory

governments—through national networks,

advisory committees and information-

sharing activities.

I thank all who have supported NICNAS in

the activities outlined in this report.

I particularly wish to thank Dr Roshini

Jayewardene, Head of our Regulatory

Strategy program, who served as Director,

NICNAS from 27 June to 26 September 2012,

prior to my appointment.

Dr Brian Richards Director

2

Role, governance and structureOur role, functions, structure and linkagesThe National Industrial Chemicals

Notification and Assessment Scheme

(NICNAS) was established in July 1990

under the Industrial Chemicals (Notificationnd Assessment) Act 1989 (the Act) and

operates according to the Act.

The objects of the 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

a

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.”1

NICNAS assesses information provided by

importers and/or manufacturers relevant

to each chemical’s human health (public

health and occupational health and

safety) and environmental risks. NICNAS

encompasses:

• a national system of notification and

assessment of industrial chemicals

(chemical entities, not products);

• the Australian Inventory of Chemical

Substances (AICS); and

• registration of persons introducing

industrial chemicals.

1 Industrial Chemicals (Notification and Assessment) Act 1989 ( www.commlaw.gov.au/Details/C2012C00811), p.1.

3


Our role in chemical regulation in Australia A range of state, territory and Commonwealth

government agencies share responsibility for

chemical safety in Australia. Each chemical

is regulated according to its use. 2 Industrial

chemicals include any chemical not falling

into one of the other categories, such as

chemicals used in solvents, adhesives,

plastics, paints, inks, fuels, or laboratory

reagents, as well as in refrigeration, cosmetics

and household cleaning.

NICNAS helps to protect the Australian

people and environment by detecting

risks associated with manufacturing,

importing or using industrial chemicals,

and by maintaining a national standard for

cosmetic products.

During 2012–13, NICNAS operated within the

Australian Government Department of Health

and Ageing (DoHA) now Department of

Health (Health). It promotes the safe use of

industrial chemicals by providing information

and recommendations to other regulators,

industry and to the public.

Any company/person proposing to

introduce (import and/or manufacture) a

new industrial chemical in Australia must

notify NICNAS. Once NICNAS has assessed

a chemical for its human health, worker

safety and environmental risks, it publishes

an assessment report that may include

recommendations for further regulatory

control of the chemical (such as by poisons

scheduling, worker health and safety or

environmental controls). NICNAS also issues

a certificate or permit to the introducer,

who must report any new information that

becomes available about the chemical.

After five years, NICNAS may authorise a

chemical for wider use by listing it on the

AICS, which currently includes about 40,000

industrial chemicals that may be used

without notifying NICNAS. Many of these were

listed without assessment when the scheme

started, on the basis of their historical use.

In July 2012, NICNAS started using the

Inventory Multi-tiered Assessment and

Prioritisation (IMAP) Framework to review

the risks of 3,000 chemicals already listed

on the AICS, which were prioritised through

a consultation process. Once an IMAP

assessment is completed, NICNAS publishes

an IMAP assessment report that may

recommend further regulatory controls (as

for new chemicals).

Regulatory planNICNAS’s regulatory plan covers business

regulation, including primary legislation,

subordinate legislation, quasi-regulation or

treaties that directly affect business, have

a significant indirect effect on business, or

restrict competition.

A statement about information that the

regulatory plan does (and does not) include,

as well as the regulatory plan itself (covering

all business regulation activities planned by

Health, including those under NICNAS) for

2013–14 and preceding years is available on

the Health website3.

2 Four schemes make up the Australian Government’s regulatory framework for chemicals: NICNAS (industrial chemicals); Food Standards Australia New Zealand (food and food additives); Australian Pesticides and Veterinary Medicines Authority (pesticides and veterinary medicines); Therapeutic Goods Administration (medicines and medical devices).

3 www.health.gov.au/internet/main/publishing.nsf/Content/regulatory-plan.

4

Cooperative arrangementsStaff employed by the Department of Health

perform public health and occupational

health and safety assessments related to

industrial chemicals for NICNAS.

Staff employed by the Department of

the Environment (Environment)4 conduct

complementary environmental assessments

for NICNAS, and provide scientific, technical

and regulatory advice on environmental

protection in relation to chemical safety.

The Office of Chemical Safety (OCS)—like

NICNAS, located within Health—applies

public health policy to assessment

outcomes.

The Environmental Health Committee

(enHealth—a subcommittee of the Australian

Health Protection Committee) coordinates

state and territory input into NICNAS public

health assessments and recommendations.

The Therapeutic Goods Administration’s

(TGA) Advisory Committee on Chemicals

Scheduling (ACCS) reviews NICNAS

recommendations for scheduling of

chemicals, for inclusion in the relevant

legislation of states and territories, with

reference to the Standard for the Uniform

Scheduling of Medicines and Poisons

(SUSMP—Poisons Standard).

The Standing Committee on Chemicals

(SCOC)—responsible to the Council of

Australian Governments (COAG)—aims to

achieve an effective and efficient system of

chemicals and plastics regulation.

The Standing Council on Environment and

Water (SCEW)5 promotes the protection

of the environment and water under

COAG, providing a forum for the Australian

Government, states and territories to

address related broad national and reform

issues. It also provides input into some

NICNAS environmental risk management

recommendations.

The Australian Competition and Consumer

Commission (ACCC)—which is responsible

for the safety of products—receives NICNAS’s

technical advice and recommendations

concerning chemicals in consumer

products.

State and territory legislation provides the

means to implement recommendations

arising from NICNAS assessments, which

are made available to relevant Australian

Government, state and territory public

health, occupational health and safety; and

environmental, transport and consumer

product safety agencies. NICNAS also

provides technical assessment services to

them, to assist with national standard setting,

implementation and enforcement activities.

NICNAS uses Model Work Health and Safety

(WHS) Regulations in reviewing occupational

health and safety assessments and

recommendations in relation to the national

occupational health and safety framework.

This includes hazard classifications and

applying labelling requirements and Safety

Data Sheet (SDS) Codes of Practice to all

industrial chemicals used in workplaces.

Details of other Australian Government

departments involved in chemicals regulation

are presented on the NICNAS website: Chemicals in Australia—who’s who. NICNAS

participates in the Regulators’ Forum with all

Australian Government regulators of chemicals,

and also on its advisory committees.

4 In 2012–13, Department of Sustainability, Environment, Water, Population and Communities (DSEWPaC)5 SCEW, which incorporates the National Environment Protection Council (NEPC), was established by COAG in 2010.

5


The United Nations (UN) Globally

Harmonised System (GHS) of Classification

and Labelling of Chemicals guides NICNAS

in classifying chemicals.

StructureNICNAS is a statutory scheme established

within Health. The Act establishes the Director,

NICNAS as a statutory office holder with

specific functions and powers with direct

responsibilities to the Minister for Health6.

The Secretary, Health makes available the

services of employees of the department to

the Director, for the purposes of assessing

chemicals and assisting in the administration

of the Act. The Secretary, Department of

the Environment (Environment—in 2012–13.

DSEWPaC) also provides staff to the Director

to conduct assessments.

The following figure depicts NICNAS’s

organisational structure for 2012–13.

Details of work performed in each of the six

programs are provided under Core activities.

Principal Scientist

New Chemicals

Principal Scientist

Existing Chemicals

New

Chemicals

Existing

Chemicals

Compliance &

Enforcement

Business

Management &

Communications

DIRECTOR

ReformRegulatory

Strategy

Science Strategy

& International

Figure 01: NICNAS organisational program structure for 2012–13

6 In 2012–13 and previously through the Parliamentary Secretary for Health and Ageing.

6

Governance through community, industry and government advisory groupsThree non-statutory committees provide

strategic development advice to NICNAS:

the Community Engagement Forum (CEF),

the Industry Government Consultative

Committee (IGCC) and the States and

Territories Memorandum of Understanding

(MoU) Group.

The Nanotechnology Advisory Group (NAG)

also provides strategic development advice

and—along with the Cosmetic Advisory

Group and Industry Engagement Group—

supports NICNAS in implementing strategies.

NICNAS also occasionally receives advice

from groups formed for specific projects.

Details of these groups and the subjects of

their meetings are provided at Appendix 07.

Figure 02: NICNAS committee structure during 2012–13

*From 18 September 2013: Assistant Minister For Health

Industry GovernmentConsultative Committee

DIRECTORNICNAS

PARLIAMENTARY SECRETARY

FOR HEALTH & AGING

Community Engagement Form

Cosmetic AdvistoryGroup

NanotechnologyAdvisory Group

(includes strategy development)

States & TerritoriesMOU Group

Industry EngagementGroup

7


OperationsThis chapter outlines NICNAS operations and

outcomes under the Act during 2012–13.

It includes progress in NICNAS’s five priority

projects as detailed in NICNAS’s Business Plan 2012–13 (the business plan). For

business plan targets, see Appendix 08.

Information about our 2012–13 performance

against agreed deliverables and key

performance indicators (KPIs) can also be

found in the Department of Health and Ageing Annual Report 2012–13 under Sub-

program 1.4.3: Industrial Chemicals.

Departmental staff assess chemicals and

carry out related activities for NICNAS.

In 2012–13 this work was performed by staff in

seven programs (see Figure 01, above).

In NICNAS’s chemical assessment programs,

staff employed by DoHA (now Health)

conduct human health (public health and

worker health and safety) assessments while

Environment staff carry out the environmental

components of assessments.

New chemicals assessmentIn 2012–13, NICNAS issued 162 certificates

and 119 permits7. We met approximately

95 per cent of statutory timelines in this

work. Figurative tables providing data about

the types of new chemical notifications we

received are at Appendix 03.

Milestone: In March 2013, NICNAS

completed its 3,000th new chemical

assessment report.

Enhance New Chemicals operations8

With the aim of improving the efficiency

and effectiveness of our new chemicals

notification program, we continued

compiling common inquiries and

categorising decisions in our internal

decision repository. We included several

‘decisions’ and ‘chemical scenarios’ in

the repository and in the log of exposure

scenarios.

We developed generic exposure scenarios

for chemicals used in automotive paints

for after-market applications (including

repackaging and reformulation activities)

and members of our Industry Engagement

Group (IEG) reviewed and supported the

scenarios (which provided options based on

the mode of import of a notified chemical/

polymer). Decisions were prepared in a

question and answer (Q&A) format for

publishing on the NICNAS website.

Implement approach for introducing substitutes for perfluorinated9 chemicals

We implemented a framework for assessing

new perfluorinated chemicals, and

undertook several assessments for new

7 Factors such as type of chemical, amount introduced, proposed use, planned period of use and company’s business needs/commitments determine whether notifiers apply for a permit or certificate.

8 Priority Project 5 in the business plan, Appendix 08.

9 Group of compounds—used to make everyday products resist stains and grease, or as wetting agents—some of which are of concern because they do not break down in the environment and can persist and accumulate to levels that can harm living systems.

8

shorter chain perfluorinated chemicals

(proposed as substitutes for long chain

perfluorinated chemicals that are known

to accumulate in the environment). The

assessments included a hazard assessment

of perfluorohexanoic acid (PFHxA), the

ultimate degradation product of the

proposed shorter chain substitutes.

Use international information effectively

Since the start of the NICNAS/United States

Environmental Protection Agency

(US EPA) bilateral arrangement, notifiers have

provided more than 30 US EPA assessments

with new chemicals notifications. This sharing

has helped NICNAS assessments, resulting in

efficiencies for NICNAS and reduced costs to

industry. Staff have documented the lessons

learned from the agreement.

On 1 July 2012, we introduced new set

fees for modular assessment categories.

They guarantee a cost saving for industry

when US assessments can be made

available to NICNAS.

In the last quarter of 2012, the value of our

agreement was realised with one large and

complex assessment in which access to US

EPA expertise was a major factor in NICNAS

being able to finalise the assessment to its

own—and the notifier’s—satisfaction.

Benefits from the exchange of new

chemicals assessments with the US EPA

encouraged NICNAS to draft and propose

several recommendations for further

developing the arrangements.

Offer industry options to introduce lower-risk new chemicals

In 2008–09 we revised the regulatory

requirement for chemicals being introduced

into Australia, making it easier to introduce

less hazardous chemicals (i.e. chemicals

that present less risk to human health or the

environment) using notification categories

that had been introduced with the Low

Regulatory Concern Chemicals (LRCC)

reforms. The number of safer and less

hazardous new chemicals that we assessed

increased three per cent from 77 per cent in

2011–12 to 80 per cent in 2012–13.

Recommend safe use of industrial chemicals

During the year, we recommended

25 assessed chemicals (both new and

existing) for hazard classification, with

16 being recommended for scheduling in

the SUSMP (Poisons Standard). Using the

IMAP Framework to assess existing chemicals

enabled us to recommend several

amendments to existing regulatory controls

and refer a number of existing chemicals for

assessment under Tier III10 (see below).

Existing chemicals assessmentNICNAS’s procedures for assessing existing

industrial chemicals underwent a major

shift in 2012–13 with the launch of the IMAP

Framework in July 2012. This was a major

outcome of the Existing Chemicals Review

which commenced in 2003—a scorecard

listing the current status of recommendations

from the review is at Appendix 04.

Stage One of the IMAP project—running

over four years— involves evaluating

around 3,000 existing chemicals that

were prioritised for assessment through

stakeholder consultation.

10 In-depth chemical assessment.

9


Milestone: In the first half of the year, we

conducted 129 chemical assessments11

at Tier I12 and eight at Tier II13 for human

health. In the second half of 2012–13 we

conducted even more assessments: 330 (for

human health) and 302 (for environment)

at Tier I, and we carried out a further 215

assessments at Tier II (human health).

Implement IMAP Framework14

At the stakeholder forum15 we held on

19 July 2012, we announced that we were

starting to use the IMAP Framework for

assessing existing chemicals. The forum

increased stakeholder understanding of

IMAP and explored opportunities for greater

national and international collaboration.

We had spent several years carefully preparing

and planning for IMAP, through consultations—

such as those on potential sources of

Australian exposure information to be used in

assessing chemicals listed on the AICS—and

the consultation process continued during

the first year of operation. For example, we

explored ways to identify chemicals (including

polymers) of low concern to human health,

and Australian scientific experts independently

validated this process.

In December 2012 we advertised the

publication of the first tranche of IMAP

assessments through our consultative

committees, the NICNAS website, the

Chemical Gazette and targeted e-mails,

and invited stakeholders to comment on

the reports. We also published the IMAP

Framework, pilot evaluation papers, four

factsheets and answers to frequently asked

questions (FAQs) on our website. These

gave the public and the chemical industry

information about the methodologies we use

for conducting risk assessments.

We continued to implement the framework

and engage with stakeholders, inviting

public comment on three further tranches of

chemical assessments during 2012–13.

Assess Stage One chemicals by effectively applying IMAP Framework

We assessed 24 per cent of all Stage One

chemicals in 2012–13, exceeding our

20 per cent target.

Altogether, we used the IMAP Framework

to complete 984 assessments for a total of

72316 chemicals (261 were assessed for both

human health and environmental impacts).

We demonstrated the effective operation

of the framework when we recommended

additional regulatory controls and/or further

assessments of a significant number of

chemicals to relevant Australian Government

and state and territory agencies.

11 We assessed some chemicals in more than one category.

12 High throughput assessment against criteria, for chemicals not considered to pose unreasonable risk to the health of workers, public health and the environment.

13 Chemical-by-chemical evaluation against criteria.

14 Full details of IMAP are available under ‘Chemical information’ on the NICNAS website at: www.nicnas.gov.au/chemical-information/imap-assessments.

15 Some details of the forum program are at Appendix 09.

16 This includes 20 chemicals that were not included in the initial IMAP Stage One list of 3,000 chemicals. They are members of groups of chemicals already being assessed in Stage One and have been added to gain further efficiencies in the implementation of the IMAP Framework.

http://www.nicnas.gov.au/chemical-information/imap-assessments

10

From July to December 2012, we:

• published assessments of 137

chemicals, for public comment

(including eight Tier II assessments

and six assessments recommending

amendments to existing regulatory

controls/further assessment);

• progressed Tier I assessments—

completing all human health hazard

classification information for the first

tranche of human health assessments;

• used the (finalised) electronic

information management system (EIMS)

to continue Tier I and Tier II assessments

in preparation for publishing further

tranches of assessments for public

comment; and

• completed a guidance manual and

EIMS user manual for IMAP assessors.

From January to June 2013, we published

three further tranches of IMAP assessments for

public comment—including: 330 Tier I (human

health) and 302 (environment) assessments—

and 215 Tier II human health assessments.

During the year we recommended 201

chemicals for referral:

• 188 to the Hazardous Substance

Information System (HSIS)

• 56 to the SUSMP

• 11 to the ACCC, and

• 13 for further Tier III assessment by

NICNAS.

Note: some chemicals had more than one

recommendation for risk management.

In addition, the Tier II assessments

contained information on the GHS17

classifications for the 223 chemicals.

Address specific health and environmental concerns when assessing chemicals of concern

During the year we progressed our

assessments of chemicals in the PEC and

Secondary Notification categories. A list of

all PEC assessments (past and current) is

available at Appendix 04.

We published final reports for diisononyl

phthalate (DINP—PEC) and polymer in

Millifluid® (Secondary Notification). We

also finalised the draft PEC report for

dibutyl phthalate (DBP) for release to

applicants and made significant progress

drafting the dimethyl phthalate (DMP) and

dimethoxyethyl phthalate (DMEP) reports for

peer review.

We also considered several inquiries related to

potential secondary notification assessments.

Use international information effectively

During the year we developed guidance

material and training activities for staff

undertaking IMAP assessments using

information/knowledge sourced overseas.

For example, we made extensive use

of international information in completing

the first tranche of IMAP assessments.

We kept international regulatory agencies

fully informed about the assessments

and the timing for their release—and

IMAP assessment reports indicate the use of

17 United Nations Globally Harmonised System of Classification and Labelling of Chemicals.

11


chemical information from international

organisations.

Sharing information with these organisations

also contributed to validating assessment

outcomes during the IMAP public

comment phase.

We engaged several international experts—

including a Bulgarian specialist—who

provided advanced training in assessment

methodologies including Quantitative

Structure Activity Relationship (QSAR)

modeling software to staff. Such expertise

made a significant contribution to the

successful implementation of IMAP in its first

year. A list of other international visitors who

provided training is at Appendix 09.

Other assessment-related activitiesNICNAS engages in many activities which

complement and support chemical

assessment work. In 2012–13 these were the

responsibility of the Science Strategy and

International (SS&I) and Reform programs.

Maintain chemical substances inventory

The Australian Inventory of Chemical

Substances (AICS) was managed under

the Reform program up to and including

2012–13. Each year it requires ongoing work

to ensure its effectiveness and that users

can access any information from it that they

require.

In response to concerns and suggestions,

we improved a number of the processes

and procedures around the maintenance

of the AICS—including those concerning

confidential listings—during the year.

Three major needs were dealt with:

1. to reduce unnecessary telephone

inquiries and improve the public’s ‘AICS

search’ experience, by ensuring that the

AICS reflects accurate information;

2. to address concerns about confidential

listing arrangements; and

3. to address concerns that the AICS

contained substances not eligible for

listing.

These concerns were addressed

(respectively) by:

1. updating CAS numbers (from a CAS

audit of the public AICS) incorporated

into the AICS, and a more informative

search interface set-up;

2. replacing the NICNAS Technical

Advisory Group (TAG)—which previously

formulated recommendations to

the Director on confidential listing

applications—with an internal process;

and

3. removing certain mixtures that do not

need to be listed on the AICS.

Assess chemicals used in hydraulic fracturing

NICNAS is leading a national assessment—

with the Commonwealth Scientific and

Industrial Research Organisation (CSIRO),

Environment and Geoscience Australia—

to examine human health and

environmental risks from chemicals used

in drilling and hydraulic fracturing for coal

seam gas (CSG)18 extraction in Australia.

18 Also known as: ‘natural gas from coal seams’.

12

The assessment focuses on risks arising from

surface handling of hydraulic fracturing and

drilling chemicals at the well site, and surface

handling of flow-back and produced waters

that flow up well bores.

We identified chemicals associated with

hydraulic fracturing in Australia through a

voluntary industry survey (with input from

government agencies, CSG companies and

the industry association). It consisted of three

separate surveys: for CSG companies, site

operators and service providers. Based on

survey responses, we drafted a report for the

Office of Water Science.

We applied IMAP-developed criteria to

determine which of the chemicals identified

in the survey were of low concern for human

health—in order to focus on those that

needed further assessment. We conducted

chemical-specific literature searches to

assess the toxicity of the chemicals and

used the resulting data to help establish

the profiles we needed to comprehensively

assess the hazards of the chemicals.

This enabled us to start drafting hazard

assessments of 12 CSG chemicals.

A paper we prepared on the methodology

for occupational and public exposure

estimation is to be further discussed at an

exposure workshop later in 2013. We have

also modified NICNAS’s internal database

of information on existing chemicals for

functionalities specific to CSG chemicals

assessment. We also participated in the

NSW Government regulatory roundtable on

unconventional gas, and provided input

into the National Harmonised Regulatory

Framework for CSG.

Report on chemicals of security concern

The public report on the NICNAS Voluntary

Call for Information on the Attorney-General’s

Department (AGD) Chemicals of Security

Concern project was published on the

NICNAS website.

Improve scientific capabilities, enhance access to expertise

The SS&I program conducted a number

of other activities which supported our

commitment to ‘continuous improvement’

during the year. These included:

• Developing internal guidance papers

on specific scientific assessment matters

such as:

› applying a ‘weight of evidence’

approach in risk assessments, helping

assessors to approach assessments

consistently

› evaluating the information from non-

testing (in silico) methods to assess

human health hazards—specifically

for mutation effects, and

› evaluating data about gene and

protein activity in the assessment of

human health hazards.

• Reviewing literature about alternatives

to animal testing methods to identify

new information, as well as updating

the internal database to allow assessors

to easily access the latest information

(about such matters as eye irritation

and corrosion, skin irritation and/or

endocrine disruption).

• Coordinating developer-conducted

training of NICNAS assessors about

using the updated OASIS Times QSAR

13


tool and the Organisation for Economic

Co-operation and Development (OECD)

Toolbox.

• Updating NICNAS’s international strategy

and drafting NICNAS’s 2013–14 strategy

for nanomaterials, including a review of

the definitions of nanomaterials used

internationally and comparing them

with NICNAS’s working definition.

Collect statistics on chemicals new to Australia

Chemical introducers are required to

lodge annual reports under section 21AA

(exemptions) and section 40N (permits/

certificates) of the Act. Our Compliance and

Enforcement program staff undertake this

work. See Table 08 at Appendix 03 for details

of annual reporting.

Regulatory strategy, scientific and reform activities

Finalise cost recovery impact statement19

Both houses of Parliament passed the

Industrial Chemicals (Notification and

Assessment) Amendment Bill to implement

the outcomes from the NICNAS Cost

Recovery Impact Statement (CRIS) for

2013–14, and it received Royal Assent. The

amendments introduced through this bill

were to:

• deliver a more equitable charging

arrangement for business, by changing

the number of tiers in the registration

structure from three tiers to four levels;

• introduce a new application fee and

remove obsolete fees; and

• make minor consequential technical

amendments.

We completed stakeholder education on

the revised fee structure, amended NICNAS’s

notification forms and the Handbook for Notifiers in time for the revised arrangements

to start on 1 July 2013.

Continue review of NICNAS

A review of NICNAS continued during

2012–13, investigating how the regulatory

settings could be improved to enhance

both the competitiveness of Australia’s

chemical industry and public health and

environmental outcomes.

NICNAS gave technical input to the

concepts and draft framework for assessing

new and existing industrial chemicals—

including cosmetics and polymers—and

into the draft regulatory impact statement

prepared for stakeholder consultation.

Strengthen science strategy

Two Principal Scientists were part of

NICNAS’s executive team in 2012–13, for

New Chemicals and Existing Chemicals.

The scientists manage NICNAS’s science

strategy for all assessment and assessment-

related work.

We managed activities under our science

strategy to enhance staff access to

expertise and contribute to advances in

methodologies for chemical risk assessment,

nationally and internationally.


14

The strategy encourages training by

international scientific speakers to be made

available for staff. Some of these sessions are

listed at Appendix 09.

We finalised the NICNAS Science Strategy 2012–14, which outlines the approaches for

enhancing staff skills and expertise.

Introduce revised sunscreen standard

We consulted on the proposed adoption

by the Cosmetics Standard 2007 of the

revised Australian/New Zealand Sunscreen

Standard20 (the 2012 Sunscreen Standard)

and published a regulatory impact

statement about it.

The (then) Parliamentary Secretary for Health

and Ageing approved this change, with

adoption to commence in August 2013 with

a five-year transition period during which

businesses will be able to produce cosmetic

sunscreen products complying with either

the 1998 or the 2012 Sunscreen Standard.

Review annotation of lead in surface coatings and inks

We reviewed the effectiveness of AICS

annotations for certain lead compounds in

industrial coatings and inks, and published

a report of the review. Noting that industry

was voluntarily phasing out the use of these

chemicals at the time, it found that the

annotations were effective in protecting

public health. The Director decided to

continue the annotations.

Strengthen national and international links

NICNAS provided technical advice to

national agencies (including Safe Work

Australia and SCOC) for managing risks

from industrial chemicals and determining

Australia’s position at international

conventions and meetings such as those of

the Stockholm and Rotterdam conventions.

Department of the Environment: NICNAS

discussed issues of mutual interest with the

(then) DSEWPaC, including the review of

NICNAS; legislative changes to the Act; the

assessment of persistent, bio-accumulative

and toxic (PBT) and persistent organic

pollutant (POP) chemicals; regulating

chemicals in the Stockholm Convention;

IMAP and the notification of CSG chemicals.

Safe Work Australia: NICNAS exchanged

information with Safe Work Australia on

activities relating to chemicals and the

workplace.

Safe Work Australia provided updates on the

model Work Health and Safety (WHS) Act and

lowering the exposure standards for lead.

Standing Committee on Chemicals (SCOC):

NICNAS participated in meetings of the

Chemicals Working Group (that supports

SCOC activities), attended SCOC meetings

as an observer and provided input into

the secretariat’s business checklist and the

review of SCOC.

Other national agencies: Assessment

reports from IMAP tranches— where

appropriate—referred to relevant national

agencies including Safe Work Australia and

the Scheduling Delegate for the Poisons

Standard (SUSMP).

20AS/NZS 2604:2012 Sunscreen products—Evaluation and classification.

15


Stockholm Convention21 We provided

technical advice on industrial chemicals

listed for discussion at the eighth

review committee: draft risk profiles

of hexachlorobutadiene (HCBD),

polychlorinated naphthalenes (PCN) and

short chain chlorinated paraffins. After review,

both HCBD and PCN were determined to

meet the review committee’s criteria.

For the ninth review committee, NICNAS

provided Australian use and volume

information on pentachlorophenol

and technical input into briefs on

hexabromocyclododecane (HBCD) for

discussion at the sixth meeting of the

Conference of Parties (COP-6) and provided

input into a Japanese government survey of

the regulation, use, manufacture and export

volumes of HBCD (and associated products)

forwarded by the (then) DSEWPaC.

Rotterdam Convention22 We provided

technical advice on commercial pentaBDE,

commercial octaBDE and PFOS to the (then)

DSEWPaC. These chemicals were listed for

discussion at COP-6.

Contribute to international harmonisation23

NICNAS participates in chemical safety

initiatives sponsored by the World Health

Organization (WHO) and represents Australia

on key chemical sub-committees of the

OECD Chemicals Committee, which reviews

international regulatory approaches.

This international engagement ensures that

NICNAS assessments are scientifically robust

and international experience is applied to

improve our regulatory systems.

In 2012–13, NICNAS participated in:

OECD Clearing House on New Chemicals:

We reviewed the list of low concern

polyesters.

World Health Organization (WHO): We

helped establish an international network

of risk assessors, under the International

Programme on Chemical Safety.

OECD Task Force on Hazard Assessment

(TFHA): We provided input into the revised

guidance on forming chemical categories to

increase the efficiency of assessments—

it assists in selecting appropriate analogue

chemicals, which can provide useful

information for assessing likely hazards

of industrial chemicals. NICNAS also

contributed to the ‘avoiding duplication’

project by sharing its current schedules

for existing chemical assessments (PEC

and IMAP) with other regulators. NICNAS

contributed to the Cooperative Chemical

Assessment Program by reviewing the

dimethyl anilines24, a six-chemical category

of interest to NICNAS.

OECD Working Party on Manufactured

Nanomaterials (WPMN): Our WPMN

participation ensured that Australian

regulatory agencies’ views were reflected in

21 Stockholm Convention on Persistent Organic Pollutants (POP).

22 Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.

23 Harmonisation of international chemical assessments, regulatory approaches and methodologies with Australian industrial chemicals assessment and management systems.

24 A chemical group used in manufacturing dyes, pigments and photographic chemicals that are of concern for human health. Selected for review because six of the chemicals are on the IMAP Stage One chemicals list. The category approach is a major and critical aspect of IMAP.

16

the draft OECD Council recommendation

(2013) that “approaches for the testing

and assessment of traditional chemicals

are in general appropriate for assessing

the safety of nanomaterials, but may

have to be adapted to the specificities of

nanomaterials”. WPMN participation also

ensures that NICNAS’s approach to hazard

and risk assessment—and regulation of

industrial nanomaterials—is science-based

and internationally harmonised.

Asia-Pacific Economic Co-operation (APEC)

Regulators Forum under the Chemical

Dialogue: The chemical dialogue agreed

to an Australian industry proposal to

examine the need for training regulators

in the risk assessment of metals and metal

compounds. As a result we are facilitating

industry to survey APEC economics during

2013–14 on the need for such training, with

the intention to run a training workshop in

2014–15, if appropriate.

Continue bilateral activities

Canada cooperative arrangement:

We continued liaising with Environment

Canada about a confidentiality agreement

(now submitted for signature) and reached

agreement with both Health Canada and

Environment Canada about the value of

a multi-partite confidentiality agreement

(that includes Health Canada and the then

DSEWPaC) to be drawn up in 2013–14.

European Chemicals Agency (ECHA) MoU:

We discussed efficient handling of inquiries

and Helpdesk arrangements with ECHA, as

well as potential copyright issues arising from

the use of data from the ECHA website and

progress with IMAP assessments.

New Zealand EPA MoU: We met with

NZ EPA so both parties could receive updates

on activities of mutual interest—specifically

existing substances, hazardous substances

and reform.

US EPA cooperative arrangement: We exchanged information on inventories,

existing chemicals and nanomaterials

activities in each country—and discussed

future information exchange. We also

discussed the need to identify overlaps and

raise awareness of assessment outcomes of

common chemicals during the draft stage.

Manage strategy for industrial nanomaterials25

In 2012–13, we continued to regulate

industrial nanomaterials. Our approach

focused on:

• educating stakeholders and monitoring

compliance with administrative

arrangements for nano-forms of new

chemicals;

• exploring options for regulating nano-

forms of existing chemicals within the

current legislative framework;

• benchmarking our regulatory

and assessment approaches with

comparable national and international

regulatory authorities, through strategic

multilateral and bilateral engagement;


17


• enhancing NICNAS’s technical

capability in assessing nanomaterials;

and

• publishing documents on the human

health hazards of nanosilver and nano

titanium dioxide.

Participate in NETS

We secured funding for the year from the

National Enabling Technologies Strategy

(NETS), administered by the (then)

Australian Government Department of

Industry, Innovation, Climate Change,

Science, Research and Technical Education

(previously DIISRTE)26 to support our technical,

international and compliance work on

industrial nanomaterials.

These funds supported NICNAS’s

participation and engagement with

the OECD WPMN, outreach activities

with universities and other research and

development facilities and developing

potential exposure scenarios for certain

industrial nanomaterials.

Compliance and enforcement activitiesMilestone: At the end of 2012–13, 5,290

businesses were registered as industrial

chemical introducers at NICNAS. Details of

the numbers of compliant introducers, and

other details are provided at Appendix 05.

Ensure introducers are compliant

Our compliance and enforcement program

continued to focus on ensuring maximum

compliance with the registration obligations

of the Act, and achieved a level of

99.7 per cent compliance among known

industrial chemical introducers. Registration

numbers exceeded those of 2011–12 by

almost 300, with around 700 introducers

registering with NICNAS for the first time.

Auditing of new chemicals obligations led

to the notification of four new industrial

chemicals with a further 35 being advised

or reported to the Director as meeting the

criteria for introduction without notification.

We continued to focus on education and

awareness raising activities with 11 training

sessions being delivered to 380 participants

(including customs brokers) in Adelaide,

Ballarat, Brisbane, Melbourne, Newcastle

and Sydney.

We monitored the introduction of new

chemicals without notification to NICNAS

and this led to us identifying three new

chemicals which were found to be

unsuitable for introduction under the

exemption provisions of the Act.

The team achieved 100 per cent compliance

by new chemical introducers with annual

reporting obligations under section 21 AA

of the Act, with 6,260 new chemicals being

reported by 170 introducers.

In accordance with the administrative

requirements of the Rotterdam Convention,

we granted 15 annual export authorisations

to companies exporting aviation gasoline—

but processed no export notifications during

the year. However we processed 67 in-bound

export notifications (concerning export from

26 Now Department of Industry.

18

elsewhere to Australia) during the year,

and subsequently advised the Australian

designated national authority (then

DSWEPaC) about the import of Rotterdam

Convention Annex III listed chemicals into

Australia.

Ensure introducers of industrial chemicals are aware of their registration obligations

To get 99.7 per cent of all identified

introducers registered, we initiated several

activities. These included:

• conducting 27 site visits to ensure

introducers were complying with their

obligations;

• undertaking more than 1,200 desktop

audits to identify unregistered

introducers—this contributed to around

700 chemical introducers registering

with NICNAS for the first time; and

• auditing 45 organisations previously

registered with NICNAS, regarding their

on-going imports.

Communication materials including

Chemical Gazette notices, fact sheets, and

materials for the website were prepared. As

NICNAS is rolling out changes to registration

levels (fees and charges) and other

elements of the program in 2013–14, details

of these were communicated towards the

end of the year.

Table 01: Auditing of high level introducers against new chemicals obligations

Activity2012–13

(total audits)

Desktop audits to identify high risk introducers for the purpose of the

audit374

On-site audits to determine compliance with new chemicals

obligations16

Closed audits where the company was able to demonstrate

compliance with obligations17

Continuing audits where the company agreed to provide evidence

of compliance within agreed timeframe5

19


Improve Tier 2 and Tier 3 introducers’ compliance with new chemicals obligations

NICNAS aimed to conduct audits of

30 per cent of Tier 2 and 3 introducers during

the year, for their compliance with new

chemicals obligations. We exceeded that

target (30.3 per cent).

Business management, communications and corporate activitiesMilestone: The new version of the NICNAS

website was launched on 27 June 2013. It

contained updated versions of most NICNAS

materials including 50 revised chemical

factsheets and the updated Handbook for Notifiers.

Manage financial performance

Compared with last year, both NICNAS’s

revenue and expenses increased. Revenue

increased by 41 per cent ($4.058m)

and expenses increased by 31 per cent

($3.070m), primarily due to new project

activities including the accelerated

assessment of existing chemicals under

the IMAP Framework (IMAP assessments)

and the national assessment of chemicals

associated with CSG extraction in Australia

(CSG assessment).

The total revenue cost-recovered from the

regulated industry was $11.089m, which is

23 per cent higher than the previous year

as a result of changes to registration levies

(informed by the NICNAS cost recovery

impact statement) to fund IMAP assessments,

and as a result of changes to fees and

charges for other activities.

Table 02: Four-year comparison of NICNAS revenue and expenses

2009–10 $’000

2010–11$’000

2011–12$’000

2012–13$’000

Industry cost recovered revenue 7,956 8,586 9,014 11,089

Other revenue 787 809 836 2,809

Total revenue 8,743 9,395 9,850 13,898

Expenses 8,748 9,259 10,004 13,074

Operating surplus/(deficit) (5) 136 (154) (824)

20

The total revenue from sources other than

the recovery of costs from industry was

$2.089m, which is 236 per cent higher than

the previous year due to the receipt of funds

to conduct the CSG assessment.

Total expenses were $13.074m, which is

31 per cent higher than the previous year in

line with the increase in activities.

The NICNAS final net result for 2012–13 was

a surplus of $0.824m, which is primarily

attributable to deferral of some assessment

activities in the IMAP project, a decrease in

the bond rate and subsequent reduction to

total long service leave provisions, and delays

in IT projects outside NICNAS’s direct control.

Detailed abstracts of NICNAS’s financial

statements are provided at Appendix 01,

and information about actual expenditure

on contracts for consultancies is available at

Appendix 02.

Manage governance

Meetings of NICNAS’s two advisory

committees and the States and Territories

MoU Group were conducted in 2012–13 (see

details at Appendix 07).

Manage communication and media relations

Providing information on the human health

and environmental impacts of industrial

chemicals is a crucial activity. A table

providing details of all communications in

2012–13 is provided at Appendix 06. Media

inquiries covered a range of topics and

these are also detailed at Appendix 06.

Survey stakeholders

The next stakeholder survey will be

conducted in the second quarter of 2013–14.

A report on progress in matters raised in the

last survey is provided at Appendix 11.

Provide advice and raise awareness

The majority of inquiries received were

handled within agreed timelines.

NICNAS staff provided education and

training to registrants and potential

registrants—see: Compliance and enforcement activities. The half-day sessions

raised awareness of requirements for

all NICNAS notification, with updates on

such topics as AICS searching, cosmetics,

nanomaterials and IMAP.

NICNAS staff also represented the scheme at

conferences and other events. A number of

these are listed at Appendix 09.

Provide staff and maintain their expertise and health

NICNAS staff members administer the Act,

meet accountability obligations and are

encouraged to take a reasonable level

of risk.

NICNAS conducted a number of activities

in 2012–13 to maintain a sustainable and

skilled workforce and integrate challenges

from Health’s People Strategy 2010–15.

These included challenges presented as

staff attempt to balance the demands of

their work and private lives, and to build/

maintain resilience and improve their health

and wellbeing.

21


NICNAS paid performance bonuses of

$46,037 during 2012–13. This total was paid to

seven staff.

Following recruitment to fill a number of

vacancies, a NICNAS orientation program

was formalised for all new staff.

For scientific staff, training in QSAR models

by an international expert was offered, as

well as in-house training on evaluation of

repeated dose toxicology studies (attended

by 15 assessment staff in November 2012)

and regular Tuesday Tune-up sessions

where issues of interest to both scientific

and all other staff are discussed. A listing of

presentations by overseas visitors is provided

at Appendix 09.

NICNAS’s staff performance is reviewed

twice each year under the Personal

Development Strategy.

Following the release of results of the (then)

DoHA 2013 Staff Survey, key actions from it

were incorporated into the NICNAS Business Plan 2013–14.

Workstation assessments were undertaken

and all updates completed, as necessary, by

the end of 2012–13.

Manage complaints, FOI requests and other matters

NICNAS published a revised version of the

NICNAS Service Charter27, which outlines

our agreed customer service commitments,

delivery and expectations.

In each of the second, third and fourth

quarters of 2012, NICNAS received one

Freedom of Information (FOI) request which

was later withdrawn. The requests related to

different matters. There were no active FOI

requests at the end of the year.

NICNAS’s information publication scheme

and FOI disclosure log are located on the

NICNAS website28.

After it received a formal complaint

(relating to the NICNAS Cost Recovery

Review 2012-16) the Commonwealth

Ombudsman reviewed the complaint and

concluded that no further investigation was

warranted. An additional complaint made by

an unregistered introducer was finalised by

providing formal advice to the complainant

of their obligations under the Act.

Details of compliance with Commonwealth

fraud control guidelines are available in the

DoHA Annual Report 2012–13.

Conduct IT strategic program, focusing on an integrated system29

Business systems were improved with the

launch (at the end of 2012–13) of the new

NICNAS website and ongoing work on the

IMAP database and its integration.

27 Available on the NICNAS website.

28 See: www.nicnas.gov.au/about-nicnas/information-publication-scheme.


http://www.nicnas.gov.au/chemical-information/imap-assessments

22

Figure 03: NICNAS website progress by quarter in 2012–13

Quarter Focus / developments

1 Redevelopment of NICNAS website

2 Presentations to CEF and IGCC November meetings on progress to date;

website build almost completed pending content migration

3 Ongoing work on IMAP database; content migration of new website

progressed with user acceptance testing (UAT)

4 Website build and content migration continues, and website goes live on

27 June 2013

The aim of each project in Figure 03 was to improve the efficiency and effectiveness of

NICNAS’s business systems. This is available on the NICNAS website.

23


AppendicesPage Appendix

24 01. Abstracts from NICNAS financial statements

28 02. Consultancies

29 03. New Chemicals assessment program

30 04. Existing Chemicals program

34 05. Compliance program

36 06. Communications and media

38 07. Advisory groups: community, industry, government

41 08. Performance: government expectations

43 09. Links: national and international

45 10. Staff profile, training, development

47 11. Update: stakeholder survey

48 12. Ecologically sustainable development

49 13. Compliance with mandatory reporting requirements

52 Glossary, acronyms and abbreviations

58 Index

24

Appendix 01—Abstracts from NICNAS financial statementsNICNAS’s 2012–13 financial statements were audited by the Australian National Audit Office as part of its audit of the

consolidated financial statements of the Department of Health and Ageing. Presented below are NICNAS’S income

statement, balance sheet, cash flow statement and statement of changes in equity which have been extracted from the

Department’s audited consolidated statements

Table 03: Statement30 of comprehensive income for the period ended 30 June 2013

2013 2012$’000 $’000

EXPENSES

Employee benefits 7,386 6,608

Supplier 5,328 3,134

Depreciation and amortisation 207 181

Write down and impairment of assets 153 81

Other expenses - -

Total expenses 13,074 10,004

LESS:

OWN-SOURCE INCOME:

Own-Source revenue

Sale of goods and rendering of services 13,518 9,423

Total own-source revenue 13,518 9,423

Gains

Sales of assets - -

Other gains - -

Total gains - -

Total own-source income 13,518 9,423

Net cost of services (444) 581

Revenue from Government 380 427

Surplus/(deficit) attributable to the Australia Government 824 (154)

OTHER COMPREHENSIVE INCOME

Items not subject to subsequent reclassification to profit or loss

Changes in asset revaluation surplus - 89

Total other comprehensive income - 89

Total comprehensive surplus/(loss) attributable to the

Australian Government824 (65)

30 Statements should be read in conjunction with accompanying notes. However no notes accompany the four tables

published in this appendix.

25


Table 04: Balance sheet as at 30 June 2013

2012–13 2011–12$’000 $’000

ASSETSFinancial assets

Cash and cash equivalents 336 333

Trade and other receivables 10,015 11,053

Other financial assets - -

Total financial assets 10,351 11,386

Non-financial assets

Land and buildings 1,364 1,524

Property, plant and equipment 89 97

Intangibles 237 124

Inventories - -

Other non-financial assets 40 28

Total non-financial assets 1,730 1,773

Total assets 12,081 13,159

LIABILITIES

Payables

Supplier payables (1,323) (1,728)

Other payables (4,129) (5,825)

Total payables (5,452) (7,553)

Provisions

Employee provisions (1,991) (1,792)

Other provisions (130) (130)

Total provisions (2,121) (1,922)

Total liabilities (7,573) (9,475)

Net assets 4,508 3,684

EQUITY

Contributed equity - -

Reserves 169 169

Accumulated deficit 4,339 3,515

Total entity interest 4,508 3,684

Total equity 4,508 3,684

26

2012–13 2011–12$’000 $’000

OPERATING ACTIVITIESCash received

Goods and services 17,590 8,299

Net GST received 189 783

Appropriations 8,676 1,632

Other - -

Total cash received 26,455 10,714

Cash used

Employees (7,136) (6,305)

Suppliers (7,665) (2,926)

Net GST paid - -31

Cash to the official Public Account (11,500) (1,205)

Other - -

Total cash used (26,301) (10,436)

Net cash from operating activities 154 278

INVESTING ACTIVITIES

Cash received

Proceeds from sales of property, plant and equipment - -

Total cash received - -

Cash used

Purchase of property, equipment and intangibles (151) (224)

Total cash used (151) (224)

Net cash used by investing activities (151) (224)

FINANCING ACTIVITIES

Cash received

Appropriations—Equity injection - -

Appropriations—Department capital budget - -

Total cash received - -

Cash used

Other - -

Total cash used - -

Net cash received from financing activities - -

Net increase/(decrease) in cash held 3 54

Cash and cash equivalents at the beginning of reporting period 333 279

Cash and cash equivalents at the end of reporting period 336 333

Table 05: Cash flow statement for the period ended 30 June 2013

31 For consolidated statements, GST was grossed up in supplier payments in 2011–12.

27


Table 06: Statement of changes in equity for the period ended 30 June 2013

Retained earnings

Asset revaluation

surplus

Contributed equity/capital Total Equity

2013 2012 2013 2012 2013 2012 2013 2012

$’000 $’000 $’000 $’000 $’000 $’000 $’000 $’000

Opening balance

Balance carried forward from previous period

3,515 3,669 169 80 - - 3,684 3,749

Adjusted openingbalance 3,515 3,669 169 80 - - 3,684 3,749

Comprehensive income

Other comprehensive income

- - - 89 - - - 89

Surplus/deficit for the period 824 (154) - - - - 824 (154)

Total comprehensiveincome

824 (154) - 89 - - 824 (65)

Contributions by owners

Return of capital:

Reduction in equity appropriation32 - - - - - - - -

Departmental capital budget - - - - - - - -

Sub-total transactions with owners

- - - - - - - -

Closing balance as at 30 June 4,339 3,515 169 169 - - 4,508 3,684

Closing balance attributable to the Australian Government

4,339 3,515 169 169 - - 4,508 3,684

32 Return of prior year appropriation relating to Appropriation Bill (No 2) 2010–11.

28

Appendix 02—ConsultanciesTable 07: New and active consultancies 1 July 2012 to 30 June 2013

Category No. of reports of new chemicals

Date

Procurement method

Value (to nearest dollar)

Start End Contract Goods receipted 2012–13

Matthew Pegg Consulting Pty Ltd

Provide advice and assistance in relation to legislative changes

14 Aug 2012

30 Jun 2013

Open/panel $4,900 $2,80033

UXC Consulting Pty Ltd

IT strategy consultant to provide a review and analysis of the existing NICNAS IT Plan 2012–14

23 Jul 2012

30 Jun 2013

Open/panel $31,581 $31,581

Tetra Tech Australia

Provide services relating to data collection and exposure modelling on nanoforms of certain chemicals, Stage 1

09 Feb 2012

31 Dec 2012

Open/ panel $40,093 $40,092

Tetra Tech Australia

Provide services relating to data collection and exposure modelling on nanoforms of certain chemicals, Stage 2

16 Nov 2012

30 Jun 2013

Open/panel $19,761 nil34

Note: Information on the value of contracts and consultancies is available on the AusTender website: www.tenders.gov.au

33 NICNAS accrued $19,761 at the end of the financial year for work performed but not yet invoiced.

34 Contract now closed—no further expenses.

http://www.tenders.gov.au

29


Appendix 03—New Chemicals assessment program Data provided in this appendix relate to new chemicals certificates and permits issued. In previous years, comparable

tables provided details of new chemicals certificates and permits applied for.

Figure 04: Number of new chemicals certificates issued by category

No certificates were issued in the SANHP (Self-Assessment for Non-Hazardous Polymer notification) or SANHC (Self-Assessment for Non-Hazardous Chemical notification) categories in 2013-13.

Figure 05: Number of new chemicals permits issued by category

No permits were issued in the EOP (Export Only Permit)or CUPR (Controlled Use Permit Renewal)categories in 2012-13.

Figure 06: Industry sectors for chemicals notified under the assessment certificate category35

35 The total of assessment certificates by use category does not include extension certificates and some chemicals are assessed for use in more than one category.

CERTIFICATES ISSUED

PLC (Polymer of Low Concern)

LTD (Limited)

STD (Standard)

SAPLC (Self-Assessment for Polymer of Low Concern Noti�cation)

EXT (Extension of Assessment Certi�cate)

SN (Secondary Noti�cation)

PERMITSISSUED

EIP (Early Introduction Permit)

LVC (Low Volume Chemical)

LVCR (Low Volume Chemical Permit Renewal)

CEC (Commerical Evaluation Chemical)

CECR (Commerical Evaluation Chemical Renewal)

CUP (Controlled Use Permit)

EOPR (Export Only Permit Renewal)

Surface coatings

Printing industry

Cosmetics/Personal

Fuel and oil

Plastics

Mining and metal extraction

Other

Engineering

Domestic Cleaning

Packaging, paper and pulp

Refrigeration

Textile processing

30

Table 08: New chemical reports in 2012-13 under sections 21AA and 40N

Each report can comprise numerous chemicals.

Category No. of reports of new chemicals for each category

<1 per cent cosmetic exemption 52

<100 kg cosmetic exemption 89

<100 kg non cosmetic exemption 79

<100 kg R&D exemption 25

Permits 278

Table 09: New chemicals exempt from notification in 2012–13, by quarter36

Quarter 1 Quarter 2 Quarter 3 Quarter 4 Total

Cosmetic chemicals 50 69 11 46 176

Non-cosmetic chemicals 12 31 14 21 78

Total 62 100 25 67 254

Appendix 04—Existing Chemicals programUnder sections 54(1) and 54(2) of the Act, the Director of NICNAS is required to maintain a list of priority existing chemicals

(PECs) and a list of chemicals that have been PECs, and under section 54(3). These lists are to be published once a year.

The following tables detail the nature of the assessment (full or preliminary). Assessments are conducted to determine the

potential risks to the public, worker health and environment associated with all uses of the chemical in Australia, unless

indicated otherwise. Assessments maybe conducted for several chemicals as a group, and these are indicated by the title

of the assessment.

More information on current PECs is available from the NICNAS website.

Table 11 indicates the publication date of the assessment reports for which the declaration of the PEC was revoked. All

published PEC reports are available from NICNAS. Electronic copies are available from the NICNAS website.

36 Exemption advice forms for cosmetic and non-cosmetic chemicals being introduced under the exemption provisions of subsection 21(4) of the legislation were acknowledged by NICNAS during 2012–13.

31


Table 10: Current Priority Existing Chemicals

Chemical CAS number Status Declaration date

Full risk assessments

Bis(2-methoxyethyl) phthalate37 (DMEP) 117-82-8 Commenced March 2006

Butylbenzyl phthalate37 (BBP) 85-68-7 Commenced March 2006

Dibutyl phthalate37 (DBP) 84-74-2 Public comment March 2006

Diisodecyl phthalate37 (DIDP) 26761-40-0, 68515-49-1 Not commenced March 2006

Dimethyl phthalate37 (DMP) 131-11-3 Commenced March 2006

Di-n-octyl phthalate37 (DnOP) 117-84-0 Not commenced March 2006

Decabromodiphenyl ether 1163-19-5 Commenced June 2005

Pentabromodiphenyl ether 32534-81-9 Commenced January 2006

Tetrabromobisphenol A 79-94-7 Commenced June 2005

Table 11: Chemicals that have been Priority Existing Chemicals

Chemical CAS number Status Publication date

Full risk assessments

1,4-dioxane 123-91-1 Completed June 1998

2-butoxyethanol in cleaning products 111-76-2 Completed October 1996

Acrylamide 79-06-1 Completed May 2002

Alkyl phosphate anti-valve seat recession additive Exempt Completed July 2003

Ammonium, potassium and sodium persulfate in hairdressing38

7727-54-0; 7727-21-1; 7775-27-1 Completed June 2001

Benzene 71-43-2 Completed September 2001

Chrysotile (asbestos) 12001-29-5 Completed February 1999

Decabromobiphenyl39 13654-09-6 Completed November 2005

Diethyl phthalate37 (DEP) 84-66-2 Completed November 2011

Diethylhexyl phthalate37 (DEHP) 117-81-7 Completed July 2010

Diisononyl phthalate37 (DINP) 28553-12-0, 68515-48-0 Completed September 2012

Formaldehyde 50-00-0 Completed November 2006

Glutaraldehyde 111-30-8 Completed July 1994

37 Assessment restricted to public health risk from use in cosmetics, children’s toys and childcare articles38 Group assessments. Refer to PEC Report for CAS numbers.39 No applications were received for assessment, and therefore, the chemical was removed from the AICS.

32

2,2-dichloro-1,1,1-trifluoroethane (HCFC-123) 306-83-2 Completed March 1996

Hexabromocyclododecane (HBCD) 25637-99-4; 3194-55-6 Completed June 2012

Lead compounds used in industrial surface coatings and inks40 Various38 Completed September 2007

Limonene40 5989-27-5; 5989-54- 8; 138-86-3 Completed May 2002

Methylcyclopentadienyl manganese tricarbonyl (MMT) 12108-13-3 Completed June 2003

N-vinyl-2-pyrrolidone (NVP) 88-12-0 Completed February 2000

Octabromodiphenyl ether39 32536-52-0 Completed February 2007

Octabromobiphenyl39 27858-07-7 Completed November 2005

ortho-dichlorobenzene 95-50-1 Completed February 2001

para-dichlorobenzene 106-46-7 Completed December 2000

Savinase – Proteolytic enzymes in detergent Various38 Completed February 1993

Sodium alkylbenzene sulfonate anti-valve seat recession additive Exempt Completed February 2004

Sodium cyanide41 143-33-9 Completed February 2010

Sodium ethyl xanthate 140-90-9 Completed May 1995

Triglycidylisocyanurate (TGIC) 2451-62-9 Completed April 1994

Trichloroethylene 79-01-6 Completed March 2000

Triclosan 3380-34-5 Completed January 2009

Tris(2,3-dibromopropyl) phosphate (TBPP) 126-72-7 Completed November 2005

Preliminary assessments

Acrylonitrile 107-13-1 Completed Feb 2000

Glycolic acid in cosmetics40 79-14-1 Completed April 2000

Hydrofluoric acid (HF) 7664-39-3 Completed June 2001

Polybrominated flame retardants Various38 Completed June 2001

Short chain chlorinated paraffins (SCCPs) Various38 Completed June 2001

Tetrachloroethylene 127-18-4 Completed June 2001

Trisphosphates Various38 Completed June 2001

40 Assessment restricted to health risk.41 Assessment restricted to environmental risk.

33


Table 12: Scorecard of progress with implementation of recommendations from the Existing Chemicals Program

Review, as at 30 June 2013

The scorecard of progress with implementation of Existing Chemicals Review recommendations has been published

annually. Activities reported as ‘completed’ in NICNAS Annual Report 2011–12 are not included.

No. Recommendation Status

Implementation Stream 1: Communications

Chapter 3 recommendations: Better engagement and communication

3.142 Promote community awareness of, education about, and participation in Existing Chemicals (Assessment) Program.

Ongoing(focus of IMAP communications)

Chapter 5 recommendation: Improve efficiency

5.1 Develop, modify and publish process to filter out and redirect matters not relevant to NICNAS and determine level of response and/or assessment required.

Ongoing 43

Implementation Stream 2: Screening, prioritisation, assessment products

Chapter 4 recommendations: Enhance mechanisms to identify chemicals of concern: new screening processes

4.2 Screen AICS-listed chemicals for hazard and/or risk indicators elements. Ongoing

Chapter 5 recommendations: Improve efficiency

5.3 Publish the prioritisation process and recommendations. Ongoing

5.4 Streamline the Secondary Notification process for existing chemicals originally assessed as new chemicals.

In progress44

Chapter 6 recommendations: Broaden assessment options

6.1 Develop new types of assessment products based on intended outputs and purposes.

Partially completed45

6.2 Develop information requirements for each new assessment type. Ongoing

Implementation Stream 3: Monitoring

Chapter 4 recommendation: Enhance mechanisms to identify chemicals of concern: new screening processes

4.3 Examine feasibility of nationally coordinated system of surveillance monitoring and post-market reporting.

In progress46

Implementation Stream 4: Consultation

Chapter 5 recommendations: Improving efficiency

5.5 Explore with states and territories improved processes for coordination and cooperation, including use of NICNAS MoU group.

Ongoing

Implementation Stream 6: Currently improve practice

5.6 Continue to participate in chemicals management forums to ensure harmonised and streamlined regulation of industrial chemicals at a national level.

Ongoing

42 NICNAS promotes community awareness and participation by using targeted, plain-English information for the

community, separate from more technical, and industry specific information.43 This work continues; the Who’s Who Guide effectively filters out non-NICNAS inquiries.44 Implementation requires legislative change to the Act; depends on outcome of the review of NICNAS. 45 Subsumed into the Tier III process of IMAP Framework. Implementation options depend on outcome of review of NICNAS.46 Being considered as part of review of NICNAS.

34

Appendix 05—Compliance program

Table 13: NICNAS registrations by tier, over three years and in each quarter 2012–13

Total registrants as at:

30 June

2011

30 June

2012

30 September

2012

31 December

2012

31 March

2013

30 June

2013

Tier 1 3,561 3,766 3,191 3,471 3,843 4,048

Tier 2 837 873 818 865 873 890

Tier 3 360 363 342 348 349 350

TOTAL 4,758 5,002 4,351 4,684 5,065 5,288

Table 14: NICNAS non-renewed registrations over three years

Non-renewals as:

at 30 June 2011 at 30 June 2012 at 30 June 2013

TOTAL 578 520 591

Table 15: Cases managed by NICNAS compliance and enforcement program 2012–13

Cases: Chemical Registration Cosmetic Other

Cases managed in 2012–13 53 25 22 2

Active cases at 30 June 2013 25 4 5 0

Table 16: Rotterdam Convention processed 2012–13

Category Numbers processed

PIC annual authorisation 15

NICNAS advice on export notification 69

35


Table 17: NICNAS registration audit activities in 2012–13, by quarter

Quarter 1 Quarter 2 Quarter 3 Quarter 4 2012–13

On-time renewal rate 84%

Late penalty issued 115 107 0 0 222

Late penalty recovered

Actual 0 135 159 207

As percentage 60% 72% 93%

Table 18: NICNAS registration level reassessments

Quarter 1 Quarter 2 Quarter 3 Quarter 4

Number of companies audited 181

Number resolved 0 167 176 181

As a percentage 92% 97% 100%

36

Appendix 06—Communications and mediaTable 19: New and revised publications

Quarters 1 and 2 (2012) Quarters 3 and 4 (2013) Total

Brochures

Revised versions of: About NICNAS, NICNAS Registration and NICNAS Service Charter published and available on new website. New brochure: The role of NICNAS in regulating cosmetics also published.

Newsletters

Chemical Gazette 6 847 14

NICNAS Matters 348 149 4

Community engagement bulletin

Publication cancelled. Community Engagement Forum matters incorporated in NICNAS Matters

Planning documents, reports and factsheets

Corporate Annual Report 2011–12 1

Business plan 2012–13 1

New chemicals 3,000th report published during second half 3,008+ reports available

Existing chemicals Diisononyl phthalate (DINP) PEC report (public health risk from use in cosmetics, children’s toys and childcare articles)PhoslockTM Secondary Notification (draft)

Diisononyl phthalate (DINP) PEC report (public health risk from use in cosmetics, children’s toys and childcare articles)PhoslockTM Secondary Notification (draft)

2 published2 drafted

IMAP assessment outcomes

129 at Tier I, eight at Tier II published

330 Tier I (human health), 302 Tier I (environment) and 215 Tier II (human health) published

984 assessments, covering 723 chemicals

IMAP documents Factsheets: Overview, Stage 1 implementation, Better chemical information, Leveraging international information

IMAP Framework document—chemicals of low concern, polymers of low concernPilot evaluation of IMAP Framework

6

Nanomaterials Factsheets and technical information sheets: nano titanium dioxide, nano silver

2+2

Other publications

Website New website launched50 Approximately 7,000 web pages

Handbook for notifiers Revised version launched on new website, 27 June 2013

Main chapters 77 webpages

Appendices 91 webpages

Chemical fact sheets Revised version of all current/relevant fact sheets launched on new website, 27 June 2013

50

Note: Overall NICNAS inquiry statistics are no longer recorded.

47 Includes special Gazettes for the release of report on PhoslockTM, 22 January and 19 March 2013.48 July 2012: HBCD PEC report/information sheet, IMAP Stage One chemicals assessments/IMAP factsheets; October 2012: New Director, transfer of cosmetic ingredients from TGA, Nanotechnology, Legislative amendments, AICS changes; December 2012: Release of first IMAP assessments, Priority projects, consultations. 49 April 2013: 3,000 new chemicals assessments, Consultations, Legislative amendments, CSG, committee reports. 50 At the end of 2012–13, new NICNAS website—a platform for improved communication—launched.

37


Table 20: Visits to the NICNAS website (www.nicnas.gov.au) in 2012–13

Quarter 1 Quarter 2 Quarter 3 Quarter 4

Total

2012–13 2011–12

Visitors 319,027 317,364 285,623 242,720 1,164,734 1,437,011

Hits to website

11,764,479 8,098,913 7,746,336 7,623,878 35,233,606 57,764,089

Table 21: Top ten most viewed web pages in 2012–13

Title of web page Number of hits Number of visits

1. Homepage—Default 12,838,695 185,544

2. AICS/Search.asp doc 130,884 2,047

3. AICS Search 116,924 21,187

4. Chemicals in Australia 19,215 808

5. Current issues/Cosmetics 18,951 1,640

6. Registration 17,536 2,425

7. About NICNAS 15,612 736

8. AICS 15,409 1,967

9. CAR (chemical assessment reports) 13,701 2,709

10. Chemical Gazette 12,743 2,842

Note: The most popular days of the week are: Wednesday and Tuesday.

Media 2012–13

• Topics/issues raised included lead, anti-ageing cosmetic claims, banned chemicals and labelling, IMAP and the

assessment of chemicals on the AICS, formaldehyde, chemicals in cleaning products, use of phthalates in cosmetics

and hydraulic fracturing chemicals.

Table 22: Media advertising organisations engaged by NICNAS

Organisation Service provided Paid $ (GST inclusive)

Adcorp Advertising in professional magazines, directories and

journals regarding NICNAS general awareness and

registration

$16,357

Note: No marketing or advertising campaigns were conducted in 2012–13

38

Appendix 07—Advisory groups: community, industry, government

NICNAS’s formal consultation mechanisms include

advisory groups drawn from community, industry and

other government agency stakeholders to provide advice

on its regulatory activities and strategies.

Note: 2012–13 advisory groups are listed in

alphabetical order.

Community Engagement Forum

Members of the Community Engagement Forum (CEF)

provide advice to NICNAS for the worker health and safety,

public health and the environment sectors. They help it

address the community’s information requirements by

developing strategies to improve public access to health

and safety and environmental information on industrial

chemicals. The CEF continued to work on improving ways

for NICNAS to engage with stakeholders, and produced

two issues of NICNAS’s Community Engagement Bulletin,

which were distributed to interested organisations and

individuals and published on the NICNAS website.

The Forum comprised the Chair and seven members:

Director/Acting Director NICNAS, two community

members representing the interests of the environment,

two representing public health, as well as two non-

government members representing the interests of worker

health and safety.

CEF membership at 30 June 2013

NICNAS: Dr Brian Richards, Mr Nick Miller (Chair), Mr Justin

Roberts (Secretariat)

Representing:

Environmental: Ms Jane Bremmer, Ms Jo Immig

Worker health and safety: Ms Renata Musolino, Ms

Pamela Grassick (to February 2013)

Public health: Dr Liz Hanna, Dr David Oakenfull

The forum met three times in 2012–13:

CEF 29 (13 August 2012): discussed NICNAS performance

update, CEF Work Plan 2012–13, topics for September

Community Engagement Bulletin. At joint CEF/IGCC

meeting on 14 August members updated the (then)

Parliamentary Secretary for Health and Ageing on current

key issues and discussed the NICNAS Strategic Plan for

2012–14 with IGCC members, NICNAS.

CEF 30 (30 November 2012): discussed NICNAS

performance update, formaldehyde, new website, LRCC

reform, inputs to CEF Work Plan 2012–13 and NICNAS

stakeholder survey.

CEF 31 (15 March 2013): discussed Coal Seam Gas (CSG)

with presentations on scope of national assessment of

chemicals associated with CSG extraction project from

the (then) DSEWPaC and NICNAS, NICNAS performance

updates and CEF Work Plan 2012–13 and stakeholder

survey.

Terms of reference for—and other details about—the

forum are available on the Community page of the

NICNAS website.

Cosmetics Advisory Group

NICNAS’s Cosmetic Advisory Group (CAG) began work

in 2009 to advise on implementing the final elements of

outstanding cosmetic reforms. The term of the group was

until 31 December 2012, having been extended from 31

December 2011. The CAG met once—for the final time—in

December 2012, having completed its remit.

The group was chaired by NICNAS and comprised one

NICNAS representative, two Australian Government

representatives, three industry representatives, three

community representatives, one health expert and one

formulation expert.

CAG membership in 2012–13:

NICNAS: Dr Matthew Gredley (Chair), Dr Harjit Deol

(Secretariat), Ms Rosemary Sager, Dr Sarah Rumble

Independent experts: Prof. Mike Roberts, Mr Ric Williams

Community: Dr Rye Senjen (National Environmental

Consultative Forum—NECF), Ms Robyn Easton (Consumers

Federation of Australia), Mr Craig Sinclair (Cancer Council

Australia)

Industry: Dr Kerryn Greive/Ms Catherine Gwynne

(Australian Self Medication Industry), Ms Dusanka Sabic

and Dr Graeme Haley (Accord Australasia)

Government: Dr Raymond Wilson (TGA),

Mr Peter Wallner (ACCC)

Industry Engagement Group

Two meetings of the NICNAS Industry Engagement Group

(IEG) were held in 2012–13 (IEG10 on 22 October 2012

39


and IEG11 on 13 May 2013).

The group was established to provide a forum for

considering and advising on technical issues relating

to the regulation of industrial chemicals and to provide

technical input towards the development of relevant

documents and proposals prior to wider consultations.

Under its terms of reference, NICNAS is committed to

working in collaboration with the group on specific

matters, with the group providing advice to the Director

on:

• specific technical matters such as review

of guidance materials for variation of data

requirements;

• avenues to enhance the arrangements for

acceptance of assessments under approved foreign

schemes;

• industry issues/concerns, as appropriate;

• current industry operations and practice; and

• planned outreach activities such as training

programs.

Industry members of the IEG represent a broad range of

sectors, including those for paper products, consumer

cosmetics, household products, paints, plastics and

petroleum.

Agenda items included: discussion of exposure scenarios

for new chemicals notifications, ideas for operational

improvements (listed on the IEG ideas ‘hopper’ list), the

prioritisation and assessment of chemicals on the AICS

(IMAP), and new chemicals operational improvements

(including a revised screening framework, the smart forms

project and the decision repository).

A notable outcome of the IEG was its role in finalising the

review of the NICNAS Handbook for Notifiers in readiness

for its publication on the NICNAS website.

IEG membership in 2012–13 represented:

NICNAS (Chair and Secretariat), 3M Australia Pty Ltd,

Accord Australasia, Australian Plantation Products and

Paper Industry Council, Aerosol Association of Australia

Inc, Australian Food and Grocery Council, Australian

Institute of Petroleum, Albright & Wilson (Australia) Ltd,

Australian Paint Manufacturers Association (APMF),

Australian Society of Cosmetic Chemists, Minerals Council

of Australia, Plastics and Chemicals Industries Association

(PACIA), Packer Leather Pty Ltd, Unilever Australasia.

Industry Government Consultative Committee

The 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 during 2012–13:

Representing:

Industry:

Australian Chamber of Commerce and Industry (ACCI):

Ms Carolyn Davis

Accord Australasia: Ms Bronwyn Capanna,

Ms Dusanka Sabic, Mr Craig Brock

APMF: Mr Richard Phillips

PACIA: Ms Margaret Donnan, Mr Geoff MacAlpine

Government:

NICNAS: Dr Brian Richards (Chair), Mr Nick Miller

(Secretary)

Australian Government Department of Education,

Employment and Workplace Relations (DEEWR, now

Department of Employment): Ms Kylie Emery

DSEWPaC (now Department of the Environment):

Mr Andrew McNee

Australian Government Department of Innovation,

Industry, Climate Change, Science, Research and Tertiary

Education (DIISRTE, now Department of Industry):

Ms Ann Bray/Ms Kathleen Allan

A representative of DoHA (now Health) is an ex-officio

member: Ms Megan Morris (First Assistant Secretary), Mr

John Barbeler (Chief Financial Officer),

Mr Graeme Barden

The IGCC held three face-to-face meetings during the

year:

40

IGCC 43 (14 August 2012): Members focused on

reviewing NICNAS’s 2011–12 financial year operational

and financial performance, as well as the committee’s

2012–13 work plan and priorities, within the budget

established through the NICNAS cost recovery impact

statement (CRIS) in line with the NICNAS planning

cycle. At a joint CEF/IGCC meeting the same day IGCC

members updated the (then) Parliamentary Secretary

for Health and Ageing on their current key issues and

discussed the NICNAS Strategic Plan for 2012–14.

IGCC 44 (27 November 2012): Members focused

on: budget and performance positions, compliance

strategies, and 2013–14 high-level revenue projections

and key priorities. They supported NICNAS’s compliance

approach and noted that the indicative 2013–14 budget

is based on the 2012–16 cost recovery impact statement

(CRIS). They received an update on the new NICNAS

website.

IGCC 45 (26 March 2013): Members focused on NICNAS’s

budget and performance positions, in line with the

IGCC’s terms of reference, and considered the handling

of strategic issues in 2013–14 and beyond. The meeting

supported arrangements to include additional chemicals

to the Stage One list for the IMAP Framework. Members

provided useful feedback on implementing revised

arrangements for NICNAS registration in 2013–14.

Nanotechnology Advisory Group

The Nanotechnology Advisory Group (NAG) was

established to advise NICNAS on regulatory and technical

matters to ensure its regulations can manage any risks

arising from industrial nanomaterials.

The group’s tenure was extended twice. While the group

did not meet face to face during 2012–13, it provided

out-of-session advice to NICNAS on new nanotechnology

publications. Its term is currently due to end in March

2014.

The NAG comprises three individuals representing the

community, three representing industry, one expert in

nanoscience, one expert in toxicology, and a NICNAS

representative.

NAG membership in 2012–13:

NICNAS: Dr Roshini Jayewardene (Chair), Dr Matthew

Gredley (member) , Ms Nicola Hall/Dr Stephen Zaluzny

(Secretariat)

Representing:

Community: Ms Renata Musolino (CEF), Dr Rye Senjen

(NECF), Dr Sam Bruschi (CEF nominee)

Industry: Mr Geoff MacAlpine (PACIA), Mr Leo Hyde (APMF),

Mr Craig Brock (Accord Australasia)

Experts:

• Nanoscience: Prof. Colin Raston

(Flinders University)

• Toxicology: Prof. Brian Priestly

(Monash University)

States and Territories Memorandum of

Understanding Group

The States and Territories Memorandum of Understanding

(MoU) group serves as a conduit for the exchange of

information and service delivery between NICNAS and

the state and territories, concerning occupational health

and safety, public health and environmental protection,

relating to the use of industrial chemicals in Australia.

The group met by teleconference on 30 January 2013

and members discussed the following items:

• Recent PEC releases;

• IMAP program;

• BRMP; and

• Obligations under Rotterdam Convention.

MoU Group membership:

NICNAS: Mr Lewis Norman (Chair), Dr Brian Richards

(Director), Dr Trang Pham, Ms Louise Stedman, Dr Adrienne

Adams (Secretariat)

Victoria: Ms Anita Aiezza, Mr Halil Ahmet

Tasmania: Mr Ian Graham, Mr Daryl Langerak

Queensland: Mr David Grantham, Ms Caroline Topping

Western Australia: Ms Sally North,

Mr Mark Lewis

New South Wales: Dr Usha St George

South Australia: Mr Chor Wong,

Ms Shelley Rowett

Technical Advisory Group

This group did not convene in 2012–13 and is not

continuing.

41


Appendix 08—performance: government expectations

Sub-Program 1.4.3: Industrial Chemicals

Sub-Program 1.4.3 aims to ensure that uses of industrial chemicals are safe for human health and the environment, and

to further improve the efficiency of the regulatory framework, for industry and the community.

Table 23: NICNAS’s performance results against PBS deliverables and KPIs in 2012–13

2012–13 NICNAS PRIORITY PROJECTS

1. Strategy for industrial nanomaterials

Address uncertainty surrounding the risk

and appropriateness of current assessment

protocols and regulatory requirements for

nano-forms of existing chemicals

Substantially met—

see p. 16-17

2. Cost recovery impact statement

Implement outcomes of review of cost recovery

arrangements

Completed—see p.13

3. Completion of cosmetic reforms

Safe use of UV filters in products transferred from

therapeutic to industrial chemicals regime

Deferred pending review

of NICNAS

4. IT strategic program, with focus on integrated system

Improve efficiency and effectiveness of business

systems

Substantially met, and

ongoing—see p. 21-22

5. Enhancements to new chemicals operations

More efficient and effective new chemicals

notification program and increased use of safer

chemicals

Substantially met—see p.7

2012–13 PERFORMANCE MEASUREMENT TARGETS FOR QUARTERLY REPORTING

Deliverable/KPI 2012–13 reference point/target Result51

Qualitative deliverables

Implement IMAP framework IMAP Framework governance arrangements

in place; ongoing stakeholder engagement

and communication strategies are effectively

implemented

Met

Implement approach for

introducing substitutes for

perfluorinated chemicals

Framework for the assessment of new

perfluorinated chemicals implemented

Met

Contribute to international

harmonisation of assessments,

regulatory approaches

and methodologies by

adjusting, as appropriate,

Australian industrial chemicals

assessment and management

systems

Review international assessments, regulatory

approaches and methodologies for their

application to NICNAS risk assessments

from three key sub committees of the OECD

Chemicals Committee

Met

Introducers of industrial

chemicals aware of their

obligations through NICNAS

Registration

Registration of all identified introducers Met

Qualitative indicator

KPI: Effective use of

international information

A. For new chemicals: finalise lessons learnt

from US EPA bilateral agreement and explore

options for further developing arrangements

B. For existing chemicals: through implementing

the IMAP Framework, developing guidance and

training on the use of international information

Met

42

Quantitative indicators

KPI: Percentage of Stage One

chemicals assessed through

effective application of IMAP

Framework

Target: 20%; Actual: 24% Met

KPI: Percentage uptake by

industry of options to introduce

new chemicals that are a

lower risk to human health or

the environment

Target: 80%; Actual: 80% Met

KPI: Percentage of those

introducing over $500,000 of

industrial chemicals assessed

for compliance with new

chemicals obligations

Target: 30%; Actual: 30.3% Met

Other targets: 2012–13 target 2012–13 actual

Percentage of variance

between actual and budgeted

expenses.

≤0.5% — 7.2% Met

Percentage of NICNAS PEC

recommendations developed

in consultation with relevant

stakeholders

100% 100% Met

Percentage of reports on

assessed chemicals posted

to the NICNAS website

New chemicals:

Existing chemicals:

All recent reports are available. Uploading all 3,000+

reports is in progress

100%

100%

100% 100%

Percentage of inquiries to

NICNAS responded to within

24 hours

95% Statistics for inquiries no longer gathered

Percentage of new chemical

assessments completed within

legislated timeframes

96% 95% Met

Percentage of legislated

timeframes adhered to

for assessment of existing

chemicals

100% 100% Met

Percentage of AICS searches

completed within five working

days

95% 97% Met

KPI: Percentage of known

industrial chemical introducers

registered and compliant

95% 99.7% Met

KPI: Percentage of customers

satisfied with NICNAS training

95% 95% Met

KPI: Percentage increase

in visitor sessions to NICNAS

website

5% — 18% (decrease) Not met

KPI: Percentage uptake of

options to introduce low risk

new chemicals

80% 80% Met

51 For commentary, see Department of Health and Ageing Annual Report 2012–13, Sub-program 1.4.3: Industrial chemicals.

43


Appendix 09—Links: national and internationalTable 24: International and national presenters to staff information and training sessions in 2012–13

Note: This listing provides an overview, only, of the range of speakers and is not all-inclusive.

Name and position From Topic

2012

Geert Dancet European Chemicals Agency

(ECHA)

EU REACH regulation, at forum to

launch IMAP

Dr Robert Kavlock US EPA Office of Research and

Development

Computational methodologies,

at forum

Hitoshi Nanimoto Ministry of Economy, Trade and

Industry, Japan

Stepwise assessment scheme,

at forum

Dr Bette Meek University of Ottawa, Canada Canadian prioritisation program

and beyond, at forum

Rob Forlong New Zealand EPA International information flows in

risk management, at forum

Dr Simon Apte

Ms Sarah Court

John Hargrave

Dr Marion Healy

Dr Stephen Healy

Prof. Ian Rae

CSIRO

ACCC

Industry expert

FSANZ

UNSW

University of Melbourne

Various topics, at forum

Prof David Berube,

Christopher Cummings

North Carolina State University,

USA

Communicating risk in the 21st

century

Steve Watson DoHA Security

Michael Borowick ACTUTuesday tune-up: Chemicals

regulation

Speaker from Black dog institute Mindfulness

Dr Joe Schwarcz McGill University, Canada Better living through chemistry

2013

Prof Arie Freiberg Monash University Tune-up: Regulation

Dr Rhian Cope Staff training: Toxicology

Michael Frost COAG Reform Council Tune-up: COAG Reform Council

and Reform

Prof. Ovanes Mekenyan Laboratory of Mathematical

Chemistry, Bulgaria

Staff training: use of OASIS TIMES

and OECD Toolbox

Dr Roger Klein University of Cambridge, UK Fluorochemicals—emerging

contaminants of concern

Ms Francine Lamoriello US Personal Care Products

Council

Cosmetics and toxicology testing

44

Speaker from Safe Work Australia Tune-up: WHS regulations, exposure

standards and health surveillance

Speakers from PACIA, ACCI, APMF Tune-up: The business of chemistry;

About ACCI; About the APMF

Ms Sue Sinclair Cancer Australia Tuesday tune-up: Cancer control

Alec Johnston Trainer Science finder training

Table 25: Additional international activity

NICNAS provided inputs to meetings of the following agencies during 2012–13

Agency NICNAS activity

APEC See Scientific, regulatory and reform activities for details.

Chemicals Evaluation and Research

Institute (CERI), Japan

Provided additional information on chemical regulation in Australia to

Japan’s CERI in response to their inquiries received during the year.

International Conference on Chemicals

Management

Provided technical advice briefs on emerging issues related to

chemicals in products, perfluorinated chemicals, nanomaterials, and

endocrine disruption.OECD/UNEP Global Perfluorinated

Chemicals Group

Compared domestic PFC uses and volumes with data in a synthesis

paper drafted by the Fluoro Council for the Global PFC Group, to

be released on the OECD portal on perfluorinated chemicals, and

observed that all Australian uses had been captured except as a mist

suppressant in metal plating.

OECD Joint Meeting of the Chemicals

Committee and the Working Party

on Chemicals, Pesticides and

Biotechnology

Drafted/coordinated briefs on eChemPortal, managing safety

of manufactured nanomaterials, hydraulic fracturing chemicals,

integrated approaches to testing and assessment, work plan for

substitution of hazardous chemicals, policy drivers influencing

chemicals management decision-making, QSAR Toolbox, survey on

PFCs.

OECD Working Party on Manufactured

Nanomaterials

See Scientific, regulatory and reform activities for details. Involved

in sponsorship program on safety testing of representative set of

manufactured nanomaterials.

45


Table 26: NICNAS presentations at Australian conferences

Note: This listing provides an overview, only, of the range of events/topics. It is not all-inclusive.

Event Topic Who Month

2012

Standards AustraliaWorkshop on

Nanomaterial definition

Dr Matt Gredley, Dr Kerry

Nugent

July World Congress on Risk Risk Several NICNAS staff

WHO combined exposure

workshopExposure Dr Sneha Satya

Dioxins conference Perfluorinated chemicals Dr Sneha Satya August

AIOH seminar Toxicological basis of

hazard classification Dr Jackie Kitching September

Accord Australasia

Regulation of chemicals

in cosmetic/personal

care products

Dr Roshini Jayewardene

OctoberCustoms broker and

fire-fighting association

conference

NICNAS requirements Lewis Norman

Regulators science

network and forumNICNAS new chemicals

Dr Brian Richards,

Dr Daniela LeonteNovember

AFP Australian chemical

diversion workshopChemical security Dr Sneha Satya December

2013

ACTRA annual scientific

meetingDr Daniela Leonte, March

HAZMAT 2013 Various topics (IMAP etc) Several staff May

Appendix 10—Staff profile, training, developmentExecutive staff, NICNAS programs at 30 June 2013

Director, NICNAS: Dr Brian Richards

Regulatory Strategy: Dr Roshini Jayewardene (Head)

New Chemicals: Dr Kate Liddell (acting Head), Dr Daniela Leonte (Principal Scientist)

Existing Chemicals: Ms Angela McKinnon (Head), Dr Kerry Nugent (Principal Scientist)

Science Strategy and International: Dr Sneha Satya (Head)

Reform: Dr Matthew Gredley (Head)

Compliance and Enforcement: Mr Lewis Norman (Head)

Business Management and Communications: Mr Nick Miller (Head)

46

Table 27: NICNAS staff profile at 30 June 2013 (Health employees)

Classification Male Female Total Total, as percentage

Holder of public office 1 - 1 1.3

Executive Level 2 Officers 5 6 11 13.9

Executive Level 1 Officers 9 17 26 32.9

APS Level 6 13 6 19 24.1

APS Level 5 - 6 6 7.6

APS Level 4 - 5 5 6,3

APS Level 3 3 7 10 12.6

APS Level 2 - 1 1 1.3

Total 31 48 79 100

Table 28: Membership of Equal Employment Opportunity groups at 30 June 2013 (Health employees)

Number As percentage of total headcount

Female 48 60.8

Aboriginal and Torres Strait Islander 1 1.3

NESB 1–2 14 17.7

People with disability 3 3.8

Table 29: Full time and part-time staff at 30 June 2013 (Health employees)

Full time—Part time Headcount As percentage

Full-time 65 82.3

Part-time 13 16.4

Casual 1 1.3

Total 79 100

Table 30: Summary of staff training, by total formal training days in 2012–13 (Health employees)

All staff formal training

Number of participants, e-Learning training 185

Number of participants, non e-Learning training 69

Total number of formal training courses (both e-Learning and non e-Learning) 254

Average number of courses per staff member 3.2

Note: In October 2012, the inaugural NICNAS staff-members-coordinated Staff Orientation Day was held for a large

number of newly-recruited NICNAS staff.

In addition, NICNAS staff attended numerous ‘Tuesday tune-up’ and other scientific sessions (as detailed at Appendix 09).

Some were presented by international speakers, some by Australian experts and some by NICNAS staff.

47


Appendix 11—Update: stakeholder survey The last NICNAS Stakeholder Survey of its customers was conducted in August 2010. It covered service in key areas but

also NICNAS’s CRIS and other specific activities. More than 1,000 responses were received from registrants, peak bodies,

government organisations and interest groups.

The survey—which confirmed that NICNAS stakeholders generally view the organisation positively—provided NICNAS with

valuable data on which to build programs and activities to improve outcomes.

The next survey is scheduled for later in 2013.

Table 31: Activity during 2012–13 on key outcomes from 2009–10 stakeholder survey

Issue Action proposed Status

Confidential AICSOpportunities to improve user experiences of

the confidential AICS process appear to be

related to the timeliness of feedback, the user

friendliness of the application form, channels

to seek further information and overall clarity

of the process for confidential listings.

Improve timeliness of NICNAS

processes

Clarify grounds for stopping

assessment when information:

inadequate

Transparency of decision-making

Completed—see: Other

assessment-related

activities

Improved clarity of AICS search

page (including pointers on nil

results page)

Completed

Communications, workshops and trainingEngagement with Tier 1 registrants

(particularly those dealing with very low

values of chemicals), as well as those in less

regular contact … and specific stakeholder

segments (such as those dealing with

cosmetics) … on rationale for fees and

charges, scope of scheme, compliance

requirements and implementation of reforms.

Improve website

Enhance chemical safety

information

Target Tier 1

Completed

Training There is a clear demand for NICNAS training,

workshops and consultations across all

stakeholder segments … this is likely to

include structuring courses to meet the needs

of small business users of chemicals, larger

operators … and specific user segments—

(e.g. cosmetics)

Targeted training Ongoing improvements to

delivery—see Appendixes

09 and 10

Overall performance Staff performance was viewed positively

Continue to promote NICNAS

service culture through measures

in place

Track progress in 2013

stakeholder survey

48

Appendix 12—Ecologically sustainable development

The Act administered by NICNAS provides for a national

notification and risk assessment scheme for industrial

chemicals. NICNAS assessment reports provide

information and recommendations to regulators

(including the Commonwealth, states and territories),

industry and the general public.

NICNAS’s risk assessment activities involve assessing

the health and environmental risks of new industrial

chemicals entering Australia for the first time (by

manufacture/import) before their use and subsequent

release to the environment. NICNAS also assesses

chemicals already in commerce, based on environmental

and/or health concerns.

All chemical risk assessment activities undertaken by

NICNAS are within an internationally-agreed policy

framework that is consistent with the principles of

ecologically sustainable development (ESD) that

comprises a hazard assessment, dose-response

relationships, exposure assessment and risk assessment,

including risk management options.

NICNAS environmental risk assessments are conducted

through a cooperative partnership arrangement with

DSEWPaC (now Environment). NICNAS’s activities are

aligned with a series of ESD principles. Decision-making

processes effectively integrate both long-term and

short-term environmental, social and equity-supporting

considerations.

NICNAS operates within an agreed framework for

chemical management that is consistent with the

National Strategy for ESD, its principles and policies. This

framework aligns with the UN Conference on Environment

and Development (UNCED) Agenda 21 (Rio Declaration),

of which Chapter 19 relates to the environmentally-sound

management of toxic chemicals.

The hazard assessment identifies the intrinsic ability of the

chemical to cause harm to human health and/or the

environment. The potential for exposure of human and

environmental species is determined for each chemical,

based on its known or anticipated use pattern. Risk

assessment integrates both the hazard and exposure

assessment to create a risk estimate and determination

of whether or not the risk is acceptable. If the risk is

considered unacceptable, recommendations for action

are provided to the relevant agency.

If there are threats of serious or irreversible

environmental damage, lack of full scientific certainty

should not be used as a reason for postponing

measures to prevent environmental degradation.

The precautionary principle guides health and

environmental risk assessments and forms the basis of

science-based risk assessment for industrial chemicals.

This principle is applied in particular where international

chemicals policy negotiations may need to rely on

precaution. Caution is applied in line with the principles

of ESD and the UNCED Agenda 21, Principle 15 (the

precautionary approach).

Environment

The principle of inter-generational equity—that the

present generation should ensure that the health, diversity

and productivity of the environment is maintained or

enhanced for the benefit of future generations—and

the conservation of biological diversity and ecological

integrity should be a fundamental consideration in

decision-making.

NICNAS’s risk assessments aim to preserve the integrity

of the environment and its biodiversity. The known

or anticipated use pattern of each chemical is

characterised within the context of the risk assessment,

taking into account Australia’s demography and

ecosystems. The outcome of the NICNAS assessment

provides the information necessary for informed, objective

and transparent decision-making, including ‘trade-offs’

between competing objectives of current utility and future

adverse environmental effects.

Improved valuation pricing and incentive mechanisms

continue to be promoted, and NICNAS’s Low Regulatory

Concern Chemical (LRCC) reforms continued to be

implemented in 2012–13. As in previous years, they

included strategies that encourage the introduction

of less hazardous chemicals that pose a lower risk to

the environment. The proportion of safer chemicals

assessed—based on their hazard and risk profile—was 74

per cent in 2010–11, 77 per cent in 2011–12 and 80 per

cent in 2012–13.

Promoting new technologies through direct financial

incentives (for chemicals that pose a lower regulatory

risk) will result in a more sustainable overall regulatory

framework, as well as a more sustainable chemical

industry in Australia.

49


How outcomes relate to ESD

Chapter 19 of UNCED Agenda 21—while acknowledging

that substantial use of chemicals is essential to meet the

social and economic goals of the world community—

identified two major problems, particularly in developing

countries:

1. a lack of sufficient scientific information for the

assessment of risks entailed by the use of a great

number of chemicals; and

2. a lack of resources for assessment of chemicals for

which data are available.

Chapter 19 concentrates on generating, harmonising and

disseminating chemical data and strengthening capacity

for chemical management. Agenda 21 programs and

objectives for chemicals, to a large extent, reflect some

important elements of the Rio Declaration including:

Principle 9 (building capacity through developing and

transferring scientific information), Principle 10 (the right

of access to information or the ‘right to know’ and the

right to participate in decisions) and Principle 15 (the

‘precautionary principle’).

Appendix 13—Compliance with mandatory reporting requirements

Mandatory requirements under the Act

In addition to the requirement to produce an annual report to Parliament on the operations of the Act and other external

scrutiny such as through the NICNAS IGCC, the Act also prescribes additional mandatory reporting requirements.

Table 32: Compliance with mandatory reporting requirements under the Act, including last/next publishing date.

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—to be published in the

October 2013 Chemical Gazette.

Number of LVC permits issued 2012–13: 36 comprising

21 LVCs and 15 LVC renewals.

Annual publication in the Chemical Gazette of a list of

current and previous Priority Existing Chemicals

[section 54].

A list of current and previous PECs is published on the

NICNAS website. This list is also available at Appendix 04.

Annual publication in the Chemical Gazette of a list of

the chemicals requiring secondary notification and a

list of those no longer requiring secondary notification

[section 71].

All assessments undertaken and published by NICNAS

are subject to secondary notification provisions.

Secondary notifications are published individually in the

Chemical Gazette. The list was published in the October

2102 edition of the Chemical Gazette, with an updated

list published in the gazette in September 2013.

A list of the chemicals undergoing secondary

notification and no longer requiring secondary

notification will be published in the Chemical Gazette in

the second quarter of 2013–14.

Written notice to the Gene Technology Regulator when a

genetically modified (GM) product is regulated by NICNAS

[section 10A].

No genetically modified chemicals were referred to the

Office of the Gene Technology Regulator for advice

during 2012–13

Annual publication in Chemical Gazette of chemicals

in respect of which controlled use permits are in force

(section 22N)

This list will be published in the November 2013

Chemical Gazette

50

Table 33: Compliance with mandatory reporting requirements by the Department of

Prime Minister and Cabinet, 2012–13

Description Page/s

Letter of transmittal iii

Table of contents v

Index 58

Glossary 52

Contact officer(s) iv

Internet home page address and address for report iv

Review by NICNAS Director 1

Overview of NICNAS’s performance and financial resultsSee DoHA Annual Report

2012–13; 19–20

Departmental overview

Role and functions 2–3

Organisational structure 5

Outcome and program structure 41–42

Where outcome and program structures differ from Portfolio Budget Statements

(PBS), details of variation and reasons for changeN/A

Report on performance

Review of performance during the year in relation to programs and contribution

to outcomesSee DoHA Annual Report

Actual performance in relation to deliverables and KPIs set out in PBS 41–42

Where performance targets differ from the PBS, details of former and new targets,

and reasons for the changeN/A

Narrative discussion and analysis of performance 7–22

Trend information 7–22

Performance against service charter customer service standards, complaints

data, and department’s response to complaints47

Discussion and analysis of department’s financial performance 19–20

Discussion of any significant changes from prior year, from budget or

anticipated to have a significant impact on future operations.20

Agency resource statement and summary resource tables by outcomes 41–42

Management and accountability 2–6

Corporate governance

Director’s certification that the agency complies with Commonwealth Fraud

Control Guidelines.See DoHA Annual Report

Statement of the main corporate governance practices 6, 39–40

Names of the senior executive and their responsibilities 45

Senior management committees and their roles 2–6

External scrutiny

Significant developments in external scrutiny 13

Judicial decisions and decisions of administrative tribunals N/A

Reports by the Auditor-General, Parliamentary Committee or

Commonwealth Ombudsman21

51


Management of human resources

Assessment of effectiveness in managing and developing human resources to

achieve objectives20–21

Workforce planning, staff turnover and retention 20–21; 46

Training and development undertaken and impact 21; 46

Work health and safety performance 21

Statistics on staffing 45–46

Enterprise or collective agreements, IFAs, determinations, common law contracts

and AWAsSee DoHA Annual Report

Performance pay 21

Assessment of effectiveness of assets management 13; See DoHA Annual Report

Assessment of purchasing against core policies and principles 13; See DoHA Annual Report

Statement detailing number of new consultancy services contracts let during

the year.28

Absence of provisions in contracts allowing access by the Auditor-General See DoHA Annual Report

Contracts exempt from the AusTender 28

Financial statements 24–27

Other mandatory information

Work health and safety (Schedule 2, Part 4 of the

Work Health and Safety Act 2011)20, 21

Advertising and market research (section 311A of the Commonwealth Electoral Act 1918) and statement on advertising campaigns

37

Ecologically sustainable development and environmental performance (section

516A of the Environment Protection and Biodiversity Conservation Act 1999)48–49

Grant programs N/A

Disability reporting—explicit and transparent reference to agency level

information available through other reporting mechanisms46; See DoHA Annual Report

Information publication scheme statement 21

Agency resource statements and resources for outcomes 24–27

List of requirements 50

52

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) body which provides independent review of administrative decisions made by

the Australian Government and some non-government bodies

Australian High Volume Industrial Chemicals (AHVIC) list of information about chemicals manufactured in and/or

imported into Australia in quantities greater than or equal to 1000 tonnes

Australian Inventory of Chemical Substances (AICS) list of chemical identity data maintained by NICNAS; legal device

that distinguishes new from existing chemicals and lists all industrial chemicals in use in Australia between 1 January 1977

and 28 February 1990; includes new chemicals assessed since February 1990 and corrections as required

Business Plan for NICNAS document describing the performance measures and data for NICNAS and how these relate

to the NICNAS Strategic Plan and Portfolio Budget Statements

Chemical Gazette government publication, published by NICNAS under its Act on the first Tuesday of each month,

containing information regarding changes to NICNAS legislation, newly assessed chemicals and the Register of Chemical

Introducers

Community Engagement Forum (CEF) NICNAS’s consultative group that identifies community concerns about the

effects of industrial chemicals on the environment, public health and/or worker health and safety

Council of Australian Governments (COAG) the peak intergovernmental forum in Australia, comprising the Prime

Minister, state premiers, Territory chief ministers and the President of the Australian Local Government Association (ALGA).

Director Director of NICNAS

Ecologically sustainable development (ESD) using, conserving and enhancing the community’s resources so that

ecological processes, on which life depends, are maintained and the total quality of life, now and in the future, can be

enhanced

Existing chemical an industrial chemical other than a new industrial chemical—see entry for Australian Inventory of

Chemical Substances (AICS)

Inventory Multi-tiered Assessment and Prioritisation (IMAP) Framework framework developed by NICNAS to assist in

the prioritisation and assessment of chemicals of concern on the AICS, leading to enhancements to chemical safety

information flow and chemicals management, 2012–15

Industrial chemical a chemical with an application, purpose or use that is industrial for registration and introduction

purposes (whether or not it also has non-industrial uses)

Industry Government Consultative Committee (IGCC) primary consultative body for industry and government on

NICNAS matters. Among other things, it reviews the use of resources against NICNAS objectives under terms of reference

set by the Minister

53


Level A, Level B, Level C, Level D NICNAS registration levels replacing tiers (see below), each relating to a range of

total values for industrial chemicals introduced in a registration year (1 September–31 August of following year), used in

assessing registration charges, commencing 1 September 2013

Low regulatory concern chemicals (LRCC) industrial chemicals which could qualify for reduced regulation on the basis

of a definition of low risk, or where regulatory input from elsewhere is sufficient to meet Australian requirements

Memorandum of Understanding (MoU) agreement between parties that details mutual obligations relating to services

and/or the exchange of information (relating to industrial chemicals). NICNAS has a States and Territories Group (MoU)

and an MoU with the Australian Customs and Border Protection Service, the Australian Taxation Office and the Office of

the Australian Safety and Compensation Council, as well as with the European chemicals agency ECHA and the New

Zealand EPA

New chemical an industrial chemical (including a polymer) not listed on the AICS

Organisation for Economic Co-operation and Development (OECD) groups 30 member countries sharing a

commitment to democratic government and the market economy; plays a prominent role in fostering good governance

in the public service and in corporate activity. Its work covers economic and social issues from macroeconomics, to trade,

education, development and science and innovation

Outcome in the context of the Portfolio Budget Statements (PBS) (see below): the results, impacts or consequences of

actions by the Australian Government on the Australian community; a stated goal for achievement by an organisation

Output in the context of the PBS (see below): the goods or services produced by agencies on behalf of the Australian

Government for external organisations or individuals; a set of activities and products that contribute to the achievement

of a stated goal of an organisation (outcome) subject to performance standards

Parallel process refers to a company notifying in multiple jurisdictions and authorising participating governments to

share information when conducting their reviews of new chemicals

Performance measures provide information on administered items and departmental outputs in terms of quality, quantity

and efficiency

Poisons Standard (SUSMP) a legislative instrument that consists of decisions regarding the classification of medicines

and poisons into schedules for inclusion in legislation of the states and territories; it includes model provisions about

containers and labels, a list of products recommended to be exempt from these provisions, and recommendations about

other controls on drugs and poisons

Portfolio Budget Statements (PBS) statements prepared by portfolios to explain budget appropriations in terms of

outcomes and outputs

Precursor chemical chemical which is known to be used in the manufacture of drugs and explosives

Priority Existing Chemical (PEC) chemical declared by the Minister for assessment under the NICNAS Existing Chemicals

Program because its manufacture, handling, storage, use or disposal gives rise or may give rise to an adverse risk to

human health and/or the environment

Rotterdam Convention the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for Certain Severely

Restricted or Banned Hazardous Chemicals and Pesticides in International Trade. Ratified by Australia on 20 May 2004.

It ensures that certain hazardous industrial chemicals comply with national and international import and export controls

Secondary notification assessment assessment of chemical/s that has been previously assessed by NICNAS and

requires re-assessment based on new data becoming available, that may change the risks identified in the earlier

assessment

Service Charter for NICNAS document that spells out the types, levels and standards of service NICNAS clients can

expect from the organisation, including details of complaint resolution procedures

54

SIDS Initial Assessment Report (SIAR) OECD Chemicals Programme report of hazards of a specific industrial chemical

based upon an evaluation of an OECD Screening Information Data Set

Stockholm Convention the Stockholm Convention on Persistent Organic Pollutants (POPs), ratified by Australia on

20 May 2004. Its review committee examines risk profiles of nominated chemicals to determine whether they may lead to

significant adverse human health and/or environmental effects that would warrant global action

Tier 1, Tier 2, Tier 3 NICNAS registration levels, each relating to a range of total values for industrial chemicals introduced

in a registration year (1 September–31 August of following year), used in assessing registration charges. New registration

levels (see above) introduced 1 September 2013 replace tiers

Tier I, Tier II, Tier III IMAP assessment levels for unassessed industrial chemicals: high throughput assessment against

criteria (Tier I), chemical-by-chemical evaluation against criteria (Tier II), in-depth chemical assessment (Tier III)

Acronyms and abbreviationsAAT Administrative Appeals Tribunal

ACCC Australian Competition and Consumer Commission

ACCI Australian Chamber of Commerce and Industry

Accord national industry association for the Australasian consumer, cosmetic, hygiene and

specialty products industry

ACCS Advisory Committee on Chemicals Scheduling

ACTRA Australasian College of Toxicology and Risk Assessment

AGD Attorney-General’s Department

AICS Australian Inventory of Chemical Substances (see Glossary, above)

AIOH Australian Institute of Occupational Hygienists

ANAO Australian National Audit Office

APEC Asia-Pacific Economic Co-operation

AHPC Australian Health Protection Committee (Health committee)

APMF Australian Paint Manufacturers Federation

APVMA Australian Pesticides and Veterinary Medicines Authority

ASCC Australian Safety and Compensation Council

ASCC Australian Society of Cosmetic Chemists

BBP butylbenzyl phthalate

BRMP Better Regulation Ministerial Partnership (review of NICNAS)

CAG Cosmetics Advisory Group (NICNAS committee)

CAS Chemical Abstracts Service, a division of the American Chemical Society

CEC Commercial Evaluation Category permit (NICNAS)

CECR Commercial Evaluation Category Permit Renewal (NICNAS)

55


CEF Community Engagement Forum (see Glossary, above)

CHNC Clearing House on New Chemicals (OECD)

COAG Council of Australian Governments (see Glossary, above)

CRIS Cost Recovery Impact Statement

CSG coal seam gas – also known as natural gas from coal seams

CSIRO Commonwealth Scientific and Industrial Research Organisation

CWG Chemicals Working Group

DBP dibutyl phthalate

DecaBDE decabromodiphenyl ether

DEEWR Australian Government Department of Education, Employment and Workplace Relations

DEHP diethylhexyl phthalate

DEP diethyl phthalate

DIISRTE Australian Government Department of Innovation, Industry, Science, Research and Tertiary Education – also

known as DSIICCRTE (with inclusion of Climate Change in the portfolio)

DINP diisononyl phthalate

DMEP bis (2-methoxyethyl) phthalate

DMP dimethyl phthalate

DoFD Australian Government Department of Finance and Deregulation

DoHA Australian Government Department of Health and Ageing—now Department of Health (Health)

DSEWPaC Australian Government Department of Sustainability, Environment, Water, Population and Communities

DWAIN NICNAS’s internal database

ECHA European Chemicals Agency

EIMS Electronic Information Management System (NICNAS–IMAP project)

EIP Early Introduction Permit (NICNAS)

enHealth Environmental Health Committee–subcommittee of Health’s AHPC

Environment Australian Government Department of the Environment (formerly DSEWPaC)

EOP (controlled use) Export Only Permit (NICNAS)

EPHC Environment Protection and Heritage Council

ERMA New Zealand Environmental Risk Management Authority (now part of the New Zealand Environmental

Protection Agency)

ESD Ecologically sustainable development

EU European Union

FSANZ Food Standards Australia New Zealand

GHS Globally Harmonised System of Classification and Labelling of chemicals (United Nations)

56

HAZMAT Hazardous materials

HBCD hexabromocyclododecane

HCBD hexachlorobutadiene

Health Australian Government Department of Health

HPV High Production Volume (chemicals)

HSIS Hazardous Substances Information System

IARC International Agency for Research on Cancer

IEG Industry Engagement Group (NICNAS committee)

IGCC Industry Government Consultative Committee (see Glossary, above)

IMAP Inventory Multi-tiered Assessment and Prioritisation (NICNAS)

Industry Australian Government Department of Industry (formerly DIISRTE / DSIICCRTE)

ISG Implementation Steering Group (NICNAS committee)

LRCC Low Regulatory Concern Chemicals (NICNAS)

LTD Limited notification category (NICNAS)

LVC Low Volume Chemical (NICNAS)

LVCR Low Volume Chemical Permit Renewal (NICNAS)

MSDS Material Safety Data Sheet

NAG Nanotechnology Advisory Group (NICNAS committee)

NChEM National Framework for Chemicals Environmental Management (EPHC committee)

NECF National Environmental Consultative Forum

NETS National Enabling Technology Strategy (DIISRTE program)

NZ EPA New Zealand Environmental Protection Agency

OCS Office of Chemical Safety

octaBDE octabromodiphenyl ether

OECD Organisation for Economic Co-operation and Development

OWS Office of Water Science (DSEWPaC)

PACIA Plastics and Chemicals Industries Association

PBT persistent bioaccumulative and toxic (chemicals)

PCN polychlorinated naphthalenes

PEC Priority Existing Chemicals

pentaBDE pentabromodiphenyl ether

PFAS perfluoroalkyl sulphonates

PFC perfluorinated chemicals

PFCA perfluoroalkyl carboxylic acid

57


PFHxA perfluorohexanoic acid

PFOA perfluorooctanoic acid

PFOS perfluorooctanyl sulfonate

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

SCEW Standing Council on Environment and Water (COAG committee)

SCOC Standing Committee on Chemicals

STD Standard notification category (NICNAS)

SUSMP Standard for the Uniform Scheduling of Medicines and Poisons (see Poisons Standard, Glossary, above)

SWA Safe Work Australia

TAG Technical Advisory Group (NICNAS)

TFHA Task Force on Hazard Assessment

TGA Therapeutic Goods Administration

TiO2 Titanium dioxide

UNCED United Nations Conference on Environment and Development

UNEP United Nations Environment Programme

US EPA United States Environmental Protection Agency

UVCB Unknown or Variable composition, Complex reaction products or Biological materials

WHO World Health Organization

WHS work health and safety

WPMN Working Party on Manufactured Nanomaterials

58

INDEXA

abbreviations and acronyms (NICNAS), 54

advertising (NICNAS), 37

advice – technical and other (NICNAS), 4-5, 44,

advisory groups (NICNAS), 6, 38-40

AICS, see Australian Inventory of Chemical Substances,

Animal testing (alternatives to), 12

annual reporting (NICNAS), 13, 30

APEC chemical dialogue and regulators forum, 16, 44

assessment/s,

and prioritisation of chemicals on the AICS inventory (IMAP) project (NICNAS), 8-11,

chemicals used in coal seam gas extraction, 11-12

existing chemicals, 10, 30-34

new chemicals, 7-8, 29-30

Attorney-General’s security chemicals framework program, 12,

audits / auditing, and investigation / monitoring (NICNAS), 13, 18, 35-36,

new chemicals, 13, 30

registration, 17-19, 34-35

Australia-Canada Bilateral Agreement, see international harmonisation

Australian Competition and Consumer Commission (ACCC), 4, 10

Australian Government Department of Health (Health) and Ageing (DoHA), 3-4

portfolio budget statement (PBS), 41-42

regulatory plan, 3

Australian Government Department of Industry (Industry) and Innovation, Science, Research and Tertiary Educations (DIISRTE), 17,

Australian Government Department of the Environment (Environment) / Sustainability, Environment, Water, Population and Communities (DSEWPaC), 4, 5, 14, 17, 18

Australian Inventory of Chemical Substances (AICS), 2, 3,

assessment and prioritisation of chemicals, see inventory multi-tiered assessment and prioritisation (IMAP), 9-11

improvements, 11

listings and search requests, 42

Technical Advisory Group, 40

Australian Pesticides and Veterinary Medicines Authority (APVMA), 3

59


B

Better Regulation Ministerial Partnership (BRMP) review, 13

business (NICNAS)

management, 19-22,

plan, 21

C

Canada, bilateral agreement, see international harmonisation

certificate (assessment) applications, 7-8, 29-30

certified agreement (NICNAS) see enterprise agreement (NICNAS)

chemicals (industrial),

cooperative assessment program (OECD), 15

exempt from notification, 13, 29-10

hydraulic fracturing, see hydraulic fracturing,

low regulatory concern (LRCC), 8, 42

regulation, 3

safer, 8,

security concern (report), see Attorney-General’s

see also existing chemicals assessment

see also new chemicals assessment

Clearing House (new chemicals) OECD, see new chemicals

Coal seam gas (CSG) chemicals, see hydraulic fracturing, assessment/s, chemicals used in coal seam gas extraction

committees (NICNAS), 38-40

communication/s (NICNAS), 36-37

Community Engagement Forum (NICNAS), 38

complaints (NICNAS), 21

compliance (NICNAS),

and enforcement program activities (NICNAS), 17-19

mandatory reporting requirements, 18-19

training for industry, 17

with DoHA regulatory requirements (NICNAS), 49

conferences, workshops and meetings attended (NICNAS), 43-44

consultancy services let during the year (NICNAS), 28

contact details (NICNAS), iv

core activities (NICNAS), 7-22

corporate governance (NICNAS), 2-6

60

cosmetics (NICNAS), 14

advisory group (NICNAS), 38

reform, 14

ultraviolet (UV) filters, see sunscreens, data requirements

cost recovery impact statement (NICNAS), 13

see also financial performance

CSIRO, 11

customer survey (NICNAS) see stakeholder survey

D

Department of Health and Ageing (DoHA), see Australian Government Department of Health (Health) and Ageing

dibutyl phthalate (DBP), 10

diisononyl phthalate – DINP (assessment), 10

dimethoxyethel phthalate – DMEP (assessment), 10

dimethyl phthalate – DMP (assessment), 10

Director’s report (NICNAS), 1

E

ecologically sustainable development (ESD), 48-49

employees (NICNAS), see people

endocrine disrupters, 12

engagement – stakeholder (NICNAS), 6, 9, 38

enterprise agreement, staff (NICNAS) , 20-21

environment, see ecologically sustainable development

European chemicals agency (ECHA), 16

existing chemicals (NICNAS), 8-11

assessments, 8-11, 30-32

priority (PEC) reports, 10, 30-32

secondary notifications, 10

see also assessments

see also international harmonisation

Existing Chemicals Program Review / reform (NICNAS) scorecard, 8, 32

F

financial,

performance (NICNAS), 19-20

revenue (NICNAS), 19

statements (NICNAS),24-27

flame retardants,

61


HBCD,

HCBD,

Food Standards Australia New Zealand (FSANZ), 3

fracking chemicals, see assessment/s, chemical used in coal seam gas extraction, hydraulic fracturing

freedom of information (NICNAS), 21

functions (NICNAS), see role, governance and structure

G

Globally harmonised system for classification and labeling of chemicals (GHS) (United Nations), 5

Glossary, 52

governance (NICNAS), see corporate governance

H

Handbook for Notifiers (NICNAS), 36

harmonisation, see international harmonisation

hazardous substances Information system (HSIS), 10

health, safety and environment outcomes (NICNAS), 9-10

hexabromocyclododecane (HBCD), see flame retardants

human resources (NICNAS), see people

hydraulic fracturing, 11-12

I

IGCC, see Industry Government Consultative Committee

IMAP framework (NICNAS), see assessment and prioritisation of chemicals on the AICS inventory

industrial chemicals, see chemicals, industrial

industrial nanomaterials, see nanomaterials

Industrial Chemicals (Notification and Assessment) Act 1989 (the Act), 2,

Industry Engagement Group (IEG) (NICNAS), 38-39

Industry Government Consultative Committee (IGCC) (NICNAS), 38-39

industry sectors for new chemicals, 29

Information Publications Scheme, 21

information technology (IT) (NICNAS), 21-22

inquiries (NICNAS), 36, 42

international harmonisation / partnerships, 13-14, 43-45

and work sharing activities, 8, 10-11,

visitors to NICNAS, 43-44

Bilateral:

62

arrangement with Canada, ECHA, NZ EPA, US EPA, 16

Multilateral:

with APEC, OECD agencies, UNEP, WHO, 15-16, 44

International treaties,

Rotterdam convention compliance and arrangements, 15, 35

Stockholm convention compliance and arrangements, 15

internet home page address and internet address for report (NICNAS), iv

inventory (NICNAS), see Australian Inventory of Chemical Substances,

inventory multi-tiered assessment and prioritisation (IMAP),

chemicals assessments, 9-11

launch, 9, 43

lead compounds in inks and coatings, 14

legislative changes, 13, 14

L

letter of transmittal, iii

low regulatory concern chemicals (LRCC), see chemicals

M

media inquiries (NICNAS), 37

memorandum(s) of understanding

States and Territories MOU Group, 6, 40

with NZ EPA and ECHA, see international harmonisation,

Millfluid PC-51 (NICNAS assessment), 10

Model Work Health and Safety Regulations, see regulations

MOUs see memorandum(s) of understanding

N

nanomaterials (industrial),16-17, 36

NICNAS regulatory activities, 16-17

working party on manufactured (OECD), 16, 36, 44

Nanotechnology Advisory Group (NICNAS), 40

national enabling technologies strategy (NETS), 17

new chemicals (NICNAS), 7-8, 29-30

assessment, see assessment/s

Clearing House (OECD), 15

enhancements (NICNAS), 7, 41

see also assessments

see also international harmonisation

63


O

occupational health and safety and assessments (NICNAS), see work health and safety assessments

see also people

octabromodiphenyl ether (octaBDE), 15

Office of chemical safety (OCS), 4

Office of Water Science, 12

Organisation for Economic Cooperation and Development (OECD), 15, 16

Working Party on Manufactured Nanomaterials, 16

see also Rotterdam Convention

see international harmonisation

organisational structure / chart (NICNAS), 5

outreach see training

P

pentabromodiphenyl ether (pentaBDE), 15

people (NICNAS), 20-21

occupational health and safety, see work health and safety assessments, staff

profile,45-46

training and development, 46

perfluorinated chemicals (PFCs), 15, 44

substitutes, 7-8

performance (NICNAS),

against government expectations, 50-51

pay (bonuses), 21

permits, assessment (NICNAS)

applications, 29-30

persistent organic pollutants, see international treaties, Stockholm convention

PFOA, PFOS, see perfluorinated chemicals

poisons scheduling,

scheduling delegate (role/actions), 4, 10

polymer in Milifluid®, 10

portfolio budget statement (PBS) see Department of Health (Health) and Ageing (DoHA)

Principal Scientists (NICNAS), 13, 45

Prior Informed Consent (PIC), see international treaties, Rotterdam Convention

prioritisation of chemicals on the inventory, see assessment/s, and prioritisation of chemicals on the inventory

priority existing chemicals (PECs) (NICNAS), see existing chemicals assessment

64

priority projects (NICNAS), 7, 13, 14, 16-17, 21-22, 41

publications (NICNAS), 20-21, 36

Q

Quantitative Structure Activity Relationship (QSAR), 12, 43, 44

R

reform

program (NICNAS), 5, 11-12

initiatives (NICNAS), 13-14, 33

registration (NICNAS),17-19, 35-36

regulation / regulatory approach, 3,

plan (NICNAS), 3

requirements (DoH), NICNAS compliance with,

strategy program (NICNAS), 13-17

revenue and expenses, see financial performance

role, governance and structure (NICNAS), 2-6

Rotterdam Convention on Prior the Informed Consent Procedure on Certain Hazardous Chemicals and Pesticides in International Trade, see international treaties, Rotterdam

S

Safe Work Australia, 4

safety data sheets, 4

science

strategy (NICNAS), 13-14

strategy and international (program), 11-13

scientists, principal, see Principal Scientists

secondary notification assessments, see existing chemicals

security, chemicals of concern, see Attorney-General’s

senior executive (Heads of Program) and responsibilities (NICNAS), 45

service charter (NICNAS),

staff (NICNAS), see people

Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), see poisons scheduling

Standing Committee on Chemicals (SCOC), 4, 15,

Standing Council on Environment and Water (SCEW), 4

States and Territories Memorandum of Understanding Group (NICNAS), see memorandum/s of understanding

65


Stockholm Convention, see international treaties

structure (NICNAS) see role, governance and structure

Sunscreen Standard

Revised Australian/New Zealand, 14

survey (stakeholder) (NICNAS), 47

T

Technical Advisory Group (TAG), see AICS

training and development (NICNAS),

for industry/community,17

for staff, 43-44, 46

treaties, see international treaties

U

United Nations Environment Program, see environment

US (United States) see international harmonisation

W

website (NICNAS), 21-22

visitors, 37, 42

weight of evidence (approach to assessment), 12

work health and safety assessments, staff (NICNAS), 21

National Industrial Chemicals Notification and Assessment Scheme

ANNUAL REPORT 2012–13

www.nicnas.gov.auAll information in this publication is correct as at October 2013 10

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