Assessment (New Chemicals)

ASSESSMENT

Existing Chemicals

Quantity

NICNAS undertakes assessments of chemicals already in use in Australia
under the Existing Chemicals program. Appendix 08 details the types
of assessments undertaken in the program.

During 2004-05, full risk assessments for two chemicals under review
as Priority Existing Chemicals (PECs) and one chemical being assessed
under the provisions for secondary notification, were completed to public
consultation stage. In addition to the three full risk assessments, hazard
assessments for 25 phthalate chemicals were completed. The phthalates
were assessed as a result of concerns raised overseas and in Australia
regarding potential health effects from their use as plastic softeners in
consumer products such as cosmetics and children's toys. In 2005-06,
these assessments will be utilised to compile a comparative hazard
compendium of important toxicological endpoints.

Also completed in 2005-05 were four Information Sheets, one NICNAS alert,
two screening assessments, six assessments examining poisons
scheduling, and one health effects assessment. These are detailed in
Table 9, and at Appendix 11.

Table 9 List of Existing Chemical assessments in final consultation phase, published, or otherwise completed by NICNAS in 2004-05
	Priority Existing Chemicals
	Formaldehyde Tris(2,3-dibromopropyl) phosphate Secondary notification of Polymer in E7581 (NA/752)
	Information Sheets
	Options for Disposal of Perfluorooctane Sulfonate (PFOS) Short-Chain Chlorinated Paraffins in Metal Working Fluids Current Activities on Polybrominated Flame Retardants (PFBRs) Current Australian Use and Regulatory Activities on Polybrominated Flame Retardants
	NICNAS Alerts
	Perfluorooctanoic Acid and its Derivatives
	Hazadous assessments
	25 phthalates* Perfluoroalkyl sulfonate
	Screening assessments
	Polyvinyl acetate Iron Carbonyl
	Poisons scheduling
	Six chemical assessment submissions to the NDPSC
	Health effects assessments
	One chemical assessment for the TGA
	* The names of the 25 phthalates are given at Appendix 11.

A target of three full assessments and ten other assessments was set
for 2004-05 to maintain an output target of 50 chemicals assessed over
a three-year period. This target was met in the case of PECs and exceeded
(by 400 per cent) in the case of other assessments. A list of chemicals that
had agreed international assessments is provided at Appendix 13.

Assessment outputs for 2004-05 are summarised in Table 10 compared
with last year's activities, and presented over a five-year period in Figure 12.

Table 10 Output data for the Existing Chemical assessment types for 2003-04 and 2004-05
		2002-03	2003-04
	Chemicals under assessment	37	46
	PECs declared for assessment (includes secondary notifications)	0	8
	Screening/other assessments commenced	25	39
	Assessment modules completed (PEC & Screening/Other)	63	80
	Assessments completed (PEC & Screening/Other)	33	43
	Chemicals subject to post-assessment activity	11	4

Figure 10 Five-year trend data of Existing Chemical assessment outputs (Click
to enlarge)

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Timeliness

We have statutory timelines for PEC and secondary notification
assessments. These include legislated deadlines mandated by the Act
for applicant and public comment on draft reports, the Director's response
to requests for variations to the draft report and for completion
of an assessment. These timelines were all met in 2004-05.

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Effectiveness

Strong partnerships with other government agencies involved with the
protection of public health and safety through assessment and management
of chemicals have continued to help the effectiveness of NICNAS.
Examples of projects undertaken this year involving collaboration with other
government regulatory agencies are detailed below.

Review

Reviews by NICNAS of five industry submissions to the National Drugs
and Poisons Schedule Committee (NDPSC) on cosmetic ingredients and
one industry submission on a non-cosmetic chemical in regard to SUSDP
scheduling, resulted in recommendations by NICNAS for consideration
at three NDPSC meetings. These reviews covered a range of issues related
to hazard and risks associated with specific uses of the chemicals. NICNAS
also provided an update on a NICNAS preliminary review of chemicals
in hair dyes at a NDPSC meeting.

Regulation

Regulatory activities related to polybrominated flame retardants (PBFRs)
and phthalates, in an environment of increasing international concern over
their wide usage and potential harmful effects. In 2001 NICNAS undertook
a preliminary PBFR assessment and in 2004-05 conducted a survey of
industry to update the 2001 collected data to help assess the need for
further regulatory action. As a result, three PBFRs were declared PECs
for full risk assessment in August 2004, and two information sheets were
published in June 2005 to inform industry and the public of proposed
regulatory activities. The DEH has commissioned studies to research levels
of the chemicals in the Australian population, indoor air and in aquatic
sediments. The findings of these studies are expected in late 2005 and
will contribute to NICNAS risk assessments on these chemicals.

Studies by Food Standards Australia New Zealand (FSANZ) on levels
of polybrominated diphenylethers (PBDEs) in food, as part of the 22nd
Australian Total Diet Survey, will also assist NICNAS in determining the
dietary contribution of PBDEs. A committee comprising members of
NICNAS, the DEH, FSANZ and the Australian Government Department of
Industry, Tourism and Resources (DITR) provides a forum for communication
on issues related to PBFRs.

Provision of expertise

NICNAS provided expertise - on behalf of the DoHA - on an EPHC working
group established by the National Environment Protection Council, namely
the Tier 2 Air Toxics Group. It is scoping which ambient air pollutants should
be added to the existing Air Quality National Environment Protection
Measure (NEPM) by designing a methodology to rank the relative risks
associated with individual air pollutant chemicals. The Air Toxics Standard
Setting Group is investigating how best to set health standards for air
pollutant chemicals underlying NEPMs.

Technical advice

NICNAS provided technical advice to ASCC, to establish an exposure
standard for the refrigerant chemical 2,2-dichloro-1,1,1-trifluoroethane
(HCFC-123), and for the chemicals 2-butoxyethanol and 2-butoxyethanol
acetate.

In 2004-05, in addition to two Information Sheets published on the
NICNAS website on the subject of Australian regulatory activities in regard
to PBFRs, NICNAS issued an Information Sheet on Short Chain Chlorinated
Paraffins in Metal Working Fluids, which summarises methods to minimize
the environmental impact of metalworking fluids, in an easy-to-read format.

The Information Sheet was distributed directly to industry as well as
published on the website. Another Information Sheet on waste disposal
options for perfluorooctane sulfonate (PFOS) was published on the NICNAS
website in 2004-05 in response to public enquiries on the issue. An alert on
PFOA and its derivatives, summarizing Australian data, national and
international activities and providing advice on safe handling, was also
published on the website.

Precursor information

NICNAS was commissioned by the Attorney-General's Department (AGD)
during the year to work within the Act and under an MOU, to obtain and
collate information on the introduction volumes and uses of 38 precursor
chemicals. Working under the auspices of the National Working Group for
the Prevention of the Diversion of Precursor Chemicals, the project aimed
to explore the feasibility of monitoring the movement of - and build a central
repository of information about - industrial chemicals which are known to
be used in the manufacture of drug precursors. The project also aimed
to determine the nature and extent of industry application of the precursor
chemicals, thereby informing consideration of rescheduling or legislative
amendments restricting the availability of these chemicals. A steering
committee was established to identify stakeholders and issues and provide
advice during the project, and NICNAS also analysed all information gained
from industry, law enforcement and intelligence agencies and other
government authorities. A report on the findings will be presented to the
Australian Crime Commission (ACC) and AGD by 31 August 2005. It has
been agreed that NICNAS will undertake further work on precursor
chemicals.

Uptake of recommendations

PEC reports make recommendations for the elimination or reduction
of hazards and risks associated with chemical use. The number of
recommendations made in PEC reports published to June 2005 is given
in Table 11.

NICNAS has continued to actively work with ASCC on the take-up of
recommendations made to that agency and consulted with ASCC over
the fast-tracking of exposure standards for 2-Butoxyethanol, 1,4-Dioxane,
Trichloroethylene, Ortho-Dichlorobenzene, Ammonium Persulfate,
Potassium Persulfate, and Sodium Persulfate in 2004-05. It is expected
that these new exposure standards will be declared in late 2005.

Table 11 Number of recommendations in PEC reports by target area to June 2005

An additional 35 recommendations were made in the other assessments
completed in 2004-05. Target areas of the recommendations are shown
in Table 12.

Table 12 Target areas of recommendations
TARGET AREA		OHS	PUBLIC HEALTH	ENVIRONMENT
	Peak bodies	26	5	0
	State and territory authorities			0
	Industry	3		1
	Total	29	5	1
	Percentage of total recommendations	83%	14%	3%

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Price

The 43 assessments completed this year represent a 30 per cent increase
over the number conducted in 2003-04 and a 400 per cent increase from
the number required for performance targets to be achieved.