Commercial interest, public interest and the statutory test
We apply the 'statutory test' to applications for exempt information or confidential listing to decide whether or not to:
- exempt information from publication
- include a chemical on the confidential Inventory
- transfer a chemical on the confidential Inventory to the public Inventory
- transfer a chemical on the public Inventory to the confidential Inventory.
We must be satisfied that:
- publishing some or all of the information could reasonably be expected to substantially prejudice the applicant’s commercial interests
- the prejudice to the applicant outweighs the public interest in publishing the information
Applying the statutory test
The statutory test requires consideration of the public interest before deciding not to publish the confidential information. Decisions are made on a case-by-case basis and applicants are encouraged to submit whatever reasons and available data (or other evidence) that they consider relevant to meeting the criteria in the statutory test.
We understand that the information and arguments used to support an exempt information application (pre-market) may not necessarily be the same as that required to support a confidential listing application (post-market).
When assessing an application, we can only take relevant considerations into account and we may seek additional information or clarification from the applicant to ensure procedural fairness.
Commercial interest criteria
The first part of the statutory test relates to an applicant’s commercial interests, in particular whether the commercial interests could reasonably be expected to be prejudiced if some or all of the information were published, and whether this prejudice to commercial interests is substantial.
Where an application for exempt information is made with a new chemical notification, a commercial interest is assumed if the information is not otherwise publicly available. However, we must still consider whether there is a prejudice to this commercial interest, whether this prejudice is substantial, and (if so) whether the commercial prejudice outweighs the public interest.
Where an application for confidential listing is made, since this application occurs up to five years after a certificate has been issued, we cannot assume that a commercial interest still exists. As such, the applicant needs to demonstrate their commercial interest.
Under both scenarios, the applicant is responsible for providing relevant information with reasons to explain why public disclosure of the information could 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 through loss of competitive advantage, intellectual property, or product and/or corporate viability;
- describing or estimating (where possible) the commercial damage that would arise from publication of the information, in the context of the business entity; and/or
- describing or estimating (where possible) the potential damage to the business (in Australia and/or globally), or to developing the next generation technology, where applicable.
The following information is designed to help you demonstrate whether public disclosure of confidential information would have a substantially detrimental effect on your business. Not all the examples will be relevant to every application, and other matters may be more relevant.
The information provided below is intended to act as a guide only, and is not intended to cover or apply to every situation. Remember, the information available and relevant at pre-market notification is likely to be different to that available and relevant once the chemical is on the market.
1. How will disclosure of the chemical identity/information lead to commercial loss for the business?
Estimate the loss if possible and consider factors such as:
- immediate and longer-term losses
- the potential for commercial loss at a local and international level
The estimated loss could be supported by information such as:
- modelling and statement of assumptions regarding the commercial impact from publishing the information. This could include:
- 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
- data estimating the actual or expected market share of sales of the chemical
- projected figures on the chemical's commercial interest and market value. This could be as part of a business plan.
- 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 that has not (at the time of application) reached its full commercial potential.
2. Has the chemical been publicly identified in a chemical inventory of another country?
If yes, 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 the fact that information is published elsewhere.
3. Has the substance already been granted confidential status in a chemical inventory of another country, based on commercial interests?
If yes, provide details.
4. Has confidential listing in any jurisdiction been sought and denied?
If yes, provide the reasons if available to you.
5. What measures have been taken by the owner to protect the confidential nature of the information, including in manufacturing and importing the substance?
How is the information protected within the company? Are details of the chemical subject to non-disclosure agreements?
6. Has the substance been identified other than by trade or generic names in journals, books or other public sources?
If yes, information should be provided supporting why granting confidential status in Australia is required to protect commercial interests.
7. Has the substance and/or its use been patented?
You should provide copies of any patents relevant to the use of the chemical in Australia and comment as to how the failure to grant confidential status will harm your commercial interests. For example, you could highlight where the coverage of the patents do not disclose the identity of the substance, the manufacturing process, or the use/application of the chemical.
Provided the application has adequate justification, the existence of a patent does not prevent granting the application where the patent does not specifically reveal the chemical name (or it cannot be obtained from the patent).
However, the case for confidential listing may be weakened where a patent discloses sufficient detail to bring the chemical identity into the public domain.
Applicants should state what is disclosed by the patent, and discuss why publication of a chemical’s particulars, or listing on the non-confidential Inventory, provides information that is not otherwise available.
8. Is the substance's name required to be disclosed on a Safety Data Sheet (SDS)?
A copy of any relevant SDS should be provided.
Where an application has adequate justification, the existence of an SDS disclosing the chemical name does not prevent the application being granted. There are examples where access to the SDS may be restricted and the chemical’s identity is not known publicly (for example where a chemical’s SDS is only available to commercial clients who have signed a non-disclosure agreement).
Public interest criteria
When the applicant has demonstrated that the publication of some, or all, of the information could reasonably be expected to substantially prejudice the commercial interests of the applicant, the public interest part of the statutory test is applied.
This part of the statutory test relates to whether the substantial prejudice to your commercial interest as an applicant outweighs the public interest in publishing the information.
Public interest and the ICNA Act
There is no definition of ‘public interest’ in the Act. However, it is implicit in the objects and structure of the Act that there is a public interest in having details of the chemicals published, because the Act requires the Director to publish assessment reports.
Public interest can include whether or not the chemical is hazardous and whether the chemical is published in relevant inventories overseas.
Demonstrating how prejudice to your commercial interests outweighs public interest
You can submit any arguments, supported by any available data to show that the substantial prejudice to your commercial interests outweighs the public interest in listing the chemical on the non-confidential Inventory or in publishing commercially sensitive information in assessment reports:
The matters of most concern to the public can include (but are not limited to):
- whether a chemical is hazardous
- how much is known of the toxicity and ecotoxicity of the chemical
- whether there is wide consumer use
- whether there is potential human or environmental exposure to the chemical and/or its degradation products
- whether the chemical is taken up by living organisms (persistent and bioaccumulative)
You should provide all relevant information available to you. You do not need to do additional chemical testing or provide additional test reports (unless we request this to address gaps in relevant information). Providing monitoring data with a confidential listing application will assist in assessing applications for hazardous chemicals. This includes those of international concern (such as potential endocrine disrupters).
If you are applying for confidential listing/re-listing on Inventory, you should check if the NICNAS chemical assessment report contained recommendations for future monitoring or testing. If testing has been performed, you should include the outcomes in your application.
The information below will guide you in matters that may be considered as part of the public interest element of the statutory test. This guidance is not intended to cover or apply to every situation. For example, the information available and relevant at pre-market notification is likely to differ to that available and relevant once the chemical is available to the market.
1. The likelihood of any beneficial impacts from use of the chemical. This may include replacing chemicals or processes harmful to human health and the environment, with less harmful ones.
2. The potential impact on innovation in Australia or available to Australians.
3. The public availability of data in literature, media, internet or other published sources. This includes data from other countries about the properties, fate or effects of the chemical substance.
4. Short and long term exposure patterns for workers, the public and the environment in manufacturing, use, transport and disposal of the chemical.
Exposure patterns will be used to consider the risks posed by hazardous substances.
Exposure scenarios considered in the new chemical assessment do not need to be reproduced in a new confidential listing application. However, applicants do need to describe new exposure scenarios that NICNAS may not have assessed.
Information on special or new technological controls to reduce exposure (such as containment facilities, special training for workers, or special packaging) should be included.
Situations likely to increase exposure may also need to be mentioned. For example where casual or contract workers are used, an explanation of how risk controls for these workers (such as communicating information on chemical hazards, exposure controls and worker training) are being implemented to minimise exposure could be included.
5. The type of information available to the public (in Australia) on the chemical. For example product sheets and brochures for the chemical and associated products, or on the operations of the chemical industry sites that handle the chemical substance.
6. Information on adverse incident reporting mechanisms for workers, including contract workers, to alert employers to problems with chemicals.
7. 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.
8. Results from monitoring studies for the chemical, by-products, degradation products, or wastes; and their level of compliance with State and Territory standards and licences where relevant.
Providing monitoring data on the fate of the chemical and on the chemical’s effects on human health and the environment may strengthen your case.
9. Whether disclosure of the 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.
10. Whether environmental, public and workers’ health and safety could be compromised through inclusion of the chemical on the confidential Inventory.
11. Whether the applicant has made sufficient information available to enable the substance to be tracked, including residues, metabolites and/or degradation products, in the environment.
12. Whether a safety data sheet (SDS) is available to workers and the public.
A current SDS is required with an application for confidential listing.
Last update 22 January 2019