Assessment (New Chemicals)

ASSESSMENT

An overview summary of key outputs against resources for each main
output category is shown at Table 5.

New Chemicals

Detailed statistics of new chemicals assessment activity are provided
at Appendix 09.

Quantity

In 2004-05, a total of 318 notifications were received and accepted,
comprising 213 applications for certificates and 105 for permits,
representing an increase of two percent and a decrease of 43 per cent,
respectively, from 2003-04.

NICNAS issued 200 assessment certificates and published assessment
reports for each chemical, an increase of 11 per cent from the previous year
and 60 per cent from 2002-03. A total of 106 new chemical permits were
issued, a decrease of 35 per cent from the previous year.

Trend analysis of assessments completed over the past 12 years is
provided in Figure 5. The data demonstrate a sudden increase in completed
certificate assessments and a decline in permit assessments reflecting the
significant drop in permit applications in 2004-05.

Figure 5 Trend analysis for completed certificate and permit applications
(Click to Enlarge)

A cyclical fluctuation has been observed with certificate applications,
reflecting general business environments over the past decade. To a certain
extent this is also the case for permits, with a trend to lower overall
numbers from 1999 onwards. NICNAS covers a wide variety of industries
that manufacture and import industrial chemicals and the fluctuations cannot
be linked to any particular industry sector. The fall in permits in 2004-05
is due mainly to a fall in Low Volume Chemical (LVC) applications, given the
change in the level for which exemption from notification can be applied
for (from 10 kg to 100 kg per annum) for chemicals which do not pose
an unreasonable risk to health or the environment.

The high level of Standard (STD) notifications received in 2003-04 was
maintained this year with a slight decrease in Limited (LTD) notifications,
and a slight increase in Polymer of Low Concern (PLC) notifications. The
number of Extension of Assessment certificates (EXT) was almost double
that of 2003-04 but still remains an option under-utilised by industry. The
reduction in the number of Commercial Evaluation Category (CEC) permits
issued in 2003-04 compared to 2002-03 reversed somewhat in 2004-05.

A summary of applications for each notification category in terms of
the number of certificates or permits received over a four-year period
is illustrated in Figure 6 below.

Figure 6 Four-year trend data for New Chemicals assessments
by category - certificates/permits received. (Click to enlarge)

Forty-nine Early Introduction Permits (EIP) were issued in 2004-05,
a reduction from 60 issued the previous year. These account for 25 per cent
of the certificate notifications received (excluding extensions). This type of
permit enables chemicals that are not hazardous substances or dangerous
goods, and which meet certain environmental criteria, to be introduced and
used while the assessment is being undertaken by NICNAS.

The issue of EIPs facilitated the introduction of 'safer' chemicals whose
entry into the marketplace would otherwise have been delayed until
completion of the full assessment.

Five-year trend data for industry utilisation of EIPs are shown in Figure 7 and
demonstrate a sustained trend of about one third of certificate assessments
preceded by an EIP up to 2004-05 where the ratio was approximately one
in eight. However there is a remarkable increase in the number of new
chemicals notified as PLCs indicating that there has been an increase in the
level of safer technology, most likely encouraged by the incentives under
the self-assessment system.

Figure 7 Trend analysis of assessment certificates preceded by EIP
(Click to enlarge)

Two applications for secondary notifications were received during 2004-05.

The changes introduced to the Act with respect to new chemicals imported
and/or manufactured under the non-cosmetic and cosmetic exemption
provisions have offered more flexibility to industry with the volume
of introduction increased to 100 kg per annum.

However introduction of these chemicals may not pose an unreasonable
risk to health or the environment. Fifty-one introducers of new chemicals
under the non-cosmetic exemption chose to submit a notification advice
during 2004-05, and 104 cosmetic exemption notifications were received
during the year, compared to 396 for 2003-04 and 388 for 2002-03. This
change reflects the fact that increased volumes for exemption categories
were introduced under LRCC. The full scale of industry's utilisation of the
new LRCC exemption categories will be measured through the annual
reporting to be introduced on 28 September 2005.

The number of assessment certificates issued (either STD, LTD or PLC
categories) since 2002-03 is represented under various industrial use
categories in Table 6. As reflected in the three-year trend data shown in the
Table, surface coatings and printing/photocopying maintained a high level
of notifications. Chemicals used in cosmetics, fuel and oil and photographic
chemicals were strong contributors to the use pattern of newly notified
chemicals.

Table 6 NICNAS financial accrual overview 2004-05
USE CATEGORY		2002-03	2003-04	2004-05
	Adhesives	7	5	5
	Building/Construction	4	1	1
	Cosmetics	25	29	25
	Domestic Use	4	6	9
	Electrical	0	0	0
	Explosives	0	0	0
	Fuel and oil	11	13	17
	Leather processing	2	0	0
	Mining	0	0	2
	Packaging	4	0	0
	Paper and pulp	2	1	2
	Photographic	0	0	18
	Plastics	10	15	11
	Printing/Photocopying	20	37	39
	Refrigeration	0	0	1
	Surface Coatings	35	56	39
	Textile processing	1	3	5
	Water treatment	3	4	0
	Other	7	19	6

In 2004-05 NICNAS considered 10 applications for listing on the
confidential section of the Australian Inventory of Chemical Substances
(AICS), a decrease of 33.3 per cent from the previous year. In considering
the case for confidential listing, the Director must weigh the commercial
interest against the public interest. NICNAS has a small group of technical
experts, the Technical Advisory Group, to provide advice in this process
(see Appendix 10).

The Director granted confidential listing for seven chemicals. There are
three pending applications. The three-year trend in outcomes for confidential
listing applications is shown in Figure 8.

Figure 8 Three-year trend data: Outcome of decisions for confidential listing on AICS (Click to enlarge)

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Timeliness

New chemical assessment output performance against target timeframes
is detailed at Appendix 09. Ninety-eight per cent of total certificate
assessment reports (164) were provided to notifiers within statutory
timeframes (90 days), above the agreed target of 95 per cent. Figure 9
shows the trend data for timeliness for assessment certificates (90 days)
over three years.

Figure 9 Three-year trend analysis of timeliness (per cent of timeframes met) for certificate categories over three years (Click to enlarge)

An analysis of the four assessment reports which did not meet the
performance standard revealed that all were completed within 92 days.
Complex classification issues delayed two, one was delayed due to
late input by the notifier on the final report and one as a result of time
management issues. DEH performance for environmental assessments
is summarised at Appendices 11 and 12.

The timeframe performances for permits exceeded the 95 per cent target
with 100 per cent of permits being issued within the agreed statutory and
non-statutory timeframes. Figure 10 shows the trend data for timeliness for
permits over a three-year period.

Figure 10 Three-year trend analysis of timeliness (per cent of timeframes met) for permit categories over three years (Click to enlarge)

Both NICNAS and industry have statutory responsibilities to publish
assessment reports. Applicants may vary the assessment report and
have a 14-day timeframe to lodge an application for variation, outlining the
reasons for change. Twelve applications for variations of the assessment
reports were received during the year, of which one was pending at 30 June
2005. All other variations were resolved satisfactorily between NICNAS
and the applicant, with no appeals made by notifiers.

Applicants may also provide written consent to publish the reports,
withdraw the application or simply allow the publication process to proceed.
If 28 days have elapsed since NICNAS provided the assessment reports
to the notifier and no response has been received, NICNAS can publish the
assessment reports. Industry performance over time against this timeframe
is shown in Figure 11.

Figure 11 Three-year trend data for percentage of companies responding
within timeframes from provision of report to written consent to publish
(calendar days) (Click to enlarge)

Approximately 67 per cent of notifiers responded within the 14-day
timeframe, a significant increase from the previous year. A further 18 per
cent responded prior to the 28-day deadline for publication, with less than
15 per cent not responding to NICNAS, triggering the publication process
to proceed after the 28-day deadline.

NICNAS issued 99 per cent of certificates within the 7-day statutory
timeframe. Three certificates did not meet this timeframe. Two certificates
were issued two days late, one due to agency delay. A third certificate was
late due to non-response from the notifier. No trend was determined on the
basis of the small number of late certificates.

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Efficiency

At the end of the 2004-05 financial year, the new chemical assessment
output was slightly less than input. NICNAS received 213 notifications in the
certificate categories and issued 200 certificates in 2004-05, a result due to
the increased number of certificate notifications in the latter part of the year.
For permits, 105 were received and 106 issued so input and output were
balanced. Table 7 details input and output for certificate and permit
categories for the past four years.

Table 7 Input and output data for certificate and permit categories for years 2001-02 to 2004-05
			2001-02	2002-03	2003-04	2004-05
	Certificates	Input Output	168 164	179 125	208 189	213 200
	Permits	Input Output	120 119	165 151	184 162	105 106

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Effectiveness

Chemical notifiers and/or their consultants met with NICNAS staff on 23
separate occasions during the year to take advantage of NICNAS's free
pre-notification consultancy service. Such consultations are part of our
ongoing commitment to improve the quality of applications, the relationship
between NICNAS and our clients, as well as optimising assessment
timeframes through the lodgement of more complete notifications.
NICNAS encourages notifiers to meet with staff at any time during the
assessment process to discuss issues arising. Numerous other
consultations were conducted by telephone or electronically.

Of the applications for certificates received in 2004-05, assessment
commenced on the day of receipt for approximately 29 per cent of
certificate notifications, reflecting either a complete data package or one
where only minor deficiencies were identified. NICNAS can only start the
assessment process once the application is basically complete. Of the
remaining applications, the clock was not activated on receipt of application
and/or the '90-day clock' was stopped part way through the assessment
process and re-started.

Flow through times, given in Table 8, indicate the EXT and LTD notification
categories to be most successful (with 50 and 43 per cent respectively) in
meeting data requirements, beginning on the date of receipt. CEC permit
and STD notification categories were the most deficient with only 15 and
nine per cent, respectively, commencing on the date of receipt. These data
will allow better-targeted training programs for industry in an effort to
improve quality of applications overall. During 2005-06 attention will be
focussed on streamlining screening activity.

Table 8 Clock start times for assessments - all categories in 2004-05
		NOT STARTED %	CLOCK STARTED ON DATE OF RECEIPT %	CLOCK STARTED UP TO 28 DAYS AFTER DATE OF RECEIPT %	CLOCK STARTED BETWEEN 28 AND 90 DAYS AFTER RECEIPT %	CLOCK STARTED MORE THAN 90 DAYS AFTER DATE OF RECEIPT %
	STD	17	29	8	23	23
	LTD	5	41	11	23	21
	PLC	26	17	18	26	14
	EXT	0	50	20	25	5
	CEC	12	16	44	28	0
	LVC	15	21	36	24	3
	EIP	33	34	26	7	0
	SN	100	0	0	0	0

The assessment of Material Safety Data Sheets (MSDS) for notified
chemicals and the products containing the chemical remain an important
part of the assessment process for all categories. In 2004-05 over 400
MSDS were assessed by NICNAS on behalf of the chemical industry
to ensure accurate and relevant information is available to workers,
consumers and the community. No new chemicals assessment decisions
were appealed in 2004-05.

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Price

A minimum of 155 chemicals was notified by industry under the low
volume exemptions in 2004-05. Before provisions for LVC exemptions
were introduced in 1999, these chemicals required notification prior to their
introduction. Estimates on the saving to industry in assessment fees in
2004-05, if priced as LVC permits, are approximately $400,000 (not including
the savings related to data generation or industry administration costs).

Overall, since introduction in 1997, the exemption (less than 10 kg) category
alone has provided access to some 1923 chemicals over seven years at
a minimum potential saving to industry of approximately $5.1 million.
Chemicals introduced for non-cosmetic use and for research and
development under the exemption category do not require notification
to NICNAS. The continued increase in PLC applications and, in particular,
self-assessments, reflects the expansion in introduction of low hazard and
low concern chemicals. The potential for non-hazardous polymers to be
notified at a lower cost also delivers the benefit of introducing safer
chemicals into use in Australia.