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2002-2003-2004
THE PARLIAMENT OF
THE COMMONWEALTH OF AUSTRALIA
HOUSE OF
REPRESENTATIVES
INDUSTRIAL CHEMICALS
(NOTIFICATION AND ASSESSMENT) AMENDMENT (LOW REGULATORY CONCERN CHEMICALS) BILL
2004
(Circulated
by authority of the Parliamentary Secretary to the Minister for
Health
and Ageing, the Hon Trish Worth)
INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT)
AMENDMENT (LOW REGULATORY CONCERN CHEMICALS) BILL 2004
Outline
This Bill makes amendments to the Industrial
Chemicals (Notification and Assessment) Act 1989 (the Act) in relation to
low regulatory concern chemicals and other miscellaneous matters. The Act
establishes a system of notification and assessment of industrial chemicals to
protect health, safety and the environment and provides for registration of
certain persons proposing to introduce industrial chemicals into
Australia.
The Bill gives effect to the Government’s response to
the Chemicals and Plastics Action Agenda in December 2002 with regard to the
treatment of industrial chemicals, which led to the establishment of the Low
Regulatory Concern Chemicals (LRCC) Reform Initiative and the LRCC Task Force in
response to the industry concerns that were raised about the current regulatory
framework. The specific issues raised by industry in the Chemicals and Plastic
Action Agenda included concerns that the current notification and assessment
requirements under the Act can result in delays to the introduction into
Australia of new chemicals with low hazard and/or low risk; that current
arrangements under the National Industrial Chemicals Notification and Assessment
Scheme (NICNAS) do not provide enough incentive to industry to encourage the
introduction of safer, more environmentally friendly industrial chemicals to the
Australian marketplace; and that current criteria are restrictive and may delay
for several months the commercial introduction of an otherwise low risk
chemical.
The chemicals industry is one of the largest sectors in the
world. In Australia in 2000-01 the chemicals and plastics industry contributed
$6.9 billion in industry value added with an annual turnover of greater than $22
billion. Chemicals are integral components of most manufactured and processed
primary products. The proposed amendments are aimed at enhancing Australian
industry capacity and addressing industry concerns about the timeliness of
assessment processes, the use of overseas assessment data and the flexibility of
the notification system with regard to the range of permits and certificates for
low risk or low hazard chemicals.
The industry reforms for fast
tracking of assessment processes are counter balanced with enhanced public
access to information, increased record keeping requirements and enhanced
compliance activity. The amendments do not change the objects of the Act, but
introduce flexibility into the current assessment process for industrial
chemicals to enable the fast tracking of low regulatory concern chemicals while
maintaining existing levels of worker safety, public health and environmental
standards. Extensive consultation has been undertaken with government, industry
and the community and there is widespread support for the reforms.
The
Bill introduces the following specific measures:
1. A new process for
audited self-assessment for Low Regulatory Concern Chemicals categories,
including an audited self-assessed assessment certificate
for:
• polymers of low concern;
• low regulatory concern
polymers;
• non-hazardous chemicals; and
• any other chemical,
or class of chemical that is prescribed by the regulations for the purposes of
the self-assessment system.
The Bill also introduces annual reporting and
record keeping obligations for the purposes of providing information to the
Director of NICNAS and for introducers to validate self-assessment data to
NICNAS inspectors during the audit process. New offence and penalty provisions
have also been introduced to support these measures.
2. New permit
categories for low-hazard and/or low concern chemicals,
including:
• a low hazard permit for chemicals of low
volume;
• an early introduction permit system for low hazard and low
risk chemicals; and
• a new permit category for controlled use
chemicals.
Some of these new permit categories are also accompanied by
annual reporting and record keeping obligations. New offence and penalty
provisions have also been introduced to support the new measures. The Bill also
adopts administrative processes for some permit renewals.
1. New
exemptions for low regulatory concern chemicals, including:
• a
transhipment exemption for chemicals off-loaded unopened at an Australian port
or airport for a short period and kept in control of Customs before leaving
Australia;
• an exemption for non hazardous and low hazardous
non-cosmetic chemicals for specified volumes;
• an exemption for low
concentration non-hazardous cosmetic chemicals imported in specified mixtures of
1% or less;
• an increase to the current exemption for research,
development and analysis and the general exemption for low volume
chemicals.
1. Other reforms, which include:
• changing the
definition of “cosmetics” in the Act to align it with that used
under the Trade Practices legislation;
• giving industry the option to
nominate an assessed chemical for immediate inclusion on the Australian
Inventory of Chemical Substances (AICS);
• giving the Director, NICNAS
the ability to put the particulars of a chemical, including any conditions to
which it is subject, on the Australian Inventory of Chemical Substances (AICS)
and making these conditions enforceable under the Act; and
• mandatory
company registration for all chemical introducers.
A number of other
miscellaneous reforms have also been introduced to address anomalies in the Act
and as consequential amendments to the Act to support the measures described
above.
There is minimal financial impact.
The current notification and assessment requirements under the Industrial
Chemicals (Notification and Assessment) Act 1989 (the Act) can result in
delays to the introduction into Australia of new chemicals with low hazard
and/or low risk. The current arrangements under the National Industrial
Chemicals Notification and Assessment Scheme (NICNAS) do not provide enough
incentive to industry to encourage the introduction of safer, more
environmentally friendly industrial chemicals on to the Australian marketplace.
Current criteria are restrictive and may delay for several months the commercial
introduction of an otherwise low risk chemical.
Industry concerns
about the regulatory framework
Industry evidence found that in some
instances, the total cost of introducing new chemicals including the cost of
providing information to the government exceeded $200,000. Industry is
particularly concerned at the high cost of generating data because of some
unique Australian requirements. In particular, in its report, industry cited the
following examples as indicative of those generating a high cost for Australian
data requirements:
• high cost of assessment for substances used in
small quantities;
• degree of testing and assessment required for
substances that are seen as of low concern in the US or Europe and, therefore
not required to be assessed in those places;
• assessments by
recognised overseas authorities not accepted in Australia. Similarly,
non-recognition of chemicals approved for use by those
authorities;
• under-estimation of the impact on new legislation and
regulations at the time of drafting, and unanticipated consequences both in
resources needed and costs required to implement them;
and
• non-uniformity of regulations across jurisdictions.
(p28-29)
Specifically, the Steering Group recommended
that:
Relevant regulatory bodies be required to alter their assessment
processes to ensure:
• Recognition of data from overseas sources
that test to accepted international standards;
• Recognition of
chemical approvals from approved countries including substances
“grandfathered” in those countries;
and
• Consistency of international definitions and/or
classifications (pvii).
In its response, the Government indicated that:
... via NICNAS, is
committed to continuing to work with industry to ensure the most efficient
regulatory system is in place for industrial chemicals, that is, a system that
does not inhibit the introduction of new and safer chemicals. The Government
will consider and develop options for access to adequately assessed and/or
tested chemicals presenting low regulatory concern. (November 2002 p7)
In Australia, industrial chemicals are regulated by the Australian
Government under the Act administered by NICNAS and located within the Health
and Ageing portfolio. While the Government has agreed to examine options for
flexibility in the assessment process for industrial chemicals, it indicated
“...recognition of unassessed grandfathered chemicals is not acceptable on
the grounds that it would impose Australia to unacceptable risks and lower our
regulatory standards and hence inhibit our opportunity to harmonise with
comparable regulators overseas” (p7). Grandfathered chemicals refer to
those chemicals which were in commercial use by industry in Australia between I
January 1977 and 28 February 1990 at the time were placed onto the Australian
Inventory of Chemical Substances (AICS). In general little is known about these
chemicals, they have not been assessed or for some, limited assessment data is
available.
The aim of the reform process is to introduce flexibility into the current
assessment process for industrial chemicals to enable the fast tracking of low
regulatory concern chemicals (LRCC) while maintaining existing levels of worker
safety, public health and environmental standards. Both industry and the
Government support the need to pursue reform in this area and have given it a
high priority.
The approach adopted during the reform process involved
NICNAS identifying categories where low regulatory concern already existed based
on experience over the range of new chemical assessments/applications processed
over the past six years. A preliminary review by NICNAS identified a number of
circumstances where reduced costs and/or data requirements are supported and/or
where reduced assessment requirements may apply. These areas were explored with
industry and the community with a view to defining LRCC to provide certainty to
industry.
Due to the diverse nature of what constitutes “low
regulatory concern”, there has always been difficulty in defining a single
category or set of guidelines that readily capture the scope of possible
reforms. A single definition of LRCC is not possible except in the most generic
sense, as follows:
Chemicals could qualify for reduced regulatory input on
the basis of a definition of low risk or where regulatory input from elsewhere
is sufficient to meet Australian requirements.
An LRCC Task Force made up of government and individuals from industry
and the community was established to assist the reform process and provide
expert input where needed. Technical working groups were established with
members from industry, government and the community working together to explore
options for LRCC and investigate the feasibility of implementation in Australia,
thereby ensuring that the affected parties were involved in, and contributed to,
the reform process.
In developing options for regulatory reform,
the technical working groups undertook regulatory impact assessments on the
range of options under consideration. These were published on NICNAS’s web
site along with the Public Discussion Paper in May 2003. The impact assessments
addressing specific options are attached, as follows:
• treatment of
low hazard and/or low risk chemicals (Attachment A);
• treatment of
chemicals assessed overseas, specifically the use of Overseas Assessments
reports (Attachment B);
• polymers of low concern (Attachment
C);
• modular Assessment - Analogue chemicals (Attachment D);
• other pathways for low regulatory concern chemicals (Attachment
E);
• cosmetics and personal care chemicals (Attachment F);
and
• mandatory registration for all chemical introducers (Attachment
G).
Following extensive consultation and development of options the LRCC
Task Force provided its final report, Final Report and Recommendations for
NICNAS Low Regulatory Concern Chemicals (LRCC) Reform Initiative to
Government in June 2003. The Final Report made 12 key recommendations, the
majority of which require legislative or regulatory amendment to the Act. The
recommendations are as follows:
8. Audited self-assessment
9. Modular
assessment
10. Exemptions
11. Polymer
regulation
12. Cosmetic chemicals regulation
13. Controlled
use
14. Incentives for the introduction of new and safer
technologies
15. International cooperation
16. Reducing
the compliance burden
17. Safe use through compliance
18.
Access to chemical safety information
19. Community
participation
While provided as a reform package, some of the recommendations listed in the
Final Report do not require legislative change as they refer to administrative
processes such as improved consultation, better targeting of information or the
development of compliance tools to assist industry with compliance. These
recommendations have been accepted by Government but have not been included in
this RIS since they are minor or administrative in nature and are principally
designed to maintain public and industry confidence in the integrity of the
Scheme.
In addition, new concepts such as automatic listing onto the
Australian Inventory of Chemical Substances (AICS) and the establishment of a
community Consultative Forum are administrative for NICNAS and as such, do not
require an impact assessment. The distinction between significant changes
requiring a RIS and those administrative activities and improvements within
NICNAS are summarised below.
Recommendations requiring legislative and/or regulatory amendment for
which a RIS was undertaken:
|
|
|
NEW CONCEPTS / ELEMENTS
|
|
ASSESSMENT
|
|
• Audited self-assessment against NICNAS criteria/guidelines
(Attachment A, option A, Attachment C)
|
|
• Modular assessments (Attachment D)
|
|
• Controlled/specified use (Attachment A, option b)
|
|
EXEMPTIONS
|
|
• Transhipment (Attachment E, option b)
|
|
• Export Only (Attachment A, option b)
|
|
• Non-hazardous Cosmetic Chemicals introduced in mixtures at
concentrations of 1% or less. (Attachment F, option c)
|
|
• Non hazardous chemicals up to 100kg (Attachment E, option c)
|
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STAKEHOLDER
|
|
• Mandatory Company Registration for all chemical introducers
(Attachment G)
|
|
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MODIFICATIONS/ IMPROVEMENTS
|
|
ASSESSMENT
|
|
• Streamline CEC, LVC renewals (unless new data)(Attachment E, option
d)
|
|
• increase bilateral agreements/foreign scheme recognition
(Attachment B)
|
|
• identify and clarify any cosmetic /drug interface issues
(Attachment F, option b )
|
|
EXEMPTIONS
|
|
• increase general <10kg exemption in volume for certain
chemicals(Attachment E option c)
|
|
• increase R&D volume (Attachment E, option a)
|
|
DEFINITIONS
|
|
• harmonise definition of cosmetic chemical (Attachment F, option
a)
|
The range of industries falling within the scope of the Act is diverse and
can cover petrochemical manufacturers, specialty and refined chemicals,
intermediate goods and components, consumer products and cosmetics. The
Australian chemicals and plastics industry is a key contributor to the
Australian economy and contributed $6.87 billion in industry value added (Allen
Consulting Group June 2003). This represented over 9.5% of manufacturing
industry value added. The sectors’ contribution to total manufacturing
industry value has declined over the last few years falling from just over 10%
in 1997-98 to 9.5% in 2000-01. This reflects the fact that from 1997-98 to
2000-01, industry value added for the chemicals and plastics industry was static
while manufacturing as a whole recorded a growth rate of over 6% for the period
(Allen Consulting Group p7-8).
The Government Response to the Chemicals
and Plastics Action Agenda report indicated that the chemicals and plastics
manufacturing industry has:
• an annual turnover for chemicals and
plastics industry is around $20 billion, or just under 10% of total
manufacturing;
• it adds nearly $7 billion in value to the Australian
economy, about 10% of the total value added by the manufacturing sector;
and
• the industry employs around 77,000 people or just over 8% of the
total manufacturing industry workforce (p3).
NICNAS currently operates on
a cost recovery basis. Cost recovery is achieved in two
ways:
• assessment and administrative charges for new chemical
assessments; and
• company registration charges.
Company
registration monies fund the assessment of existing chemicals, client awareness
and education activities, 50 per cent of the costs of compliance activities and
the administration of the company registration itself. The remaining 50 per cent
of compliance activities is funded by an appropriation from the Government.
NICNAS recovers on an annual basis approximately $4 million (0.018%) from the
industrial chemical sector. For the registration year 2003-04, there are
approximately 700 companies registered with NICNAS, that is, for the previous
year’s activity these companies imported and/or manufactured chemicals
above the threshold level of $500,000.
The overall aim in setting the fee
structure for NICNAS is to meet stakeholders’ needs as per the operations
of the Act, by appropriately reflecting the cost of service provision to
industry users, in accordance with Australian Government policies for cost
recovered services. NICNAS uses an activity based costing (ABC) model to set its
fees and charges and costs to the industry are kept to a minimum.
The
cost structure design of NICNAS is such that new chemical activities for issuing
permits and certificates should be 100% cost recovered. The funding is sourced
directly from the users of the Scheme through fees and charges for assessment of
new chemicals introduced to Australia. Most small businesses are generally
exempt from the company registration charges, but are still required to comply
with the Act. It is the intention of NICNAS that no cross subsidisation between
new chemical activities and other activities occurs. On the basis of Customs
data, and NICNAS company registrations, it is estimated that approximately 5,700
small businesses are engaged in activities for which the Act would apply, but
not the company registration requirements.
The expected changes to fast
track the assessment processes will lead to significant savings to industry in
both the cost of permits and certificates. For example with the introduction
of:
• an audited self-assessment permit for polymers of low concern,
industry could save up to $1,000 in some instances while time to market could be
reduced from 90 to 28 days; and
• administrative processes for permit
renewals could save industry approximately $2,000 and considerable saving in
time as they will not be required to resubmit a data package for re-assessment.
Implementation of the LRCC reform initiatives will introduce a new range
of exclusions, permits, and certificates and streamline some administrative
processes. Determination of costs for new permits and certificates will be on
the basis of NICNAS’s current ABC model and will not result in the
introduction of new policies in relation to cost recovery practices prior to the
Government review of NICNAS’s cost recovery policy due in 2004-05. As
indicated above, these reform initiatives are expected to provide significant
benefits to industry without compromising existing public health, worker safety
and environment standards.
Additional measures to improve compliance,
introduce mandatory registration for all chemical introducers, increase public
access to chemical safety information and increased requirement for record
keeping by the industry will maintain public confidence in the integrity of the
Scheme. The exact costs and benefits to industry are hard to quantify, but the
reform proposals have the support of all the affected parties. The additional
burden on small business due to the introduction of a requirement for mandatory
registration should not be significant. While small businesses may currently be
exempt from paying an annual registration fee, they are not exempt from the
operations of the Act and are expected to comply with it. Therefore, the
additional impost on small business is expected to be an annual registration
fee, currently estimated to be $300 per annum.
In general, the reforms
are expected to be widespread, delivering benefits to a high proportion of
NICNAS notifiers. The impact on NICNAS’s efficiency is expected to be
moderate to high with a major time and cost saving to the industry through
reduced assessment costs for permits and certificates costs based on
NICNAS’s ABC model. The community and industry will benefit through
improved access to on line chemical safety information. In addition, the
community and environment will benefit from an incentive for industry to
introduce less hazardous chemicals.
The affected parties will be Industry, Government Consumer/community and
workers.
The expected benefits are, for:
•
Government - more efficient use of limited resources, increased compliance,
focussed regulatory activity on areas of highest risk, improve Government
visibility in international forums as leader in innovation and
reform.
• Community - improved access to information,
increased participation through formal consultative mechanisms, introduction of
safer newer technologies with better performance.
•
Community
sectors:
o Workers
– introduction of safer chemicals, reduced exposure to all chemicals,
improved access to
information;
o Public
research institutions – facilitate R&D investment, increase compliance
and awareness.
• Industry - lower compliance costs,
chemicals onto market faster, more competitive industry, improved access to
information, innovation, access to newer technology, better use of information
gained from overseas experiences and harmonisation with international standards
will reduce trade barriers.
• Small business –
better access to the broader industry through listing on Company Registration,
better access to information through NICNAS’s compliance program,
chemicals onto market faster, more competitive industry, innovation, access to
newer technology, better use of information gained from overseas experiences and
harmonisation with international standards will reduce trade
barriers.
• All sectors - a better understanding and
management of the “total chemical load” and in the longer term
reduce exposure to workers, the public and the
environment.
Consultation
The
LRCC Task Force operated in an open, consultative and transparent manner. In
conducting the reform process, the LRCC Task Force and NICNAS consulted widely
with a broad range of stakeholders including: the chemicals and plastics
industry and its industry bodies; government and non-government organisations;
and worker and community representatives. Two background papers were placed on
the web site to provide information to interested parties. A quick response
electronic questionnaire was developed to provide an opportunity for those
wishing to engage in the reform process but unable to participate in detailed
consultation due to time or other constraints.
Focussed
consultations were conducted in Sydney, Melbourne and Brisbane with industry and
the community. A detailed draft options paper was provided to all participants
to assist in the decision-making process and to refine the reform options. The
LRCC Task Force and NICNAS engaged with over 90 individuals of whom 30% were
from the community or government agencies to seek additional feedback on the
reform options prior to the release of the Public Discussion Paper in May 2003.
This was in addition to the LRCC Task Force members and its various technical
working groups.
Of the 34 submissions received: 27 were from industry members and or their
associations; two were from community and worker representatives; four from
federal and state government agencies; and one from the international body, the
OECD New Chemicals Task Force on Aligning National Systems for New Chemical
Notification and Assessment, sub-group Work Element V on Exemptions and Low
Concern Chemicals.
In general, the industry submissions were highly
supportive of the reform options presented in the Public Discussion Paper
because of the perceived benefits they would bring to industry through a more
efficient and effective regulatory system. Only one submission indicated that
the proposed reform options were conservative, but nevertheless provided a good
basis upon which to commence a reform program. While regarded as conservative,
the submission nevertheless indicated that the initiative was critical to
reducing regulatory cost barriers and improving the speed and quantity of new
technology being created or entering Australia, thereby addressing
industry’s concerns raised in the Action Agenda about the regulatory
environment for industrial chemicals. There was overwhelming support for the
reform process itself, in particular the open and consultative way the LRCC Task
Force members and NICNAS conducted the review and engaged industry, government
and the community from the beginning of the reform process.
Overwhelmingly, industry saw the LRCC reform processes as part of NICNAS’s
continuous improvement process of which regulation reform was one component.
There was strong industry support for the LRCC reform aim which was
to:
... introduce flexibility and optimise risk-resource allocation in
the industrial chemicals assessment process to allow for fast tracking the
introduction of chemicals of low risk (including chemicals of low hazard or low
risk or controlled exposure) or previously assessed chemicals without
compromising public health, worker safety or the environment.
Comments from the government and community were more circumspect, but never
the less they provided in-principle support for the reform initiative. In
general, it was felt that the Public Discussion Paper focussed on the benefits
to be gained by industry in terms of time and cost savings and felt that there
was little evidence or persuasive argument provided in the Paper that the
introduction of the LRCC program would be an incentive to the introduction by
industry of less hazardous chemicals. It was felt that, “therefore, any
proposal to make it easier to introduce ‘low regulatory concern
chemicals’ must be accompanied by a parallel strengthening at the other
end of the regulation and control of use (including prohibition) of
hazardous/dangerous chemicals of high concern.”
The non-industry
submissions did not support mechanisms to facilitate the introduction of more
chemicals in the workplace, the community and/or the environment without
assurances that the current system of public health, worker safety and
environmental standards would be maintained. In order to be assured that LRCC
did in fact trigger industry to shift towards the introduction of new safer
technology, the community and government advised that monitoring of industry
trends and other related information would need to be transparent and readily
available. The jurisdictions sought reassurance that there be no additional
compliance burden placed on them and that they, like industry, be kept fully
informed of progress.
The LRCC Task Force also took advice provided by NICNAS’s Technical
Advisory Group (TAG) on confidentiality and access to information as a result of
industry and community consultations on the current NICNAS guidelines on
procedures for establishing a case for confidential listing on the AICS. The TAG
consultations identified a range of issues beyond confidentiality and AICS
listing. Community concerns were focussed on access to chemical safety
information, community right to know issues and community consultation. Industry
concerns were more focussed on the issue in hand, confidentiality but did take
the opportunity to raise concerns about the efficiency of NICNAS processes and
the cost and effort of assessment processes.
The TAG, while appointed to
advise the Director of NICNAS on public interest tests associated with
confidential listing on the AICS, has general expertise in a broader range of
public interest and community right to know issues. As a result of their
consultations with community and industry, they have offered “expertise
and assistance to NICNAS in other matters where the public interest is involved.
These include other situations in the NICNAS legislation that call for decisions
based on the public interest, acting as an informal public interest sounding
board and participating in regular and ongoing public consultation meetings and
workshops with NICNAS stakeholders.”
The LRCC initiative has followed best practice principles in the design and
execution of the reform process. The affected parties, ie. government, industry
and the community were involved from the beginning of the review through to the
final report and are expected to play a significant role in the implementation
phase. The reform options have been designed to minimise the compliance burden
and decrease industry time to market. In Australia the regulation of industrial
chemicals is “light touch” scientific assessment to identify
potential risks but does not include product registration processes. The LRCC
reform options are consistent with international trends and the concept is being
explored within the OECD New Chemicals Task Force and by the EU as it introduces
its new regulatory regime, Registration Evaluation Assessment of Chemicals
(REACH) with a view towards harmonisation and streamlining assessment
throughput. The overall aim of global (new chemicals) chemical assessment
harmonisation is to have the notification and assessment process in one country
facilitate the notification and assessment process in another country.
While legislation is required to amend the Act to enable the majority of
reforms to be implemented, further work will still be required by industry,
government and the community to develop guidelines and criteria for areas such
as low hazard, controlled use and modular assessment. The majority of
submissions indicated their willingness to work with NICNAS during the
implementation phase.
ATTACHMENT A
The current notification and assessment requirements under the
Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) can
result in delays to the introduction into Australia of chemicals with low hazard
or low risk.
The current legislation enables introduction of some new
chemicals prior to assessment being completed by NICNAS. An Early Introduction
Permit (EIP) may be used for introduction of chemicals which are not classified
as hazardous substances or dangerous goods, which comply with specified
environmental criteria and meet other prescribed matters. An Early Introduction
Permit is granted essentially on the basis that the chemical concerned is of low
hazard to health and the environment, or is contained to the extent that
environmental impact is negligible. These criteria are restrictive and may delay
for several months the commercial introduction of an otherwise low risk
chemical.
Under current legislation, chemicals that may be of higher
hazard but are of overall low risk to workers, the public and the environment
and are supported by a complete and sound data package and effective exposure
controls cannot qualify for an EIP and cannot be introduced until the assessment
certificate is issued. The only other alternative for early introduction
requires Ministerial approval. This option is reserved for chemicals that are
needed in the national interest and is not a routine option for most chemical
introductions.
It is appropriate that the existing EIP be expanded to
enable early introduction of chemicals for which hazards are defined and the
risks can be controlled when introduced in the workplace, public domain and the
environment.
EIPs are available for chemicals (including polymers) which
are not hazardous to human health or the environment. For human health, the
chemical must not be a hazardous substance according to the NOHSC Approved
Criteria. For the environment, the chemical must satisfy certain criteria, for
example, low toxicity to fish, daphnia and algae. Once an EIP is granted, the
applicant for assessment can introduce the chemical according to the permit
conditions before the full assessment is completed. Factors taken into account
include reasonable protection of occupational health and safety, public health
and the environment. Synthetic polymers of low concern (PLC) automatically
qualify for an EIP as long as they are composed mainly of carbon or silicon.
To outline a framework and criteria that can be used by NICNAS to permit
early and efficient introduction of low hazard and/or low risk substances, while
maintaining regulatory standards for OHS, public and environmental risk
determination.
Options
Option 1a – No
change to existing provisions. Chemicals may be introduced under a Section
30A Early Introduction Permit if not classified as hazardous substances or
dangerous goods and comply with specified environmental and other criteria.
Chemicals not meeting these criteria may seek introduction with Ministerial
approval under a Section 30 Permit. The Permits must be issued by NICNAS before
introduction takes place.
Option 2a – Retain existing Section 30
and 30A Permits. Expand Section 30A criteria to also enable low risk
chemicals that do not meet the current Section 30A criteria to be introduced
under permit conditions. Low hazard and/or low risk chemicals may be defined in
accordance with currently available criteria and by requirements of existing
States’ OHS legislation. The expanded criteria would include the
requirement that the chemical has a complete and sound data package, and the
exposure controls ensure low risk for workers, the public and environment. This
option will enable introduction (prior to completion of assessment) of
substances for which hazards can be determined by reference to a detailed data
package and risks can be determined and controlled by use of exposure and
control scenarios.
Parties affected include industry, the workforce, the Government (NICNAS)
and the community.
Option 1a – Maintains the current situation,
whereby chemicals meeting low hazard and environmental and other prescribed
criteria may be introduced under an EIP before the NICNAS assessment certificate
is issued. An adverse impact on timing of chemical introduction is imposed
on industry because chemicals with a defined hazard do not qualify for early
introduction even if exposure is well controlled and the overall risk is low.
These chemicals cannot be introduced for at least 3 months after chemicals are
notified to NICNAS, compared with introduction after 28 days for chemicals under
EIP.
Option 2a – Broadens the Section 30A EIP criteria to
enable substances with specified hazard and risk controls to be introduced prior
to completion of assessment by NICNAS whilst maintaining occupational health and
safety, public safety and environmental safety standards. This will enable
the introducer to obtain early commercial access to the new substance in annual
quantities as detailed in the notification statement. In turn, early
introduction will enable downstream users of the chemical to gain earlier access
and commercial benefit from the new substance. The new chemical will potentially
be introduced earlier (say 28 days) than if it was required to undergo complete
assessment before being able to be introduced.
Members of the workforce
will not be adversely affected by the earlier introduction of the new chemical
because information on its potential hazards, risk control measures and the
permit status will be detailed on product Material Safety Data Sheets (MSDS).
This information will enable employers to conduct risk analyses as required
under current States’ OHS legislation. If an EIP is granted, the hazard
and risk information conveyed to end-users will not differ from the information
that will be available when NICNAS assessment has been completed. This option
will only be available to chemicals with a complete data package that can be
used by introducers together with exposure scenarios to implement appropriate
risk control measures. The data package will also be used by NICNAS to determine
that the risk is appropriate to allow early introduction of the chemical under
permit.
The permits would require an assessment fee to cover NICNAS
activity in assessment and administration. NICNAS will be required to review the
permit application, hazard data and risk control recommendations and issue the
permit. The option should be available for NICNAS to include further specific
use conditions. Introduction of the chemical after issue of an EIP or after
complete assessment is expected to occur with the same control measures. Hence,
it is not expected that the community will be affected adversely.
Some new chemicals are not introduced to Australia because the
notification and assessment costs may not be recoverable, the chemical may have
limited available data or the quantity necessary for Australian introduction may
exceed the current permit or exemption allowances. Such chemicals are not
available to Australian manufacturing industry although they may be able to be
used in a controlled way in low risk situations and may be of benefit to the
Australian economy.
The objective is to outline a framework and criteria that can be
used by NICNAS to permit introduction of commercial quantities of low hazard
and/or low risk substances for which notification and assessment
in an existing certificate or permit category is not suitable. Regulatory
standards for OHS, public and environmental risk determinations are to be
maintained.
Option 1b – No change to existing ICNA provisions.
Commercial quantities of new chemicals may only be introduced after issue by
NICNAS of an Assessment Certificate, a Low Volume Chemical Permit, a Commercial
Evaluation Permit or if exempted under the 10kg per annum exemption
category.
Option 2b – Establish a new category and criteria for
a Controlled Use Permit. The category should consist of chemicals which
either alone, or in a mixture, or because of the way they are transported,
handled, used and/or disposed, qualify as LRCC. The following parameters are
proposed for assessing these chemicals and establishing that they present a low
risk to human health and the environment – one or more of the following
may apply:
• controlled transport and storage;
• specialised
uses;
• low public, workplace & environmental
exposure;
• containment in closed systems;
• imported as part
of a specific formulation;
• low concentration in formulation;
and
• intended for export only.
Other parameters can be
considered. The implication for this category is that no special risk management
controls (other than established good work practices, responsible disposal and
compliance with all relevant chemicals regulations) are required. The proposal
is that NICNAS would issue a LRCC Controlled Use Permit. An Assessment
Certificate would not be issued and the chemical would not ultimately be listed
on the AICS.
Parties affected include industry, the workforce, the Government (NICNAS)
and the community.
Option 1b – Maintains the current
situation. Currently, a gap exists in NICNAS permit options for chemicals of
low risk, to be introduced at volumes exceeding 100kg per year and which do not
qualify for a commercial evaluation permit. Chemicals in these situations are
obliged to be notified in either the standard or limited notification
categories, which are costly and may require a full data set. Industry is
hampered from introduction of many new substances that are used in other
countries due to lack of required notification data, due to the cost of
notification or because insufficient permit or exemption quantities are allowed.
End-user companies and/or the community are prevented from access to the
benefits of new chemical technology and the economic benefits accruing from the
ability to use the chemistry in a competitive manner
internationally.
Option 2b – Establishing a new category and
criteria for a Controlled Use Permit for chemicals to be introduced, handled and
used in low risk situations would broaden the range of new chemicals potentially
available to the Australian industry at a lower regulatory cost. This will
enable industry to bring chemicals quickly to market and capitalise on business
opportunities. For NICNAS, the new category should result in a greater number of
new chemicals being notified under the new permit. However, the new permit
assessment fee would support the screening/ review processes. Specific criteria
are to be developed to clarify which chemical types, uses or situations will be
included in this category. Establishment of the category will result in the
potential for the workforce to be exposed to a greater number of new chemicals.
It will be necessary for criteria for the category to be established such that
introducers of chemicals ensure that all hazards and risks are understood and
controlled. The guidelines for the category should also ensure that risks to the
public and to the environment are controlled.
Conclusion and Preferred
Options
Taking into account the views on the options received from the
public submissions, the focus groups and the views of the LRCC Task Force, the
following options are preferred.
The LRCC Task Force believes that the most innovative reform which has
received the greatest support is the proposal to introduce audited
self-assessment by industry for those chemicals which are considered to be of
low regulatory concern against NICNAS criteria. The range of options identified
below result in a simplified process for the issue of NICNAS permits and
certificates and introduces a new LRCC Assessment Category for defined low risk
circumstances. In each case, benefits result from audited self-assessment of
chemicals by the introducer in accordance with specific low risk criteria based
on hazard and exposure. The reduced compliance burden is a positive incentive
for industry to focus on the introduction of non-hazardous and/or low risk
chemicals thus providing benefits in terms of incentives for introduction of
safer and more environmentally friendly chemicals.
An audited
self-assessment for LRCC categories would involve:
• introducer/notifier self-assesses a chemical against specified criteria and guidelines issued by NICNAS;
• introducer/notifier to provide information to NICNAS, as specified;
• introducer/notifier to keep records to validate the self-assessment for audit purposes;
• NICNAS to undertake a screening assessment of the industry self-assessment;
• NICNAS to conduct post-market audits to ensure robustness and
integrity of the process; and
• progress in implementation, with
stakeholder involvement in the development of necessary criteria and/or
guidelines and processes.
In addition, an audited self-assessment permit
for low hazard chemicals and low risk chemicals (introduced at low volumes
100-1000kg) against NICNAS criteria and/or guidelines developed by NICNAS,
industry and the community should also be introduced.
I don’t understand the rationale for this? This
is a specific permit, not a certificate. Why would it be automatically publicly
listed?
This line should be
deleted
The impact on industry is expected to be widespread
benefits for a high proportion of NICNAS notifiers with savings in time and
money to industry (ie.>that 30%). In some instances, time to market for
audited self-assessment of low risk/low hazard chemicals could be reduced from
90 to 28 days. While savings in permits and certificate costs are expected, it
is difficult to estimate these costs until the proposals are implemented. The
proposed changes will not undermine existing levels of public health, worker
safety or environmental standards.
Given the concerns raised and the specific requirements for such a
permit, the preferred option is to examine the introduction of a controlled use
/specified use assessment (permit and/or certificate) category based on history
of use, limited exposure and/or use in controlled environments. In addition, it
is also recommended that an examination of the feasibility for an Export Only
Permit also be considered.
ATTACHMENT B
Globalisation of trade means that many new chemicals notified to NICNAS
may have been notified to and assessed by other overseas or even other
Australian regulatory agencies. Presently, for these chemicals, industry
duplicates effort in preparing notifications for each country or agency and
NICNAS duplicates effort in re-assessing these chemicals.
The overall objective of the following options is to provide
opportunities for the notification and assessment of industrial chemicals that
utilise information from overseas or other local assessment schemes (referred to
here collectively as foreign schemes), enabling or maintaining:
• optimal regulatory input from industry and Government; and
• sufficient information regarding OHS, public health and
environmental risks of the chemical.
The options should:
• maintain scientific standards in the provision
of assessment information and be flexible;
• maintain relevance to
Australian exposure scenarios;
• minimise assessment duplication by
NICNAS;
• minimise unnecessary detail and further validation of
data;
• retain existing standards for the OHS, public health and
environmental assessments;
• should not extend existing statutory
timeframes;
• be cost-effective for NICNAS and all other parties;
and
• assist public access to chemical information.
There are important differences in data requirements and assessment
processes between NICNAS and foreign regulatory agencies responsible for
industrial chemicals. For example, NICNAS publishes assessment reports whilst
the majority of regulatory agencies overseas do not. This has implications for
the free sharing of information as this is often provided to the overseas
regulatory agency on a confidential basis. Moreover, many overseas regulatory
agencies rely on third party data ie. information provided by another source
(such as another company) to fill data gaps for a particular chemical. Clearly,
if NICNAS is to use (and publish) reports containing such information,
appropriate administrative policies and procedures must be established to deal
with obvious issues of proprietary rights.
Therefore, the following
issues are relevant to considering overseas or other local agency assessment
information or reports:
Firstly, sufficient information must be provided
to determine the:
• chemical in question and the use (if any) of
analogue data;
• extent to which different assessment scenarios eg OHS,
public health, environment are covered;
• methodology for the conduct
of risk assessments and their relevance to Australian exposure scenarios;
and
• transparency of the assessment process or evidence of an agreed
standard or recognised status of authority through access to the original data
submitted for the foreign assessment.
Secondly, if a foreign assessment
report is submitted, it should be accompanied by validation from the foreign
authority that the report is the full and final report issued for that chemical.
In this way, if the chemical is subject to an ongoing assessment, this will be
noted.
Lastly, NICNAS requires a mechanism to allow information from the
foreign assessment report to be published, especially for information that is
handled as confidential by the foreign regulatory agency.
NICNAS presently allows overseas assessment reports to be submitted
through Transitional Arrangements Towards Approval of Approved Foreign Schemes
(Chemical Gazette C11 6 November 2001). This option proposes the following
criteria for a foreign assessment report acceptable to NICNAS and attracting up
to 40% rebate in notification fee:
• report to date from
post-1994;
• originate from national authority of an OECD Member
country, preferably Canada or any other EU state;
• include
confidential information eg. chemical identity. Sanitised documents are not
acceptable;
• include a summary and assessment of physicochemical
properties;
• include a summary and assessment of toxicological and
environmental effects data, as appropriate;
• include a health and
environmental risk assessment; and
• be accompanied by a letter of
validation from the overseas authority that the report is the full and final
report issued for that chemical.
With the conditions
that:
• NICNAS notification procedures are followed and Schedule
information is also submitted;
• where not covered by the foreign
notification statement, details of the overseas authority and when and where
notified are submitted;
• copy of all data submitted to the foreign
scheme are submitted to NICNAS also; and
• any other assessment
information about the chemical available to the applicant and relevant to the
Australian notification is submitted.
This last point in italics is
clarified from the original conditions for Transitional Arrangements so as only
to require data relevant to the Australian notification.
This is a minor modification of an existing mechanism of notification and would be of no negative impact to NICNAS. However, contact with overseas assessment reports would enable NICNAS (and industry) to determine commonalities between the assessment processes and outputs of NICNAS and overseas jurisdictions and allow movement towards the mutual acceptance of assessments.
For global chemical companies who notify overseas, the ability to submit an
overseas assessment report with the data originally submitted for the overseas
notification will enable time and cost savings for industry. However, advantages
for small industry participants are uncertain.
On the one hand, the
submission of information to local importers from global suppliers may be
encouraged by the option of global suppliers to submit data in the form of an
overseas assessment report and the data for the original overseas notification
rather than in a form required by a NICNAS notification. On the other hand, any
reluctance to share information, especially with small local notifiers because
of concerns with confidentiality, would not be relieved by this
measure.
For this measure to be effective in the larger companies,
sufficient communication is required between the overseas parent and the local
company office so that the local office is aware of the notification history of
a particular chemical and whether an overseas assessment report is
available.
Given no compromise of the existing NICNAS Schedule of Data Requirements, the use of overseas assessment reports per se is likely to have minimal impact on the quality and extent of regulation of chemicals in Australia. Therefore, the use of overseas assessments according to this option is unlikely to impact the community.
A foreign assessment report would be submitted in the absence of the
original notification data with a statement of validation of the assessment
report, accompanied by Australian exposure data and an Australian MSDS/label.
Without the original data for validation of the assessment report, how
can NICNAS and Industry have confidence in the assessment report? The concept of
“assessment competence” of the foreign regulatory agency becomes
relevant. By this, it is meant that the outputs of the overseas assessment
process are of sufficient scientific robustness, relevance and applicability
with regards to the Australian use of the chemical for the requirements of
NICNAS. Similarly, the “competence” of NICNAS (with regards to the
assessment processes as well as matters such as the handling of foreign data) is
relevant for the overseas (or other local) agency.
Given the duty of
care of NICNAS as a National Regulator, “competence” involves
addressing the list of considerations identified above. Given likely particular
local use and exposure patterns, but recognising agreed standards in hazard
testing of chemicals (eg. OECD Guidelines for Testing of Chemicals) mutual
recognition of the methodology and results from the hazard assessments from
overseas reports is a logical starting point with respect to using overseas
information.
Ultimately, if sufficient experience with assessment
procedures and outputs from particular foreign agencies is achieved, this option
will allow acceptance of an individual foreign assessment or parts thereof (such
as the hazard assessment) through an expedited audit of the foreign report by
NICNAS for internal consistency and coverage of essential information as
required by the Act.
There are noteworthy processes presently under
development for encouraging and facilitating the mutual acceptance of overseas
assessment reports. This option encourages their advancement:
Communicating between jurisdictions, determining “assessment
competence”, determining mechanisms of sharing assessment data including
confidential business information and ultimately the mutual acceptance of
notifications are the aims of the work of the current OECD New Chemicals
Taskforce. NICNAS is a participant in this work.
Work Element IV of the
OECD New Chemicals Taskforce specifically aims to identify opportunities for the
sharing of hazard assessment information.
NICNAS is currently facilitating the sharing of information with Canada
through an Australia-Canada Bilateral agreement. The aims of the current
Australia-Canada Cooperative Arrangement Work plan include the comparative
analysis of assessment methodologies, identifying opportunities for work sharing
such as co-notifications and electronic filing of co-notifications and staff
exchanges.
Bilateral Agreements are likely the most effective mechanism
in the short to medium term to facilitate sharing of detailed information
between particular overseas jurisdictions and NICNAS to ultimately allow
legislative recognition of foreign schemes.
As stated, the concept of “assessment competence” of the foreign
authority, ie. that for the purposes of NICNAS, outputs of the assessment
process are of sufficient scientific robustness and applicability for the local
use of the chemical, would need to be established by NICNAS. Similarly, the
competence of NICNAS (with regards to the assessment processes as well as
routine matters such as the handling of overseas data) would need to be
established for foreign jurisdictions. This work is ongoing through present OECD
New Chemicals Taskforce activities and Bilateral Cooperative Arrangements.
The development of OECD and bilateral arrangements require additional
resources from NICNAS. However, the requirements only for expedited audits of
submitted foreign assessment reports are likely to produce resource savings for
new chemicals notifications.
For global chemical companies, the acceptance of overseas assessment reports
by NICNAS would represent a significant time and cost saving. However, as for
Option 1, advantages for small industry participants are uncertain.
On
the one hand, the submission of information to local importers may be encouraged
by the option of global suppliers to submit data in the form of an overseas
assessment report rather than original notification data in a form required by
NICNAS. On the other hand, any reluctance on the part of global chemical
companies to share information, especially with small local notifiers because of
concerns with confidentiality would not be relieved by this
measure.
Similarly to Option 1, for this measure to be effective in the
larger companies, sufficient communication is required between the overseas
parent and the local company office so that the local office is aware of the
notification history of a particular chemical and whether an overseas assessment
report is available. It is possible also that multinational companies can aid
Bilateral arrangements by assisting foreign regulatory agencies with mechanisms
to share confidential business information between the overseas regulator and
NICNAS.
Given the recency of activities with regards to bilateral and multilateral
new chemicals work sharing, the impact to the community is difficult to
determine at this time.
Depending on the extent to which data are
available in assessment reports, the use of overseas assessment reports per
se may have a positive effect on the community (if additional relevant data
are available to assist the assessment process), no effect (if the current or a
revised version of the Schedule of Data Requirements and Variation of Data
Requirements provisions are satisfied) or may have a negative effect (if certain
critical data are not available).
It is envisaged that maintaining the
present NICNAS Schedule of Data Requirements, using mutually accepted hazard
assessment methodologies and risk assessment/management based on Australian
exposure data, there would be minimal community impact with the use of foreign
assessment reports.
For a new chemicals notification, this option allows industry to submit an
overseas notification statement plus an Australian MSDS and label. This would be
accompanied by a checklist indicating how data on the overseas notification
statement correspond to the NICNAS Schedule of Data Requirements.
Provided that all data required by the Schedule and that relevant supportive
data eg. test reports are submitted, the impact on daily NICNAS operations would
be minimal. However, to standardise the notification process and to provide
opportunity for industry involvement, NICNAS is encouraging the submission of
data on the New Chemicals notification template. The use of overseas
notification statements would work against the ready adoption of this template
and the associated administrative efficiencies.
Access to overseas notification statements is possible for the larger
industry participants who notify chemicals overseas. However, as for Option 1,
advantages for small industry participants are uncertain. On the one hand, the
submission of information from global suppliers to local importers may be
encouraged by the option of global suppliers to submit data in the form of an
overseas notification statement and the data for the submission rather than in a
form required by a NICNAS notification. On the other hand, any reluctance to
share information, especially with small local notifiers because of concerns
with confidentiality would not be relieved by this measure.
The use of
overseas assessments is likely to decrease costs for notifiers with access to
overseas notification statements.
Given no compromise of the present NICNAS Schedule of Data Requirements, the
use of overseas assessment reports per se is likely to have minimal
impact on the quality and extent of regulation of chemicals in Australia.
Therefore, the use of overseas notification statements is unlikely to impact the
community.
Conclusion and Preferred Option
A number of
submissions commented favourably on the current Australia-Canada bilateral
arrangements. This arrangement presented a good model on which to base further
bilateral arrangements. Industry has indicated its keenness for Australia to
commence negotiations with a number of other countries. Therefore, the
recommended option is that industry and NICNAS further cooperate to identify and
pursue agreement with countries of similar regulatory standards where bilateral
arrangements may present opportunities for cost-effective progress with
bilateral agreements.
Additional bi-lateral arrangements can improved
the efficiencies of the schemes co-operating in bi-lateral arrangements and
reduce duplication in data generation requirements on industry. NICNAS
presently allows overseas assessment reports to be submitted and this should be
encouraged. The NICNAS document, Transitional Arrangements Towards Approval of
Approved Foreign Schemes (Chemical Gazette C11 6 November 2001) outlines
criteria for a foreign assessment report acceptable to NICNAS and attracting up
to 40% rebate in notification fee. Extending bi-lateral arrangements could have
widespread benefits for a high proportion of NICNAS notifiers (ie. >30%) with
savings in time and costs, although these savings are difficult to quantify at
present but could include at least the 40% rebate in current notification
fees.
ATTACHMENT C
Certain polymers are exempt from notification and assessment in overseas
regulatory schemes. Under NICNAS, all new polymers must be notified and
assessed, although the scheme provides for an abbreviated assessment for
synthetic polymers of low concern (PLC). Therefore, under the current
arrangement, the costs incurred by industry in compiling a notification package,
and assessment by NICNAS, do not match the level of hazard or risk of the
polymers assessed.
In addition, other polymers which may not satisfy the
PLC criteria are subject to notification and assessment at a level which may
also not match their level of regulatory concern or risk. This is due partly to
a lack of flexibility in the scheme.
The overall objective is to develop feasible options for notification and
assessment of industrial chemicals of low regulatory concern, which would
enable:
• alignment of regulatory input from industry and government to
perceived risk; and
• sufficient knowledge and/or information of
occupational health and safety, public health and environmental risks of the
chemical, while maintaining regulatory standards for OHS, public health and
environmental risk assessment.
The specific objectives of the Polymer
Technical Working Group are to:
• simplify the polymer notification and
assessment process, including the PLC category;
• identify low
hazard/low risk scenarios that may be applicable to self-assessment by the
introducer or streamlined assessment by NICNAS;
• identify certain
classes of polymers that may be considered as LRCC; and
• maximise use
of overseas assessments for polymers.
The Project has been divided into two parts, PLC and Other Polymers (Low
Regulatory Concern Polymers, abbreviated as LRCPs), with options developed for
each. LRCPs have been defined by the technical group as those polymers which do
not meet the PLC criteria but, for one reason or another, do not warrant a
complete assessment. LRCPs would include other classes of low hazard polymers,
analogues, polymers assessed overseas and polymers with standard use/exposure
profiles (see list below). Work is required to develop the LRCP
criteria.
The technical group is of the view that the PLC criteria have
served the scheme well as they are scientifically based and have worked well in
identifying low risk polymers. Approximately 5-10% of PLCs have some degree of
health or environmental risk associated with their introduction, however, this
risk is usually detected during the pre-screening phase before assessment by
NICNAS.
Also, approximately 5-10% of polymers notified as PLCs do not
meet the criteria. Conversely, approximately 5-10% of polymers notified as a
Limited or Standard Notification meet the PLC criteria. This reflects a 90-95%
success rate by notifiers in self-assessing their polymers against the PLC
criteria.
Typical LRCPs, as defined above, will include the
following:
• polymers of certain classes which are of low hazard and
risk;
• polymers chemically similar to polymers already assessed by
NICNAS (analogues);
• polymers composed of similar
reactants;
• consolidated notification, where more than one polymer can
be notified and assessed together;
• polymers used in accordance with
standard use profiles, developed by industry and NICNAS;
• polymers
used in a controlled environment;
• polymers manufactured, formulated
or used on certain approved sites;
• low concern polymers which are
hazardous substances due to residual monomer content (currently polymers cannot
be PLCs if the residual content of a hazardous monomer is above the
concentration cut-off); and
• polymers assessed in overseas regulatory
schemes.
The PLC criteria already in use by NICNAS have proved to be robust and
predictive after some 6 years of use. The criteria details are listed for
information:
The first option is a tiered approach to notification and assessment,
proportional to the level of regulatory concern, for example, based on volume,
hazard and/or use pattern. It is a flexible approach to assessment where the
level of assessment required for the LRCP (and PLC in a small number of cases)
would be determined during the two-week pre-screening phase and would depend
upon factors such as volume of introduction, hazard status and use pattern
(exposure profile). Polymer added to AICS.
The second option is a modular
approach to notification and assessment where only those aspects of the risk
assessment causing concern, for example, OHS or environment, would be assessed.
It is another flexible approach to assessment where the scope of assessment
required for the LRCP (and PLC in a small number of cases) would be determined
during the pre-screening phase. Polymer added to AICS.
The combined low concern polymer option consists of a number of parts, as
listed below. The option is a special case of those options presented above for
PLC and LRCP and is dependent on the hazards of polymer classes.
Part
A: Total exemption from assessment, notification only (experience built on
10 or more past assessments, foreign scheme information and other available
reference material), 10% audit of notifications, AICS listing
Certain
classes of PLC, all with number-average molecular weight (NAMW) >
1000
Information to be provided: identity [CAS, chemical name, chosen
broad generic chemical name], use, volume, signed statement that MW, FGEW and
charge density meet PLC criteria
Part B: Self assessment and notification only (experience built on 10
or more past assessments, foreign scheme information and other available
reference material), 10% audit of notifications, AICS listing
Classes of
polymer in Part A but NAMW < 1000 or 500-1000, and other classes of PLC with
NAMW > 1000
Information to be provided: identity [CAS, chemical name],
use, volume, signed statement of conformity to PLC criteria, GPC of MW.
Analogues may be used to substitute data for notified polymer.
Part
C: Full assessment as per current PLC practice with potential to request
further information, no audit, AICS listing
Other classes of PLC in Part
B but NAMW < 1000, and non-PLC classes of polymer with NAMW > 1000 [these
are polymers which would currently be Limited or Standard
notifications]
Information to be provided: as per current PLC data
requirements, or less; overseas notification if applicable. Analogues may be
used to substitute data for notified polymer and justify immediate
introduction.
Parties directly affected by the polymer reforms are:
• industry, in
particular, the chemical industry and including small business;
and
• government.
Parties indirectly affected are workers and
the public at large. Also indirectly affected is the environment.
The Industrial Chemicals (Notification and Assessment) Act 1989 and associated regulations will require amendment.
In all cases, the level of assessment proposed is less than under current
arrangements.
No additional costs to industry or government. The only indirect costs are to
workers and/or the public where a polymer with some risk to human health and/or
the environment is either added to AICS without a risk assessment, or is not
added to AICS. Approximately 5-10% of PLC have an identifiable risk, for
example, a cosmetic polymer with eye irritant properties.
Reduction in costs to industry and government through reduction in fees and
notification costs (industry, including small business) and reduction in
assessment costs (government). In addition, industry would benefit from earlier
introduction of the polymer. Industry also claim that more new polymers would be
introduced, that is, easier access to new technological developments.
As for PLC1, except that no indirect costs to workers and/or the public would
be expected as PLC with an identifiable risk would be assessed by NICNAS, albeit
at a reduced level. If the PLC was assessed, costs would vary dependent on level
of assessment determined at the pre-screening stage
As for PLC1.
Costs less than current, however, still some costs to industry and government
due to NICNAS fees and costs associated with compiling a notification
package.
Costs less than current and therefore overall reduction in costs to industry
and government. No effect on workers and public as risk assessment of all PLC
would still be conducted.
No additional costs to industry or government. The only indirect costs are to
workers and/or the public where a polymer with some risk to human health and/or
the environment is added to AICS without a risk assessment. As for PLC, it would
be expected that some LRCPs would have an identifiable risk.
Reduction in costs to industry and government through reduction in fees and
notification costs (industry, including small business) and reduction in
assessment costs (government). In addition, industry would benefit from earlier
introduction of the polymer. Industry also claim that more new polymers would be
introduced, that is, easier access to new technological developments.
As for LRCP1, except that no indirect costs to workers and/or the public
would be expected as LRCPs with an identifiable risk would be assessed by
NICNAS, albeit at a reduced level. Costs would vary dependent on level of
assessment determined at the pre-screening stage. Indirect effect on workers and
public expected to be minor as level of risk assessment determined during
pre-screening stage, however, in most cases, risk assessment would be less
detailed than under current arrangements.
As for LRCP1. Costs substantially less than under current arrangements and
therefore overall reduction in costs to industry and government.
Costs substantially less than current, however, still some costs to industry
and government due to NICNAS fees and costs associated with compiling a
notification package.
Costs substantially less than current and therefore overall reduction in costs to industry and government. No effect on workers and public as risk assessment of all LRCPs would still be conducted.
No additional costs to industry or government. The only indirect costs are to
workers and/or the public where a polymer with some risk to human health and/or
the environment is added to AICS without a risk assessment. For example,
approximately 5-10% of PLC have an identifiable risk, for example, a cosmetic
polymer with eye irritant properties, and some LRCPs would also be expected to
have some identifiable risk.
Reduction in costs to industry and government through reduction in fees and
notification costs (industry, including small business) and reduction in
assessment costs (government). In addition, industry would benefit from earlier
introduction of the polymer. Industry also claim that more new polymers would be
introduced, that is, easier access to new technological developments.
There is general agreement that the level of notification and assessment
for polymers should be proportional to the level of risk, and that there is
ample scope for considerable simplification of the polymer process without
compromising the risks to workers, the public or the environment. All the
options proposed result in reduction of costs to industry and
government.
For PLCs, a much-simplified process is desirable, with little
or no assessment required, and the polymer added to AICS. However, as a risk is
identified in approximately 5-10% of cases, a risk assessment when necessary is
required to provide a safeguard to workers, the public and the environment.
Therefore Option PLC2 is the preferred option for PLC as it will deliver
substantial benefits to industry and government while upholding the objectives
of the scheme. One option (PLC1b) was not to add PLCs to AICS, however, many
companies have search mechanisms and systems which rely on the listing of the
substance on AICS before a product can be released for sale (Table 3
-1a).
For polymers which do not meet the PLC criteria, a flexible
approach is required to cater for other low hazard polymers and polymers which
do not warrant a full risk assessment (LRCPs), for example, analogues of
assessed polymers and polymers used in accordance with a standard controlled use
profile. Therefore the preferred option for these polymers is Option LRCP2,
where the level of risk assessment is determined during a 2-week pre-screening
phase. For some low hazard classes of polymer, no risk assessment may be
required, that is, as proposed for most PLCs. For other polymers, a lower level
of assessment will be required, using the tiered or modular approaches
described. The benefits of this option are substantial, as it will deliver
reduced costs to industry and government while providing a safeguard for human
health and the environment. Criteria will be required for other low hazard
polymers and guidelines to cater for analogues and controlled use
scenarios.
Options PLC1 and LRCP1 are not preferred as chemicals would be
added to AICS without assessment (or not added to AICS at all) and without
providing a safeguard for the proportion of polymers, albeit small for PLC, that
warrants some level of risk assessment.
Options PLC3 and LRCP3 are not
preferred as they would require a risk assessment for all polymers and, due to
the fixed set of data requirements, would not provide a flexible approach to
polymer notification and assessment. Costs would be highest and benefits least
for these two options.
The Combined PLC/LRCP Option is not preferred as,
with its focus on polymer classes, it covers a subset only of the PLC2/LRCP2
Options, but without the provision of safeguards warranted for some
PLC/LRCPs.
In summary, the overall benefits to industry from the
preferred options are a streamlining of the notification and assessment process,
earlier introduction of new polymers and encouragement to introduce more low
hazard polymers. Of particular benefit to small business would be the reduction
in data requirements, due to the difficulty small business has in accessing data
generated overseas.
Government would benefit by the reduction in
assessment costs as its resources could be directed towards chemicals of greater
hazard and risk.
The impact of the preferred options on workers is
expected to be minimal, due to the provision of safeguards to cater for polymers
where some risk to workers is identified. Similarly, the impact of the preferred
options on the community is expected to be minimal. PLCs and LRCPs are generally
of low risk to the public at large, however, where potential exposure of the
public is possible, for example, cosmetics, safeguards will allow the assessment
of public health risk where necessary. It is expected that some form of
published report or information will still be available on the NICNAS web site
for polymers identified as PLCs or LRCPs.
In addition, safeguards
provided for in the preferred options should allay concerns for polymers where
some risk to the environment is identified.
ATTACHMENT
D
In Australia, new chemicals require a full standard notification package
regardless of their similarity or analogy to other chemicals previously assessed
by NICNAS since its inception in 1990.
Industry has claimed that in
many cases such analogue chemicals represent no greater risk to human health and
the environment than an analogue already assessed by NICNAS. However,
manufacturers or importers are required to submit similar notification packages
with similar fees to those required for a standard new chemical notification. As
well as the assessment periods and the financial costs involved for analogues,
there are also potential issues such as additional animal testing and use of
regulatory resources that could be better utilised in the evaluation of
non-analogue chemicals. Additionally, industry has also raised concerns about
the lack of documentation and consistency of one-off decisions that have been
made by concerning analogues in the past.
The problem therefore
facing NICNAS and industry is to develop a mechanism to demonstrate that a
notified chemical has a similar “pattern of activity” to an
analogous chemical already assessed, thus fast-tracking the assessment process
without compromising human health and the environment. To address this problem,
the LRCC Task Force has initiated the NICNAS Analogue Working Group (AWG) to
explore and develop initiatives in this area.
The overall objective is to develop feasible options for notification and
assessment of industrial chemicals of low regulatory concern that would
enable:
• alignment of regulatory input from industry and government to
perceived risk; and
• sufficient knowledge and/or information of
occupational health and safety, public health and environmental risks of the
chemical while maintaining regulatory standards for OHS, public health and
environmental risk assessment.
Therefore, the objectives of the AWG as a
project group under the Low Regulatory Concern Chemical task force is as
follows:
• define chemical “analogue”;
• describe
the different types of analogues that may be expected to be notified, and their
suitability for a lower degree of regulatory input (for example stereoisomers
and salts of a chemical);
• suggest other likely or known scenarios
where a reduced level of regulatory scrutiny may be warranted for defined
analogues;
• suggest alternatives to current assessment procedures
which may allow for reduced regulatory input from both industry and
government;
• provide an overview of the regulatory impact that
suggested changes to NICNAS policies or the Industrial Chemicals
(Notification and Assessment) Act 1989 (the Act) may produce;
and
• propose preferred option(s) that maintain current high regard for
occupational health, public health and environmental protection.
There currently exists no mechanism to fast track the assessment of analogue chemicals via reduced testing requirements, even though, both in Australia, and overseas, a standard notification may often rely on analogue data for determination of their toxicological and environmental endpoints. Other countries such as New Zealand and the United States make allowance for chemical analogy in the assessment of new chemicals and in some circumstances provide a specific notification pathway for such chemicals.
In chemistry, an analogue can be defined as a compound similar in
structure to another compound but differing in some slight structural detail. It
is important to note however that while the differences in structure may be
slight, a chemical compound with a structure similar to that of another but
differing from it with respect to a certain component may have a similar or
opposite action metabolically.
The following elements are basic requirements for a chemical to be considered
an analogue of another:
• similar molecular size and
structure;
• contains some substructure that may play a critical
functional role;
• similar molecular property eg. lipophilicity,
electronic or steric parameters; and
• is related through some
precursor, metabolite or breakdown product.
As to what constitutes an analogue (for the purposes of notification) has
yet to be determined, it is impossible to provide an all-encompassing solution
to the problem of fast tracking the assessment process for such chemicals.
However, regardless of how close the structural relationship is between a
notified chemical and one listed on AICS list, a minimum data package would
still be required.
For physico-chemical, toxicological and environmental
endpoints, the minimum data requirements are yet to be finalised. However, it
may be that for toxicological endpoints, it is envisaged that in determining
what data is required consideration is given to animal welfare issues.
If the notified chemical is deemed to be unsuitable for assessment as
an analogue the notifier will be required to notify under one of the existing
notification categories. It has been suggested that Self-assessment may be an
alternative to this option, however it is agreed by the AWG that at least some
degree of review by NICNAS should be preserved.
In the case where a new chemical and several analogues are notified
together the notifier will be required to nominate the primary analogue which
will be assessed as a new chemical for which a certificate will be issued. It is
proposed at this stage that each additional analogue will be treated as an
“extension” to the original assessment certificate however the most
appropriate method of administrating such a scenario is yet to be
determined.
• the chemical of the highest concentration is the primary analogue and
is the chemical which appears on the assessment certificate. The notification
for the primary analogue is treated as a Standard or Limited Notification based
on existing criteria with regard to fees and timeframes;
• each
additional chemical becomes the subject of an extension to the assessment
certificate for the primary analogue with appropriately reduced timeframes and
modular fees.
It is not within the scope of this paper to develop specific criteria
which may be applied to a chemical to determine whether or not it is suitable
for a reduced level of regulatory scrutiny
Reduced cost of notification package due to reduced
toxicological/ecotoxicological testing
As these chemicals will have an analogy to chemicals already being imported,
produced and used in Australia, no additional impact is anticipated.
Appropriate use of assessment resources based on activity based costing
model.
Overseas counterparts such as the US EPA use data generated by SAR
software in the pre manufacture process. NICNAS may need to consider the
acquisition of SAR (or QSAR) software as part of a hierarchal approach, where
there are concerns that the notified chemicals may not have the same
“pattern of activity” to the analogous assessed chemical (eg as a
screening exercise to ensure that the notified and assessed chemical both
have the same QSAR/SAR profile). Acquisition of SAR or QSAR software by NICNAS
could be used as an additional (confirmatory) tool in analogue assessment. Cost
of such software is in the order of up to $100,000. Considerable resources may
be required in the development of scientific criteria to be used in Tier 1
analogue assessment.
Reduced assessment timeframes and fees in comparison to a standard
notification.
Reduced cost of notification package due to reduced
toxicological/ecotoxicological testing
Though these chemicals may have an analogy to chemicals already being
imported, produced and used in Australia, NICNAS may request additional
information on uses of the chemical and public exposure. This will ensure the
ongoing protection of the public health.
The determination the suitability of a chemical for analogue assessment will
require a combined high level of chemical and toxicological expertise. NICNAS
will need to ensure the acquisition and development of staff so that
intellectual resources are maintained.
Overseas counterparts such as the
US EPA use data generated by SAR software in the pre manufacture process. NICNAS
may need to consider the acquisition of SAR (or QSAR) software as part of a
hierarchal approach, where there are concerns that the notified chemicals may
not have the same “pattern of activity” to the analogous assessed
chemical (eg as a screening exercise to ensure that the notified and
assessed chemical both have the same QSAR/SAR profile). Acquisition of SAR or
QSAR software by NICNAS could be used as an additional (confirmatory) tool in
analogue assessment. Cost of such software is in the order of up to
$100,000.
Reduced assessment timeframes and fees in comparison to a standard
notification
As these chemicals will have an analogy to chemicals already being imported,
produced and used in Australia, no additional impact is anticipated.
Appropriate use of assessment resources based on activity based costing
model.
The option allowing for minimum regulatory input would be in developing
criteria that provide a reduced (minimum) test package for defined analogues
– Tier 1 Analogue Assessment. However, developing such criteria may prove
difficult, and may not provide the level of robustness required to adequately
deal with a variety of analogue chemical scenarios. Nevertheless, in the
meantime, this should not prevent implementation of changes to current practices
which could reduce the level of regulatory input in the assessment of chemicals
analogous to previously assessed chemicals such as Tier 2 Analogue Assessment by
NICNAS. In the absence of a defined reduced test package NICNAS could still
evaluate available analogue data and determine what toxicity tests (if any) are
initially required. It should be noted, that the results of these requested
tests would determine whether further testing is required. Regardless of the
amount of analogue data available there will always be a level of uncertainty
associated with a chemical on which a complete suite of toxicological tests have
not been performed. A conservative approach to assessment of analogue chemicals
is necessary to minimise these risks.
The systematic evaluation of
analogue chemicals and the documentation of decisions made concerning analogue
notifications would ensure consistency regardless of the type of analogue or
situation. Decisions made and knowledge gained from Tier 2 assessments could be
used in the development and refinement of Tier 1 Analogue Assessment criteria,
which could be implemented in the future.
The application of a
case-by-case option should not exclude the future development of other options.
Once established on a case-by-case basis, analogue chemicals would then be
subject to modular assessment which would significantly reduce notification
costs, reduced data preparation costs and reduce the timeframe for assessments
and permits. The changes are expected to have widespread benefits to a high
proportion of NICNAS notifiers (ie.>30%) and could result in a high costs
savings. Exact figures cannot be quantified at this
time.
ATTACHMENT E
NICNAS currently allows situations where new industrial chemicals are
exempt from notification and assessment. Other Alternative Pathways for LRCC
identifies low risk situations for the introduction of new industrial chemicals
under exemption or by administrative processes that are not effectively covered
by the other Options for Change identified in this document.
Certain situations for the introduction and use of new industrial
chemicals do not achieve a balance between notification and assessment
requirements under the Act and the anticipated low risk of introduction and
handling of chemicals in such situations in Australia. These situations can be
clearly defined. There is a need to redress the balance between regulatory input
and risk for these defined situations to better utilise regulatory
resources.
Four situations have been identified with scope for redressing
the current regulatory resource imbalance.
These are:
a)
Research, Development and Analysis Chemicals
New chemicals
introduced for research, development and analysis purposes in quantities
exceeding 50kg/12 months currently need to be notified and assessed by NICNAS
for an assessment certificate or permit. There is little information available
as to the value of the current volume limit for introduction. The category is an
exemption, so NICNAS cannot accumulate notification statistics. In addition,
given NICNAS finite resources for compliance activities, to date this area has
necessarily been given low priority. Some introducers would have knowledge of
their obligations to notify chemicals under NICNAS, especially those conducting
R, D & A projects within the traditional chemical industry. Other
introducers supplying chemicals to education or research institutions for
example may not see themselves as falling under the auspices of the Act. NICNAS
has no readily available figures on how many R, D and A chemicals are notified,
but at least some of the chemicals notified in the Commercial Evaluation Permit
(CEP) system or Low Volume Chemical (LVC) permit category would be R, D & A
chemicals that were to be introduced above the 50kg/12 month threshold.
b) Transhipment
That is, where
chemicals are off loaded at an Australian port of entry and remain in
containment in the country for a short period. These new chemicals fall within
the scope of NICNAS. Irrespective of the length of time the chemicals are off
loaded and the fact that the risk to workers, the public and the environment
would be low (except for accidental release), the importer is responsible for
compliance with ICNA. Unless the chemical qualified for an exemption, the
importer would need to apply for a NICNAS assessment certificate or permit prior
to introduction. NICNAS has no information on the extent to which transhipment
of new chemicals occurs, having received few if any notifications and not having
pursued compliance activity in this area.
c) Exemption for Low Volume Non-Cosmetic
Chemicals
There is a current exemption for introduction of new
industrial chemicals for volumes not exceeding 10kg per 12 months, unless the
introducer knows that the chemical is of unreasonable risk to occupational
health and safety, public health or the environment. NICNAS has incomplete
statistics on industry use of this exemption, because notice of introduction is
not mandatory. In addition, given NICNAS finite resources for compliance
activities, to date this area has necessarily been given low priority. Volumes
greater than 10kg need to be notified and assessed by NICNAS for a permit or
certificate. This can be restrictive and costly if proposed introduction volumes
are higher than 10kg. Introducers are then required to notify the new chemical
even if they are confident that the chemical is not of unreasonable risk.
d) Repeated applications for Low Volume Chemical Permit and Commercial
Evaluation Category Permit
Currently applicants need to provide a
new notification package and assessment fee, including a new application for
exempt information, to renew an existing permit, irrespective of whether or not
there has been a change in circumstances relevant to the original NICNAS risk
assessment and the Permit Conditions for safe use of the chemical. This
demonstrates inequity between industry resources to re-apply and NICNAS
resources to re-process an application similar to the original.
The objectives are to define conditions that would enable more efficient
introduction of new industrial chemicals in these clearly defined low risk
situations, facilitate industry compliance with NICNAS, while maintaining
regulatory standards for OHS, public and environmental risk
determination.
Options
Option 1a – No change to existing ICNA provisions, ie. exemption
from notification and assessment by NICNAS for introduction of up to and
including 50kg/12 months.
Option 2a – Increase allowable
introduction volume to 100kg/12 months for an individual introducer without
notification and assessment by NICNAS. In addition, introducers would be
required to keep records of quantities for a period of five (5) years, to be
produced for NICNAS upon request. This option would require legislative
change.
Options for either complete exemption or larger volume thresholds
are not proposed.
Parties affected include industry, chemical users, the Government
(NICNAS), human volunteers, and the community.
Option 1a –
Maintains the existing situation. This assumes that the risks to workers in
industry and educational and research institutes, and the environment are
effectively controlled for the specialist use and low volume involved. The
public at large would not be exposed to R, D & A chemicals, with the
exception of volunteers involved in human trials regulated by ethics committees.
R, D & A introductions are unlikely to attract substantial NICNAS compliance
investigations. While it is not known how many chemicals introduced for R, D
& A successfully fall within the exemption, or how many introducers fail to
notify if threshold is exceeded, we can assume that some chemicals notified in
the CEP or LVC category are R, D & A chemicals. To notify in the either
category for 51-100kg/12 months represents a high cost for introducers, in
comparison with any increase in risk likely to be associated with chemical
volumes above the current low threshold.
Option 2a – increases
the current introduction threshold to 100kg/12 months for an individual
introducer and specifies that records of introduction are to be kept for five
years for inspection by NICNAS upon request. The new threshold doubles
introduction volumes under exemption from the current low base to an increased
but still low level. The threshold is consistent with the R, D and A threshold
currently in place in the European Union (noting that the EU chemicals
regulation is under substantial review), and below that of Canada. The USA has a
“not greater than necessary...” volume limit. By default the
increased volume would increase industry compliance with ICNA. It would assist
some introducers who would otherwise need to notify 51-100kg/12 months of low
risk chemical through the CEP or LVC categories. The requirement for record
keeping would make it easier for NICNAS to undertake targeted compliance
investigations and reports on outcomes, since introducers would know to keep
records and expect that NICNAS would ask to see them. There is little additional
risk involved in doubling the R, D & A threshold to 100kg/12 months. The
chemicals are generally contained in a controlled workplace, and the risks to
workers in industry and educational and research institutes and environment are
managed by the specialist and/or supervised use. In addition, the public at
large would not be exposed to R, D & A chemicals. Human volunteers involved
in research trials would operate under consent agreements.
Option 1b – Status Quo. Unless covered by a current ICNA Act
exemption, new industrial chemicals off-loaded from ships or planes are
determined to be introduced and need to be notified and assessed by
NICNAS.
Option 2b – Transhipment Exemption for new industrial
chemicals off-loaded at an Australian port of entry for a period not exceeding
thirty working days (or another as yet undetermined reasonable period) and where
chemical is not processed in any way, including repackaging, prior to shipment
from Australia. NICNAS would not need to receive a notice of introduction,
or a notification and assessment package, and would not conduct a risk
assessment.
Options for an exemption with no time limits, exemptions
based on volume and/or time limits, or notice to NICNAS of transhipped chemicals
are not proposed.
Parties affected include industry, transport and storage workers, the
Government (NICNAS), and the community.
Option 1b – Maintains the existing situation where importers
responsibilities in this situation are not clearly defined within ICNA and the
regulatory input for importers who do comply in notifying chemicals in this
situation to NICNAS is not balanced by the risk to health and the environment
posed by temporary introduction of chemicals retained in containers.
Consequently, NICNAS currently receives very few if any notifications for
chemicals in transit and NICNAS compliance activity is difficult to institute
and is rarely if ever pursued. This option maintains the current impacts on
industry, workers, the Government and the public. It is highly likely that
industry is introducing new chemicals by transhipment without understanding that
they need to comply with ICNA. Workers would be transporting and storing such
chemicals under current regulations for transport, storage and handling of
dangerous goods and control of workplace hazardous substances, the Government
(ie. NICNAS) rarely if ever receives information on these chemicals, and the
public is unaware of any impact.
Option 2b – seeks to regularise
the regulatory environment under ICNA for new industrial chemicals in
transhipment. It brings transhipment ICNA responsibilities to the attention
of introducers, allows for short term introduction and re-export, noting that
there are existing controls for labelling, transport, storage and handling of
dangerous goods and workplace control of hazardous substances to deal with
accidental release, and sets a boundary for the exemption timeframe, to overcome
situations where chemicals may be left for long periods in storage. There is an
impact on industry because ICNA will clearly state that NICNAS will need to be
notified if the exemption timeframe is likely to be exceeded. There would be a
positive impact on workers handling the chemicals because fewer chemicals should
remain in long-term storage which involves an increasing risk of container
damage or leakage and increased chance of a break in the chain of those
responsible for the chemical (ie. changes in personnel, or company). The impact
on Government is that NICNAS should expect an increase in notifications, though
we have little information to gauge what this would be. The clearer industry
responsibilities and timeframe for the exemption give a handle for NICNAS to
commence basic compliance activity. There would be little direct public benefit
in relation to exposure to off loaded chemicals. However there would be more
information available on chemicals introduced to Australia through notifications
and compliance activity.
Option 1c – status quo under ICNA, where the current volume
restriction for introduction of a new industrial non-cosmetic chemical under
exemption is 10kg per 12 months.
Option 2c – to increase
the volume allowable under the exemption for non-cosmetic chemicals to 100kg per
12 months, per individual introducer. The existing proviso for this category
remains, namely that the introducer knows that the chemical does not pose an
unreasonable risk to occupational health, public health or the environment.
Include that introducers need to keep records of introduction and risk
assessment for a period of five years, to be produced for NICNAS upon request.
This option would require legislative change. The option is consistent with
another new proposal to increase the allowable exemption volume for cosmetic
chemicals to 100kg per 12 months.
Options for larger exemption volumes
are not proposed.
Parties affected include industry, the Government (NICNAS), and the
community.
Option 1c – To retain the exemption for non-cosmetic
chemicals at 10kg per 12 months, unless the introducer knows that the chemical
is of unreasonable risk to occupational health and safety, public health or the
environment. The main impact with maintaining the existing volume threshold
is on industry, because companies are obliged to incur the costs of notifying in
another NICNAS category for volumes greater than 10kg. The most common category
would be the Low Volume Chemical (LVC) category. In 2001-02, NICNAS issued 44
LVC permits, accounting for a total of $114,400 in assessment fees. At least
some of these permits would have been for chemicals of not unreasonable risk at
proposed introduction volumes. There is little impact on the Government because
it is not mandatory for introducers to give notice of chemicals that fit within
this exemption and consequently little regulatory resources are expended in
regulation. There is little impact on the public because cosmetic chemicals are
not included. Should the chemicals be used in other consumer or domestic
products, the low volume (up to 10kg) implies that the products either have
limited distribution, or that the end use concentration would be low in products
distributed widely.
Option 2c – increase the allowable introduction threshold to
100kg per 12 months and specifies that records of introduction and risk
assessment are to be kept for five years for inspection by NICNAS upon
request. There would be a positive impact on industry for chemicals known
not to pose an unreasonable risk, because volumes from 10-100kg would not need
to be notified and assessed by NICNAS. Previously these would have most likely
been notified in the LVC category. The change would place a higher
responsibility on NICNAS to confirm that introducers know the risk to workers,
the public and the environment of the chemicals being introduced under
exemption, and are effectively managing that risk. The requirement for industry
record keeping would make it easier for NICNAS to conduct targeted compliance
investigations and report on outcomes. There would be some community impact
because the NICNAS risk assessment process currently conducted on chemicals
introduced at volumes between 10 and 100kg would not take place. The impact
would depend on the balance of industry assessment of risk and NICNAS compliance
activity.
Option 1d – status quo under ICNA, to require a new application
package plus full fee to re-assess and process renewed applications for LVC
permits and CEP. This is an anomaly when the re-application contains no new
information relevant to the original risk assessment done by NICNAS and the
existing permit conditions set by NICNAS
Option 2d – To
institute a simplified, administrative process at NICNAS to deal with
application for renewal for LVC permits and CEP. The simplified process
would only apply if the applicant had not received any information indicating a
change to the original risk assessment done by NICNAS and the existing permit
conditions set by NICNAS.
Option 1d – maintains an inequitable situation. The anomaly
has an adverse impact on industry resources needed to compile re-applications
and pay another assessment fee. The anomaly is of benefit for NICNAS in that
fewer resources are needed to assess the re-application, as the same fee is
provided. The anomaly is of no public benefit, because the original risk
assessment and permit conditions remain relevant to the
reapplication.
Option 2d – introduces a new administrative
process. It would benefit industry because renewals would be faster and
justify a lower NICNAS fee. If the circumstances have not changed, there would
be no adverse impact on workers, the public or the environment. It is noted that
this assumes the facility to use the quicker and cheaper administrative route
does not act as a disincentive for applicants to provide new and relevant
information at the time of re-application. Government (NICNAS) would benefit
because an efficient administrative process would replace an assessment process.
.
Data from NICNAS records indicate to date that 5% (31/616) of CEP
applications and 14% (74/534) of LVC applications are renewals. This corresponds
to a cost in assessment fees of $273,000. This sum does not reflect the total
cost to industry of renewals because it does not take into account industry
resources in compiling applications, repeated applications for exempt
information, or increased costs for introducers who opted to apply for an
assessment certificate from the start, rather than a series of permits.
Conclusion and Preferred Options
The LRCC Task Force noted
that in certain situations for the introduction and use of new industrial
chemicals a balance between notification and assessment requirements under the
Act and the anticipated low risk of introduction and handling of chemicals in
such situations in Australia is not achieved. These situations can be clearly
defined. There is a need to redress the imbalance between regulatory input and
risk for these defined situations to better utilise regulatory resources.
Taking into account the views on the options from the public
consultation, the focus groups and the views of the LRCC Task Force, the
following preferred options are recommended as follows:
a)
Research, Development and Analysis Chemicals
Increase the current
exemption for Research, Development and Analysis from 50 to 100kg/12months, with
new record-keeping requirements for 5 years. This option will increase industry
flexibility to introduce new chemicals for R&D without notification and
assessment costs and will bring Australian exemptions in line with EU volumes.
By aligning Australian volume requirements with those of comparable overseas
schemes, Australian industry to be more competitive in a global marketplace.
b) Transhipment
Introduce a Transhipment Exemption for
instances when chemicals are off-loaded at an Australian port of entry and
remain in containment unopened for a short period (30 days) before reshipment
out of Australia. NICNAS would not need to be notified of introduction or
conduct a risk assessment. The exemption will clarify obligations for
introducers of chemicals in transhipment.
c) Exemption for Low Volume Non-Cosmetic Chemicals
Introduce an exemption for low-hazardous chemicals for volumes up to 100kg.
Records would be required to be kept for audit purposes with annual reporting to
NICNAS. In addition there should be an increase the general exemption for low
volume non-cosmetic chemicals in line with EU volumes, from 10kg to 100kg/12
months/introducer, maintain existing conditions and introduce new requirements
for record keeping for five years and an annual report to NICNAS. These options
will increase industry flexibility to introduce small amounts of new
non-cosmetic chemicals without notification and assessment costs. These
exemptions bring Australia in line with EU volumes. By aligning Australian
volume requirements with those of comparable overseas schemes, Australian
industry to be more competitive in a global marketplace. Guidelines for
“low hazardous” will need to be developed with the industry,
community and relevant government agencies.
d) Repeated
applications for Low Volume Chemical Permit and Commercial Evaluation Category
Permit
Permit renewals for the current Commercial Evaluation Category
and Limited Volume Chemical permits to be administrative rather than assessment
processes unless new data is available or the conditions of introduction have
significantly changed. These administrative changes will save industry time and
money. Currently a permit renewal process entails resubmitting an application
including a data package and paying the full permit fee, currently set at
$2,831. An administrative renewal will mean that industry will not be required
to resubmit a data package unless in exceptional circumstances and a lesser fee
of approximately $200 to $500 will apply.
The cosmetics industry is global, characterised by companies marketing
branded products across international boundaries. Despite its size, Australia
only accounts for about 1.2% of worldwide sales of cosmetic products. By the
very nature of the mix of companies and their product lines, this industry is an
extremely competitive one, with a high level of innovation, high product
turnover and market driven style changes. Many cosmetics are imported as
fully formulated and packaged products. The cosmetics industry, because of its
competitive nature takes measures to ensure product safety above regulatory
requirements. Market reality ensures that an unsafe product would destroy a
brand and have a significant detrimental impact on a company.
At
present, the regulatory requirements for “cosmetic products” are
identical to other classes of industrial chemicals, with the following
exceptions:
• <10kg per 12-month (for cosmetic use) NICNAS
exemption category, where additional safeguards are specified (ie. the chemical
is not introduced as a UV filter, colouring agent or preservative in a cosmetic
product, is not banned or restricted for use in cosmetics in Europe and/or the
USA, complies with relevant state/territory law, and if present in a mixture at
>1% concentration it is safe for use by sensitive subpopulations, consistent
with the anticipated pattern of consumer exposure).
• full ingredient
disclosure on cosmetic product labels, under the Trade Practices Act 1974
(TPA); and
• cosmetic products that make therapeutic claims are
regulated by the Therapeutic Goods Administration (TGA) under the Therapeutic
Goods Act 1989.
There appears to be two fundamental problems facing the cosmetics
industry in Australia, within the parameters of the low regulatory concern
chemicals reform initiative:
• When products are defined as therapeutic
goods in Australia, contrary to a cosmetic in some other countries, the TGA may
require additional assessment beyond that which would be required if the product
were regulated as a cosmetic.
• Industry argues that the lack of
cosmetic ingredients available for use in Australia compared to overseas
chemical inventories prevents the timely introduction of safe and acceptable
cosmetics (that are in use overseas) into
Australia.
Objectives
Within the context of the overall
objective of the LRCC, the specific objective of the Cosmetics Project is to
develop a framework and criteria for identification of chemicals in
cosmetic/personal care products as low regulatory concern and clarify the
cosmetic/therapeutic interface, to assist the efficient introduction of these
chemicals whilst maintaining regulatory standards for occupational health and
safety, public health and environmental risk determination.
The
following aims were identified to meet the specific objective of the Cosmetics
Project to:
• Broadly align with international cosmetic product
classifications and permissible international cosmetic ingredient lists to
minimise Australian specific data generation and/or
assessment;
• Review cosmetic definitions locally and internationally
and adopt one singular definition for Australia (across all agencies);
and
• Increase the efficiency of inclusion and therefore the number of
ingredients on the Australian Inventory of Chemical
Substances (AICS) eligible for inclusion in cosmetic products.
In order to meet the specific objectives listed above, the following
issues are identified. Options are presented for each issue.
a)
Cosmetics Definition
At present two definitions exist within the Australian regulatory system:
The Industrial Chemicals (Notification and Assessment) Act
1989 (the Act) defines a cosmetic as: “A product applied to a
person’s body for the purpose of its cleansing or care, colouring it,
influencing its smell, or otherwise changing its appearance or smell, without
affecting its structure or functions.”
The Trade Practices
Consumer Product Information Standards (Cosmetics) Regulations (1991)
defines a cosmetic product as “A substance or preparation intended for
placement in contact with any external part of the human body, including: the
mucous membranes of the oral cavity; the teeth; with a view to: altering the
odours of the body; or changing its appearance; or cleansing it; or maintaining
it in good condition; or perfuming it; or protecting it.”
Options
Option 1a - Identify one singular
definition. Adoption of a singular definition brings with it the following
advantages:
• avoids confusion and therefore increases
industry’s understanding and compliance with a single
definition;
• the potential to align with international definitions,
thereby minimising Australian specific data generation and/or assessment;
• the potential to include an indicative list of cosmetic products as
guidance for stakeholders; and
• all the above whilst maintaining
current health, safety and environmental standards.
In identifying a
single definition, it is prudent to broadly align with international cosmetic
product classifications to minimise Australian specific data generation and/or
assessment. The European regulatory scheme for industrial chemicals (with the
exception of polymers) is identified as the closest fit to the NICNAS scheme and
the definition of a cosmetic in the Cosmetics Directive aligns with the
definition in the TPA.
The Cosmetics Directive 76/768/EEC definition:
“A cosmetic product shall mean any substance or preparation intended to be
placed in contact with the various external parts of the human body (epidermis,
hair system, nails, lips and external genital organs) or with the teeth and the
mucous membranes of the oral cavity with a view exclusively or mainly to
cleaning them, perfuming them, changing their appearance and/or correcting body
odours and/or protecting them or keeping them in good
condition.”
Impact Analysis
The parties that may be directly affected by redefining a cosmetic are;
industry, and government, whilst a change may have an indirect effect on the
public, workers and the environment.
Industry
At present,
cosmetic products are labelled in accordance with the TPA and cosmetics
ingredients are regulated according to the Act. Therefore, industry is required
to maintain awareness of and comply with two definitions. The TPA also includes
an indicative list of product categories that serves as guidance to introducers
of cosmetic products. Industry familiarity with the definition in the TPA and
its guidelines potentially reduces the cost of compliance should the definition
in the TPA be adopted by NICNAS. This definition aligns very closely with the
European definition of a cosmetic. Alignment of Australian product categories
with international (European) cosmetic product categories potentially minimizes
Australian specific data generation and/or assessment.
Government
Revision of the current definition in the Act will
require one-off legislative amendment. A change in the NICNAS definition will
not impact on the TPA and associated regulations. The criteria for
classification of a product as a cosmetic or therapeutic, which is predominantly
based on product claims, will not be affected by a change in the NICNAS
definition.
Community, workers and the environment
Currently,
full ingredient disclosure is required on all cosmetic product labels, enabling
the user to be aware of the composition of a given product and avoid ingredients
to which they may be sensitive. Adoption of the TPA definition will not change
existing labelling requirements.
Revision of the definition under the
NICNAS Act will not influence current occupational health and safety standards
or labelling requirements as per the National Model Regulations for the Control
of Workplace Hazardous Substances.
A change in the definition of a cosmetic will not affect the NICNAS
assessment process, which includes an environmental assessment and
recommendations for safe use, as appropriate.
b) The Cosmetic/Therapeutic Goods Interface
When products are defined as therapeutic goods in Australia, the TGA may
require additional assessment beyond that which would be required if the product
were regulated as a cosmetic. Industry identifies the following
product categories (currently regulated as therapeutic goods) as candidates
for regulation as cosmetics:
• antiperspirants;
• mass market
anti-dandruff shampoos;
• moisturisers with SPF;
• antibacterial skin washes; and
• anti-acne
cleansers.
At present, the above product categories are subject to
varying levels of regulatory control by the TGA. See Appendix 3, Low Regulatory
Concern Chemicals, Public Discussion Paper (May 2003) for more information on
the current regulatory status of the above mentioned product categories.
Options
Option 1b - Re-classify certain product categories as
cosmetics. Any re-classification of product categories would need to be
undertaken in partnership with the TGA. Product categories may be considered (on
a case by case basis, if necessary) for reclassification as cosmetics, bringing
them under NICNAS regulation and aligned with international (European) cosmetic
definitions.
The reclassification would:
• be based on
transparent criteria (yet to be developed);
• align with international
definitions (in particular the European definition); and
• ensure that
all ingredients that remain in exempt therapeutic products as well as in
cosmetic products are regulated by NICNAS.
Option 2b - Retain
Therapeutic Goods as currently designated, with TGA to assess Exempt Therapeutic
Goods excipients. Currently, new excipients in exempt medicines, such as
antiperspirants and anti-dandruff shampoos, are not assessed by the TGA. This
option would ensure that all excipient ingredients in medicines are considered
by the TGA.
Option 3b - Regulate to create an Australian Cosmetic
Directive. To introduce a specific cosmetic directive based on the EU
Cosmetics Directive, Australia could adopt positive and negative lists for
approved or restricted ingredients from EU Annexes. Currently, the concept of
the negative list (prohibition) is maintained in Australia through poisons
scheduling, where products that contain scheduled ingredients are required to be
labelled CAUTION or POISON, thereby rendering marketing as a cosmetic generally
unacceptable.
Impact Analysis
Options 1b and 2b
These options relate to the interface between regulatory agencies that
administer separate legislation, therefore they should be considered within the
context of current regulation, both therapeutic goods and cosmetics. These
options will need to be progressed via a process that involves relevant
regulatory agencies and in consultation with stakeholders, prior to any further
impact analysis.
Creation of a cosmetic directive specifically for Australia would require
regulatory intervention, thereby it will have an impact on NICNAS. The
implications of such a directive on the current Australian poisons scheduling
process will need to be investigated. A directive has the potential to introduce
a cost and time burden to industry and as such is not supported by industry.
c) Volume/Concentration limits for
exemptions
Current exemption thresholds for cosmetics are based
on annual volumes. The general exemption threshold under NICNAS is 10kg per 12
months. However, it is a requirement that chemicals for cosmetic use
under this category require advice of introduction to NICNAS. The advice of
introduction requires the notifier to submit a summary self-assessment of the
human health and environmental effects of the chemical (to demonstrate the lack
of unreasonable risk) and a declaration that the introduction complies with
specified safeguards. This exemption category does not attract a fee. NICNAS
categories do not include exemptions based on concentration thresholds, at
present.
Under current arrangements:
• Advice of Introduction
at <10kg per 12 month for Cosmetic Use Exemption is checked (not assessed) by
NICNAS;
• The volume limits requiring “action” in Australia
are lower than those currently operating in Europe (ie. no advice of
introduction required for <10kg per 12 month chemicals);
• Multiple
<10kg exemption notifications for the same chemical may be submitted by
different companies. This has the potential to result in a cumulative volume
greater than the national limit for a single chemical of 100kg under a Low
Volume Chemical (LVC) permit;
• There is no recognition of safe use
history overseas of ingredients introduced as formulated products.
Option 1c - Alignment with current European notification
thresholds. At present, the European Directive has its lowest level
requirement beginning at 10kg to below 100kg. It has an exemption for volumes
under 10kg per 12 months and base set notification requirements for volumes
between 10 to 100kg. Under the proposed EU Strategy for Future Chemicals Policy,
it is proposed that notification will not be required for volumes of up to
1000kg and registration with basic information (chemical identity,
physicochemical data, toxicological and ecotoxicological data with testing
generally limited to in-vitro methods, use, exposure, hazard
classification, Safety Data Sheet, preliminary risk assessment and proposed risk
management measures) between 1 and 10 tonnes.
Under NICNAS, no
consideration is given to chemicals introduced at low concentrations in
mixtures. Notifiers are required to calculate the cumulative volume of each
chemical across the full range of products. This may be disproportionate to the
level of risk posed by these chemicals.
It is proposed that NICNAS
exemption and lower notification thresholds align with current EU thresholds as
follows:
• exempt all cosmetic ingredients with annual volumes of 10kg
per 12 months or less from notification; notifier to undertake risk assessment
and (a) determine that the chemical does not pose an undue risk to human health
and the environment; and (b) that it meets existing safeguards. Notifier to
retain this information that will be subject to NICNAS compliance
“spot-checks”.
• require notification for more than 10kg
up to 100kg per 12 months with Advice of Introduction; similar to the current
less than 10kg exemption notice with self-assessment statements, declaration of
compliance with current safeguards and submission of product label and MSDS. An
assessment will be undertaken by NICNAS and a permit issued as an outcome.
• introduce an Exemption “without advice” for chemicals
introduced in mixtures at 1% or less, provided they are not determined to be
hazardous substances as defined by the NOHSC Approved Criteria for
Classifying Hazardous Substances (including updates expected to be released
mid-2003 which will include appendices that provide guidance criteria for
classification based on physiochemical properties and environmental effects). No
volume threshold is proposed and the notifier is required to retain records that
will be subject to compliance audits by NICNAS.
Impact
Analysis
The parties that may be directly affected are industry, and
government, whilst a change may have an indirect effect on the public, workers
and the environment.
Industry
Alignment with current European thresholds for notification will reduce
industry compliance costs yet retain the accountability of the notifier to
ensure that the chemicals do not pose an unreasonable risk to human health and
the environment. Record keeping requirements will remain unchanged from the
present position. Introduction of an exemption category for non-hazardous
chemicals introduced at low concentrations in mixtures is expected to
significantly reduce the cost incurred by industry introducing new chemicals
into Australia.
Government
One-off amendment to the Act and associated regulations
will be required. NICNAS assessment resources will be utilised to check advice
of introduction notices for chemicals introduced at higher volumes than at
present. However, the reliance on NICNAS compliance activity will be increased
thereby shifting NICNAS resources from assessment to compliance activities.
Community, workers and the environment
The current requirement for a self-assessment by the notifier to ensure that these chemicals do not pose an unreasonable risk to human health and the environment and that existing additional safeguards are complied with remain unchanged. Record keeping requirements will be retained and such records will be subject to NICNAS audit.
d) Up-to-date access to information on assessed chemicals
Currently, information on chemicals assessed by NICNAS is made
available to stakeholders via several mechanisms. All new chemicals assessment
reports for certificate applications are published on the NICNAS web site and
available on request from NICNAS. Information on permits is made available
through the monthly Chemicals Gazette. Chemicals introduced under
exemption categories are not publicised, at present. The public section of the
AICS is available on CD-Rom and searches may be requested of NICNAS. The
confidential section of the inventory is not publicly available. Chemicals
granted NICNAS assessment certificates are listed on the inventory five years
after the certificate is issued. The list of chemicals awaiting AICS listing
(ie. those within the 5-year period) is currently retained in-house at NICNAS.
Option 1d - Improved access to information through on-line search
facility.
Institute an online facility, which would be regularly
updated by NICNAS that includes:
• a list of assessed chemicals
(permits and certificates). The list could be similar to the current
Chemicals Gazette entries for permit applications, with a link to the
public report for certificate chemicals; and
• the search facility to
include chemical names, trade name under which the notification was submitted to
NICNAS (only), alternate names, CAS number, and INCI nomenclature.
This
search facility will enable all stakeholders to access information on assessed
chemicals that is currently available via separate mechanisms.
Impact
Analysis
The parties that may be directly affected are; industry, government, the
public and workers.
Industry
Overall, the amount if information on assessed chemicals in the public domain
will remain unchanged, however, ease of access to this information will be
increased. This will be of benefit to industry.
Government
NICNAS will incur the cost of setting up and maintaining
the search facility on the web site. The change would be administrative in
nature therefore, will not require legislative changes.
The amount of information on assessed chemicals in the public domain will
remain unchanged, however, ease of access to this information will be increased.
Conclusion and Preferred Options
Taking into account the views
on the options from the public consultations, the focus groups and the LRCC Task
Force, the following the preferred options are
recommended.
o Cosmetics
Definition
Amend the definition of cosmetics currently used in the
Act to that used in the Trade Practices Act 1974 thus improving
consistency in the Government’s regulatory approach to cosmetics. This
aligns the Australian definition with European definition and should increase
stakeholder understanding and compliance with a single Australian definition.
The impact is likely to be widespread for a high proportion of NICNAS notifiers
(ie. >30%).
b) The Cosmetic/Therapeutic Goods Interface
Recognising that negotiations are ongoing between industry and the
Therapeutic Goods Administration (TGA), it is recommended that the Parliamentary
Secretary asks NICNAS and TGA to examine the reform options for addressing the
interface issues dealing with:
• antiperspirants,
• mass
market anti-dandruff shampoos,
• moisturisers with SPF,
• antibacterial skin washes; and
• anti-acne skin
cleansers.
A report on options should be provided to the Parliamentary
Secretary by December 2003. Addressing the interface issues between the
regulatory agencies, ie. NICNAS and the TGA have the potential to streamline
regulatory requirements and reduce industry compliance burden. However, further
work will be undertaken to determine the best way to proceed.
c) Volume/Concentration limits for exemptions
Introduce
audited self-assessment for all cosmetic ingredients with annual volumes of 10kg
per 12 months or less with the notifier to undertake risk assessment and (a)
determine that the chemical does not pose an undue risk to human health and the
environment; and (b) that it meets existing safeguards. Notifier to retain this
information that will be subject to NICNAS compliance audits and
“spot-checks” and an annual report to NICNAS.
This paragraph and bullets moved to
Recommendation 10
Safeguards for cosmetics will continue to include
that the chemical must not be used in the cosmetic as:
• a
preservative; or
• a colouring agent; or
• an ultraviolet
filter;
• the chemical must not be prohibited or restricted for use
as a cosmetic, or for use in cosmetics in the EU or USA under cosmetic
legislation;
• the chemical must comply with all relevant
federal/state/territory regulations; and
• if the chemical is present
in the cosmetic at a concentration of 1% or more, it must be safe for use by
high-risk groups consistent with its anticipated use pattern.
Recommendation 11 relates to cosmetic ingredients
(not non-cosmetic) – see Discussion Paper Page 30 second last bullet
point.
These two options will reduce overall industry compliance
costs, provides an incentive to introduce low risk chemicals on the Australian
market and introduces reduced assessment time frames for low volume chemicals.
The impact is likely to be widespread fro NICNAS notifiers (ie. >30%) with
significant savings in time and cost. It is not possible at this stage to
quantify potential cost savings at this time.
d) Up-to-date access to
information on assessed chemicals
An improved search facility will
enable all stakeholders to access information on assessed chemicals that is
currently available via separate mechanisms. It will reduce the compliance
burden on industry as there will be efficient access to timely information and
this will also improve public access to chemical safety information. This will
have widespread impact on NICNAS notifiers (ie. >30%) and should result in
time saving for industry.
ATTACHMENT G
Introduce mandatory registration of all chemical
introducers
Problem
Currently NICNAS does not engage directly with the broadest chemical
industry as its focus is on introducers of chemicals (importers and/or
manufacturers). Consultations have indicated that these current arrangements may
be better extended to cover all of the industry. For example, company
registration may be extended to cover those introducers below the current
threshold and/or some form of engagement with industry beyond the introducer, ie
the supply chain may need to be formalised with NICNAS. Industry members
also want the assurance that its reputation is not harmed by the actions of
those businesses who fail to comply with current regulatory requirements and
importantly those who may not comply with new approaches to assessment.
Objectives
To improve compliance and industry knowledge of NICNAS and to maintain
public confidence in the Scheme.
Options
Option 1 – Status quo for company registration
requirements with increased education and awareness raising campaigns targeted
at those introducers currently falling below the $500,000 registration
threshold.
Option 2 – A requirement for all
importers/manufacturers as defined under the NICNAS legislation to register with
NICNAS. Those businesses under the $500,000 threshold would not be required
to pay a registration fee, but would be required to notify NICNAS that they are
entities that are importing, distributing and/or manufacturing relevant
industrial chemicals. Companies falling under the current threshold would still
remain exempt from Company Registration fees, however given that NICNAS is a
fully cost recovered Scheme, and annual administrative fee would need to be
imposed to cover costs.
Impact Analysis
Option 1
Industry
No additional cost burden on industry, but
education and awareness raising may not reach all of the industry. It is a
requirement of the Act that all chemical introducers be reasonably aware of
their legal requirements whether they are registered or not with
NICNAS.
Government
Likelihood of increased awareness and
compliance by small companies is limited. The objects of the legislation require
chemical introducers whether they are registered or not, to protect worker
safety, public health and maintain environmental
standards.
Community
Confidence in the Scheme may suffer since
assurances that public health and environmental standards and worker safety are
met across the industry may not be met by all industry
participants.
Option 2
Industry
To
introduce mandatory registration can increase the compliance costs of those
small businesses currently exempt from Company Registration requirements under
the Scheme. The number of small businesses estimated to be exempt stands at
5,700, based on Customs data for the 2000-01 registration year. The LRCC Task
Force is of the view however, that the benefits will outweigh the costs in the
longer term and note that the only financial cost is likely to be a small annual
administrative fee (currently $300). The advantages of this option is that
NICNAS and the community will have better information about companies falling
under the scope of the legislation and NICNAS will be able to target its
information and education activities towards this sector.
Industry, and
in particular, small business compliance will improve since companies will be
more aware of their regulatory obligations because of the requirement to engage
directly with the NICNAS. In moving to full cost recovery in 1997, a tiered
approach to charges for Company Registration was introduced, exempting small
business under the $500,000 threshold. The exemption from Company Registration
does not exempt introducers from regulatory requirements. However, this may have
inadvertently happened and the threshold exemption may have unwittingly exposed
small business to compliance action.
The Register of Industrial
Chemicals Companies in Australia is a public list. The inclusion of all
businesses dealing with industrial chemicals on this list could open up business
opportunities for smaller companies as many larger companies source suppliers
from the Register. In addition, mandatory registration with a national
regulatory agency can enhance industry credibility along the supply chain as
well as with the general public.
Government
Additional
administrative burden will be off set by recouping costs from industry. NICNAS
has an activity based costing model which reflects time taken to perform the
task. Administrative costs have been calculated to be a minimal impost of $300
per annum. Mandatory registration will assist state and territory government
agencies wanting to target users of particular
chemicals.
Community
Community confidence in the integrity of
the Scheme will be maintained in the knowledge that full coverage of industry is
engaged in the regulatory process.
Consultation
Industry submissions to the Public Discussion Paper overwhelmingly supported
the proposal to introduce mandatory registration of all introducers of
industrial chemicals. This proposal was also welcomed by States and Territories
and the community also supported this at focus group consultations.
Conclusion and Preferred Option
Taking into account the views
on the options from the public consultations, the focus groups and the views of
the LRCC Task Force, the preferred option is to introduce mandatory registration
of all chemical introducers. The impact would be widespread affecting a
potential 5,700 small businesses at a potential cost of $1.7M per
annum.
INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT) AMENDMENT (LOW
REGULATORY CONCERN CHEMICALS) BILL 2004
NOTES ON CLAUSES
Clause 1: Short Title
The short title of the legislation is
the Industrial Chemicals (Notification and Assessment) Amendment (Low
Regulatory Concern Chemicals) Act 2004.
The commencement date for sections 1 to 3 of the legislation is the day
on which the Bill receives Royal Assent.
The commencement date for Schedule 1 is a single day to be fixed by
Proclamation. However, if any of the provision(s) do not commence within the
period of 6 months beginning on the day on which the Bill receives the Royal
Assent, they commence on the first day after the end of that period.
Clause 3 has the effect of amending the Industrial Chemicals
(Notification and Assessment) Act 1989 (the Act) in the manner specified in
Schedule 1.
Schedule 1 – Amendment of the
Industrial Chemicals (Notification and Assessment) Act
1989
Part 1 – Amendments
This item amends section 5 of the Act by inserting a new definition of
“chargeable person.” Because the registration requirements under
Part 3A of the Act are being extended to cover all persons who introduce
relevant industrial chemicals, this new definition is necessary to differentiate
between persons who are currently required to apply or registration, being
persons who propose to introduce relevant industrial chemicals in a registration
year of a value that equals or exceeds the threshold value, which is currently
$500,000 per annum, and persons who will be required to apply for registration,
being persons who introduce relevant industrial chemicals below this threshold
value. Persons in the former category will be defined as “chargeable
persons” and will be required to pay a registration charge under Part 3A
of the Act, whereas those in the latter category will only be required to pay a
nominal administration fee, which is currently $336 per registration year. The
term “chargeable person” is to replace the term “registrable
person” throughout the Act.
This item amends section 5 of the Act by making a reference to subsection
12(4A) in the definition of “confidential section.” Subsection
12(4A) is a new subsection to be inserted by the Bill. It contains a reference
to the “confidential section” of the Australian Inventory of
Chemical Substances.
This item repeals the definition of “confidentiality request”
in section 5 of the Act as it refers to previous arrangements under the Act and
is an obsolete definition.
This item inserts a new definition of “controlled use permit”
in section 5 of the Act for the purposes of new Division 1C in the Act, which is
to be inserted by the Bill.
This item amends the definition of “cosmetic” in section 5 of the Act to align it with the definition of “cosmetic product” in the Trade Practices (Consumer Product Information Standards) Cosmetics Regulations 1991.
This item provides for the definition of “hazardous chemical” in
section 5 of the Act to be prescribed by the regulations.
This item repeals the definition of “hazardous substance” in
section 5 of the Act, as the proposed new definition of “hazardous
chemical” in section 5 of the Act will be a more appropriate
definition.
This item extends the definition of “holder” in section 5 of
the Act to apply to a person in relation to whom a permit or an assessment
certificate is issued.
This item amends the definition of “low volume permits” in
section 5 of the Act to include low volume permits that are issued following a
renewal application under new subsection 21U(2A), inserted by Item 72.
This item amends the definition of “new industrial chemical”
in section 5 of the Act. This is a consequential amendment as a result of new
section 13, which allows the Director, NICNAS to specify conditions of use of an
industrial chemical on the Australian Inventory of Chemical Substances (AICS).
The definition of “new industrial chemical” has therefore been
amended to reflect the new requirement for an industrial chemical to be
re-notified to NICNAS if the chemical is listed on the AICS for a particular
use, but is to be introduced for a different use that is not listed.
This item substitutes the reference “subsection 12(3)” in
place of “subsection 12(2)” to correctly identify the subsection
that describes what is to be included in the non-confidential part of the
Inventory.
This item inserts a new definition of “non-hazardous
chemical” and provides for this to be defined in new subsection
5(2).
This item inserts the definition of a permit to specify that it means a
permit under one of the four permit categories under the Act.
This item inserts a new definition for “polymer of low
concern” in section 5 of the Act. This new definition is considered by
industry and by NICNAS to be a more accurate definition than the existing
definition of “synthetic polymer of low concern” in section 5 of the
Act.
This item repeals the definition of “registrable person,” as
this definition will be replaced by the new definition of “chargeable
person” for the reasons discussed in the notes on Item 1
above.
Item 16
This item substitutes the term
“registrable person” with “chargeable person” for the
reasons discussed above in the notes on Item 1.
Item
17
This item inserts a new definition of “self-assessed
assessment certificate” in section 5 of the Act for the purposes of the
new self-assessment certificate system under Part 3 of the Act and specifically
for certificates given under new subsection 39(1A) of the Act.
Item 18
This item deletes the definition of “synthetic polymer of low
concern” for the reasons discussed above in the notes on Item
14.
Item 19
This item inserts a new definition of
“non-hazardous chemical” in new subsection 5(2) of the Act. This
definition will be applied to self-assessment applications under the new
self-assessment certificate system in Part 3 of the Act that must meet
non-hazardous criteria to be considered a “non-hazardous chemical”
for the purposes of new subsection 23A(1). It will also be applied to new
subparagraph 21(6)(c)(i), where a chemical must be a “non-hazardous
chemical” to meet the criteria in the new exemption category for chemicals
introduced in a cosmetic in a concentration of 1% or less. New subsection 5(2)
stipulates a number of conditions that must be met for a chemical to be defined
as a non-hazardous chemical under the Act. This includes a provision for
additional conditions to be prescribed by the regulations under new paragraph
5(2)(d) that must be met before a chemical can be considered a non-hazardous
chemical under the Act.
One of the conditions prescribed by new paragraph
5(2)(e), is that the introduction of the chemical must be consistent with the
reasonable protection of occupational health and safety, public health and the
environment. New subsection 5(3) provides a number of matters that the Director
must take account of in assessing whether this condition has been met. This
includes new paragraph 5(3)(g), which allows additional matters to be prescribed
by the regulations.
Item 20
This item deletes the note in
subsection 11(3) so that an amended note may be inserted after new subsection
11(4).
Item 21
This item inserts new subsection 11(4). The
effect of this new subsection is to make it clear that although subsection 11(3)
provides that a chemical that is included in the Inventory may be introduced
without obtaining an assessment certificate or permit, if the introduction of
the chemical is subject to a condition under new section 13, the chemical may
only be imported or manufactured in accordance with the condition, otherwise an
assessment certificate or permit will be required.
This item also inserts
the note from the end of subsection 11(3) at the end of new subsection 11(4).
It amends the note by including a reference to the fact that there may be a
condition on the importation or manufacture of a chemical in the
Inventory.
Item 22
This item adds new particulars
to the content of the non-confidential section of the Inventory in new
paragraphs 12(3)(f) and (g) to reflect the ability of the Director to annotate
the Inventory under new section 13 to include additional details, e.g. details
of the assessment, any condition(s) to which the introduction of a chemical is
subject.
Item 23
This item adds new particulars to the
content of the confidential section of the Inventory in new subsection 12(4A) to
reflect the ability of the Director to annotate the Inventory under new section
13 to include additional details, e.g. details of the assessment, any
condition(s) to which the introduction of a chemical is subject.
Item
24
This item inserts new section 13, which gives the Director the
ability to annotate the Australian Inventory of Chemical Substances (AICS) to
include additional particulars. These include details of the assessment of the
industrial chemical, details of use, if applicable, and any other conditions,
such as conditions that may give rise to secondary notification requirements.
This will give industry and the community better access to information
about industrial chemicals and introducers will no longer have to try to
envisage what uses their chemicals might be put to in the future because a
particular chemical will only be able to be introduced for the specific use or
uses that are specified for that chemical in the AICS. This will also prevent
chemicals that have been assessed for a particular use from being imported or
manufactured for a different use that has not been assessed, and which could be
more harmful to health, safety and the environment.
New subsection
13(2) also gives the Director the power to include particulars either at the
time the chemical is included in the AICS or at a later time; and to vary or
remove such details from the AICS, where applicable.
This item also
inserts new section 13A, which imposes a requirement on the Director to publish
a notice in the Chemical Gazette where the Director proposes to include or vary
the particulars of a chemical on the AICS. It also requires the Director to
send a copy of the notice to a person that is introducing or proposing to
introduce the chemical if the person’s name and address is known to the
Director.
This will mean that in circumstances where the Director
proposes to include particulars, such as conditions, at the same time as adding
a chemical to the AICS then the Director will be required to publish a notice in
the Chemical Gazette before the chemical is added to the AICS.
New
section 13A provides the details that must be included in the notice and
requires the Director to reconsider the proposed inclusion or variation of the
particulars if a person writes to the Director giving reasons why the
particulars should not be included or varied. New section 13A gives the
Director the power to accept or reject these reasons and to make a decision
about whether or not to include or vary the particulars in light of these
reasons. New subsection 102(1)(1A) provides for a decision made by the Director
under new section 13A to be appealable to the Administrative Appeals Tribunal
and new paragraph 13A(6)(b) therefore prevents the Director from including or
varying the particulars (where the Director has rejected the reasons why they
should not be included or varied) until 28 days after the date of giving the
notice or until any Administrative Appeals Tribunal review of the decision has
been finalised.
Item 25
This item inserts new section 13B.
This section gives certificate holders the option to request that an assessed
chemical be included on the non-confidential section of the AICS before the
five-year period following the assessment of the chemical has ended. This
provides an optional alternative to the current system where chemicals are not
listed on the AICS until five years after they are assessed. A certificate
holder may make this request at any time between being given an assessment
certificate and expiry of the five-year period following the assessment of the
chemical, but there is an incentive for certificate holders to make the request
within 28 days of being given an assessment certificate as the early listing of
the chemical in these cases will not attract a fee. Certificate holders who
make an application for early listing after 28 days of the giving of the
certificate will be required to pay a fee.
Where there are two or more
assessment certificates in force for the same chemical and one certificate
holder has requested that the chemical be listed on the AICS before the five
year period following assessment expires, the Director must write to each
certificate holder to give them the opportunity to object to the proposed early
listing. If any certificate holder objects to the proposed early listing then
the early listing of the chemical in the AICS must not proceed and the Director
must inform the applicant(s) of this and repay any fee paid by the
applicant.
If an application for early listing is rejected under this
section the chemical will still be automatically listed on the AICS under
section 14 of the Act.
Item 26
This item adds a note at
the end of subsection 14(1). This note makes it clear that the Director can
include particulars in respect of the chemical on the AICS under section 13.
Item 27
This item creates an offence under new section
15A for failing to comply with a condition to which a chemical is subject under
the AICS. This offence will incur a penalty of 120 penalty units. This is a
serious offence under the Act, as a breach of a condition that has been assessed
in the context of a very specific combination of circumstances such as use,
handling and storage of the chemical, could present a serious danger to
occupational health and safety, public health and the environment if the
industrial chemical is used, handled and/or stored for a different, unassessed
use.
Item 28
This item amends paragraph 18(1)(a) to
take into account new subsections 18(3) and (4) that enable the Director of
NICNAS to disclose information about conditions included in the confidential
section of the Register. The amendment means that an officer must not publish
or disclose any of the particulars recorded in the confidential section of the
Inventory except as permitted in section 18.
Item 29
This
item inserts new subsections 18(3) and 18(4). New subsection 18(3) allows a
person who intends to introduce a chemical that is not on the non-confidential
section of the Inventory to write to the Director and ask whether it is on the
confidential section of the Inventory and whether its introduction is subject to
a condition of use. The person who seeks this information from the Director
must tell the Director the intended use of the chemical and if the Director is
satisfied that the chemical is to be introduced for the same use then the
Director may disclose the condition to the person. New subsection 18(4) allows
the Director to disclose any other conditions to which a chemical on the
confidential section may be subject to a person to whom the Director has
disclosed a condition of use under new subsection 18(3).
Item 30
This item amends subsection 18A(2) to allow any particulars that are
listed on the Inventory in respect of a chemical to be transferred along with
the chemical in circumstances where a chemical is transferred from the
non-confidential section to the confidential section of the
Inventory.
Item 31
This item amends subsection 19(2) to
allow any particulars that are listed on the Inventory in respect of a chemical
to be transferred along with the chemical in circumstances where a chemical is
transferred from the confidential section to the non-confidential section of the
Inventory.
Item 32
This item amends paragraph 19(7)(b) to
ensure that, where the Director decides to transfer a chemical to the
non-confidential section of the AICS and the transfer of the chemical must be
delayed for at least 28 days or pending the completion of a review by the
Administrative Appeals Tribunal, the transfer of the particulars of the chemical
must also be delayed.
Item 33
This item amends the heading
in Division 3 of Part 2 of the Act to read “Amendment of Inventory”
rather than “Correction of Inventory” as this is a more accurate
heading in the context of the changes to Division 3 Part 2 of the
Act.
Item 34
This item inserts a note at the end of
section 20 to make it clear that the Director can add or vary information on the
Inventory about the particulars of a chemical to chemicals that are already
included in the Inventory. That is, the particulars about the chemical, such as
the conditions to which its introduction is subject, do not necessarily have to
be included at the same time as the chemical is included in the Inventory and
can be included at some later point in time.
Item 35
This
item takes into account new section 13 and amends paragraph 20AA(5)(a) to ensure
that a chemical that is left on the AICS under this provision is left on the
AICS with the particulars of that chemical.
Item 36
This
item is a consequential amendment resulting from new section 13, which allows
the Director to list particulars of the chemical on the AICS. It amends
paragraph 20AA(6)(b) so that in a situation where the Director proposes to
remove a chemical from the AICS that is believed to be wrongly included in the
AICS, the Director must not remove the chemical or the particulars in respect of
the chemical until 28 days after the giving of notice of the proposed removal or
until any Tribunal review is finalised.
Item 37
This item
is a consequential amendment resulting from new section 13, which allows the
Director to list particulars of the chemical on the AICS. It inserts a note
under subsection 20AB(4A) explaining that in a situation where the particulars
of the chemical making up the trade name product have been included in the AICS
and the Director proposes to include the chemical in the confidential section of
the AICS, new section 13 enables the particulars in respect of the chemical to
also be included in the confidential section.
Item 38
This
item is a consequential amendment resulting from new section 13, which allows
the Director to list particulars of the chemical on the AICS. It inserts a note
under paragraph 20AB(4B)(b) explaining that in a situation where a person
applies to have a chemical included in the confidential section of the AICS and
the Director rejects this application, the Director must delay including the
chemical and any particulars in respect of the chemical that may be included in
the AICS under new section 13 until 28 days after the giving of notice or until
any Tribunal review is finalised.
Item 39
This item amends
paragraphs 21(2)(aa) to (b) to create a new permit category for controlled use
chemicals. The controlled use permit system is provided for in the new Division
1C of Part 3 of the Act.
Item 40
This item removes the
research, development and analysis exemption in paragraph 21(3)(d) for chemicals
introduced in a quantity of up to 50 kilograms in a 12-month period so that this
amended exemption can be included in new subsection 21(6).
Item 41
This item amends subsection 21(4) to increase the quantity under the
low volume chemicals exemption from 10kg in any 12 month period to 100kg in any
12 month period.
Item 42
This item amends paragraph
21(4)(b) to provide that a person introducing chemicals under the low volume
chemicals exemption of up to 100kg per year must meet certain requirements
prescribed in the regulations. The regulations will ensure that the increased
quantity allowed under the exemption is balanced with requirements for the
introducer to keep records for 5 years and to make an annual report to the
Director. Paragraph 21(4)(b) differentiates between cosmetic chemicals and
non-cosmetic chemicals because the prescribed requirements will be different for
each category.
A person who fails to meet the prescribed requirements in
the regulations will commit an offence under section 21(1) of the Act, as the
person will not be covered by these exemption categories under subsections 21(4)
and (6). The corresponding penalty for an offence under 21(1) is 300 penalty
units.
Item 43
This item amends section 21 to
insert a new paragraph 21(5) to allow the regulations to prescribe different
requirements for different volumes of particular chemicals introduced under the
increased low volume exemption category in new paragraph 21(4)(b). For
example, chemicals introduced in higher volumes will be expected to meet
prescribed low hazard criteria under the regulations.
New subsection
21(6) introduces a range of new exemptions or qualifies existing exemptions
under the Act. Each of the new or amended exemptions under new section 21(6)
are accompanied by new annual reporting requirements for introducers under each
exemption category, in new section 21AA.
New paragraph 21(6)(a) amends
the current exemption by increasing the quantity of industrial chemicals that
may be introduced by a person for research, development and analysis from 50kg
in any 12 month period to 100kg in any 12 month period.
New paragraph
21(6)(b) introduces a new transhipment exemption for instances when chemicals
are off-loaded at an Australian port of entry (i.e. port or airport) and remains
subject to the control of Customs at all times before leaving Australia.
New paragraph 21(6)(c) introduces an exemption for non-hazardous
chemicals included in a cosmetic in a concentration that is at 1% or less. The
definition of a non-hazardous chemical is provided by a new amendment to section
5 of the Act. New subparagraph 21(6)(c)(iv) also allows for the regulations to
prescribe further requirements that must be met in relation to the introduction
of a chemical under this category.
If a person fails to meet the
prescribed requirements in the regulations or breaches any of the provisions in
section 21(6), they will commit an offence under section 21(1) of the Act, as
the person will not be covered by the exemption categories under section 21(6).
The corresponding penalty for an offence under 21(1) is 300 penalty units.
Note 1 at the bottom of section 21 relates to the burden of proof, which
places the onus on the defendant in subsection 21(6). This is necessary to
ensure consistency under Division 1 Part 3 of the Act of the Act. Currently,
the offence under Division 1 Part 3 of the Act for introducing new chemicals
does not apply where the chemicals are introduced in the circumstances described
in subsections 21(1A), (2), (3) and (4), however it is up to the defendant to
establish that the introduction occurred under one of these particular.
Item 44
This item introduces new sections 21AA and
21AB.
New section 21AA introduces annual reporting obligations for
introducers under the exemption categories in subsections 21(4) and 21(6). New
section 21AA requires these introducers to provide an annual report to the
Director, NICNAS stating the name and volume of the chemical that was introduced
in the year. The annual report will be provided in an approved form and must be
provided by 28 September each year. This gives introducers 28 days from the
end of the company registration year on 31 August to provide the annual report.
A registration year is defined in section 5 of the Act as a period of 12 months
beginning on 1 September. This means that a person who introduces
chemicals under the exemption categories in subsections 21(4) and (6) will be
required to make an annual report for chemicals introduced in the 12 month
period from 1 September – 31 August. If a person fails to provide an
annual report they will commit an offence under new section 21AA. This is a
continuing offence under new subsection 21AA(4), which means that in accordance
with subsection 4K(2) of the Crimes Act 1914, a person who fails to
provide an annual report by the final date required will be guilty of a separate
offence for each day of non-compliance and will incur 10 penalty units per day
up to a maximum of 120 penalty units, which would be reached in 12 days. This
will provide a strong incentive for compliance with the continuing obligations
under section 21AA.
New section 21AB requires the Director to maintain a
list of the chemical names and volumes reported under new section 21AA and to
publish this list in the Chemical Gazette at least once during the following
registration year.
Item 45
This item adds new subsections
(2) and (3) to section 21B. These subsections amend the Act to allow a person
who holds a commercial evaluation permit to renew this by an administrative,
rather than an assessment, process. This is limited to only one renewal of each
commercial evaluation permit and is subject to a number of conditions that must
be met to indicate that no new data is available in respect of the chemical and
the conditions of introduction have not significantly changed. Under new
subsection 21H(3A), an application to renew a commercial evaluation permit may
be refused if the Director is not satisfied that these conditions have not been
met.
If a permit renewal application is refused, the applicant can apply
for a new permit under subsection 21B(1) through the full assessment
process.
Item 46
This item amends subsection 21D(1) to
include a reference to applications for renewals of commercial evaluation
permits in setting out the form of a commercial evaluation
permit.
Item 47
This item amends subsection 21D(2) to
reflect the fact that an application for a commercial evaluation permit, other
than an renewal application for a commercial evaluation permit, must be
accompanied by data and other information.
Item 48
This
is a consequential amendment that requires paragraph 21B(b) to be renumbered as
paragraph 21B(1)(b), because of new subsection 21B(2).
Items 49 and
50
This item is a consequential amendment to reflect the changes made by new
subsection 21B(2. It amends subsection 21E(3) to include a reference to an
application for a renewal of a commercial evaluation permit.
These items amend the words “the application” to read “an
application” in section 21F and subsections 21G(1), 21H(1), (2) and (3) to
take into account that there is more than one form of an application for a
commercial evaluation permit.
This item is a consequential amendment as a result of new subsection
21B(2). It amends paragraph 21H(3)(c)(i) to include a reference to an
application for a renewal of a commercial evaluation permit.
New subsection 21H(3A) provides that an application to renew a commercial
evaluation permit under subsection 21B(2) may be refused if the Director is
satisfied that the conditions outlined in subsection 21B(2) have not been met.
For example, the Director may be satisfied that the conditions of introduction
of the chemical have changed.
If a permit renewal application is refused,
the applicant can apply for a new permit under subsection 21B(1) through the
full assessment process.
The new note at the end of subsection 21L(1) draws attention to the new
annual reporting requirements in new section 40N for those who hold commercial
evaluation permits.
These items are consequential amendments as a result of new subsection
21B(2). They amend subparagraph 21N(1)(b)(i) and subsection 21P(1) to include a
reference to an application for a renewal of a commercial evaluation
permit.
Paragraph 21Q(a) is amended to read “the person” instead of
“any person or persons.”
This item amends the object of the permit system for low volume chemicals
in paragraph 21Q(a) to reflect the fact that the quantity of chemicals
introduced under a low volume permit will be increased from 100kg to 1000kg in
certain cases. This will only be allowed where prescribed guidelines for
introducing such a quantity have been met, as set out in new subsection
21U(2).
Item 64
This item adds new subsections (1A) and
(1B) to section 21R. New subsection (1A) allows a person who holds a low volume
permit to renew this by an administrative, rather than an assessment process.
Subsection (1B) provides that low volume permits may be renewed any number of
times. Renewal applications are subject to a number of conditions that must be
met to indicate that no new data is available in respect of the chemical and the
conditions of introduction have not significantly changed. Under new subsection
21U(2A), an application to renew a low volume permit must be granted if the
Director is satisfied that these conditions have been met and the approved form
has been complied with under section 21S.
This item amends subsection 21R(2) to allow 2 or more persons to make a
joint application to renew of a low volume permit.
Item 66
This item amends subsection 21S(1) to include a reference to
applications for renewals of low volume permits in setting out how the
application is to be made.
Item 67
Subsection 21S(2) is
amended to insert the words “An application for a low volume permit”
instead of “The application”, to indicate that the requirements of
subsection 21S(2) do not apply to applications for renewals.
This item adds new subsection 21S(3) to provide that unless payment of a
prescribed fee accompanies an application for the renewal of a low volume
permit, the application is deemed not to have been duly made.
Subsection 21SA(1) is amended to substitute “an applicant” in
place of “the applicant.”
Subsection 21SA(1), which allows the Director to request further
information about low volume permit applications, is amended to extend this to
requesting further information about a matter referred to in an application for
a low volume permit renewal.
Subsection 21U(1) is amended to substitute “an application”
in place of “the application.”
This item amends subsection 21U(2) to increase the quantity of chemicals
introduced under a low volume permit from 100kg to 1000kg in certain cases.
This will only be allowed where prescribed guidelines for introducing a quantity
of up to 1000kg have been met. In all other cases, where the guidelines
prescribed for introducing up to 1000kg are not met, the quantity permitted
under a low volume permit will remain at a maximum of 100kg and the current
safeguards under subsection 21U(2) will remain unchanged in respect of the
conditions that an applicant for a low volume permit for chemicals up to 100kg
must satisfy.
Under new subsection 21U(2A), an application to renew a low volume permit
must be granted if the Director is satisfied that the conditions set out in new
subsection 21R(1A) have been met and the approved form has been complied with
under section 21S.
This is a consequential amendment to include a reference to applications
for a renewal of a low volume permit.
This item amends subsection 21W(1) as a consequential amendment to new
subsection 21R(1)(1A), which allows a holder of a low volume permit to renew the
permit by administrative processes. Subsection 21W(1) now makes a reference to
when the permit was last issued, as opposed to when the permit was
issued.
This item amends subsection 21W(1)(b), which states that the holder of a
low volume permit must notify the Director if the holder has exceeded or is
likely to exceed the quantity of the chemical that is stated in the written
statement provided to the Director in the holder’s application for a low
volume permit. Subsection 21W(1)(b) is amended to extend this requirement to
permit holders who have exceeded or are likely to exceed the quantity of the
chemical that is stated in the application for the renewal of the permit.
Item 77
Paragraph 21W(1) (c) requires a holder of a low
volume permit to notify the Director if a chemical that was not proposed to be
manufactured in Australia when the permit was issued has begun to be
manufactured. This item amends paragraph 21W(1)(c) to extend this notification
requirement to situations where a chemical that was not proposed to be
manufactured in Australia when the permit was renewed has begun to be
manufactured in Australia.
These items replace the words “adverse health effects or adverse
environmental effects” with “an adverse effect of the chemical on
occupational health and safety, public health or the environment” in
paragraphs 21W(1)(d) and (e) and subsection 21W(3).
This note at the end of subsection 21W(1) draws attention to the need for
holders of low volume permits to also comply with obligations in new Division 3B
of Part 3 of the Act. These new obligations relate to record keeping and annual
reporting requirements.
Item 82
Subparagraph 21W(6)(b)(i)
is amended to extend the Director’s power to cancel a low volume permit
where a written statement provided in connection with an application for a
renewal of a low volume permit was false or misleading in a material
particular.
Item 83
Subparagraph 21ZB(1) is amended to
allow low volume permit renewal applications to include an application that
certain information be treated as exempt information under section 75 of the
Act.
Item 84
This item inserts new sections 22A –
22O under a new Division 1C in Part 3 of the Act to introduce a controlled use
permit system. This provides an alternative to the assessment certificate
system in respect of industrial chemicals that are low risk to occupational
health and safety, public health and the environment because of their highly
controlled use, handling and exposure. A person who makes an application for a
controlled permit under this new Division will also have to meet relevant
safeguards.
These safeguards include the requirements set out in new
section 22C which states that the applicant must provide a written statement
about the chemical about its proposed use; a summary of its effects on
occupational health and safety, public health and the environment; and the
quantity of the chemical proposed to be introduced between the application date
and the end of the calendar year and the quantity proposed to be introduced in
each of the next three calendar years. New paragraph 22C(2)(e) also allows the
regulations to prescribe further information that may be required from an
applicant for a controlled use permit. New section 22D allows the Director to
request further information, of a kind described in subsection 22D(1), from an
applicant about their application for a controlled use permit. If this
information is not provided to the Director within the period specified in the
notice (this must be at least 14 days), then under subsection 22F(3) the
application is treated as having been withdrawn.
Additional safeguards
are contained in new section 22F, where the Director must only grant the
application and issue the controlled use permit if he/she is satisfied that the
requirements in section 22C have been complied with, that the intended use of
the chemical does not pose an unreasonable risk to occupational health and
safety, public health or the environment, and any other matters that the
Director considers relevant. In making this assessment, the Director must have
regard to the inherent nature of the chemical, any guidelines prescribed in the
regulations for the purposes of this provision and any other matters that the
Director considers relevant. Further, new subsection 22H(5) provides that the
Director may grant a controlled use permit subject to any conditions considered
necessary or desirable to ensure that the use of the chemical will not result in
an unreasonable risk to occupational health and safety, public health or the
environment.
New section 22H also provides a number of specific
conditions that a controlled use permit will be subject to, including a
condition of use and other secondary notification requirements that must be met
if new data becomes available in respect of the chemical, or its conditions of
introduction e.g. the function or use or method of manufacture of the chemical,
change. New subsection 22H(6) also gives the Director the power to impose
further conditions on a controlled use permit and to revoke or vary a condition.
Under new subsection 22H(7), the Director must specify the date that the
condition being imposed or varied comes into effect, or is to be revoked, being
a day that must not be less than 28 days after the giving of the notice.
New section 22I creates an offence and a penalty of 300 units for
contravening a permit condition. This is consistent with equivalent offence and
penalty provisions in the commercial evaluation permit system and the low volume
permit system. The Director also has the ability to cancel a controlled use
permit when a condition has been contravened or the Director discovers that
false or misleading information was provided in the permit application or
renewal application.
Controlled use permit holders also have obligations
with which they must comply under new Division 3B of Part 3 of the Act. The
note at the end of new paragraph 22H(1) draws attention to the additional annual
reporting and record keeping obligations of controlled use permit holders under
new Division 3B.
Under new section 22G, controlled use permits can be in
force for any period of time up to 36 months. The period of time for the permit
to remain in force must be stated in the permit. Note, however, that in theory
these types of permits can be in force indefinitely (because there is no limit
on the amount of renewal applications that can be made), providing they continue
to meet conditions for their issue/renewal.
New subsection 22B(2)
provides that controlled use permits may be renewed while still in force if a
number of conditions are met to indicate that no new data is available in
respect of the chemical and the conditions of introduction have not
significantly changed. The Director must also be satisfied that the requirements
in subsections 22C(1) and (3) have been met before renewing a controlled use
permit. A controlled use permit can be renewed any number of times and joint
applications, involving two or more persons, can be made under this permit
category.
If a permit renewal application is refused, the applicant can
apply for a new permit through the full assessment process.
An applicant
may include an application for the treatment of certain information as exempt
information under the Act with the controlled use permit application under new
section 22O. Under new section 22L, a notice must be published in the Chemical
Gazette as soon as practicable after a controlled use permit is issued, setting
out the name of the permit holder, the trade name of the chemical and its use
and the period of the permit. The Director is also required, under new section
22N, to maintain a list of chemicals in respect of which controlled use permits
are in force, including their corresponding conditions of use.
The
Director may refuse an application for a controlled use permit under new section
22M and must provide reasons and evidence to the applicant, in writing, for the
decision to refuse the application.
Item 85
This item
inserts a new object and overview of the assessment certificate system at the
beginning of Division 2 of Part 3 of the Act, in new section 22P. The object
and overview explains the difference between the self-assessed system and the
non-self assessed system, where a NICNAS officer assesses the chemical. The new
processes for audited self-assessment of low regulatory concern chemicals are
contained in Division 2 and Division 3 of Part 3 of the Act. The new audited
self-assessment system allows introducers under the Act to self-assess a
chemical against criteria and guidelines issued by NICNAS and/or prescribed by
the regulations. This will introduce flexibility into the current assessment
process for industrial chemicals to enable the fast tracking of low regulatory
concern chemicals while maintaining existing levels of worker safety, public
health and environmental standards. The increased flexibility of the
self-assessment system is balanced with record keeping and annual reporting
requirements for introducers who hold self-assessment certificates, which are
outlined in new Division 3B of the Act. Holders of self-assessment certificates
will also be subject to audits by NICNAS inspectors under Part 4 of the Act to
ensure compliance with the self-assessment requirements.
Item 86
This item amends the notification statement requirements for certain
new industrial chemicals and for polymers in subsections 23(4) to (9). It
provides for the requirement for Part D, and in some cases Part C, of the
Schedule to the Act to apply to polymer notifications in subsections 23(6) to
(8). This will address a gap that currently exists in the Act, as Part D of
the Schedule to the Act is needed for polymer notifications. This overcomes the
previous need for NICNAS to use section 27 of the Act (which provides that the
Director may require further information from an applicant) to obtain Part D
information in relation to polymer notifications, as Part D of the Schedule to
the Act is now required for polymer notifications
Item 87
This item inserts new section 23A, which provides an option for
introducers of polymers of low concern, non-hazardous chemicals and other
chemicals or classes of chemicals that are prescribed by the regulations, to
make an application for a self-assessed assessment certificate.
Item
88
This item amends section 24A by replacing the reference to
“synthetic polymer of low concern” with “polymer of low
concern” as the previous term has been replaced by the new definition for
“polymer of low concern” inserted by item 14.
Item 89
This item amends section 24A of the Act to require an approved form
rather than a prescribed form to accompany an application for an assessment
certificate.
Items 90 and 91
These items amend section 25
to allow self-assessment certificate applicants to apply for certain information
to be treated as exempt information under section 75 of the Act.
Item
92
This item amends subsection 26(1) to extend the ability of
assessment certificate applicants to withdraw an application, to cover
self-assessment certificate applicants as well.
Items 93 to 96
These items amend section 27 to extend the ability of the Director
to require further information from applicants where insufficient information
has been provided, to require information in these circumstances from
self-assessment certificate applicants as well.
Item 97
This item amends subsection 28(1) to extend the requirement for
applicants to provide additional assessment information to the Director if they
become aware of this, to cover self-assessment applicants as
well.
Items 98 to 103
These items amend section 30A to
redefine the categories of chemicals that may be the subject of an application
for an early introduction permit system. The classes are non-hazardous
chemicals, polymers of low concern and other chemicals or classes of chemicals
prescribed by the regulations. Applicants under both the non self-assessed
assessment certificate system and the self-assessed certificate system will have
access to an early introduction permit. Other amendments are consequential
amendments (Items 102 and 103) that take into account the various categories of
chemicals listed in new subsection 30A(1A)
Item 104 and
105
This item is a consequential amendment following the insertion of
new subsection 30A(1A). It amends paragraph 30C(1)(b) to allow the Director to
revoke a permit or reconsider the decision to grant the permit if the chemical
is not a chemical of a kind specified in subsection 30A(1A).
Item 105
amends the heading of Division 3 of part 3 to read “Assessment,
self-assessment and reports”
Items 106 to 108
These
items amend subsection 31(1) to extend the current requirement for the Director
to cause a chemical to be assessed once an application has been made and (where
applicable) further information has been provided on request, to cover self
assessment applications as well. The note at the end of subsection 31(1) draws
attention to the fact that in cases of self assessed assessment applications for
polymers of low concern, under section 33B the application form will often
become the assessment report.
Item 109 and 110
These
items remove the provisions dealing with time periods for completing assessments
in relation to applications for assessment certificates and insert new
provisions that set out the time periods for completing assessments for
applications for non-self assessed assessment certificates, under new section
31A and time periods for applications for self-assessed assessment certificates,
under new section 31B. Under the new self-assessment scheme, where a
self-assessment application is accepted, the assessment report, full public
report and summary report will be completed by the NICNAS officer within 28 days
after the day the application was made. Where an application is refused under
new section 33C(2), the applicant must be notified of this refusal within 28
days after the day the application was made. Where an officer requires further
information in relation to the self-assessment application, the clock stops and
restarts again so that the assessment report, full public report and summary
report or a notification of a refusal must be completed by the NICNAS officer
within 28 days after the day the additional information was provided by the
applicant.
The time periods for non self-assessed assessments under new
section 31A(1) remain unchanged and must be completed within 90 days of the day
on which the application was made. Where a notice requiring further information
from the applicant under section 27 of the Act has been given, the assessment
must be completed within 90 days after the day that the information was provided
by the applicant.
The Minister may extend the time period by up to 90
days for non self-assessed assessment applications and by up to 28 days for
self-assessed assessment applications.
Item 111
This item
amends section 32 of the Act to make it clear that the assessment process under
this provision applies only to applications under section 23, being non
self-assessed assessment applications.
Item 112
This item
amends section 33 of the Act to make it clear that the assessment report under
this provision applies only to applications under section 23, being non
self-assessed assessment applications. The heading to section 33 is also
changed to refer to “non self-assessed assessment
reports”.
Item 113
This item inserts new sections
33A, 33B and 33C. New section 33A requires NICNAS to pre-screen self-assessed
assessment applications to determine whether the chemical is a polymer of low
concern, a non-hazardous chemical or another chemical or class of chemical
prescribed by the regulations as a chemical in relation to which an introducer
can apply for a self assessed assessment certificate; and whether there is any
risk of adverse effects of the chemical.
If the self-assessed assessment
application passes this pre-screening, NICNAS is required to adopt the
application made under section 23A as the assessment report, under new section
33B.
New section 33C provides that if a self-assessed assessment
application is refused by NICNAS on the basis of this pre-screening, then the
application must be refused. The applicant can, however, be moved from the
self-assessed to the non-self-assessed system in these circumstances, and may
make an application under section 23 to do so. In these cases the applicant
will be required to pay an additional application fee to make up the difference
between the smaller fee already paid in respect of the self-assessed assessment
application under section 23A and the higher fee required under the non
self-assessed system.
Item 114
This item amends section
36 to explain the Director’s obligations on completion of a non self
assessed assessment report and on completion of a self-assessed assessment
report.
New subsections 36 (1) and (2) require the Director to provide
the applicant with a copy of the applicable assessment report, the full public
report and the summary report, after completing either the non self-assessed
assessment report or the self-assessed assessment report. For non-self assessed
assessment certificate applicants, the Director must also provide a notice
setting out the terms of an application for variation of the report and the
terms of the assessment report’s publication. As a self-assessed
assessment application is adopted as the assessment report, the self-assessed
assessment applicant does not have the option to seek a variation of the report
under section 37. Accordingly, the Director is required to provide a notice
setting out the terms of the assessment report’s publication, but no
notice regarding the terms of an application for variation.
Item 115
The effect of this amendment is clarify that an application to vary
an assessment report is only available to a person who lodges an application for
a non self-assessed assessment report.
Item 116
This
amends paragraph 38(3)(a) to ensure that the Director does not publish an
assessment report until he/she has made a decision about any application under
section 25 or section 37. Previously this paragraph only referred to a decision
about an application under section 37. Section 25 allows a person to make an
application to the Director for some information to be treated as exempt
information for the purposes of the Act. The effect of this amendment is that a
person may make an application under section 25 and the Director’s
decision in response to this, in accordance with the criteria set out in section
75 is reviewable by the Administrative Appeals Tribunal under section 102 of the
Act.
Item 117
This inserts new subsection 39(1A) to
provide that the Director must give a self-assessed assessment certificate
applicant an assessment certificate at the same time as providing the applicant
with the notice setting out the terms of publication of the assessment report
under section 38 of the Act.
The Note below this new subsection draws
attention to the annual reporting and record keeping obligations of a
self-assessed assessment certificate holder in new Division 3B of Part 3 of the
Act.
Item 118
This item makes a minor amendment to
subsection 39(1) to take into account new subsection 39(1A).
Item 119
This item amends section 39 to make it clear that when an applicant
is given an assessment certificate the Director must also notify the applicant
of the option to apply for the chemical to be included in the non-confidential
section of the AICS at the same time, as provided for by new section
13B.
Item 120
This amends subsection 40A(1) to make it
clear that self-assessed assessment certificates may not be extended to cover
any other introducer.
Item 121
This replaces the term
“synthetic polymer of low concern” with “polymer of low
concern” in subsections 40A(3) and (4).
Item 122
This item amends the subsection 40A(4) to replace the reference to a
“prescribed” form with a reference to an “approved”
form, so that the forms need no longer be prescribed by
regulations.
Item 123
This item is a consequential
amendment to new section 13, which gives the Director the ability to annotate
the AICS to include additional particulars, including details of use. The
amendment to section 40H means that in circumstances where there is no condition
of use included in the AICS, the certificate ceases to be in force when the
chemical that it relates to is included in the AICS. However, where a condition
of use is included on the AICS in respect of a chemical, the certificate will
only ceases to be in force in relation to that particular condition of use.
Item 124
This item inserts new sections 40K, 40L, 40M,
and 40N under a new Division 3B in the Act, which sets out the obligations
relating to commercial evaluation permits, low volume permits, controlled use
permits and self-assessed assessment certificates.
New section 40K
requires all holders of these permits and certificates to keep records for 5
years for audit purposes. If a person fails to keep these records a
penalty of 120 units is applicable to this offence.
New section 40L
gives the Director the power to require all holders of these particular permits
and certificates to provide information in or in connection with their
application for, or application for renewal of, the permit or certificate that
they hold, to the Director on request. The Director’s request must be
made in writing and give the person at least 14 days to respond.
New
section 40M makes the provision of information subject to the privilege of
self-incrimination. The offence for failing to provide this information is 60
penalty units. This is consistent with similar offences under the Act and
corresponding penalties involving the failure of a person to provide information
to the Director on request under s48(7), s58(8) and s69(4) of the Act.
New section 40N requires all holders of these permits and certificates
to make an annual report to the Director stating the name and volume of the
chemical, together with any adverse effect of the chemical on occupational
health and safety, public health or the environment. The annual report must be
provided on or by 28 September of each year. This gives introducers 28 days
from the end of the company registration year on 31 August to provide the annual
report.
A person who fails to provide an annual report by the date
required will commit an offence. This is a continuing offence under new section
40N, which means that in accordance with subsection 4K(2) of the Crimes Act
1914 a person who fails to provide an annual report by the final date
required will be guilty of a separate offence for each day of non-compliance and
will incur 10 penalty unit per day up to a maximum of 120 penalty units, which
would be reached in 12 days. This will provide a strong incentive for
compliance with the continuing obligations under section 40N.
Items
125 and 126
These items amend paragraph 41(3)(d) and subsection
44(1) to make it clear that these provisions only apply to applications under
section 23 of the Act, that is, non-self assessed assessment certificate
applications.
Item 127
`This amends section 47 to include
a reference to chemicals that are covered by the new exemptions in paragraph
21(6)(a) or (b), for the purposes of excluding those chemicals from the
application of Division 5- Priority Existing Chemicals.
Item 128
This item amends the secondary notification requirements in section
64 of the Act to link these requirements with the new provisions relating to the
Director’s ability to include particulars in relation to a chemical on the
AICS, including conditions to which the chemical is subject. Paragraph
64(1)(a) now makes it clear that where either or both the assessment report
and/or the particulars about a chemical on the AICS recommend(s) the secondary
notification of the chemical in particular circumstances and any of those
circumstances should occur, the affected person must notify the Director about
this.
Items 129 and 130
These items amend paragraphs
64(2)(d) and (e) to substitute the words “adverse health effects or
adverse environment effects” with “an adverse effect of the chemical
on occupational health and safety, public health or the
environment.”
Item 131
This item inserts new
sub-paragraph 64(2)(2A) to make it clear that the reference to “an
industrial chemical that has been assessed” in subsection 64(2) includes
chemicals that have been self-assessed and chemicals that have been assessed
under the Act [at any point in time, whether these are included on the AICS or
not. – is this correct? Or does it only cover chemicals that have been
assessed and are on AICS?]
Item 132
This item amends
subsection 75(1) to include a reference to section 22O, which enables an
applicant under that provision to apply for information to be treated as exempt
information .
Items 133 to 166
These items amend Part 3A
of the Act to introduce mandatory company registration of all persons who
introduce (i.e. import and/or manufacturer) or propose to introduce relevant
industrial chemicals, as defined in section 7A of the Act. These changes are
likely to improve industry knowledge of NICNAS and compliance with the Act, as
well as maintaining public confidence in the regulatory scheme.
In
extending the company registration provisions to cover all introducers, those
who introduce relevant industrial chemicals below the threshold value (currently
$500,000) per company registration year, which runs from 1 September to 31
August in the following year, will continue to be exempt from company
registration charges. However, as NICNAS is a fully cost recovered scheme a
small annual administration fee (currently $336) will be required from all those
who register.
A person who introduces or proposes to introduce relevant
industrial chemicals above the threshold value in the company registration year
is defined as a “chargeable person.” In short, all introducers will
be registered persons, but only those who introduce or propose to introduce
chemicals above the threshold value will be chargeable persons who must pay a
company registration charge as well as the administration fee. This is
explained in the amended section 80A of the Act.
Those who do not pay the
charge but introduce more than the threshold value are required to provide the
Director with a final statement. The Director also has the power under the
amended subsection 80W(1) to request a written statement from any person that
the Director reasonably believes may have introduced a relevant industrial
chemical during the particular registration year, indicating the value of the
industrial chemicals that the person introduced in that year. This will enable
the Director to identify situations where an unregistered person is required to
be registered and, in some cases, where an unregistered person is also required
to pay the company registration charge.
The current record keeping
provision, in section 80QD of the Act, has also been extended to require all
registered persons to retain records for 5 years after the end of the
registration year.
Further, given the significant increase in the
number of persons who will be registered under the company registration scheme
under these changes, section 80Y has been repealed. An amended version of this
has been moved to Part 6 of the Act (new section 110C) and provides that the
Director must cause the Chemical Gazette to be publicly available,
instead of requiring the Director to use his/her best endeavours to provide a
copy of each Chemical Gazette to each registered person in each company
registration year.
Item 167
This item amends paragraph
102(1)(a), which lists the decisions of the Minister made under the Act that are
reviewable by the Administrative Appeals Tribunal, to replace references to
repealed subsection 31(3) with new subsection 31A(3) and 31B(3). This
consequential amendment enables the Minister’s decision to extend the time
periods allowed for finalising both non-self-assessed and self-assessed
assessment certificate applications to be reviewable.
Items 168 and
169
These items amend paragraph 102(1)(b), which lists decisions of
the Director under the Act that are reviewable by the Administrative Appeals
Tribunal, to include decisions made by the Director under subsections 22F(4),
22H(5) or (6), section 22J, subsection 30(C)(1) and section 33C.
Item
170
This item removes the reference to subsections 80G(2), 80KA(3)
and 80KB(4) from paragraph 102(1)(b) as these provisions have been repealed as a
result of changes made to the company registration provisions in Part 3A of the
Act.
Item 171
This item inserts new paragraph 102(1)(c) to
provide that the imposition of a condition of use to which a controlled use
permit is subject may be a reviewable decision by the Administrative Appeals
Tribunal. It also inserts new paragraph 102(1)(d) to provide that a decision by
the Director under new section 13A to include or vary particulars in respect of
a chemical on the AICS is reviewable by the Administrative Appeals
Tribunal.
Item 172
This item inserts new paragraph 102(1A)
to provide that if a person has made or could have made an application under
section 37 of the Act to vary the assessment report in respect of the chemical
and the recommendations in the report, and the recommendations are the same or
similar to the particulars on the AICS in respect of the chemical, the person
will be prevented from making an application for review to the Administrative
Appeals Tribunal in respect of a decision that was made by the Director under
section 13A to include or vary particulars in respect of a chemical on the
AICS.
Item 173
This item is a consequential amendment and
applies the definition for “decision” to new subsection 102(1A),
where the word “decision” is used.
Items 174 to 176
These items amend section 110 to allow fees to be prescribed by the
regulations in respect of applications under section 13B for optional early
listing of chemicals in the AICS before 5 years; in respect of applications for
the renewal of commercial evaluation permits; applications for low volume
permits and renewals; applications for controlled use permits and renewals; and
applications for self-assessed assessment certificates made under section 23A.
Item 177
This item amends paragraph 110(1)(g) to allow
fees to be prescribed by the regulations in respect of applications for
information to be treated as exempt information under section
22O.
Item 178
This makes a minor amendment to substitute
“80F” for “80F(1)”to reflect the change made to Part 3A
of the Act.
Item 179
This item removes a semi-colon (;) and
substitutes a full stop (.) in its place.
Item 180
This
item repeals paragraph 110(1)(v) as it is now included in paragraph
110(1)(cc).
Item 181
This item inserts a new subparagraph
110(1)(1A) to provide that different fees or methods for calculating fees may be
prescribed for self-assessment certificate applications in respect of different
chemicals or classes of chemicals.
Item 182
This item
inserts new section 110B, which provides that forms approved by the Director
under the Act may be electronic. It also inserts new section 110C, which
provides that the Director must ensure that the Chemical Gazette is made
publicly available.
Item 183
This item amends Part A of
the Schedule to remove the reference to subsection 23(9).
Item 184
This item amends item 3 of Part A of the Schedule to substitute the
term “hazardous chemical” for “hazardous substance”, for
which there is a new definition.
This item ensures that the amendment made to the definition of
“cosmetics” under section 5; amendments made to the exemption
provisions in subsections 21(4) to (6); and amendments made to the application
of Division 5- Priority Existing Chemicals, apply to introductions on or after
the commencement date of the Act.
Under this item, the new annual reporting obligations of introducers
under the exemption categories in subsections 21(4) and (6) will apply in
respect of chemicals introduced in registration years on or after commencement
of the Act. The registration year under the Act runs from 1 September to 31
August of the following year.
Item 187
This item ensures
that the amendments to the definition of “polymer of low concern”
will apply to applications made on or after the commencement date of the
legislation.
Item 188
This item makes it clear that the
Director may add particulars in respect of a chemical on the AICS, such as
conditions of use, to any industrial chemical, including chemicals that are on
the AICS before the commencement date of the legislation.
Item 189
This item ensures that applications for or renewals of low volume
permits may be made in accordance with the amended provisions which increase
introductions under this permit category to 100kg in a 12 month period and in
some cases 1000kg in a 12 month period from the commencement date.
Item 190
This item makes it clear that commercial
evaluation permits and low volume permits may be renewed in accordance with the
new administrative renewal procedures from the commencement date of the
legislation.
Item 191
This item ensures that the new
audited self assessment system comes into force and that applications for a self
assessed assessment certificate under section 23A can be made from the
commencement date of the legislation.
Item 192
This item
ensures that the annual reporting and record keeping obligations and
requirements to provide information to the Director on request under new
Division 3B of Part 3 of the Act imposed on those persons holding certain
permits and self-assessed assessment certificates come into effect on the
commencement date of the legislation.
Item 193
This item
provides that the amendments to the company registration scheme, including
mandatory registration for all introducers and company registration fees, will
apply respect of chemicals introduced in registration years on or after
commencement of the Act. The registration year under the Act runs from
1
September to 31 August of the following year.
Item 194
This item defines “commencement date” as the date on
which Schedule 1 commences.