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2010-2011
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT)
AMENDMENT (INVENTORY) BILL 2011
EXPLANATORY MEMORANDUM
(Circulated by authority of the Parliamentary Secretary to the Minister for Health and
Ageing the Honourable Catherine King MP)
INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT)
AMENDMENT (INVENTORY) BILL 2011
OUTLINE
The Industrial Chemicals (Notification and Assessment) Amendment (Inventory) Bill
2011 (the Bill) amends the Industrial Chemicals (Notification and Assessment) Act
1989 (the Act). The proposed amendments to the Act are intended to:
· provide legislative underpinning for completion of the cosmetic regulatory
reforms largely implemented through amendment of the Act in 2007 (part of the
Low Regulatory Concern Chemicals (LRCC) reform initiative). The amendments
will:
- enable the Director of the National Industrial Chemicals Notification and
Assessment Scheme (NICNAS) to add to the Australian Inventory of
Chemical Substances (the Inventory) chemicals that are transferred to the
industrial chemicals framework from another Commonwealth regulatory
scheme. For example, cosmetic ingredients in products previously regulated
by the Therapeutic Goods Administration (TGA) and now within the remit of
NICNAS; and
- formalise notification and assessment arrangements for ultra-violet (UV)
filters in secondary sunscreen products which have been in place since 7
October 2008; and
· make technical amendments to the Act to afford a more effective administration of
the assessment scheme by:
- removing the need to prepare and publish summary assessment reports; and
- amending information requirements in the Schedule to the Act consistent with
international best practice data requirements for industrial chemicals.
FINANCIAL IMPACT STATEMENT
The initiatives implemented through this Bill are cost neutral.
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INDUSTRIAL CHEMICALS (NOTIFICATION AND ASSESSMENT)
AMENDMENT (INVENTORY) BILL 2011
NOTES ON CLAUSES
Clause 1 - Short title
This clause provides that the Bill, once enacted, may be cited as the Industrial
Chemicals (Notification and Assessment) Amendment (Inventory) Act 2011.
Clause 2 - Commencement
This clause provides that the amendments to the Act commence on the day after the
Bill receives Royal Assent.
Clause 3 - Schedule(s)
This clause provides that each Act that is specified in a Schedule to this Act is
amended or repealed as set out in the relevant Schedule. Any other item operates
according to its terms.
Schedule 1 - Industrial Chemicals (Notification and Assessment) Act 1989
Items 1 to 4
These items amend, repeal or add definitions within subsection 5(1) of the Act.
The changes include:
· repeal of the definition of `full public report' (item 1) and insertion of a new
definition of `public report' (item 3). The Act currently imposes an obligation on
the Director of NICNAS to prepare a summary report as part of the assessment of
a chemical (be it a new or existing chemical). As NICNAS now publishes the full
public report, which includes the conclusions and recommendations of the
assessment, on the NICNAS website, it is proposed that the requirements in the
Act for the publication of summary reports be removed. As the Bill removes the
need to prepare and publish summary reports, the definition of a full public report
is no longer required. It is replaced with a definition of a `public report';
· amendment to the definition of new industrial chemical (item 2). This item
amends the definition of a new industrial chemical in subsection 5(1) to take into
account the addition to the Inventory of a previously-regulated chemical under
new section 15AA. When such a chemical is added to the Inventory, conditions
may be applied (as is the case for other chemicals on the Inventory). If a
condition of use is applied for a chemical, introduction of the chemical for a
different use deems it to be a new industrial chemical under the Act, and therefore
subject to notification and assessment before introduction. The amendment to the
definition of new industrial chemical ensures that this will also be the case for
chemicals that enter the Inventory through proposed new section 15AA; and
· repeal of the definition of `summary report' (item 4). As the Bill removes the
need to prepare and publish summary reports, the definition of a summary report
is no longer required.
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Items 5 to 9
Items 5 to 9 of the Bill make consequential changes to various sections, recognising
the insertion of new sections 15AA and 15AB. Specifically:
· Item 5 amends subsection 11(4) so that requirements relating to conditions on
chemicals in the Inventory also apply where chemicals are added to the Inventory
through section 15AA.
· Item 6 inserts new paragraphs 12(3)(da) and (db) to provide for the non-
confidential section of the Inventory to contain a chemical that is transferred to the
industrial chemicals framework from another Commonwealth regulatory scheme,
or a chemical in a product that is transferred to the industrial chemicals
framework. For example, the Inventory could contain a chemical in a cosmetic
product previously regulated by the TGA, even though the same chemical is also
in a different product that continues to be regulated by the TGA.
· Item 7 amends paragraph 12(3)(f) to enable a condition of use to be added to a
chemical on the Inventory that has been placed on the non-confidential section of
the Inventory through transfer to the industrial chemicals framework from another
Commonwealth regulatory scheme. For example, conditions placed on a chemical
in a sunscreen product when regulated by the TGA could be added to the non-
confidential section of the Inventory when the chemical is transferred to the
industrial chemicals framework.
· Item 8 amends paragraph 12(3)(g) to enable any other particular, apart from a
condition of use, to be added to a chemical on the Inventory that has been placed
on the non-confidential section of the Inventory through transfer to the industrial
chemicals framework from another Commonwealth regulatory scheme.
· Item 9 amends paragraph 15A(b) to take into account the addition to the Inventory
of a previously-regulated chemical under new section 15AA, including the
addition of a condition of use or another condition. It is an offence to introduce a
chemical on the Inventory for a use different to the condition of use for the
chemical included in the Inventory.
Item 10
This item inserts a new Division (Division 1A, comprising sections 15AA and 15AB)
into the Act to enable the Director of NICNAS to decide to add or not add certain
chemicals in products transferred from other Commonwealth regulatory schemes onto
the public section of the Inventory. The decision by the Director is subject to appeal
to the Administrative Appeals Tribunal (AAT). This amendment to the Act is
intended to avoid the re-assessment of chemicals already assessed by another
Commonwealth chemical regulator (either as a stand alone chemical or as part of a
chemical product).
Currently industrial chemicals can only be added to the Inventory if they have been
assessed by NICNAS and an assessment certificate issued to the applicant. This
amendment provides a mechanism by which a chemical can be transferred onto the
public section of the Inventory when the chemical or a product containing the
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chemical ceases to be regulated by another Commonwealth regulator and the chemical
comes within the scope of NICNAS.
For example, a chemical in a cosmetic product, such as a secondary sunscreen product
previously regulated by the TGA, could be added to the Inventory. This discretionary
power will also facilitate future reforms involving transfer of regulatory responsibility
to NICNAS from other Commonwealth regulators, namely, TGA, the Australian
Pesticides and Veterinary Medicines Authority and Food Standards Australia and
New Zealand.
The amendment also empowers the Director, at the same time as the chemical is
included on the Inventory, to annotate the Inventory with any pre-existing controls on
the chemical that were put in place by the previous regulator. This is critical as, once
the chemical or product containing the chemical ceases to be regulated by another
Commonwealth agency, any pre-existing controls will cease to have effect.
Section 15AA Proposal to include previously-regulated chemical to Inventory
For the purposes of this section, a definition of a previously-regulated chemical is
inserted in the Act (in subsection 15AA(9)) as:
· a chemical that has been, but is no longer, within the regulatory scope of another
Commonwealth chemicals law; or
· a chemical in a product that has been, but is no longer, within the regulatory scope
of the Commonwealth chemicals laws for agricultural and veterinary chemicals,
therapeutic goods or food and food additives.
Subsection 15AA(1) provides that the Director may propose to include or not include
a previously-regulated chemical onto the Inventory. It is not intended that chemicals
would be placed on the Inventory that are not currently in use, as this would
undermine the currency of the Inventory.
Subsection 15AA(2) provides that the Director may propose to include a condition of
use or another condition when proposing to include or not include a previously-
regulated chemical in the Inventory. This provision is similar to existing section 13 of
the Act which enables the Director to add conditions to a chemical listed on the
Inventory.
The provision enables the Director to include conditions that applied to the chemical
(or product containing the chemical) when it was previously regulated under another
scheme. For example, conditions of use which applied to a chemical when regulated
under TGA could be included as a condition of use when the chemical was added to
the Inventory.
Subsection 15AA(3) provides that the Director must take into account the potential
risk of the chemical to people and the environment when considering a proposal to
include or not include a previously-regulated chemical onto the Inventory. This
provision is intended to prevent the addition of high-risk chemicals to the Inventory
without further consideration, assessment or control. Detailed guidance on
`unreasonable risk to occupational health and safety, public health or the
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environment' is provided in the NICNAS Handbook for Notifiers on the NICNAS
website www.nicnas.gov.au.
Subsections 15AA(4) and 15AA(5) provide that the Director must give public notice
of any proposal to include or not include a previously-regulated chemical on the
Inventory. The notice must be placed in the Chemical Gazette and include particulars
about the chemical, including reasons supporting the Director's proposal. These
procedures are similar to existing procedures in section 13A of the Act. The notice
must also include a statement advising that a person may object to the Director's
proposal within 28 days of the publication of the notice.
Subsection 15AA(6) requires the Director to send a copy of the Chemical Gazette
notice to any person who is, or might be, introducing the chemical if the identity of
that person is known to the Director. This will assist persons who are possibly
affected to become aware of the Director's proposals.
Subsection 15AA(7) requires the Director to make a final decision on whether to
include or not include a previously-regulated chemical on the Inventory, including a
decision on whether to include conditions on the chemical. The decision must take
into account any statements provided to the Director and be made within 28 days after
the end of the objection period.
The final decision by the Director is also reviewable by the AAT.
Subsection 15AA(8) provides for publication of the Director's final decision in the
Chemical Gazette. It also requires the Director to give a copy of the final decision to
any person who provided a statement on the Director's proposal.
Section 15AB Inclusion of previously-regulated chemical in Inventory
Subsection 15AB(1) provides that the Director must add a previously-regulated
chemical to the Inventory, including any conditions, 28 days after:
· the publication of the Director's final decision (if no review by the AAT has been
sought); or
· after finalisation of any review by the AAT.
Once a chemical is added on the Inventory, the Director can add or vary conditions in
the same manner as for any other chemical on the Inventory.
Subsection 15AB(2) provides that the chemical can only be added to the non-
confidential section of the Inventory, and that a notice must be placed in the Chemical
Gazette, including notice of any conditions placed on the chemical. The option to
include the chemical on the confidential section of the Inventory is not provided so as
to ensure public scrutiny over the inclusion of chemicals onto the Inventory that have
not been assessed by NICNAS.
Item 11
Currently the Act requires that a manufacturer or importer of a new industrial
chemical must apply for an assessment certificate or a permit before the chemical can
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be introduced to Australia, unless the chemical is eligible for introduction under the
exemption provisions of the Act. Section 23 sets out the specific requirements for an
application for an assessment certificate.
Item 11 inserts a new subsection 23(9) to provide for specific data to be included in
the notification statement for an ultra-violet (UV) filter in a cosmetic to be applied to
the skin, for example, UV filters in secondary sunscreens.
Under the cosmetics reforms in 2007, it was agreed that the data requirements which
applied under the TGA be maintained when these chemicals were assessed by
NICNAS. As some of the data required by TGA were not listed in the NICNAS
Schedule to the Act, this Bill inserts a new Part E to the Schedule to cater for these
additional requirements.
As with all notification statements, an application to vary the data requirements listed
in the Schedule for UV filters can be made by the applicant to the Director. Similarly,
the Director has the power to request information additional to that listed in the
Schedule.
Items 12 to 36
The Act imposes various obligations on the Director of NICNAS to prepare a
summary report as part of the assessment report about a chemical (be it a new or
existing chemical). Since the Act was enacted, NICNAS has changed its
administrative procedure in publishing assessment reports. NICNAS now publishes
the full public report on the NICNAS website, which includes the conclusions and
recommendations of the assessment. As the full report is available to all, the need for
a summary report is obviated.
The Bill therefore amends all sections that currently reference the preparation of a
summary report (including provisions in relation to assessment of new chemicals,
existing chemicals and secondary notification of chemicals). The affected sections
are 31A, 31B, 34, 35, 36, 37, 38, 40, 40A, 40G, 44, 60F, 68, 70 and 78.
Item 37
This item enables an application to the AAT for a review of the Director's final
decision to include or not include a previously-regulated chemical on the Inventory
(refer proposed new subsection 15AA(7) described at item 10).
Items 38
This item amends section 104A which relates to delegation by the Director of
NICNAS. This item prevents the Director from delegating his or her power to add a
chemical to the Inventory.
Item 39
This item repeals paragraph 110(1)(t). This is a consequential amendment related to
the publication of all NICNAS full public assessment reports on the NICNAS website.
No fee is applicable for the inspection of a NICNAS public assessment report.
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Items 40 to 58
These items amend the Schedule to the Act which sets out matters to be dealt with in
notification statements about a chemical.
The amendments to the Schedule are intended to cater for the following notification-
related matters:
· the assessment of new active ingredients (UV filters) in secondary sunscreens,
which were previously regulated by the TGA prior to the cosmetic reform
amendments to the Act in September 2007; and
· other amendments in accordance with international best practice, including a
revised requirement for public exposure to the chemical and revision of some
physical and chemical properties.
Item 40
This item simplifies the list of notification categories where Part A of the Schedule is
required. Rather than specifying each individual subsection consecutively, namely,
23(4), (5), (6), (7) and (8) and the new subsection 23(9) (see item 9), it simply states
the range of subsections (23(4) to (9)). Each `notification category' has its own set of
data requirements, for example, as outlined in section 23 of the Act.
Item 41
This item amends clause 4 of Part B of the Schedule to include the physical state of a
chemical, in addition to its appearance. The physical state is helpful in estimating
exposure and therefore the risk to health, safety and the environment.
Item 42
This item amends clause 5 of Part B of the Schedule to enable a more accurate
measure of the introduction volume to be provided where available. This will assist in
the risk assessment, for example, the risk for one tonne of chemical may be
significantly less than the risk for 10 tonnes. It is recognised that some notifiers may
only be able to estimate the volume as a range, for example, 10-100 tonnes, and this
will be reflected in the guidance in the NICNAS Handbook for Notifiers.
Item 43
This item deletes the requirements in subparagraph 6(a)(i) of Part B of the Schedule to
provide the number of workers potentially exposed to a chemical as it is often difficult
for notifiers to estimate the exact numbers of workers for a chemical yet to be
introduced.
Item 44
In order to carry out an adequate risk assessment, NICNAS needs information on
possible public exposure. This amendment replaces clause 8 of Part B of the Schedule
with a new clause that is designed to assist applicants in providing more relevant
information for public exposure, thereby minimising the need for NICNAS to go back
to the applicant for more information.
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Item 45
This item amends paragraph 9(k) of Part B of the Schedule. The wording specifying
the method used for determining flash point has become superfluous and has therefore
been removed by this amendment.
Items 46 to 49
These items amend paragraphs 9(m), 9(p) and 9(q) of Part B of the Schedule.
Some of the current data requirements in the Schedule (for example, for flammability,
explosive properties, stability and reactivity) were included prior to the international
classification of chemicals as hazardous substances and/or dangerous goods.
Over time, these properties, as described in the Schedule, have become inconsistent
with these classification systems and therefore inconsistent with current international
test protocols (that is, those specified by the Organisation for Economic Cooperation
and Development and by the European Union). Therefore the revision of these data
requirements is designed to make the NICNAS requirements more consistent with
hazard classification requirements and international test protocols.
Item 50
This item amends the duration of the short-term repeat dose toxicity study required for
assessment from 10-14 days to 28 days (in paragraph (g) of Part C of the Schedule).
Globally, short-term repeat dose toxicity studies tend to be conducted over 28 days
rather than 10-14 days.
Item 51
This item amends the requirement (in paragraph (j) of Part C of the Schedule) for an
in vivo genotoxicity study. On the advice of genotoxicity experts, and for consistency
with other international assessment schemes and current practice, the new requirement
for genotoxicity in vivo is regarded as being more suitable for the evaluation of the
chemical's genotoxic potential in the risk assessment.
Items 52 and 53
These items provide for deletion of a superfluous requirement regarding use of the
chemical in paragraph (u) in Part C, closing the Part at paragraph (t). Although use of
the chemical is considered in the risk assessment, Part C is concerned with the toxicity
of the chemical and consideration of the chemical's use is not required by the
applicant when submitting test data for the chemical's genotoxic potential.
Item 54
This item adds the requirement (in clause 4 of Part D of the Schedule) to provide
information on the proportion of polymer molecules with number-average molecular
weight less than 500 daltons. Molecules may be absorbed by the body at a molecular
size of about 400-500 daltons and below. Therefore knowledge of the proportion of a
polymer's molecules with molecular weight less than 500 daltons is more important
than the proportion less than 1000. However, it is usual for chemical analysts to
measure both proportions (the proportion less than 500 daltons and the proportion less
than 1000 daltons) when estimating the molecular weight distribution of a polymer.
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Item 55
This item inserts a new Part E into the Schedule which lists the data requirements for
UV filters in cosmetics as applied to the skin which are not covered by requirements
listed in other parts of the Schedule (for example, Part C which lists acute toxicity,
skin and eye irritation and skin sensitisation). See item 11.
Item 56
This item is an application provision which relates to item 10 regarding the addition
of a previously-regulated chemical to the Inventory.
This item clarifies that amendments made by item 10 of the Bill apply to any chemical
that was previously regulated (within the meaning of subsection 15AA(9) of the Act)
whether the chemical became previously regulated before or after the commencement
of item 10.
Item 57
This item is an application provision relating to the amendments about UV filters that
are made by items 11, 40 and 55 of the Bill.
The item clarifies that the amendments about UV filters only apply to those
applications for a non-self assessed assessment certificate that are made on or after the
date that the amendments to the Act take effect. This means that applications for
assessment certificates that have already been made are not affected by these changes.
Item 58
This item is an application provision relating to removal of the need to prepare and
publish summary reports.
The application provision provides that the amendments made by items 1, 3, 4, 12-35
and 39 of the Bill apply to assessment reports (within the meaning of subsection 5(1)
of the Act) published on or after the day Schedule 1 of the Bill takes effect.
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