Bills Digest No. 19, 2017-18
PDF version [906KB]
Dr Emily Hanna
Science, Technology, Environment and Resources Section
April Voigt
Law and Bills Digest Section
16 August 2017
Contents
The Bills Digest at a glance
Purpose of the Bills
Structure of the Bills
Commencement
Background
Animal testing
European Union and other
international examples
Committee consideration
Senate Community Affairs Legislation
Committee
Senate Standing Committee for the
Scrutiny of Bills
The Industrial Chemicals Bill
The Consequential Amendments Bill
The Notification and Assessment
Amendment Bill
The Charges (General), the Charges
(Customs) and Charges (Excise) Bills
Policy position of non-government
parties/independents
New chemicals regime
Labor
Australian Greens
Animal testing
Private Member and Senator Bills
Position of major interest groups
New chemicals regime
Animal testing
Financial implications
Statement of Compatibility with Human
Rights
Parliamentary Joint Committee on
Human Rights
Key issues and provisions
Industrial Chemicals Bill
Preliminary Provisions
The Executive Director
Registration of introducers of
industrial chemicals
Industrial chemicals’ categorisation
and assessment
Listed introductions
Exempted introductions
Reported introductions
Assessed introductions
Commercial evaluation and exceptional
circumstances introductions
Evaluations
Australian Inventory of Industrial
Chemicals
Offences and Enforcement
Offences
Enforcement
Establishment of AICIS and the
Special Account
Application of international
agreements
Cosmetics Standard
Animal testing
Scope of the changes
Application to substances for use
‘solely’ in cosmetics
Historical animal test data
Human health and environmental
concerns
Constitutional limitations
International free
trade obligations
Will animal testing continue?
Notification and Assessment Amendment
Bill
Charges (General), Charges (Excise)
and Charges (Customs) Bills
Date introduced: 1
June 2017
House: House of
Representatives
Portfolio: Health
Commencement: The
substantive provisions of the Industrial Chemicals Bill will commence on 1
July 2018. The commencement dates of the other Bills are specified in
subclause 2(1) of each Bill and outlined in this Bills Digest.
Links: The links to each Bill,
its Explanatory Memorandum and second reading speech can be found on each Bill’s home page, or through the Australian
Parliament website.
When Bills have been passed and have received Royal Assent,
they become Acts, which can be found at the Federal Register of Legislation
website.
All hyperlinks in this Bills Digest are correct as
at August 2017.
The Bills Digest
at a glance
Purpose of the Bills
- The
Bills establish a new legislative scheme, called the Australian Industrial
Chemicals Introduction Scheme (AICIS), to control the introduction of
industrial chemicals. AICIS will replace the National Industrial Chemicals
Notification and Assessment Scheme (NICNAS).
- The
purpose of the new regime is to reduce regulatory burden while still protecting
human health and the environment by making the level of assessment required for
the introduction of an industrial chemical proportionate to its potential risk.
It also provides that animal testing data cannot be relied on to support the
introduction of chemicals that will be solely used in cosmetics.
Structure of the Bills
- This
is a package of six associated Bills.
Background
- A
review of NICNAS was undertaken after stakeholder complaints. The resultant
Bills aim to ‘streamline the assessment process for industrial chemicals to
reduce the regulatory burden on the sector, while also ensuring Australia’s
robust safety standards are maintained’.
Stakeholder concerns
- Groups
concerned about public health, workers in the industry and the environment are
worried by the reduction of oversight and limited amount of detail included in
the Bills and the possible resultant risks.
- Groups
interested in animal welfare believe that the measure relating to animal
testing for cosmetics is too narrow.
Key elements
- The
Industrial Chemicals Bill 2017 sets out new categories for introduction of
industrial chemicals, with new requirements for introductions.
- There
will also be a new inventory listing industrial chemicals, the Australian
Inventory of Industrial Chemicals.
- The
Industrial Chemicals Bill 2017 prohibits the inclusion of animal test data
obtained from tests conducted on or after 1 July 2018 in an application to
introduce a new industrial chemical for an end use solely in cosmetics.
Key issues
- One
major issue that applies to the whole Industrial Chemicals Bill 2017 is that
little detail of the scheme is included in the Bill itself. Instead, the Bill
provides an overarching framework and the detail of how the scheme will operate
is left to delegated legislation. This greatly reduces the level of
parliamentary scrutiny that can apply to the scope and actual operation of the
scheme.
- Record
keeping requirements in the new scheme do not require introducers of chemicals
to inform AICIS of which chemicals they have introduced in the ‘exempted
introductions’ category (the lowest risk category), only whether they have
introduced chemicals in this category. This means that there will be no
complete Government record of the industrial chemicals introduced into
Australia.
- There
are concerns that only banning animal test data for industrial chemicals which
will be solely used in cosmetics will allow animal testing to continue for new
industrial chemicals with multiple end uses, even if one is cosmetic use.
Purpose of the Bills
This Bills Digest is for a package of six Bills:
The purpose of the Industrial Chemicals Bill is to
establish a new legislative scheme, called the Australian Industrial Chemicals
Introduction Scheme (AICIS), to control the introduction of industrial
chemicals. AICIS will replace the National Industrial Chemicals Notification
and Assessment Scheme (NICNAS). The purpose of the new regime is to:
- reduce
regulatory burden while still protecting human health and the environment by making
the level of assessment required for the introduction of an industrial chemical
proportionate to its potential risk and
- provide
that animal testing data cannot be relied on to support the introduction of
chemicals that will be solely used in cosmetics.
The purpose of the Consequential Amendments Bill is to:
The purpose of the Notification and Assessment Amendment
Bill is to amend the ICNA Act with some reforms before the new regime
comes into effect. This includes changing definitions to allow certain polymers
to be introduced into Australia more easily, as well as changes in reporting
requirements.
The purpose of the Charges (General) Bill, Charges
(Customs) Bill and Charges (Excise) Bill are to allow the Government to impose
an annual charge for registration of an introducer of industrial chemicals
under the new regime. These three Charges Bills allow, respectively, charges
that are not an excise or customs duty, excise charges and customs charges. The
three Charges Bills are separate due to the Constitutional requirement for
taxation, duties of excise and duties of customs to be dealt with in Bills that
only include that individual, respective type of charge.[2]
Structure
of the Bills
The Industrial Chemicals Bill is divided into multiple
parts. Each part of the Bill addresses different requirements that are needed
to run the new scheme for introduction of industrial chemicals:
- Part
1 contains preliminary provisions, including definitions
- Part
2 establishes the Register of Industrial Chemical Introducers
- Part
3 specifies the new categories of industrial chemicals and their required
levels of assessment
- Part
4 specifies when an evaluation of an industrial chemical or related matter can
be initiated by the Executive Director
- Part
5 establishes the new Australian Inventory of Industrial Chemicals
- Parts
6–8 outline information and reporting requirements as well as provisions
for the establishment, administration and enforcement of AICIS, and create the
role of Executive Director
- Part
9 specifies relevant international agreements and their application and
- Part
10 contains miscellaneous provisions, including the general rule making
power and one of the clauses which restricts the use of animal testing for
cosmetics.[3]
The Consequential Amendments Bill is divided into two schedules.
Schedule 1 repeals the current legislation controlling industrial
chemicals and amends various Acts that reference the ICNA Act, while Schedule 2
contains mainly transitional provisions.
Commencement
The new Industrial Chemicals scheme is proposed to
commence on 1 July 2018.[4]
The schedules of the Consequential Amendments Bill
commence on the later of:
- the
day after Royal Assent and
- immediately
after the commencement of the Industrial Chemicals Act 2017.[5]
Clauses 1 to 3 of the Notification and
Assessment Amendment Bill commence on the day that Bill receives Royal Assent,
while Schedule 1 commences on the latest of the following:
1 July
2017
- the
day that the Notification and Assessment Amendment Bill receives Royal Assent
- the
day that the Industrial Chemicals Bill receives Royal Assent
- the
day that the Charges (General) Bill receives Royal Assent
- the
day that the Charges (Customs) Bill receives Royal Assent and
- the
day that the Charges (Excise) Bill receives Royal Assent.
However, if the related Bills mentioned above do not receive
Royal Assent, then Schedule 1 will not commence.[6]
Clauses 1 and 2 of the Charges (General)
Bill, Charges (Customs) Bill and Charges (Excise) Bill all commence on Royal
Assent while clauses 3 to 9 of each Bill commence on the later
of:
-
the day after Royal Assent and
-
immediately after the commencement of the Industrial
Chemicals Act.
If the Industrial Chemicals Act does not commence,
then the three Charges Bills will not commence.[7]
Background
Chemicals introduced to Australia (whether through importation
or manufacture) are regulated through four federal schemes. The schemes are
divided by end use of the product. The four areas concentrate on:
The last category, industrial chemicals, is currently
regulated under the ICNA Act. Under the ICNA Act, the NICNAS began
in 1990. NICNAS, which is administered by the Department of Health, ‘helps
protect the Australian people and the environment by assessing the risks of
industrial chemicals and providing information to promote their safe use’.[12]
The current scheme lists approximately 40,000 ‘existing’ chemicals on the Australian
Inventory of Chemical Substances (AICS). These ‘existing’ chemicals do not
require assessment before being used in goods nor is notification to NICNAS
required before they enter the Australian market.[13]
In 2015–16, Australian industrial chemical imports and
exports were worth over approximately $62 billion.[14]
Approximately 9,000 ‘new’ chemicals are introduced into
Australia each year which do not need assessment before entering the market.
This is because they are included in one of the categories that are granted
exemption from assessment.[15]
Examples of exemption categories include:
- chemicals
introduced solely for research, development or analysis (in an amount not
greater than 100kg per year) and
- chemicals
that are in Australia for less than 30 days after introduction, which do not
leave a port or airport and are constantly under Customs and Border Protection
Service control.[16]
NICNAS must still be notified of the introduction of exempt
chemicals annually (post-market). As well as this, approximately 300 chemicals
a year must be assessed by NICNAS to determine their risk to human health and
the environment. They are not permitted to enter the Australian market until
they have been granted an assessment certificate or permit.[17]
A review of NICNAS was undertaken in 2012–13 to determine
‘how the existing regulatory settings may be improved to enhance both the
competitiveness of the Australian chemical industry and public health and
environmental outcomes’.[18]
A number of stakeholders, including community and industry groups, had called
for NICNAS to be improved. Community groups wanted continued assurance that the
health of Australian people and the environment was being appropriately
protected. Industry groups wanted the system to work faster and believed that
in its current form, NICNAS encouraged the use of already listed chemicals,
which could potentially be more harmful than newer industrial chemicals. The
review found that ‘NICNAS’s assessment framework is not sufficiently based on
the likely risk of a chemical’, that the ‘[l]egislative requirements create
inefficient regulatory processes’ and that there were ‘[i]nconsistencies and
uncertainties in regulatory coverage’.[19]
A number of reforms were suggested to deal with these issues, and further stakeholder
consultation was carried out.
In 2015, the Government announced that industrial chemical
regulation reforms would be implemented by September 2018.[20]
Stakeholder consultation continued and a total of five consultation papers have
been published covering topics including matters to be included in delegated
legislation under the new regime.[21]
The resultant Bills are designed to deliver the proposed reforms to NICNAS and
aim to ‘streamline the assessment process for industrial chemicals to reduce
the regulatory burden on the sector, while also ensuring Australia’s robust safety
standards are maintained’.[22]
Animal testing
There is currently no national legislative scheme banning
animal testing for cosmetic purposes, or the sale of such products, in
Australia. Despite this, very little (if any) animal testing for cosmetic
purposes occurs in Australia as it is made largely impractical by legal
barriers imposed by animal welfare and research laws of the states and
territories, particularly through compliance with the National Health and
Medical Research Council’s influential Australian
code for the care and use of animals for scientific purposes (the Code).[23]
The states and territories incorporate the Code into their
animal research and welfare laws (albeit to varying degrees) with the aim of
achieving the objective of the Code ‘to promote the ethical, humane and
responsible care and use of animals used for scientific purposes’.[24]
These laws (like the Code) do not ban animal testing for cosmetic purposes but
they do make it difficult, which contributes to the lack of such testing
currently taking place in Australia.[25]
For example, in jurisdictions where the Code has been incorporated into law,
research institutions are required to establish an animal ethics committee to
determine whether animal testing is ‘essential’ and ‘justified’ by balancing
the scientific or educational value against animal welfare.[26]
Overcoming this hurdle may be difficult where there are existing non-animal
cosmetic testing alternatives.
At the national level, a number of proposals to restrict
animal testing for cosmetic purposes, and the sale of cosmetic products tested
on animals, have been put before the Australian Parliament in the past, in line
with changing domestic and international attitudes evidenced, for example, by
animal testing bans across the European Union (EU) (discussed in more detail below).[27]
There was an increase in political momentum in 2014 to regulate such testing at
a national level following the introduction of Greens’ Senator Lee Rhiannon’s End Cruel Cosmetics
Bill 2014 and the release of the Australian Labor Party’s public
consultation report which reflected widespread public support for increased
regulation.[28]
During the 2016 election campaign, the Coalition announced
that, on re-election, it would implement a:
... policy to ban the testing of finished cosmetic products on
animals in Australia, the testing of cosmetic ingredients on animals in
Australia and the sale of cosmetic products and ingredients that have been
tested on animals outside of Australia.[29]
The ban was proposed to come into effect from 1 July 2017.
The Government followed this announcement with public consultation with
industry, animal welfare organisations and the general public which commenced
in late 2016. The outcomes, published in a consultation
paper in March 2017, indicate that there is general support to bring
Australia in line with international approaches to animal cosmetic testing.
However, that consultation also found that such regulation should not have a
significant detrimental impact on industry or consumers and should be overseen
by the government to ensure compliance.[30]
The Coalition subsequently announced in its 2017–18 Budget that it would
‘provide $2.1 million over two years from 2017–18 to implement its 2016
election commitment to ban cosmetic testing on animals in Australia’.[31]
As will be discussed in further detail later in this
Digest, the Industrial Chemicals Bill does not purport to expressly ban animal
testing for cosmetic purposes, or the sale of such products. Instead it
restricts the circumstances in which data obtained by animal testing may be
relied upon in applying under the industrial chemicals regulations to
manufacture or import chemicals for cosmetic purposes in a manner similar to
the animal testing regulations of the EU. While the Industrial
Chemicals Bill does not expressly ban animal testing for cosmetic purposes on
its own, it is proposed to be a part of a broader policy framework which
includes amending the Code to include an outright cosmetic testing ban and to
work with the states and territories to incorporate the amended Code into their
respective laws.[32]
European Union and other international examples
The Industrial Chemicals Bill aims to
‘bring Australia into line with the EU’ in relation to animal testing for
cosmetic purposes.[33]
Since 2003 the EU has prohibited the:
- marketing
of cosmetics that have been, or that include ingredients that have been, tested
on animals and
- conduct
of animal testing for cosmetic purposes testing within the EU, after the time
at which alternative non-animal methods are validated.[34]
Although there is no reference to importation, the
practical effect of the EU marketing ban is that cosmetic products tested on
animals in countries outside the EU cannot be sold within EU countries. Further
comparisons between the EU regulations and the Industrial
Chemicals Bill are made in Key issues and provisions, below.
Other countries which have moved away from animal cosmetic
testing include:
New Zealand introduced an express ban on animal testing of
cosmetics, or ingredients for exclusive use in a cosmetic, although this does
not apply to imports.[39]
It should be noted that New Zealand does not have the same division of powers
between the states and territories and the Commonwealth as Australia. This
means introducing such a ban in New Zealand does not encounter the same
constitutional issues as those that arise in the Australian context. These
constitutional restraints are discussed in further detail in the Key issues
and provisions section below.
Committee
consideration
Senate
Community Affairs Legislation Committee
The package of Bills was referred to the Senate Community
Affairs Legislation Committee for inquiry and report by 13 June 2017. The
reporting date was extended until 8 August 2017. The report and details of the
inquiry are at the inquiry
homepage.[40]
Sixteen submissions were received from stakeholders including industry, health
and animal welfare groups.[41]
The majority report of the Committee recommended that the Bills
be passed and made no other recommendations.[42]
However, there were additional comments from Labor[43]
and a dissenting report from the Greens.[44]
These are discussed below in ‘Policy position of non-government
parties/independents’.
Senate
Standing Committee for the Scrutiny of Bills
The Industrial Chemicals Bill
The Senate Standing Committee for the Scrutiny of Bills
raised three issues with the Industrial Chemicals Bill. The first related to the
review of decisions made under the Industrial Chemicals Bill. Clause 166 includes
a table that lists the decisions made by the Executive Director which are
classified as a ‘reviewable decision’, where ‘[a] “reviewable decision” is one
which sets out a process for reconsideration by the Executive Director and
review by the Administrative Appeals Tribunal’.[45]
However, the Committee noted that not all decisions made under the Bill are
listed as reviewable, which is not explained in the Explanatory Memorandum.
Likewise, it does not explain why some decisions are included as reviewable decisions
while others are not, and the Committee believes that ‘if decisions are
excluded that might have an adverse impact on an individual’, justification is
required. The Committee requested the Minister’s advice on this issue.[46]
The Minister explained that ‘[a]ll decisions that could adversely affect the
interests of an applicant are reviewable’.[47]
He stated that the non-reviewable decisions were purposely excluded from being
reviewable as ‘for example, the decision will have no adverse impact on the
applicant, will not change the status quo or is automatic’.[48]
Another issue raised by the Committee was that the
Industrial Chemicals Bill overrides the common law principle of a person being
excused from giving evidence that will incriminate him or herself in particular
circumstances. Under clause 161, the Executive Director can require a
person to provide information or documents that ‘it is reasonably necessary to
obtain for the purpose of Australia’s compliance with its obligations under the
Rotterdam Convention’.[49]
Subclause 175(1) then states that a person is not excused from providing
this information or document because it may incriminate him or her or result in
a penalty. However, subclause 175(2):
... provides that the information or documents produced, or
anything obtained as a direct or indirect consequence of the production of the
information or documents, is not admissible in evidence in most proceedings.[50]
Despite this, the Committee was concerned at the
abrogation of the privilege against self-incrimination, especially given there
was no justification for this in the Explanatory Memorandum. The Committee
requested an explanation for the abrogation from the Minister.[51]
The Minister replied that the abrogation was limited, as it could only apply in
the ‘very limited’ circumstances allowed by clauses 175 and 161
described above, and that the ICNA Act contains a provision with the
same effect so Australia can meet its international obligations.[52]
The Minister stated that ‘[t]he provision has been included ... so that there is
no change or disruption in the arrangements described in the new law, as they
relate to Australia's international obligations’.[53]
The final issue that the Committee raised related to clause
180 of the Industrial Chemicals Bill, which provides that the rules made under
the Bill ‘may make provision in relation to a matter by applying, adopting or
incorporating any matter contained in any other instrument or other writing as
in force or existing from time to time’, despite subsection 14(2) of the Legislation Act
2003.[54]
Incorporating external documents into law raises a number of issues, as it ‘can
create uncertainty in the law’, means that it is possible the law can change
without parliamentary scrutiny and can make it difficult for people to access
the provisions of the law they are meant to be following.[55]
The Explanatory Memorandum states that the external materials are anticipated
to include relevant international lists of chemicals that the introducer must
use to determine whether the chemicals they wish to introduce are known to have
particular hazards. The Explanatory Memorandum goes on to explain that as the
lists could be regularly updated, referencing them at certain dates will not be
meaningful.[56]
However, the Committee was concerned about the availability of the relevant
lists for interested parties and has sought the Minister’s advice as to whether
the relevant international lists will be made freely available.[57]
The Minister replied that ‘[a]ny materials to be incorporated by reference are
readily accessible (at no cost) and links to the materials will be made
available on the AICIS website’.[58]
The Consequential Amendments Bill
The Senate Scrutiny of Bills Committee raised the issue of
the retrospective application of rules allowed by item 50 of Schedule
2 of the Consequential Amendments Bill. Subitem 50(4) of the
Consequential Amendments Bill states that ‘subsection 12(2) of the Legislation
Act 2003 does not apply to rules made before 1 July 2020’. Subsection 12(2)
‘prohibits the retrospective application of legislative instruments which have
a detrimental effect on a person or impose retrospective liability on a
person’.[59]
This means that the rules could apply retrospectively, in contrast to the
general principle that laws should apply prospectively, and that the
retrospective application could negatively affect individuals. The potential
for rules to have a retrospective detrimental impact is a ‘particular concern’
of the Committee, especially since the reason for it is not included in the
Explanatory Memorandum. The Committee thus asked the Minister to explain the
reason behind this aspect of the legislation.[60]
The Minister explained that allowing the transitional
rules to apply retrospectively was required to deal with any unforeseen gaps
and unintended consequences due to the replacement of the complex ICNA Act
with the ‘significantly different’ new scheme.[61]
He also confirmed that ‘[i]t is not intended or anticipated that persons would
be disadvantaged through retrospective application of the rules’.[62]
The Senate Scrutiny of Bills Committee also raised concern
about subitem 50(3), which allows delegated legislation to modify
the application of primary legislation. The Committee explained the problem
with allowing delegated legislation to modify legislation examined by
Parliament:
There are significant scrutiny concerns with enabling delegated
legislation to override the operation of legislation which has been passed by
Parliament as such clauses impact on the level of parliamentary scrutiny and
may subvert the appropriate relationship between the Parliament and the
Executive. As such, the committee expects a sound justification ... in the
Explanatory Memorandum.[63]
The Committee accepted that it may be suitable for the delegated
legislation to amend the primary legislation in the circumstances covered by
the Bill, particularly given the detailed justification in the Explanatory
Memorandum. This justification included the ‘significant consequences for not
having the right transitional arrangements in place’ and the complexity of
transitioning from the old law.[64]
The Notification and Assessment Amendment Bill
The Scrutiny of Bills Committee had no comment on the
Notification and Assessment Amendment Bill.[65]
The Charges (General), the Charges (Customs) and Charges
(Excise) Bills
The Scrutiny of Bills Committee had the same concern for
all three of the Bills related to charges—the Charges (General) Bill, the
Charges (Customs) Bill and Charges (Excise) Bill. Subclause 7(1) of each
Bill provides for the amount of the registration charge to be set by
regulations. The Committee expressed concern that the Bills do not set a limit
on the charge. The Committee has requested the Minister’s advice as to why the Bills
do not specify a maximum charge and also ‘whether guidance in relation to the method
of calculation of the charge and a maximum charge’ can be included in each Bill.[66]
The Minister replied that there was no maximum amount
included in the Bills for reasons including that it would misrepresent the
amount payable since it would have to be higher than the maximum amount
payable.[67]
Due to the large variance in fees between individuals, an included maximum
charge would also ‘misrepresent the magnitude of charge likely to be payable by
most registrants (reducing transparency)’.[68]
The flexibility of having the charge calculation method or specific charges in
regulations, rather than the primary legislation, allows charges to be changed
as required to avoid over or under recovery of costs. The Minister also
explained that the present approach complies with the Australian Government
Cost Recovery Guidelines and relies ‘on the general cost recovery rules to
provide the necessary assurances and transparency to stakeholders’.[69]
Policy position
of non-government parties/independents
New chemicals
regime
Labor
In their additional comments in the Senate Committee
report on the Bills, Labor Senators indicated that they do not oppose the
Industrial Chemicals package of Bills. However, they did have some concerns and
believe that some amendments are required. Similar to many interest groups (see
below in Position of major interest groups), Labor Senators were
concerned by the lack of detail in the Bills themselves and the reliance on
regulation, stating that ‘Government is once again asking the Parliament to
pass the Bills and trust it on the implementation’.[70]
Given that, Labor Senators reserved ‘their right to closely scrutinise the
regulations and to disallow any which do not adequately ensure health and
environmental protections are not diminished’.[71]
Labor Senators were also concerned about the lack of
notification to the regulator of industrial chemicals introduced in the ‘Exempted
Introduction’ category, especially given the lack of chemical tracking (for
more information see Key issues and provisions, below). Although the
introducer will need to inform the regulator that they have introduced
chemicals in this category, Labor Senators did not believe that this was
sufficient as it does not tell the regulator which specific chemicals were
introduced into Australia. They believed that introducers should have to submit
‘the name, volume and date of introduction of the industrial chemical’ to the
regulator annually.[72]
This would ‘preserve the principle of a register of industrial chemicals,
provide greater transparency and should new information about the nature of a
chemical come to light, make tracking exposures far easier’.[73]
Labor also suggested that the Inventory
Multi-tiered Assessment and Prioritisation (IMAP) process be included in
the new legislation.[74]
IMAP is currently being used to assess the potential health and environmental
impacts of industrial chemicals on the AICS which have not previously been
assessed. Despite the assurances of the Department of Health that IMAP or a
similar process would continue in a strengthened form under the new chemicals
scheme, Labor Senators were concerned there was a scarcity of information on
this topic in the Industrial Chemicals Bill and its Explanatory Memorandum. As
such, Labor Senators would be ‘further reassured if this commitment was
included in the primary Bill’.[75]
Australian Greens
In their Dissenting Report, the Australian Greens were
also concerned about the Exempted Introduction category of industrial chemicals
and the continuation of IMAP. The Greens believe that the ‘expansion of the
exempted chemicals classification creates an unacceptable situation in which
the regulator has no knowledge of chemicals in the Australian market’ and that
‘many chemicals which may be thought to be low‑risk can be found to lead
to greater risk over time’.[76]
As such, the Greens recommended that the Bill ‘be amended to ensure that no
chemicals introduced into the Australian market, including those classified
under the proposed system as “very low risk”, are exempt from notification’.[77]
The Greens also recommended that the Bill be amended to ‘enshrine
the continuation’ of the IMAP framework for assessing existing chemicals. They
believe this is necessary due to ‘the huge backlog of unassessed chemicals
currently in use in Australia’ (currently, approximately 25,000–30,000), and
the lack of detail in the Industrial Chemicals Bill about how these chemicals
can be assessed under the new regime.[78]
Animal
testing
Labor supported banning animal testing for cosmetics, and
supported having a ban in the Industrial Chemicals Bill. However, they noted concerns
raised by animal welfare groups about the narrowness of the ban in the
Industrial Chemicals Bill as well as its ‘loophole which would allow animal
test data to be used in industrial chemicals introduced for multi end use’.[79]
Labor thus believed that there should be an amendment to broaden the ban on
animal test data for cosmetics as it would make the ban more comprehensive and
provide ‘much more confidence in the system’.[80]
The Greens are also strong supporters of banning animal
testing for cosmetics and supported the ban in the Industrial Chemicals Bill.[81]
However, they also believed that the proposed ban is too narrow, and recommended
‘that the Bill be amended to ensure that applications to introduce chemicals
for cosmetic end-use do not use animal tested data under any circumstances’.[82]
Private
Member and Senator Bills
The broad cross-party support for greater regulation of
cosmetic testing on animals has resulted in the previous introduction of Bills
banning animal testing for cosmetics.[83]
Both Labor and the Greens have introduced private members’ Bills aimed at
banning testing:
On 27 November 2014, the Senate passed a motion with
support of all parties and most crossbenchers, including Senator Xenophon, urging
the Government ‘to aspire to eliminate unnecessary animal test methods to
evaluate the safety of cosmetic products and ingredients’.[86]
Broadly, each of the private members’ Bills proposes to
amend the ICNA Act to create an offence for testing a cosmetic, or a
substance for use in a cosmetic, on an animal.[87]
Additionally, the Ethical Cosmetics Bill 2016 proposed to create offences
relating to the importation and manufacturing of cosmetic products, or
substances for use in cosmetic products, which were tested on animals.[88]
The End Cruel Cosmetics Bill 2014 includes similar offences and proposes
further offences for the marketing and/or selling of cosmetic products, or
substances for use in cosmetic products, which are tested on animals.[89]
While the Ethical Cosmetics Bill 2016 lapsed at
prorogation of the 44th Parliament on 15 April 2016, the End Cruel Cosmetics
Bill 2014 was restored to the Notice Paper after commencement of the 45th
Parliament, and remains before the Senate.[90]
Position of
major interest groups
New
chemicals regime
Opinions on the new chemical introduction scheme have been
mixed. The scheme as a whole has been welcomed by industry groups and chemical
companies such as Chemistry Australia (formerly the Plastics and Chemicals
Industry Association) and Dow Chemical. This is due to factors including the
chemical assessment process being streamlined and the associated reduction of
red tape and decreased time for assessment of new chemicals.[91]
For example, ACCORD (the association for the
hygiene, cosmetic and specialty products industry) has labelled the Bills a
‘vast improvement’ on the current ICNA Act and recommend that it is
passed as written.[92]
However, groups concerned about public health, workers in
the chemical industry and the environment are worried by the reduction of
oversight and lack of detail in the Bill (due to multiple clauses leaving
detail to legislative rules) and the possible resultant risks. For example, in
its submission to the Senate inquiry, the Public Health Association of Australia
(PHAA) expressed disappointment ‘that the proposed reforms will now allow many new
chemicals to be imported into or manufactured in Australia without any
Government or public record of these introduced chemicals’.[93]
The PHAA further stated it:
... cannot support reforms in the proposed Australian
Industrial Chemicals Introduction Scheme (AICIS) that erode the capacity of
current regulations in the NICNAS to perform the Government’s key role of
“regulating to protect human health and the environment”. Furthermore, prioritising
“easing regulation for industry” over “protecting the Australian people and the
environment” runs counter to the justified expectations of the Australian
people.[94]
The National Toxics Network commented that the ‘reforms do
not strike a balance, but seek to erode protections and establish what will
largely be a deregulated approach to industrial chemicals in Australia’.[95]
The Cancer Council Australia was concerned that certain parts contain ‘insufficient
clarity to ensure the health of the population’.[96]
The Cancer Council Australia also raised concerns about moving the assessment
of many chemicals from pre- to post-market, the ‘substantial powers and
responsibilities’ that will likely be granted to a bureaucrat and the lack of a
commitment to continue assessing the over 30,000 unassessed chemicals in the
chemical register.[97]
Numerous interest groups also thought the time available
to make submissions in response to the Senate Committee’s inquiry into the legislation
was too limited, making it difficult to give the legislation proper scrutiny.
As the Automotive, Food, Metals, Engineering, Printing and Kindred Industries
Union (Australian Manufacturing Workers Union or AMWU) said:
The 2015 Federal Budget announced these reforms yet the
current the [sic] time frames severely restrict the ability of the public and
parliamentarians to scrutinise the Bill. The second reading speech was on the
1st June, submissions to the Senate Committee are due on 12th June [a public
holiday for much of the country] and the Committee’s reporting date is 13th
June 2017. This is not urgent legislation – it should be open to proper
scrutiny from the Parliament and the community.[98]
As noted earlier, the Senate Community Affairs Legislation
Committee reporting date was subsequently extended until 8 August 2017.[99]
Animal
testing
The RSPCA and Be Cruelty-Free Australia (‘a partnership
between Humane Society International (Global and Australia) and Humane Research
Australia’) support the introduction of limits on animal testing for cosmetics
but believe that the proposed limits should be stronger.[100]
The RSPCA commended ‘the Government for taking action to ban cosmetic testing
on animals’ and stated it ‘is encouraged to see this basic policy position
[banning animal testing for cosmetic purposes] accepted and embraced by major
parties across the political spectrum and we commend all parties for taking
this important stance’.[101]
Be Cruelty-Free Australia acknowledged that the measures in the Industrial
Chemicals Bill ‘represent an important step toward the Government’s commitment
to ending cosmetic animal testing and trade in Australia’.[102]
However, the RSPCA and Be Cruelty-Free Australia both consider
that the clauses in the Industrial Chemicals Bill (clauses 103 and 168)
limiting animal testing are too narrow.[103]
This is because the animal testing restriction currently in the Industrial
Chemicals Bill only applies to chemicals that will be used solely in cosmetics,
allowing the ban to be circumvented simply by saying the chemical will be used
in a non-cosmetic product as well as a cosmetic product. The organisations both
believe the clauses need to be broadened so that they cover chemicals used ‘solely
or substantially’ in cosmetics (the RSPCA) or for ‘all cosmetic end uses’,
whether or not the chemical is also used in products that are not cosmetics (Be
Cruelty-Free).[104]
More information on the views of interest groups is
included in Key issues and provisions below.
Financial
implications
According the Explanatory Memoranda, there is no financial
impact on the Commonwealth from the package of Bills.[105]
This is because it is still ‘Government policy that the cost of the
Commonwealth industrial chemicals introduction scheme is fully recovered from
the regulated industry’.[106]
Statement of Compatibility with Human Rights
As required under Part 3 of the Human Rights
(Parliamentary Scrutiny) Act 2011 (Cth), the Government has assessed the
Bills’ compatibility with the human rights and freedoms recognised or declared
in the international instruments listed in section 3 of that Act. The
Government considers that the Bills are compatible.[107]
Parliamentary
Joint Committee on Human Rights
The Parliamentary Joint Committee on Human Rights did not raise
any human rights concerns for any of the Bills.[108]
Key issues
and provisions
Industrial
Chemicals Bill[109]
The Industrial Chemicals Bill is the main Bill for the new
industrial chemicals scheme. One major issue that applies to the whole Bill is
that little detail of the scheme is included in the Bill itself. Instead, the
Bill provides an overarching framework and the detail of how the scheme will
operate is left to ‘rules’ made by the Minister under clause 180 of the
Bill. As the AMWU commented, ‘[t]he Bill or the EM outlines processes but provides
no detail on the “what”’.[110]
Major parts of the Bill, including, for example, how to determine the different
categories of risk that will be used to decide whether or not chemicals need be
assessed before they are introduced, are reliant upon these rules. Although the
rules will be a legislative instrument, disallowable by either House of
Parliament, this greatly reduces the level of parliamentary scrutiny that can
apply to the scope and actual operation of the scheme and limits present
clarity of the scheme.[111]
Despite the public consultation that has been carried out on the new
legislative scheme, including on the content of some of the rules, numerous
interest groups, including the AMWU and Cancer Council Australia, were
concerned that so much of the detail is left to the rules.[112]
Preliminary
Provisions
Part 1 of the Industrial Chemicals Bill contains
preliminary provisions relating to the new industrial chemicals scheme,
including the objects of the regime[113]
and definitions applicable to the regime.
Clauses 9 and 10 contain numerous relevant
definitions. A key definition in clause 9 is to ‘introduce’ an
industrial chemical, which means importing or manufacturing the chemical in
Australia. Clause 10 defines an ‘industrial chemical’ basically as one
which has an ‘industrial use’. ‘Industrial use’ is then defined in clause 9 as
‘a use other than (or in addition to)’ use as an agricultural or veterinary
chemical product, a therapeutic good, human or animal food or any use
prescribed by the rules. The Explanatory Memorandum explains that these three
terms have ‘the same scope’ as the matching terms used in the ICNA Act.[114]
Under paragraph 10(1)(f), it will also be possible
for additional types of chemicals or substances with an industrial use to be
added to the definition of industrial chemical by the rules. Subclause 10(2)
also allows the rules to exclude certain chemicals from the definition of
industrial chemical. The Explanatory Memorandum states that the ability to
change the definition of industrial chemical and industrial use through the
rules will ‘provide flexibility to make changes over time to ensure the key
definitions that confine the parameters of the scheme remain both current and
accurate’.[115]
Clause 11 sets out certain types of introductions that
will not be covered by the proposed Act. These are referred to as ‘excluded
introductions’, and include industrial chemicals introduced at an Australian
port or airport which leave Australia within 25 working days and are under customs
control for the whole time, and industrial chemicals introduced for personal
use.[116]
Subclause 11(4) allows the rules to also define further excluded
introductions.
The
Executive Director
Clause 141 establishes the Executive Director of
the AICIS. Under clause 142, the Executive Director’s functions include ‘to
promote the international harmonisation of regulatory controls or standards for
industrial chemicals’ as well as functions conferred by other provisions of the
Bill, the rules or any other Act. Clause 143 provides that the Executive
Director is appointed in writing by the Governor-General on a full-time basis. Under
clause 144, that appointment must not be for more than five
years. However, the Executive Director can be appointed to the role multiple
times.[117]
The conditions under which the Executive Director can be terminated by the
Governor-General are set out in clause 151. These include, for example,
misbehaviour, bankruptcy and not disclosing interests that could conflict with
his or her duties.[118]
Clause 172 allows the Executive Director to use a
computer program to make administrative decisions, with these decisions
regarded as decisions made by the Executive Director. Subclause 172(3) proposes
a safeguard, allowing the Executive Director to substitute a different decision
if he or she is satisfied that the one from the computer program is wrong.[119]
Registration
of introducers of industrial chemicals
Part 2 of the Industrial Chemicals Bill establishes
the registration process for ‘introducers’ of industrial chemicals. Under clause
13, it is an offence for a person to introduce industrial chemicals into
Australia without being registered for the relevant registration year (see Offences
and Enforcement, below for more information, including on penalties). Registration
years will begin on 1 September, with the first one starting in 2018.[120]
Under clause 15, certain details of registered
introducers of industrial chemicals must be kept on a publically available
Register, called the Register of Industrial Chemical Introducers. Clause 14 provides
that the Register will be established by the Executive Director. Clause 20
provides that a registration charge will be applied, with clause 21
specifying that the amount charged will be determined under regulations made
under the Charges (General), Charges (Excise) and Charges (Customs) Bills
(these Bills are discussed in further detail later in this Digest). Under clause
16, a person can apply to the Executive Director for registration for a particular
registration year provided his or her registration has not been cancelled by
the Executive Director in the current registration year, or the previous three
years, due to a contravention of the Act or the provision of false or
misleading information. Provided that the application is in order, under subclause
17(1), registration must be granted by the Executive Director. Clause 19
provides the circumstances in which a registration may be cancelled; these
include at the registered person’s request and on the Executive Director’s
initiative if, for example, the registered person was convicted of an offence
or subject to a civil penalty under the proposed Industrial Chemicals Act.[121]
The Consequential Amendments Bill ensures that businesses
that are already validly registered to introduce chemicals under NICNAS will
continue to be registered under the new regime. Under item 9 of Schedule
2 of that Bill, people already registered under the ICNA Act to
introduce chemicals ‘immediately before 1 July 2018’ will be taken to be registered
under the new regime for the 2018–19 registration year. Similarly, under item
10 of Schedule 2, an application for registration made under the old
regime which are pending ‘immediately before 1 July 2018’ will be taken to be
an application made under the new regime. This applies whether the application
is a renewal or a new application.[122]
Industrial
chemicals’ categorisation and assessment
Part 3 sets out six introduction categories for
industrial chemicals: listed, exempted, reported, assessed, commercial
evaluation and exceptional circumstances introductions. This is where the
Government’s risk-based approach to assessment of industrial chemicals is being
implemented. The different categories reflect different levels of indicative
risk to human health and the environment (judged on both hazard and exposure)
as well as different obligations to be met before and/or after introduction. These
are further discussed under the individual type of introduction below. According
to the Explanatory Memorandum, ‘[e]xempted, reported and assessed introductions
are categorised based on indicative risk determined by the introducer in
accordance with the rules’.[123]
In contrast, ‘commercial evaluation and exceptional circumstances introductions
are both authorisations based on particular circumstances for the introduction’.[124]
If an industrial chemical is introduced without
authorisation under any of the six categories (that is, it does not meet any of
the requirements), penalties may apply. Clause 24 provides both criminal
offences and a civil penalty provision. See Offences and Enforcement,
below for more information on offences and penalty.
Listed
introductions
Clause 25 covers the introduction of listed
industrial chemicals. This allows any registered introducer to introduce the
industrial chemicals on the Inventory (see below for information on the
Inventory), provided it is done in accordance with any restrictions listed in
the Inventory. The Explanatory Memorandum shows that this category can have
industrial chemicals with any level of indicative risk. No interaction with
AICIS is required before introduction.[125]
Exempted
introductions
Clause 26 provides that exempted introductions
allow the introduction of industrial chemicals that are permitted under the
rules made for this clause. The only detail provided in the Bill is a note
in subclause 26(2) that ‘[a]n exempted introduction is an industrial
chemical introduction that poses a very low risk to human health and the
environment’. The Explanatory Memorandum explains that there is no requirement
for a pre-introduction interaction with AICIS due to the very low risk of the
introduction.[126]
Examples of exempted introductions expected to be prescribed by the rules are:
- chemicals
introduced in limited amounts purely for research and development
- low
concern polymers[127]
- an
imported chemical that is not opened before being exported and
- chemicals
that meet the information requirements in the rules to show they pose ‘no
hazards to human health or to the aquatic environment, no bioaccumulation
potential and no persistence in the environment’.[128]
The lack of interaction with AICIS before introduction of
chemicals in this category, combined with limited post-introduction records of
introduced chemicals, has raised concerns amongst interest groups, Labor and the
Greens. This is due to the possibility of new chemicals being introduced into
Australia without any government records (see Introduction records,
below). For example, PHAA discussed the resultant risks:
The PHAA and other community groups remain very concerned
that the proposed new category for Exempted Chemicals will result in a large
number of new chemicals being introduced into Australia without prior
notification to the AICIS Regulator and without entry into any Government or
public record...
This may contribute to reducing the regulatory burden on
industry by about $23 million annually, but it is at an increased risk to the
health of people and the environment. It is not sufficient that the only
compliance requirement is an annual declaration with no reporting on the volume
or identity of the chemical to be imported or manufactured in Australia.
...
Furthermore, many examples exist whereby chemicals, once
thought to be non-hazardous, are later re-categorised as harmful. Absence of
routinely [sic] data of chemical volumes, usage and location would negate any
meaningful subsequent assessment of human risk.[129]
A further concern of the PHAA was the raised risk due to
the categorisation of the chemicals being done by the introducer, as it ‘could
lead to misclassification and insufficient incentive for introducers to collect
the information on a chemical’s risks to people or the environment’.[130]
Reported
introductions
Clause 27 provides that reported introductions must
also be made in accordance with the relevant rules and it is noted that they pose
‘a low risk to human health or the environment’.[131]
However, unlike exempted and listed introductions, which do not require any
interaction with AICIS before introduction, a reported introduction is only
authorised if ‘a pre-introduction report for the industrial chemical’ is
submitted in accordance with clause 97 and the introduction meets
the terms of that report.[132]
Clause 97 provides that the pre-introduction report must include the
information required under the rules and be given to the Executive Director
before the first introduction of the particular industrial chemical. However
the rules may specify that certain types of reported introduction are subject
to different reporting requirements (subclause 97(4)), in which
case the rules can specify information that must be given to the Executive
Director before the first introduction while the remaining information must be
submitted to the Executive Director within 12 months of the first introduction.
Subclause 97(3) provides that the industrial chemical’s proper name and
end use as well as the information the introducer used to determine that it was
a reported introduction could (but does not have to) be information required
for the report.
As is the case in relation to exempted introductions under
subclause 26(3), the rules for reported introductions may include requirements
related to the hazards of the industrial chemical to human health and/or the
environment as well as the potential exposure (paragraphs 27(3)(a) to (d)).
Additionally the rules may also prescribe that an introduction is a reported
introductions if the chemical has been assessed by an international body.
According to the Explanatory Memorandum, reported introductions ‘will generally
be low risk introductions’, but:
... will also include the introduction of
potentially higher risk chemicals that would otherwise be categorised as
assessed introductions. This will be on the basis of a risk assessment or
evaluation undertaken by, or in association with, a trusted international body
(prescribed in the rules).[133]
The Explanatory Memorandum included ‘New Substance
assessments by Environment and Climate Change Canada/Health Canada under the Canadian
Environmental Protection Act 1999’ as an example of evaluations by trusted
international bodies that could be included in the rules.[134]
Assessed
introductions
Clause 28 provides that assessed introductions are
only permitted where the introducer both has a relevant assessment certificate
for the industrial chemical and the introduction meets the terms of the
certificate. It is noted that this category is generally for medium to high
risk introductions (whether the risk is to human health or the environment),
and that normally an introduction of an unlisted industrial chemical which is
not an exempted or reported introduction will fall in this category.[135]
Division 3 of Part 3 covers the
administration of assessment certificates, including applications for
certificates and the powers of the Executive Director in relation to the
assessment. Under clause 31, applications must be made to the Executive
Director; these can be made individually or jointly by multiple people. Clause
32 provides that the application must be considered by the Executive Director,
who must include in the consideration:
- any
potential risks to the environment and human health as well as any conditions
that may be required to control these risks
- any
further information requested in writing by the Executive Director under clause
33
- submissions
from the applicant on the draft assessment statement (which must be provided to
the applicant under clause 36)
- advice
requested by the Executive Director under clause 34 from bodies
prescribed under the rules
- advice
from the Gene Technology Regulator under clause 35, which provides
that the Gene Technology Regulator must be asked for advice (but does not have
to reply) if the relevant industrial chemical is or contains a genetically
modified product.[136]
Clause 37 provides that, after considering the
application, the Executive Director must decide to issue or not issue an assessment
certificate. Subclause 37(7) states that the assessment statement must
also be published on the website.[137]
In general, decisions must be made within 70 working days.[138]
Under clause 39, assessment certificates are valid until they are
cancelled, the time has expired (if it contained a time condition), the
chemical is listed on the Inventory or its listing is varied.
Assessment certificates can be cancelled on either the
holder’s or Executive Director’s initiative. Clause 51 allows the holder
of an assessment certificate to apply to the Executive Director for
cancellation. This must be granted if all certificate holders agree. Clause
52 provides that the Executive Director can cancel an assessment
certificate under his/her own initiative if particular requirements are met.
These requirements include the completion of an evaluation of the introduction
(see below for information on evaluations), with a published statement, where
the Executive Director has concluded that that he/she is ‘not satisfied that
the risks to human health or the environment from the introduction and use of
the industrial chemical can be managed’.[139]
Commercial
evaluation and exceptional circumstances introductions
Clauses 29 and 30, respectively, provide that
commercial evaluation and exceptional circumstances introductions are only
authorised if the person holds the relevant authorisation and the introduction
meets the terms of the authorisation. Under clause 53, an application
must be made to the Executive Director for a commercial evaluation
authorisation. They are only granted under particular circumstances including
that the introduction’s purpose is to assess the commercial applicability of
the chemical and that the chemical will not be available to the public or
released untreated into the environment. For example, the Explanatory
Memorandum suggests that a commercial evaluation introduction could apply when
a company wants to trial ‘an ingredient in house paint that needs weather
testing, or a new ingredient in ink that needs testing to determine optimal
application conditions’ to determine commercial advantage.[140]
Under paragraph 59(1)(b), a commercial evaluation authorisation cannot
be in force for greater than four years. Similar to assessment certificates, under
clause 66 the Executive Director can cancel an authorisation if he or she
is ‘not satisfied that the risks to human health or the environment from the
introduction and use of the industrial chemical can be managed’.[141]
Under clause 166, a decision by the Executive Director to cancel a
commercial evaluation authorisation is reviewable. Likewise, decisions to not
issue, vary or not vary a term of the authorisation are reviewable.[142]
Subclause 67(1) provides that ‘the Minister may
issue an exceptional circumstances authorisation for the introduction of an
industrial chemical’. Exceptional circumstances authorisations will only be
granted by the Minister after consultation with the Executive Director and if
he or she is ‘satisfied that the introduction of the industrial chemical is in
the public interest to address significant risks to human health or the
environment’.[143]
Neither the Bill nor the Explanatory Memorandum provides information on an
application process (if any) for this type of introduction. The written
authorisation granted by the Minister must include details such as the period
of time for which the authorisation is valid and any conditions required to manage
environmental and health risks.[144]
Information on the exceptional circumstances authorisation, such as the name of
the industrial chemical and that the exceptional circumstances authorisation
applies for that chemical, must be published on the AICIS website.[145]
The Explanatory Memorandum suggests that such an authorisation may apply to ‘an
industrial chemical that is not otherwise authorised for use in Australia that
can be imported and used to treat an oil spill that is threatening an
Australian waterway’.[146]
Introduction records and oversight
Part 6 of the Industrial Chemicals Bill sets out
information and reporting requirements relating to the new scheme.
In particular, clause 99 provides that introducers
of industrial chemicals must make an annual declaration if they have introduced
industrial chemicals in the relevant registration year. However, the
legislation has no information on what must be included in the declaration,
except that it must ‘contain the information prescribed by the rules for the
purposes of this paragraph’.[147]
It also says that information required by the rules ‘may include information
about the categories of introductions of industrial chemicals made by the
person during the year’.[148]
The Explanatory Memorandum provides as an example of ‘[t]he types of matters to
be included in annual declaration’ that a declaration may include whether or
not exempt chemicals were introduced with a confirmation that ‘the relevant
criteria are satisfied (tick boxes)’.[149]
This means that the specific chemicals introduced as an exempted introduction
in the new scheme are not required to be reported to the Government, as
confirmed by the Department of Health in the Community Affairs Legislation
Committee inquiry.[150]
Under clause 104, the introducer must keep records
of all industrial chemicals introduced in a registration year, including their
category and the information used by the introducer to determine the
introduction category. The records must be kept for five years (from the
beginning of the registration year following the introduction) and be provided
to the Executive Director if requested.[151]
Criminal offences and civil offences are available if records are not kept in
accordance with clause 104 (the fault-based offence has a penalty of up
to 300 penalty units, the strict liability offence a penalty of up to 60
penalty units and the civil penalty provision a penalty of up to 300 penalty
units; see Offences and Enforcement for more information on offences).
Under the new chemical regime, the level of pre-market oversight
of introduced chemicals will be reduced. There is no oversight by AICIS before
the introduction of industrial chemicals in the exempted and listed categories.
Pre-introduction assessments of industrial chemicals are predicted to fall by
more than 70% under the new scheme, meaning that only approximately 0.3% of new
chemicals will be assessed before introduction (from approximately 3%).[152]
As well as this, it is the introducers that decide which categories their
chemicals will fall into, rather than AICIS. While this reduces regulatory
effort, as well as making it easier and cheaper for introducers, it also raises
the potential of misclassification of the risks and hazards of chemicals. Although
under clauses 99 and 104, offences exist for contravention
of the annual declaration and record keeping requirements, the new regime does
not appear to provide a safeguard against misclassification of introduced
chemicals as exempted introductions.
Another problem which could be raised by the exempted
introductions category is when new information comes to light about the hazards
to the environment and health. Clause 100 appears to provide a
potential safeguard from introducers not informing the Executive Director about
new information which could cause a change of introduction category or
conditions for an industrial chemical. Clause 100 does this by obliging
relevant people to report new information about the hazards of industrial
chemicals that they have introduced. However, this clause only applies to:
(a) a person who holds, or is covered by, an assessment
certificate for the introduction of an industrial chemical; or
(b) a person who has introduced an industrial chemical within
the previous 12 months:
(i) for which there is an Inventory listing; and
(ii) for which there is an assessment statement or
evaluation statement.[153]
Exempted introductions would not fall under this provision.
This means that even if new information suggests that the exempted chemical
should be in a different introduction category and possibly have had limits put
on its use, the introducer is not obliged to tell AICIS that information or
even that they had introduced the chemical in the last 12 months.
The introduction of the new scheme means that there will
not be a current-time record of the industrial chemicals being used in
Australia due to AICIS only being informed of exempted and listed categories introductions
after they occur (as mentioned above in the relevant introduction category). Indeed,
as discussed above in relation to clause 99, it is likely that there
will never be a complete record of introduced chemicals under the new regime. This
could be highly problematic, as sometimes information becomes available showing
that chemicals once believed safe are actually risky (for example, phthalates),
and it will be impossible to track exposure to, and subsequent risk from, these
chemicals without detailed records.[154]
This possibility was mentioned by Labor Senators in their Additional comments
to the Community Affairs Legislation Committee inquiry report, as well as the
Greens in their dissenting report for the inquiry.[155]
As noted earlier in this Digest, another issue with the
proposed industrial chemical introduction categories is the major reliance on
the ‘rules’. There is very little detail in the primary legislation on the
differences between the chemicals covered by reported, exempted and assessed
introductions apart from the level of risk of the chemical. Even then, there is
no detail on how the level of risk is defined, leaving that to delegated
legislation. This means that despite the public
consultation on the matters to be included in delegated legislation, [156]
the Parliament will have limited oversight (basically consisting of the ability
of either House of Parliament to disallow the rules) of how different
risk-level chemicals should be checked before being allowed into the Australian
market, and indeed, even what those levels of risk represent.
Evaluations
The Executive Director has the authority to initiate, at
any time, evaluations of industrial chemicals and related matters under Part
4. There are two processes for conducting evaluations.
First, Division 2 of Part 4 provides for
evaluations of chemical introductions authorised by an assessment certificate.[157]
Under subclause 69(2), the assessment certificate holders must be
given written notice of the planned evaluation, including the reasons for it,
by the Executive Director. The process followed in the evaluation is similar to
the process described for the original assessment for the assessment
certificate (described above in ‘Assessed introductions’) except that in this
situation, the time period for the evaluation will be specified in the notice
of the proposed evaluation.[158]
The Executive Director must take into account, under subclause 69(4),
whether there are any human or environmental risks which would occur from
the introduction and use of the industrial chemical as well as relevant
information from the certificate holder. Clause 73 provides that the
Executive Director must issue an evaluation statement containing information
including a summary of the evaluation and any relevant risks, including, if
risks were identified, the means to control these risks. As well as being
published on the AICIS website, the Executive Director must give a copy to holders
of the assessment certificate.
In Division 3 of Part 4, subclause 74(1) provides
that the Executive Director can also initiate evaluations of ‘matters relating
to industrial chemicals’. This includes evaluations of matters such as a class
of industrial chemicals, hazards or exposure to an industrial chemical or class
of them and the use of an industrial chemical or class of industrial chemicals.[159]
An evaluation is required for a variation under clause 86.[160]
Both initiation of an evaluation of this type and the final evaluation
statement (which contains information including a summary of the evaluation and
any relevant risks, including, if risks were identified, the means to control
these risks), must be published on the AICIS website.[161]
Australian
Inventory of Industrial Chemicals
A new inventory listing industrial chemicals is
established under clause 80 in Part 5 of the Industrial Chemicals
Bill. This inventory, the Australian Inventory of Industrial Chemicals (AIIC),
will list the industrial chemicals that any registered introducer can introduce
into Australia provided they follow any introduction restrictions included on
the listing. Subclause 81(2) provides that the listing must include any introduction
conditions related to: the volume of chemical able to be introduced, where the
industrial chemical can be introduced or used and conditions prescribed by the
rules.
The Consequential Amendments Bill provides for the continuation
of previously listed chemicals in the new scheme. Items 39 and 40
in Schedule 2 of the Consequential Amendments Bill provide that the chemicals
listed on AIIC will include the industrial chemicals which are listed on the
old chemical inventory (AICS, under NICNAS) ‘immediately before’ 1 July 2018. Currently,
there are over 40,000 industrial chemicals on the public (non-confidential)
part of AICS.[162]
Applications to have industrial chemicals listed on the inventory which are
pending ‘immediately before’ 1 July 2018 will be taken to have been made under
the new regime.[163]
These transfers will apply whether the listing was under the confidential or non-confidential
parts of the old inventory.
Clause 82 of the Industrial Chemicals Bill provides
that industrial chemicals which have held a valid assessment certificate for
five years will be added to the AIIC. Under clause 83, an industrial
chemical with a valid assessment certificate that has been held for under five
years can be added to the AIIC if the assessment certificate holder applies for
it to be listed. Subclause 83(1) specifies that the industrial chemical
can only be listed if the assessment certificate does not have a time
restriction and if the industrial chemical is not already listed on the AIIC. Similar
to the old inventory, proper chemical name or end use of the industrial
chemical can be kept confidential for business reasons.[164]
Division 4 of Part 5 grants the Executive
Director the power to vary industrial chemical listings on the Inventory. This
can occur in the following situations:
- under clause 85, minor variations to listings such as the correction of an
error or the addition of information can be carried out provided there is no
regulatory impact from the variation
- clause
86 allows for variations after the Executive Director undertakes an
evaluation
- clause
87 provides for variation to reflect new assessment certificates and
- clauses
88–93 allow for variations after a person applies to have the listing
changed.
The Executive Director also has the power to remove the
Inventory listing for industrial chemicals under limited circumstances. This
includes where he or she:
- is
‘not satisfied that the risks to human health or the environment from the
introduction or use of the industrial chemical can be managed’ (subparagraph
95(1)(c)(i)) or
- has
concluded that the industrial chemical has been wrongly listed on the AIIC (subparagraph
95(1)(c)(ii)).
Removal in either situation can only occur after an
evaluation and public consultation.[165]
This could be very useful in situations where, like mentioned above, a chemical
that was originally believed to pose little risk was found later to pose a
significant risk to human health or the environment.
Offences
and Enforcement
Offences
The Industrial Chemicals Bill contains numerous offences. The
Explanatory Memorandum explains that, to allow a proportionate response to a
breach of the Bill, all offences throughout the Bill have a fault based
criminal offence (where both the physical element and fault element, for
example, intention, apply), a strict liability criminal offence where only the
physical element is required and there is no requirement to prove fault, and a
civil penalty (which is established on the balance of probability).[166]
This allows the Commonwealth to choose the provision under which to charge a
person.[167]
For example, as previously discussed, it is an offence under clause 13 to
introduce industrial chemicals without being a registered introducer of
industrial chemicals for the relevant registration year. Clause 13 sets
out the three different offences for this action:
- subclause 13(2) sets out a fault-based offence, with a
penalty of up to 500 penalty units (currently equivalent to $105,000) for an individual
or 2,500 penalty units ($525,000) for a body corporate[168]
- subclause 13(3) sets out a strict liability offence, with
a penalty of up to 60 penalty units ($12,600) for an individual or 300 penalty
units ($63,000) for a body corporate and
- subclause 13(4) sets out a civil penalty, with a penalty
of up to 500 penalty units for an individual or 2,500 for a body corporate.[169]
Other examples of proposed contravention provisions under
the Industrial Chemicals Bill and their penalties include:
- clause
24, which provides that it is a contravention for a person to
introduce an industrial chemical that is not authorised under any of the
introduction categories. The maximum penalty for a fault-based offence is 500
penalty units, the maximum penalty for a strict liability offence is 60 penalty
units and the maximum civil penalty is 500 penalty units and
- clause
99, which provides that it is a contravention for a person to
introduce an industrial chemical and not make the required declaration of
introduction ‘within 4 months after the start of the last month’ of the
registration year in which the chemical was introduced’.[170]
The maximum penalty for a fault-based offence is 300 penalty units, the maximum
penalty for a strict liability offence is 60 penalty units and the maximum civil
penalty is 300 penalty units.
In the Industrial Chemicals Bill, all strict liability
offences have a potential penalty of 60 penalty units while the fault-based
offences and civil penalty provisions have potential penalties of either 300 or
500 penalty units (the same potential penalty applies for both the fault-based
offence and civil penalty provision for a particular offence). Commentary on
the new scheme has stated that ‘[i]t appears that, generally, the fault based
and civil penalties are greater than the penalties under the current Act’.[171]
Enforcement
Part 7 provides for enforcement of the new regime through
application of relevant provisions from the Regulatory Powers
(Standard Provisions) Act 2014 (the Regulatory Powers Act).
The Executive Director and authorised inspectors[172]
are granted monitoring, investigation and enforcement powers so as to be able
to enforce the obligations created under the Industrial Chemicals Bill.
Monitoring powers are provided under Part 2 of the Regulatory Powers Act
while investigation powers are provided under Part 3 of the Regulatory
Powers Act. Enforcement, including civil penalties, infringement notices
and injunctions, are provided under Parts 4 to 7 of the Regulatory Powers
Act.[173]
The Industrial Chemicals Bill proposes to grant greater
enforcement powers to the new scheme than were possessed under the old regime.
However, concerns have been raised about the power placed in the hands of one
individual (the Executive Director) as well as the lack of detail in the
legislation and Explanatory Memorandum about the actual monitoring of
compliance. As AMWU stated:
Part 7 of the Bill grants increased enforcement powers
to NICNAS. These are strongly supported...
During the consultation phase NICNAS provided estimates on
post market auditing – again there is no information provided in the [Explanatory
Memorandum] on what actual monitoring will occur. If the “reforms” are to allow
increased focus on “risky” chemicals, it is incumbent on the government to
outline how this will be achieved – otherwise it appears to be a matter of
“faith/trust” in the processes.
The Bill invests substantial powers and responsibilities in
the Executive Director. These powers are necessary and appropriate however it
makes the agency and the legislation, and their purpose, vulnerable to the
correct appointment of one individual. This highlights a flaw in the mechanisms
allowed for in the Bill eg if the Executive Director fails to use the
provisions of Part 4 there are no governance arrangements that could rectify
such a problem.[174]
Establishment
of AICIS and the Special Account
The Australian Industrial Chemicals Introduction Scheme (AICIS)
is established under clause 140 of the Industrial Chemicals Bill. Under
section 100A of the ICNA Act, a special account was created for the
operation of NICNAS. Subclause 155(1) provides for the special account to
be continued under the new regime, albeit renamed the Industrial Chemicals
Special Account. Under subclause 155(2), it is a special account under
the Public
Governance, Performance and Accountability Act 2013.
Application
of international agreements
Similar to Part 5A of the ICNA Act, Part 9
of the Industrial Chemicals Bill implements obligations that Australia has
under the Rotterdam
Convention on the Prior Informed Consent Procedure for Certain Hazardous
Chemicals and Pesticides in International Trade (Rotterdam
Convention) and other international agreements that apply to the movement
of industrial chemicals in or out of Australia.[175]
The Rotterdam Convention aims to manage ‘the international trade of
certain hazardous chemicals in order to protect human health and the
environment from potential harm’ and ‘contribute to the environmentally sound use
of those hazardous chemicals’ including by promoting information exchange on
the chemicals’ characteristics.[176]
As a result, Australia has legal obligations such as exchange of particular information
about industrial chemicals.
Clause 159 provides that the Executive Director
must inform Australia’s designated national authority if, for the reason of
risks to human health or the environment, laws are made or actions taken by the
Executive Director that have ‘the effect of banning or severely restricting the
introduction or use of an industrial chemical’.[177]
This applies whether they are laws or regulations under the proposed Industrial
Chemicals Act or state or territory laws.[178]
Under subclause 159(4), the designated national authority must then
notify the Rotterdam Convention Secretariat to meet Australia’s obligations
under the Rotterdam Convention. Under clause 160, relevant
information about notified industrial chemicals must also be provided to the
designated national authority so it can be given to the Rotterdam Convention
Secretariat.[179]
Clause 161 provides that the Executive Director may
obtain information from people who have ‘information or a document that it is
reasonably necessary to obtain for the purpose of Australia’s compliance with its
obligations under the Rotterdam Convention’.[180]
Under clause 175, a person is not excused from providing the clause 161
information because of the possibility of self-incrimination, but they are
provided with use and derivative use immunity.[181]
As discussed earlier in this Digest, the Senate Standing Committee for the
Scrutiny of Bills raised concerns in this context about removing the common law
principle that excuses a person from giving evidence that will incriminate him
or herself.
Subclause 163(1) also allows for industrial
chemicals that are ‘the subject of a prescribed international agreement or a
prescribed international arrangement’ to be banned from entering or leaving
Australia or have conditions put on their entry or exit by the rules. Under subclauses
163(3) and 163(4), the Executive Director may give other
countries, their relevant authorities and appropriate international
organisations information on these industrial chemicals’ movements in or out of
Australia. Interestingly, clause 163 applies whether or not Australia is
actually a party to the international arrangement (although it must be a party
to a prescribed international agreement).[182]
Cosmetics
Standard
Part 3B of the ICNA Act currently provides for the
Minister to determine standards cosmetics imported into, or manufactured in,
Australia (see section 81). Under section 81A of the ICNA Act, it is an
offence to import or manufacture a cosmetic that is subject to that standard if
the cosmetic does not meet the standard. The penalty is up to 120 penalty units
(equivalent to $25,200) for an individual or $126,000 for a body corporate.[183]
The Cosmetics Standard
2007, made under section 81, currently sets standards for products
including sunscreen, anti-bacterial skin products, acne products and
anti-dandruff products.
The repeal of the ICNA Act by the Consequential
Amendments Bill will mean that the Cosmetics Standard is no longer valid.
However, the third consultation paper on the proposed reforms stated:
... Government has decided that NICNAS should be a chemical
substance regulator, and that it should not have responsibility for regulating
products. Government has agreed that the responsibility for administering the
Cosmetics Standard should transfer from NICNAS to the ACCC [Australian
Competition and Consumer Commission]. This change is intended to clarify the
principal regulatory roles of each agency: NICNAS is to regulate chemicals
introduced for ‘industrial’ purposes (including ingredients in cosmetics); and
ACCC is the consumer product safety regulator.[184]
However, no mention of the Cosmetics Standard, or its
future, is made in the Explanatory Memoranda or Second Reading Speech for any
of the Bills. Further, no provision appears to have been made in the Bills for
transferring the Cosmetics Standard or its equivalent to other legislation.
While the ACCC does currently regulate the labelling of cosmetic products[185]
(and product safety more generally[186]),
it is not clear whether, for example, relevant legislation[187]
will be amended to incorporate the standards currently set out in the Cosmetics
Standard.
Animal testing
Clauses 103 and 168 are the primary provisions
of the Industrial Chemicals Bill relating to animal
testing for cosmetic purposes.[188]
For the purposes of the Industrial Chemicals Bill, a cosmetic
is ‘a substance or preparation intended for placement in contact with any
external part of the human body’ to alter body odour, change its appearance,
clean it, maintain it in good condition, perfume or protect it. It also
includes a substance or preparation prescribed in the anticipated rules to the Industrial Chemicals Bill.[189]
This includes, but is not limited to, perfume, shampoo and make up but does not
extend to therapeutic goods under the Therapeutic Goods
Act 1989 or as prescribed by the rules.[190]
While clauses 103 and 168 do not ban cosmetic testing outright
(discussed below), they restrict how the resulting data can be used in
introducing (that is, importing or manufacturing)[191]
industrial chemicals for cosmetic purposes in Australia.
Clause 168 prohibits the inclusion of animal test
data obtained from tests conducted on or after 1 July 2018 in an application to
introduce a new industrial chemical for an end use solely in cosmetics. This
requirement is mandatory, subject to the corresponding rules. As the rules are
not yet available, it is unclear how the rules might impact this provision.
Clause 103 does not propose any mandatory
requirement but rather sets out that a rule may be made for the purposes
of clause 102 which relates to the information keeping requirements
connected with determining the category of introduction of an industrial
chemical. If implemented in the rules, the requirement set out in subclause
103(2) would prohibit animal test data obtained from tests conducted on or
after 1 July 2018 from being used in determining the category for introduction
of an industrial chemical for an end use solely in cosmetics. The
Explanatory Memorandum to the Industrial Chemicals Bill does not state why the
provision is expressed in discretionary terms, but asserts that the intended
effect of clause 103 is to actually prohibit the use of such animal test
data to determine the category of introduction of a substance for cosmetic use,
subject to the corresponding rules.[192]
This may suggest that the Department intends that such a requirement will
be made mandatory under the rules. However, clause 103 does not create
any obligation for this to be the case.
If the subclause 103(2) requirement
is in fact included in the rules, any contraventions of this will constitute an
offence under clause 102 with
a penalty of up to 300 penalty units for an individual or 1,500 penalty units
for a body corporate.[193]
Scope of the changes
Application to substances for use ‘solely’ in cosmetics
The Industrial Chemicals Bill’s
proposed restrictions on the use of animal test data in relation to introducing
industrial chemicals apply only to those used solely in cosmetics. This
has been criticised by some animal welfare interest groups as being too narrow
in its application and even described as ‘a glaring and dangerous loophole’ by
the Humane Society International and Humane Research Australia who contend that
most ingredients for cosmetics have multiple end uses.[194]
Of primary concern is that some introducers of cosmetic products might attempt
to circumvent restrictions on the use of animal test data by claiming an
industrial chemical (primarily for use in a cosmetic) is for multiple purposes.
As such, the chemical would not be for use solely in a cosmetic and clauses
103 and/or 168 would not be triggered. Accordingly, the RSPCA
suggests that the application of clauses 103 and 168 be
broadened to include chemicals used ‘solely or substantially’ in cosmetics,[195]
whereas Humane Society International and Humane Research Australia suggest
removing the ‘sole use’ qualifier entirely.[196]
This would reflect the EU approach which does not restrict the use of
substances that are to be used only in a cosmetic product but restricts the use
of substances that are to be used ‘exclusively or mainly’ (emphasis
added) in a cosmetic product, with some exceptions.[197]
Historical animal test data
Clauses 103 and 168 do not apply to
historical animal test data—that is, these restrictions only apply to data
obtained by a test conducted after 1 July 2018. Data obtained before these
dates can continue to be used. This is a similar approach to the
animal testing restrictions in the EU Regulations, which were implemented in
stages to allow manufacturers and importers time to adapt to the changes by
developing and adopting non‑animal testing methods. The EU marketing ban
came into effect on 11 March 2009 for tests relating to most human health
effects, with the exception of repeated-dose toxicity, reproductive
toxicity and toxicokinetics[198]
for which the marketing ban applied from 11 March 2013.[199]
Human health and environmental concerns
A submission from the Department of Health asserts that,
following ‘extensive research’, the Australian population is generally
supportive of the ban proposed in the Industrial Chemicals
Bill provided that safety is not compromised.[200]
According to the Explanatory Memorandum, the rules are likely to address this
by prescribing limited circumstances in which animal test data may continue to be
required to ensure the protection of human health or the environment.[201]
This may be compared with the EU approach to animal testing for cosmetic
purposes which only allows derogation from the animal testing ban where the
ingredient cannot be replaced with a non-animal tested equivalent and ‘the
specific human health problem is substantiated and the need to conduct animal tests
is justified’.[202]
Clause 100 acts as a further safeguard to human
health and the environment. This is achieved by requiring information,
including information obtained through animal testing,[203]
to be provided to the Executive Director if a hazard (or increased severity of
a hazard) to human health or the environment becomes apparent after the
introduction of an industrial chemical has been approved.
While the details of the human health and environmental
exception in the Australian context are yet to be provided, it has the
potential to undermine the purpose of clauses 103 and 168 to
address animal welfare concerns, as is also a criticism of the EU provision.[204]
The EU has partially addressed this concern with the establishment in 2011 of
the European Union Reference
Laboratory for alternatives to animal testing (EURL ECVAM) to meet the
increasing need for new non-animal testing methods.[205]
Additionally, the EU’s Regulation
(EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH) was ‘adopted to improve the protection of
human health and the environment from risks that can be posed by chemicals,
while enhancing competitiveness of the EU chemicals industry’.[206]
The European Commission and the European Chemicals Agency (ECHA) have attempted
to clarify the apparent tensions between the REACH animal testing requirements
and the aims of the EU Regulation to protect animal welfare. They noted:
- Registrants of substances that are exclusively used in cosmetics
may not perform animal testing to meet the information requirements of the REACH
human health endpoints, with the exception of tests that are done to assess the
risks to workers exposed to the substance. Workers in this context, refers to
those involved in the production or handling of chemicals on an industrial
site, not professional users using cosmetic products as part of their business
(e.g. hairdressers).
- Registrants of substances that are used for a number of purposes,
and not solely in cosmetics, are permitted to perform animal testing, as a last
resort, for all human health endpoints.
- Registrants are permitted to perform animal testing, as a last
resort, for all environmental endpoints.[207]
Constitutional limitations
The Commonwealth does not have
constitutional jurisdiction to broadly regulate animal welfare—this power is
generally held by the states. While it is not necessarily beyond the power of
the Commonwealth to impose a comprehensive testing ban in some circumstances,[208]
animal welfare objectives appear to be outside the objective of the Industrial Chemicals Bill to ‘provide for a national scheme to
regulate the introduction of industrial chemicals in Australia’.[209]
Accordingly, in contrast to the private members Bills put forward
by the ALP and Greens, the Industrial Chemicals Bill does not attempt to impose
an express ban on the testing of cosmetic products on animals, nor does it
propose to create offences for the testing of cosmetics, or substances for use
in cosmetics, on animals. Instead, the Industrial Chemicals Bill proposes
restrictions on the use of animal test data by importers and manufacturers
introducing industrial chemicals into Australia. While the Industrial Chemicals
Bill does not directly state which constitutional powers provide its basis, clause
4 indicates that the Commonwealth is using the external affairs,
constitutional corporations and constitutional trade powers. This binds most
corporations to the laws in the Industrial Chemicals Bill without limiting the
constitutional basis of the legislation.
Despite the Industrial Chemicals Bill’s
broad impact, there are some situations in which it might be possible, although
unlikely, to avoid scrutiny under the Industrial Chemicals Bill, for example,
where an industrial chemical is introduced by a non-corporate entity for sale
within a single state. However, the broad impact of the Industrial Chemicals
Bill remains and by limiting the use of animal test data, it is expected that
the demand for animal testing will reduce.[210]
However, such a testing ban may not be far away as,
according to the Department of Health website, the Government will work with
the states to implement an outright testing ban through their respective
legislation, triggered by changes to the Code.[211]
Such animal testing bans implemented by the states and territories would likely
avoid possible constitutional barriers.
International free trade obligations
Regulating substances for use in cosmetic products affects
the goods that may enter Australia. Consequently, the regulations should adhere
to international trade laws to which Australia is party. Relevantly, the World
Trade Organization (WTO) General
Agreement on Tariffs and Trade (GATT), particularly article III(4) states:
[... t]he products of the territory of any contracting party
imported into the territory of any other contracting party shall be accorded
treatment no less favourable than that accorded to like productions of national
origin in respect of all laws, regulations and requirements affecting their
internal sale, offering for sale, purchase, transportation, distribution or
use.[212]
Clauses 103 and 168 appear to avoid
discriminating between countries under international trade laws as the
requirements for determining categorisation and making applications to
introduce industrial chemicals apply equally to both international and domestic
bodies.[213]
However, the majority of Australian companies are, in practice, unlikely to
rely on animal test data as it is not required, nor does testing appear to
currently occur, for cosmetic purposes in Australia. Accordingly, the new
requirements under the Industrial Chemicals Bill may place
an additional burden on international companies who are required to undertake
animal testing under laws of their own country, or where non-animal testing is
expensive or unfeasible, by requiring these companies to undertake additional non-animal
testing to comply.[214]
However, Article XX of the GATT sets out a number of exceptions to its rules,
which may arguably apply to the restrictions proposed by the Industrial
Chemicals Bill. In particular, it could be contended that the
requirements as described in the Industrial Chemicals Bill
are necessary to protect public morals or animal life or health.[215]
In addition to issues arising from the GATT, clauses 103
and 168 may be considered ‘unnecessary obstacles to international trade’
under the WTO’s Agreement on
Technical Barriers to Trade (TBT).[216]
However, like the exceptions under Article XX of the GATT, such obstacles are
acceptable if ‘necessary to fulfil a legitimate objective’ which includes the
protection of animal life or health and the protection of public morals.[217]
However, there may be potential problems with this justification. Difficulties
are likely to centre on counter-arguments to the effect that animal tests are
necessary for the protection of human life and health. On the other hand, such
an argument could be rebutted if a range of alternative methods affording
equivalent protection to consumers have been validated.
International trade law concerns have been raised in
relation to the EU animal testing restrictions.[218]
However, in the absence of any complaint being brought before the WTO to test
these potentially discriminatory provisions, it is unclear whether a challenge
to such provisions in the EU or the Industrial Chemicals Bill would be
successful. Despite this, the EU has previously relied on the public morals
exception under the GATT to defend its general ban on the sale and importation
of seal products.[219]
Unlike the animal testing provisions described in the Industrial Chemicals
Bill, the question of human health was not raised during this complaint. As
such, in the case of an animal testing ban for cosmetic ingredients and
products to be used by humans, the animal health and moral protection
exceptions will need to be balanced against arguments for the protection of
human health.
As discussed above, the Commonwealth cannot regulate the
introduction of chemicals outside of its jurisdiction and it is possible that
there are entities within Australia that may not fall within the scope this
jurisdiction. For example, a non-corporate entity may be able to manufacture an
industrial chemical for supply within a state to another non-corporate entity.
This is unlikely to occur but could raise issues relating to discrimination
under the GATT and the TBT under the provisions discussed above.
Will animal testing continue?
In the absence of further regulation, it is likely that
many companies will continue to undertake animal testing for cosmetic purposes
to meet the requirements for sale in other countries. For example, animal
testing is no longer required for the sale of domestic products in China but is
still required for imported cosmetic products.[220]
Additionally, the proposed requirements of the Industrial
Chemicals Bill do not prohibit animal testing from being undertaken but
do prohibit the data from being relied upon in applications to introduce, or
categorise, the relevant chemical. Relevantly, the European Federation for
Cosmetic Ingredients challenged Article 18(1)(b) of the EU Regulation in the
Court of Justice of the European Union (CJEU), seeking clarification on whether
animal testing undertaken to meet requirements of a non-EU country could be
relied upon in applying to sell the products in the EU.[221]
The CJEU confirmed that animal-tested cosmetic products cannot enter the EU
market ‘if the resulting data is used to prove the safety of those products for
the purposes of placing them on the EU market’.[222]
However, this does not prevent companies from continuing to test on animals to
access other markets where bans on animal testing do not apply, so long as the
animal test data is not used to access the EU market. Clauses 103 and 168
are likely to perform in a similar way. However, while the Industrial Chemicals
Bill does not ban the testing of cosmetics, or cosmetic ingredients, on animals
or the sale of cosmetic ingredients that have been tested on animals, the
practical effect of the Industrial Chemicals Bill may
reduce the amount of cosmetics products being made available within Australia
that have been tested on animals.
Notification
and Assessment Amendment Bill
The Notification and Assessment Amendment Bill amends the ICNA
Act to allow some parts of the broader changes under the new chemicals
regime to begin before the new regime comes into effect. The major effects of
this Bill will be changing the definition of a ‘polymer of low concern’ with associated
changes to allow certain polymers to be introduced into Australia more easily.[223]
This Bill also makes changes to reporting requirements, as set out in further
detail below.
Item 2 replaces the existing definition of ‘polymer
of low concern’ in subsection 5(1) of the ICNA Act. The Explanatory
Memorandum explains that this will achieve greater similarity with the relevant
United States and Canadian schemes.[224]
The new definition for ‘polymer of low concern’ changes the definition by replacing
one of the defined types of polymer. This results in a greater number of
polymers covered by the definition of ‘polymer of low concern’.
Section 21 of the ICNA Act provides that a person
must not introduce a new industrial chemical in Australia, except in certain
circumstances. Item 3 inserts proposed paragraph 21(6)(d) into
the ICNA Act, which will add polymers of low concern to the list of
industrial chemicals that are allowed to be introduced into Australia. Under proposed
subparagraph 21(6)(d)(ii), those introductions are required to meet any
conditions prescribed by regulation. There is no detail on potential requirements
in the Bill or Explanatory Memorandum. The effect of this amendment is that
polymers that fall into this category will be able to be introduced without
obtaining a certificate or permit from NICNAS.[225]
Certain reporting requirements under the ICNA Act
are also removed by the Notification and Assessment Amendment Bill. Item 5
repeals section 40N of the ICNA Act, which currently specifies the
circumstances in which annual reports must be provided to the Director of NICNAS.
In other words, this removes the requirement of providing annual reports to
NICNAS.
Item 6 repeals section 80Q of the ICNA Act, which
removes the requirement for certain registered introducers to provide a
statement including the value of relevant chemicals they introduced in a
registration year. Item 7 proposes to replace subsection 80QA(1) of the ICNA
Act, to change the way registration charges are calculated so that the
calculation method is no longer dependent on the existence of these value statements.
These changes are intended to reduce regulatory burden.[226]
Charges
(General), Charges (Excise) and Charges (Customs) Bills
The Charges (General), Charges (Excise) and Charges
(Customs) Bills (the Charges Bills) allow the Government to charge for registration
of introducers of industrial chemicals. The Bills apply, respectively, to
charges that are not excise or customs, charges that are excise, and customs
charges. As noted earlier, the three Charges Bills are separate due to the Constitutional
requirement for taxation, duties of excise and duties of customs to be dealt
with in Bills that only include that individual, respective type of charge.[227]
Charging the introducers of industrial chemicals for
registration allows the Government to cover the cost of the Industrial
Chemicals Scheme, ensuring there is no financial impact on the Australian
public.[228]
However, this model has also been criticised by interest groups for potentially
compromising the ability of the regulator to control industrial chemical
introduction. For example, Cancer Council Australia said:
The structure needs to be carefully considered. The user pays
model allows industry to place demands on NICNAS depicting itself as “customer
demanding efficient service” rather than acting as an industry legitimately
subject to reasonable regulation. This has the potential to compromise the
capacity for NICNAS to fulfil its role as regulator.[229]
The AMWU also believes that this is a problem, and that
‘[a]t a minimum such systems require structures to guard against such outcomes.
There are no proposals in the Bill which mitigate against the risk of “industry
capture”’.[230]
Another issue, as noted by the Senate Scrutiny of Bills
Committee (discussed earlier in this Digest), is that the Charges Bills contain
no enforceable guidance on how the charges will be calculated, leaving it to
regulations. Subclause 7(1) of each of the Charges Bills state that the
charge amount will be prescribed or calculated with a method prescribed by the regulations.
Under subclause 7(2), the charge amount could be related to value of the
introduced industrial chemicals in the relevant registration year. In the
Second Reading Speech for the Charges (General) Bill, the Assistant Minister
for Health, Dr David Gillespie, said that including setting the amount of the
charges ‘in regulations, as opposed to the act itself, provides the department
with sufficient flexibility to ensure that these matters are appropriate in all
circumstances’.[231]
The Explanatory Memoranda for the Charges Bills explain
that it is ‘anticipated’ that the charge amount could be related to the value
of the introduced chemical. They also explain that the method used for
determining the charges will be included in a cost recovery implementation
statement and subject for public consultation before introduction.[232]
This does allow feedback on the charges from the public, including affected
parties. However, given that the Charges Bills contain no limits on the
regulatory power to determine the charge (for example, factors that need to be
included in calculation or maximum amounts that can be charged), the parliamentary
oversight of these charges is severely limited, consisting only of disallowance
of the rules by either House of Parliament under section 42 of the Legislation
Act. The Senate Standing Committee for the Scrutiny of Bills also raised
this issue; see Senate Standing Committee for the Scrutiny of Bills,
above for the Committee comments.
[1]. The
three related charges Acts are: Industrial
Chemicals (Registration Charge—Customs) Act 1997; Industrial
Chemicals (Registration Charge—Excise) Act 1997 and Industrial
Chemicals (Registration Charge—General) Act 1997.
[2]. Australian
Constitution, section 55.
[3]. The
Explanatory
Memorandum to the Industrial Chemicals Bill 2017 has a summary of each Part
of the Industrial Chemicals Bill on page 4.
[4]. Industrial
Chemicals Bill 2017, clause 2.
[5]. Consequential
Amendments Bill, clause 2.
[6]. Notification
and Assessment Amendment Bill, subclause 2(1), table item 2.
[7]. Charges
(General) Bill, subclause 2(1), table item 2; Charges (Customs) Bill, subclause
2(1), table item 2; Charges (Excise) Bill, subclause 2(1), table
item 2.
[8]. Department
of Health Therapeutic Goods Administration (TGA), ‘Legislation and
legislative instruments’, TGA website.
[9]. Food
Standards Australia New Zealand (FSANZ), ‘Food
law, treaties and agreements’, FSANZ website.
[10]. Australian
Pesticides and Veterinary Medicines Authority (APVMA), ‘Legislative framework’, APVMA
website, 7 April 2017.
[11]. National
Industrial Chemicals Notification and Assessment Scheme (NICNAS), ‘What we do’, NICNAS
website, 17 July 2017.
[12]. NICNAS,
‘How we work’,
NICNAS website, 11 August 2017.
[13]. Department
of Prime Minister and Cabinet (DPMC), Options
for reforming the national industrial chemicals notification and assessment
scheme: regulation impact statement, DPMC, Canberra, November 2014, p.
6.
[14]. D
Gillespie, ‘Second
reading speech: Industrial Chemicals Bill 2017’, House of Representatives, Debates,
1 June 2017, p. 6014.
[15]. DPMC,
Options
for reforming the national industrial chemicals notification and assessment
scheme: regulation impact statement, op. cit., p. 6.
[16]. For
more information on exempt chemicals, see NICNAS, ‘Chemicals
exempt from notification’, NICNAS website, 25 July 2017.
[17]. DPMC,
Options
for reforming the national industrial chemicals notification and assessment
scheme: regulation impact statement, op. cit., p. 6.
[18]. Ibid.,
p. 7.
[19]. Ibid.
[20]. F
Nash (Assistant Minister for Health), Industrial
chemical assessments simplified, media release, 26 May 2015.
[21]. For
further information on the public consultation, see NICNAS, ‘Reforms’, NICNAS website, 24 July
2017.
[22]. Department
of Health, ‘Implementing
industrial chemicals reforms through the new Australian industrial chemical
introduction scheme’, Department of Health website, 5 June 2017; D
Gillespie (Assistant Minister for Health), Australian
industrial chemicals reform, media release, 1 June 2017.
[23]. Australian
Government National Health and Medical Research Council (NHMRC), Australian
code for the care and use of animals for scientific purposes, 8th edn,
Canberra, 2013.
[24]. Ibid.,
p. 1. The Code is implemented in state and territory legislation (and
respective regulations) as follows: Animal
Welfare Act 1992 (ACT), paragraph 21(a) and Part 4; Animal
Research Act 1985 (NSW), particularly section 4; Animal
Welfare Act (NT), section 24 and Part 5; Animal Care
and Protection Act 2001 (Qld), section 91 and Chapter 4; Animal
Welfare Act 1985 (SA), section 3 and Part 4; Animal
Welfare Act 1993 (Tas), section 34; Prevention
of Cruelty to Animals Act 1986 (Vic), section 7 and Part 3; Animal
Welfare Act 2002 (WA), Part 2 and paragraph 94(2)(d).
[25]. Department
of Health (DoH), Ban
on the testing of cosmetics on animals: consultation paper, DoH,
Canberra, March 2017, p. 6.
[26]. Australian
code for the care and use of animals for scientific purposes, op. cit., p.
9.
[27]. Australian
examples include a recommendation by the Senate Select Committee on Animal
Welfare to ban Draize testing and introduction of the National Animal Welfare
Bill 2003 by former senator Andrew Bartlett which proposed a ban on the use of
animals for some scientific purposes involving cosmetics: Senate Select
Committee on Animal Welfare, Animal
experimentation, The Senate, Canberra, 1989, pp. xv and 97–124; National
Animal Welfare Bill 2003, proposed section 80.
[28]. C
O’Neil, National
consultation on cosmetics and animal testing, report prepared for the
Australian Labor Party, 17 September 2014, p. 4.
[29]. Liberal
Party of Australia, The
Coalition will ban cosmetic testing on animals, media release, 3 June
2016, p. 1.
[30]. See:
DoH, Ban on the testing of cosmetics on animals, op. cit., pp. 11–12.
[31]. Australian
Government, ‘Part
2: expense measures’, Budget measures: budget paper no. 2: 2017–18, p.
104.
[32]. Australian
Government Department of Health, Ban on the testing of cosmetics on animals,
op. cit., p. 14.
[33]. D
Gillespie, ‘Second
reading speech: Industrial Chemicals Bill 2017’, House of Representatives, Debates,
1 June 2017, p. 6014.
[34]. First
implemented by Directive
2003/15/EC which amended the Council
Directive 76/768/EEC but is now enshrined in Article 18 of the Regulation
(EC) 1223/2009 (collectively, the EU Regulations): European Union, Council
Directive 76/768/EEC of 27 July 1976, On the approximation of the laws of the
member states relating to cosmetic products [1976] OJ L 262/169;
European Union, Regulation (EC) No 1223/2009 of the European Parliament and
of the Council of 30 November 2009 on cosmetic products (recast), [2009] OJ
L 342/59, article 18.
For further information on the EU animal
testing ban see: European Commission, ‘Ban on
animal testing’, European Commission website.
[35]. Prevention of
Cruelty to Animals Law (Experiments on Animals) 5754-1994 and 5761-2001
(Israel), Chapter 3. Note that this is an unofficial translation of the statute
which is otherwise in Hebrew.
[36]. Republic
of India, The Gazette of India, No
F No. X-11014/7/2013-DFQC, 21 May 2014, p. 2.
[37]. Cosmetics
Act (Republic of Korea), Article 15-2. This provision relates to
the importation and sale of animal tested substances.
[38]. Animal
Welfare Act 1999 (NZ), section 84A.
[39]. Ibid.
[40]. Parliament
of Australia, ‘Senate
Community Affairs Legislation Committee: Industrial Chemicals Bill 2017 and
related Bills’, Parliament of Australia website.
[41]. Community
Affairs Legislation Committee, Industrial
Chemicals Bill 2017 [Provisions] and related bills, The Senate,
Canberra, 2017, p. 27.
[42]. Ibid.,
p. 13.
[43]. Ibid.,
pp. 15–17
[44]. Ibid.,
pp. 19–25.
[45]. Senate
Standing Committee for the Scrutiny of Bill, Scrutiny
digest, 6, 2017, The Senate, 14 June 2017, p. 35.
[46]. Ibid.
[47]. Senate
Standing Committee for the Scrutiny of Bill, Scrutiny
digest, 8, Ministerial responses, 2017, The Senate, 9 August 2017, p.
20.
[48]. Ibid.
[49]. Industrial
Chemicals Bill, subclause 161(1).
[50]. Senate
Standing Committee for the Scrutiny of Bill, Scrutiny
digest, 6, op. cit., p. 36.
[51]. Ibid.
[52]. Senate
Standing Committee for the Scrutiny of Bill, Scrutiny
digest, 8, op. cit., p. 22. Section 100H of the ICNA Act.
[53]. Ibid.
[54]. Senate
Standing Committee for the Scrutiny of Bill, Scrutiny
digest, 6, op. cit., p. 37; Subsection 14(2) of the Legislation Act
2003 states that ‘Unless the contrary intention appears, the
legislative instrument or notifiable instrument may not make provision in
relation to a matter by applying, adopting or incorporating any matter
contained in an instrument or other writing as in force or existing from time
to time’.
[55]. Senate
Standing Committee for the Scrutiny of Bill, Scrutiny
digest, 6, op. cit., p. 37.
[56]. Explanatory
Memorandum, Industrial Chemicals Bill 2017, p. 99.
[57]. Senate
Standing Committee for the Scrutiny of Bill, Scrutiny
digest, 6, op. cit., p. 37.
[58]. Senate
Standing Committee for the Scrutiny of Bill, Scrutiny
digest, 8, op. cit., p. 24.
[59]. Ibid.,
p. 39.
[60]. Ibid.
[61]. Senate
Standing Committee for the Scrutiny of Bill, Scrutiny
digest, 8, op. cit., pp. 23–24.
[62]. Ibid.,
p. 24.
[63]. Senate
Standing Committee for the Scrutiny of Bill, Scrutiny
digest, 6, op. cit., p. 38.
[64]. Ibid;
Explanatory
Memorandum, Consequential Amendments Bill, p. 23.
[65]. Senate
Standing Committee for the Scrutiny of Bills, Scrutiny
digest, 6, op. cit., p. 44.
[66]. Ibid.,
pp. 40–43.
[67]. Senate
Standing Committee for the Scrutiny of Bill, Scrutiny
digest, 8, op. cit., p. 25.
[68]. Ibid.
[69]. Ibid.,
pp. 25–26.
[70]. Labor
Senators, Additional Comments, Community Affairs Legislation Committee, Industrial
Chemicals Bill 2017 [Provisions] and related bills, op. cit., p. 15.
[71]. Ibid.;
For more information on disallowance, see Parliament of Australia, ‘Brief
Guides to Senate Procedure: No. 19 Disallowance’, Parliament of Australia
website.
[72]. Labor
Senators, Community Affairs Legislation Committee, Industrial
Chemicals Bill 2017 [Provisions] and related bills, op. cit., p. 16.
[73]. Ibid.
[74]. For
more information on IMAP, see NICNAS, ‘IMAP’,
NICNAS website.
[75]. Labor
Senators, Community Affairs Legislation Committee, Industrial
Chemicals Bill 2017 [Provisions] and related bills, op. cit., p. 16.
[76]. Australian
Greens, Dissenting Report, Community Affairs Legislation Committee, Industrial
Chemicals Bill 2017 [Provisions] and related bills, op. cit., p. 20.
[77]. Ibid.,
p. 21.
[78]. Ibid.,
pp. 22–23.
[79]. Ibid.,
p. 16.
[80]. Ibid.
[81]. Ibid.,
pp. 23–25.
[82]. Ibid.,
p. 25.
[83]. Australian
Labor Party (ALP), Labor
national platform: a smart, modern, fair Australia, ALP policy
document, 18 August 2015, p. 151; Australian Greens, Election
2016: what the Greens will do for Australia, Australian Greens policy
document, Election 2016, p. 37.
[84]. Parliament
of Australia, ‘End
Cruel Cosmetics Bill 2014 homepage’, Australian Parliament website.
[85]. Parliament
of Australia, ‘Ethical
Cosmetics Bill 2016 homepage’, Australian Parliament website.
[86]. Australia,
Senate, Journals, 70,
2013–14, p. 1897.
[87]. Ethical
Cosmetics Bill 2016, proposed subsections 81B(5)–(6); End Cruel Cosmetics Bill
2014, proposed subsection 81B(1).
[88]. Ethical
Cosmetics Bill 2016, proposed subsections 81B(1)–(2).
[89]. End Cruel Cosmetics
Bill 2014, proposed subsections 81B(2)–(3).
[90]. Ethical
Cosmetics Bill 2016 homepage, op. cit.; End Cruel Cosmetics Bill 2014 homepage,
op. cit.
[91]. Chemistry
Australia, Submission
to Senate Standing Committee, Inquiry into the Industrial Chemicals Bill
2017 and related Bills, 12 June 2017, p. 1; Dow Chemical (Australia), Submission
to Senate Standing Committee, Inquiry into the Industrial Chemicals Bill
2017 and related Bills, 9 June 2017, p. 1.
[92]. ACCORD,
Submission
to Senate Standing Committee on Community Affairs, Inquiry into Industrial
Chemicals Bill 2017 and related Bills, 9 June 2017, p. 1.
[93]. PHAA,
Submission
to Senate Standing Committee, Inquiry into the Industrial Chemicals Bill
2017 and related Bills, 9 June 2017, p. 5.
[94]. Ibid.
[95]. National
Toxics Network, Submission
to Senate Standing Committee, Inquiry into the Industrial Chemicals Bill
2017 and related Bills, June 2017, p. 3.
[96]. Cancer
Council Australia, Submission
to Senate Standing Committee, Inquiry into the Industrial Chemicals Bill
2017 and related Bills, 9 June 2017, p. 1.
[97]. Ibid.,
pp. 1–2.
[98]. AMWU,
Submission
to Senate Standing Committee, Inquiry into the Industrial Chemicals Bill
2017 and related Bills, June 2017, p. 2.
[99]. Parliament
of Australia, ‘Senate
Community Affairs Legislation Committee: Industrial Chemicals Bill 2017 and
related Bills’, op. cit.
[100]. Be
Cruelty-Free Australia (Humane Society International (Global and Australia) and
Humane Research Australia), Submission
to Senate Standing Committee, Inquiry into the Industrial Chemicals Bill
2017 and related Bills, 9 June 2017; RSPCA, Submission
to Senate Standing Committee, Inquiry into the Industrial Chemicals Bill
2017 and related Bills, 9 June 2017.
[101]. RSPCA,
op. cit., pp. 1–2.
[102]. Be
Cruelty-Free Australia, op. cit., p. 1.
[103]. Ibid.;
RSPCA, op. cit.
[104]. Be
Cruelty-Free Australia, op. cit., p. 2; RSPCA, op. cit., p. 2.
[105]. Explanatory
Memorandum, Industrial Chemicals Bill, p. 4; Explanatory Memorandum,
Consequential Amendments Bill, p. 2; Explanatory Memorandum, Notification and
Assessment Amendment Bill , p. 1; Explanatory Memorandum, Charges (General)
Bill 2017, p. 1; Explanatory Memorandum, Charges (Customs) Bill 2017, p. 1; Explanatory
Memorandum, Charges (Excise) Bill 2017, p. 1.
[106]. Explanatory
Memorandum, Industrial Chemicals Bill, p. 4.
[107]. The
Statements of Compatibility with Human Rights can be found at pages 5–10 of the
Explanatory Memorandum to the Industrial Chemicals Bill, pages 3–5 of the Explanatory
Memorandum to the Consequential Amendments Bill, pages 2–3 of the Explanatory
Memorandum to the Notification and Assessment Amendment Bill, and page 2 of the
Explanatory Memoranda for each of the Charges (General) Bill, Charges (Customs)
Bill and Charges (Excise) Bill.
[108]. Parliamentary
Joint Committee on Human Rights, Report,
5, 2017, Canberra, 28 March 2017, p. 49 and Report,
7, 2017, 8 August 2017, p. 36 footnote 1.
[109]. Unless
otherwise identified, references to clauses in this part of the Digest are to
clauses of the Industrial Chemicals Bill.
[110]. AMWU,
op. cit., p. 3.
[111]. Legislation Act
2003, section 42.
[112]. Cancer
Council Australia, op. cit.; AMWU, op. cit.; NICNAS, ‘Reforms’, NICNAS website.
[113]. Industrial
Chemicals Bill, clause 7.
[114]. Explanatory
Memorandum, Industrial Chemicals Bill, p. 18.
[115]. Ibid.
[116]. Industrial
Chemicals Bill, subclauses 11(3) and (5).
[117]. Ibid.,
Note to clause 144.
[118]. Ibid.,
clause 149, paragraphs 151(1)(a), 151(2)(d) and subparagraph
151(2)(a)(i).
[119]. For
a more detailed discussion of the use of computers in administrative
decision-making, see for example, S Power and A Grove, National
Health Amendment (Pharmaceutical Benefits) Bill 2016, Bills digest, 66,
2016–17, Parliamentary Library, Canberra, 2017.
[120]. See
the definition of ‘registration year’ in clause 9 of the Industrial
Chemicals Bill.
[121]. Industrial
Chemicals Bill, subclauses 19(1), 19(2).
[122]. Consequential
Amendments Bill, paragraph 10(1)(a).
[123]. Explanatory
Memorandum, Industrial Chemicals Bill, p. 22.
[124]. Ibid.
[125]. Explanatory
Memorandum, Industrial Chemicals Bill, pp. 22–23.
[126]. Ibid.
[127]. Note
that these are currently defined in the ICNA Act, and the definition is
proposed to be amended by the Notification and Assessment Amendment Bill (as
discussed further later in this Digest).
[128]. Explanatory
Memorandum, Industrial Chemicals Bill, p. 25.
[129]. PHAA,
op. cit., pp. 6–7.
[130]. PHAA,
op. cit., p. 7.
[131]. Industrial
Chemicals Bill, Note to subclause 27(2).
[132]. Industrial
Chemicals Bill, paragraphs 27(1)(b), 27(1)(c).
[133]. Explanatory
Memorandum, Industrial Chemicals Bill, pp. 25, 26.
[134]. Ibid.,
p. 26.
[135]. Industrial
Chemicals Bill, clause 28, Note 1.
[136]. Ibid.,
subclause 32(3).
[137]. Note
that the assessment statement is distinct from the assessment certificate. The
assessment statement must include certain information, as specified in the
definition of assessment statement in clause 9. This includes, for
example, the name of the chemical and a summary of the assessment and any risks
to human health or the environment from the introduction or use of the
industrial chemical.
[138]. Ibid.,
subclause 32(2).
[139]. Under
clause 166 of the Industrial Chemicals Bill, all decisions by the
Executive Director related to ‘Assessed Introductions’ are reviewable
decisions.
[140]. Explanatory
Memorandum, Industrial Chemicals Bill, p. 37.
[141]. Industrial
Chemicals Bill, subclause 66(1).
[142]. Ibid.,
subclause 166(1).
[143]. Ibid.,
subclause 67(2).
[144]. Ibid.,
subclause 67(3).
[145]. Ibid.,
subclause 67(5).
[146]. Explanatory
Memorandum, Industrial Chemicals Bill, p. 43.
[147]. Industrial
Chemicals Bill, paragraph 99(2)(b).
[148]. Ibid.,
subclause 99(3).
[149]. Explanatory
Memorandum, Industrial Chemicals Bill, p. 59.
[150]. Labor
Senators, Additional comments, op. cit., p. 15.
[151]. Industrial
Chemicals Bill, subclauses 104(3), 104(4).
[152]. NICNAS,
‘About
the NICNAS reforms’, NICNAS website.
[153]. Industrial
Chemicals Bill, subclause 100(1).
[154]. AMWU,
op. cit., pp. 4, 6.
[155]. Labor
Senators, Additional comments, op. cit., pp. 15–16; Australian Greens,
Dissenting report, op. cit., pp. 19–21.
[156]. NICNAS, ‘Development
of reforms implementation detail’, NICNAS website.
[157]. This
is the evaluation that is required to vary or cancel an assessment certificate
under clauses 50 and 52.
[158]. Industrial
Chemicals Bill, subclause 69(3).
[159]. Ibid.,
subclause 74(2).
[160]. Ibid.,
Part 5 and clause 78, Note 1. However, evaluations are not
required for minor variations: see clause 85.
[161]. Ibid.,
subclauses 74(3), 78(3).
[162]. NICNAS, ‘Chemical inventory
(AICS)’, NICNAS website.
[163]. Consequential
Amendments Bill, items 41 and 42.
[164]. Industrial
Chemicals Bill, Part 6, Division 4.
[165]. Ibid.,
paragraph 95(1)(b).
[166]. See
further Chapter 2 of the Criminal Code Act
1995 (Criminal Code), which sets out the general principles of
criminal responsibility that apply to Commonwealth offences.
[167]. Explanatory
Memorandum, Industrial Chemicals Bill, pp. 12–14.
[168]. As
of August 2017, one penalty unit is equal to $210: Crimes Act 1914,
subsection 4AA. Subsection 4B(3) of the Crimes Act 1914
provides that the maximum penalty applicable to a corporation convicted of a
Commonwealth offence is five times the maximum penalty that could be imposed on
an individual.
[169]. Paragraph
82(5)(a) of the Regulatory
Powers (Standard Provisions) Act 2014 provides that for civil
penalty provisions enforceable under that Act, the maximum pecuniary penalty
for a body corporate is five times the pecuniary penalty specified for the
provision.
[170]. Industrial
Chemicals Bill, paragraph 99(1)(b).
[171]. C
Covington and C Loos, ‘Industrial
Chemicals Bill 2017: A new era of regulation in Australia’, Corrs In Brief,
Corrs Chambers Westgarth lawyers, 23 June 2017.
[172]. Under
clause 137, the Executive Director may appoint an Executive Level 1 APS
employee (or higher) as an authorised inspector.
[173]. For
further information on the Regulatory Powers Act, see C Raymond, Regulatory
Powers (Standardisation Reform) Bill 2016, Bills digest, 42, 2016–17,
Parliamentary Library, Canberra, 22 November 2016.
[174]. AMWU,
op. cit., p. 4.
[175]. Rotterdam
Convention on the Prior Informed Consent Procedure for Certain Hazardous
Chemicals and Pesticides in International Trade, done at Rotterdam 10
September 1998, [2004] ATS 22 (entered into force for Australia 18 August 2004).
[176]. Secretariat
of the Rotterdam Convention, ‘Overview’,
Rotterdam Convention website.
[177]. Industrial
Chemicals Bill, clauses 158, 159.
[178]. Ibid.,
paragraphs 159(2)(b), 159(2)(c).
[179]. ‘Notified
industrial chemical’ is defined as ‘an industrial chemical that has at any time
been the subject of a notification by Australia, or any other Party to the Rotterdam
Convention, under paragraph 1 or 2 of Article 5 of the Rotterdam Convention’;
Industrial Chemicals Bill, clause 9.
[180]. Industrial
Chemicals Bill, subclause 161(1).
[181]. Use
immunity means that the information or evidential material given, and
the fact that the person has given the information or evidence, is not
admissible evidence in criminal proceedings against that person (paragraph
175(2)(a) and (b) of the Industrial Chemicals Bill). Derivative use
immunity means that any information, document or thing obtained as a
direct or indirect consequence of the person having given information or
evidence is not admissible in criminal proceedings against that person (paragraph
175(2)(c)). See C Raymond, Regulatory
Powers (Standardisation Reform) Bill 2016, op. cit., p. 54.
[182]. C
Covington and C Loos, ‘Industrial
Chemicals Bill 2017: A new era of regulation in Australia’, Corrs In Brief,
Corrs Chambers Westgarth lawyers, 23 June 2017. See also the definitions of
‘prescribed international agreement’ and ‘prescribed international arrangement’
in clause 9.
[183]. As
of August 2017, one penalty unit is equal to $210: Crimes Act 1914,
subsection 4AA. Subsection 4B(3) of the Crimes Act 1914
provides that the maximum penalty applicable to a corporation convicted of a
Commonwealth offence is five times the maximum penalty that could be imposed on
an individual.
[184]. NICNAS,
‘Consultation
Paper 3: Other changes’, NICNAS website, 29 April 2016.
[185]. ACCC
Product Safety Australia, ‘Cosmetics
ingredients labelling’, ACCC website.
[186]. ACCC,
‘ACCC Role’,
ACCC website.
[187]. This
includes, in particular, the Trade Practices
(Consumer Product Information Standards) (Cosmetics) Regulations 1991.
[188]. A
cosmetic is defined in clause 9 of the Bill and includes,
but is not limited to, perfume, shampoo and make up but does not extend to
therapeutic goods under the Therapeutic Goods
Act 1989.
[189]. Industrial
Chemicals Bill, clause 9.
[190]. Ibid.
[191]. Ibid.
[192]. Explanatory
Memorandum, Industrial Chemicals Bill 2017, p. 61.
The corresponding rules are yet to be
handed down. Accordingly, assertions as to their content are speculation based
on supporting documentation to the Bill and other secondary sources.
[193]. Industrial
Chemicals Bill, subclauses 102(4)–(6). As noted earlier, one penalty
unit is currently $210. Penalty units are reviewed every three years.
[194]. Be
Cruelty-Free Australia, op. cit., p. 2. See also: RSPCA, op. cit.
[195]. RSPCA,
Submission to Senate Standing Committee on Community Affairs, op. cit., p. 2.
[196]. Humane
Society International and Humane Research Australia, Submission to Senate
Standing Committee on Community Affairs, op. cit., p. 2.
[197]. European
Union, Regulation
(EC) No 1223/2009 of the European Parliament and of the Council of 30 November
2009 on cosmetic products (recast), [2009] OJ L 342/59, article 2.
[198]. ‘Toxicokinetics’
describes how the body handles a chemical as a function of dose and time in
terms of the rate of chemical absorption from the site of application into the
blood stream, the rate and extent of chemical movement out of the blood into
the tissue (known as ‘distribution’), the rate and extent of chemical
biotransformation into metabolites (that is, metabolism) and the rate of
chemical removal from the body (that is, excretion): European Union Reference
Laboratory for Alternatives to Animal Testing (EURL ECVAM), ‘Toxicokinetics’,
EURL ECVAM website.
[199]. European
Union, Regulation (EC) No 1223/2009 of the European Parliament and of the
Council of 30 November 2009 on cosmetic products (recast), [2009] OJ L
342/59, article 18.2.
[200]. Australian
Government Department of Health, Submission
to Senate Standing Committee on Community Affairs, Inquiry into the
Industrial Chemicals Bill 2017 and related Bills, 12 June 2017, p. 5. Broad
public support for an animal testing ban was also identified in Labor’s
cosmetics and animal testing policy consultation in 2014 during which it received
13,680 public submissions: C O’Neil MP, National
consultation on cosmetics and animal testing, op. cit., p. 4.
[201]. Explanatory
Memorandum, Industrial Chemicals Bill 2017, pp. 61 and 93. This is again
repeated in: Australian Government Department of Health, Implementing
reforms to the National Industrial Chemicals Notification and Assessment Scheme
(NICNAS), consultation paper prepared by the Australian
Government Department of Health, June 2017, pp. 93–94.
[202]. See:
European Union, Regulation (EC) 1223/2009 on Cosmetics, article 18.2.
[203]. Note
that clause 100 of the Industrial Chemicals Bill does not explicitly
refer to animal testing but it does not preclude it either.
[204]. J
Klein, ‘EU
cosmetics directive and the ban on animal testing: compliance, challenges and
the GATT as a potential barrier to animal welfare’, Transnational Law
and Contemporary Problems, 21(251), 2012, p. 262, HeinOnline database.
[205]. EURL
ECVAM, European Union Reference
Laboratory for Alternatives to Animal Testing website. Note that EURL ECVAM
was formerly named the European Centre for the Validation of Alternative
Methods.
[206]. European
Chemicals Agency (ECHA), REACH,
ECHA website.
[207]. European
Commission and ECHA, ‘Clarity
on interface between REACH and the Cosmetics Regulation’, ECHA/NA/14/46,
Helsinki, 27 October 2014. Despite this clarification, it is unclear whether
the reference to chemicals of which the purpose is ‘exclusively or mainly’
cosmetic in Article 2 of the EU Regulations continues to apply.
[208]. Such
as under the constitutional corporations and constitutional trade
powers.
[209]. Industrial
Chemicals Bill, clause 7.
[210]. Department
of Health, ‘Ban
on cosmetic testing on animals’, Department of Health website.
[211]. Ibid.
[212]. General
Agreement on Tariffs and Trade entry into force in Marrakesh, 1 January
1995, [1995] ATS 8 (entered into force for Australian and generally on
1 January 1995), Appendix, article III:4.
[213]. ACCORD
also supports the clauses stating that ‘that the negative trade policy
scenarios [an expert report commissioned by ACCORD] reported are not believed
to be triggered by the Bill’s provisions, as drafted’.: ACCORD, Submission to
Senate Standing Committee on Community Affairs, op. cit., p. 4.
[214]. Klein,
‘EU cosmetics directive and the ban on animal testing’, op. cit., p. 270.
[215]. GATT,
op. cit., Appendix, article XX(a) (protection of public morals) and XX(b)
(protection of human, animal or plant life or health).
[216]. Agreement on
Technical Barriers to Trade opened for signature 15 April 1994,
1868 UNTS 120 (entered into force 1 January 1995), article 2. ‘Technical
regulation’ is defined in Annex 1 of the TBT and includes ‘administrative
provisions, with which compliance is mandatory’.
[217]. Ibid.,
article 2.2.
[218]. For
example, see: Klein, ‘EU cosmetics directive and the ban on animal testing’, op.
cit., pp. 268–272; K Cook and D Bowles, ‘Growing
pains: the developing relationship of animal welfare standards and the world
trade rules’, Review of European Community and International
Environmental Law, 19(2), 2010, pp. 230–238, Ebsco Host database.
[219]. See: WTO, European
Communities: Measures Prohibiting the Importation and Marketing of Seal
Products: Reports of the Appellate Body WT/DS400/AB/R and WT/DS401/AB/R, 22
May 2014.
This
was an appeal of a WTO Panel decision on a complaint brought by Canada and
Norway against the EU. In summary, Norway and Canada claimed that they were suffering
discrimination against WTO trade principles because their seal products were
not being afforded access to the EU market while, in specific circumstances,
select countries (such as Greenland) were allowed access through an exception
to the restrictions allowing seal products derived from Inuit hunts and those
obtained from hunts for marine resource management purposes. The WTO Appellate
Body found that the EU’s animal welfare objectives in prohibiting the sale or
importation of seal products fell within the scope of Article XX(a) of the GATT
on the grounds that the measure is necessary to protect public morals. However,
the prohibition was still found to be unjustifiable where seal products were
derived from hunts by Inuit or indigenous communities or hunts for marine
resource management purposes as the EU did not demonstrate that the
restrictions met the requirements of Article XX of the GATT.
Useful
summaries of these disputes, including a one-page summary of the key findings,
can be found on the WTO website for Canada’s
complaint and Norway’s
complaint.
[220]. Z
Sheftalovich, ‘Testing
times’, Choice.com.au, May 2013.
[221]. A
press release of the Court of Justice of the European Union provides a helpful
summary of the matter: Court of Justice of the European Union, EU
law protects the EU market from cosmetic products containing ingredients which
have been tested on animals, Press Release No 105/16, 21 September
2016.
[222]. European
Federation for Cosmetic Ingredients v Secretary of State for Business,
Innovation and Skills, Attorney General (Court of Justice of the
European Union, C-592/14, 21 September 2016). Note that the EU also bans the
testing of cosmetics and the substances used in cosmetics on animals that does
not take place in the EU, subject to limited exceptions.
[223]. A
polymer is a large molecule made up of many repeating small units: see the ICNA
Act, section 5. An example of a common synthetic polymer is polystyrene.
[224]. Explanatory
Memorandum, Notification and Assessment Amendment Bill, p. 5.
[225]. Ibid.,
p. 6.
[226]. Ibid.,
pp. 6–7.
[227]. Australian
Constitution, section 55.
[228]. Gillespie,
‘Second
reading speech: Industrial Chemicals Bill 2017’, op. cit., p. 6014.
[229]. Cancer
Council Australia, op. cit., p. 1.
[230]. AMWU,
op. cit., p. 2.
[231]. Gillespie,
‘Second
reading speech: Industrial Chemicals Charges (General) Bill 2017’, op.
cit., p. 6017.
[232]. Explanatory
Memorandum, Charges (General) Bill, p. 4; Explanatory Memorandum, Charges
(Customs) Bill, p. 4; Explanatory Memorandum, Charges (Excise) Bill 2017, p. 4.
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