In delivering its goal of chemical safety and maintaining the integrity
of the scheme through partnership with industry, NICNAS needs an effective
compliance program coupled with an enhanced strategic alliance
with stakeholders.

During 2003-04, NICNAS reviewed its compliance and enforcement
style and introduced new systems and standardised procedures aimed
at providing a compliance function that is, and is seen to be, firm, fair
and consistent.

NICNAS’s compliance strategic focus provides a proactive and responsive
enforcement strategy through the adoption of best practice compliance
models and engagement with industry, the community and Government

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Enforcement Tools

In 2003-04, guidelines were developed for compliance officers on the most
appropriate action to take when enforcement is necessary. NICNAS
enforcement tools are divided in to two categories: Administrative (informal)
enforcement action and Formal (court based) enforcement action. NICNAS
believes that the most effective method of resolving inadvertent breaches
is by the use of informal enforcement tools.

Administrative procedures and decision-making processes were reviewed
and mechanisms put in place to ensure that compliance case records and
all decisions are documented in a transparent and consistent manner, and in
accordance with procedural fairness principles. The NICNAS database (D@N)
is relied upon as the compliance tracking system for all cases and audit
management work.

In 2003-04, almost all NICNAS staff received training in the new
administrative and record keeping procedures and external accredited
training in compliance auditing.

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Inspectors’ Manual

The NICNAS Inspectors’ Manual was developed for NICNAS Inspectors to
guide them through the auditing and inspection techniques used to monitor
compliance with the Act. The manual is based on best practice models
adopted by other Australian Government regulators and relevant Australian
Standards. Inspectors’ audit techniques were tested at a pilot site visit aimed
at gaining an understanding of industry practices and record keeping
systems. The manual was also reviewed by IGCC and States and Territories
MOU Members.

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Industry Guidance

In line with NICNAS’s commitment to establish clear industry guidance
on the regulatory requirements of the Act, the document ‘Understanding
the Act’ was developed as plain language guidance on how to comply with
the roles and duties of the inspectorate. IGCC Members were consulted
and provided comments on the document. This publication will be available
on the NICNAS website during early 2004-05 and will continually be updated
to capture new and revised NICNAS regulatory requirements.

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Strategic Alliance

In response to the growing concerns about children’s cosmetics, NICNAS
held discussions with the ACCC about conducting random surveys of retail
outlets. Consequently, the ACCC withdrew 32 children’s products from sale
during 2003-04. NICNAS continues to liaise with ACCC on matters
concerning cosmetic product safety.

The States and Territories are seen as key stakeholders for NICNAS
compliance operations. While matters relating to the control of industrial
chemicals are the responsibility of the States and Territories, it is through the
MOU that NICNAS works closely to help ensure that there is an effective
interface of these responsibilities. During 2003-04, the MOU Members were
consulted on the development of NICNAS inspection tools.

The effectiveness and efficiency of the MOU agreement was reviewed,
in particular with respect to exchange of information on certain matters.
As such, arrangements will be put in place to facilitate disclosure of certain
exempt information under agreed national guidelines with the States
and Territories.

Improved barrier control of imports is achieved through strategic alliance
with the Australian Customs Service. During 2003-04, NICNAS continued to
strengthen its ties with the Australian Customs Service. Annual import data
for 2002-03 were provided to NICNAS for the purposes of enforcement and
monitoring compliance with registration requirements. Also, mechanisms to
disseminate targeted information to Customs Brokers and importers through
Australian Customs Notices and new alert messages mounted on import
entries are being discussed to be in place for 2004-05.

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Compliance Case Management

NICNAS manages compliance cases from instigation to resolution or
prosecution, and undertakes audits and inspections to ascertain compliance
with the Act.

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  A summary of all compliance cases involving breaches related to industrial
chemicals (referred to as chemical cases) for 2003-04 is shown in Table 13.
A total of 32 cases involving breaches related to new and existing industrial
chemicals were resolved for the year 2003-04, compared with 26 cases for
2002-03. Only three cases were active as at the end of 2003-04: of these,
two cases related to the introduction of two new industrial chemicals by the
same company, while the remaining case was about secondary notification
of an existing assessed chemical.

In 2003-04, three existing chemicals cases were received. One case
involved a priority existing chemical and the other was about lack
of response to a Section 48 call for information.

Completed cases were resolved using informal enforcement actions through
working with industry to achieve compliance. NICNAS’s conciliatory style
and approach to enforcement is effective in resolving most of the generated

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Industry profiles

The 32 cases investigated in 2003-04 were from a broad range of industries,
as indicated in Figure 14. Of the 13 industries represented by companies
investigated, the chemical supply and distribution industry provided
the greatest number of cases (25 per cent).



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Sources of cases

NICNAS generates casework from self-reported breaches, in-house through
audits, from inspections or internal checks, and from third party allegations
from the public, industry or government agencies. Figure 15 shows four-year
trend data for sources of case types.

All third party allegations are examined to determine whether a breach
has occurred. This year, NICNAS received eight third party allegations:
two from industry associations and the rest from industry. Only four
out of the eight allegations were found to be potentially in breach of the
legislation, with no further action taken on the remaining four because
of lack of adequate information on the alleged offence.

Of the 23 compliance cases received in 2003-04, nine per cent (two cases)
were detected in-house through audits and internal checks, 74 per cent (17
cases) were self-reported and 17 per cent were reported through third party
allegations (four cases).

The percentage of internally generated, third party allegations, and selfreported
compliance cases were similar to those of the previous year,
reflecting the ongoing cooperative approach used when dealing with selfreported
cases. The high proportion of self-reported cases in 2003-04 (74 per
cent) and the year before (71 per cent) indicates the success of NICNAS’
approach to compliance enforcement. Figure 16 shows the trend
in compliance cases by category since the introduction of the compliance
program in 1998-99.

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Of the 35 cases investigated during 2003-04 (ie, those cases opened during
the year and those carried over from the previous year), 32 (91.5 per cent)
were resolved. Thirty new chemicals cases were finalised out of a total of
32 (94 per cent). Thirty out of the 32 resolved cases were completed within
100 days (94 per cent). The integration of the compliance function with New
Chemicals assessments and NICNAS’s approach of timely follow-up and
prompt assistance to industry yielded good outcomes with 20 notifications
submitted within agreed time frames. Two of the notifications (Standard
and LVC Category) were generated as a result of NICNAS inspections during
2003-04. Figure 17 shows the percentage of cases resolved within the
target timeframe of 100 days, plus those which took longer than 100 days
to resolve.


The 23 cases generated during this year involved 20 companies
contravening the Act. The outcomes of the investigations involving industrial
chemicals are shown in Table 14.

In the majority of cases (62 per cent), the investigation resulted
in the lodgement of a new chemicals notification by the offending company.
In 19 per cent of cases, companies were able to demonstrate compliance by
providing requested documentation to NICNAS. A small percentage of cases
were either found through the course of the investigation to be compliant
(three per cent), or the case was written-off due to lack of substantiation
of claimed breaches of the Act.

The distribution of new chemicals assessments between the notification
categories arising from compliance actions is shown in Figure 18. During
2003-04, the NICNAS approach for managing self-reported breaches and
applying discretion when permitting introduction of a new chemical, was
strengthened by requiring the importer and/or manufacturer to undertake
an agreement to meet the notification timeframes.

Importantly, while undertaking compliance agreements with NICNAS, these
companies did not encounter disruption to their import or manufacturing
schedules and hence maintained their supply commitments. This was
possible as each case is evaluated for health, safety, and environmental risks
posed by the breach. In all 20 cases, the risk was judged to be low provided
full compliance with NICNAS compliance agreements was met.

Non-compliance with a NICNAS agreement is considered a serious breach
and can lead to an escalation of enforcement actions to prosecution.

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NICNAS Regisrations

  NICNAS Registration audits are a routine function of NICNAS’s cost recovery
mechanism using import data based on the previous registration year
(1 August 2002 to 31 September 2003) supplied by the Australian Customs
Service under a MOU. A summary of NICNAS registration casework
is provided in Table 15.


  In total, 107 cases were resolved involving companies identified as potential
new registrants based on 2002-03 Customs data (New Registration Cases)
and companies failing to renew their 2003-04 NICNAS registration
(Registration Renewal Cases).

New Registrations

In 2003-04, a review of import data for 2002-03 produced a total of 525
companies identified for pre-screening; in turn, this produced a list of 228
companies which might be liable for company registration requirements.
Further investigation showed that 105 of these companies were highly likely
to be registrable. When these companies were informed of their possible
NICNAS registration obligations, 65 new introducers were added to the
register and 24 were found to be non-registrable. The industry profile of the
65 new introducers is shown in Figure 19. Eleven identified companies were
written-off due to lack of adequate information to proceed with the
investigation. Five potential new registrations were outstanding at the end
of 2003-04, with four of those cases near completion as they were granted
a deadline extension for payment of registration fees.

The number of new registration cases continued to increase,
as demonstrated by Figure 20, with the number of cases received during
the year 11 per cent greater than in the previous year. Figure 20 shows
trends in the number of new company registration cases.

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Nineteen registrants were referred to compliance for failing to renew their
2003-04 registration by 31August 2003. Some of these companies paid their
registration fees and charges but not the late penalty fees. Most cases were
resolved via administration letters and follow up. The remaining two cases
were near completion at the end of the reporting period.

One registration case involved a repeated offender who showed lack
of willingness to comply. This case involved a company which had failed to
register for the past three registration years. In establishing evidence for the
case, NICNAS liaised with Customs and the Australian Government Solicitor.
A range of enforcement actions included warning letters, site visits and use
of the Director’s powers to require information. Before 30 June the company
registered retrospectively for each outstanding year, as well as for 2003-04.



  One hundred and seven registration cases were finalised out of 114 (94 per
cent) during the year. Six of the seven remaining cases were nearly resolved
by the end of the year with potential registrants committed to compliance
and their outstanding fees. Except for one case (carried over from 2003-04),
all resolved cases involving NICNAS registrations were finalised within 100
days and met the internal target of 95 per cent.


  The outcomes of the NICNAS registration investigations for 2003-04 are
shown in Figure 21. A total of 72 per cent of investigations resulted in either
a new registration (57 per cent) or a renewed registration (15 per cent).
Twenty-two percent of investigated companies did not require registration.

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No prosecutions or penalties were applied by NICNAS in 2003-04. In
accordance with prosecution guidelines developed by the Director of Public
Prosecutions (DPP), an enforcement policy defining the circumstances
in which NICNAS refers certain matters to the DPP was drafted and will
be finalised during 2004-05 for publication on the NICNAS website.

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Monitoring Compliance

The 2003-04 compliance program focused on CEC and LVC permits, and LTD
certificates. The purpose of the audit program is to monitor compliance
with permit conditions and secondary notification requirements. Phase I
of the audits involved identification of notifiers to be surveyed. Using a risk
assessment approach, Phase II entailed screening and assessing
the responses for selection of a targeted list of inspections.

During the year, 69 LVC and CEC permits and 11 Limited Notification (LTD)
certificates were audited, involving 38 different companies across a range
of industries. Uses included cosmetics, fuel additives, paints, and printing ink
cartridges and toners.

Inspected companies were contacted before inspection and received
concise guidance on how to comply with the permit and secondary
notification requirements.

Compliance Inspectors completed nine inspections in Sydney
and Melbourne in accordance with the NICNAS Inspectors’ Manual.
These inspections covered ten different permit/certificates and a number
of different outcomes were recorded. These are detailed in Table 16.
Five permit/certificate holders were found to be fully compliant with their
obligations under the Act, while another two were found to have committed
minor breaches which were considered oversights and were quickly rectified
by the company. The inspections did, however, result in the lodgement
of two notifications and one new company registration.

Companies found to be in compliance with their obligations under the Act
were issued with a final inspection report soon after inspection.
Where a breach was identified, the company was issued a compliance
notice outlining the actions required, and the timeframe to correct identified
deficiencies. Once all issues were resolved, the final inspection report
was issued.

In general, all companies showed full cooperation with NICNAS Inspectors
and in most cases demonstrated that they have adequate compliance
systems to monitor introduction volumes and durations of permits/
certificates. The securing of an ongoing yearly registration from one
company and the submission of a Standard Notification and LVC Permit
notification, as well as the resolution of other minor breaches, demonstrates
the importance of the audit program.

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Education and raising awareness activities

Industry Training

The Compliance team took part in a range of training activities in 2003-04.
A half-day seminar delivered to 20 companies in Perth in September
enhanced understanding of the scheme.

A one-day workshop, divided into two sessions, was delivered in Sydney
in April and Melbourne in May. Session One focussed on raising awareness
of the scheme and reform activities, while Session Two concentrated
on using the New Chemicals Template. More training seminars are planned
for 2004-05.

In response to an increasing number of enquiries about the status of toners
and inks in relation to the NICNAS registration program, a fact sheet on
obligations and responsibilities was prepared for the toner and ink industry
sector. Special notices were published in NICNAS Matters and the Customs
Brokers and Forwarders Council of Australia Bulletin. In addition, a seminar
was delivered to the Consumer Electronic Suppliers Associations targeting
the toner and ink industry.

Outreach Program

As part of the Compliance Team’s Education and Promotion strategy, five
outreach visits to first-time registrants took place during the year. Invitations
were sent to 23 companies which had registered with NICNAS for the first
time in 2003-04. These visits were well received by recipients. Among the
issues discussed were:

• Procedures for determining if a chemical is listed in AICS
• Proposed changes to the current legislation
• Notification requirements
• Registration levels

In summary, NICNAS site visits were associated with inspections (nine),
outreach (five), compliance visits (four) and enforcement issues (two).
NICNAS will undertake more outreach visits, as required, throughout 2004-05.


  Although it is difficult to quantify, the NICNAS compliance program should
result in significant cost savings to industry. In general, compliance is an
integral part of a company’s overall corporate goals and contributes to building
and maintaining a company’s status as a good corporate citizen.
The benefits of compliance are many and can include:
• avoidance of personal liability relating to breaches of occupational health and
   safety requirements;
• the potential benefits flowing from a good corporate image;
• avoidance of damage to a corporate image or brand if the company is in
   breach of compliance obligations, particularly if the breach is related to a
   significant adverse event; and,
• savings in legal and related costs flowing from failure to exercise due
   diligence and from avoidance of potential significant adverse events.

NICNAS compliance cases have resulted in 65 new registrations and 17
registration renewals resulting in $103,515 as additional revenue to NICNAS,
and 20 new chemicals notifications resulting in $156,000 in assessment fees
paid by industry (as opposed to potential fines of $16.5 million).

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Australian Inventory of Chemical Substances

As in previous years, most searches were for less than ten chemicals per
inquiry, some 91 per cent in 2003-04 (462 out of 507). The remainder included
24 enquiries for 11-20 chemicals, 19 for 21-50 chemicals and two for more
than 50 chemicals. Most of the larger inquiries related to cosmetic ingredients.
The three-year trend data for searches per inquiry are shown in Table 17.

The AICS CD-ROM 2003 was the last CD ROM to be released, with none
planned for the future.



  A summary of targets and performance for AICS searching is provided in
Table 18. The time required to complete an AICS search varies considerably
depending on the level of information provided for the search and the
complexity of the chemical structure.



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