This year NICNAS has successfully implemented a raft of important
reforms to the regulation of industrial chemicals which have led
to significant benefits including reduced regulatory ‘red-tape’ and costs,
better stakeholder engagement and enhanced confidence that best
regulatory practice is in place. These achievements complement
the significant performance achievement we delivered in virtually all
the operational areas within NICNAS.

However our high performance would not have been possible if it were not
for the professional and committed staff at NICNAS and the contribution of
our many partner agencies, stakeholders and individuals who worked with
us. I greatly appreciate their input, their support, and their willingness to
assist us in our regulatory and reform work.

As part of our innovative Low Regulatory Concern Chemicals (LRCC)
reform agenda, we fully implemented some 73 per cent of the key
recommendations for regulatory reform initiatives. Importantly this saw the
registration of all persons who introduce industrial chemicals into Australia,
lifting the number of registered companies from previous years to 4505
(a 477 per cent increase). The introduction of a new Tier 1 NICNAS
Registration was a considerable undertaking, involving NICNAS contacting
a potential 16,000 persons who may import and/or manufacture industrial
chemicals for commercial purposes. It is a testament to our open
consultative processes and administrative efficiency that we achieved such
high compliance levels and managed to respond quickly and effectively to
nearly 9000 client enquiries on the matter. In addition we received very few
(0.3 per cent of all people contacted) complaints about the regulatory costs.
We also moved closer to achieving complete self-assessment by

introducers in those categories identified as being of low regulatory concern.
In particular the introduction of audited self-assessment for polymers of
low concern and non-hazardous chemicals saw an impressive take up by
industry heralding the more rapid introduction of safer chemicals with less
cost and time for industry. Importantly, all audits of our self-assessment
applications found industry to be in full compliance with the legislative
requirements. This builds further confidence that we can successfully
apply other LRCC reform concepts such as low hazard and low risk into
the scheme next year.

As part of the LRCC reform initiative we also introduced enhancements to
the cooperative frameworks that are needed for the safe use of chemicals
in Australia. Importantly, based on expert advice from our Community
Engagement Forum, we developed the NICNAS Community Engagement
Charter which outlines the policy and protocols that NICNAS commits to
following when engaging all stakeholders.

The Charter is a first for a chemical regulatory agency in Australia and will
effectively guide NICNAS stakeholder engagement activities and provide
a consistent and open framework to deliver our commitment to community
right to know principles. The Charter was implemented in draft form to
guide the review of the existing chemicals assessment program at NICNAS.
This year we increasingly operated in wider cooperation with other
agencies, as part of our commitment to a whole-of-government approach
to industrial chemicals regulatory matters. With NICNAS being located in
the Office of Chemical Safety within the Department of Health and Ageing,
we have cooperated to deliver a ‘one-stop shop’ for the human health
assessment and management of chemical safety in Australia. This year
we have worked with the various areas of the Office of Chemical Safety
to improve human health risk assessments and provide toxicological advice
to other regulatory authorities on public health issues relating to a the broad
range of industrial chemicals.

In particular, together we provided technical policy advice on national and
international chemicals negotiations and treaties. When the Rotterdam
Convention came into force for Australia on 18 August 2004, NICNAS
implemented new regulations and established an export control system
for Australian industry trading in industrial chemicals listed within the
Rotterdam Convention. This guarantees Australia continues to meet
its chemical safety commitments internationally and supports industry
in its compliance obligations.

In this as in all our work, the protection of human health and the
environment from potential harm from industrial chemicals – and the
commitment to contribute to the environmentally sound use of such
substances – has been foremost.

Important emerging issues, including security aspects of chemicals and
how best to assess the safety of nanotechnology, provided challenges
in determining best regulatory control practices which still encourage
innovation and legitimate use while protecting all Australians.

I am pleased that we had the opportunity to participate as an equal, credible
contributor to dialogue on these and other issues working on a whole-of-government
level. It is through such processes that best regulatory policy
and practice can be achieved.

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Future Directions

  The coming year will present a number of new challenges that we will meet
with a growing team of expert staff and the strong networks we have built
with other agencies and departments across government, industry and the
wider community. Our focus during 2005-06 will continue to be to build
better outcomes through enhanced engagement.

NICNAS will continue to deliver its reform agenda in 2005-06 including
finalising LRCC implementation, completing and implementing the
recommendations relating to improvements in our existing chemicals
assessment activities and enhancing our bilateral relationships with
Canada and the USA.

The reform initiative for all chemical importers and/or manufacturers to
register with NICNAS has, for the first time, enabled all legitimate players
in the Australian chemical industry to be identified. This is expected to
provide essential information as well as potential control mechanisms
for the Government’s counter terrorism activities.

In addition, NICNAS’s information gathering and dissemination role will be
utilised as part of ensuring a whole-of-government approach to the control
and monitoring of chemicals that are precursors for illegal drug manufacture.
This will provide intelligence for law enforcement agencies and a potential
national access control mechanism.

Key activities will include:
• Implementation of the remaining 27 per cent of recommendations
arising from the Low Regulatory Concern Chemicals initiative
• Finalisation and implementation of the recommendations of the
Existing Chemicals Review
• Design and building of a tracking system for precursor chemicals that
have the potential to be diverted for the manufacture of illicit drugs
under contract for the Attorney General’s Department
• Completion of a compendium of hazard profiles and rapid risk
assessments for some 25 phthalates of concern
• Implementation of online facility/functionality for NICNAS Registration
• Implementation of online facility/functionality for NICNAS Annual
• Enhancement of availability of Compliance systems training for
Tier 1 registrants
• Dissemination of the NICNAS Community Engagement Charter
and Community Engagement Forum resources
• Launch of an updated, streamlined new NICNAS website

In July 2005, NICNAS will celebrate its fifteenth year of operation.

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Key Achievements 2004-05


  • Timeframe targets for issuing certificate assessments and permits
    - 200 assessment certificates completed, 98 per cent within
      timeframe (target: 95 per cent)
    - 106 permits completed, 100 per cent within timeframe
      (target: 95 per cent)
• No appeals
• NICNAS’s recommendations for 196 of 200 (98 per cent) New
   Chemicals assessments (target 95 per cent) accepted in full by industry
• 100 per cent of NICNAS’s recommendations for hazard
   classification accepted by ASCC
• Eight chemicals declared for priority review
• Draft risk assessment reports published to time, quality and to target:
    - Two Priority Existing Chemicals (formaldehyde and tris 2,3
      dibromopropyl phosphate)
    - One Secondary Notification Assessment (Polymer in E 7581)
• 40 other assessments completed (target: 10) including:
    - Hazard assessments on 25 phthalates
    - Information sheets (Options for Disposal of Perfluorooctane Sulfonate
        – PFOS, Short-Chain Chlorinated Paraffins in Metal Working Fluids,
           Current Australian Use and Regulatory Activities on Polybrominated
           Flame Retardants)
    - One update and one alert (Perfluorooctanoic Acid and its Derivatives)
    - Five public health assessments for poison scheduling
• 59 international chemical assessments peer reviewed and
  102 assessments agreed to, as part contribution to international
  harmonisation commitment


• Key regulatory reform initiatives implemented:
    - 73 per cent of LRCC recommendations implemented
    - Full implementation of Tier 1
    - New exemptions, Self-assessment provisions and AICS annotation
    - Auditing, annual reporting
• Existing Chemicals Program Review recommenced
• OECD New Chemicals Task Force pilot phase for the Parallel Process
   begins NICNAS ANNUAL REPORT 2004-05 21


• Rotterdam Convention and Stockholm Convention came into force for
   Australia on 18 August 2004 Compliance
• No appeals lodged against any decisions of the Director, NICNAS
• 22 finalised investigations of breaches relating to the introduction
   of industrial chemicals
• 251 finalised investigations relating to breaches of Registration
• NICNAS enforcement policy guidance published
• Tier 1 registrants, customs brokers and industry training
• Establishing a Case for Confidential Listing of Chemicals on the
   Australian Inventory of Chemical Substances guidelines finalised
• Publications released included:
    - 3 NICNAS Matters
    - 13 Chemical Gazettes
    - 234 Chemical assessments
    - 6 Information sheets/alerts
• 594,614 user sessions hosted on NICNAS website (compared
   to 445,619 in 2003-04 – an increase of 34 per cent)
• Service Charter performance targets achieved, with high industry
   client satisfaction


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