Harmonisation Activities

HARMONISATION ACTIVITIES

Quantity

OECD New Chemicals Task Force

NICNAS aims to reduce the regulatory burden on both industry and
government through work sharing activities, leading to gains in efficiency,
effectiveness and consistency with other national schemes. Work in
2004-05 focussed on developing the Parallel Process and Equivalence
Framework, key concepts which arose out of a suggestion from NICNAS
emphasising the achievability of significant work sharing opportunities.

The Parallel Process primarily focuses on sharing hazard assessments using
the Australian experience as a model. NICNAS attended a meeting of the
OECD Steering Group formed to pilot the Parallel Process in Tokyo in March
2005 where procedures for the pilot phase were developed. Four chemicals
are being assessed under the work sharing arrangements and NICNAS will
prepare initial assessments for one of the chemicals in 2005-06.

International Existing Chemicals

NICNAS participates in two international programs related to the safety
assessment and risk management of existing chemicals. These are the
International Programme on Chemical Safety (IPCS) Concise International
Chemical Assessment Document (CICAD) activity, and the OECD's
Screening Information Data Set (SIDS) Program. A description of these
programs is provided at Appendix 08.

One IPCS and two OECD SIDS meetings were attended by NICNAS during
2004-05. The number of chemical assessments presented at these forums,
and the number approved following peer review of the assessments by
member countries are shown in Table 13 along with four-year trend data.

Table 13 Four-year trend data for participation in international assessment activities for the Existing Chemical Program
		2001-02	2002-03	2003-04	2004-05
	Number of international assessment meetings attended	3	2	2	3
	Number of international assessments discussed at meetings	75	85	139	106
	Number of international assessments reviewed by NICNAS prior to the meetings	45	44	61	59
	Number of international assessments agreed at the meetings	72	75	124	102

NICNAS supports the use of these internationally agreed assessment
reports in national assessment programs and provides links to the reports
via the NICNAS website.

Top of Page

NICNAS continued to play an active part in the ongoing cooperation
on perfluorinated chemicals such as perfluorooctane sulfonate (PFOS),
perfluoroalkyl sulfonate (PFAS), perfluorooctanoic acid (PFOA) and their
related chemical substances being undertaken by the OECD, this year.
Results of a questionnaire of OECD countries on the production and use
of these chemicals conducted by Australia on behalf of the OECD were
presented to the November 2004 Joint Meeting of the Chemicals
Committee and the Working Party on Chemicals, Pesticides and
Biotechnology.

To assist countries reporting in the next round of data collection, Australia
also undertook to prepare comprehensive consolidated lists of PFOS, PFAS,
PFOA and their related fluorinated chemicals. These lists were presented at
the June 2005 Joint Meeting. The compilation of these lists was a complex
task and OECD countries were highly complimentary of the work done
by Australia

NICNAS commenced active consideration of nanomaterials and their
regulation this year, and is a member of the OECD Steering Group for
Nanotechnology. Australia made a joint presentation with Canada on issues
being faced in the regulation of these materials to a Special Session on the
Potential Implications of Manufactured Nanomaterials for the June 2005
OECD Joint Meeting of the Chemicals Committee and the Working Party
on Chemicals, Pesticides and Biotechnology

Recognition of foreign schemes

NICNAS recognises chemical assessments conducted by other OECD
countries and rebates of up to 40 per cent are available when foreign
scheme assessment reports are provided. Most of these reports are from
Canada, due to the Australia-Canada Bilateral Arrangement signed by both
countries in 2002. The Arrangement, under which a free Early Introduction
Permit (EIP) is also available for PLCs, is currently being renewed.
Eleven applications under the Arrangement have been received this year,
including two applications for a free EIP. In addition, four notifications
based on previous assessments in the European Union were received.

In 2004-05, the 15 applications under the foreign scheme provisions
resulted in potential savings up to $78,000. Since 2000-01, a total of up
to $230,000 was returned to industry as reduction in assessment fees for
applications made under the foreign scheme arrangements.

Through cooperative work in the OECD, NICNAS is progressing the
development of a similar bilateral arrangement with the US Environmental
Protection Agency (EPA). NICNAS also held preliminary discussions with the
Japanese Government and industry in March 2005, with a view to
developing similar cooperative arrangements.

Top of Page

Efficiency

Cooperative international activity on existing chemical assessment helps
to avoid duplication of effort between countries in testing chemicals for the
fulfilment of various national and regional requirements and international
commitments. Where they are available, and as part of standard good
practice, international assessments are consulted and utilised when they
are relevant to NICNAS's chemical assessments.

Participation in international assessment programs improves the
effectiveness of our assessments by ensuring that they are of world
standard, incorporating the latest scientific knowledge and developments
in assessment methodology.