2001 Report
excellence
Annual Report 2000-01
The Operation of the Industrial Chemicals (Notification & Assessment) Act 1989
N AT I O N A L I N D U S T R I A L C H E M I C A L S N O T I F I C AT I O N A N D A S S E S S M E N T S C H E M E
innovation
2001 Report 9/14/01 11:06 AM Page 2
Annual Report on the Operations of the Industrial Chemicals
(Notification and Assessment) Act 1989
2000-01
excellenceinnovationcooperationachievement
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 3
?Commonwealth of Australia 2001
ISSN 1037-6909
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NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 4
The Hon Tony Abbott, MP
Minister for Employment, Workplace Relations and Small Business
Parliament House
Canberra ACT 2600
Dear Minister
I have pleasure in submitting to you for presentation to the Parliament, the
Annual Report on the Operation of the Industrial Chemicals (Notification and
Assessment) Act 1989, as amended (the Act), for the year ending 30 June 2001.
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
2000 to 30 June 2001.
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.
As part of the National Occupational Health and Safety Commission, audited
financial statements for NICNAS can be found in the National Occupational
Health and Safety Commission Annual Report 2000-01.
Yours sincerely
Dr Margaret Hartley
Director
Chemicals Notification and Assessment
5 September 2001
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 5
contents
C O NTA C T DETAILS
National Industrial Chemicals Notification
and Assessment Scheme (NICNAS)
GPO Box 58
SYDNEY NSW 2001
Telephone: 61-2-9577 9400
Facsimile: 61-2-9577 9465
Freecall: 1800 638 528
Web site: www.nicnas.gov.au
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 6
5
Letter to Minister
Contact Details
List of Appendices
Page
8. Director's Overview
12. Corporate Overview
16. Management and Accountability
22. Operational Performance
23. Assessment
36. Compliance
41. Communications
48. Compliance with Annual Report Guidelines
50. Appendices
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 7
appendices
NICNAS ANNUAL REPORT 2000-01
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1. Mandatory Reporting Requirements Under the Act
2. NICNAS Industry Government Consultative Committee -
Terms of Reference and Membership
3. Staff Profile and Training
4. Consultancies Commissioned
5. Media Advertising Organisations Used
6. Ecologically Sustainable Development
7
7. Types and Categories of NICNAS Assessments
8. New Chemical Notification and Assessment Statistics
9. Confidential Listing of Chemicals on the Australian Inventory
of Chemical Substances
10. Summary of Priority Existing Chemical (PEC) Assessment Activity
11. List of Chemicals that had Agreed International Assessments
for 2000-01
12. Presentations, Conferences, Harmonisation Meetings and Site Visits
13. Partner Agency Assessment Performance
14. Enquiry Statistics and Response Times
15. Website Usage Statistics
16. New and Revised Publications in 2000-01
NICNAS ANNUAL REPORT 2000-01
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Director's overview
Dr Margaret Hartley
Director
8
NICNAS is a scientific assessment organisation responsible for identifying the potential
risks to workers, the public and the environment from the introduction, use and disposal
of industrial chemicals. Our business is built around the vision of safe chemical use and a
regulatory environment that promotes sustainability.
It is now four years since we commenced operating in a full cost recovery environment.
We have used this challenge to introduce significant changes to how we work, including
shifting our operational focus from process to achievement. The delivery of high quality
outcomes has been driven by our organisational values. Specifically, we have sought to:
Excel by achieving high quality scientific and other work through a high level of
competence, integrity and professionalism;
Innovate by enhancing our creativity in all aspects of work and being flexible in our
approach with unique and independent ideas;
Cooperate by always interacting with others in a pleasant, open and responsive manner
and listening to our stakeholders;
Achieve by serving our clients well and by pursuing our goals with enthusiasm.
This has seen NICNAS lift its operational performance against output measures and
targets in the four years since we moved to full cost recovery. Further, the strategic
promotion of our assessment outputs has provided greater access to chemical safety
information in a more user-friendly format to a wider range of stakeholders.
During this year, we have built on earlier initiatives to strengthen our corporate identity
and the level of open and consistent service delivery. We have continued to improve our
performance standards and communication strategies as part of building effective
alliances with government, industry and the public. A particular focus has been to ensure
we are able to innovate and change the regulatory environment for our clients. This has
involved change in the day-to-day operations of the organisation to a new focus on teams.
NICNAS ANNUAL REPORT 2000-01
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9
Over the past four years, we have implemented more than 23 reform initiatives. This year
has allowed uptake trends and cost impacts to be evaluated as a measure of the
effectiveness of these reforms.
Overall, NICNAS has delivered high level quality outputs across all operational areas in
2000-01. This was achieved largely by continuous improvement in procedures and by
finding new approaches to assessment in order to find better ways to deliver the required
outputs and outcomes. This has assisted in making NICNAS a more focused organisation,
with the genesis of the majority of regulatory improvements being initiatives identified
from within NICNAS itself.
Achievements 2000-01
Our key achievements include:
?Increase in outputs by 22 per cent for all assessment categories in 2000-01 while
...New Chemicals
meets all targets... maintaining the 1997-98 fee structure;
?Elimination of our assessment backlog (a major problem prior to moving to full cost
recovery) with outputs keeping pace with inputs to avoid future backlogs;
?For the first time, all quality and timeframe targets met across all assessment and
permit categories and exceeded in many cases. Our achievement of performance
within a targeted timeframe (100 per cent in 2000-01 compared with 51 per cent in
1996-97) is a result of a three-year commitment to improve through a multifaceted
management plan;
?Strong uptake by industry of reform initiatives leading to estimated savings to industry
in the range of $1.7 to $6.3 million since July 1997.
?NICNAS exceeded our commitment to review 50 priority existing chemicals (PECs) in
...PEC targets
exceeded... three years by 10 per cent (ending in April 2001), with the completion of 12 full
assessments (target was 10) and 43 preliminary assessments (target was 40). This
represents a tenfold increase in productivity with a yearly average of 18 assessments from
1998-2001, compared with an average of only one assessment per year prior to 1997-98;
NICNAS ANNUAL REPORT 2000-01
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" ...Over the past four years
NICNAS has lifted its operational
performance, providing greater
access to safety information to
a wider range of stakeholders..."
10 ?A further 106 screening assessments were completed for the PEC candidate list;
?Introduction of the practice of monitoring the uptake of recommendations made in PEC
reports. This is to provide feedback to stakeholders on our review products and on the
delivery of better outcomes for the safe use of chemicals;
?Enhanced usefulness of our assessment services both in terms of a strategic broadening
of the range of stakeholders and of tailoring a range of assessment outputs, e.g. the
introduction this year of Safety Info Sheets on each PEC for display in workplaces.
...Greater use ?A fivefold increase in the use of overseas reports within our PEC assessments; ongoing
of overseas work to enhance access to overseas reports for use in the New Chemicals assessment
assessments... program, resulting in more assessment output for the same or reduced resource inputs;
?A further 55 international assessments agreed to by Australia, which make a valuable
addition to our overall assessment information, available nationally.
?Introduction of an effective compliance strategy with 235 new cases over the past 4
years, compared with 2 in the previous 6 years to 1996-97;
?Sustained case investigation performance in terms of timeliness and effectiveness with
all 61 case investigations this year completed within target timeframes and compliance
achieved through cooperation with industry.
?Successful redesign and promotion of our web site as the focal point of NICNAS
...Enhanced
information delivery, as evidenced by nearly one million hits in its first 8 months and
information
online... 93 per cent of respondents to a survey of industry registering awareness of the web site;
?Increased access to better chemical safety information (more than 1000 chemical
assessments now on the web site);
?Chemical Gazette published free online at a saving to industry and NICNAS of about
$40,000 per year in subscription costs;
?Handbook for Notifiers available free on line (formerly $103 per copy);
?Positive feedback from industry clients on our overall service provision;
?Australia's first High Volume Industrial Chemical List published.
Importantly, our increase in productivity and outputs has been delivered with no increase
in fees or charges to industry and reflects efficiency gains of about 10-15 per cent this
year alone. This year also saw the independent review of operations of company
registration. The overall conclusion is that this activity has been well planned and
executed resulting in substantial growth in registrants and achievement of an appropriate
and secure revenue base. A number of recommendations from this review will be
considered for implementation next year.
NICNAS ANNUAL REPORT 2000-01
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11
Future Directions
Our business focus next year will be on the successful transition to working in teams,
and on extending our communication strategy and delivering further innovation.
Specific activities will include:
?Evaluation of the three-year PEC program, with the lessons learned to be implemented
into a new program cycle. During this evaluation, the assessment output will be
maintained at current levels;
?Introduction of the assessment template in the New Chemicals area will be a priority
and should lead to a streamlined application process for industry. In addition, it will
facilitate harmonisation activities by better aligning NICNAS's with those of EU
countries;
?An activity-based costing review of the fees and charges for new chemicals in 2001-02
to ensure there is no cross-subsidisation with levy revenue;
?Industry Government Consultative Committee (IGCC) operating and reporting under
defined performance measures;
?Ongoing development of our web site; a new safety information series for public use to
be developed and public statistics on chemicals to be extended.
While some e-commerce activities, such as credit card payment facilities, have been
introduced, progress has been below our expectation. Delays have been encountered with
our corporate service provider and we are working with them to ensure a suite of
e-commerce options will be developed over the next 12 months.
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Corporate overview
12
Role and Functions
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) aids
in the protection of people at work, the public and the environment from the harmful
effects of industrial chemicals. NICNAS operates under the Commonwealth Industrial
Chemicals (Notification and Assessment) Act 1989 (the Act). NICNAS ensures the safe
use of chemicals by making 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 Commonwealth government
agencies.
The Scheme assesses industrial chemicals that are new to Australia, before they are used
or released to the environment. Chemicals that are already in use in Australia (existing
chemicals) are also assessed on a priority basis, in response to specific concerns about
potential health and/or environmental effects.
There are a large number (more than 40,000) of chemicals listed on the Australian
Inventory of Chemical Substances (AICS) that are available for use in Australia. The
industrial uses of these chemicals are broad, involving dyes, solvents, plastics, cement,
adhesives, printing and photographic chemicals, plus there are those chemicals used in the
home, for example, paints, cleaning agents and cosmetics.
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Organisational Structure
NICNAS is a statutory scheme administered corporately by the National Occupational
Health and Safety Commission (NOHSC), within the portfolio of the Minister for
Employment, Workplace Relations and Small Business, the Hon Tony Abbott, MP. Policy
responsibility for NICNAS resides with the Department of Employment, Workplace
Relations and Small Business (DEWRSB).
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 Minister.
NICNAS began to examine its internal organisational structure and its work processes in
2000-01. This was in response to feedback from staff about work practices and
management structures within the organisation. A staff working group was formed to
identify better ways of working, in particular for opportunities to streamline activities and
improve performance. The key outcome of this work was a decision to shift to a team
based organisational structure.
Rationalisation of the business management and administrative activities was also a key
...New team
13
approach... component of seeking a better way of working, due in part to the impending relocation of
NOHSC to Canberra from 1 July 2001. Our change management process is driven by our
organisational values: excellence, achievement, cooperation and innovation. These values
underpin our productivity goals and work ethic. It is expected that a move away from the
more traditional hierarchy of reporting and management will provide an environment
conducive to promoting innovation by all staff. Further, the team based structure offers
benefits in increased flexibility in staff activities and responsibilities, and facilitates
greater internal cooperation.
The first stage of the team based approach was implemented with the establishment of
nine teams under the leadership of a management executive in May 2001. Staff in all
teams now have greater involvement in decisions regarding work input and achievement
of planned objectives. It is expected that team based work will lead to greater
productivity, enhance the skill base of all staff, increase job satisfaction and facilitate
better allocation of resources for high priority Scheme activities.
Cooperative Arrangements
...Outsourced NICNAS contracts assessment work from Commonwealth agencies on a fee for service
services... basis. Environment Australia undertakes environmental risk assessments (including
hazard and exposure) and the Therapeutic Goods Administration undertakes public health
risk assessments (using the NICNAS health hazard assessment). These partnership
arrangements provide the mechanism for input of environmental and public health policy
into the overall risk assessment and recommendations for the safe use of chemicals by
NICNAS.
NICNAS contracts corporate services on a fee for service basis from NOHSC.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 15
Outcomes and Output Framework
NICNAS seeks 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. We work to encourage the safe and sustainable use of
industrial chemicals.
The Scheme contributes to safe chemical use through the scientific assessment of
chemical risk and by providing recommendations for controlling these risks. Our
assessment information is made widely available and assists State and Territory
occupational health and safety (OHS), public health and environmental regulatory
agencies in the control of the sale, use, release and disposal of industrial chemicals.
Assessment information also provides risk and safety information to workers, the public
and industry so as to promote greater awareness of how to use chemicals safely.
NICNAS's outcomes and outputs are located within the NOHSC outcome/output structure
(namely Outcome 2, Output 2.1) of the 2000-01 DEWRSB Portfolio Budget Statements.
The relationship between the NICNAS outcome and contributing output is shown in
Figure 1 below.
Figure 1 NICNAS Outcome/Output Statements.
14
* Note: A further $0.104m is included in the appropriation under NOHSC Outcome 1 and is made available to fund the
Commonwealth Government's contribution to 50 per cent of the costs of NICNAS's compliance program.
NICNAS ANNUAL REPORT 2000-01
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The performance information and measures used for accounting against outputs
and outcomes is shown in Table 1.
Table 1 NICNAS Performance Information.
Effectiveness ?Overall Achievement of Outcome
(Measures, Indicators and Targets Used as Appropriate)
Chemical safety and sustainable use Number of NICNAS recommendations adopted
of industrial chemicals Level of awareness of chemical risk (by industry,
state and territory governments and the public)
Performance Information for Outputs
Output 2.1 Quality:
Scientific assessment and ?Extent to which risk assessments, guidance
management of chemical risk for documents and policy advice are of high
people and the environment standard, evaluated according to appropriate
service standards (as defined in the NICNAS
Service Charter) and by international benchmark
?Legislated and service charter timeframes met
Quantity:
15
?Number of assessments against agreed targets
Price: $3.785m
?Cost per unit assessment
?Cost for government policy activities*
* Note: NICNAS fully recovers the cost of assessment, registration and information services from industry. Compliance
is 50 per cent funded by the Commonwealth Government (partially reported under NOHSC Outcome 1, Output 1.3).
Regulatory Linkages
NICNAS, the Australia New Zealand Food Authority, the National Registration Authority
for Agricultural and Veterinary Chemicals and the Therapeutic Goods Administration
form the regulatory assessment framework for chemicals. These schemes are
complementary in nature and are designed to avoid duplication of regulation.
To avoid duplication of assessment activities, NICNAS has partnership agreements and/or
liaises with the Commonwealth and the jurisdictions. 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. Our assessment partnerships also allow for considerations of public health
and environmental controls in the jurisdictions.
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Management and accountability
16
Corporate Governance
NICNAS's business strategies including performance measures are detailed in the
NICNAS Strategic Plan 1999-2002, the NICNAS Business Plan 2000-01 and the
NICNAS Service Charter 2000. In addition, certain mandatory performance requirements
(such as assessment timeframes, and public reporting of prescribed information) are
established in the Act (see Appendix 1). Performance reporting against the legislation,
corporate plans and operational plans is undertaken quarterly and is detailed in the
Operational Performance section of this report.
Internal audit arrangements are covered under our corporate service arrangements with
NOHSC. Internal audit activities for 2000-01 are reported in the NOHSC Annual Report
2000-01.
Administrative arrangements established under the Act mean that our staff are employees
of NOHSC. As such, NICNAS staff are covered by NOHSC's Certified Agreement,
governance policies and practices including the establishment and maintenance of
appropriate ethical standards under the Australian Public Service Values and Code of
Conduct; compliance with Freedom of Information and Occupational Health and Safety
legislation; Commonwealth Disability Strategy; workplace diversity policy; and other
internal policies and procedures. Performance for these matters is covered within the
NOHSC Annual Report 2000-01.
IGCC members and
observers at the 10th
meeting in Sydney on
21 August 2000.
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2001 Report 9/14/01 11:06 AM Page 18
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. There was one breach of these policies in 2000-01: an unauthorised file
destruction, by a contractor engaged by our service provider, NOHSC.
The efficient and effective utilisation of cost recovered resources and the NICNAS
...IGCC leads
reforms... Industry Government Consultative Committee (IGCC), which is appointed by the
Minister, oversees the Scheme's operational performance. The IGCC membership and
Terms of Reference are at Appendix 2.
The IGCC met three times during 2000-01 in August, December and April. In line with
the focus of the Business Plan, a major initiative was the IGCC endorsement of the
NICNAS Communication Plan 2000-03. This provides a strategic plan of our education
and awareness activities with a particular focus on access to user-friendly information for
all stakeholders. The year saw significant progress in key reform initiatives, which are
being directed through the IGCC. These include:
?Commercial Evaluation Category The need to reform the Commercial Evaluation
Category (CEC) Permit provisions was identified in 1999. The aim was to ensure that
all industry sectors could utilise the system to evaluate the market potential of new
17
chemicals, while maintaining adequate safeguards for protection of people and the
environment. NICNAS initiated a survey to analyse commercial evaluation practices
for industrial chemicals in Australia. Survey findings were presented to IGCC in April
and to industry groups during May and June 2001. The major changes suggested for
the current system were: volume, time and customer agreement arrangements for the
permits. The survey report provided a valuable resource to support and inform
development of a public discussion paper. This paper will be used as a basis for
community and industry consultation on the reform process and proposals in 2001-02.
?Low Regulatory Concern Criteria It is sound regulatory practice to match assessment
effort to the level of risk posed by individual chemicals. The Scheme currently has
several levels of categories reflecting low hazard and low risk and the incorporation of
additional criteria was investigated this year. NICNAS held an in-house workshop in
November to identify possible areas for change that would improve the efficiency of
the Scheme while retaining appropriate community and environmental safeguards. A
number of areas for reform were identified, underpinned by suggestions for specific
improvements to support these reforms. The industry members of IGCC are
coordinating a similar exercise within their membership. Industry input has been
delayed but is expected in early 2001-02 after which the development of further low
regulatory concern criteria can be progressed.
?Compliance The IGCC has a specific role in providing direction for the NICNAS
compliance activities. Initiatives that were introduced in 2000-01 include enhanced
awareness for importers through the provision of an entry message advice for goods
under certain customs tariff codes, better linkages with custom brokers, targeting
compliance messages through magazines and journals and the development and
implementation of audit programs. Our compliance activities are reported in full in the
Operational Performance section of this report.
NICNAS has a Memorandum of Understanding (MOU) with each State and Territory
...State/Territory
OHS authority. This reflects the fact that workers generally have the highest potential for
Cooperation...
exposure to industrial chemicals and therefore to possible adverse effect. The MOU
representatives undertake jurisdictional liaison on behalf of their own public health and
environmental agencies. This ensures that NICNAS's assessment outputs and
recommendations are appropriately utilised across the broad array of downstream control
arrangements for the safe use of industrial chemicals.
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External Scrutiny
The Act specifies those decisions of the Director that may be taken before the
...Legal
appeals... Administrative Appeals Tribunal (AAT) for review. Appealable matters include decisions
on confidentiality, company registration and variations of draft assessment reports.
Four applications to the AAT for review of the Director's decisions on Company Registration
charges were lodged in 2000-01: Director NICNAS v Chanel (Australia) Pty Ltd, Juvena
Australia Pty Ltd, Parfums Christian Dior (Australia) Pty Ltd, Trimex Pty
Ltd and the Cosmetics Toiletry and Fragrances Association of Australia (CTFAA).
These relate to NICNAS's assessment of the registration charge payable by the applicants
for the 1999-2000 registration year, with the exception of the CTFAA which has joined the
appeal as an interested party. These matters were still before the AAT on 30 June 2001.
The total number of completed appeals against NICNAS decisions to date is three, with
one withdrawn and two found in favour of NICNAS.
Management of Human Resources
18
At 30 June 2001, NICNAS employed 37 full-time equivalent (FTE) staff. The staffing
profile for NICNAS at the NOHSC Sydney office is shown in Appendix 3.
In October 2000, another Organisational Culture Inventory survey was conducted as a
follow-up to the March 1999 survey. The results were used to assist in identifying
priorities for NICNAS change management activities and planning. The feedback
received from the staff survey led to the shift to a team based approach in the way we
work (see organisational structure in the Corporate Overview section of this report).
Training and development activities for NICNAS staff are reported in Appendix 3. A total
of 143 days of formal training (approximately 3.8 days per person) were undertaken in
2000-01, including orientation and induction training for new staff.
During 2000-01, the NOHSC OHS Committee undertook one OHS inspection of the
NICNAS office. No major health and safety issues within the NICNAS accommodation
were reported.
Equity Performance
Our contribution to the outcome of safe chemical use is underpinned by the accessibility
of assessment reports and other information to workers, the community, industry and
...Transparency and
open access... other regulatory agencies. Indeed, the legislation mandates that a public report must be
published for all assessments carried out by NICNAS. To ensure open access, assessment
reports, guidance documents and other information resources are available free of charge
directly from NICNAS as well as through our website. Further, information is specifically
targeted to the varied needs of end users. For example, NICNAS publishes Safety Info
Sheets which can be downloaded from our web site for display specifically in the
workplace.
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2001 Report 9/14/01 11:06 AM Page 20
NICNAS routinely liaises with industry applicants, employer and worker representatives,
and the public through our assessment process, which under the Act, mandates extensive
and open consultation. Wide public consultation is undertaken on changes affecting the
Scheme. The public may also nominate chemicals to NICNAS for consideration for
review. Any member of industry or the community may also appeal the Director's
decisions under the Act through the AAT process.
Financial Performance
NICNAS operates on a cost recovery basis. Cost recovery is achieved through company
...Cost recovery...
registration fees and charges, 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 Commonwealth
Government.
NICNAS's financial services are provided by NOHSC under a service level agreement.
Total funds cost-recovered from industry in 2000-01 were $3,685,182. At 30 June 2001, a 19
total of $1,204,208 in cash reserves (including an accommodation fund of $700,000) was
available for carryover into 2001-02.
Table 2 provides a summary of NICNAS's financial performance for the year. Audited
financial statements, incorporating NICNAS, can be found in the NOHSC Annual Report
2000-01.
Table 2 NICNAS Financial Overview 2000-01.
Revenue $ `000
Assessments 1,508
Company Registration 2,152
Publication Sales 25
Government Subsidy 104
Total 3,789
Expenditure
Salaries 2,421
Administration 555
Indirect Overheads 1,452
Total 4,428
Surplus/(Deficit) (639)
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 21
At 30 June 2001, there were 702 companies listed in the Register of Industrial Chemical
...Company
Registration Introducers (chemical importers and/or manufacturers), a 6.8 per cent increase over
growth... 1999-2000.
Of these, 473 (67.4 per cent) companies were registered at the lower registration level
with introduction values greater than $500,000 but lower than $5 million, and 229
(32.6 per cent) companies were registered at the upper registration level with introduction
values greater than $5 million.
Figure 2 shows the number of registrants by level over the four years the Company
Registration system has been operating.
Figure 2 Number of registrants in Company Registration system
over period of operation.
720
620
520
20
420
320
220
120
The number of introducers registered with NICNAS has continued to increase each year,
confirming the robustness of our compliance audit program. Results of our audit program
for 2000-01 are detailed in the Compliance section of this report.
An independent evaluation of the company registration provisions of the Act was
...Streamlining
and options for completed in August 2000. The final report on the evaluation, released in September
change... 2000, concluded that the program "meets the objective of raising sufficient funds to
underwrite the existing chemicals assessment program" and noted that "compliance
activities have been generally well planned and executed, have resulted in a substantial
growth in registrants and have secured growth in the revenue base, provided for improved
equity between registrants (by reducing `free riders') and have avoided the possibility of
any need for a fee increase." The report recommended options for change with respect to
the threshold and fee structure and in the area of administrative streamlining. Following a
lengthy consultation process and based on industry feedback and our own experience with
company registration, a number of changes will be considered next year with a view to
possible implementation.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 22
Consultancies Commissioned and Discretionary Grants
Consultancies commissioned in 2000-01 are listed in Appendix 4. NICNAS did not make
any discretionary grants.
Advertising and Market Research
Media advertising organisations used by NICNAS in 2000-01 are listed in Appendix 5.
Freedom of Information
NICNAS received no Freedom of Information requests in 2000-01.
Ecologically Sustainable Development and Environmental
Performance
NICNAS operates its chemical risk assessment activities to be consistent with the policy
21
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 cooperative partnership arrangements with Environment
Australia, which incorporates related ESD policy in their assessment activity
(see Appendix 6 for details).
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 23
Operational performance
22
Performance Measurement Framework
NICNAS provides information to its stakeholders on the hazards and risks posed by
...Focus on
chemicals to workers, the community and the environment. This information is in the
outcomes...
form of high quality scientific assessments of risks posed from the import, manufacture,
handling, use, storage and disposal of chemicals. Our assessments recommend ways of
addressing these risks.
The key output is effective, accessible and reliable scientific information for other
chemical control frameworks, workers, the public, industry and other interested parties.
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 Scheme activities are summarised in Table
3 and are reported against performance targets in this section of the report.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 24
Table 3 Summary of output performance measures for Scheme activities.
Quantity
Type Performance measure
Quantity Number of outputs (assessments, compliance investigations, audits, site
visits, guidance notes, publications etc) against agreed targets
Timeliness
Quality Number of outputs to appropriate benchmark/target use:
Assessments
?Timeliness
Efficiency
?Effectiveness eg. acceptable to international scientific assessment
standards and implementation within national control framework
Effectiveness
?Efficiency
Technical Guidance/Compliance/Service/Outreach
?Timeliness
Price
?Effectiveness, acceptable standards as defined by Service Charter and/or
published guidelines and/or legislation
23
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 all the types of assessments undertaken by NICNAS is provided in
Appendix 7.
New Chemicals
Quantity
The number of applications for new industrial chemicals was consistent throughout the
year, reflecting solid activity across industry sectors and over the range of assessment
options and categories. Detailed new chemical assessment statistics for each quarter in
2000-01 are given in Appendix 8.
...Assessments This year a total of 563 notifications were received and accepted, comprising 182
keep pace with applications for assessment certificates, 148 permit applications and 233 exemption
applications... notifications. This figure represents an increase of 22 per cent over the previous year's
total. Over the same period NICNAS delivered 183 assessment certificates (with reports)
and 138 permits to the chemical industry, again a substantial increase (15 per cent) over
the previous year's total.
Trend analysis of applications received and completed for the three financial years 1998-
99 to 2000-01 are shown in Figure 3. The trend data show the elimination of the backlog
of certificate assessments (some 60 applications) within NICNAS from 1998-99 to the
current year. For permits, the number of assessments completed continued to keep pace
with the number received, thus maintaining the elimination of the backlog of assessments,
which was achieved last financial year.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 25
Figure 3 Three-year trend data for certificate and permits received and
completed.
200
180
160
140
120
100
24
Industry continues to use the less than 10kg per year exemption category, which was
introduced in July 1997. A total of 559 cosmetic chemicals and 84 non-cosmetic
chemicals have been introduced over the four years of operation of this category, with the
predominant usage being by the cosmetic industry. Figure 4 shows the four-year data for
applications received under this category.
Figure 4 Four-year data on usage of the less than 10kg per year
exemption category.
600
500
400
300
200
100
0
Within the certificate categories, growth continues to be observed in the synthetic polymer
...PLC growth
continues... of low concern category (PLC), particularly in the second half of the year (see Appendix
8). This increase reflects the revision of the PLC criteria in 1999, and their application
under transitional arrangements from August 1999 on a case-by-case basis. The reduction
in data requirements and certain specifications resulted in more polymers qualifying to be
notified and assessed under this category. Figure 5 shows the four-year trend data for PLC
applications received and assessments completed. NICNAS increased its outputs in this
assessment category this year again, eliminating any backlog in this assessment category.
Our assessment findings of low risk status of these PLC applications confirm the predictive
power of the new criteria in determining low regulatory concern with these chemicals.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 26
Figure 5 Four-year trend data for PLC applications and
completed assessments.
80
60
40
20
0
25
Notifications in the all other certificate categories were similar to the previous year and
no applications for secondary notification were received during 2000-01.
Applications for low volume chemical (LVC) and commercial evaluation category (CEC)
permits increased over the previous year, by 18 per cent and 34 per cent respectively.
Output has maintained pace with applications.
Applications for early introduction permits (EIPs) decreased slightly (by 13 per cent) over
last year. The introduction of this category in 1997 has facilitated the introduction of a
total of 146 non-hazardous chemicals whose entry into the marketplace would otherwise
have been delayed until completion of the full assessment.
Figure 6 Four-year data for EIP categories first introduced in July 1997.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 27
The use of this category by industry remains steady. This is disappointing as the category was
...No growth
in EIPs... specifically designed to promote the introduction of non-hazardous chemicals into Australia.
Surveyed data in relation to industry use of our commercialisation permit system provides
further evidence that industry does not have the introduction of non-hazardous chemicals as a
primary driver of developing new chemicals. The introduction of less hazardous chemicals
was rated lower than customer requests, head office product launch and profit as a driver for
introducing new chemicals into Australia. NICNAS assesses Material Safety Data Sheets
(MSDSs) for all new chemicals being introduced into Australia (including in products).
During 2000-01 NICNAS assessed approximately 500 MSDSs for the chemical industry,
helping to ensure that accurate and relevant information on new chemicals exists for the
benefit of workers, customers and the community. This was about a doubling of the number
of MSDSs reviewed last year. The overall standard of MSDSs was generally good; however,
approximately 15 per cent were found to be deficient and required substantial revision.
The number of chemicals notified for certificates, broken down into Organisation for
Economic Cooperation and Development (OECD) industrial use categories, is shown in
Appendix 8 both as a total since 1990 and as three-year trend data from 1998-99 onwards. The
highest use category is the surface coatings/adhesives category, particularly for PLCs used in
automotive paint applications. The other major use categories are fuel and oil, e.g. petrol
additives, plastics additives, cosmetics and photocopier toners. A significant increase in the
26 number of new chemicals used in packaging was noted for this year.
NICNAS received 29 applications for confidential listing on the Australian Inventory of
...Confidential
listings... Chemical Substances (AICS) under the new criteria developed last year. Of these, 3 were
subsequently withdrawn, 14 were deemed incomplete and the decision is pending, and the
Director decided on 3 chemicals for public listing and 12 for confidential listing. In
undertaking consideration of confidential listing, the commercial interests must be
weighted against the public interest and NICNAS has a small independent group of
technical experts to provide advice on this process (see Appendix 9 for details).
Timeliness
Output performance against assessment target timeframes is detailed in Appendix 8.
Of significance in 2000-01 is that all assessments were completed within the statutory
and/or agency timeframes, completing our three-year commitment to turn around
underperformance in assessment times. Indeed, performance exceeded targets (95 per
cent) in the majority of categories. This reflects the consolidated work over the past three
years to eliminate the backlog of assessment applications and to streamline processes to
ensure timely completion of our assessment work. The trend data for timeliness of
certificate assessments (90 days) is shown in Figure 7.
Figure 7 Certificate assessments completed against statutory (90 day)
timeframes (target 95 per cent reached over 3 years).
...All timeframe
targets met...
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 28
Of the three certificate assessment reports not issued within the 90-day timeframe, two
were issued within the next 14 days, the other being one of the backlog of assessments
from early 2000.
Performance for certificate extensions (target 95 per cent) exceeded target with 100 per
cent of assessments completed within the 45-day timeframe. This compares dramatically
with performance in 1999-2000 (38 per cent) and 1998-99 (67 per cent).
Permit timeframes reached or exceeded targets as well, and performance data over the
past three years is summarised in Table 4.
Table 4 Permits completed against statutory/agency timeframes
(target 95 per cent).
Assessment Category 1998-99 (%) 1999-2000 (%) 2000-01 (%)
Commercial Evaluation Category 57 60 95
Low Volume Chemical 89 72 100
Early Introduction Permit 77 78 100
27
...Industry Early introduction permits (EIPs, see Appendix 7) were issued for approximately 30 per
timeliness cent of completed assessments during the year. This allowed 5-10 per cent of chemicals in
remains low... standard and limited notifications and approximately 62 per cent of PLCs to be imported
and/or manufactured within the 28-day statutory timeframe while assessments were still
being undertaken by NICNAS.
Both NICNAS and the chemical industry have statutory responsibilities with regard to
report publication. The applicant for a certificate or permit is provided with a 14-day
timeframe in which to comment on the report before publication. Industry performance
against this timeframe is summarised in Figure 8. Approximately half the number of
applicants responded within the statutory timeframe, compared with 39 per cent in
1999-2000. For applicants taking more than 28 days to respond, the figure was 19 per
cent in 2000-01 compared with 40 per cent last year. To further reduce delays and
administration in protracted follow up with the industry, current NICNAS practice is to
publish the report if the applicant has not responded within 28 days.
Figure 8 Timeframes for industry consideration of final assessment report
(Standard, Limited and PLC) against the 14-day statutory timeframe.
54
50
40
39
29
23
21 21 19
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 29
Efficiency
NICNAS has worked hard to reduce the backlog of new chemical assessments from the
level that existed at the end of 1996-97. Assessment output is now keeping pace with
input (see Figure 3), with 183 assessment certificates issued during the year, compared
with 182 applications. This is a considerable improvement on the previous year's
performance (152 issued /176 received). For permits, the performance for 2000-01 (138
issued/148 received) is slightly below that of the previous year (128 issued/130 received).
Additionally, despite a 22 per cent increase in applications received this year, the number
of submissions active as at 30 June 2001 was 135, representing an 11 per cent reduction
from the previous two years (152 in 1999-2000 and 150 in 1998-99). This reflects
efficiency gains within the NICNAS office.
NICNAS undertook work on the notification and assessment package designed to
increase efficiency and reduce costs for both industry and the Scheme. A draft new
electronic notification form that is harmonised with the assessment and summary report
templates and includes guidance for notifiers was developed and tested during 2000-01.
The package is due for trial release to industry in the first quarter of next year.
No new chemical assessment decisions were appealed to the AAT in 2000-01.
28
Effectiveness
NICNAS provides a service to industry by encouraging potential notifiers to discuss their
notifications with NICNAS staff before a formal application is made, thereby enabling
industry to determine their best option in terms of cost and usage of the chemical. These
...Free consultation
consultations have improved the relationship between NICNAS and industry clients and
service available...
raised the overall standard of applications. NICNAS New Chemicals staff conducted 22
meetings with industry representatives and made 7 site visits relating to new chemicals
notifications and assessments. NICNAS has also benefitted from the practice as it allows
better planning of assessments and time savings during the prescreening process.
Price
The introduction of the low volume <10kg/per year category in July 1997 has facilitated
the safe use of some 643 chemicals which would otherwise have required assessment at a
cost to industry or the chemicals would not have been marketed. Estimates on the saving
in assessment fees to industry ranges from a minimum of $1,671,800 (if all priced as low
volume permits) to a maximum of $6,301,400 (if all priced as limited certificate
applications). This estimate in savings does not include the savings related to data
...Reforms deliver
generation or industry administration costs.
potential savings of
$1.6 - 6.3m...
Similarly, the EIP category enabled some 150 chemicals to be introduced prior to the
assessment timeframe for certificate categories. This translates to financial benefits for
industry as they access markets sooner.
Two applications for the Foreign Scheme 40 per cent rebate arrangements were received,
granted and issued at a total saving to these two companies of $13,600.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 30
Existing Chemicals
Quantity
A range of assessment activities is undertaken within the Priority Existing Chemicals
(PEC) program (see Appendix 7) and outputs and performance statistics for 2000-01 are
detailed in Appendix 10.
This year was the final year in the three-year PEC program (established in April 1998)
...Targets
exceeded... which had an output target set at 50 chemical assessments, comprising 10 full (risk)
assessments and 40 preliminary assessments. This target has been exceeded by 10 per
cent with a total of 55 assessments completed. The 55 assessments comprised 43
preliminary and 12 full assessments. Assessment activity/output areas for 2000-01 are
summarised in Table 5.
Table 5 2000-01 output data for PEC assessments.
2000-01
Number
PECs under assessment 54
29
PECs declared for assessment 6
Assessment modules completed 155
Reports released for comment 47
Reports published 47
The most significant improvement achieved this year was the number of reports
...Sixfold increase
in output... published, with a greater than sixfold increase in annual output from the previous year.
Figure 9 shows the three-year data comparing assessment output, showing upward trends
for numbers of reports completed and published. Two of the preliminary assessments did
not proceed to full risk assessment, resulting in substantial cost saving in terms of
resources such as staff and duration of assessment. Prior to the legislative changes in July
1997, the option of conducting full or preliminary assessments was not available.
Figure 9 Assessment output comparison for the 3 years
(April 1998-April 2001) noting the assessment target of 50 chemicals
over the period.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 31
The Candidate List of chemicals is an outcome of the screening and ranking of publicly
...Candidate List
reviewed... nominated chemicals. The Candidate List includes a section containing chemicals with
either international assessments currently underway, additional testing being conducted in
other countries or with insufficient data - the so-called `standby section'. This list is
reviewed periodically against chemical databases, and government and agency Internet
sites for new information not available in the initial screening. As a result, chemicals are
either moved into the main section of the Candidate List or removed from the Candidate
List. The number of screening assessments conducted by NICNAS for 2000-01 is shown
in Table 6.
Table 6 Screening assessment outputs for 2000-01.
Number
Screening assessments on Standby Section as derived from 32 chemicals
Candidate List (20 in 3 groups)
Chemicals on Candidate List 74 chemicals and
7 groups
Chemicals declared from Candidate List for assessment 2 chemicals
30
Limonenes and acrylamide were declared from the Candidate List in 2000-01 and are
currently within the assessment review process. In addition, chemicals used as Anti Valve
Seat Recession (AVSR) fuel additives were declared as PECs for assessment.
Timeliness
The extent to which statutory deadlines and achievements against the three-year program
goals are met comprises measures for timeliness. Statutory assessment deadline targets for
existing chemical assessments in 2000-01 were met in full (100 per cent).
In most cases, statutory timeframes for submission of data (timeframes are stipulated
under the Act) by industry stakeholders for PEC assessments were not breached.
Nevertheless, in a small number of cases, an extension of deadlines was granted to assist
industry.
Effectiveness
Assessment effectiveness is measured using multiple endpoints. Collectively, these
provide an indicator of quality and include:
?the outcome of the statutory consultation and appeal phases;
?the integrity of peer review processes;
?feedback from readers; and
?acceptance of reports by international assessment programs.
Table 7 provides information against each of the quality indicators relevant for 2000-01.
Table 7 Performance against quality indicators in 2000-01.
1999-2000 2000-01
Number of substantial errors notified in correction phase 0 0
Draft reports subject to internal and external expert peer 100% 100%
review including use of international peer reviewed reports
AAT appeals
- Number of AAT appeals against decisions on public comment 1 0
Number of chemicals sponsored by Australia agreed 2 1
by international programs
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 32
Performance for the period 2000-01 remains of sufficiently high standard in that no
substantial errors were notified in the corrections phase nor were any AAT appeals
lodged.
Another measure of effectiveness is the extent to which the selection of chemicals for
...Open selection
of PECS... assessment is responsive to community concerns. Chemicals selected for assessment
included those nominated by labour organisations, industry, the public and other
government departments, demonstrating NICNAS's responsiveness to community
concerns. The source of nominations for the 55 chemicals assessed over the past three
years is shown in Table 8.
Table 8 Nominations by source for PEC chemicals completed from April
1998 to April 2001.
Nomination source Number of Chemicals/Chemical Groups nominated*
Non-government Organisations (NGO) 4 chemicals + 3 groups
(including labour organisations)
Government 2 chemicals + 4 groups
31
NICNAS 3 chemicals
Industry 2 chemicals
Member of the public 1 chemical
*Secondary notifications not included. Note: Some chemicals/chemical groups were nominated by more than one group.
Of these, NGOs and government represented the major source of nominations.
NICNAS is currently conducting a screening assessment of a diesel fuel additive, on the
request of Environment Australia. This demonstrates cooperative collaborative efforts
with government agencies to provide information for decision-making.
A key measure of effectiveness is the actual level of uptake of report recommendations,
as these aim to protect the health of workers, the public and the environment. The
NICNAS Memorandum of Understanding (MOU) with the states and territories requires
each state or territory to "consider and wherever possible implement each
recommendation in an assessment report published by the Director and also inform the
Director of any consequential action taken".
Analysis of the recommendations by area ?occupational health and safety (OHS), public
health and environment - is shown in Table 9. More than 85 per cent of total
recommendations made involve OHS recommendations, the target of which being equally
directed to peak bodies as well as to industry.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 33
Table 9 PEC report recommendations by area (OHS, public health and
environment) for the period 1998-2001.
...Recommendations OHS Public Health Environment
target OHS... Action area Up to Up to Up to Up to Up to Up to
June June June June June June
1999 2001* 1999 2001* 1999 2001*
Peak bodies** 24 30 4 6 2 0
State & territory 2 8 0 2 0 0
authorities
33 57 4 3 1 4
Industry
Totals 59 95 8 11 3 4
% Total 85.6 10.5 3.9
recommendations
* Data includes total recommendations in reports published to June 2001.
** Peak bodies include NOHSC, National Drugs and Poisons Scheduling Committee, National Environmental Protection
Council and the Australia New Zealand Food Authority.
32
The predominant recommendation area in OHS relates to the hazardous substances
regulatory framework and as such these recommendations are referred to NOHSC. The
breakdown of recommendation and response rate for OHS peak bodies (NOHSC) and
regulatory authorities for all PEC reports published by NICNAS up to the period ending
December 2000, are shown in Table 10. It is noted that 8 assessment reports were
published from January 2001 to June 2001. Any uptake of these recommendations has not
been followed up as implementation by regulatory authorities will require some time.
Activity for these will be reported in 2001-02.
Table 10 Implementation of report recommendations by NOHSC and other
(state and territory) regulatory agencies for the period ending December 2000.
Up to 1999 2000*
NOHSC Other NOHSC Other
Recommendations 22 8 10 5
Considered 9 n/a n/a n/a
Implemented 8 5 4** 1
* Data shown represents recommendations to Dec 2000 only.
**Proposed for publication by NOHSC in 2001-02.
Of the recommendations adopted by NOHSC, the majority (10 out of 12) were the
adoption of hazard classifications under agreed NOHSC processes. Follow up of the
chrysotile assessment recommendations is now in progress and will see a further eight
NICNAS recommendations implemented by NOHSC. NOHSC and NICNAS have
discussed ways of improving both recommendations and their uptake to ensure better
outcomes for the PEC program in terms of promoting safe use.
NICNAS is also working with its state and territory MOU group (which met twice in
2000-01) to see more effective uptake of PEC recommendations. The recommendations to
the states and territories from six recent PEC reports facilitated new approaches in
ensuring a national effort to achieve compliance with changed labels and Material Safety
Data Sheets (MSDSs). The PEC report on trichloroethylene provided an effective
document for both information dissemination and a coordinated approach toward industry
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 34
compliance in amending MSDSs and labels. It was agreed that the compliance with
existing requirements for hydrofluoric acid is a priority and that a coordinated approach is
needed to ensure safe use of this chemical. Members also made a commitment to provide
ongoing feedback to NICNAS on the uptake of PEC recommendations.
Recommendations to industry make up a significant number of PEC recommendations.
No follow-up of industry responses to PEC recommendations has been done to date. An
evaluation of industry actions in response to PEC recommendations was planned for
2000-01, however priority was placed on finalising PEC assessments. Evaluation of
industry's performance against PEC recommendations will now take place in 2001-02.
Efficiency
The assessment team members responsible for undertaking the 55 PECs since April 1998
were awarded the NOHSC Australia Day Award for 2001. The award was made in
recognition of the successful development, implementation and completion of an
accelerated existing chemical program within NICNAS to complete more than 50
chemicals within a three-year timeframe.
Price
The trend in reduced costs associated with the generation of PEC assessment reports over 33
recent years has continued through 2000-01. The number of assessment modules
completed during this period has increased more than threefold with no increase in staff
or cost recovery targets on industry. Assessment modules produced over the past three
years averaged 19 (1998-99), 48 (1999-2000) and 155 in 2000-01. This was achieved
through ongoing process improvement in addition to use of overseas assessments where
appropriate (see Table 11).
Table 11 Extent of use by NICNAS in the PEC program of overseas
assessment reports in 2000-01.
Target Achieved
Number of overseas reports used in PEC assessments 4 30 (24)
(no. chemicals covered by reports)
Number of international assessment meetings attended 2 2
Number of international assessments agreed n/a 55*
...More value
for money... * Actual number of chemicals is larger as group assessments are counted as one assessment.
The number of reports able to be used exceeded planned targets more than fivefold,
representing significant savings on the assessment effort that would otherwise have been
required. For members of the OECD and industry, results of the work done by the OECD
on chemicals has reduced barriers to trade and saved time and money, estimated in 1998
at US$46 million per year.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 35
International Assessment
Quantity
The international assessment program involves countries, including Australia, collectively
assessing existing chemicals once, and agreeing on the assessment findings. This occurs
under the programs of the OECD and the International Program on Chemical Safety
(IPCS). These programs require each country to contribute draft assessments and the
reports are published internationally.
The number of international reports considered and agreed to for the period 2000-01 is
shown in Table 12. The output of the international assessment program was very similar
to that of the previous year.
Table 12 Output of international assessment activity participated in by
NICNAS.
International assessment activity 1999-2000 2000-01
Number of international assessments considered 53 52
34 Number of international assessments agreed 46 47*
* Actual number of chemicals is larger as group assessments are counted as one assessment.
The list of chemicals assessed and agreed to by NICNAS is at Appendix 11. Details of the
...NICNAS
contributes to international meetings involved in determining these chemical assessments are provided
47 international in Appendix 12.
assessments...
This represents a significant achievement in that a large number of assessments are
available to industry and the public and may be directly used by NICNAS and other
organisations in Australia to manage risks posed by chemicals. Australia is currently
sponsoring one OECD assessment, ortho-Dichlorobenzene, and will be required to
sponsor further chemicals next year.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 36
Efficiency
In 2000-01, NICNAS participated in the OECD New Chemicals Program and worked
with Environment Canada and Health Canada to establish a bilateral arrangement with the
Canadian Government.
Most effort in the OECD New Chemicals Program focused on how to exchange
confidential data within the shared activities. This matter was sufficiently resolved with a
number of OECD member countries, including Australia, and four major international
chemical companies agreeing to exchange assessment reports on new chemicals and to
compare assessment methods against agreed timelines in 2000-01. NICNAS also provided
comments on other program activities, namely the standardised notification form and the
international comparison of Low Concern and Exempt Chemicals.
Under this Australia-Canada bilateral activity, both agencies are investigating a range of
...Australia -
Canada bilateral... aspects of the draft agreement, prior to signing. We have established a candidate list of
chemicals for retrospective comparison of assessment reports, to be agreed with the
respective companies in Australia and Canada, and have the agreement of another
company to share assessment information for a notification currently submitted in both
countries.
35
NICNAS would like to thank all companies who assisted in the international New
Chemicals Program in 2000-01.
Partner Agency Assessment Performance
Performance information on NICNAS activities for Environment Australia and the
Therapeutic Goods Administration (TGA) in 2000-01 is provided in Appendix 13.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 37
36
COMPLIANCE
Quantity
A summary of all compliance investigations for 2000-01 including ongoing and new
cases and category of case under investigation is shown in Table 13. No existing
chemicals or secondary notification cases arose for 2000-01.
Table 13 Summary of the number of compliance investigations undertaken
in 2000-01.
Active at the Investigations Investigations
end of New cases completed in active for
Compliance area 1999-2000 2000-01 2000-01 2001-02
New Chemicals 9 50 43 16
Company Registration 1 19 18 2
Total 10 69 61 18
A total of 61 investigations were completed for the year compared with the 68 completed
for 1999-2000. Two Company Registration cases and 16 New Chemicals cases have been
carried over to 2001-02.
Of the 50 new compliance cases in New Chemicals, 18 per cent (9) were brought to our
...Investigations
remain steady... attention by third parties, 78 per cent (39) were detected internally, and 4 per cent (2)
were self-reported (see Figure 10). Most of the internally detected cases were based on
the audits of importers of new chemicals (32 of the 39). Of the 19 new cases in company
registration, 84 per cent (16) were detected internally by NICNAS and 16 per cent (3)
were brought to our attention by third parties.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 38
Figure 10 New Chemicals cases (%) by reporting source for 2000-01.
Investigation activity in the New Chemicals area has been part of a strategic focus by
NICNAS this year, as reflected in the high percentage of new cases arising internally at
NICNAS.
Figure 11 shows trends in case types since 1997-98. This year saw a slight increase (6 per
37
cent) in the number of new cases from 1999-2000, a 10 per cent decrease from 1998-99
and a 200 per cent increase from 1997-98.
Figure 11 Number of new cases by compliance category for the four years
1997-2001.
Category 1997-98 1998-99 1999-2000 2000-01
New Chemicals 14 24 40 50
Company Registration 8 51 25 19
Existing Chemicals 0 1 0 0
Secondary Notification 1 2 0 0
Total 23 78 65 69
Company Registration audits are a routine function of our cost recovery mechanisms. The
audit uses import data supplied by the Australian Customs Service to ensure compliance
with Company Registration requirements, including identifying new introducers entering
the market, lower threshold registrants, and introduction values for companies that have
claimed not to require registration for various reasons.
In 2000-01, a total of 861 audits were undertaken. This is an increase of 74 per cent over
...Increase
1999-2000 (495 audits). As a result, 109 companies (12 per cent) were pursued, of which
in Company
Registration 107 cases (98 per cent) were finalised, resulting in 71 companies being required to
audits... register. Two cases are yet to be finalised.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 39
A total of 12 importers of new chemicals were audited as part of a pilot strategy to
...New Chemicals
audits introduced... improve compliance with new chemicals requirements. The companies audited
represented the extractive, printing and dyes and the specialty chemicals industries. These
sectors were chosen because they are not well represented as new chemicals notifiers, and
it is possible there may be low levels of compliance. Of the 12 companies audited, 7
showed a high level of awareness of NICNAS. Five companies showed a low level of
awareness, causing NICNAS to carry out briefings to explain the Scheme in detail to
them.
Of the 12 companies audited, 9 were found to be fully compliant with the Australian
Inventory of Chemical Substances (AICS). One of the companies that displayed a high
level of awareness of NICNAS was found to be non-compliant, as was one of the
companies that displayed a low level of awareness. Investigations are continuing with one
of the remaining companies in order to ascertain compliance.
Timeliness
Of the 50 new chemicals cases under investigation in 2000-01, 43 (86 per cent) were
brought to completion during the year. Performance against the target timeframe (80 per
cent within 100 days) was good with 79.6 per cent of cases meeting the target.
38 Eighteen of the 20 Company Registration cases under investigation were completed
during the year. Performance against our timeframe target (80 per cent of cases completed
within 60 days continued to be strong with 83 per cent of cases (15 out of 18) meeting the
target. This compares to 85.7 per cent in 1999-2000.
Industry compliance with statutory timeframe requirements for the lodgement of
...Industry
compliance registration renewals and final statements of introduction continued to be poor despite the
remains poor... significant streamlining of processes within NICNAS this year. Table 14 shows the
percentage of renewals and final statements received within the statutory deadline since
1998-99.
Table 14 Renewals and final statements received by the statutory deadline.
% Received by statutory deadline
1998-99 1999-2000 2000-01
Renewals 53 51 52
Final Statements of Introduction 66 64 70
The pursuit of late renewals and final statements takes significant staff and administrative
resources, all at a cost to industry. We undertook consultation with industry during the year
to explore ways of improving compliance in this area and at their suggestion, NICNAS will
implement an invoicing system for renewals next year. Other mechanisms for improving
compliance, such as a late payment penalty, have been considered as part of the Company
Registration evaluation and will be considered for implementation in the future should
compliance with the statutory deadline not improve with the invoicing process.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 40
Effectiveness
The results of the New Chemical investigations are shown in Table 15 and for Company
Registration in Figure 12. A number of cases involved more than one company and/or
more than one chemical.
Table 15 Outcomes of New Chemicals case investigations completed
in 2000-01.
Outcome/Results No. of cases % of cases
Company already compliant 28 47
Company not introducing chemical(s) 10 17
Not a NICNAS matter 3 5
Company ceased introducing the chemical(s) 1 2
Notification made/to be made 1 2
Cases unresolved in 2000-01 10 17
Companies in breach (i.e. non-compliant) 6 10
39
where cases still being pursued
The New Chemicals case outcomes include the 10 cases carried over from 1999-2000.
...Breaches of the
There were six cases (10 per cent) in which there was an established breach of the Act.
Act detected...
These cases are currently being pursued for corrective action and compliance and at least
six new notifications to NICNAS are expected to be made in 2001-02.
Where companies have made notifications to NICNAS as a result of our investigations,
they did so through a partnership agreement with us whereby a timetable and conditions
was agreed and the companies were permitted to continue to trade in the chemical
pending notification processes.
No new chemicals were notified to NICNAS in 2000-01 as a result of any compliance
case. However, it is expected that at least 6 chemicals from 10 unresolved cases will be
notified in 2001-02, having originated in 2000-01. Some of these chemicals will have
originated from the audits of importers of new chemicals. The exact number of chemicals
is unknown at this stage, as the importers are still liaising with their suppliers and/or
manufacturers to ascertain their status on the AICS.
Figure 12 Outcomes for Company Registration investigations for 2000-01.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 41
Site visits by NICNAS staff and client meetings are often the most efficient and effective
way of handling compliance matters. An analysis of our investigation records show that
complex cases or cases which have been unresolved for several months are often resolved
very quickly (usually within a couple of weeks) following a meeting or site visit. During
2000-01, there were five specific compliance related site visits, as well as 12 visits for the
audits of importers of new chemicals. There were also five client meetings held, which
considered effective means for disseminating information regarding the operations of
NICNAS.
The new chemicals pilot audit program provided an opportunity for companies to raise
issues or concerns with respect to new chemicals requirements. The concerns raised were
related to the time taken for assessments ?companies felt that assessment timeframes
were too long for products which have a short market life in a very competitive market;
and the costs of assessments ?this being a particular issue for the smaller companies who
reported that unlike their multinational counterparts, they could not recoup costs. This
information has been fed into the NICNAS reform programs being considered via the
IGCC.
...Import alert To raise awareness of industry obligations under the Act, an Entry Message Advice
established... (EMA) strategy was devised and implemented with the cooperation of the Australian
40 Customs Service. This strategy alerts importers (brokers and/or companies) of potential
obligations to NICNAS if they are importers of chemicals. It resulted in 296 enquiries to
NICNAS since the EMA was implemented in July 2000. As well, more than 300
NICNAS information packs were distributed to importing brokers, agents and individual
companies.
NICNAS also conducted a series of seminars for relevant stakeholders/sectors who had
been identified as having gaps in their regulatory or compliance knowledge through
audits, examination of trends in data on non-compliance and enquiry types. These are
detailed in Appendix 12.
Price
As a result of the company registration audits, there were 71 new registrations identified
for 2000-01 leading to additional revenue of $86,000.
NICNAS staff on
a site visit.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 42
COMMUNICATION
Quantity
NICNAS responded to a total of 1,752 telephone enquiries and 205 written enquiries in
2000-01. This represented an 8.5 per cent increase in telephone and a 7 per cent increase
in written enquiries over 1999-2000 (1,598 telephone enquiries and 187 written
enquiries). Full details are presented in Appendix 14.
During 2000-01 NICNAS received two formal complaints, which were resolved within
agreed timeframes to the satisfaction of those who complained.
...Search requests Table 16 below summarises the number of enquiries from industry concerning the
remain high... Australian Inventory of Chemical Substances (AICS) over the past four years, including
requests for NICNAS to search the AICS. The number of enquiries declined in 1998-99
when the AICS was made available for purchase on CD ROM, enabling industry to do
their own searching. Despite this, the level of search requests remains relatively steady.
Table 16 Three-year trend data for AICS enquiries and searches.
41
1997-98 1998-99 1999-2000 2000-01
Enquiries 451 550 393 411
Searches 1319 1792 1819 1757
For 2000-01 more than 90 per cent of AICS enquiries (385 out of 411) concerned fewer
than 10 chemicals per enquiry. Of the remainder, 19 concerned 11-20 chemicals, 4
concerned 21-50 chemicals and 3 more than 50 chemicals.
A major initiative this year was the redesign and launch of the NICNAS web site in
...NICNAS online
nears 1 million November 2000. During the seven months to end of June 2001, there were close to one
hits... million (987,572) hits. Full details are provided in Appendix 15.
The average number of hits per day increased from 3,076 (November to early April) to
6,555 by end of June. The highest activity levels during the week were around Tuesday
and Wednesday, due largely to the publication of the Chemical Gazette on the first
Tuesday of each month. Activity slumped in April due mainly to the Easter holiday break.
The most requested pages after the home page were publications, the public chemical
assessment reports, forms, and the industry page.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 43
NICNAS published 12 issues of the Commonwealth Chemical Gazette in 2000-01.
...Gazette online...
NICNAS took over publication of the Chemical Gazette from the Commonwealth
Government publisher, beginning with the issue dated February 2001, which was
produced in electronic format. The Chemical Gazette is now posted on the NICNAS web
site on the first Tuesday of each month. Clients were surveyed in October 2000 regarding
the format they preferred: print copy or via the Internet. All former subscribers now
access the Chemical Gazette free of charge and receive an email alert service provided by
NICNAS for each new issue.
In keeping with Commonwealth Government publishing guidelines, NICNAS maintains
copies of printed information material and provides a print on demand service from its
web site. A list of printed new or revised information material in 2000-01 is detailed in
Appendix 16.
42
Timeliness
All NICNAS timeframe targets for responsiveness to enquiries by telephone (85 per cent
to be replied to within 24 hours) and in writing (85 per cent to be replied to in 7 days,
remainder in 28 days for technically complex enquiries) were exceeded in 2000-01
(see Appendix 14 for details).
The performance for searches of the AICS against targets for 2000-01 is summarised in
Table 17. Performance targets are dependent upon the number of searches linked to an
enquiry.
Table 17 Summary of timeliness for searches of the AICS for 2000-01.
Searches per enquiry
1-10 11-20 21-50 >50
Number of enquiries by category 385 19 4 3
Target for completion of search 48 hours 7 days 14 days 28 days
Response time met (%) 76% 89% 100% 100%
The overall 48-hour response time, irrespective of the number of searches per enquiry, is 74
...Most AICS
searches done in per cent in 2000-01 compared with 65 per cent in 1999-2000 and 58 per cent in 1998-99.
48 hours...
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 44
All 12 issues of the Chemical Gazette were published within the statutory deadline i.e. the
first Tuesday of each month.
Effectiveness
Using the eponymous address of www.nicnas.gov.au, the new web site was developed as
a focal point in NICNAS's communications with its clients as a key part of our
Communication Strategy. The strategy aims to assist importers and manufacturers of
industrial chemicals in Australia in fulfilling their obligations under NICNAS by
presenting instructions and information in the clearest, most accessible form, with
electronic media playing an important role.
NICNAS information material has been carefully designed to promote a consistent visual
identity.
Our new approach towards ensuring enhanced communications for users of the Scheme is
seen in the plain language revision and professional typesetting of the NICNAS
Handbook for Notifiers. The handbook is a manual of essential information about
NICNAS procedures for importers and manufacturers of industrial chemicals in Australia.
It was added to the NICNAS web site with simple instructions.
43
In 2000-01, a customer survey was conducted on the performance against service
...Customer service
continues to standards as defined in the NICNAS Service Charter. The telephone survey canvassed the
improve... 65 companies that the various sections of NICNAS most often deal with and the 22
companies with whom NICNAS has the least contact. In all, 87 companies were
contacted with 70 interviewed, a response rate of 82 per cent. Last year's response rate
was 21 per cent. The sampling methods and conduct of the survey differed between the
two surveys.
Figure 13 indicates the NICNAS information material most used by industry respondents.
The online Handbook for Notifiers and Chemical Gazette constitute a major information
source for industry.
None of the companies surveyed this year made any complaints in relation to our service.
The survey showed that:
?93 per cent found staff to be always helpful and courteous (80 per cent last year);
?83 per cent found their questions and enquiries always answered promptly (63 per cent
last year);
?71 per cent found written explanations always clear (79 per cent last year);
?93 per cent of companies surveyed are aware of the NICNAS web site. Of these,
82 per cent found the web site easy to navigate.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 45
Figure 13 NICNAS information sources used by businesses in Service
Charter survey.
44
The PEC report on benzene was released for public comment on 5 June 2001. To
facilitate the public comment process, NICNAS conducted a series of seminars in
conjunction with the Therapeutic Goods Administration (TGA) and Environment
Australia (EA). These were held in capital cities from 30 May to 7 June and covered:
...Benzene seminars ?Human health and environmental hazards;
well received... ?Occupational, public health and environmental risk assessments;
?Draft recommendations, such as recommendations to revise the occupational exposure
standard and to set an ambient air level.
A total of 171 people attended, with good representation from government
(Commonwealth 29, State 75), industry (47) and the public (20) alike. Feedback from the
seminars was positive.
In partnership with compliance activities, articles outlining obligations under NICNAS
were submitted to industry publications including:
?State Motor Trades Association journals;
?Workwords, published by the Victorian WorkCover Authority; and the
?Custom Brokers Council of Australia's national bulletin.
Editorial and advertising was taken out in the National Safety Council of Australia's
Australian Safety News magazine. NICNAS took out a joint advertisement with the
National Occupational Health and Safety Commission in the occupational health and
safety supplement published in The Australian national newspaper in February
(see Appendix 5 for a full list of media organisations used for advertising).
NICNAS was a minor sponsor of the Mutagenesis and Experimental Pathology Society of
Australia (MEPSA) conference at Mount Buller, Victoria, in December 2000.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 46
Left to right: Benzene seminar presenters Deborah Willcocks
(NICNAS), Sheila Logan (TGA), Chris Lee-Steere (EA)
45
In September 2000, NICNAS released a call for information on industrial chemicals
...High volume
chemicals in manufactured in Australia in large quantities as Stage I of the establishment of a High
Australia now Volume Industrial Chemicals (HVIC) List in Australia. Stage II, to be undertaken next
identified... year, will involve collecting similar information on imported industrial chemicals.
Companies manufacturing industrial chemicals in volumes of over 100 metric tonnes in
1999 were required to submit information about the volumes manufactured and general
uses of the chemicals. The information received on manufactured chemicals has been
collated, and 212 chemicals were reported as being manufactured at 100 tonnes per year.
The minimum threshold for publication on the HVIC List is an aggregate volume of
1,000 tonnes per year.
There were 146 chemicals that satisfied this criterion for manufacture alone and these are
listed below. Guidance material and reporting packages were sent to over 600 companies
registered through NICNAS company registration. Of the 642 responses received:
?86 (13%) companies manufacture industrial, reportable chemicals at
100 tonnes per year;
?20 (3%) companies manufacture reportable industrial chemicals at
100 tonnes per year;
?33 (5%) companies manufacture industrial but not reportable chemicals
(such as polymer, reaction intermediates or naturally occurring chemicals);
?503 (78%) companies do not manufacture industrial chemicals.
The data for manufactured chemicals will be combined with the data on imported
chemicals (collected in Stage II) to produce a public HVIC List, which will include
aggregate quantities reported in bands (e.g. 1,000-9,999 tonnes) and additional
information on use, including industries in which the chemicals are used and the use
categories.
The full list of chemicals manufactured in Australia in quantities of 1,000 tonnes was
published in the Chemical Gazette, 1 May 2001.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 47
Efficiency
The redevelopment of the NICNAS web site has created a user friendly single entry point
for business and a one stop shop to access our information products on chemical safety.
More than 1,000 public chemical assessment reports on individual industrial chemicals
...Enhanced
information through are featured on the web site. New chemical assessments are added as they are completed.
e-business... Users can conduct searches of these reports by chemical name, trade name, Chemical
Abstracts Service (CAS) number, hazardous status and OECD industry use category.
Summary reports are also available separately for those not wishing to download the
whole public assessment report.
All draft Priority Existing Chemical (PEC) reports are posted on the web site during the
period they undergo public comment. Once finalised the full PEC report is published on
the web site. All NICNAS forms are now in an electronic format to allow on line
completion and lodgement.
In providing an overview of chemical regulation in Australia, NICNAS collaborated with
participating agencies to revise and update the Assessment and Regulation of Chemicals
in Australia brochure for web site publication. A link to this information was provided for
small business through the Business Entry Point site. Similarly, NICNAS teamed with the
46 Therapeutic Goods Administration and the Australian Competition and Consumer
Commission to produce a guide for keeping cosmetics safe, published on the NICNAS
site with links to participating agencies' web sites. This cooperative approach ensures
areas of potential duplication are detected and eliminated from the regulatory framework
and promotes ongoing administrative efficiencies.
Price
A total of 183 New Chemicals public reports completed by NICNAS in 2000-01 were
made available to the public free of charge. In addition, all New Chemicals public reports
and summary reports completed from 1990 to June 2001, amounting to more than 1,000
reports, are now posted on the NICNAS web site. Prior to 1997-98, the public had to
purchase assessment reports at $30 per report.
...Web based access The reorganisation of NICNAS's information delivery into a more electronic format
delivers savings... forms the basis of savings in the printing budget for at least the next two financial years.
For example, the Chemical Gazette now online at no charge translates to a saving of
about $40,000 per year in subscription charges for industry clients.
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 48
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 main outputs and resources per output category.
Outputs Resource $,000
Assessment New Chemicals Certificates received 182
Certificates issued 183
Permits received 148
Permits issued 138 2,065
Active submissions @ 30/6/00 135
MSDSs assessed 500
Exemptions 467
Existing Chemicals Screening assessments completed 32
47
PEC Assessments:
chemicals under review 54
assessment modules completed 155
reports published 47
Overseas assessments reviewed 52
Overseas assessments agreed 47
Compliance New cases 50 2,363*
Investigations completed 43
Audits 873
Site visits/client meetings 22
Chemical notification agreements 7
Number of prosecutions 0
Outreach AICS searches 1,757
Enquiries 1,957
Publications/documents 264
Seminars/workshop 6
Presentations/meetings 27
* Compliance 50 per cent funded through cost recovery and 50 per cent funded via Commonwealth Government appropriation
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 49
Compliance with annual report guidelines
NICNAS ANNUAL REPORT 2000-01
2001 Report 9/14/01 11:06 AM Page 50
49
Page
3. Letter of Transmittal
5. Table of Contents
4. Contact Details
8. Director's Overview
12. Corporate Overview
16. Management and Accountability
19. Financial Performance
18. External Scrutiny
16. Corporate Governance
18. Management of Human Resources
22. Performance Reports
21. Consultants
21. Discretionary Grants
18. Equity Performance
see also NOHSC Annual Report 2000-01
18. Occupational Health and Safety
21. Freedom of Information see also NOHSC Annual Report 2000-01
21. Advertising and Market Research
21. Ecologically Sustainable Development and Environmental Performance
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 1
appendix
50
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 2
Appendix 1
Mandatory Reporting Requirements Under the Act
In addition to this Annual Report, and other external scrutiny through the NICNAS Industry
Government Consultative Committee (refer Appendix 2), the Act stipulates other mandatory reporting
requirements. These are detailed in the table below, along with information on the last date of
publication.
Requirement Last Published
Annual publication in the Chemical Gazette Proposed for July 2001
of the list of chemicals which are the
subject of low volume chemical permits
[subsection 21ZA(2)]
Annual publication in the Chemical June 2001
Gazette of a list of current and previous
51
priority existing chemicals [section 54]
Annual publication in the Chemical Gazette June 2001
of a list of the chemicals requiring
secondary notification and a list of those
no longer requiring secondary notification
[section 71]
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 3
Appendix 2
NICNAS Industry Government Consultative Committee ?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 the National Industrial Chemicals
Notification and Assessment Scheme (NICNAS).
In order to ensure that industry has the opportunity to participate in the NICNAS budgetary process, a
joint Industry Government Consultative Committee (IGCC) is to be established. The Committee will
appendix
meet at least twice a year.
The Committee will have eight members, including four industry representatives and four Government
representatives. Membership will consist of one representative from each of the following
organisations:
52
Industry members
Australian Chemical Specialties Manufacturers' Association (ACSMA)
Plastics and Chemicals Industries Association (PACIA)
Australian Paint Manufacturers' Federation (APMF)
Australian Chamber of Commerce and Industry (ACCI)
Government members
NICNAS (Chair)
Department of Employment, Workplace Relations and Small Business (DEWRSB)
Department of Industry, Science and Resources (DISR)
Environment Australia (EA) - Department of Environment and Heritage
Given the integral relationship between the Director NICNAS and the Chief Executive Officer (CEO)
of the National Occupational Health and Safety Commission (NOHSC), the NOHSC CEO will be an
ex-officio member of the IGCC.
The IGCC will:
(a) review the utilisation of resources against NICNAS objectives;
(b) review 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) develop strategies for improving the efficiency and effectiveness of NICNAS operations within
the context of (i) established goals and objectives and (ii) developing and emerging issues; and
(d) develop compliance strategies and monitor the effectiveness of these strategies in promoting
compliance with the Scheme.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 4
The Chair of the Committee will report as necessary (at least every six months) to the Minister for
Employment, Workplace Relations and Small Business on the outcomes of the Committee.
IGCC Membership at 30 June 2001 and attendance at 2000-01 meetings
Affiliation IGCC 10 IGCC 11 IGCC 12
Meeting Meeting Meeting
21 Aug 11 Dec 27 April
2000 2000 2001
Dr Margaret Hartley (Chair), NICNAS
Ms Bronwyn Capanna ACSMA
Mr Nick Munafo PACIA
Mr Michael Hambrook APMF
Ms Sylvia Kidziak ACCI
53
Mr John Rowling DEWRSB
(representative attended 11)
Mr John Dean DISR
(representative attended 10, 12)
Mr Peter Burnett EA
(representative attended 10)
Mr Alan Rowe (10); NOHSC
Mr Robin Stewart-Crompton-
ex-officio (11, 12)
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 5
Appendix 3
Staff Profile and Training
There were 37 staff employed within NICNAS at 30 June 2001. Of these, 26 are permanent employees
and 11 are contract or temporary staff. The staffing profile at 30 June 2001 by classification and
membership of equal employment opportunity groups are shown in the following tables.
NICNAS Staffing Profile at 30 June 2001
Classification Male Female Total
Statutory Officers 0 1 1
Executive Level 2 Officers 1 5 6
appendix
Executive Level 1 Officers 8 4 12
APS Level 5 & 6 Officers 6 5 11
APS Level 1 - 4 Officers 0 7 7
54 Total 15 22 37
Membership of Equal Employment Opportunity Groups
EEO Group No. of Staff % of Total Staff
Women 22 59.5
Aboriginal and Torres Strait Islander People 2 5.4
Non-English Speaking Background 7 18.9
People with Disabilities 2 5.4
Training and development outcomes are reported as total number of training days and the average
number of training days per staff member in the table below. 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.
Summary of Staff Training by Category 2000-01
Total No. of Average No. of Days
Training Days per Relevant Staff
Scientific/Technical Related 52.75 1.8
Information Technology Related 18.25 0.5
Scheme Performance/Professional
Development Related* 67.6 1.8
New Staff - Orientation/
Induction Related 4.5 1.5
*Includes activities such as customer service training, corporate governance activities, financial management,
policy development, e-commerce etc.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 6
Appendix 4
Consultancies Commissioned
Five consultancies were commissioned by NICNAS during 2000-01. Details are provided below.
Snap Printing dot com
Consultancy for printing of PEC Reports. Total cost $30,000 (approx).
Bruce Rowe & Associates
Consultancy to provide organisation development. Total cost $20,000.
Ken Filewood Consulting Pty Ltd
Consultancy to analyse relocation requirements. Total cost $5,000.
SHE Pacific Pty Ltd
Consultancy to document the range of commercial evaluation practices for new industrial chemicals
in Australia. Total cost $60,754. 55
Computer Systems Australia Pty Ltd
Consultancy for NICNAS database development. Total cost $200,000.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 7
Appendix 5
Media Advertising Organisations Used
Company Description Cost ($) Date
AIS Media NICNAS - Using industrial chemicals 1,287 July 2000
safely, Australian Safety News
AIS Media NICNAS - Using industrial chemicals 1,287 August 2000
safely, Australian Safety News
AIS Media NICNAS - Do you import or manufacture 1,287 Sept 2000
industrial chemicals?, Australian
appendix Safety News
N/A Listing for NICNAS in Australian 75 plus GST 01 Sept 2000
Safety Buyers Guide published for the
56 National Safety Council of Australia by
Custom Media Group
AIS Media NICNAS - Expression of interest: Data 946 21 Nov 2000
system for the management of technical
business information, The Australian
(IT section)
AIS Media NICNAS corporate advertisement 7,098 16 Feb 2001
The Australian, (Special report on OHS)
AIS Media NICNAS corporate advertisement - 528 27 April 2001
National Farmers' Federation yearbook
2001
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 8
Appendix 6
Ecologically Sustainable Development (ESD)
NICNAS performance against ESD principles and practice parameters is achieved through our
relationship with key ESD government bodies such as Environment Australia and the alignment of our
risk assessment policies and methodologies with ESD. Thus, in determining the risk to the environment,
public health and occupational health and safety, the principles of ESD (a) to (e) apply as follows.
(a) Decision-making processes should effectively integrate both long-term and short-term economic,
environmental, social and equitable considerations.
NICNAS undertakes risk assessment of chemicals within an agreed policy framework and includes
overall process of decision making, taking into account hazard assessment, establishment of dose-
response relationships, exposure assessment and risk management. 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 agreed government policy for the environmentally sound
57
management of chemicals. This is based on the principles and policy of ESD and aligned with the
United Nations Conference on Environment and Development (UNCED) Agenda 21, Chapter 19. The
economic and social benefits of risk reduction are 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.
(d) The conservation of biological diversity and ecological integrity should be a fundamental
consideration in decision making.
The risk management controls recommended by NICNAS aim to ensure ongoing environmental
integrity and biological diversity. The risk assessments integrate hazard assessment with any unique
exposure or use patterns and also take into consideration the unique nature of the national ecosystems
and fauna and flora.
(e) Improved valuation pricing and incentive mechanisms should be promoted.
NICNAS has introduced a number of initiatives since 1997 such as Early Introduction Permit (EIP)
and revision of criteria for polymers of low concern (PLC) to promote introduction of less hazardous
chemicals and minimise risk to environment and human health. These initiatives provide financial
incentives to industry. EIPs allow industry to market their chemical immediately, avoiding any
assessment time. The new PLC criteria increase the number of chemicals in this category, which has a
lower assessment fee and reduced data requirements.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 9
Appendix 7
Types and Categories of NICNAS Assessments
New Chemicals: An industrial chemical or synthetic polymer not listed on the Australian
Inventory of Chemical Substances (AICS).
Certificates
Chemicals can only be released onto the Australian market by the certificate holder (unless the
chemical is covered by a permit or under specific NICNAS exemptions) for a period of five years
after which the chemical is listed in the Australian Inventory of Chemical Substances and is then
available for open use. The assessment report is provided to the notifier, who is able to use the
appendix
report, for example, to support responsibilities under State and Territory hazardous substances
legislation, environmental legislation or poisons scheduling. The full public report and
recommendations on safe use may be used by State and Territory agencies and at the workplace.
Standard These are required for all new industrial chemicals where the chemical is
58
Notification introduced in quantities greater than 1,000 kg/year; or is a new synthetic
polymer with a number-average molecular weight (NAMW) of less than
1,000 daltons. This category requires the highest level of new chemical
data including chemical identity, physico-chemical properties, use pattern,
occupational, environmental and public exposure, toxicity, ecotoxicity,
environmental fate, Material Safety Data Sheet (MSDS) and the label.
Limited These are required for all new industrial chemicals where the chemical is
Notification introduced at less than 1,000 kg/year; or research, development or
analytical chemical or polymer imported in quantities of 50-1,000
kg/year; or new synthetic polymer with a NAMW greater than 1,000
daltons. Data requirements are less than for a standard notification and
include the chemical identity, physico-chemical properties, use pattern,
occupational, environmental and public exposure, an MSDS and the label.
Polymers of Low These chemicals are defined by predetermined criteria to be of low
Concern (PLC) concern to humans and the environment. PLC can be introduced into
Australia with reduced fees and reduced data requirements.
Extension of The original certificate can be can be extended to include other
Original New introducers, providing the original certificate holder agrees in writing. In
Chemical addition to specific data requirements, any new information on exposure or
Assessment adverse health or environmental effects must also be provided.
Certificate
Permits
Permits allow chemicals to be introduced conditionally, without a full assessment, providing
certain information is provided on identity, hazard and exposure. NICNAS assesses permit
applications under shorter timeframes and for a reduced fee.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 10
Commercial Chemicals that are to be introduced solely for determination of their
Evaluation commercial potential. The maximum quantity of chemical allowed under a
Category (CEC) CEC permit is 1,000 kg for a maximum period of one year or 2,000 kg for
two years (based on additional justification). Data requirements include
chemical identity, use and distribution arrangements, volume and duration
of introduction of the chemical, occupational, environmental and public
exposure, an MSDS and the label. In addition, customer agreements must
be provided for each proposed user of the chemical.
Low Volume Available for the introduction of a chemical 10-100 kg/year (nationwide
Chemicals (LVC) volume limit). Two or more companies may apply for a permit with the
quantity shared between them. Data requirements include chemical
identity, use, volume and duration of introduction of the chemical,
occupational, environmental and public exposure, an MSDS and the label.
The maximum LVC permit period is three years, with the provision for
59
unlimited renewal.
Early Available for a non-hazardous chemical with respect to human health
Introduction effects or a dangerous good that meets certain environmental criteria
Permit for Non- undergoing assessment for a certificate. Once an EIP is granted, the
Hazardous applicant may introduce the chemical according to the permit conditions,
Chemicals before the full assessment has concluded. Other factors taken into
account include reasonable protection of occupational health, public
health and the environment and any adverse effects on human health or
the environment.
Small volumes Allows for introduction of small volumes of new chemicals provided certain
requiring criteria are met. The exemption does not apply to chemicals that
notification pose an unacceptable risk to occupational health, public health or the
only ? environment. The introducer is responsible for conducting the risk
The <10kg rule assessment. There are specific criteria for cosmetic chemicals,
?cosmetic and incorporating safeguards for consumer use. For instance, a cosmetic
non-cosmetic chemical must not be used as a preservative, a colouring agent or an
chemicals 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.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 11
Research, There are no restrictions on volumes of new industrial chemicals
development or manufactured in Australia solely for research, development or analytical
analytical purposes. Information must first be provided to NICNAS on the type and
(R&D&A) location of the apparatus (a fixture), description of the program, type of
purposes chemical and description of procedures for safe disposal of the chemical
and any hazardous degradation products.
Small volumes This is for chemicals that are imported or manufactured in volumes less than
for R&D&A - 50 kg/year. These are to be used only for research, development or analytical
exemption purposes (as defined), and do not require notification.
Existing Chemicals: Chemicals already in use in Australia
Assessments
appendix
Assessments include screening assessments, PEC assessments (full, preliminary and
secondary) and international assessments. PEC assessments are comprised of assessment
modules, with the modular makeup of each assessment varying depending on the scope of
60 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 assessment
Assessments 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 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.
Full Full assessments usually include information on chemical and physical
Assessments 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 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.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 12
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 in
Assessments 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 which have been
assessed by NICNAS.
61
International Assessment Programs:
There are two international assessment programs for existing chemicals, under the auspices
of the Organisation for Cooperation and Development (OECD) and the International Program
on Chemical Safety (IPCS). OECD SIDS Initial Assessment Reports (SIARs) are
comprehensive hazard assessments of chemicals and are prepared and reviewed by
member countries. IPCS publishes Concise International Chemical Assessment Documents
(CICADs), which provide summaries of the relevant scientific information concerning the
potential effects of chemicals upon human health and/or the environment. CICADs are based
on national or regional documents and are internationally peer reviewed.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 13
Appendix 8
New Chemicals Notification and Assessment Statistics
This appendix shows the number of new chemical submissions (total and by assessment category)
received and completed for the past three years, including our assessment performance against statutory
timeframes. The industrial uses for each of the notified chemicals since the Scheme's inception in 1990
are also shown by OECD industrial use category.
Total Submissions Quarter Total Total Total
1st 2nd 3rd 4th 2000/01 1999/00 1998/99
Applications Received 48 34 53 47 182 176 167
appendix
- Certificates
148 130 153
Applications Received 44 26 35 43
- Permits
62
Certificates Issued 48 31 62 42 183 152 107
Permits Issued 36 31 27 44 138 128 117
Total Active* 149 152 138 135 135 152 150
(end of the final month) (end June 01) (end June 00) (end June 99)
EIP Received 14 3 23 12 52 53 41
* Active includes all submissions accepted but not finalised (i.e. certificate or permit not signed). Active submissions
may be in prescreening, under assessment, with the notifier for comment before final publication of the report, or
awaiting additional information from the notifier.
Standard Notification Quarter Total Total Total
1st 2nd 3rd 4th 2000/01 1999/00 1998/99
Applications Received 16 14 11 11 52 47 55
Certificates Issued 5 14 18 11 48 56 35
EIP Received 1 0 1 0 2 5 3
Total Active* 47 44 35 34 34 37 52
(end of the final month) (end June 01) (end June 00) (end June 99)
* Active includes all submissions accepted but not finalised (i.e. certificate or permit not signed). Active submissions
may be in prescreening, under assessment, with the notifier for comment before final publication of the report, or
awaiting additional information from the notifier.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 14
Limited Notification Quarter Total Total Total
1st 2nd 3rd 4th 2000/01 1999/00 1998/99
Applications Received 13 11 16 16 56 64 61
Certificates Issued 20 8 19 12 59 48 42
EIP Received 0 1 3 3 7 17 15
Total Active* 43 43 39 41 41 46 37
(end of the final month) (end June 01) (end June 00) (end June 99)
* Active includes all submissions accepted but not finalised (i.e. certificate or permit not signed). Active submissions
may be in prescreening, under assessment, with the notifier for comment before final publication of the report, or
awaiting additional information from the notifier.
Polymer of Low Concern Quarter Total Total Total
1st 2nd 3rd 4th 2000/01 1999/00 1998/99
Applications Received 14 8 24 18 64 57 44 63
Certificates Issued 20 8 23 14 65 40 27
EIP Received 12 2 14 8 36 31 23
Total Active* 32 34 33 37 37 39 26
(end of the final month) (end June 01) (end June 00) (end June 99)
* Active includes all submissions accepted but not finalised (i.e. certificate or permit not signed). Active submissions
may be in prescreening, under assessment, with the notifier for comment before final publication of the report, or
awaiting additional information from the notifier.
Certificate Extension Quarter Total Total Total
1st 2nd 3rd 4th 2000/01 1999/00 1998/99
Applications Received 5 1 2 2 10 8 7
Certificates Issued 3 1 2 5 11 8 3
Total Active* 5 5 5 2 2 4 5
(end of the final month) (end June 01) (end June 00) (end June 99)
* Active includes all submissions accepted but not finalised (i.e. certificate or permit not signed). Active submissions
may be in prescreening, under assessment, with the notifier for comment before final publication of the report, or
awaiting additional information from the notifier.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 15
Low Volume Chemicals Quarter Total Total Total
1st 2nd 3rd 4th 2000/01 1999/00 1998/99
Applications Received 14 5 3 24 46 39 60
Permits Issued 11 10 6 18 45 36 47
Total Active* 8 7 3 6 6 10 13
(end of the final month) (end June 01) (end June 00) (end June 99)
* Active includes all submissions accepted but not finalised (i.e. certificate or permit not signed). Active submissions
may be in prescreening, under assessment, with the notifier for comment before final publication of the report, or
awaiting additional information from the notifier.
Commercial Quarter Total Total Total
appendix
Evaluation Category 1st 2nd 3rd 4th 2000/01 1999/00 1998/99
Applications Received 16 18 10 7 51 38 52
Permits Issued 11 12 8 11 42 43 35
64 Total Active* 8 14 12 9 9 4 10
(end of the final month) (end June 01) (end June 00) (end June 99)
* Active includes all submissions accepted but not finalised (i.e. certificate or permit not signed). Active submissions
may be in prescreening, under assessment, with the notifier for comment before final publication of the report, or
awaiting additional information from the notifier.
Early Introduction Quarter Total Total Total
Permit 1st 2nd 3rd 4th 2000/01 1999/00 1998/99
Applications Received 13 3 18 12 46 53 41
Permits Issued 14 9 13 15 51 49 35
Total Active* 6 5 11 6 6 12 8
(end of the final month) (end June 01) (end June 00) (end June 99)
* Active includes all submissions accepted but not finalised (i.e. certificate or permit not signed). Active submissions
may be in prescreening, under assessment, with the notifier for comment before final publication of the report, or
awaiting additional information from the notifier.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 16
Assessment Performance Against Timeframes 2000-01
Including Comparison with 1999-2000 and 1998-99
All Assessments Target Quarter 2000/01 1999/00 1998/99
1st 2nd 3rd 4th Total % % %
Certificates and 84 62 89 86 321
permits issued
Reports to notifier 90 days 34/36 43/44 52/52 34/34 163/166 98 57 53
within statutory (all
timeframes categories
except
Extension)
45 days 2/2 3/3 0 6/6 11/11 100 38 67
(Extension)
90 days not
met; EIP n/a n/a n/a n/a n/a 65
issued
Certificate issued
(following receipt <7 days 45/48 31/31 57/62 42/42 183 96 86 75
from notifier)
Permits issued 20 days 11/11 10/10 6/6 18/18 45/45 100 72
within statutory/ (LVC) 76^
non-statutory 14 days 11/11 12/12 6/8 11/11 40/42 95 60
timeframes (CEC)
28 days 14/14 9/9 13/13 15/15 51/51 100 78 77
(EIP)
^ combined LVC and CEC.
n/a ?not applicable due to either (a) EIP not sought or (b) 90 day statutory timeframe met.
Standard Target Quarter 2000/01 1999/00 1998/99
Notification 1st 2nd 3rd 4th Total % % %
Certificates issued 5 14 18 11 48
Reports to notifier 90 days 6/6 18/19 16/16 12/12 52/53 98 46 34
within statutory
timeframe 90 days not
met; EIP n/a n/a n/a n/a n/a
issued
Certificate issued <7 days 5/5 14/14 17/18 11/11 47/48 98 91 74
(following receipt
from notifier)
n/a ?not applicable due to either (a) EIP not sought or (b) 90 day statutory timeframe met.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 17
Limited Target Quarter 2000/01 1999/00 1998/99
Notification 1st 2nd 3rd 4th Total % % %
Certificates issued 20 8 19 12 59
Reports to notifier 90 days 13/14 10/10 18/18 13/13 54/55 98 58 60
within statutory
timeframe 90 days not
met; EIP 1/1 n/a n/a n/a 1/1 100
issued
Certificate issued <7 days 20/20 8/8 18/19 12/12 58/59 98 88 79
(following receipt
from notifier)
n/a ?not applicable due to either (a) EIP not sought or (b) 90 day statutory timeframe met.
appendix
Polymer Target Quarter 2000/01 1999/00 1998/99
66 of Low Concern 1st 2nd 3rd 4th Total % % %
Certificates issued 20 8 23 14 65
Reports to notifier 90 days 15/16 15/15 18/18 9/9 57/58 98 70 67
within statutory
timeframe 90 days not
met; EIP 1/1 n/a n/a n/a 1/58 2
issued
Certificate issued <7 days 17/20 8/8 21/23 14/14 60/65 92 83 70
(following receipt
from notifier)
n/a ?not applicable due to either (a) EIP not sought or (b) 90 day statutory timeframe met.
Certificate Target Quarter 2000/01 1999/00 1998/99
Extension 1st 2nd 3rd 4th Total % % %
Certificates issued 3 1 2 5 11
Reports to notifier 45 days 2/2 3/3 0 6/6 11/11 100 38 67
within statutory
timeframe
Certificate issued <7 days 3/3 1/1 1/2 5/5 10/11 91 63 100
(following receipt
from notifier)
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 18
Low Quarter 2000/01 1999/00 1998/99
Volume Chemicals 1st 2nd 3rd 4th Total % % %
Permits issued 11 10 6 18 45
Permit issued within
statutory timeframe 11/11 10/10 6/6 18/18 45/45 100 72 89
(20 days)
Commercial Quarter 2000/01 1999/00 1998/99
Evaluation Category 1st 2nd 3rd 4th Total % % %
Permits issued 11 12 8 11 42
Permit issued within
non-statutory timeframe 11/11 12/12 6/8 11/11 40/42 95 60 57
(14 days)
67
Early Quarter 2000/01 1999/00 1998/99
Introduction Permit 1st 2nd 3rd 4th Total % % %
Permits issued 14 9 13 15 51
Permit issued within
statutory timeframe 14/14 9/9 13/13 15/15 51/51 100 78 77
(28 days)
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 19
Industrial Uses of Notified Chemicals (Standard, Limited and PLC)
for the Past Three Years
Use Category
1998-99 1999-2000 2000-01
Building/Construction 0 6 7
Cosmetics 14 11.5 16
Domestic use 4 5.5 7
Electrical 1 1 0
Fuel and oil 13 15 22
Leather processing 3 1 1
appendix
Mining 1 8.5 2
Packaging 0 0 16
Paper and pulp 1 3 1
Photographic 1 6 1
68
Plastics 6 20 13
Printing/Photocopying 6 14 17.5
Refrigeration 2 0 0
Surface coatings/Adhesives 37 50.5 55
Textile processing 8 7 4
Water treatment 0 2 4
Other 1 3 8.5
Industrial Uses of Notified Chemicals (Standard, Limited and PLC) for the Period
July 1990 to 30 June 2001
Note: where two uses were identified, each is allocated 0.5 (hence some categories with fractions).
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 20
Appendix 9
Confidential Listing of Chemicals on the Australian Inventory of
Chemical Substances (AICS)
Technical Advisory Group (TAG) Membership
Professor Graham A R Johnston, AM FRACI, FTSE (reappointed October 2000)
Professor of Pharmacology, University of Sydney
Professor Ian Rae, FRACI, FTSE (reappointed October 2000)
Department of History and Philosophy of Science, University of Melbourne
Ms Mariann Lloyd-Smith (reappointed October 2000)
Coordinator, National Toxics Network, Canberra
Mr James Smith (appointed August 2000)
69
Chemical Engineering Advisor, Melbourne
The TAG met six times during 2000-01. During the year they finalised the document Guidelines
for Establishing a Case for Confidential Listing of Chemicals on the Australian Inventory of
Chemical Substances (The Guidelines) which was endorsed by the tenth meeting of the Industry
Government Consultative Committee (IGCC). The Guidelines were published in the November
2000 Chemical Gazette and on the NICNAS web site.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 21
Appendix 10
Summary of PEC Assessment Activity
Full PEC Assessments: 2000-01 Activity
Quarter 1st 2nd 3rd 4th
New declarations (cumulative) 2 4 0 0
Number under review/review published 8 12 12 12
? Data gathering phase* 6 12 12 12
? Assessment phase* 6 6 12 12
? Hazard assessment completed 6 6 6 6
appendix
? Exposure assessment completed 6 6 6 6
? Risk assessment/current controls completed 5 6 6 6
Environment report completed by EA+
? 3 3 3 3
Public health report completed by TGA+
70 ? 5 6 6 6
? Recommendations/final draft 5 5 6 6
report completed
? Consultation (corrections/variations)* 2 5 5 6
? Appeals* 0 0 0 0
? Publication phase* 1 2 2 6
Number published in total (and number 0 1 2(2) 5(5)
within statutory deadline)
* Phase underway or completed.
+ Number may be smaller than total completed, as some assessments do not require environment or public health
assessments.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 22
Preliminary PEC Assessments: 2000-01 Activity
(Note preliminary assessments are either hazard or exposure assessments)
Quarter 1st 2nd 3rd 4th
New declarations in quarter 0 0 0 0
Number under review/review completed 41 41 41 41
? Data gathering phase* 41 41 41 41
? Assessment phase* 41 41 41 41
? Hazard or exposure assessment completed 40 41 41 41
Environment report completed by EA+
? 1 41 41 41
Public health report completed by TGA+
? 1 41 41 41
? Recommendations/final draft 0 41 41 41
report completed
? Consultation phase* 0 41 41 41
? Appeals* 0 0 0 0
? Publication phase* 0 0 0 41 71
Number published in total (and number 0 0 0 41(41)
within statutory deadline)
Secondary Notification Assessments: 2000-01 Activity
Quarter 1st 2nd 3rd 4th
New declarations in quarter 0 0 0 0
Number under review/review completed 1 1 1 1
? Data gathering phase* 1 1 1 1
? Assessment phase* 1 1 1 1
? New data assessment completed 1 1 1 1
Environment report completed by EA+
? 1 1 1 1
Public health report completed by TGA+
? 1 1 1 1
? Recommendations/final draft 1 1 1 1
report completed
? Consultation phase* 0 1 1 1
? Appeals* 0 0 0 0
? Publication phase* 0 0 1 1
Number published in total (and number 0 0 1(1) 1(1)
within statutory deadline)
? Post publication variations requested** 0 0 0 0
? Post publication variations finalised** 0 0 0 0
* Phase underway or completed.
+ Number may be smaller than total completed, as some assessments do not require environment or public health
assessments.
** Applicable to secondary notifications only, which until legislative change is finalised must go through the New
Chemicals process.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 23
Appendix 11
List of Chemicals that had Agreed International Assessments for 2000-01
OECD SIDS Initial Assessment Reports (SIARs)
1,2-Benzenedicarbonitrile
1-Chloro-1,1-difluoroethane
1- Decene
1,1-Dichloro-1-fluoroethane
1-Dodecene
appendix
1-Hexane
1-Methoxy-2-propanol
1-Methoxy-2-propanol acetate
1-Octene
72
1-Tetradecene
2-Propanol, 1,1'-oxydi-
3,4-Dichloro-1-buten
3-Methyl-1,5-pentadiol
6,6'-Di-t-butyl-4,4'-dimethyl-2,2'-methylenediphenol
Acrylamide
Benzene
Butane, 1,2-epoxy-
Citric acid
Dibutyl phthalate
Dimethyl terephthalate
Dipropylene glycol
Dipropylene glycol methyl ether
Edetic acid
Edetic acid tetrasodium salt
-Caprolactam
Ethyl acetoacetate
Glyoxal
Hexamethylene diisocyanate
Methacrylic acid
Methyl methacrylate
Methyl tert-butyl ether
Nonyl phenol
m-Toluidine
Pentabromodiphenyl ether
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 24
Phenol, 4-nonyl-, branched
Propylene glycol
Sulfuric acid
Terephthalic acid
Tributyl phosphate
Toluene
Toluene, o-chloro-
World Health Organisation Concise International Chemical Assessment
Documents (CICADs)
Acrylonitrile
Chlorinated naphthalenes
Diethylene glycol dimethyl ether
Formaldehyde
73
Methyl- and ethylcyanoacrylate
N-Nitrosodimethylamine
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 25
Appendix 12
Presentations, Conferences, Harmonisation Meetings and Site Visits
Presentations
Zhang, J, "Physiological and Subjective Responses in Air Purifying Respirators", 4th International
Scientific Conference of 6th International Occupational Hygiene Association, Cairns, Queensland,
10-14 July 2000.
Jayewardene, R, "Regulation of Cosmetic Chemicals Under NICNAS", Cosmetic Medicine
Conference, Sydney, 31 July 2000.
appendix
Hartley, M, "Harmonisation of the Approaches to the Assessment of Risk from Exposure to
Chemicals" for the Intergovernmental Forum on Chemical Safety, Brazil, 17 October 2000.
Graf, R, "Synthetic Polymers of Low Concern ?Criteria for Determining Polymers of Low
74
Human and Environmental Hazard", 24th Australasian Polymer Symposium, Beechworth,
Victoria, 4-8 February 2001.
Nugent, K, "Regulatory Aspects of Development and Commercialisation of New Polymers", 24th
Australasian Polymer Symposium, Beechworth, Victoria, 4-8 February 2001.
Hartley, M, "Launch of Coatings Care Programme of Australian Paint Manufacturers' Federation
Inc", Sydney, 20 April 2001.
Willcocks, D, Logan, S and Lee-Steere, C, Priority Existing Chemicals Benzene Seminars,
Brisbane, Canberra, Melbourne, Sydney, Adelaide and Perth, May/June 2001.
Hartley, M, "New Initiatives in NICNAS" at "Early Warning for Industry ?the Issues You Need
to Know - Major Changes to Queensland Legislation Affecting Chemical Users", Australian
Chemical Specialties Manufacturers' Association, (ACSMA) Brisbane, 20 June 2001.
Jenkins, C, "Report on Commercial Evaluation Practices for Industrial Chemicals", Australian
Business OHS Policy Committee, Sydney, 29 June 2001.
Conferences attended
10-14 July 2000 4th International Scientific Conference of the International Occupational
Hygiene Association, Cairns, Queensland.
24 July 2000 National Environmental Protection Council forum to consider Risk
Assessment Task Force draft report on Risk Assessment
approaches/framework to setting ambient air quality standards,
Sydney, NSW.
31 July 2000 Cosmetic Medicine Conference 2000, Sydney, NSW.
24 August 2000 Plastics and Chemical Industries Association
(PACIA) Seminar on Endocrine Disruption, Melbourne, Victoria.
14-15 October 2000 International Dry-Cleaning Convention.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 26
26-30 November 2000 15th International Clean Air and Environment Conference
7-10 December 2000 MEPSA Conference, Is Cancer a Preventable Environmental Disease?,
Mt Bulla, Victoria
4-8 February 2001 24th Australasian Polymer Symposium, Beechworth, Victoria
25 May 2001 The New Zealand Hazardous Substance Regulations, ACSMA seminar,
Sydney, NSW
Meetings attended for progressing international harmonisation activities
October 2000 International Programme on Chemical Safety (IPCS) Harmonisation
Project Steering Committee for the Harmonisation of Risk Assessment
Methodologies, Washington DC, USA
October 2000 IPCS Exposure Assessment Planning Workgroup Meeting,
Washington DC, USA
November 2000 OECD New Chemicals Task Force ?two
and June 2001 teleconferences
November 2000 ? OECD Issue Team for Tools for R & D 75
April 2001 Screening ?five teleconferences attended
June 2001 OECD Joint Meeting of the Chemicals Committee and the Working Party
on Chemicals, Pesticides and Biotechnology
International assessment meetings
January 2001 OECD (SIDS Initial Assessment Meeting (SIAM) 11), Orlando, Florida, USA
January 2001 OECD Meeting on PFOS (perflurooctyl sulfonates) and Related
Chemicals, Orlando, Florida, USA
June 2001 OECD (SIAM 12), Paris, France
Site visits (not compliance related)
August 2000 Benzene ?Existing Chemicals Team
nine site visits
September 2000 Tetra Chloro Ethylene ?Existing Chemicals Team
five site visits
October 2000 Persulfate ?Existing Chemicals Team two site visits
November 2000 Coates Brothers, Auburn, NSW ?New Chemicals Team
November 2000 Ausmelt Ltd, Dandenong, Victoria
December 2000 Ciba Specialty Chemicals Australia Pty Ltd, Thomastown, Victoria
December 2000 and Fairfax Printers, Greenacre, NSW ?New Chemicals Team
April 2001
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 27
April 2001 Plastral Fidene, Sydney, NSW
May 2001 Lubrizol, Sydney, NSW ?New Chemicals Team
May 2001 Nalco Australia Pty Ltd, Botany, NSW ?New Chemicals Team
Compliance related seminars/meetings
November 2000 Customs Brokers and Importers Council of Australia
November 2000 Mineral and Mining Council of Australia
Victorian WorkCover Authority, (resulting in an article in Workwords
November 2000
highlighted the obligations of introducers of new chemicals).
appendix
March 2001 Printing and Industry Association of Australia
76
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 28
Appendix 13
Partner Agency Assessment Performance
Environment Australia
Environment Australia 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 Environment Australia during 2000-01
is shown below.
Assessments Completed by Environment Australia in 2000-01
77
Number of Environment
Assessment Category Assessment Reports sent to NICNAS
1999/2000 2000/01
Standard Notification 49 51
Limited Notification 50 53
Polymer of Low Concern (PLC) 44 66
Extensions / Secondary Notifications 9 16
Subtotal 152 186
Commercial Evaluation Certificates (CEC) 8 16
Low Volume Chemicals (LVC) 8 5
Early Introduction Permits (EIP) 50 49
Subtotal 66 70
Total New Chemicals 218 256
Total Priority Existing Chemical Reports 8 5
The number of reports completed by Environment Australia increased over the previous year, with
170 completed standard, limited and polymer of low concern environment reports compared with 143
in 1999-2000. Most of the increase was in the PLC category (66 compared with 44 in 1999-2000).
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. Environment Australia staff attended several meetings with NICNAS and industry personnel
on general policy issues, and NICNAS reforms in New Chemicals.
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 29
Therapeutic Goods Administration (TGA) of the Department of Health and Aged Care
The TGA provides advice to NICNAS on the public health 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
public health effects resulting from the stated use patterns of the chemicals.
A summary of assessment reports completed by the TGA during 2000-01 is shown below.
Assessments Completed by the TGA in 2000-01.
Number of Public Health
Assessment Category Assessment Reports Sent to NICNAS
1999/2000 2000/01
appendix
Standard Notification 51 48
Limited Notification 55 50
Polymer of Low Concern (PLC) 57 61
78
Extensions / Secondary Notifications 10 9
Subtotal 173 168
Commercial Evaluation Certificates (CEC) 8 19
Low Volume Chemicals (LVC) 19 23
Early Introduction Permits (EIP) No statistics available
Subtotal 27 42
Total New Chemicals 200 210
Total Priority Existing Chemical Reports 4 5
The TGA also participated as presenters in NICNAS seminars for industry, and attended
meetings on NICNAS reforms in New Chemicals.
NICNAS ANNUAL REPORT 2000-01
COMPLETED ACKNOWLEGED NO. (%)
2001 Appendices
FINALISED WITHIN
TOTAL NO. TOTAL WITHIN OR FINALISED GREATER
28 DAYS
OF CALLS HOURS 24 HOURS WITHIN 7 DAYS THAN
RECEIVED SPENT
No. % No. % No. % 28 DAYS
9/14/01
TELEPHONE Business Mgt &
Compliance
?Company Reg. 243 36.75 242 99.6 1 0.4
?Compliance 356 77.3 355 99.7 1 0.3
Appendix 14
?General NICNAS 60 9.3 59 98.3 1 1.7
?Public 10 2.0 10 100.0
11:21 AM
New Chemicals
?General NICNAS 979 189 977 99.8 2 0.2
?Public 0
Existing Chemicals
Page 30
?PEC 67 20.75 65 97.0 2 3.0
?General NICNAS 0
?Public 37 24.5 33 89.2 4 10.8
SUB TOTAL 1,752 359.50 1,741 99.4 11 0.6
WRITTEN Business Mgt &
Compliance
?Company Reg.
?Compliance
?General NICNAS 1 0.5 1 100.0
?Public
New Chemicals
?General NICNAS 161 109.75 90 55.9 53 32.9 13 8.1 5
?Public
Existing Chemicals
?PEC 7 18.75 5 71.4 2 28.6
?General NICNAS
NICNAS Enquiries Yearly Summary July 2000 - June 2001.
?Public 36 133.50 25 69.4 9 25.0 2 5.6
SUB TOTAL 205 262.5 121 59.0 64 31.2 15 13.6 5
TOTAL 1,957 622.0 1,862 95.1 75 3.8 15 0.8 5
NICNAS ANNUAL REPORT 2000-01
79
2001 Appendices 9/14/01 11:21 AM Page 31
Appendix 15
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.
Successful Hits
appendix
80
Visitor Sessions
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 32
Activity Level by Day of Week
81
Most Requested Pages
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 33
Appendix 16
NICNAS New and Revised Publications for 2000-01
Information Product Format Print
About NICNAS brochure Both electronic and print brochure. Yes
More about us brochure Print version superseded by web site. No
Service Charter Both electronic and printed format. Yes
Postcard on web site Promotional item for the focal Yes
point of information delivery.
Compliance Brochure to last until 2003. As needed
appendix
Compliance Plan Available from web site, marked up in HTML. No
Handbook for Notifiers Now an in-house desktop product for updates. Photocopied
Available in PDF on web site. only
82 Print out on demand for charge of $55 a copy.
Business Plan, Web versions only. No
Strategic Plan
NICNAS matters Newsletter printed triannually and on web site. Yes
Chemical Gazette Online from February 2001. Email alert Photocopied
subscription available. Print copies available on demand
on demand. Also option of emailing the whole only
gazette in a PDF file for those who have email
in their workplace but not Internet access.
Forms All available for completion and printing from No
web site or supply print on demand.
New Chemicals Revised in plain language and in folder format Yes
brochure/folder for use with updated Fact Sheets.
Safety Info Sheets Plain language fact sheets on PEC reports for Print-on-
use in the workplace. Print versions for PECs demand
1-12 and available on web site. Remainder
PECs 13-19 web site version only, can be printed
out in A4 or A3 sizes.
Brochure: Your Guide to New brochure ?web publication only. No
Keeping Cosmetics Safe
New Chemicals 183 new reports on web site. No
Assessment Reports
PEC Assessment Reports 47 new reports on web site. Print-on-
Hardcopies provide free of charge on request demand
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 34
notes 83
NICNAS ANNUAL REPORT 2000-01
2001 Appendices 9/14/01 11:21 AM Page 35
notes
84
NICNAS ANNUAL REPORT 2000-01
cooperation
achievement
w w w.nicnas.gov.au
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