revised draft guidelines

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COMMENTS SOUGHT ON REVISED GUIDELINES
FOR LISTING/RE-LISTING CHEMICALS ON THE CONFIDENTIAL
SECTION OF THE AUSTRALIAN INVENTORY OF CHEMICAL
SUBSTANCES AND FOR APPLICATIONS THAT CERTAIN
INFORMATION PROVIDED TO NICNAS BE EXEMPTED FROM
PUBLICATION
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is
seeking feedback on revised guidelines relating to listing chemicals on the
confidential section of the Australian Inventory of Chemical Substances (AICS) and
for applications that certain information be exempted from publication.
Background
In January 2014, NICNAS sought stakeholder views on proposed draft Guidelines for
making and considering applications to list/re-list an industrial chemical on the
confidential section of the Australian Inventory of Chemical Substances. Following
comments received, the draft guidelines were revised and have since been considered
by NICNAS’s Industry Government Consultative Committee and the Industry
Engagement Forum.
Acting on advice from the Industry Engagement Forum, NICNAS undertook a
targeted consultation through various industry associations and further refined the
draft guidelines, this time including guidance on applications for certain information
provided to NICNAS to be exempted from publication.
The Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) provides
for a chemical to be included in the confidential section of the AICS and for
information to be exempted from publication if the Director of NICNAS (his/her
delegate) is satisfied that the publication of some or all of the chemical's particulars
could reasonably be expected to prejudice substantially the commercial interests of
the applicant, and the prejudice outweighs the public interest in the publication of
those particulars.
In making an application for a chemical to be listed in the confidential section of the
AICS, or for certain information to be exempted from publication, the onus is on the
applicant to provide data relevant to three key elements in the test:
1. Whether the applicant has a commercial interest in the chemical;
2. Whether the applicant’s commercial interest would be prejudiced substantially
by the publication of specified particulars about the chemical;
3. Whether the prejudice to the applicant’s commercial interest outweighs the
public interest in the publication of those particulars.
It is not necessary for the applicant or Director to determine whether a public interest
exists; this is assumed to be the case by the legislation.
Feedback requested from stakeholders
Stakeholders are requested to provide their views on the clarity and practicality of the
attached draft guidelines.
For further information, please contact the AICS Officer on 02 8577 8883.
Written comments can be provided to:
AICS Consultation
Corporate and Regulatory Strategy Programme
NICNAS
GPO Box 58, Sydney, NSW 2001
email: [email protected]
Submissions should be received at NICNAS by c.o.b 29 July 2014.
Please note:
Submissions will be made public unless the author expressly requests all or part of
the submission to remain confidential.
Submissions, or parts thereof, that are intended to remain confidential should be
clearly marked as such and justifications provided. Submitters should be aware that
confidential submissions may still be subject to access under freedom of information
law.
Attachment
Draft Guidelines for Applying for Certain Information to be Exempt from Publication
by NICNAS and Establishing a Case for Confidential Listing of Chemicals on the
Australian Inventory of Chemical Substances—June 2014
Draft Guidelines
Applying for Certain Information to be Exempt from
Publication by NICNAS
and
Establishing a Case for Confidential Listing of Chemicals on
the Australian Inventory of Chemical Substances
June 2014
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Contents
Background .................................................................................................................... 5
Purpose of these guidelines ............................................................................................ 5
Making an application.................................................................................................... 6
Exempt information ................................................................................................... 6
Confidential listing..................................................................................................... 7
Forms ......................................................................................................................... 7
What information is required from the applicant? ......................................................... 7
Commercial Interest Criteria.......................................................................................... 8
Public Interest Criteria ................................................................................................. 10
Making a Decision ....................................................................................................... 12
Exempt information ................................................................................................. 12
Confidential listing................................................................................................... 12
Options available to an applicant if the decision is to reject an application ................ 13
Exempt information ................................................................................................. 13
Confidential listing................................................................................................... 13
The AAT .................................................................................................................. 13
Attachment A ............................................................................................................... 15
Attachment B ............................................................................................................... 18
Attachment C ............................................................................................................... 20
Attachment D ............................................................................................................... 21
Attachment E ............................................................................................................... 22
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Background
In Australia, industrial chemicals are regulated under the Industrial Chemicals
(Notification and Assessment) Act 1989 (the ICNA Act). The National Industrial
Chemicals Notification and Assessment Scheme (NICNAS) administers the ICNA
Act to aid in the protection of the Australian people and the environment by assessing
the risks of industrial chemicals and providing information to promote their safe use.
NICNAS maintains the Australian Inventory of Chemical Substances (AICS), which
is the legal device that distinguishes new industrial chemicals from existing industrial
chemicals in Australia. The AICS consists of a confidential section and a nonconfidential section. The purpose of the confidential section of the AICS is to allow
introducers of chemicals to maintain confidentiality over a chemical’s particulars,
subject to legislated criteria being met.
Purpose of these guidelines
These guidelines are intended to assist:
 applicants to prepare applications for:
o listing/re-listing of an industrial chemical on the confidential section of
the AICS (referred to in these guidelines as a confidential listing
application);
o certain information given to NICNAS to be treated as exempt from
publication (referred to in these guidelines as an exempt information
application);
 NICNAS staff to review applications for exempt information and confidential
listing/relisting;
 the Director of NICNAS (the Director) to make decisions on these
applications.
These guidelines are not intended to:
 specify the information that must be provided with each application;
 provide legal advice on the interpretation of the various sections of the ICNA
Act governing confidential listing or exempt information applications;
 detail the steps applicants must take when seeking review of a decision in the
Administrative Appeals Tribunal (AAT- refer below for further information);
or
 provide an exhaustive list of what data/arguments might satisfy the statutory
test (refer below for details on the statutory test) in all situations.
Applicants should consider how the information contained in these guidelines may be
relevant to their own particular circumstances when making an application.
Attachment A provides answers to some common questions about these processes.
Background information on the AICS and provisions for exempt information and
confidential listing are provided at Attachment B. Flow charts of the process
undertaken for confidential listing/re-listing and for applications for exempt
information by NICNAS are at Attachments C and D respectively. Attachment E
gives hypothetical examples of successful and unsuccessful applications for
confidential listing.
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Making an application
The ICNA Act sets out the process (known as a “statutory test” – see Attachment A
Q2 for further information) to be followed when:
a) including a chemical in the confidential section of the AICS;
b) transferring a chemical from the non-confidential section to the confidential
section of AICS (and vice versa); and
c) granting exemption from publication for certain information given to
NICNAS.
The statutory test is identical in all these circumstances. It requires that the decision
maker, who is the Director or delegate of the Director1, be satisfied that the
publication of some or all of the information could reasonably be expected to
prejudice substantially the commercial interests of the applicant, and that this
prejudice outweighs the public interest in the publication of that information.
The terms “commercial interest” and “public interest” are not defined in the ICNA
Act or Regulations but in all cases their scope will be limited by the objects of the
Act. Further explanation of these terms is provided in Attachment A (Q7 and Q8).
Applicants are free to provide all relevant information and argument they consider
would assist the Director in making a decision. It is important to note that the Director
can only take relevant considerations into account and cannot take into account
irrelevant considerations. Further explanation of these terms is provided in
Attachment A (Q10 and Q11).
While the statutory test is the same under circumstances a, b and c above, this does
not mean that the type of relevant information and argument that might satisfy the
decision maker would be the same for each case. Each of the above categories will
have different types and levels of information available to applicants and will require
differing arguments to support applications.
Exempt information
For any information to be exempted from publication, a person must make an
application to the Director, providing reasoned argument supported by quantitative
data or other evidence where available. There are fees associated with making an
application and these can be found on the NICNAS website (www.nicnas.gov.au).
An exempt information application will be considered internally within NICNAS and
a decision made by the Director.
The Director must not grant an application for exempt information in relation to
“basic information” about a chemical. The definition of “basic information” in the
ICNA Act and Regulations and is reproduced at Attachment A, Q12.
1
References in these guidelines to decisions made by the Director include decisions made by a delegate
of the Director where appropriate.
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Confidential listing
To list a chemical in the confidential section of AICS (or to maintain listing in the
confidential section, which is reviewed every five years), the holder of the assessment
certificate must make an application to the Director. There are fees associated with
making an application and these can be found on the NICNAS website
(www.nicnas.gov.au). For an application to be successful (that is, for the Director to
be satisfied that the requirements of the statutory test have been met), reasoned
argument supported by quantitative data (where available) or other relevant evidence
should be provided with the application.
A confidential listing application is firstly considered internally within NICNAS and a
recommendation made to the Director. The Director will then decide whether to grant
confidential listing.2
Forms
Applications are made on the approved form. Approved forms are available from the
NICNAS website (http://www.nicnas.gov.au). Approved forms are intended to assist
applicants to provide information expected to be relevant to the consideration of their
application. Applicants may provide additional information that they regard as
relevant to their application. Forms include a declaration which must be signed by an
authorised officer of the applicant. In making the declaration, applicants should be
aware that penalties may apply for making statements that are false or misleading3.
What information is required from the applicant?
Decisions are made on a case-by-case basis and NICNAS may seek clarification or
further information from the applicant. If so, the applicant is given a specific
timeframe to respond, generally not less than 28 days.
The applicant may provide whatever reasoned argument and available data or other
evidence that they feel addresses the commercial and public interest elements of the
statutory test in support of their exempt information application or confidential listing
application. The types of information that may assist the Director to make a decision
are discussed below.
Data and arguments provided in support of an exempt information application may be
different from data and arguments provided in support of confidential listing. Where
applicable, applicants seeking confidential listing are encouraged to provide
information that may have become available since the NICNAS assessment was
completed. Similarly, applications for confidential re-listing could include
information that has become available since the previous decision. This enables
NICNAS to check that the conclusions and recommendations of the original
assessment are still relevant, or whether new information requires consideration.
Applicants are reminded that information relating to secondary notification
requirements should have been provided to NICNAS within 28 days of becoming
aware of the information. Further information on secondary notification is provided
on the NICNAS website (www.nicnas.gov.au).
2
3
Under the ICNA Act this power cannot be delegated by the Director.
Criminal Code Act 1995 Part 7.4
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Commercial Interest Criteria
The first part of the statutory test relates to an applicant’s commercial interests. In
particular, the Director must consider whether the applicant’s commercial interests
could reasonably be expected to be prejudiced by publication of some or all of the
information. Furthermore, the Director must be satisfied that the prejudice to the
applicant’s commercial interests is substantial. If the Director is not satisfied of this,
the application cannot be granted.
It is the responsibility of the applicant to explain why public disclosure of the
information would have a substantially detrimental effect on the applicant’s business.
This may be done by:
 Describing the pathway from publication of the information to commercial
loss, such as competitive advantage, intellectual property, or product and/or
corporate viability.
 Describing or quantifying (where possible) the loss in the context of the
business entity.
 Describing or quantifying (where possible) the potential damage to the
business (in Australia and/or globally), or to development of next generation
technology, where applicable.
Answers to the following questions may be relevant to the Director’s consideration of
the first part of the statutory test, although not all matters will be relevant to every
application, and other matters may also be relevant. It is recognised that information
available and relevant at pre-market notification (i.e. request for exempt information)
may be different from that available and relevant once the chemicals on the market
(i.e. confidential listing application). Applicants should use this list as a guide only –
it is neither exhaustive nor applicable to every situation, and should not limit the type
of supporting information provided.
(a) How will disclosure of the chemical identity/information lead to
commercial loss for your business?
Quantify the loss if possible. Consider factors such as:
 immediate and longer term losses;
 the potential for commercial loss locally and internationally;
This could be supported by information/data such as:
o modelling and statement of assumptions regarding the commercial
impact of the publication of the information, which could include:
o an estimation of the decrease in dollar value and/or market share of
sales of the chemical if the information were published, and an
explanation of how that decrease was estimated;
o data quantifying the actual or expected market share of sales of the
chemical;
o data on the size of the market for the chemical: for example, a small
dollar value loss of sales could be relevant in a small total market;
 description of the role of the chemical as part of new technology which has not
at the time of application reached its full commercial potential.
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(b) Has the chemical been publicly identified in a chemical inventory of
another country? If so, in which country(ies) or inventory(ies) is it
published? Discuss how confidential listing or exemption from
publication in Australia will protect commercial interests despite
publication of this information elsewhere.
(c) Has the substance already been granted confidential status in a chemical
inventory of another country, based on commercial interests?
If so, this information should be provided.
(d) Has confidential listing in any jurisdiction been sought and denied?
If so, the reasons should be provided, if available.
(e) What measures have been taken by the owner to protect the confidential
nature of the information, including in manufacture and importation of the
substance?
(f) Has the substance been identified by other than trade or generic names in
journals, books or other public sources?
If so, information should be provided on why granting of confidential
status in Australia is required to protect commercial interests.
(h) Has the substance and/or its use been patented?
Applicants should provide copies of patent(s) relevant to the use of the
chemical in Australia and comment as to how the failure to grant
confidential status will harm their commercial interests. Patent coverage
may not necessarily involve transparent disclosure of the substance, the
manufacturing process, or the use/application of the chemical.
Provided that the application has adequate justification for confidential
listing, the existence of a patent does not militate against confidential
listing when it does not specifically reveal the chemical name (or it cannot
be gleaned from the patent).
However, the case for confidential listing may be weakened when patents
disclose the chemical in sufficient detail to bring the chemical identity into
the public domain. Applicants should provide an analysis of what is
disclosed by a patent and argument as to why publication of a chemicals
particulars or listing on the non-confidential AICS provides information
that is not otherwise available.
When the applicant has demonstrated that the publication of some or all of the
information could reasonably be expected to prejudice substantially the commercial
interests of the applicant, the second part of the statutory test is applied.
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Public Interest Criteria
The second part of the statutory test relates to the public interest. In particular, the
Director must consider the relative weight to be given to the substantial prejudice
caused to the applicant’s commercial interests, against the interests of the Australian
people, in the publication of the information.
There is no definition of what ‘the public interest’ is in any given set of circumstances
(see Attachment A Q6). However, the Explanatory Memorandum to the Industrial
Chemicals (Notification and Assessment) Amendment Bill 1997 suggests that the
public interest, in this particular context, may include whether or not the chemical is
hazardous and whether the chemical is published in relevant inventories overseas.
Consideration of the public interest is also limited by the objects of the ICNA Act
(refer to Attachment A Q9 for details).
Applicants need to be aware of the matters of most concern to the general public.
These include (but are not limited to) how much is known of the toxicity and
ecotoxicity of the chemical, whether or not there is wide consumer use and hence
potential exposure to the chemical and/or its degradation products, whether or not the
chemical is taken up by living organisms (persistent and bioaccumulative), and the
means used to dispose of chemical wastes.
Applicants should provide all relevant information accessible to them. Applicants do
not need to undertake additional chemical testing or provide additional test reports
unless requested by NICNAS to address gaps in relevant information. Where a
substance has been identified as hazardous, provision of monitoring data by the
applicant will assist in consideration of the application. Chemicals in this category
would include those of international concern, such as potential endocrine disrupters.
Occasionally, where NICNAS has assessed the chemical, the assessment report may
note that future monitoring or testing is to be undertaken. Applicants subsequently
seeking confidential listing or re-listing on the AICS need to check if this work has
been done, and include the outcomes in their application.
Confidential listing applications should:
 ideally, refer to the original NICNAS assessment.
 provide any new information relevant to the application.
 provide information addressing the matters listed below.
While applications for exempt information may not have a previous NICNAS
assessment to refer to, applicants still need to consider relevant matters and provide
data where available. If information is not available, an explanation is required. In
general, the more data provided in support of an application, the stronger the case.
The case is strengthened, particularly for hazardous substances, by the provision of
monitoring data on the fate of and on the human health and environmental effects of
the chemical.
The following matters may be relevant to the public interest component of the
statutory test, although not all matters will be relevant to every application (applicants
should treat this list as a guide only – it is neither exhaustive nor applicable to every
situation):
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(a) the likelihood of beneficial impacts flowing from the use of the chemical.
Examples could include benefits to society from its use such as
replacement of old more harmful chemistry (replacement of chemicals or
processes harmful to human health and the environment, with less harmful
ones).
(b) the potential impact on innovation in Australia, or available to
Australians.
(c) the public availability of data, including data from other countries,
concerning the properties, fate or effects of the chemical substance.
Chemical information may be available in literature reports, media reports
and other published sources including the Internet.
(d) exposure patterns for workers, the public and the environment, both short
and long term, in manufacture, use, transport and disposal of the chemical.
While exposure scenarios considered in the new chemical assessment do
not need to be reproduced, applicants need to describe new exposure
scenarios that may not have been assessed by NICNAS. Information on
special or new technological controls to reduce exposure (for example,
use of special containment facilities, special training for workers, or
special packaging) may need to be included.
Similarly, situations likely to increase exposure (such as the use of casual
or contract workers) may need to be mentioned with an explanation of
how risk controls for these workers (transfer of information on chemical
hazards, exposure controls and worker training) are being implemented to
minimise exposure. Exposure patterns will be used to consider the risks
posed by hazardous substances.
(e) the type of information available to the public (in Australia) on the
chemical, for example product sheets and brochures for the chemical and
its products, or on the operations of the chemical industry sites that handle
the chemical substance.
(f) information on adverse incident reporting mechanisms for workers,
including contract workers, to alert employers to problems with
chemicals.
(g) information on the potential of the chemical substance or degradation
products or by-products or wastes from its manufacture or formulation
to cause adverse short term or long term impacts directly or synergistically
on human health and/or in the environment.
(h) results from monitoring studies for the chemical, by-products, degradation
products, or wastes; and their on the level of compliance with State and
Territory standards and licences, where relevant.
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(i) whether disclosure of chemical identity is required under other Australian
Commonwealth State or Territory legislation.
For example, hazardous substances regulations, poisons scheduling,
environmental regulations, the National Pollutant Inventory etc.
(j) how environment, public and workers’ health and safety could be
compromised by the inclusion of the chemical on the confidential section
of AICS.
(k) that the applicant has made sufficient information available to enable
tracking of the substance, including residues, metabolites and/or
degradation products, in the environment.
(l) whether a safety data sheet is available to workers and the public, and
describe how a person can access the SDS.
Note: A current SDS is required with the application.
Making a Decision
Exempt information
For an application for exempt information to succeed, the Director must be satisfied
(taking into account information provided by the applicant and the objects of the
ICNA Act) that:
a) the applicant’s commercial interests would be prejudiced by the publication of
the information;
b) the prejudice to the applicant’s commercial interests would be ‘substantial’;
and
c) the public interest inherent in the publication of the information is outweighed
by the substantial prejudice to the applicant’s commercial interests.
Decisions are made on a case-by-case basis. Reasoned argument supported by
relevant data and other relevant evidence submitted by the applicant will be
considered.
Confidential listing
For an application for confidential listing to succeed, the Director must be satisfied
(taking into account information provided by the applicant and the objects of the
ICNA Act) that:
a) the applicant’s commercial interests would be prejudiced by the publication of
the information;
b) the prejudice to the applicant’s commercial interests would be ‘substantial’;
and
c) the public interest inherent in the publication of the information is outweighed
by the substantial prejudice to the applicant’s commercial interests.
The Director is required to make a decision based on the information provided by the
applicant. It would be difficult for the Director to decide in favour of the applicant on
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the basis of assertions by an applicant that are not substantiated by reasoned argument
or data (refer to Attachment A Q4) that demonstrate the substantial nature of the
prejudice to the commercial interests of the applicant that would arise from listing the
chemical in the non-confidential section of the AICS.
The Director is more likely to be able to decide in favour of the applicant if the
application is supported by relevant evidence and reasoned argument demonstrating
the prejudice that may reasonably be expected to arise from the publication of
information about the chemical, and why this prejudice outweighs the public interest
in the publication of this information.
In making a decision on any aspect of the test, the Director will not be justified in
finding in favour of the application unless, at the time the decision is made, the
Director has real and substantial grounds for thinking that publication of the
information could be expected to substantially prejudice the applicant’s commercial
interests and that any such prejudice would outweigh the public interest in publication
of the information.
Applicants are notified of the Director’s decision in writing (subsection 14(5)). Refer
below for the applicant’s right to apply for review of the Director’s decision at the
Administrative Appeals Tribunal (AAT).
Options available to an applicant if the decision is to reject
an application
Exempt information
Decisions made by the Director regarding exempt information applications are
reviewable by the AAT under section 102 of the ICNA Act.
If an application to exempt information from publication relating to a new chemical
certificate or permit is refused, the assessment application may be withdrawn at any
time before the permit is issued or the assessment report is published (for a certificate
application).
Confidential listing
Decisions made by the Director regarding confidential listing applications are
reviewable by the AAT under section 102 of the ICNA Act.
Should an applicant apply to the AAT for review and the Director’s decision is
affirmed, the chemical will be listed on the non-confidential section of the AICS,
unless a further appeal regarding the AAT decision is made to the Federal Court.
Once a chemical is listed on the non-confidential section of AICS there are limited
circumstances in which the chemical may be transferred to the confidential section or
alternatively removed from the AICS entirely.
The AAT
An application for review to the AAT must be lodged within 28 days of the decision
being made by the Director. Information that is the subject of an exempt information
application cannot be published before an AAT review of the Director’s decision is
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finalised. Similarly, a chemical that is the subject of a confidential listing application
cannot be listed in the non-confidential section until an AAT review is finalised.
To assist applicants in deciding whether to appeal the Director’s decision, the decision
will set out the findings on material questions of fact, refer to the evidence or other
material on which those findings were based and gives the reasons for the decision
(see Attachment E).
Further information on the AAT review process can be found on the AAT website at
http://www.aat.gov.au/.
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Attachment A
Frequently asked Questions and Answers
Q1: How is commercially sensitive material provided to NICNAS protected?
Commercially sensitive material provided to NICNAS is treated with the utmost
caution. Access to such material is restricted to those officers who require access to
this material to carry out their functions under the ICNA Act, and is not disclosed by
NICNAS without the consent of the applicant.
Q2: What factors are considered by NICNAS when making a decision on an
exempt information application or a confidential listing application?
The statutory test requires that the decision maker must be satisfied (taking into
account all relevant information provided by the applicant and the objects of the
ICNA Act) that:
a.
the applicant’s commercial interests would be prejudiced by the
publication of the information; and
b.
the prejudice to the applicant’s commercial interests would be
‘substantial’; and
c.
the public interest in the publication of the information is outweighed by
the substantial prejudice to the applicant’s commercial interests.
Q3: What data or argument would satisfy the decision maker when applying the
statutory test?
Each application is different and is assessed on its own merits. NICNAS is not able to
specify the information required to satisfy the statutory test in every instance,
although unsubstantiated assertions are unlikely to allow the decision-maker to decide
in favour of the applicant. All relevant information and arguments will be considered,
and therefore applicants should not feel constrained in the data and argument they put
forward. NICNAS staff will evaluate each application without pre-conceptions or
assumptions, but also cannot make assumptions favouring any particular application.
Q4: What is meant by the term “unsubstantiated assertions”?
An unsubstantiated assertion is a simple statement in support of a proposition without
reasoned argument or other evidence to justify the statement. For example, an
application accompanied only by the statement “We will suffer substantial prejudice
to our commercial interests if the chemical is listed in the non-confidential section of
the AICS, and this prejudice would outweigh any interest of the public in having the
chemical’s particulars published” is not likely to allow the elements of the test to be
satisfied.
Q5: Can NICNAS provide examples of acceptable and unacceptable
applications?
As all applications involve different considerations and are treated individually on
their merits, NICNAS is not able to provide examples that would illustrate every
situation.
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Q6: What is the definition of “commercial interest"?
Commercial interest is not defined in the ICNA Act. Applicants may submit any
arguments supported by any available data to show its commercial interest could be
substantially prejudiced by NICNAS publishing commercially sensitive information
in assessment reports or listing the chemical on the non-confidential section of AICS.
Q7: What is “public interest"?
Public interest is not defined in the ICNA Act, but it is implied by the objects of the
ICNA Act that there is a public interest in having details of chemicals published.
Applicants may submit any arguments supported by any available data to show that
the substantial prejudice to their commercial interests outweighs the public interest if
NICNAS listed the chemical on the non-confidential section of AICS or published
commercially sensitive information in assessment reports.
Q8: What are the objects of the ICNA Act?
The objects of the ICNA Act are to provide for:
a. a national system of notification and assessment of industrial chemicals for the
purposes of:
(i) aiding in the protection of the Australian people and the environment by
finding out the risks to occupational health and safety, to public health
and to the environment that could be associated with the importation,
manufacture or use of the chemicals; and
(ii) providing information, and making recommendations, about the
chemicals to Commonwealth, State and Territory bodies with
responsibilities for the regulation of industrial chemicals; and
(iii) giving effect to Australia’s obligations under international agreements
relating to the regulation of chemicals; and
(iv) collecting statistics in relation to the chemicals;
being a system under which information about the properties and effects of the
chemicals is obtained from importers and manufacturers of the chemicals; and
b. national standards for cosmetics imported into, or manufactured in, Australia
and the enforcement of those standards.
Q9: What is considered relevant information when applying the statutory test?
Relevant information is information or material that rationally or reasonably relates to
the statutory test and its elements (the balance of commercial prejudice and public
interest). Relevant information would include evidence or reasoned argument
regarding the commercial implications of publication of information about the
chemical, or information about the chemical that is already in the public domain.
Q10: What is considered irrelevant information when applying the statutory
test?
Irrelevant information is information that has no bearing on the application of the
statutory test in a particular circumstance, and could not be taken into account in
reaching a fair decision.
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Q11: What types of information can be granted exemption from publication
(exempt information)?
Exemption from publication means the information will not be included in publiclyavailable versions of the assessment report or in the Chemical Gazette. More
common examples of exempt information include the chemical name and CAS
number, exact function of the chemical in a product, and exact introduction volume.
These details are covered in the public reports by the name by which the chemical is
publicly known (eg trade name), generic function of the chemical and a volume range
or upper limit.
NICNAS cannot exempt certain items of 'basic information' from publication – refer
to Q12 below.
Q12: What information is considered “basic information” under the ICNA Act?
The ICNA Act defines basic information, in relation to a chemical, as:
a. the name or names by which the chemical is known to the public or is intended
by its importer or manufacturer to be known;
b. the chemical’s general uses;
c. the precautions and restrictions to be observed in the manufacture, handling,
storage, use and disposal of the chemical;
d. recommendations arising from the assessment of the chemical under this Act
that relate to disposing of the chemical and rendering it harmless;
e. the procedures to be following in the event of an emergency involving the
chemical;
f. prescribed physical and chemical data about the chemical, not being data that
would reveal the chemical’s composition;
g. prescribed data relating to the health effects or the environmental effects of the
chemical.
Prescribed data relevant to f. and g. above are specified in the schedules to the ICNA
Act (http://www.comlaw.gov.au/Details/C2013C00643/Html/Text#_Toc370725447).
17
Attachment B
The Australian Inventory of Chemical Substances
The Australian Inventory of Chemical Substances (AICS) is the legal device that
distinguishes new industrial chemicals from existing industrial chemicals in Australia.
All chemicals on the AICS are defined as existing industrial chemicals, while
industrial chemicals not included on AICS are defined as new industrial chemicals
and must be notified and/or assessed by NICNAS before they can be introduced (by
import or manufacture), unless exempt under the ICNA Act. The AICS consists of a
non-confidential section and a confidential section. The current AICS lists
approximately 38,000 non-confidential, and fewer than 100 confidential chemicals.
Both sections include only the chemical name, Chemical Abstracts Service Registry
Number (CAS number) (or an AICS number in certain circumstances), molecular
formula and synonyms.
The non-confidential section of AICS is publicly available and may be searched
through the NICNAS website (www.nicnas.gov.au). The confidential section is kept
electronically in a secure form by NICNAS. Access to the confidential section of the
AICS is restricted to the Director of NICNAS and NICNAS staff who require access
to this information in carrying out their duties under the ICNA Act.
Exempt Information
The ICNA Act allows applications to be made for information accompanying
different applications and provision of information, under other specified
circumstances to be treated as exempt information.
An application for exempt information can be submitted with:
 Annual reporting obligations.
 Commercial evaluation permit applications or renewal applications.
 Low volume chemical permit applications or renewal applications.
 Controlled use permit applications or renewal applications.
 Non-self-assessed and self-assessed assessment certificate applications, further
information supplied by the applicant and associated requests from the
Director for further information.
 Extension of original assessment certificate applications.
 Early introduction permit applications.
 A statement of matters given to the Director under approved state and territory
notification procedures [Note, none currently in operation].
 Particulars about a new industrial chemical where the chemical has been
notified and assessed under an approved foreign scheme.
 Information about the use and introduction of existing chemicals given to the
Director for decision on recommendation to declare a priority existing
chemical.
18



Information about the use and introduction of existing chemicals given to the
Director for decision on recommendation to declare a priority existing
chemical.
Information about a priority existing chemical.
Secondary notification applications.
A person can also make an application for exempt information for information
supplied, or information in a document produced, or information obtained because of
the entry or the exercise of powers of an inspector to monitor compliance with the
ICNA Act.
Unlike confidential listing, there is no legislated requirement to re-apply for
information to be kept exempt from publication.
Confidential Listing
New chemicals which have been assessed by NICNAS and for which an assessment
certificate has been issued (that is, Standard, Limited and Polymer of Low Concern
notifications) are included on the AICS 5 years after the date that the assessment
certificate was issued. The initial 5-year term is to prevent others from benefiting
from the costs the introducer has borne in complying with the NICNAS requirements.
At the end of 5 years, the holder of the assessment certificate (i.e. the ‘holder of the
confidence’) may apply to have the chemical listed in the confidential section
(subsection 14(1)). If no such application is made, or the application is refused, then
the chemical will be automatically listed on the non-confidential section (subject to
any available appeal).
A chemical is only permitted to remain in the confidential section for a 5 year period.
At the end of each 5-year period, a new application is required and a new decision is
taken as to whether or not it should remain for another 5-year term (a process known
as re-listing). There is no limit to the number of times an introducer can apply for relisting, but the statutory test must be met on each occasion (taking into account
information relevant to the circumstances regarding the chemical at the time of each
application) for re-listing to occur.
19
Attachment C
APPLICATIONS FOR CONFIDENTIAL LISTING
NICNAS screens application. Has
the applicant addressed the
different parts of the statutory
test?
NO
Give applicant an opportunity to
correct any deficiency in the
application
NO
Recommend to Director to
refuse confidential listing
NO
Recommend to Director to refuse
confidential listing
Y
E
S
Consider application
Is there evidence the applicant has a
commercial interest?
Y
E
S
Has applicant shown that its
commercial interest could
reasonably be prejudiced
substantially?
Y
E
S
Does the substantial prejudice to
commercial interests outweigh the
public interest* in publication?
Y
E
S
Recommend to Director to approve
application
NO
Recommend to Director to refuse
confidential listing
* A public interest regarding
chemicals is assumed as a
consequence of the legislative
test.
20
20
Attachment D
APPLICATIONS FOR EXEMPT INFORMATION
NICNAS screens application. Has
the applicant addressed the
different parts of the statutory
test?
NO
Give applicant an opportunity to
correct any deficiency in the
application.
Y
E Consider application
S
Is there evidence the applicant has a
commercial interest?
NO
Delegate refuses to exempt
particulars from publication
Y
E
S
Has applicant shown that its
commercial interest could
reasonably be prejudiced
substantially?
NO
Delegate refuses to exempt
particulars from publication
Y
E
S
Does the substantial prejudice to
commercial interests outweigh the
public interest* in publication?
Y
E
S
Delegate approves exemption of
particulars from publication
NO
Delegate refuses to exempt
particulars from publication
* A public interest regarding
chemicals is assumed as a
consequence of the legislative
test.
21
21
Attachment E
The examples below are presented in the format of a proposed decision
document
Example of a hypothetical successful application
Applicants should note that the figures for business dollar value and market share loss
provided in this example should not be taken to mean all applications which disclose
those exact or similar quantum losses will be successful.
Background
On 00 January 2014 the applicant lodged an application under s 14(3) of the Industrial
Chemicals (Notification and Assessment) Act 1989 (the Act) to list XXXX in the
confidential section of the AICS. That application is accompanied by:
1. Form AICS-1 including responses to the questions on the form.
2. Search results of CAS number on Chemlist database.
3. Search results of CAS number on Google.
4. MSDS for XXXXX.
Additional Material Considered in making a recommendation
1. New Chemicals assessment report number STD/0000 dated 00 February 2009
including information exempted from publication.
Findings of Fact
Based on the information submitted by the applicant and contained in the NICNAS
assessment report the following findings of fact are made:
1. The chemical is a hardener for two-part epoxy resin.
2. The Applicant advises that the chemical and/or products containing it are not
available to the public.
3. The Applicant submits that the use of the chemical and the estimated import
volume have not changed since the original application.
4. The chemical is classified as a dangerous good under the UN guidelines (UN
2735).
5. The Applicant advised that the chemical has not been publicly identified on
overseas inventories.
6. The Applicant advises that chemical has been granted confidential status under
the Toxic Substances Control Act (US EPA).
7. The Applicant submits that the identity of the chemical is protected through
treating manufacturing instructions as commercial-in-confidence and a needto-know basis. The identity of the chemical is not identified on the MSDS,
technical data sheet or other public documentation (commercial name is
recorded).
8. The Applicant advises that it would be difficult to reverse engineer the
chemical from the commercial product.
9. The Applicant advises that the name of the commercial product appears in
some patents, but the notified chemical has not been described or covered by
any patents.
22
10. The Applicant has estimated the loss of competitive advantage as > $5 million
if the chemical is listed on the public AICS, and provided a discussion of how
that figure was arrived at.
11. The Applicant advises its product holds 70% of the market in Australia for the
particular use.
12. The Applicant estimates it could lose up to 60% of its market share if the
chemicals details are made public, and provided a discussion of how that
figure was arrived at.
13. The chemical is not considered to pose a risk to the environment based on its
reported use pattern.
14. There is moderate concern to occupational health and safety under the
conditions of the chemical’s occupational use.
15. There is negligible concern to public health based on the chemical’s reported
use pattern.
Consideration of the application
1. Has the applicant established a relevant commercial interest?
Yes √
No
Reasons
Company developed and introduced the chemical.
Company has put in place measures to protect the confidentiality of the
chemicals identity.
The company’s product accounts for 70% of the Australian market in the
product category.
2. Has the applicant demonstrated that the publication of some or all of the
chemical’s particulars could reasonably be expected to prejudice substantially
the commercial interests of the applicant?
Yes √
No
Not Applicable
Reasons
The Applicant has estimated loss of competitive advantage at >$5m and
described how they think a competitor will use the identity of the chemical to
the disadvantage of the Applicant, which could result in a loss of up to 60% of
market share. The applicant provided a detailed discussion of its estimation of
loss of market share if the chemical’s particulars are published.
3. Does the prejudice to the applicant’s commercial interest outweigh the public
interest in disclosure of the chemical’s particulars?
Yes √
No
Not Applicable
Reasons
Company has identified the use of the chemical would reduce the need to use
product formulations that are high in volatile organic compounds, which is of
benefit to the public and the environment.
There is low exposure of the public to the chemical and based on pattern of
use described there is negligible concern to public health. The notified
chemical is not considered to pose a risk to the environment. The Applicant
has advised that there has been no increase to the import volume of the
chemical and the release levels have not changed.
23
Example of a hypothetical unsuccessful application
Applicants should note that the figures for business dollar value and market share loss
provided in this example should not be taken to mean all applications which disclose
those exact or similar quantum losses will be unsuccessful.
Background
On 00 January 2014 the applicant lodged an application under s 19(4) of the Industrial
Chemicals (Notification and Assessment) Act 1989 (the Act) to re-list XXXX in the
confidential section of the AICS. That application is accompanied by:
1. Form AICS-1 including responses to the questions on the form.
2. Copy of United States Patent number 0,000,000 dated 00 March, 1995.
3. Material Safety Data Sheet for XXXX dated 14/07/2011.
4. Product Information brochure for XXXX.
Additional Material Considered in making a recommendation
New Chemicals assessment report number STD/0000 dated 00 February 2004
including information exempted from publication.
Findings of Fact
Based on the information submitted by the applicant and contained in the NICNAS
assessment report the following findings of fact are made:
1. The chemical is used as a surfactant in detergent products for industrial use.
2. Originally the product was not sold to the general public though the public
could be exposed as a result of accidental spillage during transport of the
chemical. Since June last year the applicant has been marketing the detergent
product to consumers as well as to industrial users.
3. The chemical is not classified as hazardous under the NOHSC Approved
Criteria for Classifying Hazardous Substances but is classified under the
Globally Harmonised System for Classification and Labelling of Chemicals as
“Harmful to aquatic life with long lasting effects”.
4. Based on the changed use pattern, the chemical may pose a risk to the
environment.
5. There is low concern to occupational health and safety under the conditions of
the chemical’s occupational use.
6. There is negligible concern to public health based on the chemical’s reported
use pattern.
7. The chemical has not been publicly identified on overseas inventories.
8. The applicant has in place significant measures to protect the identity and
manufacturing process of the chemical.
9. The chemical would be difficult to identify from analysis of the product in
which it is used.
10. Manufacture of the chemical uses a unique proprietary process making it
difficult for third parties to produce it.
11. The chemical is included in an active patent but it is not identified in the
patent.
12. The global business in the chemical is valued by the applicant at a total of US
$15 million.
13. The chemical is not manufactured in Australia.
24
14. The volume of the chemical introduced into Australia has decreased by 40%
since the chemicals introduction.
15. The applicant will provide a chemical’s identity if requested by a medical
practitioner or a Poisons Information Centre.
Consideration of the application
4. Has the applicant established a relevant commercial interest?
Yes √
No
Reasons
Company developed and introduced the chemical.
Company has put in place measures to protect the confidentiality of the
chemical’s identity.
The company values its global business in the chemical at $US15 million.
5. Has the applicant demonstrated that the publication of some or all of the
chemical’s particulars could reasonably be expected to prejudice substantially
the commercial interests of the applicant?
Yes
No
√
Not Applicable
Reasons
The Applicant has estimated the value of the chemical to the business at
US$15 million and states that release of the chemical’s particulars would
result in a substantial loss of market share. No evidence was provided to
support these assertions by the applicant. No data on the estimated loss of
market share nor data on current market share were made available, so a
consideration of loss of market share compared with actual market share could
not be made. Although the applicant states that import volume into Australia
has decreased, no data are provided on whether globally sales have decreased,
hence it cannot be determined whether the decrease in Australia is indicative
of a global decrease in sales or is limited to Australia only. Noting the decline
in import volume since the chemical was first introduced, the uncertain
quantum of commercial loss and the lack of data on global sales, the applicant
has not demonstrated that publication of some or all of the chemical’s
particulars could reasonably be expected to prejudice substantially its
commercial interests.
6. Does the prejudice to the applicant’s commercial interest outweigh the public
interest in disclosure of the chemical’s particulars?
Yes
No
Not Applicable
√
Reasons
The company has not satisfied the second arm of the statutory test therefore it
is not necessary to consider whether prejudice to the applicant’s commercial
interest outweigh the public interest in disclosure of the chemical’s particulars.
25
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