NIC_02/03_cover
NICNAS ANNUAL REPORT 2002-03 ACHIEVEMENT THROUGH STRATEGIC ALLIANCES
02- 03
ANNUAL REPORT 2002-03
ACHIEVEMENT THROUGH STRATEGIC ALLIANCES
The Operation of the Industrial Chemicals (Notification & Assessment) Act 1989
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
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02-03
ANNUAL REPORT
ACHIEVEMENT THROUGH STRATEGIC ALLIANCES
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?Commonwealth of Australia 2003
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ISSN 1037-6909
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The Hon Trish Worth MP
Parliamentary Secretary to the Minister for Health and Ageing
Parliament House
Canberra ACT 2600
Dear Parliamentary Secretary
I have pleasure in submitting to you for presentation to the Parliament,
the Annual Report of the Operation of the Industrial Chemicals (Notification
and Assessment) Act 1989, as amended (the Act), for the year ending
30 June 2003.
The Annual Report details the performance of the National Industrial
Chemicals Notification and Assessment Scheme (NICNAS) against
outcome and output measures as detailed in the Portfolio Budget
Statements for the period 1 July 2002 to 30 June 2003.
The Annual Report has been prepared in accordance with section 108 of
the Act.
A summary of financial information for NICNAS is included in this report.
Audited financial statements for NICNAS can be found in the Australian
Government Department of Health and Ageing Annual Report 2002-03
reflecting administrative arrangements for 2002-03.
Yours sincerely
Dr Margaret Hartley
Director
NICNAS
26 September 2003
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Contact
National Industrial Chemicals Notification
and Assessment Scheme
GPO Box 58
Sydney NSW 2001
Australia
T +61-2-8577 8800
F +61-2-8577 8888
Freecall: 1800 638 528
www.nicnas.gov.au
Annual Report web page:
www.nicnas.gov.au /publications /annualreports /2002-03 /
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Contents
3 Letter to Minister
4 Contact Details
5 Contents
6 Glossary
10 List of Appendices
12 Director's Overview
20 Corporate Overview
26 Management and Accountability
38 Reform Initiatives
50 Operational Performance
52 Assessment
52 ?New Chemicals
64 ?Existing Chemicals
70 Harmonisation Activities
74 Compliance
82 Communication and Services
90 Compliance with Annual Report Guidelines
92 Appendices
137 Index
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Glossary
This glossary contains a brief description of terms relevant to an
understanding of the NICNAS Annual Report for 2002-03. The terms
described in the glossary do not substitute for definitions contained in the
Industrial Chemicals (Notification and Assessment) Act 1989 (the Act).
An interpretation of terms relevant to the operation of the Industrial Chemicals
Notification and Assessment Scheme is given in Part 1 Section 5 of the Act.
the Act Commonwealth Industrial Chemicals (Notification and Assessment) Act 1989
Administrative Appeals body which provides independent review of a wide range of administrative
Tribunal (AAT) decisions made by the Australian Government and some non-government
bodies
audit formal review of procedures and practices in relation to obligations under
the Act
Australian Department provides data to help improve the Department's performance as an
of Health and Ageing organisation while at the same time making it a better place to work
Staff Survey
Australian High Volume list of information about chemicals manufactured in and/or imported into
Industrial Chemicals Australia in quantities greater than or equal to 1000 tonnes
(HVIC) list
Australian Inventory of list of chemical identity data maintained by NICNAS; legal device that
Chemical Substances distinguishes new from existing chemicals and lists all industrial chemicals
(AICS) in use in Australia between 1 January 1977 and 28 February 1990; includes
new assessed chemicals since February 1990 and corrections as required
Australian Public articulated in section 10(1) of the Public Service Act 1999; provide
Service (APS) the real basis and integrating element to the Australian Public Service, its
Values professionalism, its integrity and its impartial and responsive service to the
government of the day
Business Plan for document describing the performance measures and data for NICNAS and
NICNAS how these relate to the NICNAS Strategic Plan
candidate list list of chemicals selected for possible assessment, following a screening
process, from chemicals nominated to NICNAS by industry, unions, the public
and government
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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
Concise International concise, informative document published under the IPCS that provides a
Chemical Assessment summary of the relevant scientific information concerning the potential effects
Document (CICAD) of a chemical on human health and/or the environment
consultancy procurement of external specialists to provide advice and services where
NICNAS staff either do not have the expertise or have overriding obligations
Director Director of NICNAS
due diligence level of judgement, care, prudence, determination and activity with which a
person would reasonably be expected to perform under particular
circumstances
ecologically sustainable using, conserving and enhancing the community's resources so that ecological
development (ESD) processes, on which life depends, are maintained and the total quality of life,
now and in the future, can be enhanced
existing chemicals industrial chemicals other than new industrial chemicals
industrial chemical chemical that has an industrial use (whether or not it also has other non-
industrial uses)
Industry Government primary consultative body for industry and government on NICNAS matters;
Consultative Committee among other things, reviews the utilisation of resources against NICNAS
(IGCC) objectives under terms of reference set by the Minister
International Program co-operative venture of the World Health Organisation, International Labour
on Chemical Safety Organisation and United Nations Environmental Programme formed with the
(IPCS) objective of establishing the scientific basis for the assessment of the risk to
human health and the environment from exposure to chemicals and to
provide technical assistance to strengthen national capacities for the sound
management of chemicals
Low regulatory concern industrial chemicals which could qualify for reduced regulatory input on the
chemicals (LRCC) basis of a definition of low risk or where regulatory input from elsewhere is
sufficient to meet Australian requirements
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Material Safety Data document that describes the properties and uses of a substance, i.e. identity,
Sheet (MSDS) chemical and physical properties, health hazard information, precautions
for use and safe handling information
Memorandum of agreement between parties that details mutual obligations in relation to
Understanding (MOU) services and/or the exchange of information (relating to industrial chemicals)
new chemicals industrial chemicals (including polymers) not listed on the Australian Inventory
of Chemical Substances
occupational health and general area of concern in employment which spans the physiological and
safety (OHS) psychological needs and well-being of persons engaged in occupations, work-
related trauma and death, the prevention of work-related trauma and death,
the protection from, or from risk of, work-related trauma and death, and the
rehabilitation and retraining of persons who have suffered work-related trauma
(CCH Occupational Health and Safety: Glossary, CCH International, 1992)
Office of Chemical part of the TGA Group of Regulators in the Australian Government Department
Safety (OCS) of Health and Ageing and comprises NICNAS; public health risk assessment
for veterinary chemicals, pesticides and other environmental chemicals;
establishment of public health controls and standards, and the secretariat for,
poisons scheduling; and compliance and monitoring of narcotics and other
prohibited goods under UN Treaties and the Customs Act.
Organisation for groups 30 member countries sharing a commitment to democratic
Economic Co-operation government and the market economy; plays a prominent role in fostering
and Development good governance in the public service and in corporate activity; work covers
(OECD) economic and social issues from macroeconomics, to trade, education,
development and science and innovation
Outcome in the context of the PBS, a stated goal for achievement by an organisation
Output in the context of the PBS, a set of activities and products that contribute
to the achievement of a stated goal of an organisation (outcome); subject
to performance standards
Portfolio Budget document that details proposed allocation of resources to government
Statement (PBS) outcomes by agencies within a portfolio; facilitates understanding
of the proposed appropriations in Appropriation Bills and provides sufficient
information, explanation and justification to enable parliament to understand
the purpose of each outcome proposed in the Bills
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priority existing chemical declared by the Minister for assessment under the NICNAS
chemical (PEC) 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
Screening Information agreed minimal data set as determined by the OECD that allows
Data Set (SIDS) for the establishment of the hazards of a specific industrial chemical
Service Charter for document that spells out the types, levels and standards of service NICNAS
NICNAS clients can expect from the organisation, including details of complaint
resolution procedures
SIDS Initial Assessment OECD Existing Chemicals Programme report of hazards of a specific industrial
Report (SIAR) chemical based upon an evaluation of an OECD Screening Information
Data Set
Strategic Plan for document that details the strategies NICNAS will use to achieve its stated
NICNAS goals and values for the three years 2002-05
Therapeutic Goods is a unit of the Australian Department of Health and Ageing
Administration (TGA)
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Appendices
PAGE APPENDIX
93 01 Compliance with Mandatory Reporting Requirements Under
The Act
94 02 External Accountability Arrangements
100 03 Organisational Chart, Staff Profile, Training and Development
Activities
103 04 Consultancies Commissioned
104 05 Media Advertising Organisations Engaged by NICNAS 2002-03
105 06 Ecologically Sustainable Development (ESD)
108 07 Types and Categories of NICNAS Assessments
113 08 New Chemicals Notification and Assessment Statistics
118 09 Confidential Listing of Chemicals on the Australian Inventory
of Chemical Substances
119 10 Summary of Existing Chemicals Assessment Activity
124 11 Partnership Agency Assessment Performance
125 12 List of Chemicals that had Agreed International Assessments
127 13 Presentations, Conferences, Harmonisation and International
Meetings and Site Visits undertaken by NICNAS
132 14 Inquiry Statistics
133 15 NICNAS Web Site Usage Statistics
135 16 NICNAS New and Revised Publications and Media Coverage
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Why partnerships are so
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important to NICNAS
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Good regulation is achieved by the regulator balancing the needs of industry
with the community's expectation for safety, and in delivering the regulatory
process as efficiently as possible. While NICNAS undertakes scientific
assessment to identify the potential risks associated with industrial chemicals,
the actual control and management of chemical risk is undertaken by other
national agencies and/or regulatory authorities in the states and territories.
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OVE and the community are important in achieving environmentally sound
management of chemicals.
There is a paradox that the regulation of industrial chemicals, which has
a lighter touch regulation compared with other chemical sectors, has the
greatest complexity in its structure and delivery of regulatory objectives.
Complexity is brought about by the large number of players at various levels
of government involved in delivering safe use of chemicals for workers,
the public and the environment.
NICNAS stakeholders in a number of reviews over the past few years,
including in the small business deregulation review, Time for Business, have
raised complexities as an area of frustration for business. Most recently, the
issue of regulatory complexity in the number of agencies delivering industrial
chemicals management at the various tiers of government, triggered a call by
industry for regulatory reform under the Chemicals and Plastic Action Agenda.
The Government, in responding to the industry Action Agenda report, agreed
to look at a range of regulatory issues including best practice, efficiency and
effectiveness and streamlining options. A feature of the Government's
commitment was to introduce flexibility into NICNAS's assessment processes
to allow fast tracking of previously assessed new chemicals without
compromising health and safety standards.
In March 2003, the Environment Protection and Heritage Council released a
report by its National Chemicals Taskforce Towards Sustainable Management
of Chemicals in Australia noting that the complexity in chemicals regulation
in Australia is ongoing and the problem was both at the `institutional
and legislative framework' level.
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For NICNAS to deliver its goal of `safe and sustainable use of industrial
chemicals', effective partnerships between the regulator, industry and the
community and collaborative alliances with the wide range of downstream
controls agencies are vital.
It is for these reasons we aim to work collaboratively with our colleagues and
our external stakeholders. In doing this, NICNAS has established formal
governance arrangements involving industry and government (Industry
Government Consultative Committee) and the states and territories (State
and Territory Memorandum of Understanding Group). This year saw the
establishment of an MOU between NICNAS and the National Occupational
Health and Safety Commission (NOHSC) in recognition of the Commission's
role in providing the national framework for hazardous chemicals in the
workplace.
Further strategic alliances have come from the formation of the Office of
Chemical Safety within the Australian Government Department of Health and
Ageing which has provided closer links to the public health standard setting
arrangements for chemicals (poison scheduling) and a leadership role for
NICNAS in the Government's chemicals clearing house which was
established to deliver key chemical policy issues in an efficient and effective
manner.
NICNAS has played a lead role in establishing the Science Forum on
regulatory best practice in scientific risk assessment methods. The success of
these strategies is seen by recent comments from the industry's Chemicals
and Plastic Leadership Group which "acknowledges improvements in
consultation and dialogue across agencies through initiatives such as the
Science Forum".
NICNAS continued to build on its strategic initiatives from the previous year
by focusing its existing chemicals assessment program on chemicals that
were of national significance primarily through environmental initiatives such
as the Air Toxics Program and review of fuel additive under the Fuel Quality
Standards Act 2000. We have also responded to priority workplace issues for
certain chemicals through our links to the NOHSC. This has seen our
assessment program deliver high quality scientific risk assessments that have
been used to determine chemical management options and strategies
nationally. The 2002-03 customer survey provided positive feedback noting
"high scientific quality and well balanced" assessments.
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We have committed considerable resources to work within the OECD this year
aimed at sharing assessments between countries; culminating in the signing
of a bilateral agreement with Canada. Work flowing from this activity includes
the development by NICNAS of an electronic notification and assessment
template for new industrial chemicals that has been adapted by the OECD
and promoted for global use. This alone, has enormous potential to deliver
efficiencies and saving to industry with a single globally accepted notification
and assessment report for new chemicals.
The considerable efforts we have made in reform and innovation are reflected
in the fact that we now require a separate chapter on these activities in this
year's Annual Report.
A key achievement of 2002-03 has been the Low Regulatory Concern
Chemicals (LRCC) reform initiative. The success of the LRCC can be
attributed to government, industry and the community working together to
deliver better regulatory outcomes through a balance between developing
actions to reduce the compliance burden with actions to strengthen
compliance, transparency and access to chemicals safety information.
To date, community consultation has been carried out on a program specific
basis and we have established a technical advisory group (TAG) to the
Director on matters pertaining to the establishment of public interest test
against commercial interest for confidential listing of chemicals on our
inventory. The TAG has general expertise on a broader range of public
interest and community right to know issues. The TAG serves to provide
"expertise and assistance to NICNAS in other matters where the public
interest is involved. These include other situations in the NICNAS legislation
that call for decisions based on the public interest, acting as an informal
public interest sounding board and participating in regular and ongoing
public consultation meetings and workshop with NICNAS stakeholders."
I am pleased that one outcome of the LRCC is the establishment of a formal
community consultation committee which will be added to NICNAS's
governance and accountability arrangements in 2003-04.
Another benefit of having open and effective dialogue with our partners is that
NICNAS becomes more open to new ideas and different ways of delivering
our goal of safe use.
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The outstanding performance of NICNAS in 2002-03 is reflected by the
positive feedback we continue to enjoy in relation to our scientific excellence,
our focus on customer service and the efficiency with which we deliver
the regulatory program.
We have noted a significant improvement in the level of service -
NICNAS is very supportive to industry needs.
Staff are very professional.
Industry Customer Survey response ?June 2003
NICNAS was highly successful in achieving its planned outputs
and outcomes for 2002-03. A summary of key achievements follows.
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Key Achievements 2002-03
Assessment ?Assessed 125 new chemical certificates and 151 new chemical permits to agreed targets
?New ?26 new notifications in new template format with 15% fee rebate
Chemicals
?21% of new chemical permit applications now on new electronic template
?29% increase in industry responsiveness to commenting on final new chemical reports
(1-14 days)
?Implementation of state-of-the-art tracking system for new chemical notifications
?Enhanced alliances with OECD member countries sharing new chemical assessment
methodology and assessment knowledge to enhance NICNAS activities with a 140%
(from 5 in 2001-02 to 12 in 2002-03) increase in new chemical notification using
overseas (particularly Canadian) assessment reports
Assessment ?2 priority existing chemicals (PECs) reviewed, introduction of NICNAS Alerts for chemicals
?Existing of concern and focused information sheets on priority chemicals
Chemicals ?Building information sources for chemicals on the High Volume Industrial Chemicals List
with 10 new information sheets produced
?Continued use of overseas existing chemical assessments within NICNAS assessment
program (for example, as a basis for information sheets)
?Stronger strategic alliances with stakeholders through participation in (for example):
?waste water treatment factors workshop with state and territory environment protection
authorities,
?national air toxics program,
?NOHSC Chemical Standards Sub-Committee
Reform ?Delivery of reform initiative on Low Regulatory Concern Chemicals (LRCC) through
a partnership effort between government, industry and the community
?In-principle agreement to the LRCC Final Report and Recommendations by the
Parliamentary Secretary for Health, the Hon Ms Trish Worth MP
?Amendment of the Act to increase the quantity from 2 to 4 tonnes under a commercial
evaluation permit
?Amendment to regulations for enhanced data requirement and improved reporting
for health and environmental effects for commercial evaluation permits
?Bilateral agreement with Canada established
Compliance ?144 compliance case investigations completed within target timeframes
?Raised awareness of industry's obligations under NICNAS by completing 18 site visits
?Development and review of compliance procedures and policies
?Upgrade and publication of AICS CD-ROM
Communication ?Redesigned web site and increase (42%) in web site usage from 9,610 to 13,621 hits
each day
?150 media inquiries leading to increased public awareness of chemical safety issues
?Increased awareness of chemical safety issues by NICNAS presence in industry and
professional conferences and workshops
?Publication of chemical safety information targeted for industry, the public and workers
?Three successful IGCC meetings
?Two successful State and Territory MOU Group meetings
?Service Charter performance targets met, survey results show high industry client
satisfaction
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This year also saw NICNAS complete negotiations with IGCC to implement
new fees and charges following an activity based costing study, which
indicated cross-subsidisation was occurring for certain new chemical
categories. The new fees and charges will be implemented from 1 July 2003.
Future Directions
Our focus for 2003-04 will be on regulatory efficiency. This will see the
continuation of the reform agenda and an increase in the flexibility for our
operations.
Key activities will include:
?Increasing the flexibility of the Scheme for new chemicals by implementing
LRCC reforms including:
?Establishing NICNAS Community Consultative Committee
?Introducing audited self-assessment for industry
?Develop and implement compliance strategies for chemicals
introduced under LRCC
?Increasing availability of new electronic template for notification
and assessment
?Recognising Canada as an approved foreign scheme under the
Act
?Reviewing the efficiency and effectiveness of the Existing Chemicals
Program and position the Program to be more responsive to stakeholders'
needs
?Providing information for a greater number of existing chemicals by
broadening the range of information products
?Strengthening links with other national schemes, including New Zealand
?Improving compliance programs (including enforcement techniques) with a
focus on developing partnership with industry and strengthen compliance
links with state and territory agencies, customs and others
?Improving NICNAS web site with a focus on AICS online, annotation of AICS
with links to chemicals information elsewhere on the site, introduction of
FAQs and an A-Z search index.
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EW OVERVIEW OVERVIEW OVERV
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Corporate Overview
Role and Functions
The National Industrial Chemicals Notification and Assessment Scheme
(NICNAS) aids in the protection of workers, the public and the environment
from the harmful effects of industrial chemicals. NICNAS operates under
Commonwealth legislation known as the Industrial Chemicals (Notification
and Assessment) Act 1989 (the Act).
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The Scheme aims to ensure the safe use of chemicals by making risk
assessment and safety information on chemicals and their potential
occupational health and safety (OHS), public health and environmental risk
widely available to workers, the public, industry and other state, territory
and federal government agencies.
NICNAS assesses industrial chemicals that are new to Australia for their
health and environmental effects before they are used or released to the
environment. NICNAS also assesses those chemicals that are already in use
in Australia (known as `existing chemicals') on a priority basis in response
to specific concerns about potential health and/or environmental effects.
Organisational Structure
NICNAS is a statutory scheme. The Director of NICNAS is a statutory office
holder and has specific functions and powers under the Act. In the exercise
of these functions, the Director is directly responsible to the Parliamentary
Secretary to the Minister for Health and Ageing. NICNAS moved from the
Department of Employment and Workplace Relations to the Department of
Health and Ageing (DoHA) with effect from 3 July 2002 and is located within
the Office of Chemical Safety within the TGA Group of Regulators.
This placement provides for an ongoing, consistent approach to the
protection of human health from the effects of industrial chemicals. NICNAS
has continued to build on its team-based organisational structure within the
Office of Chemical Safety structure further utilising the considerable synergies
collocation with other chemical regulatory functions within the Department
of Health and Ageing has brought.
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Co-operative Arrangements
Partnership arrangements with the Australian Government Department
of Environment and Heritage (DEH) are in place for the provision of
environmental risk assessments (including hazard and exposure).
NICNAS contracted corporate services on a fee-for-service basis from both
the Therapeutic Goods Administration (TGA) and the DoHA for 2002-03.
In addition, IT, library services and property services were purchased from
National Occupational Health and Safety Commission (NOHSC) under a
Memorandum of Understanding (MOU).
Outcome and Output Framework
NICNAS's mission is to be recognised as the leading national authority for
the scientific assessment and management of risks to people and the
environment associated with the use of industrial chemicals. NICNAS works
to encourage the safe and sustainable use of industrial chemicals, including
cosmetics.
NICNAS pursues its goal of safe chemical use through the scientific
assessment of chemical risk and by making recommendations for controlling
these risks. NICNAS assessment information is made widely available and
assists state and territory occupational health and safety (OHS), public health
and environmental agencies in regulating the control of use, release and
disposal of industrial chemicals. NICNAS assessments also provide risk
and safety information to industry, workers and the public to promote greater
awareness of the dangers of chemicals and how to use chemicals safely.
NICNAS's activities are within the DoHA portfolio budget statement (PBS)
outcome/output structure for 2002-03. NICNAS's outcome /output statements
were originally included in NOHSC's PBS under Outcome 2, before NICNAS
was transferred to DoHA on 3 July 2002. Adjustments for the transfer went
through the Portfolio Additional Estimates Statements for 2002-03. The
relationship between the NICNAS Outcome and contributing Output is shown
in Figure 1. The performance measures used for accounting against outputs
and outcomes are shown in Table 1.
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Figure 1 NICNAS Outcome / Output statements
Outcome 1: Population Health and Safety
To promote and protect the health of all Australians and minimise the
incidence of preventable mortality, illness, injury and disability.
Achieved through:
Output Group 1 Policy Advice; and
Output Group 3 Agency Specific Service Delivery
(regulatory activity through pre-introduction of new industrial
chemical assessments and review of priority existing chemicals for
health and environmental risk).
Estimate ($m) Actual ($m)
Total Price of Outputs: $3.725 $4.388
Departmental Outputs Appropriation: $3.7 $4.236
Note: The above appropriation is cost recovered funds. The additional funds associated with
the total price come from Government and are applied specifically to cover 50 per cent of the
costs of NICNAS's compliance program as well as technical policy work undertaken by the
staff of NICNAS for the Government.
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Table 1 NICNAS performance information against Output
Output PBS Performance Measures
Effective Regulation through: Quality
?pre-introduction assessment ?evaluations and appeals of decisions
of new industrial chemicals of applications for industrial chemicals
and review of priority existing are made within legislative and other
chemicals (including for OHS agreed timeframes
and public health and ?number of NICNAS recommendations
environmental risk); and adopted
Quantity
?timely production of quarterly and
annual reports
?number of assessments for new
chemicals
?number of existing chemical reviews
(contributing to a target rate of
50 chemicals over a 3-year period)
?provision of information. Quality
?high level stakeholder satisfaction with
relevance, quality and timeliness of
information and education services
Quantity
?number of publications circulated
including 3 issues NICNAS matters,
12 issues NICNAS Chemical Gazette
?5% growth in internet site user
sessions
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Regulatory Framework Linkages
NICNAS is one of the four main regulatory assessment and/or registration
schemes for chemicals within the Australian Government. The Scheme
is designed to be complementary to other regulators (food, medicines,
pesticides) and to avoid duplication of assessment and safety regulation.
To avoid duplication of assessment activities, NICNAS has the lead in the
risk assessment for industrial chemicals and provides these assessments
to other federal and state/territory agencies and authorities. NICNAS's
assessment partnership with the DEH on environmental issues allows
for efficient consideration by the appropriate authorities for downstream
control and regulation of chemicals.
In general, the control of the supply, use and disposal of chemicals
is a matter for state and territory law.
For worker safety issues, nationally consistent OHS regulations
are achieved through the jurisdictions adopting the NOHSC Model
Regulations for the Control of Workplace Hazardous Substances.
The NOHSC model regulations consist of codes of practice and guidance
notes (e.g. classification, labelling, material safety data sheets (MSDS),
exposure monitoring). NICNAS applies the NOHSC classification,
labelling and MSDS codes to its assessments and recommendations to
facilitate a consistent national approach to achieving safe chemical use.
These linkages on OHS policy and practice were formalised for 2002-03
through a MOU between NOHSC and the DoHA.
Public health safety for chemicals is achieved in part, through
appropriate controls via the Standard for the Uniform Scheduling
of Drugs and Poisons (SUSDP). The secretariat of the National Drugs
and Poison Scheduling Committee is also located within the Office
of Chemical Safety, along with NICNAS, to further facilitate effective
regulatory processes.
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MANAGEMENT & ACCOUNTABILITY
MANAGEMENT & ACCOUNTABILITY MANAGEMENT & ACCOUNTABILITY MANAGEMENT & ACCOUNTABILITY MAN
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Management and
Accountability
Corporate Governance
The stated outcome and outputs for NICNAS's operations together with
performance measures for NICNAS are detailed in the DoHA budget
statements (PBS), the NICNAS Strategic Plan 2002-05, the NICNAS
Business Plan 2002-03 and the NICNAS Service Charter 2002-05.
ANA
In addition, certain mandatory performance requirements (such as
assessment timeframes and public reporting of prescribed information) are
established in the Act. Performance reporting against the legislation,
corporate plans and operational plans is undertaken quarterly and is detailed
in the Operational Performance section of this report.
In accordance with the Act, NICNAS also has certain annual mandatory
reporting requirements all of which were met in 2002-03 (see Appendix 01).
Internal audit arrangements are covered under the corporate service level
agreement (SLA) with DoHA. Internal audit activities for 2002-03 are reported
in the DoHA Annual Report 2002-03.
The Therapeutic Goods and Other Legislation Amendment Act 2002 was
NICNAS move to
passed by Parliament on 3 July 2002. NICNAS staff were effectively
Health transferred from NOHSC to DoHA on this date. NICNAS's library and IT
services were sourced from NOHSC for 2002-03 under a MOU signed on
27 September 2002. The MOU also includes provision of NICNAS
administrative resources to NOHSC to accommodate office supplies and
equipment needs for the NOHSC Agricultural and Veterinary Chemicals
(AgVet) Assessment Team co-located with NICNAS. NICNAS outsourced
its HR and finance and other corporate services from within the DoHA
in 2002-03.
NICNAS staff are covered by the DoHA Certified Agreement 2002-04 and
are also covered by DoHA's governance policies and practices, including
the establishment and maintenance of appropriate ethical standards under
the Australian Public Service (APS) Values and Code of Conduct, compliance
with Commonwealth Freedom of Information (FOI), Privacy and Occupational
Health and Safety legislation, Commonwealth Disability Strategy, workplace
diversity policy and other internal policies and procedures. Performance data
for governance policies and practices, relating to NICNAS, can be found in
the DoHA Annual Report 2002-03.
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NICNAS has additional internal policies to cover the physical security and
protection of commercial-in-confidence information it receives from industry
in support of chemical notifications.
In 2002-03, NICNAS received one formal complaint on its operations
compared to seven in 2001-02 and two in 2000-01.
The complaint concerned an allegation of NICNAS breaching confidential
information. This matter involved the access to third party data as part of an
application for assessment to NICNAS. The complaints process was followed
and the Director of NICNAS conducted an investigation in the ten-day period
established for resolution.
The complaint against NICNAS was found to be baseless, a fact agreed
Complaints down in to by both the notifying company and the owner of the third party data.
2002-03 As a result of the investigation, new forms are being designed at NICNAS
to better assist industry in notifying NICNAS of applications that may contain
third party data. It remains the obligation of industry to identify confidential
data matters to NICNAS at the time of submitting notifications
for assessment.
NICNAS Industry Government Consultative
Committee
Parliamentary Secretary with industry members and observers of IGCC ?prior to 16th IGCC
meeting on 13 August 2002 (L to R): Mr Terry Slater (TGA), Mr David Shaw (ACCI),
Mr Nick Munafo (PACIA), Dr Margaret Hartley (NICNAS), The Hon Trish Worth MP,
Mr Michael Hambrook (APMF), Mr Martin Jones (PACIA), Mr Geoff MacAlpine (ACSPA),
Ms Bronwyn Capanna (ACSPA), Ms Margaret Donnan (PACIA).
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The NICNAS Industry Government Consultative Committee (IGCC) was a key
IGCC leads reform driver in ensuring NICNAS continued to broaden its strategic alliances
to better shape and deliver regulatory outputs in 2002-03.
The efficient and effective utilisation of NICNAS resources and the Scheme's
operational performance are overseen by the IGCC, which is appointed by the
Minister. The IGCC membership, terms of reference and meeting details
for 2002-03 are at Appendix 02.
The IGCC met three times during 2002-03 and in addition held an out-of-
session meeting to specifically consider proposed fees and charges for
2003-04. In addition to overseeing resource utilisation and providing priority
advice on compliance, the IGCC has been a key mechanism for consultation
with industry on the transfer of NICNAS to the DoHA.
The focus of activities this year was on progressing proposed fees and charges
for 2003-04 and a number of key reform initiatives, which are detailed
at NICNAS's Reform Agenda section in this report.
IGCC members endorsed the NICNAS 2003-04 Operational Plan, the 2003-
04 Budget and at meetings during the year evaluated the efficiency
and performance of the IGCC process. Feedback included:
?papers were received on time which allowed members adequate time
to consult stakeholders;
?papers were focused and of good quality; and
?the meeting concentrated on the key issues to move NICNAS forward.
NICNAS/State and Territory Memorandum of
Understanding
The NICNAS/State and Territory Memorandum of Understanding (MOU)
State/Territory Group continued through 2002-03 as a feature of the co-operative
co-operation arrangements NICNAS has established with other governmental bodies,
continues to assist in the exchange of chemical safety information and discussion
on chemical management issues including the dissemination
and implementation of risk reduction recommendations made by NICNAS.
Chaired by the Director of NICNAS the MOU group meets biannually,
and consists of representatives drawn from the OHS authorities of the various
states and territories, NOHSC, the DEH and NICNAS. During 2002-03
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meetings were held on 7 November 2002 and 9 May 2003.
The NICNAS/State and Territory MOU Group Membership and Terms of
Reference details for 2002-03 are outlined in Appendix 02.
State and territory representatives liaise with other agencies in their respective
jurisdictions to ensure NICNAS responds to their needs in the area of
industrial chemicals and to assist with the integration of NICNAS
recommendations into the controls applying to chemical usage. The Group is
also a key consultative point of contact on reform programs at NICNAS such
as the Low Regulatory Concern Chemicals and the review of the Existing
Chemicals program.
External Scrutiny
Administrative Appeals Tribunal
The Act specifies those decisions of the Director that may be taken before the
No legal appeals Administrative Appeals Tribunal (AAT) for review. Appealable matters include
decisions on confidentiality, company registration and variations of
assessment reports.
No applications were made to the AAT during 2002-03 (compared to four in
2001-02). The total number of appeals against the Director's decisions since
the introduction of the Scheme in 1990 is seven, with five withdrawn and two
found in favour of NICNAS.
Management of Human Resources
At 30 June 2003, NICNAS employed 37 full-time equivalent (FTE) staff.
The staffing profile for NICNAS is shown in Appendix 03.
In addition 4.2 FTE assessment staff were funded by NICNAS as part of the
fee-for-service arrangements for environmental risk assessment with DEH.
In April 2003, NICNAS participated in the DoHA Staff Survey. The overall
feedback from staff indicated that most feel involved, enthusiastic and
stimulated at work. The main area for action is in career planning which will
be addressed in 2003-04.
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Training and development activities for NICNAS staff in 2002-03 are reported
in Appendix 03. A total of 135 days of formal training (approximately 3.65
days for each person) was undertaken in the year, including orientation and
induction training for new staff. Compulsory training in awareness of APS
values was introduced for all new staff and offered to all existing staff on a
voluntary basis. New staff also received compulsory customer service
training.
As part of a NICNAS-sponsored activity, four staff successfully completed
subjects in the Royal Melbourne Institute of Technology post-graduate
program 'Toxicology on-line'. Another staff member undertook other post-
graduate study under APS Study Bank provisions.
Occupational Health and Safety
During 2002-03, two OHS inspections were undertaken of the Marrickville
office. As this office houses both NICNAS and NOHSC staff, these
inspections were jointly undertaken with the NOHSC Health and Safety
Representative. The inspections indicated there were no major health or
safety issues within NICNAS. Ergonomic requirements identified for individual
staff members were all promptly addressed.
Equity Performance
NICNAS's contribution to the outcome of safe chemical use is underpinned
Public access by the accessibility of assessment reports and other information to workers,
and participation the community, industry and other regulatory agencies. To ensure open
a priority access, assessment reports, guidance documents and other information
resources are available free-of-charge directly from NICNAS and also from
the web site. Information is specifically targeted to the varied needs of the
end users. For example, the Safety Info Sheets produced by NICNAS are
specifically designed for display in the workplace.
NICNAS routinely liaises with industry applicants, employer and worker
representatives and the public through the assessment process and wide
public consultation is undertaken on changes affecting the Scheme. The
public can also nominate existing chemicals to NICNAS for consideration
for review. Any member of industry or the community can also appeal the
Director's decisions under the Act through the AAT process.
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Financial Performance
NICNAS operates on a cost recovery basis. Cost recovery is achieved in two
ways: company registration charges and fees, and fees and administrative
charges for new chemical assessments. Company registration monies fund
the assessment of existing chemicals, client awareness and education
activities, 50 per cent of the costs of compliance activities and the
administration of company registration itself. The remaining 50 per cent
of compliance activities is funded by an appropriation from the Government.
Under administrative arrangements, NICNAS's financial services matters are
Cost recovery provided through DoHA. These are purchased through a service level
arrangements agreement. These administrative arrangements include the provision of fraud
control measures, disability and purchasing strategies, and the management
of human resources.
Total funds cost recovered from industry in 2002-03 were $4,082,272.
At 30 June 2003, a total of $1,699,107 of cost recovered funds was available
for carryover into 2003-04.
Table 2 provides a summary of NICNAS's financial performance (accrual)
for the year. Auditing of NICNAS's financial performance is undertaken
as part of the TGA-wide auditing process and is included in the financial
performance reporting in the DoHA Annual Report 2002-03 where NICNAS's
financial performance also includes government appropriation.
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Table 2 NICNAS financial overview 2002-03
Revenue $'000
Assessments 1,498
Company Registration 2,527
Publication sales 18
Interest 39
Government subsidy 152
Expenditure
Salaries 2,554
Administration 434
Indirect overheads 1,400
Surplus / (Deficit) (154)
Company Registration
At 30 June 2003, there were 759 companies listed in the Register of
5% increase
Industrial Chemical Introducers. This is a 4.7 per cent increase in registered
in registered companies from 2001-02.
companies
Some 515 (68 per cent) of these companies were registered at the lower
registration level with introduction values greater than $500,000 but lower
than $5,000,000, and 244 (32 per cent) companies were registered at the
upper registration level with introduction values greater than $5,000,000.
Figure 2 shows the number of registrants by level over the six years the
company registration system has been operating.
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Figure 2 The number of registrants by level over the six years
the company registration system has been operating
Upper Registrants Lower Registrants Total
800
Steady growth in
registrations 700
600
500
400
300
200
0
1997-98 1998-99 1999-2000 2000-01 2001-02 2002-03
The number of introducers registered with NICNAS has continued to increase
each year, confirming the robustness of our compliance audit program.
Results of the NICNAS audit program for 2002-03 are detailed in the
Compliance section of this report, and continue to be on a steady rate
of increase.
Industry Compliance with Company Registration
Renewals
Industry compliance with the renewal deadline (1 August) remained low for
the year. Figure 3 shows industry's timeliness pattern in relation to renewals
over the past five years.
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Figure 3 Registrants' timeliness in company registration renewals over
the past five years
100
91 91
85
88
80
79
% of companies
60
renewed by the
55
53 52 deadline
51 50
40 % of companies
renewed 1 month
20 after the deadline
0
1998 1999 2000 2001 2002 Registration Year
Industry's compliance rate with the renewal date has been consistently low.
Industry compliance Furthermore, an average of 10 per cent of the registrants failed to renew by
remains low the start of the new registration year. NICNAS has had to allocate significant
resources on pursuing outstanding renewals and this has added substantially
to compliance costs. To address this persistent poor compliance by industry,
and in order to shift the entailed compliance costs from the general registrant
to the late registrant, a late renewal penalty will be introduced in
the registration year 2003-04 (see section on NICNAS Reform).
Consultancies Commissions and Discretionary Grants
Consultancies commissioned by NICNAS in 2002-03 are listed in Appendix
04. NICNAS did not make any discretionary grants for 2002-03.
Advertising and Market Research
Media advertising organisations used by NICNAS in 2002-03 are listed
in Appendix 05.
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Freedom of Information
NICNAS contributes
to ESD outcomes
NICNAS received no Freedom of Information requests in 2002-03.
Ecologically Sustainable Development and
Environmental Performance
NICNAS operates its chemical risk assessment activities to be consistent with
the Government's policy parameters of ecologically sustainable development
(ESD) as outlined in section 3A of the Environment Protection and
Biodiversity Conservation Act 1999. NICNAS ensures that ESD policy is
applied consistently in the assessment of environmental risk for individual
chemicals through the co-operative partnership arrangements with DEH, who
apply scientific principles and related ESD policy in undertaking
environmental risk assessment activities. Details of how the principles and
practices of ESD are applied to NICNAS risk assessment practice are found
in Appendix 06.
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S INITIATIVES INITIATIVES INITIATIVES INITIATIVES INITIATIVES INITIATIVES INITIATIVES INITIATIVES INITIATIV
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Reform Initiatives ?balancing
the needs of industry,
government and the community
Consistent with NICNAS's commitment to continuous improvement,
NICNAS's Industry Government Consultative Committee (IGCC) agreed
to a program of reforms for 2002-03. The year saw the finalisation of
a number of projects and the commencement of a new round of reform
initiatives, including the following activities:
?finalisation of the low regulatory concern chemicals reform initiative;
ATIV ?establishment of a Science Forum to promote best practice approaches
to risk assessment;
?changes to the Commercial Evaluation Permit (CEP) category;
?amendments to company registration to improve compliance;
?introduction of new fees and charges to reflect the costs of the regulatory
scheme;
?development of an electronic template for notifiers;
?recognition of Foreign Schemes including the Australia-Canada Bilateral
Arrangement;
?aligning notification and assessment reports for international harmonisation
through the OECD New Chemicals Task Force; and
?commenced the review of NICNAS's existing chemicals program.
The Low Regulatory Concern Chemicals (LRCC)
reform initiative
...a commendable job in proposing innovative and practical alternatives
to the regulatory compliance of chemicals in Australia.
Industry submission ?June 2003
The release of the Government response to industry's Chemicals and Plastics
Action Agenda in November 2002, provided a valuable framework to pursue
reform of industrial chemicals regulation, and in particular, to pursue reform
of the LRCC assessment category. The Government had agreed to consider
options to fast track assessment processes to enable industry to access
adequately assessed and/or tested chemicals more quickly. Industry,
government and the community supported the need to pursue reform
in this area and gave it a high priority. The Government requested firm
proposals for change to be put to it by 30 June 2003.
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Industry, government and community working together on LRCC
An LRCC Task Force, made up of individuals from government, industry
and the community was established to oversee the LRCC initiative and
provide expert input where needed. The membership details are provided at
Appendix 02. Technical working groups were established with members from
industry, government and the community working together to explore options
for LRCC and investigate the feasibility of implementation in Australia.
Extensive consultation was undertaken with industry and the community
Consultation sectors including focus group discussions in Sydney, Melbourne and
delivers innovative Brisbane. Advertisements seeking public comment on the Low Regulatory
ideas Concern Chemicals Public Discussion Paper ?May 2003 and its
supplementary paper, LRCC Draft Regulation Impact Assessments for Reform
Options were placed in the Chemical Gazette and The Australian on 6 May
2003 and the documents were placed on the NICNAS web site
on 7 May 2003. The public consultation period concluded on 30 May 2003,
but submissions sent as late as 23 June 2003 were accepted. Thirty-four
submissions and comments were received.
The industry submissions were highly supportive of the reform process and
the options presented in the Public Discussion Paper. In particular, industry
was highly complimentary of the way NICNAS undertook the consultation
process:
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...the success of the project has been a good example
of a leadership approach between government,
industry and the community towards finding beneficial
and practical regulatory solutions.
Industry Submission - June 2003
In providing its report, the LRCC Task Force considered that its
recommendations offered an innovative approach to introduce flexibility into
the current scheme. Amongst the recommendations, a number are new
to the current scheme, a number are aimed at modifying existing processes
to bring about a more efficient regulatory system, while a number arise as
a result of the first two categories. The success of the entire reform package
is dependant upon these three elements being implemented as a package,
not in isolation of each other. This is to ensure that full community
confidence is maintained in NICNAS and its operations while allowing
industry the benefits of the reforms. Throughout the review process,
the LRCC Task Force was aware of the need to balance the needs of industry
with those of government and the community.
The LRCC Task Force was satisfied that the reforms are consistent with
LRCC offers better international practices. The LRCC proposals are compatible with the work
regulation of the OECD New Chemicals Task Force. The submission from the OECD
Task Force supported the continued development of low regulatory concern
polymers and analogue chemicals in conjunction with the OECD so that
the potential of the work can be extended internationally. Implementation
of the proposed package will support harmonisation of the Australian
notification and assessment scheme for new chemicals amongst comparable
international schemes.
The Hon Trish Worth MP, Parliamentary Secretary to the Minister for Health
was provided with the report, Final Report and Recommendations
for NICNAS Low Regulatory Concern Chemicals (LRCC) Reform Initiative
on 24 June 2003. The LRCC Task Force sought in-principle agreement
to the 12 key recommendations put forward, noting that further work,
consultation and impact analysis would be needed prior to implementation.
The Task Force recommended that the final report and an implementation
plan be made public. The final report was placed on the NICNAS web site
on 30 June 2003.
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Science Forum for best practice approaches to
health risk assessment
I wish to express my office's appreciation for the opportunity to participate
in the inaugural Science Forum for Best Practice Approaches to Health
Risk Assessment of Chemicals. The attendance on the day was reflective
of the enthusiasm this initiative has received by practitioners across
a wide range of agencies.
Government agency response - June 2003
The Parliamentary Secretary to the Minister for Health and Ageing,
Forum delivers best
announced the establishment of the Science Forum in February 2003.
practice science The Chemicals and Plastics Action Agenda Steering Group Industry Report,
Underpinning Australia's Industrial Growth, has regulatory reform as a key
component and recommended specific measures aimed at instituting best
practice regulation. The establishment of a Science Forum for best practice
approaches to health risk assessment (Science Forum) under the auspices
of the Office of Chemical Safety (OCS) to bring together health regulatory
agencies TGA, NICNAS, Office of Gene Technology Regulator and the Food
Standards Australia New Zealand gives effect to the Government's
undertaking in relation to the Chemicals and Plastics Action Agenda on
regulatory efficiency and best practice. Other agencies with an interest in this
area such as the Agricultural Pesticides and Veterinary Medicines Authority,
the NOHSC and the DEH are also participating, as is the Environmental Risk
Management Agency (ERMA), New Zealand.
The specific objective of the Forum is to enhance the efficiency of chemicals
regulation in Australia through comparison of current regulatory assessment
practices and methods among participating agencies, consideration of
international trends and harmonisation of best practice risk assessment
methodology. The Forum will convene regularly to discuss technical issues
covering a range of risk assessment methods.
The inaugural Science Forum was held on 30 May 2003, with over 100
government regulatory scientists in attendance. The meeting included
networking and small group discussions to identify issues for consideration
at future Forum meetings. NICNAS sponsored a technical session on the
acceptability of the Mouse Local Lymph Node Assay (LLNA) as a preferred
test for assessing skin sensitisation potential. Based on the outcome of the
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Science Forum ?regulatory scientists workshop key issues
30 May 2003
technical session, the opinion of participating regulatory authorities are being
sought on endorsing this test method, noting it would represent regulatory
efficiency and best practice models across the portfolio, as well as animal
welfare benefits and reduction in safety testing costs to industry.
Changes to the Commercial Evaluation Permit
Category
Improvements to NICNAS activity concerning reform of the Commercial Evaluation Permit
commercialisation (CEP) was completed in 2002-03. The reform will ensure that all industry
opportunities sectors will be able to utilise the system to evaluate the market potential of
new chemicals while enhancing existing health and environmental standards.
The Regulation Impact Statement was finalised in September 2002 and the
Parliamentary Secretary to the Minister for Health gave policy approval for
the reforms in December 2002. NICNAS released the Final Report Reform
of the Commercial Evaluation Permit (CEP) System including the Response
to Public Comment, via notice in the Chemical Gazette and NICNAS web site
publication in February 2003. NICNAS amended procedures, forms and
checklists to reflect the administrative changes and published new guidance
on how to utilise the CEP system in the Chemical Gazette of April 2003.
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The Industrial Chemicals (Notification and Assessment) Amendment Act 2003
Enhanced health &
was introduced in to the House of Representatives on 28 May 2003, debated
safety data for CEP on 18 June 2003 and passed through the Senate on 27 June 2003. The Bill
provides for an increase in the volume for the CEP from two to four tonnes.
Amendment of the Industrial Chemicals (Notification and Assessment)
Regulations 1990 was approved by Executive Council on 19 June 2003
and gazetted on the same day, (Statutory Rules 2003 No. 121 ?Industrial
Chemicals (Notification and Assessment) Amendment Regulations 2003
(No.1)). The Regulation introduces new safety measures for the CEP system
by requiring industry to provide a summary of the chemical's health and
environmental effects.
The CEP has provided a regulatory bridging step for nearly 500 new
chemicals to be tested in the market since its inception in 1992, with about
30 per cent of these being successful and continuing in the Australian market
with further notifications to NICNAS.
Reform to Company Registration ?introduction of a
late penalty fee to improve compliance
Changes to the Act to improve industry compliance with company registration
were made in June 2003. The Industrial Chemicals (Notification and
Assessment) Amendment Bill 2003 was passed by the Senate on 27 June
2003. The need for these changes was identified in a review of Company
Registration procedures in 2000. The legislative amendments will be
implemented in the 2003-04 registration year. These changes will streamline
administration and strengthen regulatory compliance.
Key changes are:
Penalty introduced ?alignment of the registration expiry date with the renewal date, i.e. the new
deadline for renewals of registration will be 31 August each year;
?setting 31 August as the deadline for a registrant to notify the Director
of NICNAS if the registrant may not be renewable for the next registration
year;
?establishment of a late renewal penalty, in place of the current urgent
handling fee, for renewals received after the renewal deadline; and
?transfer of the fee setting provisions for company registration out of the
Act and into the Industrial Chemicals (Notification and Assessment)
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Regulations 1990 (the regulations), to allow greater flexibility in adjusting
fees to fully recover the cost of administering and implementing the Act
and regulations.
These combined measures will encourage timely renewals and strengthen
regulatory compliance. They will improve the collection of cost recovery
revenues for the health and safety and environmental regulation of industrial
chemicals in Australia.
Introduction of new fees and charges to accurately
reflect the costs of the regulatory scheme
NICNAS's IGCC agreed in February 2003 to a modest increase in fees and
charges for 2003-04. The agreed increases will be an 8.9 per cent increase
in New Chemical assessment fees and an 11.9 per cent increase in New
Chemical administrative fees and charges. The aim of the fee increases is to
generate a small surplus to ensure the financial sustainability of NICNAS. The
surplus will be used to build, over two years, an Operating Reserve with a
New fees & charges
target set at $400,000. Additional surplus funds beyond this reserve will be
for 2003-04 set-aside in an Industry Incentive Reserve for legislative and regulatory reform
to maximise the efficiency of the scheme. It is proposed that $300,000 be
allocated to this reserve. Funds in excess of this are to be placed in a Fee
Adjustment Reserve to be returned to industry as reduced fees, charges and
other adjustments.
In July 1997 NICNAS moved from 50 per cent cost recovery to full cost
recovery and increased fees and charges. In the most part, fees and charges
did not increase the full 100 per cent. From 1 July 1997 to 30 June 2002
NICNAS has incurred Consumer Price Index (CPI) increases of 14.5 per
cent, Public Sector Wage Cost Index (WCI) of 17.2 per cent and an increase
to the Super Guarantee Charge of three per cent. NICNAS has absorbed
these costs through improved efficiencies, increasing the company
registration revenue base through compliance activities and running down
reserves primarily to fund its reform activities.
During this period industry has benefited from decreased assessment times,
introduction of a 40 per cent rebate of fees for some categories, improved
reporting within time frames achieved without any increase in fees or
charges. This reflects a policy of passing efficiency gains directly to industry.
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Under the current regulatory framework, no additional avenues for further
efficiencies remain and costs continue to increase.
Development of an electronic template for notifiers
The new notification template for applications where the notifier seeks the
Streamlining available rebate for provision of a draft assessment report has been available
assessment to a number of notifiers under a pilot scheme to examine its acceptability
processes to industry and the cost savings available to NICNAS. During the year,
27 notifications using the new template were received, and these have led to
significant timesavings in the NICNAS assessment process. The availability of
the template is to be broadened in the coming year, based on these results.
A template for submission of permit applications (for Commercial Evaluation
and Low Volume Chemical permits) was provided to all interested parties
at the beginning of the year, and 32 submissions were received using this
template. The use of the permit template is increasing, with 14 out of 33
relevant applications using the template method in the last four months of the
year. Significant efficiency advantages were seen from use of this submission
method, primarily in the completeness of submissions as received, allowing
quicker consideration of applications overall.
Recognition of Foreign Schemes including the
Australia-Canada Bilateral Arrangement
The concept of collaborating with other countries working with similar
frameworks can only be welcomed as an obvious step in reducing local
(Australian) costs of compliance.
Industry Submission to LRCC Public Discussion Paper ?May 2003
Under the New Transitional Arrangements Towards Approval of Approved
Foreign Schemes, implemented in November 2001, NICNAS provides
for lower notification fees when assessment reports are available from other
OECD countries. Most foreign scheme assessment reports received by
NICNAS are from Canada, a direct result of the Australia-Canada Bilateral
Arrangement, signed by Australia in May 2002 and Canada in August 2002.
Under the Arrangement, a free Early Introduction Permit (EIP) is also
available for polymers of low concern (PLCs). Four applications under
this provision have been received this year.
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Following the successful visit to NICNAS in February 2002 by representatives
from Environment Canada, Health Canada and Canadian industry, NICNAS
representatives visited Canada in October 2002, meeting with government
and industry representatives. NICNAS delivered a paper on the bilateral
arrangement to the Canadian industry conference in Toronto and the
American Chemistry Council/Synthetic Organic Chemical Manufacturers
Association conference in Baltimore, USA. The objective of the bilateral
arrangement is to obtain meaningful financial and other benefits for
government and industry, including formal recognition by NICNAS of
the Canadian scheme as a recognised foreign scheme under the Act.
A work plan has been developed and regular teleconferences are conducted
Bilateral delivers between the scientific officers of both countries. Activities completed under
savings the work plan in 2002-03 included:
?comparison of assessment reports on selected chemicals leading
to compilation of a report outlining the lessons learned;
?exchange of guidance material for assessing industrial chemicals; and
?exchange of information on tools for assessing industrial chemicals,
for example, models.
NICNAS would like to acknowledge the contribution of those companies who
assisted in the cooperative program between NICNAS and Canada in 2002-
03. In May 2003 NICNAS's IGCC agreed to work with industry and NICNAS
to identify and develop further opportunities for bilateral arrangements.
Aligning notification and assessment reports for
international harmonisation through the OECD
New Chemicals Task Force
Australian government and industry are to be congratulated
for introducing some intriguing, challenging and novel concepts.
OECD New Industrial Chemicals Task Force Working Group: Low Concern
and Exempt Chemicals Submission to LRCC Public Discussion paper ?br>
June 2003
NICNAS is committed to more efficient and effective delivery of chemical
assessment and regulation and more efficient use of resources and
consistency among assessments by participating in global harmonisation
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activities. Avoidance of duplication of assessments by regulators is a key
principle to deliver more safety information about chemicals with the same
resources.
NICNAS has membership on the OECD New Chemicals Task Force, which
reports each year to the OECD Joint Meeting of the Chemicals Committee and
the Working Party on Chemicals, Pesticides and Biotechnology. The principal
aim of the Task Force is to reduce the burden on industry and NICNAS by
aligning notification requirements and standardising assessment reports. The
harmonisation will facilitate work sharing and the exchange of information on
new chemicals between member countries. The Task Force has developed a
work plan consisting of the following seven work elements (WE), namely:
I. Learning from Experience with Multilaterals in Sharing and
NICNAS leads
Comparing Assessments
innovation at OECD II. Standardised Notification Form
III. Standardised Formats for Assessment Reports
IV. Hazard Assessment ?Promoting the Exchange of Common Elements
V. Minimal and No-Notification Requirements for Low Concern and
Exempt Chemicals (Exclusions and Exemptions)
VI. Confidential Business Information (CBI) ?Proprietary Information
VII. Mutual Acceptance of Notifications
Australia (NICNAS) has the lead in WE III, is co-chair of WE V, and is an
active member of the WE I, II and IV working parties. NICNAS attended the
Task Force meeting in Ottawa, Canada in October 2002 and attends the
regular teleconferences held by the Task Force and the individual working
parties.
The Task Force has adopted the NICNAS notification/assessment report
template as the model for harmonisation of assessment reports (WE III). Work
is progressing on integration of the template with the electronic notification
form being developed under WE II. The comparison of assessment reports
under WE I will lead to acceptance and exchange of overseas assessments,
particularly hazard assessments. NICNAS has made a significant contribution
to WE V through its development of proposals for assessing LRCC.
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Contributions to other OECD forums
NICNAS is also represented on other OECD groups which impact on the
assessment of New Chemicals. The OECD Steering Group on R&D Tools
which examined the availability of quantitative structure-activity relationships
(QSAR) models for use by companies at the R&D phase of product
development completed its work during the year, and the final report was
passed on to a special session on QSAR at the OECD Joint Meeting of the
Chemicals Committee. NICNAS is represented on the Working Group on use
of QSAR models in assessment and regulation of industrial chemicals which
arose from this meeting.
NICNAS presented the electronic notification template to the OECD Electronic
Tools Workshop held in Canada in October 2002. This was enthusiastically
received by other governments and industry alike.
Review of Existing Chemicals Program
NICNAS commenced a review of its existing chemicals program in May 2003.
The aim of the review is to assess the efficiency and effectiveness of the
current Program with a view to positioning it to be more cost effective as well
as more responsive and timely to stakeholder needs.
While it is clear that assessing existing industrial chemicals for health and the
Improving NICNAS
environment is a necessary activity within any regulatory framework, the issue
assessments
of how to do this is under review. NICNAS will consider issues such
as changes to overseas existing chemicals assessment programs currently
underway or already in place, in particular the processes involved
in nomination, prioritisation and assessment as well the effectiveness
of overseas assessment outcomes. NICNAS will be looking at how
to determine national priorities for assessment, how better to utilise overseas
testing and assessment program outputs and the needs of the community
to have access to sound information on chemical hazards and risks.
Extensive consultation will be undertaken throughout the review process.
A background paper and a questionnaire to facilitate the review process were
placed on NICNAS's web site in June 2003.
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Operational Performance
Performance Measurement Framework
NICNAS contributes to the safe use of chemicals by providing information
to its stakeholders on the hazards and risks posed by chemicals to workers,
the community and the environment. This information is in the form of high
quality scientific assessments of risks posed from the import, manufacture,
handling, use, storage and disposal of chemicals.
Importantly, the assessments recommend ways of addressing these risks.
The key NICNAS output is effective, accessible and reliable scientific
information for other chemical control frameworks, workers, industry
and other interested parties to implement controls as required to ensure
safe use of chemicals. To ensure this, the Scheme also contributes outputs
in the areas of compliance, customer service, education and awareness-
raising activities.
Output performance measures as they relate to all Scheme activities are
summarised in Table 3 and are reported against performance targets in this
section of the report.
Table 3 Summary of Output Performance Measures
for the Scheme
Type Performance measure
Quantity
Quantity Number of outputs (assessments, compliance investigations,
audits, site visits, guidance notes, publications etc) against
Timeliness
agreed targets
Quality Number of outputs to appropriate benchmark/target used:
Assessments
Efficiency
?Timeliness
?Effectiveness, e.g. acceptable to international scientific
assessment standards and implementation within national
Effectiveness
control framework
?Efficiency
Technical Guidance/Compliance/Service/Outreach
Price ?Timeliness
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?Effectiveness, acceptable standards as defined by Service
Charter and/or published guidelines and/or legislation
Price Cost recovery targets
Contained and/or reduced assessment costs through utilisation
of overseas reports
Contained and/or reduced administrative and other Scheme
costs
ASSESSMENT
A description of the various types of assessments undertaken by NICNAS
is provided in Appendix 07.
New Chemicals
Quantity
Detailed statistics of new chemicals assessment activity are provided
in Appendix 08.
The number of certificate and permit applications for new industrial
125 new chemicals in 2002-03 increased significantly from the previous year and
assessments marginally from 2000-01. A total of 344 notifications were received and
completed accepted, comprising 179 applications for certificates and 165 for permits;
an increase of 7 and 37 per cent respectively, from the previous year.
NICNAS issued 125 assessment certificates and published assessment
reports for each chemical. A total of 151 new chemical permits were issued.
Trend analysis of assessments completed over the past 12 years is provided
in Figure 4. The data demonstrate a decrease in completed certificate
applications since 2000-01, while apart from a slight decrease last year,
permit applications have continued to increase since 1997-98.
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Figure 4 Trend analysis for completed certificate and permit
applications
Certificates Permits
Trends towards 200
lower volume
applications
150
100
50
0
0
9
1
2
3
7
6
2
8
4
3
5
00
-0
-9
-0
-0
-9
-9
-0
-9
-9
-9
-9
00
98
01
02
96
95
01
97
94
93
92
-2
99
19
19
19
20
19
20
20
20
19
19
19
19
The number of certificate applications was substantially higher in the second
half of 2002-03. This has resulted in a substantially higher number of active
notifications at the conclusion of the third and fourth quarters.
An analysis of the number of applications received reveals a trend towards
the lower volume categories at the expense of the standard notifications.
Although the overall number of applications increased in 2002-03,
PLCs up by 14%
the quantity of Standard notifications decreased during this period continuing
the trend seen last year. Limited notifications were up slightly compared
to the previous two years while the number of extensions remained similar
to numbers in previous years. The number of applications for extensions
remains low, indicating poor utilisation of this option by industry.
The number of PLC notifications increased by 14 per cent from the previous
two years with this category continuing to receive the highest number
of applications.
CEC and EIP applications were similar in number to previous years however
the number of LVC applications increased by 76 and 72 per cent from
2001-02 and 2000-01 respectively.
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A summary of applications for each notification category in terms of the
number of certificates or permits received is illustrated in Figure 5 below.
Figure 5 New Chemicals Assessments by category ?br>
certificates / permits received
2002-03
2000-01 2001-02
80
70
60
50
40
30
20
10
0
d
C
rd
C
T
C
P
ite
EX
PL
CE
EI
LV
da
Lim
an
St
Thirty-nine Early Introduction Permits (EIP) were issued in 2002-03.
23% of notifications These account for 22 per cent of the certificate notifications received
have EIP (excluding extensions). This permit enables non-hazardous chemicals
that meet certain environmental criteria to be introduced and used while the
assessment is being undertaken by NICNAS. Issue of these permits facilitated
the introduction of `safer' chemicals whose entry into the marketplace would
otherwise have been delayed until completion of the full assessment.
The number of EIP applications received in 2002-03 was consistent with
the number received in 2001-02 (38). Five-year trend data for industry
utilisation of EIP shown in Figure 6 demonstrates a sustained trend of about
one third of certificate assessments preceded by an EIP. The trend indicates
that there has been no increase in the introduction of safer technology
despite incentives to do so.
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Figure 6 Trend analysis of assessment certificates preceded by
EIP
EIP Issued
Total Certificates Issued
250
200
150
100
50
0
1998-99 1999-2000 2000-01 2001-02 2002-03
One application for secondary notification was received during 2002-2003.
<10kg usage up
46% Less than 10 kg per year exemption notifications continued to increase
substantially from previous years, up overall by 46 per cent from 2001-02,
again reflecting the trend towards introduction of new chemicals at lower
volumes. There was an increase of 41 per cent in cosmetic chemicals and
an increase of 183 per cent for non-cosmetic chemicals, despite the fact
that notification for non-cosmetic chemicals (introduced at <10 kg/year)
is not a statutory requirement and may be underreported to NICNAS.
Figure 7 shows three-year trend data for use of the <10 kg per year
exemption system with NICNAS.
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Keeping in touch with Industry: NICNAS site visit to Malabar Sewage Treatment Plant
Figure 7 Trend analysis for annual <10 kg/year exemption
notifications
Non-Cosmetic
Cosmetic
400
350
300
250
200
150
100
50
0
2000-01 2001-02 2002-03
The number of certificate chemicals notified (either Standard, Limited or PLC
categories) since 2000-01 broken down into OECD industrial use categories,
is shown in Table 4.
As reflected in the three-year trend data shown in Table 4, surface coatings
is again the highest used category with a similar number of new chemicals
to last year. A significant increase was noted in 2002-03 for chemicals used
in cosmetics, of which a significant number were fragrance oil components.
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Table 4 Industrial uses of certificate chemicals
(standard, limited and PLC) assessed over the period July 2000
to June 2003
Use category 2000-01 2001-02 2002-03
Adhesives * 8 7
Building /Construction 7 7 4
Cosmetics 15 17 25
Domestic use 7 4 4
Electrical 0 0 0
Explosives 0 2 0
Fuel and oil 20 10 11
Leather processing 1 2 2
Mining 2 3 0
Packaging 16 5 4
Paper and pulp 1 9 2
Photographic 1 1 0
Plastics 14 13 10
Printing /Photocopying 18 27 20
Refrigeration 0 2 0
Surface Coatings 50 37 35
Textile processing 5 11 1
Water treatment 3 6 3
Other 9 4 7
*Adhesives combined with surface coatings in previous years
In 2002-03 NICNAS considered 17 applications for listing on the confidential
section of the Australian Inventory of Chemical Substances (AICS). This is a
decrease of 58.5 per cent from the previous year. In considering the case for
confidential listing, the Director must weigh the commercial interest against
the public interest. NICNAS has a small group of technical experts, the
Technical Advisory Group, to provide advice in this process (Appendix 09).
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TAG
(Technical Advisory
Group)
with Director NICNAS
(L to R)
Graham Johnston,
Mariann Lloyd-Smith,
James Smith,
Margaret Hartley
(Director NICNAS),
Ian Rae
The Director made decisions for the public listing of four of these applications
and granted confidential listing for nine chemicals. The remaining four
applications are still under review pending further information from
applicants. The three-year trend in confidential listing applications is shown
in Figure 8.
Figure 8 Three-year trend data: Outcome of decisions for
Confidential listing on AICS
Confidential Public
Pending
50
40
30
20
10
0
2000-01 2001-02 2002-03
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Timeliness
New chemical assessment output performance against target timeframes
is detailed in Appendix 08. Ninety-four per cent of total certificate assessment
Certificate
reports (134) were provided to notifiers within statutory timeframes (90 days),
timeframes down slightly below the agreed target of 95 per cent. Figure 9 shows the trend data
for timeliness for certificate assessments (90 days) over three years.
Figure 9 Trend analysis of timeliness (per cent of timeframes
met) for certificate categories over three years
LTD PLC
STD
100
80
Per cent of timeframes met
60
40
20
2000-01 2001-02 2002-03
The slight drop-off in performance coincided with the substantial increase
in certificate notifications in the second half of the year.
Efficiency rate for permits exceeded the 95 per cent target with 97 per cent of
Permit timeframes
permits being issued within the agreed statutory and non-statutory timeframes.
met Figure 10 shows the trend data for timeliness for permits over three years.
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Figure 10 Trend analysis of timeliness (per cent of timeframes
met) for permit categories over three years
LVC EIP
CEC
100
80
Per cent of timeframes met
60
40
20
0
2000-01 2001-02 2002-03
Both NICNAS and industry have statutory responsibilities with regard to the
Significant increases
publication of assessment reports. Applicants may vary the assessment report
in industry and have a 14-day timeframe to lodge an application for variation, outlining
responsiveness the reasons for change. Applicants may also provide written consent
to publish the reports, withdraw the application or simply allow the
publication process to proceed. If 28 days have elapsed since NICNAS
provided the assessment reports to the notifier and no response is received,
NICNAS can publish the assessment reports. Industry performance against
this timeframe is shown in Figure 11.
Approximately 83 per cent of notifiers responded within the 14-day
timeframe, a significant increase from the previous year. A further one per
cent responded prior to the 28-day deadline for publication. Less than 10
per cent did not respond to NICNAS, triggering the publication process
to proceed after the 28-day deadline.
Five applications for variations of the assessment reports were received
during the year. All variations were resolved satisfactorily between NICNAS
and the applicant, with no appeals made by notifiers.
Trend analysis data at Figure 11 shows a similar picture in timeframe
responsiveness by industry overall for the last three years.
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Figure 11 Percentage companies responding within timeframes
from provision of report to written consent to publish (calendar
days)
1-14 days 15-28 days > 28 days or no response
100
80
60
40
% Responses
20
0
2000-01 2001-02 2002-03
NICNAS issued 90 per cent of certificates within the 7-day statutory
timeframe. Twelve certificates did not meet this timeframe with most delays
ranging from one to eight days. One certificate was delayed by one month
due to payment related issues.
Efficiency
At the completion of the 2002-03 financial year, new chemical assessment
output is slightly less than input. NICNAS received 179 notifications in the
Certificate inputs certificate categories and issued 125 certificates in 2002-03. This result is
exceed outputs due to the increased number of certificate notifications in the second half of
the year. Permit outputs however are keeping pace with inputs ?165 permit
applications were received and 151 permits were issued. Table 5 details input
and output for certificate and permit categories for the past three years.
Table 5 Input and output data for certificate and permit
categories for years 1999-2000 to 2001-02
1999-2000 2000-01 2001-02 2002-03
Certificates Input 176 182 168 179
Output 152 183 164 125
Permits Input 130 148 120 165
Output 128 138 119 151
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The number of active applications within the certificate and permit categories
Pemits outputs
is indicative of the input:output ratio. The number of active notifications
keep pace with at the end of each quarter in 2002-03 was overall 22 per cent greater than
inputs in 2001-02.
New initiatives were undertaken by NICNAS to streamline the notification
and assessment process during 2001-02. A new Template for New
Chemicals Notifications was developed in 2001-02 to assist notifiers in
qualifying for a rebate of up to 15 per cent of the notification fee for Standard
and Limited notifications. The new template is part of a combined electronic
notification package, which also includes administrative forms and
a notification checklist. It enables notifiers to submit information to NICNAS
electronically and in the format in which the assessment report is published.
Following an In-House Trial and an Industry Pilot in 2001-02, wider
Template pilot
availability commenced at the beginning of 2002-03. Since then 26
successful notifications have been received in the electronic format, a potential saving
to industry of about $45,630.
NICNAS also developed an electronic format for the submission of CEC
and LVC permits in 2001-2002. The use of this format is highly encouraged
as it is designed to deliver efficiencies to both industry and NICNAS in terms
of ease of notification and compilation of internal file notes, respectively.
This initiative has been widely adopted by industry with 21 per cent of permit
applications being received in electronic format in 2002-03.
Effectiveness
Chemical notifiers and/or their consultants took advantage of NICNAS's free
consultancy services on 30 separate occasions throughout the year. Such
Industry access consultations are part of our ongoing commitment to improve the quality
of applications, the relationship between NICNAS and our clients, as well
consultancy service
as optimising assessment timeframes. NICNAS encourages notifiers to meet
with staff at anytime during the assessment process to discuss issues arising.
Of the applications for certificates received in 2002-03, the assessment
commenced on the day of receipt for approximately 38 per cent of certificate
notifications, reflecting either a complete data package or one where only
minor deficiencies were identified. Of the remaining applications, the clock
was not activated on receipt of application and/or the clock was stopped part
way through the assessment process and re-started. Flow through times,
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illustrated in Figure 12, indicate the Extension and Limited notification
Applications
category to be the most successful in meeting the data requirements,
require with 50 and 49 per cent respectively, beginning on the date of receipt.
improvement Early introduction permit and standard notification categories were the
most deficient category with only 21 and 25 per cent beginning on the date
of receipt. These data will allow better targeted training programs for industry
in an effort to improve the quality of applications overall.
Figure 12 Clock start times for assessments
100
80
60
40
20
0
CEC EIP EXT Limited LVC PLC Secondary Standard
Notification
Clock started
Clock started Clock started Clock started
Never started
up to 28 days
on date of between 28 and more than 90
after receipt
receipt 90 days after days after date
receipt of receipt
The assessment of Material Safety Data Sheets (MSDS) and labels for notified
chemicals and the products containing the chemical remains an important
part of the assessment process for all categories. In 2002-03 approximately
500 MSDS were assessed by NICNAS on behalf of the chemical industry,
helping to ensure that accurate and relevant information is available
to workers, consumers and the community.
No new chemicals assessment decisions were appealed in 2002-03.
Price
A minimum of 422 chemicals were introduced under the low volume < 10
kg/year category in 2002-03. Before provisions for low volume exemptions
were introduced in 1999, these chemicals required notification prior to their
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introduction. Estimates on the saving to industry in assessment fees in 2002-
<10kg saves
03 if priced as low volume permits is approximately $1.1M (This estimate
$3.52M over does not include the savings related to data generation or industry
6 years administration costs). Overall, since introduction in 1997, this exemption
category alone has provided access to 1,353 chemicals over six years
at a minimum potential saving to industry of $3.52M. Chemicals introduced
for non-cosmetic use under this category and chemicals for research and
development introduced at < 50 kg/12 months do not require notification
to NICNAS. Further, the sustained increase in PLC applications reflects
the expansion of this category and the potential for polymers to be notified
at lower cost and requiring less data.
Existing Chemicals
Quantity
NICNAS undertakes assessments of chemicals already in use in Australia
under the Existing Chemicals program. Appendix 07 details the types
of assessments undertaken in the Existing Chemicals program. Appendix 10
summarises the Existing Chemicals program's assessment activities for
2002-03, and provides a list of the chemicals assessed.
A target of three full and 13 preliminary or other assessments was set for this
Assessment targets
year, to maintain the target rate of 50 chemicals assessed over a three-year
met period. These targets were met in 2002-03.
Assessment outputs for 2002-03 are summarised in Table 6 and are
compared with last year's activity. The five-year trend is shown in Figure 13.
A total of 105 individual companies participated in assessments during
2002-03 providing valuable information and experience considered
in the assessment.
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Table 6 Output data for the Existing Chemicals Assessment
types for 2002-03 and 2001-02
2002-03 2001-02
Chemicals under assessment 20 32
PECS declared for assessment 2 3
Screening/other assessments commenced* 13 24
Assessment modules completed 46 60
Assessments completed 16 27
Chemicals subject to post-assessment activity 9 5
* Other assessments include chemical information sheets and alerts.
Figure 13 Existing Chemicals output data for 1998-99 to
2002-03
Assessments completed
Modules completed*
200
155
150
100
62
48 47 46
50
27
15 16
6
2
0
1998-99 1999-2000 2000-01 2001-02 2002-03
* assessments comprise several modules which are described in Appendix 07.
The Candidate List of chemicals is an outcome of the screening and ranking
of publicly nominated existing industrial chemicals for which there is health
and/or environmental concern. Table 7 details the status of the Candidate List
for 2002-03 and Appendix 10 details the chemicals on the Candidate List.
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Table 7 Details of the Candidate List and Candidate List
screening outputs for 2002-03
Chemicals on main section of candidate list 32 chemicals and
4 chemical groups
(comprising >8
chemicals)
Chemicals in stand-by section of candidate list 4 chemicals and 2
chemical groups
(comprised of 17
chemicals)
Screening assessments of chemicals on candidate list 1
Chemicals declared from candidate list for assessment 1
Public consultations on chemicals on candidate list 4
In 2002-03, NICNAS introduced new assessment activities which focus
on ensuring enhanced information flow to stakeholders and the public.
For example, the introduction of special alert assessment was undertaken
for the perflurooctanyl sulfonate (PFOS) and related chemicals which
are subject to international regulatory action.
Timeliness
Statutory timelines exist in relation to existing chemical full risk and
preliminary assessments. These include compulsory deadlines, mandated
Timeframes met by the Act, for applicant and public comment on draft reports, Director's
response to requests for variations to the draft report, and for completion
of an assessment. These timelines were all met. NICNAS continues to work
with industry to secure the provision of information for assessments within
timeframes reasonable for both.
Effectiveness
Assessment outputs in 2002-03 addressed an increasing demand for concise
and easily accessible information resources on chemicals. Several
Information Sheets were developed as a response to media and public
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enquiries on specific chemicals and chemical-related subjects. This initiative
was extended into a program to provide information on chemicals on the High
Volume Industrial Chemical List (HVICL) (compiled in 2002). Five chemicals
from the HVICL, for which a full independent hazard assessment had not
been conducted by NICNAS, were selected and information sheets containing
import, manufacturing and use data, a summary of health and safety
information from overseas reviews and the regulatory status of the chemical
in Australia were prepared. Feedback on this program is being sought
to better tailor information products to the needs of industry, the public,
and regulatory authorities.
Safety Information Sheets on three chemicals, derived from completed PEC
assessments of the chemicals, were compiled and distributed to industry
and unions. The aim is to have these safety information sheets displayed
in the workplace.
In the context of seeking to ensure efficiency and effectiveness in the
government's approach to the assessment and management of chemicals,
NICNAS has continued to work with, and build strategic alliances with, other
agencies. For example, a collaborative effort between NICNAS and NOHSC,
with input from professional dermatologists, to classify the hazard of common
allergens used in skin patch testing commenced in 2002-03.
Recommendations to regulatory bodies and industry aimed at protecting
the environment, the health of workers and the public are key outcomes
of the PEC assessments. A measure of the effectiveness of the Existing
Chemicals program is the adoption of these recommendations
by "downstream" control agencies and industry itself.
Table 8 shows the number of recommendations made in all PEC reports
published until June 2003 categorised into the three broad areas of OHS,
public health and the environment. Three PEC reports were published, or
reached publication phase, in 2002-03. The majority of recommendations this
year, as in previous years, relate to OHS. However the trend towards a greater
percentage of public health and environmental recommendations continues.
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Table 8 Number of recommendations in PEC reports by target
area to June 2003
Target Area OHS Public Health Environment
Feb 1993 -
Feb 1993 -
Feb 1993 -
June 2000
June 2000
June 2000
2002-03
2002-03
2002-03
2000-01
2001-02
2000-01
2001-02
2000-01
2001-02
Peak bodies 37 15 11 1 10 3 8 1 0 1 0 0
State & Territory
authorities 1 7 2 0 0 1 1 1 1 0 0 0
Industry 61 29 17 8 3 2 1 3 2 4 0 1
Total 99 51 30 9 13 6 10 5 3 5 0 1
Target area as % of
total recommendations 86 82 75 60 11 10 25 33 3 8 0 7
Many of the OHS recommendations made in PEC reports are referred
to the NOHSC, as they impact on the regulatory framework for hazardous
substances in the workplace. Table 9 shows the proportion
of recommendations made to NOHSC and that agency's reported activity
NOHSC actions
in relation to the recommendations. The updating by NOHSC in 2002-03
recommendations
of hazard classifications in its Designated List of Hazardous Substances
for certain substances, in accordance with NICNAS recommendations,
and in consultation with NICNAS, has accounted for a significant increase
in the number of NICNAS recommendations implemented or under
consideration by NOHSC. Also contributing to the increase is the
consideration by NOHSC of exposure standards for certain chemicals
in accordance with NICNAS recommendations. This enhanced
responsiveness to NICNAS recommendations by NOHSC has resulted
in better OHS outcomes in terms of more accurate labelling and better
information available to workers who use the hazardous chemicals.
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Table 9 Implementation of PEC report recommendations
by NOHSC (cumulative)
June 2001 June 2002 June 2003
Total recommendations 32 45 52
Number under consideration 9 26 11
Number implemented 8 11 35
Number not implemented 15 8 6
% considered or implemented 53 82 88
A project to follow-up the extent of implementation of recommendations
made to industry from PEC reports was begun in 2001-02 but was deferred
in 2002-03 to await the outcome of the review of the Existing Chemicals
Program.
Three PEC reports went through the corrections/variations phases in 2002-
03. No substantial errors were notified in the corrections phase. Requests
to vary the report were received for two chemicals, with 41 requests received
and considered by the Director. Ten of the requests were not granted.
No variation decisions were appealed at the Administrative Appeals Tribunal.
A major review of the Existing Chemicals program was initiated in 2002-03
to examine its efficiency and effectiveness, and to position the Program
to better meet the needs of stakeholders. Analysis of overseas existing
chemicals schemes was undertaken, and focused consultation with key
individuals and users of NICNAS assessment products commenced.
Price
The use of overseas assessment reports to provide information to facilitate
efficiencies in Existing Chemical assessments has continued to help maintain
cost savings. For example, the use of several overseas reports enabled the
fast production and distribution of a number of chemical information sheets.
Nineteen overseas reviews were used in assessments this year, including
PEC assessments.
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Work continued in 2002-03 on the investigation of PFOS-based chemicals
19 overseas
in Australia in coordination with an international hazard assessment of these
assessments chemicals by the OECD. Information from the OECD assessment,
ultilised in conjunction with information gained from consultation with Australian
industry, was used to identify essential uses of the chemicals in Australia,
and resulted in two alerts issued by NICNAS, detailing the concerns about
and uses of the chemicals. This use of overseas assessment activity
to facilitate risk management strategies within our own assessment program
further reduces the costs to industry as denovo hazard assessments have
not needed to be undertaken by NICNAS.
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HARMONISATION ACTIVITIES
Participation in chemical harmonisation activities is undertaken to reduce
duplication and enhance the amount of chemical risk assessment information
that is available globally, thus enhancing the safe use of chemicals.
NICNAS's international harmonisation activities support the Government
policy of ensuring regulatory efficiency whilst maintaining health and
environmental safety standards. The overall aim of global (New Chemical)
chemical assessment harmonisation is to have the notification
and assessment process in one country facilitate the notification
and assessment process in another country.
New Chemicals
Efficiency
Details on the Canadian Bilateral and OECD program for New Chemicals
are covered in the Reform section.
Price
The Transitional Arrangements Towards Approval of Approved Foreign
Schemes (Transitional Arrangements) were first introduced in 1998.
NICNAS further revised Transitional Arrangements in 2001-02, increasing
opportunities for industry to either access 40 per cent assessment rebate
by submitting assessment reports prepared by national authorities and/or be
Rebates deliver eligible for a waiver of the EIP fee for PLCs assessed in Canada. In 2002-03,
$36,000 in savings 12 applications for the rebate under the Transitional Arrangements were
received from industry based on previous assessment in Canada and the
European Union, resulting in approximately $36,000 savings to these
companies. Additionally, the fee for an EIP was waived on five occasions
representing a further saving of $2,500.
The four-year trend data (Figure 14) in foreign scheme use shows
a significant increase in use since 1999-2000 to about seven per cent
of all certificate applications in 2002-03.
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Figure 14 Four-year trend data for of savings to industry under
the transitional arrangements
$40,000
Industry increase
use of foreign $30,000
assessments
$20,000
$10,000
0
1999-2000 2000-01 2001-02 2002-03
Existing Chemicals
Quantity
NICNAS participates in international activities relating to existing chemicals
involving peer review of assessment products of other participating countries.
NICNAS participated in the International Programme on Chemical Safety
(IPCS) Concise International Chemical Assessment Document (CICAD)
activity, whereby national risk assessments of existing chemicals are
internationalised. NICNAS also participated in the OECD High Production
Volume (HPV) Program for industrial chemicals by peer reviewing the
Screening Information Data Set (SIDS) Initial Assessment Reports produced
by the OECD. These programs are detailed in Appendix 07.
The number of international reports considered and agreed in 2002-03
is shown in Table 10, along with four-year trend data. NICNAS has set
a target of reviewing and providing comments on 50 per cent of all
assessment reports provided by the two overseas chemicals programs.
This target was exceeded during this financial year.
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Table 10 Four-year trend data for participation in international
assessment activities for the Existing Chemicals program
1999-2000 2000-01 2001-02 2002-03
Number of international 4 2 3 2
assessment meetings attended
Number of international 53 52 75 85
assessments considered at
the meetings
Number of international 31 44 45 44
assessments reviewed by
NICNAS prior to the meetings
Number of international 46 47 72 75
assessments agreed at the
meetings
The OECD scientific assessment report of PFOS and its salts was accepted
International
by the OECD member countries. NICNAS was actively involved in the OECD
co-operational on assessment through scientific peer review. The OECD countries agreed that
PFOS assessment individual governments continue their own assessment work and exchange
information. Australia is facilitating the collection of production and use
information on PFOS related chemicals in the OECD countries. This
information will assist in identifying current uses globally and to better identify
essential uses. In line with this, NICNAS called for information on chemicals,
including polymers, which are derived from perfluorooctanesulfonic acid and
its higher and lower homologues; collectively referred to as perfluoroalkyl
sulfonates (PFAS) and perfluoroctanoic acid (PFOA) and its derivatives,
including, telomers which may degrade to PFOA.
The existing chemicals assessment program has sponsored a chemical
for assessment through the OECD Program and reviewed 41 of the 78
international hazard assessments considered in 2002-03 by the OECD.
In addition, discussions are currently underway with the Soap and Detergent
Association in the United States regarding a program to jointly sponsor
a group of chemicals as part of the OECD Program. Seven CICADs were
received and three reviewed by NICNAS. Details of these activities are
included in Table 10.
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Efficiency
The number of assessments considered at international meetings increased
by approximately 13 per cent compared with 2001-02 when three meetings
were held, and by 44 per cent compared with 2000-01 (two meetings).
Co-operation One of the consequences of the increase in international cooperation
in chemicals assessment evident by this rise in the number of assessments
reduces duplication
considered is a reduction in duplication of assessment effort. In 2002-03
overseas assessment reports were used for chemicals declared as PECs,
in preparing a number of information sheets on chemicals listed in the
national high volume industrial chemicals list, and in responding to general
public enquiries on chemical safety issues. These information sheets will
be made publicly available on the NICNAS web site providing chemical safety
information to workers and the public to ensure risks associated with
chemicals are understood and that chemicals are adequately controlled
to ensure their safe use.
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COMPLIANCE
Quantity
The Australian Inventory of Chemical Substances (AICS), a list of more than
38,000 industrial chemicals in use in Australia, is a key compliance tool as
it is the means by which new chemicals are identified under the Act. NICNAS
is responsible for maintaining and providing access to the public AICS.
AICS searches
Since 1999, the inventory has been supplied to the public on CD-ROM.
remain steady
NICNAS also provides a free AICS search service.
An AICS inquiry can request a search for any number of chemicals.
The number of requests to search the AICS continued to increase from
previous years although the number of individual searches showed no
change compared to 2001-02. The three-year trend data for search requests
of the AICS (inquiries) and the resultant number of searches are summarised
in Table 11.
Table 11 Three-year trend data for AICS inquiries and searches
2000-01 2001-02 2002-03
Inquiries 411 595 666
Searches 1,757 2,682 2,683
For 2002-03 more than 92 per cent of AICS inquiries (616 out of 666)
included less than 10 chemicals per inquiry. The remainder included 27
(11-20 chemicals), 20 (21-50 chemicals) and 3 (more than 50 chemicals).
Most of the bigger inquiries related to cosmetic ingredients. The three trend
data for searches per inquiry is shown in Table 12.
Table 12 Three-year trend in searches per AICS inquiry
2000-01 2001-02 2002-03
No. (% total) No. (% total) No. (% total)
1-10 385 (94) 529 (89) 616 (92.5)
11-20 19 (5) 41 (7) 27 (4.1)
21-50 4 (1) 15 (3) 20 (3.0)
>50 3 (1) 10 (2) 3 (0.1)
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The ongoing rise in the number of inquiries could be attributed to the growing
awareness amongst importers of the need to notify chemicals that are not
on the AICS. This awareness has been achieved through the company
registration process - especially through the highlighting of compliance
obligations, the web site and specific advertising. NICNAS compliance
activities particularly the Due Diligence framework created for industry
by NICNAS are major contributors to industry awareness of the need
to ascertain AICS status of chemicals.
The AICS CD-ROM 2003 was released in June 2003 and covers AICS listings
to the May 2003 Chemical Gazette. This is the fourth update of the CD-ROM
produced by NICNAS.
An agreement with the Chemical Abstract Service (CAS) in May 2003 has
made it possible for AICS to be put online. NICNAS is in negotiation with CSA
to achieve this for 2003-04.
A key activity of the Compliance program is the investigation of all potential
compliance cases. A summary of all compliance investigations by type for
2002-03 is shown in Table 13.
Table 13 Summary of the number of compliance investigations
undertaken in 2002-03
Compliance New cases Investigations Investigations
Category Active reported in completed in active at end
investigations 2002?3 2002?3 2002?3
at the end of
2002?3
New Chemicals 15 21 26 10
cases
Company 3 117 118 2
Registration cases
Total cases 18 138 144 12
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One hundred and forty-four investigations were completed for the year
Investigations on
2002-03 compared with 85 for 2001-02. Two company registration cases
the rise and 10 new chemicals cases have been carried over for completion
of investigations and actions in 2003-04.
Of the 21 new compliance investigations concerning new chemicals in
2002-03, 17 were considered to be cases involving possible breaches of the
legislation, and four were audits, which were resolved without outstanding
compliance actions. Eighteen per cent (3 cases) were brought to our attention
by third parties, 12 per cent (2 cases) detected in-house, and 71 per cent
(12 cases) self-reported.
There were 117 new company registration case investigations reported
Shift to self- for the year 2002-03. Of these, 80 were considered to be compliance cases
reporting by involving possible breaches of the legislation. Of the remaining 37 cases,
industry 13 were technically debt recovery, for example, registration upgrades required,
and 24 were audits, which were satisfactorily resolved without further
compliance actions - all were detected in-house by NICNAS.
Figure 15 shows a four-year trend data for the source of new chemicals cases.
Figure 15 Four-year trend in case types for new chemicals cases
during 1999-2003
1999-2000 2000-01 2001-02 2002-03
6 (15%) 2 (4%) 10 (30%) 2 (12%)
5 (13%) 9 (18%) 8 (24%) 3 (18%)
29 (72%) 39 (78%) 6 (47%) 12 (71%)
Third party report In-house Self-reported
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Compared to the previous year, the percentage of self璻eported compliance
cases is higher, which correlates with the approach used when dealing with
self-reported cases; however, the percentage of cases generated in-house
and by third parties were reduced compared with last year. It is envisaged
that during 2003-04, there will be a focus on conducting audits, and
education and raising awareness activities. Figure 16 shows trends in case
types since 1998-99. This year saw a remarkable increase in the number
of company registration cases and a decrease in new chemicals cases,
with an overall increase in the total number of new cases.
Figure 16 Four-year trend in compliance case categories since
the introduction of the compliance strategy in 1998-99
New Chemicals Company Registration
Existing Chemicals Secondary Notification Total
100 97
85
80
78
80
69
65
60
21 51
50
40
40
31
25
24
19
20 17
12 00 00 00 00
0
1998-99 1999-2000 2000-01 2001-02 2002-03
Company Registration audits are a routine function of our cost recovery
66 more mechanism. Investigations are undertaken using import data supplied
companies by the Australian Customs Service. In 2002-03 a review of the customs data
registered for 2001-02 revealed a total of 458 companies potentially above the
registrable threshold. This is a decrease of only two per cent from the audit
conducted during 2001-02 (469 companies). Further investigation showed
that 74 of these companies were highly likely to be registrable.
These companies were informed of their possible company registration
obligation with 66 new introducers added to the register.
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Timeliness
A summary of targets and performance for AICS searching is provided in
Table 14. Time required to complete AICS searches varies considerably
depending on the level of information provided for the search and the
complexity of the chemical structure.
Table 14 Summary of Timeliness for Searches of AICS for
2002-03
Category searches per inquiry*
1-10 11-20 21-50 >50
Increase in AICS No. of inquiries by category 616 27 20 3
searching times Target for completion of search (days) 2 7 14 28
Response time met (%) 90.9 96.3 100 100
The response times have continued to improve over the last three years as
shown in Table 15.
Table 15 Trend in Timeliness for Searches of AICS for
2002-03
Response time met for AICS (%)
No. of searches per category
1-10 11-20 21-50 >50
2000-01 76 89 100 100
2001-02 78 98 100 100
2002-03 91 96 100 100
Of the 156 investigations in 2002-03, 144 investigations (92%) were brought
to completion during the year. Ten new chemicals cases were finalised out of
18 (56%), resulting in 19 notifications (see outcomes in Table 16). NICNAS's
target is to complete 80 per cent of new chemical cases within 100 days.
Most of the outstanding cases are awaiting data to support the notification
of the chemical under investigation.
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For company registration, 78 company registration cases were finalised out of
Investigation
80 (97.5%) within the timeframe set. (NICNAS's target is to complete 80 per
timeframes met cent of company registration case investigations within 60 days.)
The current protocols used for reporting the number of cases, their types and
outcomes will be modified for the year 2003-04 to reflect a better distinction
between case types and audits.
There were no existing chemical compliance case investigations for 2002-03.
Effectiveness
The outcomes of the new chemical investigations are shown in Table 16 and
for company registration in Figure 17. A number of cases involved more than
one chemical per company.
Table 16 Outcomes of new chemical case investigations
completed in 2002-03
Outcome / Result * Number of cases (%)*
Company already compliant 1 (8)
Company not introducing chemical(s) 0
Not a NICNAS matter 0
Company ceased introducing the chemical(s) 2 (17)
Notification made** 19 in 9 cases (75)
Permit ownership transferred 0
Permit limit increased 0
Improved monitoring systems 0
* includes carry-over cases from previous year where outcome is estimated.
The % estimated is based on 12 cases finalised
** notification numbers are counted for each chemical under investigation
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Figure 17 Outcomes of company registration investigations
for 2002-03
100
83.5
80
66
60
40
20
Compliance through 11.4
9
industry璑ICNAS 3 3.8
2 1.3
0
agreements
Company Registered Not Required to Register Write-offs Outstanding
Outcome
For the one new chemical case finalised (8 per cent), the company was
found not to be in breach and no further action was required. There were
19 notifications made involving 9 cases (75 per cent) in which there was an
established breach of the Act and all of these chose to make notifications
through a partnership agreement with NICNAS following self-reporting and a
compliance meeting. A timetable and conditions for notification were agreed
and the companies were permitted to continue to trade in the chemical.
This approach is proving to be an effective way of achieving compliance
and encourages self-reporting.
Eighteen companies were visited by NICNAS inspectors regarding their toner
import operations. These visits were by appointment and were conducted as
useful exercise of raising awareness of NICNAS's regulatory requirements and
for monitoring compliance. Site visits and client meetings remain an efficient
and effective way of handling compliance matters.
No prosecutions or penalties were applied by NICNAS in 2002-03.
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Price
Although it is difficult to quantify, the NICNAS compliance program arguably
results in cost savings to industry. In general, compliance is an integral part
of a company's overall corporate goals and contributes to building and
maintaining a company's status as a good corporate citizen. The benefits
of compliance are many and can include:
?avoidance of personal liability relating to breaches of occupational health
and safety requirements;
?the potential benefits flowing from good corporate image;
?avoidance of damage to corporate image or brand of a breach, particularly
if related to a significant adverse event; and,
?savings in legal and related costs flowing from failure to exercise due
diligence and from avoidance of potential significant adverse events.
NICNAS compliance investigations have resulted in 66 new company
$209,800 additional
registrations resulting in $79,200 as additional revenue, and 19 new
revenue through chemical notifications resulting in $130,600 in new chemical assessment
compliance fees (as opposed to potential fines to industry of $2,475,000).
Since 1 September 2002, NICNAS has been using the integrated database
(D@N) for AICS searches. A break-up of AICS searches by NICNAS company
registration status for the ten months, 1 September 2002 ?30 June 2003,
is shown below:
Registration status Enquiries Chemicals searched
Registered 63 278
Non-registered 272 1984
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COMMUNICATION AND SERVICES
Information is a key focus of NICNAS in achieving its outcome of safe
chemical use. Our communication strategies focus on strategic alliances
with industry, Government, the community and media to ensure increased
knowledge and awareness on the work of NICNAS, regulatory requirements
and the safe use of chemicals.
Quantity
During 2002-03 NICNAS responded to 1,804 (compared to 2,123 in
2001-02) inquiries, which took 658 (696 in 2001-02) hours to handle.
This was made up of 1,446 telephone inquiries and 358 written inquiries.
The number of telephone inquiries dropped from previous years (1,725
in 2001-02, 1,752 in 2000-01, 1,598 in 1999-2000), while written inquiries
remained at the level of the previous year (398 in 2001-02, 205 in 2000-01
and 187 in 1999-2000). Full details on inquiries to NICNAS are at
Appendix 14.
NICNAS received 150 media inquiries during 2002-03 (152 in 2001-02).
Media inquiries
Key issues included PFOS, hair dyes, cosmetics (general), phthalates,
remain steady sodium lauryl sulfate, triclosan, AICS CD-ROM, glycolic acid, LRCC Task
Force, cabin air quality, formaldehyde, Commercial Evaluation Permit (CEP)
final report and Endocrine Disrupting Chemicals (EDCs).
As part of the Chemicals and Plastics Action Agenda the Australian
Government Department of Industry, Tourism and Resources released
a Media Kit Underpinning Australia's Industrial Growth ?Chemicals and
Plastics to 1,500 key stakeholders on 4 December 2002. The kit included
the Media Release from Parliamentary Secretary to the Minister for Health
and Ageing, The Hon Trish Worth MP, on the Reform to National
Chemicals Scheme.
NICNAS released two issues (December 2002, April 2003) of its newsletter
NICNAS matters. NICNAS matters 6 (December 2002) featured articles
on LRCC, global co-operation ?Canada and New Zealand, electronic New
Chemicals templates, customer survey, Australian High Volume Industrial
Chemicals List, site visit, NICNAS Innovation Award and new staff. NICNAS
matters 7 (April 2003) featured a range of technical articles on LRCC.
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NICNAS advertisement activity are detailed at Appendix 05 and include an
advertisement on 22 August 2002 in Australian Financial Review Special
Reports, page 17, promoting the AICS CD-ROM and NICNAS compliance
activities.
NICNAS publications for 2002-03 are detailed at Appendix 16 and include
12 editions of the Chemical Gazette; NICNAS Service Charter 2002-05, the
Australian High Volume Industrial Chemical List, Release of the Report on
Low Regulatory Concern Chemicals Reform Initiative, four Chemical
Information Sheets and two NICNAS PFOS Alerts.
The updated AICS CD-ROM was released in June 2003.
Web site statistics for 2002-03 are detailed at Appendix 15. Web usage
increased on the NICNAS web site from 9,610 hits each day at the end
30% increase in
of June 2002 to 13,621 (30% increase against a target of 5%) hits each
web site usage day at the end of June 2003 (compared to 6,555 hits each day at the end
of June 2001). Total hits for the year were just over four million (three million
in 2001-02), with 273,343 (143,346 in 2001-02) visitor sessions ?br>
an average of 749 (392 in 2001-02) each day. The most requested pages
are shown in Table 17.
Table 17 Most requested web site pages
Rank Page Hits
1 Home Page 37,856
2 NICNAS Publications 12,867
3 Search 11,481
4 Chemical Assessment Reports 8,632
5 NICNAS Forms 8,190
6 Industry Page 7,605
7 PEC Reports 6,623
8 Chemicals in Australia 6,513
9 Media Page 6,509
10 New Chemical Assessment Reports 6,099
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NICNAS staff were active in awareness raising and information exchange
activities such as presentations (28), conferences (24), meetings
for progressing international harmonisation activities (3), international
assessment meetings (7) and site visits (31). These are detailed
at Appendix 13.
Timeliness
All NICNAS's timeframe targets for responsiveness to inquiries by telephone
(99 per cent of which were completed within 24 hours - target 85 per cent
and remainder were within 7 days) and in writing (70 per cent finalised within
24 hours and 25 per cent in 7 days, that is, 95 per cent within 7 days - target
is 85 per cent) were exceeded in 2002-03 (see Appendix 14).
Timeframes met
with all inquiries
All media inquires were handled within agreed timelines.
All 12 issues of the Chemical Gazette were published within the statutory
deadline, that is, on the first Tuesday of each month, and subscribers receive
an email alert for each new issue.
Effectiveness
During 2002-03 NICNAS continued to provide clear and accessible
information on its web site (www.nicnas.gov.au) to assist importers and
manufacturers of industrial chemicals in Australia in fulfilling their obligations.
In addition, specific chemical safety material for broad stakeholder groups,
including the public, was expanded and made more accessible with the
redesigned web site.
The newsletter NICNAS matters is an integral element of the NICNAS
Communication Plan to relay important information to industry clients,
the public, government agencies and the media. Printed copies of the
December 2002 and April 2003 issues were distributed to 1,500 clients
and stakeholders. It was also available through the web site.
NICNAS's communication staff maintained an effective media management
strategy and provided considerable assistance to media in accessing
scientific information on chemical matters. In addition NICNAS handled
specific media inquiries resulting in substantial print, television and radio
coverage as detailed in Appendix 16.
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We have found the NICNAS staff including
management to be extremely helpful and will work
with business to resolve concerns. NICNAS is very
cooperative and business-focused. Keep it up!
Industry customer survey response ?June 2003
Customer Survey
High customer
The NICNAS Service Charter defines NICNAS's service standards. In 2002-
satisfaction 03, a customer survey was conducted on NICNAS's performance against its
maintained service standards. A mail and telephone survey canvassed 100 randomly
selected organisations with which NICNAS had had contact with through the
existing and new chemical programs, company registration, and compliance
team activities. The response rate for the survey was 65 per cent.
Overall, positive feedback was received indicating a good level of service:
?86 per cent found staff to be helpful and courteous always or most
of the time;
?83 per cent found their questions and inquiries were answered in 7-28
days always or most of the time;
?86 per cent found written explanations clear always or most of the time;
?85 per cent found that NICNAS provided accurate and consistent
information always or most of the time; and
?82 per cent of organisation surveyed were aware of NICNAS web site.
Of these 79 per cent found the web site easy to navigate.
Using feedback from the 2001-02 survey, NICNAS implemented strategies
to improve its written communications including updating the web site to
address the areas of concern raised by NICNAS's customers. It was therefore
pleasing to see an increase in customer satisfaction in 2002-03 with our
written material and the web site indicating the success of our strategies.
In 2002-03, NICNAS conducted for the first time a survey of CEOs from
New CEO survey
the 25 leading companies which have significant involvement in industrial
introduced chemicals. Fourteen companies responded to the survey. While the response
rate was lower than the general customer survey, the results indicate a higher
level of satisfaction with NICNAS's service. The issues CEOs identified
as requiring attention by NICNAS were similar to those of the general
customer survey.
From the comments received regulatory efficiency was identified as an issue
that concerns NICNAS clients:
Whilst we have noticed a significant amount of work on reforms, further
reforms must be considered to increase "speed to market" of innovative
and safer chemicals. As a whole we congratulate NICNAS for the
noticeable improvement in the standard and quality of its services.
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Barrier to industry. Need for more flexibility in NICNAS regulations.
Industry customer survey responses ?June 2003
As a result of this feedback, regulatory efficiency will be NICNAS's business
focus for 2003-04.
Figure 18 NICNAS information sources used by companies
in the 2002-03 Service Charter survey
35 34
35
31
30
25 24
Brochures / NICNAS matters
21 21
20
20
Chemical Gazette online
Chemical Gazette online
New Chemical reports
Not an option in 2002
15
15
hardcopy subscriber
15
Gazette hardcopy
Chemical Gazette
NICNAS matters
10
Brochures /
Info Sheets
Info Sheets
PEC Safety
PEC Safety
subscriber
Chemical
5
0
2003 2002
Australian High Volume Industrial Chemicals List
An important determinant of chemical safety is information on the actual
HVICL published
volume of chemicals used in Australia. Assuming potential exposure may
be related to volume, chemicals used in high volume may pose greater risks
to health and the environment.
In July 2002, NICNAS published a list of industrial chemicals that are used
in large quantities in Australia based on information supplied by companies
during 2001 and 2002. The Australian High Volume Industrial Chemicals List
(HVICL) is a combined list of chemicals manufactured in or imported
to Australia in quantities 1000 tonnes/year. The HVICL contains aggregate
quantities of chemicals in volume bands.
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The list also includes use information for each chemical according to OECD
industry and use categories. In a few instances, confidentiality has been
granted for certain information supplied on a chemical, such as Chemical
Abstracts Service (CAS) number, chemical name or precise uses.
A total of 303 chemicals are listed on the HVICL. The list is used by NICNAS
for the screening of existing chemicals for assessment and to focus our
program of provision of public information on chemicals of greater interest.
As such, Chemical Information Sheets have been prepared for selected high
volume chemicals, available through the NICNAS web site. The HVICL
is available on the NICNAS web site at
www.nicnas.gov.au/obligations/highvolume/index.htm.
Efficiency
This site rocks. I'd never had thought that boring old government info
could be so interesting!
Industry customer survey responses ?June 2003
Web site `rocks'
The new NICNAS web site went live on 30 May 2003 and has received
positive feedback. Testing and content updates are ongoing.
Just under 1,400 chemical assessment reports on individual industrial
chemicals are featured on the web site. Further chemical assessments
are added upon completion. Users can conduct searches on assessment
reports by:
?chemical name;
?trade name;
?Chemical Abstracts Service (CAS) number;
?hazardous status; and
?OECD industry use category.
All material on the NICNAS web site is freely available. This allows greater
1,400 chemical
access to chemical safety information by the public, government agencies
assessments online
and industry, thus fulfilling a key requirement of the Act. In line with
Commonwealth Government publishing guidelines, NICNAS maintains copies
of printed information material and provides a print-on-demand service from
its web site.
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PEC reports are available to download from the web site both during the
public comment period and on completion as a final assessment report.
All NICNAS forms are in an electronic format to allow online completion
and lodgement. NICNAS has very high compliance with the Government's
requirement for mandated time boxes on all forms, which is aimed at
reducing the burden on small business.
Web-based Safety Information Sheets for each PEC and the Chemical Info
D@N fully sheets have helped increase public awareness of NICNAS and the safe use
operational of chemicals by providing user-friendly, plain language information on the
scientific risk assessment of chemicals used in Australia.
Database at NICNAS
In 2001-02 NICNAS designed and built an integrated database to record and
track all NICNAS business information, including AICS-listed chemicals, new
chemicals, company registration and compliance. This integrated information
system, Database at NICNAS (D@N), went live in August 2002 and has led
to greater efficiencies within the organisation. The database was built using
web-based technology to enable linking to any future e-commerce facilities
NICNAS may need to develop.
Price
Thirteen copies of the Handbook for Notifiers and 79 AICS CD-ROMs were
sold in 2002-03 (5 and 20 respectively in 2001-02) and all other NICNAS
printed materials are available free-of-charge to industry. A total of 125 new
chemicals reports completed by NICNAS in 2002-03 were made available
to the public free-of-charge. Ongoing savings to industry are achieved
by a focus on electronic publications.
The move to place the Handbook for Notifiers online has led to savings
to industry in the order of $20,000 over the past three years.
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Consolidated Summary Outputs / Resource Table
An overview summary of key outputs against resource for each main output category
is provided in Table 18.
Table 18 Summary of key outputs and resources for each output
category
Outputs Resource $,000
Assessment New Chemicals Certificates received 179
Certificates issued 125
Permits received 165
Permits issued 151
Active submissions at 30/6/03 180 1,594
MSDS assessed 500
(approx.)
Exemptions 422
Consultations 30
Site visits 1
Existing Chemicals Screening assessments 13
including completed
PEC & other chemicals under 20
review
Assessment modules completed 46
PEC & other assessment reports 1,543
published 16
Overseas assessments reviewed 44
Overseas assessments agreed 84
Site visits 12
Compliance New cases 138
including* Investigations completed 144
Number of companies in 458
company registration audit
Site visits 18
Chemical notification made 19
Number of prosecutions 0
Communication AICS searches 2,863 1,251
including Inquiries 1,804
Publications /documents 164
Presentations 28
Conferences 24
International meetings 10
Reform Activities Meetings 3
Publications 5
Consultations 5
Recommendations 12
Legislation changes 3
* Compliance 50 per cent funded through cost recovery and 50 per cent funded through
Government appropriation.
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COMPLIANCE WITH ANNUAL REPORT GUIDELINES
3 Letter of Transmittal
5 Table of Contents
137 Index
6 Glossary
4 Contact Details
12 Director's Overview
20 Corporate Overview
27 Management and Accountability
32 Financial Performance
90 Resource Tables by Outcomes
94 External Scrutiny
27 Corporate Governance
32 Fraud Measures see also DoHA Annual Report 2002-03
30 Management of Human Resources
101 Statistics on Staffing
27 Certified Agreements and AWAs see also DoHA Annual Report 2002-03
51 Performance Reports
32 Purchasing see also DoHA Annual Report 2002-03
103 Consultants
35 Discretionary Grants
31 Equity Performance
32 Disability Strategy see also DoHA Annual Report 2002-03
31 Occupational Health and Safety see also DoHA Annual Report 2002-03
36 Freedom of Information see also DoHA Annual Report 2002-03
35 Advertising and Market Research
36 Ecologically Sustainable Development and Environmental Performance
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Compliance with Mandatory Reporting
Requirements Under The Act
In addition to the requirement to produce an Annual Report to Parliament on
the operations of the Act and other external scrutiny such as through the
NICNAS Industry Government Consultative Committee, the Act also prescribes
additional mandatory reporting requirements. These are detailed in the
following table along with information on the last/next publishing date.
Requirement Last Published/Next Published
Annual publication in the Chemical Gazette List of low volume chemical permits in
of the list of chemicals which are the force at 30 June 2003 published in July
subject of low volume chemical permits 2003 Chemical Gazette. Number of
[Subsection 21ZA(2)]. permits issued 2002-03: 69
Annual publication in the Chemical Gazette A list of current and previous PECs was
of a list of current and previous Priority published in the June 2003 Chemical
Existing Chemicals (PECs) [Section 54]. Gazette.
Annual publication in the Chemical Gazette All assessments undertaken and
of a list of the chemicals requiring published by NICNAS are subject to
secondary notification and a list of those secondary provisions. These are
no longer requiring secondary notification published on our web site. A list of the
[Section 71]. chemicals no longer requiring secondary
notification was published in the June
2003 Chemical Gazette.
Written notice to the Gene Technology Number of genetically modified
Regulator when a genetically modified (GM) chemicals referred to the Office of Gene
product is regulated by NICNAS Technology for advice: 0
[Section 10A].
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External Accountability Arrangements
NICNAS Industry Government Consultative Committee
(IGCC) ?Terms of Reference and Membership
Terms of Reference
In March 1997, the Government agreed to amend the Industrial Chemicals
(Notification and Assessment) Act 1989 to introduce new funding
arrangements for NICNAS. Under these arrangements, the chemical industry
will directly contribute to the operating costs of NICNAS.
In order to ensure that industry has the opportunity to participate
in the NICNAS budgetary process, a joint Industry Government Consultative
Committee (IGCC) was established. The Committee meets at least twice
a year.
The Committee has eight members, including four industry representatives
and four Government representatives. The membership consists of one
representative from each of the following organisations:
Industry
? Australian Consumer & Specialty Products Association (ACSPA)
? Plastics and Chemicals Industries Association (PACIA)
? Australian Paint Manufacturers' Federation (APMF)
? Australian Chamber of Commerce and Industry (ACCI)
Government
?NICNAS (Chair)
?National Occupational Health and Safety Commission (NOHSC)
?Department of Industry, Tourism and Resources (DITR)
?Environment Australia (EA) ?Australian Government Department
of Environment and Heritage
Given the integral relationship between the Director NICNAS and the National
Manager of the Therapeutic Goods Administration (TGA), the National
Manager TGA will be an ex-officio member of the IGCC.
The IGCC:
(a) reviews the utilisation of resources against NICNAS objectives;
(b) reviews the performance of NICNAS against agreed performance
indicators (including those established in the NICNAS Service Charter and
Corporate Plan), and in particular the impact on industry and the protection
of human health and the environment;
(c) develops strategies for improving the efficiency and effectiveness of
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NICNAS operations within the context of (i) established goals and objectives
and (ii) developing and emerging issues; and
(d) develops compliance strategies and monitors the effectiveness of these
strategies in promoting compliance with the Scheme. The Chair of the
Committee has reported as necessary (at least every six months) to the
Minister on the outcomes of the Committee. The administrative arrangements
to transfer NICNAS to the Department of Health and Ageing were achieved
with amendments to the Act (3 July 2002). As a consequence of changed
arrangements, the Government membership was amended for 2002-03.
In addition to the meetings outlined below, the IGCC held an out-of-session
meeting on 17 December 2002 to consider proposed increases to fees
and charges for 2003-04.
IGCC Membership at 30 June 2003 and attendance at 2002-03 meetings
Members Organisation 16th 17th 18th
Meeting Meeting Meeting
13 August 19 Nov 6 May
2002 2002 2003
Dr Margaret Hartley (Chair) Director NICNAS
Ms Bronwyn Capanna Representing ACSPA
Mr Nick Munafo Representing PACIA
Mr Michael Hambrook Representing APMF
Ms Sylvia Kidziak AM Representing ACCI
Mr Robin Stewart-Crompton Representing NOHSC
(IGCC 16)
Mr Tom Fisher (17,18)
Mr Detlef Jumpertz (16) Representing DITR
Mr Bob Summerville (17)
Mr Michael Flaherty (18)
Mr Peter Burnett (16,17) Representing EA
Mr Chris Lee-Steere (18) Representing EA
Mr Terry Slater Representing TGA
Ex-officio
Note: The number in the bracket refers to which meeting the representative attended.
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NICNAS / State and Territory Memorandum of
Understanding (MOU) Group ?Terms of Reference and
Membership
The States/Territories Memorandum of Understanding (MOU) group exists as
a conduit for the free flow of information and needs between the
States/Territories and the Commonwealth on OHS, environmental and health
matters relating to the use of chemicals in Australia.
Each jurisdiction has a representative nominated as a member of the MOU.
That person liaises with contacts from various departments, such as
environment, health etc, within their State/Territory. This allows those working
at the "coalface" to raise issues of concern regarding chemicals with the
federal agencies through their MOU representative and for the
Commonwealth to pass information etc to those involved in the day-to-day
implementation of chemical regulation and policy.
The MOU was signed in 1991 with the intention of formally recording
arrangements to facilitate the operation of the Commonwealth Industrial
Chemicals (Notification and Assessment) Act (the Act), under which NICNAS
was established, and State and Territory legislation relating to industrial
chemicals. Under the MOU, each State and Territory is to consider and
wherever possible implement each recommendation in an assessment report
published by the Director of NICNAS and to inform the Director of any
consequential action taken in respect of any recommendations. The
agreement also provides mechanisms in relation to facilitating the operation
of specific sections of the Act relating to new and existing chemicals.
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MOU Group Membership as at 30 June 2003 and attendance at 2002-03
meetings
Members Organisation 7 November 9 May
2002 2003
Dr Margaret Hartley Director NICNAS
Dr Roshini Jayewardene (Chair)
Ms Marie Mannion Representing ACT
Mr Greg Balka Representing VIC
Mr Gary Rhyder Representing NSW
Mr David Grantham Representing QLD
Mr Trevor Jones Representing SA
Mr Joe Crea Representing SA
Dr Jeff Langley Representing WA
Mr Phillip Riley Representing TAS
Mr Stephen Zaluzny Secretariat
Mr Neil Watson Representing NT
Low Regulatory Concern Chemicals Task Force ?Terms of
Reference and Membership
Introduction
The Chemicals and Plastics Action Agenda provides the framework
for NICNAS to pursue ongoing regulatory reform for industrial chemicals.
The LRCC Task Force is established to assist the Director NICNAS with
the development of reform proposals in relation to low regulatory concern
chemicals. The LRCC Task Force will report to the Industry Government
Consultative Committee (IGCC) via the Director NICNAS.
Membership
The LRCC Task Force shall consist of seven members, including the Director,
NICNAS, (who will Chair the Task Force). Members have been appointed
on the basis of either their technical knowledge of industrial chemicals
in a regulatory context, ability to provide expert technical advice,
an understanding of community concerns related to the regulation
of chemicals and/or knowledge of Government processes involving
industrial chemicals regulation. Membership will comprise three industry
representatives, one of which will be a member of the Chemicals and Plastics
Leadership Group, two members representing the public interest,
a State/Territory representative and the Director NICNAS.
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At its initial meeting, the LRCC Task Force will comment on the draft Terms of
Reference, the review process and budget, the establishment of technical
working groups and if necessary, provide recommendations for amendment
to the Director NICNAS.
It is expected that the LRCC Task Force will meet two to three times in the
next nine months, with additional work out of session. Meetings will be
conducted either face-to-face, or through tele-conferencing. A quorum will
constitute the Chair or her nominee, at least one industry representative and
one non-industry member. The LRCC Task Force will be able to seek
additional expert advice, for example from individuals, technical working
groups or consultants as needed. The LRCC Task Force is expected to
provide a final report to the IGCC by June 2003.
Terms of Reference
The LRCC Task Force will:
(1) provide advice on the development of reform proposals relevant
low regulatory concern chemicals;
(2) contribute to, and provide strategic direction on the:
?investigative approach and methodology to be undertaken in the review
process, including over sighting the direction of technical working groups
?development of discussion papers addressing key issues relating to
reform including:
?criteria for low regulatory concern chemicals
?regulatory impacts, economies; and efficiency of
reform proposals; and
?international trends and practices;
(3) contribute to, and provide strategic direction on the consulta
strategy, including participation in consultations as appropriate
and consideration of submissions from the public and
stakeholders;
(4) review public discussion papers prior to release;
(5) review progress and expenditure against the project plan,
advise on strategies for additional funding as appropriate;
(6) provide a report to IGCC by June 2003; and
(7) assist with other tasks relevant to the LRCC process at the requ
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of the Director NICNAS.
LRCC Task Force Membership as at 30 June 2003
Dr Margaret Hartley (Chair) Representing NICNAS
Ms Sylvia Kidziak Representing industry
Mr Geoff MacAlpine Representing industry
Ms Margaret Donnan Representing industry
Ms Laurel Wolfram Representing the public
Professor Neil Gunningham Representing the public
Dr David Grantham Representing government
Dusanka Sabic LRCC Secretariat
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Organisational Chart, Staff Profile, Training and
Development Activities
NICNAS Organisational Chart as at 30 June 2003
Parliamentary Secretary to the Minister for Health and Ageing
The Hon Trish Worth MP
NICNAS TGA
IGCC
Group of
Regulators
Director
Dr Margaret Hartley
Core Executive Team
Dusanka Sabic
Dr Roshini Jayewardene
Nick Miller
New Chemicals Existing Business Innovation &
Assessment Chemicals Management & Compliance
Assessment Communication
Team Leader
Team Leaders Team Leaders Team Leader
Deborah
Bob Graf Nick Miller Hana Hamdan
Willcocks
Dr Kerry Nugent
Dr Sneha Satya
Reform
Dusanka Sabic
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Staff Profile and Training and Development
Activities
There were 37 staff employed within NICNAS at 30 June 2003. Of these,
29 are permanent employees and 8 are non-ongoing staff. The staffing profile
at 30 June 2003 by classification and membership of equal employment
opportunity groups (EEO) are shown in the following tables.
NICNAS Staffing Profile at 30 June 2003
Classification Male Female Total
Statutory Officers 0 1 1
Executive Level 2 Officers 2 6 8
Executive Level 1 Officers 4 5 9
APS Level 5 and Level 6 Officers 7 6 13
APS Level 1 ?4 Officers 0 6 6
Total 13 24 37
Membership of Equal Employment Opportunity Groups
EEO Group No. of Staff % of Total Staff
Women 23 62.2
Aboriginal and Torres Strait Islander People 1 2.7
Non-English Speaking Background 11 29.7
People with Disabilities 3 8.1
The training and development outcomes are reported as total number
of training days and the average number of training days per staff member
is shown in the table on page 102. Training and development activities
covered a broad range, including formal courses, in-house training,
participation in conferences and other representational activities as well
as technical training activities.
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Summary of Staff Training by Category 2002-003
Total No. of Average No. of
Formal Training Formal Training
Days Days per
Staff Member
All staff Scientific / Technical Related 54.0 1.5
All staff Information Technology Related 20.0 0.5
All staff Scheme Performance /
Professional Development Related* 60.0 1.6
New staff Orientation / Induction Related 1.0 1.3
All staff Total formal training+ 135.0 3.65
* Formal training activities include customer service training, corporate governance activities,
financial management, policy development etc.
+ The total number of formal days training and the average number of formal training days
for all staff members includes orientation and induction-related training for one new staff
member.
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Consultancies Commissioned
Three consultancies were commissioned by NICNAS during 2002-03. Details
are provided below. Consultancy services are contracted by NICNAS to
ensure the achievement of high quality assessments of chemicals and more
efficient and effective delivery of regulation and related outputs.
The method of selection for each consultancy commissioned by NICNAS
during 2002-03, was by direct engagement. They were chosen on the basis
of pre-eminent expert advice, relevant to science expertise and, direct
knowledge of NICNAS organisational development programs for ongoing
development resulting from staff surveys.
Bruce Rowe & Associates
Consultancy to develop staff survey forms enabling comparison of results for
ongoing organisational development. Total cost $5,830. This amount includes
$2,200 payable from 2001-02 consultancy engagement.
University of Sydney
Consultancy to engage Professor John Mackie, Department of Chemistry from
the University of Sydney to provide:
?expert advice on tailpipe emissions for Ph-AVSR. Total Cost $460.
?expert advice on likely high temperature final tailpipe emission products of
sodium AVSR additive. Total Cost $460.
?expert advice on likely high temperature final tailpipe emission products of
phosphorous AVSR additive. Total Cost $2,300. This amount was payable
from the 2001-02 consultancy engagement.
SAS Strategic Pty Ltd
Consultancy engaged to provide training services for LRCC working groups.
Total cost $2,380.
Note: All total costs include GST.
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Media Advertising Organisations Engaged by
NICNAS 2002-03
Organisation Service Provided Cost ($)
HMA Blaze Pty Ltd Advertisement in The Australian 7 May 2003 1,390
to promote the NICNAS Low Regulatory
Concern Chemicals Public Discussion Paper
?Call for Public Comment
Starcom Worldwide Advertisement in the Australian Paint and 1,213
(Australia) Pty Ltd Ink Year Book August 2002 to promote the
AICS CD-ROM
Starcom Worldwide Advertisement in the Australian Financial 2,870
(Australia) Pty Ltd Review 22 August 2002 to promote the
AICS CD-ROM
Starcom Worldwide Recruitment advertisement in The Sydney 3,513
(Australia) Pty Ltd Morning Herald 31 August 2002
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Ecologically Sustainable Development (ESD)
Accordance of NICNAS activities with Ecologically
Sustainable Development (ESD) Principles
(a) decision-making processes should effectively integrate both long-term
and short-term economic, environmental, social and equitable considerations.
NICNAS undertakes risk assessment within an agreed policy framework
and includes within the overall process of decision-making, the hazard
assessment, dose-response relationships, exposure assessment and risk
management options. Hazard assessment identifies the set of inherent
properties that make a chemical capable of causing both short-term
and long-term adverse effects to human health or the environment.
Based on risk estimates, risk management strategies are recommended.
When recommending risk management strategies and consideration of what
constitutes acceptable risk NICNAS operates within an agreed framework
for the environmentally sound management of chemicals, based on the
principles and policy of ESD and aligned with the United Nations Conference
on Environment and Development (UNCED) Agenda 21 (Rio Declaration),
which includes Chapter 19 on the Environmentally Sound Management
of Toxic Chemicals. The economic and social benefit of risk reduction action
is balanced with the economic, political and social costs of implementing
the strategies. Risk management also involves monitoring, evaluating
and reviewing the strategies recommended.
(b) if there are threats of serious or irreversible environmental damage,
lack of full scientific certainty should not be used as a reason for postponing
measures to prevent environmental degradation.
Caution is applied implicitly or explicitly while conducting risk assessments.
In particular, where international chemicals policy negotiations may need
to rely on precaution this is applied in line with the principles of ESD
and the UNCED Agenda 21, Principle 15 (precautionary approach).
(c) the principle of inter-generational equity ?that the present generation
should ensure that the health, diversity and productivity of the environment
is maintained or enhanced for the benefit of future generations and d) the
conservation of biological diversity and ecological integrity should be a
fundamental consideration in decision making.
The risk management controls recommended by NICNAS are aimed
at allowing ongoing environmental integrity and biological diversity. Our risk
assessments integrate hazard assessment with any unique exposure or use
patterns and also take into consideration the unique nature of Australia's
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demography and the national ecosystems and fauna and flora. In this way
NICNAS provides the information necessary that will allow informed
democratic and transparent decisions to be made including trade-offs
between competing objectives of current utility and future adverse
environmental effects.
(e) improved valuation pricing and incentive mechanisms should be
promoted.
NICNAS's approach to regulation reflects a risk based resource focus,
whereby initiatives such as Early Introduction Permit (EIP) for non-hazardous
chemicals and revision of criteria for polymers of low concern (PLC) have
been developed specifically to promote introduction of less hazardous
chemicals and minimise risk to the environment and human health. These
initiatives provide financial incentives to industry. EIPs allow industry to
immediately market their chemical whilst undergoing regulatory assessment;
the PLC criteria increase the number of low risk chemicals coming onto the
market and attract a lower assessment fee and has reduced data
requirements, and hence reduced cost to industry. NICNAS reforms to
regulation aimed at promoting innovation and less hazardous chemicals have
been estimated to have saved the Australian industry some $1.6 million to
$6.3 million in regulation costs since 1997.
How Outcomes Relate to ESD
Chapter 19 of UNCED Agenda 21, whilst acknowledging that substantial use
of chemicals is essential to meet the social and economic goals of the world
community, identified two major problems, particularly in developing
countries, namely (a) lack of sufficient scientific information for the
assessment of risks entailed by the use of a great number of chemicals, and
(b) lack of resources for assessment of chemicals for which data are at hand.
Chapter 19 is focused on the generation, harmonization and dissemination of
chemical data, and strengthening capacity for chemical management The
Agenda 21 programs and objectives for chemicals, to a large extent, reflect
some important elements of the Rio Declaration including: Principle 9
(building capacity through developing and transferring scientific information),
Principle 10 (the right of access to information or the "right to know" and the
right to participate in decisions) and Principle 15 (the "precautionary
principle").
The activities of NICNAS are fundamentally focussed on these principles.
NICNAS assesses the health and environmental risks of new industrial
chemicals entering Australia for the first time (by manufacture or import)
before their release to the environment. NICNAS also assesses priority
chemicals already in use based on environmental and health concerns.
NICNAS assessment reports provide information and recommendations to
regulators (including Commonwealth, States/Territories), industry and the
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general public. The development and operation of NICNAS represents
significant capacity building in Australia for the management of chemicals.
Effects of NICNAS Activities on the Environment and measures to
minimise them
The positive environmental effects of NICNAS are detailed above.
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Types and Categories of NICNAS Assessments
New Chemicals: Industrial chemicals and polymers not listed on the
Australian Inventory of Chemical Substances (AICS)
Certificates Chemicals not on AICS can only be introduced by the holder of an
assessment certificate (unless the chemical is covered by a permit
or under specific NICNAS exemptions). After five years, the chemical
is listed on AICS and is available for open use. The assessment report
is provided to the notifier, who is able to use the report to support their
responsibilities for control of the chemical, for example, State and
Territory hazardous substances legislation, environmental legislation and
Poisons Scheduling. The full public report, including recommendations
on safe use, is available to the public on the NICNAS web site
(www.nicnas.gov.au) and may be used by State and Territory agencies
and in the workplace. Commercially sensitive information may
be exempt from publication in the full public report, if the commercial
interest outweighs the public interest. Summary reports of each
assessment are published in the Commonwealth Chemical Gazette.
Standard Required for all new industrial chemicals and biopolymers where the
Notification volume of introduction is greater than 1,000 kg/year, and new synthetic
polymers with a number-average molecular weight (NAMW) less than
1,000 daltons (except certain polyesters of low risk). This category
requires the highest level of data including toxicological
and ecotoxicological test data, chemical identity, physico-chemical
properties, use pattern, occupational, environmental and public
exposure information, environmental fate data, Material Safety Data
Sheet (MSDS) and label.
Limited These are required for all new industrial chemicals and biopolymers
Notification where the volume of introduction is less than 1,000 kg/year, and new
synthetic polymers with a NAMW greater than 1,000 daltons. Standard
data requirements are less than for a standard notification (includes
chemical identity, physico-chemical properties, use pattern,
occupational, environmental and public exposure, MSDS and label),
however, all available data must be provided.
Polymers of Low These chemicals are defined by predetermined criteria to be of
Concern (PLC) low hazard to humans and the environment. PLC can be introduced
into Australia with reduced fees and reduced data requirements.
Extension of The original assessment certificate can be extended to include other
Original introducers, providing the original certificate holder agrees in writing.
Assessment In addition to specific data requirements, new information on exposure
Certificate or adverse health and environmental effects must also be provided.
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Permits Permits allow chemicals to be introduced conditionally, without a full
assessment, providing certain information is provided on identity, hazard
and exposure. MSDS and labels must also be provided. NICNAS
assesses permit applications under shorter timeframes and reduced
fees.
Commercial Chemicals to be introduced solely for determination of their commercial
Evaluation potential are eligible for assessment as CECs. The application can be
Category (CEC) for introduction of up to 2,000 kg for up to two years provided that the
quantity and timeframe requested by the notifier can be justified as
necessary for commercial evaluation purposes. Data requirements
include health and environmental effects information, chemical identity,
use and distribution arrangements, volume and duration of introduction,
occupational, environmental and public exposure, MSDS and label.
Customer agreements must be provided for each proposed user of the
chemical. At the time of publication, it was proposed that the current
upper limit of 2,000 kg be increased to 4,000 kg.
Low Volume LVCs are available for chemicals introduced at 10-100 kg/year
Chemicals (LVC) (nationwide volume limit). Data requirements include health and
environmental effects information, chemical identity, use, volume and
duration of introduction, occupational, environmental and public
exposure, MSDS and label. The maximum LVC permit period is three
years, with the provision for unlimited renewal.
Early Introduction EIPs are available for the introduction of non-hazardous chemicals with
Permit for Non- respect to human health and the environment. Once an EIP is granted,
Hazardous the applicant may introduce the chemical according to permit
Chemicals (EIP) conditions before the full assessment has been completed. Factors
taken into account include reasonable protection of occupational health,
public health and the environment.
Small volumes This provision allows for introduction of small volumes of new
notification only ? chemicals and polymers provided certain criteria are met.
the <10 kg The exemption does not apply to chemicals that pose an unacceptable
rule ?cosmetic risk to occupational health, public health or the environment.
and non-cosmetic The introducer is responsible for conducting the risk assessment. There
chemicals are specific criteria for cosmetic chemicals, incorporating safeguards
for consumer use, for instance, a cosmetic chemical must not be used
as a preservative, a colouring agent or an ultraviolet filter. In addition,
the chemical must not be prohibited or restricted for cosmetic use in
either the European Union under directive 76/768/EEC as amended or
the USA under the Food, Drugs and Cosmetics Act 1938 as amended.
More information is required in relation to effects in high-risk consumer
groups consistent with the anticipated use of the cosmetic product,
if the chemical is present at greater than one per cent.
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Research, RD&A chemicals that are imported or manufactured in volumes less
development or than 50 kg/year do not require notification. At higher volumes, the same
analytical (RD&A) provisions apply as for other new chemicals and polymers. An exception
purposes applies in certain specific cases where an RD&A chemical is
manufactured in Australia at greater than 50 kg/year in situations where
smaller volumes cannot be manufactured, for example, limitations on
the size of equipment available for manufacture. In these cases,
information must be provided to NICNAS on the type and location of the
apparatus (a fixture), the program of work, type of chemical and
procedures for safe disposal of the chemical and any hazardous
degradation products.
Existing Chemicals: Chemicals already in use in Australia
Assessments Assessments include screening assessments, Priority Existing Chemical
(PEC) assessments (full, preliminary, and secondary) and international
assessments. PEC assessments are comprised of assessment modules,
with the modular make-up of each assessment varying depending on
the scope of the assessment. The modules are: hazard assessment,
exposure assessment, risk assessment/current controls, environment
assessment, public health assessment, and recommendations/final draft
report.
Screening Candidate chemicals to be considered for full or preliminary
Assessments assessment are assessed by an expert agency panel against a set of
criteria covering issues in public health, occupational health and safety
and the environment. The data used for the screening comprise health
and environmental hazard data plus exposure data submitted by
industry in response to notice in the Chemical Gazette. Screening allows
the chemicals to be ranked on the basis of the perceived severity of the
threat posed to human health or the environment. Results of screening
assessments are made public.
Other Assessments This class of assessment provides for the fast collection and distribution
of data on one or more aspects of a chemical that may be of concern,
but which has not been declared a PEC. They serve the situation where
there is an identified need for data on a chemical, but not necessarily
for an evaluation of the data. Related or similar chemicals may be
considered as a group. The draft reports are circulated for comment to
interested parties before publication.
Full Assessments Full assessments usually include information on chemical and physical
properties, uses, exposure, kinetics and metabolism, effects on
experimental animals and in vitro test systems, and human health
effects. They include a hazard assessment and classification, a section
on risk characterisation, risk management, and recommendations. Full
assessments include an occupational, consumer and/or environmental
risk assessment. Sometimes related or similar chemicals are assessed
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7
as a group, and the assessment can focus on specific areas of concern.
This flexibility in assessment ensures that NICNAS resources are
targeted effectively to priority areas of concern.
Preliminary Preliminary assessments are less detailed, tailored to the particular
Assessments aspects that are the focus of the assessment. Preliminary assessments
do not include a risk assessment. As with full assessments, preliminary
assessments can apply to the chemical generally, or can focus on
particular uses of the chemical, or on its manufacture, handling, storage
or uses in a specified geographical area or in specified circumstances.
Secondary Following the publication of a PEC assessment, there may be changes
Assessments in circumstances, which necessitate a reassessment of particular
aspects of the chemical. The secondary notification and assessment
process is implemented when a new use of the chemical occurs or
when significant new information about the health or environmental
effects, or circumstances of use of the chemical become available.
Secondary assessments may also be required for new chemicals that
have been assessed by NICNAS.
International There are two international assessment programs for existing chemicals,
Assessment under the auspices of the OECD and the International Program on
Programs - Chemical Safety (IPCS). These programs coordinate international
IPCS/CICADS; agreement on one assessment of a chemical, based on a draft
OECD - SIDS; assessment contributed by one of the participating countries, thereby
OECD - HPV avoiding duplication of the assessment by the other participating
countries. The outcomes of international assessments are routinely
considered by NICNAS. This is a cooperative program of the World
Health Organisation (WHO), the United Nations Environment
Programme (UNEP) and the International Labour Organization (ILO).
Concise International Chemical Assessment Documents (CICADs) are
published under this program. They are summaries of relevant scientific
information based on selected national or regional evaluation
documents.
The OECD Screening Information Data Set (SIDS) program concentrates
on the potential hazards of high production volume chemicals (HPV),
which are defined as chemicals being produced in quantities of at least
1,000 tonnes per year in at least one OECD member country. In order to
share the burden of testing and assessing these chemicals, member
countries work together to cooperatively investigate HPV chemicals.
Reports prepared by a country are available to all other member
countries. The assessments are considered and member countries
agree on conclusions about the hazards of the chemical and
recommendations concerning the need for follow-up actions. The
chemical industry play a significant voluntary role in this program.
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The OECD High Production Volume (HPV) program is based
on the assumption that production volume is a surrogate for data
on occupational, consumer and environmental exposure. The overall
objective of the HPV industrial chemical program is to cooperatively
undertake internationally an initial hazard assessment of HPV
chemicals, to screen such chemicals and agree on the need
for further work.
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8
New Chemicals Notification and Assessment
Statistics
This appendix shows the number of new chemical submissions (total and
assessment category) received and completed for 2002-03 (by quarter and
total) and compares these to 2001-02 and 2000-01 figures. Data include
performance against statutory timeframes.
Total submissions 2002-03 Quarter Total Total Total
1st 2nd 3rd 4th 2002-03 2001-02 2000-01
Applications Received - Certificates 27 45 64 42 179 168 182
Applications Received - Permits 51 40 44 30 165 120 148
Certificates Issued 41 29 21 34 125 164 183
Permits Issued 31 35 42 43 151 119 138
Total Certificates Active * 78 118 144 146 146 102 114
(end of the final month)
Total Permits Active * 28 26 25 34 34 21 21
(end of the final month)
*Active includes all submissions accepted but not finalised (that is, certificate or permit not
signed). Active submissions may be in pre-screening, under assessment, with the notifier for
comment before publication of the final reports, or awaiting additional information from the
notifier.
Certificate Category 2002-03 Quarter Total Total Total
1st 2nd 3rd 4th 2002-03 2001-02 2000-01
Applications Received
STD 3 10 9 10 32 43 52
LTD 10 16 28 10 64 53 56
PLC 13 16 23 21 73 64 64
Extension 1 3 4 2 10 8 10
Certificates Issued
STD 10 1 5 2 18 49 48
LTD 11 8 11 15 45 63 59
PLC 19 18 4 13 54 47 65
Extension 1 2 1 4 8 5 11
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Permit Category 2002-03 Quarter Total Total Total
1st 2nd 3rd 4th 2002-03 2001-02 2000-01
Applications Received
CEC 14 10 15 4 43 33 51
LVC 27 22 18 12 79 45 46
EIP 10 8 11 14 43 42 46
Permits Issued
CEC 8 12 14 17 51 37 42
LVC 12 20 15 14 61 44 45
EIP 11 3 13 12 39 38 51
All Assessments Target 2002-03 Quarter 2002-03 2001- 2000-
02 01
1st 2nd 3rd 4th Total % % %
Certificates and 72 64 63 77 276 -- -- --
permits issued
Reports to notifier 90 days 33/33 25/26 25/28 32/35 115/122 94 100 98
within statutory (all categories
timeframes except
Extension)
45 days 2/2 1/1 2/2 1/1 6/6 100 100 100
(Extension)
90 days N/A N/A 1/3 N/A 1/3 33 -- --
not met; EIP
issued prior
Certificates issued
(upon receipt of 7 days 39/41 27/29 19/21 28/34 113/125 90 93 96
notifier's reply to
final reports)
Permits issued 14 days (CEC) 8/8 10/12 14/14 17/17 49/51 96 95 95
within statutory/ 20 days (LVC) 11/12 20/20 14/15 14/14 59/61 97 100 100
non-statutory 28 days (EIP) 11/11 3/3 12/13 12/12 38/39 97 100 100
timeframes
N/A ?not applicable due to either (i) EIP not sought or (ii) 90 day statutory timeframe met.
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Standard Target 2002-03 Quarter 2002-03 2001- 2000-
Notification 02 01
1st 2nd 3rd 4th Total % % %
Certificates issued 10 1 5 2 -- --
Reports to notifier 90 days 5/5 1/1 7/7 4/5 17/18 94 100 98
within statutory
timeframes 90 days
not met;
EIP issued
prior N/A N/A N/A N/A N/A -- --
Certificates issued
(upon receipt of
notifier's reply to 7 days 9/10 1/1 4/5 2/2 16/18 89 96 98
final reports)
N/A ?not applicable due to either (i) EIP not sought or (ii) 90 day statutory timeframe met.
Limited Target 2002-03 Quarter 2002-03 2001- 2000-
Notification 02 01
1st 2nd 3rd 4th Total % % %
Certificates issued 11 8 11 15 -- --
Reports to notifier 90 days 11/11 8/9 11/13 16/18 46/51 90 100 98
within statutory
timeframes 90 days
not met;
EIP issued
prior N/A N/A N/A N/A N/A N/A -- --
Certificates issued
(upon receipt of
notifier's reply to 7 days 11/11 8/8 10/11 14/15 43/45 96 90 98
final reports)
N/A ?not applicable due to either (i) EIP not sought or (ii) 90 day statutory timeframe met.
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Polymer of Low Target 2002-03 Quarter 2002-03 2001- 2000-
Concern 02 01
1st 2nd 3rd 4th Total % % %
Certificates issued 19 18 4 13 54 -- --
Reports to notifier 90 days 17/17 16/16 7/8 12/12 52/53 98 100 98
within statutory
timeframes 90 days
not met;
EIP issued
prior N/A N/A N/A N/A N/A -- --
Certificates issued
(upon receipt of
notifier's reply to 7 days 19/19 17/18 4/4 12/13 52/54 96 94 92
final reports)
N/A ?not applicable due to either (i) EIP not sought or (ii) 90 day statutory timeframe met.
Certificate Target 2002-03 Quarter 2002-03 2001- 2000-
Extension 02 01
1st 2nd 3rd 4th Total % % %
Certificates issued 1 2 1 4 8 -- -- --
Reports to notifier
within statutory 45 days 2/2 1/1 2/2 1/1 6/6 100 100 100
timeframes
Certificates issued
(upon receipt of
notifier's reply to 7 days 0/1 1/2 1/1 0/4 2/8 25 100 91
final reports)
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Commercial 2002-03 Quarter 2002-03 2001-02 2000-01
Evaluation Category 1st 2nd 3rd 4th Total % % %
Permits issued 8 12 14 17 51 -- --
Permits issued within
non-statutory 8/8 10/12 14/14 17/17 49/51 96 95 95
timeframes (14 days)
Low Volume 2002-03 Quarter 2002-03 2001-02 2000-01
Chemicals 1st 2nd 3rd 4th Total % % %
Permits issued 12 20 15 14 61 -- --
Permits issued within
statutory timeframes 11/12 20/20 14/15 14/14 59/61 97 100 100
(20 days)
Early Introduction 2002-03 Quarter 2002-03 2001-02 2000-01
Permit 1st 2nd 3rd 4th Total % % %
Permits issued 11 3 13 12 39 -- --
Permits issued within
statutory timeframes 11/11 3/3 12/13 12/12 38/39 97 100 100
(28 days)
<10kg per year
Exemption Category 2000-01 2001-02 2002-03
Cosmetic 197 276 388
Non-cosmetic 36 12 34
Total 233 288 422
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Confidential Listing of Chemicals on the
Australian Inventory of Chemical Substances
Technical Advisory Group Membership
Professor Graham A R Johnston, AM FRACI, FTSE
(re-appointed October 2002)
Professor of Pharmacology, University of Sydney
Professor Ian Rae, FRACI, FTSE (re-appointed October 2002)
Department of History and Philosophy of Science, University of Melbourne
Ms Mariann Lloyd-Smith (re-appointed October 2002)
Co-ordinator, National Toxics Network Canberra
Mr James Smith CEng, FIChemE, BCom (Melb) (appointed August 2000)
Chemicals Advisor, Melbourne
The Technical Advisory Group met six times in 2002-03. During the year
NICNAS completed the stakeholder consultations on revisions to the
guidelines for confidential listing on the Australian Inventory of Chemical
Substances, with community meetings in Melbourne (28 August 2002) and
Sydney (17 October 2002). The Technical Advisory Group reported on
stakeholder suggestions to NICNAS. Draft revisions to the NICNAS Guidelines
for Establishing a Case for Confidential Listing on the Australian Inventory of
Chemical Substances, June 2003 and the NICNAS application form (FORM
AICS-1) were released for public comment in June 2003.
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Summary of Existing Chemicals Assessment
Activity
PEC Assessments/Secondary Notifications: 2002-03 Activity
Jul-Sep Oct-Dec Jan-Mar Apr-Jun
2002 2002 2003 2003
New declarations in quarter 0 1 0 1
Number under review / review published 5/0 6/0 7/0 8/2
Data gathering phase* 0 2 0 1
Assessment phase 5 6 4 4
?Uses 0 1 2 2
?Hazard assessment completed 1 2 0 1
?Exposure assessment completed 0 1 0 2
?Risk assessment/current controls completed 1 1 0 0
?Environment report completed by EA+ 1 1 0 1
?Recommendations/final draft report completed 0 3 0 0
Consultation (corrections/variations) 0 2 3 0
Appeals 0 0 0 0
Publication phase 0 0 0 1
Total Number published 0 0 0 2(2)
(and number within statutory deadline)
No. PEC Safety Info Sheets published 2 0 0 0
Data call-ins 1 0 3 2
* Phase underway or completed.
+ Number may be smaller than total completed as some assessments do not require
environmental assessments.
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Screening and Other Assessments*
Jul-Sep Oct-Dec Jan-Mar Apr-Jun
2002 2002 2003 2003
New assessments commenced in quarter* 4 0 3 6
Number under review 4 2 3 8
Assessment phase 2 2 2 7
?1st module completed 2 2 2 7
?2nd module completed 2 2 2 7
No. of reports released for comments 0 0 2 1
Total Number published 2 2 1 8
* Other assessments include chemical information sheets and alerts
List of PEC Chemical Assessments published or
in publication phase under the Existing Chemicals Program
2002-03
Chemical Name CAS Number
Alkyl Phosphate Anti-Valve Seat Recession Additive Exempt from publication
Methocyclopentadianyl manganese tricarbonyl 12108-13-3
Polymer in Reactint Red X64 (Secondary Notification) Not assigned
List of screening/other chemical assessments published under
the Existing Chemicals Program 2002-03
Chemical Name CAS Number
Ammonium lauryl sulphate 2235-54-3
Calcium hemihydrate 10034-76-1
Copper 7440-50-8
Ethene,chlor- 75-01-4
Information sheet on chemicals `banned' or severely not applicable
restricted in Australia
Material Safety Data Sheet for hydrofluoric acid 7664-39-3
Ortho-phthalaldehyde 643-79-8
PFOS Alert no.1 various
PFOS Alert no.2 various
Sodium hydroxide 1310-73-2
Sodium lauryl sulphate 151-21-3
Sulphuric acid 7664-93-9
Urea 57-13-6
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Candidate List of Chemicals
NICNAS undertakes a process of consultation with its stakeholders
and the general public on chemicals to be assessed. At any time anyone may
nominate a chemical for assessment, and from time to time NICNAS calls
for nominations by advertisement in the press. Nominated chemicals
are screened according to published criteria and are either selected
for assessment and placed in the Candidate List, or not selected. A summary
of the results of screening and reasons for not selecting a chemical
are published in the Chemical Gazette.The Candidate List also includes
a Standby Section containing chemicals with either international assessments
currently underway, additional testing being conducted in other countries
or with insufficient data. This list is reviewed annually against new published
literature, chemical databases, and government/agency Internet sites for new
information. As a result, chemicals are either moved into the main section
of the Candidate List or removed from consideration. In the latter case,
a summary of the results of screening and reasons for non-selection are
published in the Chemical Gazette. From time to time chemicals are selected
from the Candidate List for assessment, and recommended to the Minister for
declaration as Priority Existing Chemicals following consultation with industry.
Table 10.1 Candidate List of Chemicals
Chemical Name CAS Number
Various Azo dyes
Alkyl phenol ethoxylates including
Nonyl phenol ethoxylate 9016-45-9
Nonyl phenol ethoxylate blend 63496-57-1
Octylphenolethoxylate 9036-19-5
1,3 butadiene 106-99-0
2-hydroxy 2',4,4'-trichlorodiphenyl ether 3380-34-5
Bismuth oxychloride 7787-59-9
t-butyl alcohol 75-65-0
Carbon disulphide 75-15-0
Chromium (VI) compounds
Lead chromate 7758-97-6
Lead sulphochromate 1344-37-2
Zinc chromate 13530-65-9
N,N Dimethylformamide 68-12-2
Epichlorohydrin 106-89-8
Ethylene oxide 75-21-8
Hydroquinone 123-31-9
Isocyanates including:
2,4 TDI 584-84-9
2,4'-MDI 5873-54-1
2,6-TDI 91-08-7
4,4'-MDI 101-68-8
Polymethylene polyphenylene isocyanate 9016-87-9
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Isopropyl alcohol, isopropanol 67-63-0
Mercury compounds
Methyl ethyl ketone peroxide 1338-23-4
Methyl ethyl ketone 78-93-3
Methyl methacrylate 80-62-6
Methyl tert butyl ether 1634-04-4
Methylene chloride 75-09-2
N-methyl pyrrolidone 872-50-4
Peracetic acid 79-21-0
Phenolphthalein 77-09-8
Sodium hydroxide 1310-73-2
Sodium hypochlorite 7681-52-9
Styrene 100-42-5
1,1,1,2-tetrafluoroethane 811-97-2
Tetrafluoroethylene 116-14-3
Toluene 108-88-3
Triethanolamine 102-71-6
Triethyl tetramine 112-24-3
Xylene ?mixed 1330-20-7
o-xylene 95-47-6
p-xylene 106-42-3
m-xylene 108-38-3
Table 10.2 Standby Section
Chemical Name CAS Number
Mobil jet oil:
1-Naphthalenamine 134-32-7
1-Naphthalenamine, N-phenyl 90-30-2
2-Naphthalenamine 91-59-8
2-Naphthalenamine, N-phenyl 135-88-6
Tricresol phosphate 1330-78-5
Naphthalene 91-20-3
Nickel 7440-02-0
Nickel oxide 1313-99-1
Nickel sulfate 7786-81-4
Phthalates including:
diethylhexyl phthalate (DEHP) 117-81-7
Diethylphthalate (DEP) 84-66-2
Dibutylphthalate 84-74-2
di isodecyl phthalate (DIDP) 26761-40-0
di isononyl phthalate (DINP) 28553-12-0
butylbenzyl phthalate (BBP) 85-68-7
dimethyl phthalate (DMP) 131-11-3
dicyclohexyl phthalate 84-61-7
di-n-hexyl phthalate 84-75-3
di-n-pentyl phthalate 131-18-0
di-n-propyl phthalate 131-16-8
di(2-ethylhexyl) adipate 103-23-1
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Table 10.3 Chemicals Moved from Main or Standby Sections of the Candidate
List
Chemical Name CAS Number Moved from Reason
Alkyl-phenol ethoxylates including:
Nonyl-phenol ethoxylate 9016-45-9 Standby Section Moved to main section.
Nonyl-phenol ethoxylate
blend 63496-57-1 Standby Section Moved to main section.
Octylphenolethoxylate 9036-19-5 Standby Section Moved to main section.
Carbon disulphide 75-15-0 Standby Section Moved to main section.
Chlorinated styrenes including 29082-74-4 Main section Assessment undertaken
octachlorostyrene on uses & quantities in Aust.,
no further work to be done.
Formaldehyde 50-00-0 Main section Declared a PEC.
Methyl methacrylate 80-62-6 Standby Section Moved to main section.
N-methyl pyrrolidone 872-50-4 Standby Section Moved to main section.
Naphthalene polychlorinated 70776-03-3 Main section Assessment undertaken on
uses & quantities in Aust.,
no further work to be done.
Polychlorinated biphenyl ethers Main section Assessment undertaken on
uses & quantities in Aust.,
no further work to be done.
Sodium cyanide 143-33-9 Main section Declared a PEC.
1,1,2,2,-tetrabroroethane 79-27-6 Standby Section Moved to Not Selected List.
1,1,2,2,-tetrachloroethane 79-34-5 Standby Section Moved to Not Selected List.
Tetrachlorobenzyltoluenes including:
Dichloro [(dichlorophenyl) 76253-60-6 Main section Assessment undertaken
methyl] methyl benzene on uses & quantities in Aust.,
(Ugilec 141) no further work to be done.
(chlorophenyl)(chlorototyl) No CAS Main section Assessment undertaken
methane, mixed isomers Number on uses & quantities in Aust.,
(Ugilec 121) no further work to be done.
Triethyl tetramine 112-24-3 Standby Section Moved to main section.
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Partnership Agency Assessment Performance
Australian Government Department of Environment and
Heritage (DEH)
The DEH provides advice to NICNAS on the environmental implications of the
importation/manufacture and use of new and existing industrial chemicals.
The assessment reports submitted to NICNAS include recommendations
for the avoidance or minimisation of adverse environmental effects resulting
from the stated use patterns of the chemicals.
A summary of chemical assessment reports completed by DEH during
2002-03 is shown below.
Assessments completed by DEH in 2002-03 compared with 2001-02
Assessment Category Number of Environment
Assessment Reports sent to NICNAS
2001-02 2002-03
Standard Notification 45 17
Limited Notification 55 47
Polymer of Low Concern (PLC) 49 54
Extensions/Secondary Notifications 6 6
Subtotal 155 124
Commercial Evaluation Certificates (CEC) 1 5
Low Volume Chemicals (LVC) 0 1
Early Introduction Permits (EIP) Not available* Not available*
Subtotal 1 6
TOTAL New Chemicals: 156 130
3#
Priority Existing Chemical Reports 5
* See Appendix 08 for data on EIPs # Of these, two assessment reports are yet to be finalised
The number of environmental reports completed decreased over the previous
year, with 118 completed standard, limited and polymer of low concern
environment reports compared with 149 in 2001-02. There was a substantial
decrease from the previous year, in the number of standard notifications
received by DEH from the previous year, from 45 down to 17.
In addition to the preparation of environmental assessment reports, other
consultations on environmental aspects of matters of interest to NICNAS have
also been undertaken during the year. DEH staff attended several meetings
with NICNAS and industry personnel on general policy issues and NICNAS
reforms in New Chemicals.
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List of Chemicals that had Agreed International
Assessments
OECD SIDS Program
Chemical Reviewed
1,1,2-Trichloroethane
1,2-Dichloroethane
1,3-Isobenzofuranedione, tetrahydromethyl Yes
1-Hexen-3-ol, 3,7,11,15-tetramethyl Yes
1-Propene
2-Buten-1-ol, 3-methyl
2-Chloro-1,1,1,2-tetrafluoroethane
2-(Dimethylamino)ethyl acrylate Yes
2-Ethylhexyl acrylate
2-Methyl-2-propenamide Yes
2-Naphthol
3,5,5-trimethyl-2-cyclohexen-1-one
Acrylic acid, iso-butylester
Adipic acid, compound with hexane-1,6-diamine (1:1)
Benzene, 1-chloro-4-nitro-
Benzoyl Peroxide Yes
Bis(pentabromophenyl)ether Yes
Butanedioic acid, disodium salt Yes
Butyric acid
Butyric anhydride
Calcium chloride Yes
Category Diarylide Yellow pigments: Pigment Yellow 12 Yes
Category Diarylide Yellow pigments: Pigment Yellow 13 Yes
Category Diarylide Yellow pigments:Pigment Yellow 83 Yes
Category: High Boiling Ethylene Glycol Ethers Yes
Category: High Boiling Ethylene Glycol Ethers Yes
Category: High Boiling Ethylene Glycol Ethers Yes
Category m-,p-Cresols: m-Cresol Yes
Category m-,p-Cresols: m-,p-Cresol Yes
Category m-,p-Cresols:p-Cresol Yes
Category: Xylenes: m-xylene Yes
Category: Xylenes: o-xylene Yes
Category: Xylenes: p-xylene Yes
Chlorine Yes
Chloromethane
C.I. Pigment Brown 24 Yes
C.I. Pigment Yellow 53 Yes
Cyclohexene
Diisopropylbenzene Yes
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Chemical Reviewed
Diphenyl ether, octabromo derivative Yes
Ethane, 1,1,2,2-Tetrachloro
Ethanol, 2-(diethylamino)- Yes
Formaldehyde, reaction products with sulfonated 1,1'-
oxybis[methylbenzene], sodium salts (FSD-Na)
Hexadecanoic acid, 2-sulfo-1-methylester, sodium salt Yes
Hydrochloric acid
Isophthalic acid
m-Cresol, 6-tert-butyl Yes
Methylacrylate Yes
L-Menthol Yes
D-Menthol Yes
D/L-Menthol Yes
m-Toluenesulfonic acid, 6-amino
m-Toluic acid
n-Butyl Acrylate Yes
N-tert-butyl-2-benzothiazosulfenamide Yes
Nicotinamide Yes
o-Acetoacetotoluidide
Phenol, 2,4-dichloro
p-t-Butylphenol
Sodium Carbonate Yes
Sodium hydrogencarbonate
Sulfuryl chloride
Triacetin Yes
Triethyl phosphite
Trimellitic acid
Trimellitic anhydride
Triphenyl phosphate Yes
Undecanoic acid, 11-amino Yes
xylene, mixed isomers Yes
IPCS CICADS PROGRAM
1,1-Dichloroethene
1,2,3-Trichloropropane
Arsine. Human health aspects
Ethylene oxide Yes
Hydrogen sulfide. Human health aspects Yes
Thiourea
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13
Presentations, Conferences, Harmonisation
and International Meetings and Site Visits
undertaken by NICNAS
Presentations
Margaret Hartley, `NICNAS's Regulatory Approach', AFFA Seminar Series,
Canberra, ACT, 17 July 2002
Margaret Hartley, `Chemicals Regulation in Australia', TGA/Singapore
Medicines Authority Meeting, Canberra, ACT, 5 August 2002
Rosemary Sager, `PIC Procedures', PIC/POPS Stakeholder Meetings, DFAT,
Canberra, ACT
Hana Hamdan, `Endocrine Disrupting Chemicals ?A Global Problem',
Endocrine Disrupting Chemicals ?TGA Chemicals Unit Seminars, Canberra,
ACT, 29 August 2002
Margaret Hartley, `Industrial Chemicals Management; Key Aspects and
Issues', Environmental Protection and Heritage Council ?National Taskforce
on Chemical Management & Regulation, Stakeholder Workshop, Sydney,
NSW, 29 August 2002
Margaret Hartley, `The NICNAS Perspective on GHS for the Notification and
Assessment of Industrial Chemicals in Australia', ACSPA Globally Harmonised
System of Classification and Labelling of Chemicals (GHS), Seminar and
Workshop, Sydney, NSW, 6 September 2002
Sneha Satya, Jane Weder, Kim Patience ?Poster ?`Perfluoroalkyl Chemicals,
Fire Fighting Foams & Industrial Chemical Assessment in Australia',
Australasian Fire Authorities Council Conference, Broadbeach, Qld,
28-29 September 2002
Kerry Nugent, Demonstration of NICNAS Template for Electronic Notification
of New Chemicals, OECD Electronic Tools Workshop, Ottawa, Canada,
2-4 October 2002
Bob Graf, Australia-Canada Bilateral Arrangement, Industry Consulting Group
Conference, Toronto, Canada, 9-10 October 2002
Dusanka Sabic, NICNAS's Low Regulatory Concern Chemicals (LRCC)
Reform Initiative, ACSPA Technical Committee, Canberra, ACT, 11 November
2002
P | 127 NICNAS ANNUAL REPORT 2002-03
Appendix amended index 10/9/03 6:57 PM Page 128
13
Roshini Jayewardene, IPCS Harmonisation Project ?Exposure Assessment
Activity ?Overview of Terminology Project, Exposure Assessment Planning
Workgroup Meeting, Geneva, Switzerland, 11-13 November 2002
Bob Graf, `Taking NICNAS to the World', Surface Coatings Association
of Australia (NSW branch), Sydney, NSW, 21 November 2002
Graham Harvey and Dusanka Sabic, `The Australian High Volume Industrial
Chemicals List' and `NICNAS's Low Regulatory Concern Chemicals (LRCC)
Reform Initiative', PACIA NSW Regulatory Affairs Network, Sydney, NSW,
27 November 2002
Sneha Satya, `Hydrofluoric Acid: An Update on Health Risks and Controls
Required for Safe Use', Australian Institute of Occupational Hygienists
Conference, Geelong, Vic., 3 December 2002
Dusanka Sabic, `NICNAS's Low Regulatory Concern Chemicals (LRCC)
Reform Initiative', PACIA Community Advisory Panel, Melbourne, Vic.,
4 February 2003
Jane Weder, Deborah Willcocks, Graham Harvey - Poster - `Draft Hazard and
Risk assessment of the Fuel additive MMT', National Conference of the Royal
Australian Chemical Institute, Melbourne, Vic., 3-6 February 2003
Bob Graf, `NICNAS on the Move ?Recent Developments', Australian Paint
Manufacturers Association (OHS Committee), Sydney, NSW, 13 February
2003
Margaret Hartley, `Overview of Chemicals Regulation in Australia', EPHC
National Taskforce on Chemicals Management Community Consultation
Workshop, Sydney, NSW, 14 February 2003
Margaret Hartley, `Overview of Chemical Harmonisation Opportunities',
International Paint & Ink Council (IPIC) Meeting, Sydney, NSW, 28 February
2003
Roshini Jayewardene; `NICNAS Reforms: Low Regulatory Concern Chemicals;
An Overview' Australian Society of Cosmetic Chemists ?Annual Conference,
Hamilton Island, Qld, 14 March 2003
Roshini Jayewardene; Australian Industrial Chemicals Notification and
Assessment Scheme: An Overview, American Chemistry Council, Global
Chemical Regulations Conference, Baltimore, USA, 1 April 2003
Warwick Shaw , `How to classify according to the GHS', presentation given
to OCS/EA/NOHSC, Canberra, ACT, 7 April 2003
P | 128 NICNAS ANNUAL REPORT 2002-03
Appendix amended index 10/9/03 6:57 PM Page 129
13
Dusanka Sabic, `NICNAS's Low Regulatory Concern Chemicals (LRCC)
Reform Initiative', Botany & Eastern Region Environmental Protection Agency
Inc, Sydney, NSW, 9 April 2003
Dusanka Sabic, `NICNAS's Low Regulatory Concern Chemicals (LRCC)
Reform Initiative', PACIA's NSW Regulatory Affairs Network, Sydney, NSW,
28 May 2003
Megan Smith, `NICNAS's Low Regulatory Concern Chemicals (LRCC) Reform
Initiative', PACIA's Victorian Regulatory Affairs Network, Melbourne, Vic.,
29 ,May 2003
Margaret Hartley, `The Impact of Global Trends on National Chemicals
Regulation', HAZMAT 2003, Sydney, NSW, 30 April 2003
Paul Harvey, `Regulatory Aspects of Skin Sensitisation Testing: a UK
Perspective', Science Forum, Canberra, ACT, 30 May 2003
Sneha Satya, Jane Weder, `Existing Chemicals Program Review', Royal
Australian Chemical Institute (RACI) Environment and Hazardous Materials
Group Meeting, Melbourne, Vic., 19 June 2003
Conferences
2 July NOHSC Chemicals Substances Sub-committee, Canberra,
2002
ACT
4 July Chemical Clearinghouse Meeting, Canberra, ACT
18 July Leadership in Sustainable Development, Canberra, ACT
18-19 July Workshops on Implementation of the International Cyanide
Management Code and Technical Issues in the Use and
Management of Cyanide in the Gold Industry, Perth, WA
13 August CASANZ Technical Meeting, Sydney, NSW
15 August The 4th Australian Conference on Culture and Leadership,
Sydney, NSW
20 August NOHSC Chemical Standards Sub-committee Meeting,
Canberra, ACT
20-22 August 16th International Clean Air and Environment Conference,
New Zealand
5 September Chemicals Clearinghouse Meeting, Canberra, ACT
10 September Clean Air Society of Australia New Zealand ?Indoor
Allergens, Sydney, NSW
20 September Environmental Manager Conference, Sydney, NSW
28-29 September Australasian Fire Authorities Council Conference,
Broadbeach, Qld
P | 129 NICNAS ANNUAL REPORT 2002-03
Appendix amended index 10/9/03 6:57 PM Page 130
13
9-10 October Industry Consulting Group Conference, Toronto, Canada
20 November NOHSC Chemicals Standards Sub-committee, Canberra,
ACT
25-29 November Australian Health & Medical Research Congress,
Melbourne, Vic.
28 November APS Seminar on Performance Management, Sydney, NSW
28-29 November Second National Conference on Women in Science
Technology and Engineering, University of Sydney, Sydney,
NSW
1 December Workshop on Health Based Risk Assessment & Exposure
Standard Setting, Geelong, Vic.
2-4 December Australian Institute of Occupational Hygienists Conference,
Geelong, Vic.
2003 3-6 February National Conference of the Royal Australian Chemical
Institute (Inorganic Chemistry Division), Melbourne, Vic.
14 March Australian Society of Cosmetic Chemists ?Annual
Conference, Hamilton Island, Qld
19 March 7th Chemical Standards Sub-committee Meeting,
Canberra, ACT
12-13 May PACIA National Conference, Sydney, NSW
30 May Science Forum, Canberra, ACT
Meetings for International Harmonisation
11-13 November IPCS Harmonisation Project - Exposure Assessment
2002
Planning Workgroup Meeting, Geneva, Switzerland
7-8 October OECD New Chemicals Task Force, Ottawa, Canada
7-10 October IPCS Harmonisation of Chemical Risk Assessment
Methodology, Steering Committee, Geneva, Switzerland
International Assessment Meetings
2-4 October OECD Electronic Tools Workshop, Ottawa, Canada
2002
22-25 October OECD 15th SIAM, Boston, USA
5-8 November OECD 34th Joint Meeting of the Chemicals Committee
onThe Working Party on Chemicals, Pesticides and
Biotechnology, Paris, France
11-13 November IPCS Harmonisation of Approaches to the Assessment of
Risk from Exposure to Chemicals ?Exposure Assessment
Planning Workgroup Meeting, Geneva, Switzerland
P | 130 NICNAS ANNUAL REPORT 2002-03
Appendix amended index 10/9/03 6:57 PM Page 131
13
2-7 March Prior Informed Consent (PIC) ?4th Meeting of the Interim
2003
Chemical Review Committee and pre-meetings, Rome,
Italy
27-30 May OECD 16th SIAM, Paris, France
5-6 June ILSI ?Dose Selection II Working Group, Washington DC,
USA
Site Visits (not compliance-related)
28 August Urban and Industrial Air Quality Group; CSIRO Energy
2002
Technology, Ryde, NSW (Existing Chemicals)
27 Sept State and Territory Fire & Rescue Authorities,
Broadbeach, Qld (Existing Chemicals)
31 October Site visits to Woochem Australia Pty Ltd and Carter Holt
Harvey Panels Ltd, Oberon, NSW (Existing Chemicals)
12 November Colgate-Palmolive, Villawood, NSW (New Chemicals)
18 November Use of formaldehyde in embalming Gordon, NSW
(Existing Chemicals)
26 November Formaldehyde manufacture, Laverton, Vic.
(Existing Chemicals)
27 November Formaldehyde manufacture, Dear Park, Vic.
(Existing Chemicals)
28 November Use of formaldehyde in pathology lab, Clayton, Vic.
(Existing Chemicals)
29 November Use of formaldehyde in film processing, Blackburn, Vic.
(Existing Chemicals)
12 December F.C Production ?a company using formaldehyde in film
processing, Leichhardt, NSW (Existing Chemicals)
28 January Foam manufacture using Methylene chloride and
2003
PRRX64, Joyce Foam Products, Sydney, NSW
(Existing Chemicals)
5 May Huntsman Chemicals, Sydney, NSW (Existing Chemicals)
5 May Huntsman Chemicals, Sydney, NSW (Existing Chemicals)
P | 131 NICNAS ANNUAL REPORT 2002-03
NICNAS Inquiries Yearly Summary 2002-03
Appendix amended index
COMPLETED ACKNOWLEDGED OR
TOTAL No. OF TOTAL FINALISED WITHIN
WITHIN FINALISED
CALLS HOURS 28 DAYS
24 HOURS
RECEIVED SPENT WITHIN 7 DAYS
P | 132
No. % No. % No. %
10/9/03
14
Compliance
?Company Registration 146 26.05 145 99.3 1 0.7
?General NICNAS/Public 17 5.5 17 100.0
Compliance
6:57 PM
TELEPHONE
?General/Public 269 64.49 269 100.0
New Chemicals
?General NICNAS/Public 898 163.55 891 99.2 6 0.7 1 0.1
Inquiry Statistics
Existing Chemicals
?PEC 105 123.15 97 92.4 8 7.6
Page 132
?General NICNAS/Public 11 19.95 11 100.0
SUB TOTAL 1446 402.69 1430 98.9 15 1.0 1 0.1
Business Management &
Compliance
N I C N A S ANNUAL REPORT 2002-03
?Company Registration 5 2.30 5 100.0
?General NICNAS/Public 3 1.35 3 100.0
WRITTEN
Compliance
?General/Public 35 15.5 34 97.1 1 2.9
New Chemicals
?General NICNAS/Public 277 169.5 182 65.7 78 28.2 17 6.1
Existing Chemicals
% GREATER THAN 28 DAYS NOT APPLICABLE
?PEC 33 42.75 24 72.7 9 27.3
?General NICNAS/Public 5 25.25 3 60.0 2 40.0
SUB TOTAL 358 256.65 251 70.1 90 25.1 17 4.7
TOTAL 1804 659.34 1681 93.2 105 5.8 18 1.0
Appendix amended index 10/9/03 6:57 PM Page 133
15
NICNAS Web Site Usage Statistics
The charts in this appendix describe the successful hits on the site, the
number of visitor sessions and their activity level during the week, as well as
most requested pages and Information Sheets.
Successful Hits
450,000
400,000
350,000
300,000
250,000
Successful Hits
200,000
150,000
100,000
50,000
0
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ch
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Visitor Sessions
32,500
30,000
27,500
25,000
22,500
20,000
17,500
15,000
Visitor Sessions
12,500
10,000
7,500
5,000
2,500
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P | 133 NICNAS ANNUAL REPORT 2002-03
Appendix amended index
P | 134
Number of Downloads Visitor Sessions
10/9/03
15
0
2,500
5,000
7,500
10,000
12,500
15,000
17,500
20,000
22,500
25,000
27,500
30,000
0
50
100
150
200
250
300
350
400
450
500
550
600
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Page 134
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NICNAS ANNUAL REPORT 2002-03
ed
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Appendix amended index 10/9/03 6:57 PM Page 135
16
NICNAS New and Revised Publications and Media
Coverage
Information product Format Print
About NICNAS Reprinted and available on web site Yes
NICNAS Annual Report Available in PDF and HTML on web site and Yes
2001-02 in printed format
NICNAS Business Plan Both electronic and printed format Yes
2002-03
Chemical Gazette Available on web site; email alert subscription Print on request
available; print copies available on demand;
also option of emailing the whole gazette in a
PDF file for those who have email in their
workplace but not internet access
Existing Chemicals Info 4 new Existing Chemical Info sheets on web Print on request
Sheets site
Forms All available for completion and printing from Print on request
web site or printed on demand
Handbook for Notifiers Available in PDF on web site; print copies Print on request
available on demand for charge of $55 each
Final Report and Both electronic and printed format Yes
Recommendations for
NICNAS Low Regulatory
Concern Chemicals
(LRCC) Reform Initiative
New Chemical 125 new reports on web site Yes (limited).
Assessment Reports Hard copy
provided to
libraries
NICNAS matters Two issues of NICNAS newsletter available on Yes
issues 6, 7 web site and in printed format
Other Existing Chemical 8 other new reports on web site Print on request
Reports
PEC Assessment 3 new reports on web site; hard copies Yes
Reports provided free of charge on request
Safety Info Sheets 2 new Safety Info Sheets available on the web Print on request
numbers 22-23 site
Service Charter 2002-05 Both electronic and printed format Yes
NICNAS Strategic Plan Available on web site and in printed format Yes
2002-05
P | 135 NICNAS ANNUAL REPORT 2002-03
Appendix amended index 10/9/03 6:57 PM Page 136
16
NICNAS Media Coverage 2002-03: Highlights
Print
Australian Paint & Industry Yearbook 2002, August 2002, page 15 - NICNAS;
CCH Hazard Alert, 7 August 2002, page 7, NICNAS profile;
ACT Workcover news, Issue 14, August-October 2002, page 5, limonene;
Chemistry in Australia September 2002 ?proposed PECs, triclosan;
Australian Doctor 25 October 2002 pages 21-23 "Something fishy" on
Endocrine disrupting chemicals (EDCs) including interview with Director;
Environmental Manager, 6 November 2002, "Chemical agency to review
industry uptake of recommendations";
Trends, November 2002, "Taking a new approach in the office";
Environmental Manager 10 December 2002 and Occupational Health News
11 December 2002 - LRCC Task Force;
Chemistry in Australia, December 2002 - Chemical Info Sheets;
Chemistry in Australia, March 2003 page 39, LRCC task force;
Chemistry in Australia, April 2003 EDCs, Chemicals Screening Information
Dataset;
L'expression, Internal newsletter of L'Oreal Australia, April 2003, page 4
"Leading scientists in town to spread message"; and
Environmental Manager, Issue 436, 13 May 2003, page 5, "Triclosan
declared a priority".
Television
Channel 10 News Adelaide and Brisbane 6 March 2003, cosmetics,
including comment from Office of Chemical Safety.
P | 136 NICNAS ANNUAL REPORT 2002-03
Appendix amended index 10/9/03 6:57 PM Page 137
Index
Administrative Appeals Tribunal, see external scrutiny
advertising and market research, 35
AICS, see Australian Inventory of Chemical Substances
Air Toxics Program, 14
assessments, 52-70
and Australian Government Department of Environment and
Heritage, 124
types of, 108-112
best practice initiatives in, 42-3
see also existing chemicals assessment
see also new chemicals assessment
see also international harmonisation
auditing,
internal audit arrangements, 27, 32
company registration compliance audits, 78
Australia-Canada Bilateral Arrangement, see international harmonisation
Australian Government Department of Environment and Heritage, 22, 29, 42,
124
Australian Government Department of Health and Ageing
transfer of NICNAS to, 21, 27
service level agreement with NICNAS, 22, 27, 32
Australian High Volume Industrial Chemicals List, 67, 87-8
Australian Inventory of Chemical Substances
confidential listing on, 57-8, 118
online, 76
promotion of, 84
trend data for inquiries and searches, 75-6, 82
timeliness of searches, 79
Australian Public Service, 27,31
candidate list, 65-6, 121-3
CEO survey, 86-7
CEP, see Commercial Evaluation Permit category
certified agreement, 27
Chemical Gazette, 84-5
Chemicals and Plastics Action Agenda, 13, 39, 42, 83
chemicals
list of chemicals having internationally agreed assessments, 125-6
list of existing chemicals assessed, 120
public health and safety, 25
regulatory framework for, 13, 25
see also existing chemicals assessment
see also new chemicals assessment
Commercial Evaluation Permit category
reform of, 43-4
communication and services, 83-9
CEO survey, 86
customer survey, 14, 86
effectiveness, 85-8
P | 137 NICNAS ANNUAL REPORT 2002-03
Appendix amended index 10/9/03 6:57 PM Page 138
Index
efficiency, 88-9
information sheets, 66, 73, 88, 135
inquiries, 83, 132
integrated database, 89
media advertising, 35, 84, 104
media coverage, 135
media inquiries, 83, 85
newsletter, 83, 85
price, 89
publications, 84, 88-9, 135
quantity, 83
timeliness, 85
web site, 84-5, 88-9, 133-4
see also conferences
see also meetings
see also presentations
community consultation, 15, 40-1, 97, 118
company registration, 33-35
compliance audits, 78
industry compliance with renewals, 34-35
reform of, 44-5
see also compliance
complaints, 28
compliance, 75-82
and the Australian Inventory of Chemical Substances, 75-6
investigations, 76-82
quantity, 75-8
timeliness, 79-80
effectiveness, 80-1
price, 82
with annual report guidelines, 91
with mandatory reporting requirements, 27, 93
conferences, 129-30
confidential information, 28, 57-8, 118
consultancies, 35, 103
contact details, 4
co-operative arrangements, see partnerships
corporate governance, 27-8
corporate overview, 21-25
corporate services, 22, 27
cost recovery see financial performance
customer survey, 86
Department of Environment and Heritage, see Australian Government
Department of Environment and Heritage
Department of Health and Ageing, see Australian Government Department
of Health and Ageing
Director's Overview, 13-18
P | 138 NICNAS ANNUAL REPORT 2002-03
Appendix amended index 10/9/03 6:57 PM Page 139
disability strategy, 27, 32
discretionary grants, 35
ecologically sustainable development, 36, 105-7, 124
electronic notification template, see Template for New Chemical Notification
employees, see staff
equal employment opportunity, 101
equity, 31-32
ESD, see ecologically sustainable development
existing chemicals assessment, 64-9
availability of publications, 88-9
candidate list, 66, 121-3
effectiveness, 66-9
information sheets, 66, 74, 88, 135
list of chemicals assessed, 120
output data, 65
price, 69-70
quantity, 64-6
review of Existing Chemicals Program, 49,69
summary of activities, 119-120
timeliness, 66
types of, 110-112
uptake of report recommendations, 68-9
use of international reports in, 69-70
see also international harmonisation
external scrutiny, 30, 94-9
financial performance, 32-3
foreign schemes, see New Transitional Arrangements Towards Approval of
Foreign Schemes
fraud measures, 32
freedom of information, 27, 36
glossary, 6
harmonisation, see international harmonisation
High Volume Industrial Chemical List, see Australian High Volume Industrial
Chemical List
human resources, see staff
HVICL, see Australian High Volume Industrial Chemical List
IGCC, see Industry Government Consultative Committee
industry
compliance with company registration renewals, 34-5
consultancy service for, 62
see also Chemicals and Plastics Agenda
see also Industry Government Consultative Committee
Industrial Chemicals (Notification and Assessment) Act 1989, 21
Industrial Chemicals (Notification and Assessment) Amendment Bill 2003,
44
Industry Government Consultative Committee, 28-9,
terms of reference, membership and meetings, 94-5
P | 139 NICNAS ANNUAL REPORT 2002-03
Appendix amended index 10/9/03 6:57 PM Page 140
Index
inquiries, 83, 85, 132
international harmonisation,
Australia-Canada bilateral arrangement, 14, 46-7
efficiency, 74
international assessment programs, 111-2
New Transitional Arrangements Towards Approval of Foreign
Schemes, 46, 71
OECD New Chemicals Task Force, 47-8
of existing chemicals assessment, 72-4, 125-6
of new chemicals assessment, 71
perflurooctanyl sulfonate (PFOS) assessment, 73
price, 71
quantity, 72-3
see also New Transitional
International Programme on Chemical Safety, 72, 111
labels, 63
letter of transmittal, 3
Low Regulatory Concern Chemicals category
reform of, 15, 39-41
Task Force terms of reference and members, 97-9
management and accountability, 26-36
management of human resources, 30-1
Material Safety Data Sheets, 63
media, see communication and services
meetings, 130-1
memorandums of understanding, see National Industrial Chemicals
Notification and Assessment Scheme
National Industrial Chemicals Notification and Assessment Scheme
chemicals regulatory framework linkages, 25
corporate governance, 27-8
fees and charges, 18, 45
future directions, 18
financial performance, 32-33
media coverage, 135
memorandum of understanding with National Occupational Health
and Safety Commission, 14, 22, 27
memorandum of understanding with states and territories, 14, 29-
30, 96-7
organisational structure, 21, 100
partnerships, 13-18, 22, 68, 124
reform initiatives, 39-49
review of existing chemicals program, 49, 69
role and functions, 21
service level agreement with Australian Government Department of
Health and Ageing, 22, 27, 32
P | 140 NICNAS ANNUAL REPORT 2002-03
Appendix amended index 10/9/03 6:57 PM Page 141
Service Charter and customer survey, 27, 86-7
summary of key achievements, 17
transfer to Department of Health and Ageing, 27
see also outcomes and outputs
see also staff
National Occupational Health and Safety Commission,
memorandum of understanding with NICNAS, 14, 22, 27
uptake of NICNAS assessment report recommendations, 68-9
new chemical assessment, 52-64
availability of reports, 31, 88
Commercial Evaluation Permits, 43-4
confidential information, 57-8, 28, 118
consultancy service for industry, 62
effectiveness, 62-3
efficiency, 61-2
fees and charges, 45
industry compliance with statutory timeframes for publication of
reports, 60
Low Regulatory Concern Chemicals, 39-41, 97-9
material safety data sheets and labels, 63
price, 63-4
quantity, 52-8
statistics, 113-7
template for notifiers, 46
timeliness, 58-61
trends analysis, 52-60
use categories, 56-7
use of foreign schemes assessments in, 46
see also assessments
see also international harmonisation
see also low regulatory concern category
New Transitional Arrangements Towards Approval of Foreign Schemes, 46, 71
NICNAS, see National Industrial Chemicals Notification and Assessment
Scheme
occupational health and safety, 31
see also National Occupational Health and Safety Commission
Office of Chemical Safety, 14, 21, 25, 42
Organisation for Economic Cooperation and Development, 47-9, 70, 72
outcomes and outputs
framework, 22
performance measures for, 22-4, 27, 51-2
statement of, 23
summary against resources, 90
partnerships, 13-18, 22
performance reports, 51
portfolio budget statement, 22, 24, 27
P | 141 NICNAS ANNUAL REPORT 2002-03
Appendix amended index 10/9/03 6:57 PM Page 142
Index
presentations, 127-9
priority existing chemicals, see existing chemicals assessment
publications, 84, 88-9, 135
purchasing, 32
reform initiatives, 13, 39-49
resource tables by outcomes, 90
site visits, 131
Science Forum, 14, 42-3
Screening Information Data Sets (SIDS), 72, 111-2
staff, 31
certified agreement, 27
presentations, conferences and meetings attended by, 127-31
profile, 101
services, 22, 27, 32
statistics, 101-2
training and development, 31, 101-2
transfer to Australian Government Department of Health and
Ageing, 27
see also equal employment opportunity
Technical Advisory Group, 15, 118
template for new chemical notifications, 15, 46, 62
template for submission of permit applications, 46, 62
Therapeutic Goods Administration, 21, 32, 42
Therapeutic Goods and Other Legislation Amendment Act 2002, 27
training, see staff
web site, 84-5, 88-9, 133-4
P | 142 NICNAS ANNUAL REPORT 2002-03
Appendix amended index 10/9/03 6:57 PM Page 143
Notes
P | 143 NICNAS ANNUAL REPORT 2002-03
Appendix amended index 10/9/03 6:57 PM Page 144
Notes
P | 144 NICNAS ANNUAL REPORT 2002-03
NICNAS ANNUAL REPORT 2002-03 ACHIEVEMENT THROUGH STRATEGIC ALLIANCES
WWW.NICNAS.GOV.AU
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