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Industrial Chemicals Bill 2017

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2016-2017

 

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

 

 

HOUSE OF REPRESENTATIVES

 

 

 

 

 

 

 

 

 

 

 

INDUSTRIAL CHEMICALS BILL 2017

 

 

 

 

 

EXPLANATORY MEMORANDUM

 

 

 

 

 

 

 

 

 

 

 

 

(Circulated by authority of the Assistant Minister for Health, the Hon Dr David Gillespie MP)





TABLE OF CONTENTS

 

OUTLINE..................................................................................................................... 3

Financial Impact Statement.................................................................... 4

Statement of Compatibility with Human Rights....................... 5

NOTES ON CLAUSES............................................................................................. 11

General Introduction........................................................................................ 11

Rules made under the Act..................................................................................... 11

Offences and civil penalty provisions throughout the Bill..................................... 12

Criminal offences............................................................................................. 12

Strict liability offences..................................................................................... 13

Civil penalty scheme........................................................................................ 14

Which provision will apply?............................................................................. 14

Penalties........................................................................................................... 14

General application provision (clause 167) for all applications throughout the Bill 15

General consultation requirements....................................................................... 15

Consultation with prescribed bodies................................................................ 15

Consultation with the Gene Technology Regulator......................................... 16

Clock is paused for consideration periods....................................................... 17

PART 1 - PRELIMINARY..................................................................................... 17

Part 2 - Registration of industrial chemical introducers........................ 19

Division 1 - Simplified outline of this Part........................................................... 19

Division 2 - Registration...................................................................................... 20

Division 3 - Registration charge........................................................................... 21

Part 3 - Categorisation and assessment of industrial chemicals............ 22

Division 1 - Simplified outline of this Part........................................................... 22

Division 2 - Introduction categories..................................................................... 24

Division 3 - Assessment certificates..................................................................... 28

Subdivision A - Obtaining a certificate........................................................... 28

Subdivision B - Changes to certificate holders or persons covered by a certificate  32

Subdivision C - Varying the terms of an assessment certificate..................... 33

Subdivision D - Cancelling an assessment certificate..................................... 35

Division 4 - Commercial evaluation authorisations............................................. 37

Subdivision A - Obtaining an authorisation.................................................... 37

Subdivision B - Changing authorisation holders............................................. 40

Subdivision C - Varying the terms of an authorisation................................... 40

Subdivision D - Cancelling an authorisation................................................... 41

Division 5 - Exceptional circumstances authorisations........................................ 42

Part 4 - Evaluations initiated by Executive Director................................ 43

Division 1 - Simplified outline of this Part........................................................... 43

Division 2 - Evaluations of introductions authorised by an assessment certificate 44

Division 3 - Evaluations of other introductions or matters.................................. 46

Part 5 - Australian Inventory of Industrial Chemicals............................ 50

Division 1 - Simplified outline of this Part........................................................... 50

Division 2 - Establishment and contents of Inventory.......................................... 50

Division 3 - Inclusion of industrial chemicals on Inventory................................. 51

Division 4 - Varying the Inventory....................................................................... 53

Subdivision A - Variation on Executive Director’s initiative and variation relating to subsequent assessment certificates........................................................................................................ 53

Subdivision B - Variation on application........................................................ 54

Subdivision C - Variation following revocation of confidential business information approval       56

Subdivision D - Removing listed industrial chemicals.................................... 56

Part 6 - Information, reporting and confidentiality.................................. 57

Division 1 - Simplified outline of this Part........................................................... 57

Division 2 - Reporting.......................................................................................... 58

Division 3 - Record keeping and information gathering...................................... 61

Subdivision A - Confidentiality of proper name or end use in certain circumstances           62

Subdivision B - Confidentiality of information in other circumstances.......... 67

Subdivision C - Disclosure of information....................................................... 69

Part 7 - Enforcement.......................................................................................... 70

Division 1 - Simplified outline of this Part............................................................ 70

Division 2 - Monitoring and investigation powers................................................ 71

Division 3 - Civil penalty provisions, infringement notices and injunctions.......... 77

Division 4 - Miscellaneous................................................................................... 80

Part 8 - Administration...................................................................................... 82

Division 1 - Simplified outline of this Part........................................................... 82

Division 2 - Australian Industrial Chemicals Introduction Scheme and the Executive Director            82

Division 3 - Appointment of the Executive Director............................................. 83

Division 4 - Terms and conditions for the Executive Director............................. 84

Division 5 - Persons assisting the Executive Director.......................................... 85

Division 6 - Industrial Chemicals Special Account.............................................. 86

Part 9 - International agreements and arrangements............................... 87

Division 1 - Simplified outline of this Part........................................................... 87

Division 2 - Information exchange under the Rotterdam Convention.................. 87

Subdivision A - Notification of ban or restriction........................................... 87

Subdivision B - Exchange of certain information........................................... 89

Subdivision C - Information gathering............................................................ 89

Division 3—Movements of industrial chemicals into or out of Australia.............. 90

Part 10 - Miscellaneous..................................................................................... 91



 

INDUSTRIAL CHEMICALS BILL 2017

 

OUTLINE

 

The Industrial Chemicals Bill 2017 establishes the legislative framework for a new risk-based regulatory scheme for the Commonwealth to continue to regulate the introduction of industrial chemicals in Australia. This Bill implements arrangements that will see regulatory effort more proportionate to the level of risk to human health and safety or the environment from the introduction and use of industrial chemicals, while maintaining Australia’s robust health, safety and environmental standards.

 

The Australian Industrial Chemicals Introduction Scheme (AICIS) will replace the National Industrial Chemicals Notification and Assessment Scheme (NICNAS).

 

The Bill rebalances pre- and post-introduction regulatory controls for industrial chemical introductions so that there will be less emphasis on pre-introduction assessment of lower risk new chemicals and a greater focus on post-introduction evaluation and monitoring.

 

This approach responds to the concerns of stakeholders in a balanced and considered way, through deregulation for industry for lower risk chemicals and increased transparency for the community through better availability of information on higher risk chemicals. These are balanced against increased post-introduction monitoring and compliance capability for the regulator and certain confidentiality protections for commercial business information for industry. Improved post-introduction monitoring and compliance powers will provide the safeguards necessary to ensure that protections of health and safety of consumers, workers and the environment are maintained.

 

An important benefit of realigning regulatory effort towards industrial chemicals with a higher risk profile is that the costs to businesses and consumers using lower risk chemicals will be reduced. The faster regulatory pathway for lower risk chemicals provides an incentive to introduce safer new industrial chemicals, including replacing more hazardous existing chemicals.

 

The core elements of the reformed scheme are:

 

·          rebalanced regulatory burden through reducing the number of introduction categories (with different requirements) to six (largely based on self-categorisation), with regulatory effort focused on assessing higher risk chemicals

·          improved approaches to reviewing chemicals on the market by replacing an overly prescriptive post-market assessment process with a more responsive and flexible evaluation process

·          greater transparency by striking a balance between confidentiality and publicly available information through publication of more meaningful information, with confidentiality achieved through masking the chemical name or end use

·          a new power for the Executive Director to refuse introduction of an industrial chemical if risks to human health or the environment cannot be managed.



 

In summary, the Bill:

 

·          defines an industrial chemical for the purposes of the legislation (Part 1)

·          requires introducers of industrial chemicals to be registered (Part 2)

·          establishes a streamlined system of  risk-based categorisation of industrial chemical introductions (Part 3)

·          provides a framework for the Executive Director to initiate evaluations of industrial chemicals or matters relating to industrial chemicals (Part 4)

·          establishes the Australian Inventory of Industrial Chemicals (Part 5)

·          describes the information and reporting obligations of introducers, holders of certificates and authorisations, and persons covered by certificates (Part 6)

·          enables people to apply for the protection of confidential business information (Part 6)

·          provides AICIS with access to more contemporary tools to enable it to monitor compliance and take action in the event of non-compliance (Part 7)

·          establishes the AICIS and an Executive Director, and describes the role and functions of the Executive Director (Part 8)

·          implements Australia’s obligations under certain international agreements, including provisions enabling bans or restrictions on industrial chemicals subject to certain international agreements  (Part 9)

·          establishes the power for the Minister to make rules which will contain the operational detail of the Act, as well as general provision for applications and for review rights (Part 10).

 

The Bill establishes a principles-based framework, and rules to be made under the Industrial Chemicals Act 2017 will establish the technical and operational details of the AICIS.

 

The Bill also implements the 2016 election commitment to ban animal testing for new chemical ingredients of cosmetics from 1 July 2018. The Bill includes two provisions (clause 103 and 168) to disallow the use of new animal test data to support the introduction of chemicals used exclusively as cosmetic ingredients. This seeks to create a disincentive to use animals for unnecessary purposes by encouraging the use of alternative test methods.

 

Financial Impact Statement

 

It remains Government policy that the cost of the Commonwealth industrial chemicals introduction scheme is fully recovered from the regulated industry. Therefore, the initiatives implemented through this Bill are cost neutral.

 



Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Industrial Chemicals Bill 2017

 

This Bill is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 .

 

Overview of the Bill

The Industrial Chemicals Bill 2017 establishes the legislative framework for a new scheme to be known as the Australian Industrial Chemicals Introduction Scheme (AICIS). This scheme replaces the existing National Industrial Chemicals Notification and Assessment Scheme (NICNAS), established in 1989, and enables the Commonwealth to continue to regulate the introduction of industrial chemicals in Australia.

The Industrial Chemicals Bill 2017 also establishes the Executive Director of AICIS as an independent statutory officer-holder, to exercise powers and functions under the Act and be responsible for administering the scheme. 

The Bill rebalances the current regulatory approach to be more proportionate to risk, and to promote safer innovation by encouraging the introduction of lower risk chemicals. This new approach encourages greater harmonisation with international approaches to the regulation of industrial chemicals and provides for the use of assessments of comparable international regulators.

The Bill improves transparency, striking an appropriate balance between confidentiality and publicly available information, as the Executive Director will publish information that is more meaningful for industry and the public about chemical assessments, while allowing for appropriate confidentiality for business information through partially masked names and/or end use when in the public interest.

The monitoring and enforcement powers are also enhanced, with powers to identify and manage non-compliance more effectively to maintain current levels of health and environmental protections while reducing pre-market assessment effort.

Human rights implications

The Bill engages the following rights:

 

·          Right to health - Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR)

·          Right to privacy and reputation - Article 17 of the International Covenant on Civil and Political Rights (ICCPR)

·          Right to fair trial and fair hearing rights - Article 14 of the ICCPR

·          Right to Freedom of expression - Article 19 of the ICCPR

Right to health

Article 12(1) of the ICESCR promotes the right of all individuals to enjoy the highest attainable standard of physical and mental health. This includes the improvement of all aspects of environmental and industrial hygiene (Article 12(2)(b)). While the ICESCR contains no definition of health, the UN Committee on Economic Social and Cultural Rights (‘the Committee’) provides further guidance, stating that the right to health is not to be understood as a right to be healthy. Accordingly the right also contains entitlements, which include the right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.

The Committee’s definition is relevant to this Bill, because while the Bill does not explicitly relate to the right of a person to enjoy the highest attainable standard of physical and mental health, the proposed new regulatory scheme being established in the Bill provides a system of checks and balances necessary to protect human health and the environment. The objects of this Bill specify that it will achieve this protection through: the regulation of the introduction of industrial chemicals; the assessment and evaluation of the introduction and use of certain industrial chemicals; and the provision of information and recommendations about managing the risks arising from the introduction and use of industrial chemicals.

This Bill focuses on reducing unnecessary regulatory burdens, but not at the expense of reducing protection of public health. The Bill re-balances regulatory effort based on risk, by reducing the emphasis on pre-market assessments of lower risk chemicals, to focusing on higher risk chemicals, and reviewing chemicals already in use to assist in maintaining the health and safety of consumers, workers and the environment.

Chemicals expected to be of medium to higher potential risk will continue to be subject to pre-market assessment and require a certificate before introduction. To further protect the public, the Bill allows the Executive Director to impose conditions of introduction or use on an assessment certificate for a new chemical, and in some circumstances refuses to issue a certificate at all if risks are unable to be managed, which the Director of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) cannot currently do. Improved compliance powers will also assist in managing non-compliance more effectively. There will still be an obligation on introducers to report to the Executive Director on adverse effects of an industrial chemical on work health and safety, public health or the environment of which the introducer of the chemical has become aware.

The Bill also provides a greater degree of transparency and protection for workers because the Executive Director’s assessment statements will be publicly available and linked to the relevant entry on the Australian Inventory of Industrial Chemicals (the Inventory). This will facilitate access to health and environmental information, including risk management measures and conditions (where applicable). In streamlining the new chemical introduction process, the reforms will also encourage the introduction of newer and safer (lower-risk) chemical products for consumers.

The measures in this Bill are therefore consistent with the right to health, and promote the improvement of all aspects of environmental and industrial hygiene by minimising, so far as is reasonably practicable, the causes of health hazards inherent in a working environment that involves exposure to industrial chemicals.

Right to privacy and reputation

Lawful interference with the right to privacy is permitted under Article 17 of the ICCPR, provided it is not arbitrary.  In order for an interference with the right to privacy to be permissible, the interference must be authorised by law, be for a reason consistent with the ICCPR and be reasonable in the particular circumstances. The United Nations Human Rights Committee has interpreted the requirement of ‘reasonableness’ to imply that any interference with privacy must be proportional to the end sought and be necessary in the circumstances. The provisions of this Bill engage the right to privacy in the following key areas:

Publication of information in relation to introducers

Part 2 of the Bill engages Article 17 of the ICCPR by the requiring that the name and registration number of each registered introducer be entered on the Register of Industrial Chemicals Introducers and published on the AICIS website. While some of the information may constitute personal information for the purposes of the Privacy Act 1998 (the Privacy Act); it is disclosed in a way that is reasonable, proportionate and consistent with industrial chemicals regulation adopted internationally.

In a majority of cases the name of the introducer is a company or business name that is already in the public domain; and for the minority of sole traders who are represented on the register, the ABN details are still publicly available.

 

Nonetheless, the Bill introduces a number of safeguards to protect the privacy of the introducer of industrial chemicals, by only publishing the names of registered introducers and withholding the addresses.

 

This approach is consistent with the approach to industrial chemicals regulation adopted internationally. For example ECHA-REACH (European regulation) has commercial introducers (active and inactive registrants) publicly linked to individual chemicals on the ECHA Inventory.

 

Disclosure of protected information in limited circumstances

 

Part 6, Division 4, Subdivision C of the Bill establishes a scheme for the protection of certain information and for the disclosure of such information in limited circumstances. The Bill engages the right to protection against arbitrary and unlawful interferences with privacy by describing an approach that assumes protection of protected information (with penalties for inappropriate disclosure by entrusted persons) while also enabling disclosure where this is reasonable and warranted.  For example, where disclosure is necessary in the course of a person exercising powers, or performing functions or duties, under this Act; to assist another entity to exercise its powers, or perform its functions or duties; the person is required to do so by the law; or the disclosure is necessary to prevent or lessen a serious risk to public health or the environment. Further, the information that can be disclosed in the circumstances described above is defined such that it does not include personal information - rather it is information relating to industrial chemicals for which protection has been granted. This includes, for example the name of the industrial chemical, the end use of the chemical and other information relating to industrial chemicals such as data submitted to the Executive Director.

 

Publication of assessment statements and evaluation statements

 

There are several other provisions in the Bill requiring information to be made publicly available. This includes assessment statements and evaluation statements prepared by the Executive Director following an assessment or an evaluation of an industrial chemical or class of chemicals. The publication of this information is reasonable and necessary because it provides introducers and the general public with important information relating to the risks of the industrial chemicals that have been assessed and the means for managing those risks. The information published will not include personal information, such as the name of applicants or introducers.  

                                                   

Monitoring and enforcement powers derived from the Regulatory Powers (Standard Provisions) Act 2014 (the Regulatory Powers Act)

 

The Bill includes monitoring and enforcement powers derived from the Regulatory Powers Act. These powers are for the legitimate purposes of determining whether a provision of the Bill has been or is being complied with, or to determine whether information given in compliance or purported compliance with a provision of the Bill is correct.

 

These powers protect against arbitrary interference with privacy, as they are constrained in various ways, including: requiring consent to entry into premises or prior judicial authorisation in the form of a warrant; requiring authorised persons and any persons assisting them to leave the premises if the occupier withdraws their consent; only permitting an issuing officer to issue an investigation warrant when satisfied, by oath or affirmation, that there are reasonable grounds for suspecting that there is, or may be within 72 hours, evidential material on the premises; and only permitting an authorised person to enter premises under a warrant when their identity card is shown to the occupier of the premises.

The Bill describes additional monitoring powers (beyond the standard powers) relating to powers to take and keep samples of any substance at any premises entered by the Executive Director or an authorised inspector.  It is necessary for the Executive Director and inspectors to have this additional power because substances introduced contrary to the provisions of the legislation have the potential to cause harm to human health and the environmental. For example, it may be necessary to take samples to determine the chemical identity of substances found during a monitoring inspection, which an authorised person reasonably suspects were not lawfully introduced. The seizure of samples allows necessary tests to be conducted on items and substances in order to determine compliance with the legislation. The power to sample anything on any premises may not be exercised without a monitoring warrant, or the occupier’s consent to enter the premises (providing safeguards to occupiers).

A further safeguard provides that the Executive Director can only appoint inspectors when satisfied that the authorised persons has the knowledge or experience necessary to properly exercise the powers of an authorised inspector.

These constraints on the exercise of the powers limit their susceptibility to arbitrary use or abuse and ensure that their use is reasonable and proportionate to ensuring that industrial chemicals being introduced in Australia do not create undue risks to public health and safety or the environment.

Right to fair trial and fair hearing rights

Triggering the provisions relating to monitoring and investigation powers in the Regulatory Powers Act causes offences to apply in relation to monitoring and investigating under the Bill. For example, under subsection 24(3) of the Regulatory Powers Act, where entry is authorised by a monitoring warrant, the authorised person may require any person on the premises to answer questions or produce documents relating to information or provisions subject to monitoring. It is an offence not to do so.

The application of these offences under the Regulatory Powers Act engages the fair trial rights, minimum guarantees in the determination of a criminal charge and other criminal process rights contained in Article 14 of the ICCPR. However, these offence provisions do not restrict the person’s access to a fair trial or limit the other criminal process rights in any way. The Regulatory Powers Act in sections 17 and 47 clearly specifies that the privileges against self-incrimination and legal professional privilege have not been abolished by the monitoring and investigation powers provisions, including the offence provisions. These protections guarantee the criminal process rights protected in paragraphs 14(3)(d) and(g) of the ICCPR.

Right to freedom of expression

Article 19(2) of the ICCPR provides that everyone has the right to freedom of expression, including the freedom to impart information and ideas of all kinds, regardless of frontiers, either orally, in writing or in print, in the form of art or through any other media. Article 19(3) provides that this right may be limited on grounds including national security or of public order or of public health or morals. However, any limitations must be prescribed by legislation and be reasonable, necessary and proportionate to achieve the desired purpose.

The Bill limits the right of individuals to receive information, through the protection of confidential information and by making it an offence to disclose information relating to confidential business information. There are limited circumstances when confidential business information can be disclosed and as such, the limitation on the right is necessary to prevent or lessen the risk to public health or the environment.

Similarly the right to obtain confidential information in the first instance requires an assessment by the Executive Director as to whether the publication of the information related to an industrial chemical could reasonably be expected to substantially prejudice the commercial interests of any applicant; and whether the prejudice outweighs the public interest in the publication of the proper name or end use (as the case requires) for the industrial chemical.

This public interest test is a limitation to the right Article 19(2) of the ICCPR and is reasonable and proportionate to its objective of protecting the integrity of the Bill and protecting against risks to human health or the environment

 

Conclusion

The Bill is compatible with human rights because to the extent that it may limit human rights, those limitations are reasonable, necessary and proportionate for the protection of human health and the environment.

 

The Hon Dr David Gillespie MP, the Assistant Minister for Health



INDUSTRIAL CHEMICALS BILL 2017

 

NOTES ON CLAUSES

General Introduction

There are a number of matters within the Bill that have general application throughout the new Act. These are explained in this general introduction.

 

Rules made under the Act

The rules to be made under the Act will be made by the Minister and will be a legislative instrument. As such, the rules will be subject to disallowance by parliament. It is intended that the rules will include the technical and operational details for the scheme.

 

The capacity to prescribe matters in rules is consistent with good regulatory practice, particularly in an area such as industrial chemicals where there is a high level of scientific and technical detail that underpins the legislative scheme. For example:

·          clause 163 enables the rules to prohibit the introduction or export of certain industrial chemicals where this is required because of an international agreement or arrangement to which Australia is a party. The rules will therefore prescribe a list of over 25 chemicals that are the subject of the Rotterdam Convention and are prohibited to be imported without prior approval. This list of chemicals requires updating as the chemicals named under the Rotterdam Convention change over time. Timely updating of the lists can best be achieved through the chemicals being listed in rules rather than in the Act

·          several of the clauses refer to prescribed bodies. These are organisations with which the Executive Director must consult (or may consult) in relation to applications made under the Act. It is intended that the prescribed bodies will be the government bodies regulating uses of industrial chemicals, also known as risk managers. These include, for example, Environment Protection Authorities, Departments of Health (for scheduled substances) and work health and safety bodies. The names of these organisations can change along with machinery of government changes. Prescribing the bodies in rules rather than in the Act enables timely and more efficient updating of the lists of bodies

·          clauses 26 and 27 enable the rules to prescribe the circumstances in which an introduction will be exempted or reported. It is intended that the rules will include significant detail about how an introducer determines the categorisation of a chemical including the information necessary to support categorisation. The technical complexity and extent of information needed means that the detail is best placed in rules rather than in the Act. This also enables regular updating as the science changes, or as authoritative international lists of chemical information are changed.

Using rules enables flexibility and adaptability in an area where there are frequent scientific developments and advancements in relation to chemical identification, the hazards associated with chemicals and their risks to human health or the environment. It also enables adjustments to be more readily made to technical details and data requirements as, over time, new information comes to light about the evaluation of risks of chemicals.

 

Offences and civil penalty provisions throughout the Bill

Each of the offences set out in this Bill is a fault based criminal offence, which also has a corresponding strict liability offence (that is, where no fault elements apply to the physical elements of the offence), as well as a civil penalty provision for the same conduct. This gradation of offences and penalties is intended to enable the Executive Director to apply a proportionate response to non-compliance based on the severity of the contravention and the person’s history of non-compliance.

 

Criminal offences

Careful consideration has been given to the need for criminal offences, and the conduct that should be subject to a criminal offence . The fault-based criminal offences described in the Bill are ones for   which an accused individual or corporation may be prosecuted and each element of the offence must be proved beyond reasonable doubt in court.

 

Unless otherwise specified, section 5.6 of the Criminal Code specifies which fault element applies depending on whether the physical element is conduct, or a result or a circumstance. Where the physical element is conduct, the default element of intention will apply to the proposed offence that constitutes conduct. This means that a person must intentionally engage in that conduct to be found guilty of the offence. Where the physical elements of an offence consist of circumstances or a result, the default element is recklessness.  For example, under subclause 24 1(a), a person would contravene the fault element provision, when they intentionally introduce an industrial chemical, as the relevant physical element is conduct. The person would also be reckless if the introduction is not authorised by the listed provision (24 1(b), as the relevant physical element is a circumstances or a result.

 

Criminal offences should be used to promote compliance with the regulatory scheme and prevent considerable harm to society, or has the potential to cause, considerable harm to society or individuals, the environment or Australia’s national interests, including security interests. The Bill includes criminal offences relating to:

 

·          the unauthorised introduction of an industrial chemical (clauses 13, 24, 164), on the basis that non-compliant conduct could cause damage to human health or the environment if not introduced in accordance with any conditions necessary to ensure its safe introduction and use, or that introduction or export is prohibited or restricted by international agreements (clause 164)

·          failure to provide information to the Executive Director (clauses 70, 77, 100, 101, 102, 162), such as withholding information on the hazards of a chemical, meaning  that the Executive Director does not have relevant information to properly assess the risks of a chemical and the introduction could result in harm to people or the environment, or that the Executive Director cannot ensure compliance with Australia’s obligations under an international agreement (clause 162)

·          failure to make an annual declaration (clause 99) or to keep required records (clause 104), meaning the Executive Director is unable to properly monitor compliance with the legislation, and may not be able to identify chemicals that have been introduced or whether any risks to people or the environment are being appropriately managed

·          disclosure of confidential information by AICIS staff and others (clauses 115) except as authorised in the circumstances prescribed under clauses 116 to 126. Unauthorised disclosure of such information could have financial and business ramifications for the holder of the confidence.

Criminal penalties have been included for the various types of conduct detailed above to deter non-compliance where there is the potential for significant and lasting consequences as the result of non-compliance, to ensure Australia can deliver on its international obligations, and for consistency with other like offences under Commonwealth law such as existing criminal offences relating to the introduction and use of agricultural and veterinary chemicals other than in accordance with the relevant legislation.

 

Strict liability offences

For a strict liability offence, only the physical elements of an offence must be proven, and not fault elements. Strict liability is used in circumstances when requiring ‘fault’ to be proven would undermine compliance with the law; the consequences of the action are less significant, but nonetheless the conduct could, if continued, have significant impacts; there is public interest in ensuring that the regulatory schemes is observed; and the defendant because of his or her professional involvement can reasonably be expected to be aware of their duties and obligations under the law

 

For example, a person introducing a chemical without categorising the chemical (such that the risk of the chemical is unknown) or introducing a chemical at volumes higher than those approved for effective risk management may trigger a strict liability offences. In these scenarios, the integrity of the regulatory scheme, for reasons of promoting public health and safety, depends on the Commonwealth being able to take proportionate action (including issuing infringement notices for strict liability offences under clause 131) in order to put the person on notice that their conduct is non-compliant and to reduce the risk of ongoing non-compliance. Furthermore, people who are in the business of industrial chemical introductions, as opposed to members of the general public, can be expected to be aware of their duties and public health obligations to workers, the environment and the wider public.

 

Each physical element of the strict-liability offence must be proved beyond reasonable doubt, and the defence of honest and reasonable mistake of fact is available to the defendant (see section 9.2 of the Criminal Code). If a person has considered the relevant facts and is under a mistaken, but reasonable, belief about those facts, he or she is not liable for an offence.

 

The strict liability offences described in this Bill have only been applied where the penalty does not include imprisonment, the fine does not exceed 60 penalty units for an individual, and a strict liability offence is necessary to ensure the integrity of the regulatory regime as it relates to public health and the environment.

 

Strict liability offences also minimise the cost of prosecution (noting that industrial chemicals are extensively used in Australia, with over 50,000 industrial chemicals subject to regulation in Australia, and over 6,000 registered introducers). Generally, the application of strict liability offences (with the possibility of issuing infringement notices rather than pursuing prosecution) is appropriate for less serious offences that can be efficiently resolved outside of court, preserving resources to prosecute more serious breaches under the fault-based offences.

 

Strict liability offences will generally be pursued where the Executive Director can confidently determine that conduct is non-compliant with regulatory obligations and that such action reduces the risk of ongoing non-compliance.

 

Civil penalty scheme

The civil penalty scheme is designed to encourage compliance with the legislative requirements without resorting to criminal prosecution. Deterrence is the primary factor to be taken into account in determining civil penalties. Civil penalty amounts should be proportional to the seriousness of the contravention and should take into account losses or gains caused by a person/body corporate for contravention of civil penalty

 

The civil penalty scheme allows the Executive Director or a delegate to apply to the Federal Court, the Federal Circuit Court of Australia and a court of a State or Territory with jurisdiction in relation to matters arising under the Act for an order that a person must pay a civil penalty for contravention of the relevant provision. Contraventions of a civil penalty provision must be proved on the balance of probabilities in a court, and the court may order a monetary amount to be paid as the penalty.

 

Which provision will apply?

The Commonwealth will decide in each case whether to prosecute a person for a fault based or strict liability offence, or whether to bring proceedings for a civil penalty order. Where conduct is subject to both criminal and civil penalties, the civil penalty should take into account the stigma attached to a criminal offence. Accordingly, it is possible that civil penalties for contraventions of civil penalty provisions may be larger than the criminal penalty for a parallel criminal offence. A person may only be prosecuted for a fault based or strict liability offence, not both, and once convicted of a criminal (fault based or strict liability) offence a person could not be pursued for civil penalties. However, proceedings for a contravention of a civil penalty provision could be brought prior to a person being prosecuted for a criminal offence.

 

Penalties

The penalty units described in this Bill have been set following a review of like legislation and comparable offences. The penalty units are comparable to those for similar offences under the Gene Technology Act 2000, the Agriculture and Veterinary Chemicals Code Act 1994 and the Environment Protection and Biodiversity Conservation Act 1999 (for non-aggravated offences) and, more recently, the Tobacco Plain Packaging Act 2011 .

 

In setting the penalties consideration has been given to ensuring adequate deterrence, that the penalty take into account the cost of pursuing the action in court, and ensuring that the penalty amounts are proportionate to the seriousness of the contravention. Part 4AA of the Crimes Act 1914 specifies the monetary value of a penalty unit at any particular time.

 

The maximum penalty for a fault based criminal offence committed by an individual is 500 penalty units . The penalties are consistent with Part 5.1 of A Guide to Framing Commonwealth Offences, Infringement Notices and Enforcement Powers.

 

These moderately high maximum penalties are intended to address the most serious cases of non-compliance, such as individuals or corporations who have a high volume of non-compliant industrial chemical introductions, and to address repeat offenders. The maximum penalties are intended to be a deterrent, and are also intended to take into account the gains that a person may make through non-compliant activity. For example, an introducer of industrial chemicals who is not registered or who does not comply with the industrial chemicals legislation reduces their overall costs (because they do not have to pay for registration or to meet the relevant regulatory requirements). This provides an uneven playing field compared to other compliant introducers. The penalties therefore need to be adequate to offset this advantage or benefit that the introducer may obtain through non-compliant action

 

The maximum penalty for a strict liability offence committed by an individual is set at the Guide’s recommended 60 penalty units. This penalty is significantly lower than the maximum penalties for fault based offences and civil penalty provisions, in recognition of the fact that strict liability offences will, for example, be pursued to put small volume introducers and first offenders on notice that they are committing an offence under the requirements of the Bill, and to deter recurrent non-compliance. The higher maximum penalties will be applied in cases of deliberate and recurrent non-compliance.

 

The maximum civil penalty that may be awarded is the same as for fault-based criminal offences.

 

Some offences described in the Bill are accompanied by a lower maximum penalty - 300 penalty units for the criminal offence and civil penalty (and 60 penalty units for strict liability offences). This lower penalty (300 penalty units compared to 500 penalty units) is used for offences that are more administrative in nature and relate to, for example, failure to provide information to the Executive Director. The lower penalty for offences of this type is also consistent with the approach adopted under similar Commonwealth legislation.

 

General application provision (clause 167) for all applications throughout the Bill

All applications made under the Act will be made in accordance with clause 167 which requires that applications be in the approved form, contain any information or documents required by that form or by the rules, and be accompanied by the relevant fee for that application type. There is a note under each clause containing an application to direct the reader to clause 167.

 

General consultation requirements

 

Consultation with prescribed bodies

When considering taking certain regulatory actions, the Executive Director is required to consult with relevant bodies (prescribed in the rules) and in other circumstances has discretion as to whether to undertake such consultation. These are described in clauses 34, 46, 56, 71, 91 and 107. The relevant body will depend on the purpose and context of the consultation. The following are examples of some of the bodies that may be prescribed in the rules, noting that different bodies may be consulted for differing purposes:

 

·          National risk managers such as the:

-         Department of the Environment and Energy (in their role in the administration of the proposed legislation enacting the National Standard for the environmental risk management of industrial chemicals)

-         Attorney-General’s Department (for chemicals of security concern)

-         Safe Work Australia (for workplace chemicals)

-         Australian Competition and Consumer Commission (for chemicals in consumer goods)

-         Therapeutic Goods Administration - the Secretary’s delegate for Chemicals Scheduling and the secretariat of the Advisory Committee on Chemicals Scheduling (for chemicals used by the general public, including household chemicals and chemicals in cosmetics)

-         National Transport Commission (for transportation of chemicals)

·          Other national authorities such as:

-         National Health and Medical Research Council;

-         Food Standards Australia New Zealand

·          State and Territory risk managers such as:

-         Environment Protection Authorities in each State and Territory

-         Departments of Health (for scheduled substances) in each State and Territory

-         Work Health and Safety bodies in each State and Territory.

 

In consulting with prescribed bodies, the Executive Director must provide a notice to the relevant prescribed body and allow a response timeframe of at least 20 working days, or ten days in relation to a commercial evaluation authorisation. There is no consequence for not responding. Any advice received after the response period may still be considered by the Executive Director, if received before a decision is made. A delay in provision of advice will not delay the consideration of the application.

 

Nothing in this Bill prevents the Executive Director from consulting any of the prescribed bodies at any time.

 

Consultation with the Gene Technology Regulator

If an application involves an industrial chemical that is or contains a genetically modified (GM) product the Executive Director must seek advice by written notice from the Gene Technology Regulator. A GM product is defined in the Gene Technology Act 2000 as a thing (other than a genetically modified organism (GMO)) derived or produced from a GMO).

 

In consulting with the Gene Technology Regulator, the Executive Director must provide a notice and allow a response timeframe of at least 20 working days, or ten days in relation to a commercial evaluation authorisation. There is no consequence for not responding. Any advice received after the response period may still be considered by the Executive Director, if received before a decision is made. A delay in provision of advice will not delay the consideration of the application.

 

Clock is paused for consideration periods

Clause 169 provides that certain days are to be disregarded for the purposes of working out the consideration period. Applicable circumstances are listed in the table, relating to circumstances when the Executive Director requests, by written notice, further information from an applicant, or consults with a prescribed body or the Gene Technology Regulator. For example, days when the Executive Director is awaiting a response from the applicant for a request for further information relevant to consideration of the application, are disregarded.

 

The rules may prescribe different consideration periods for certain types of applications. This is because some applications may take a longer or shorter period to assess. It may become apparent after implementation of the reforms that a shorter timeframe is more appropriate in certain circumstances. An example is if another Australian regulator has assessed the chemical or if the chemical introduction is only categorised as assessed due to one aspect (human health or environment). On the other hand, longer assessment times might be appropriate for an industrial chemical that is part of a group or type of chemicals that has raised significant concerns, or been associated with significant risks and/or adverse events, in the past.

 

PART 1 - PRELIMINARY

 

This Part sets the constitutional basis for the Australian Industrial Chemicals Introduction Scheme (which is established under clause 140), as well as the objects and key definitions applicable to the Act. It also modernises the standard legislative provisions relating to the Act.

 

Clause 1 - Short title

 

The short title of the Act is the Industrial Chemicals Act 2017.

 

Clause 2 - Commencement

 

Clauses 1 and 2 of the Bill will commence the day the Act receives the Royal Assent and all other clauses in the Bill will commence on 1 July 2018.

 

Clause 3 - Act binds the Crown

 

The Act will bind the executive governments in each of the States, and the Territories. The Act will not bind the Commonwealth. This means that the Commonwealth cannot be prosecuted for an offence, be subject to a civil penalty, or be given an infringement notice under the Act.

 

Clause 4 - Alternative constitutional basis for this Act

 

If certain provisions cannot apply because of constitutional limitations, the provisions apply to the extent that they are supported by an alternative constitutional basis.



 

Clause 5 - Extension to external Territories

 

The Bill extends to every external Territory of Australia and therefore to: Ashmore and Cartier Islands; Christmas Island; the Cocos (Keeling) Islands; the Coral Sea Islands; the Australian Antarctic Territory; the Territory of the Heard and McDonald Islands and Norfolk Island. 

 

Clause 6 - Relationship to other laws

 

The Bill does not exclude or limit the operation of a law of a State or Territory that can operate concurrently with the Bill. The provisions of this Bill are in addition to, and not in substitution for, the requirements of any other law of the Commonwealth. This ensures that there is no implication that the Commonwealth is attempting to extend beyond its own jurisdictional reach, for the purposes of the operation of section 109 of the Constitution.

 

Clause 7 - Objects of this Act

 

The four main objectives of the new Act are to:

 

·          establish a national regulatory scheme for the introduction of industrial chemicals

·          aid in the protection of human health and the environment

·          provide for the collection and publication of information and statistics relating to industrial chemicals

·          give effect to Australia’s obligations under international agreements relating to industrial chemicals.

 

Clause 8 - Simplified outline of this Act

 

This clause summarises the main components of the new regulatory scheme that will be established by the Act.

 

Clause 9 - Definitions and Clause 10 - Definition of industrial chemical

 

This clause set out the definitions that are relied on throughout the Act.

 

The key definitions— introduce , industrial chemical , and industrial use —together establish the parameters of the industrial chemicals introduction scheme under which it is only the manufacture or importation of chemicals where they are for an industrial use that is regulated. These terms cover the same scope as similar terms used in the Industrial Chemicals (Notification and Assessment) Act 1989 (the ICNA Act). They have been simplified and modernised, with the aim to improve clarity and to harmonise with definitions used in laws of comparable international jurisdictions, particularly where they interact with other definitions.

 

A rule-making power has been included in the definitions of industrial chemical and industrial use which 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. For example, scientific developments may necessitate inclusion of currently unknown information to define industrial chemical , and the rule-making power enables the addition or exclusion of a chemical or substance to the definition. Or, changes to other Commonwealth chemical regulatory frameworks may need to be reflected in the definition of industrial use .

 

Similarly, the definitions of use , end use , article, and naturally-occurring chemical have also been improved, although these too largely cover the same scope as similar terms used in the ICNA Act. The definitions of use , article and naturally-occurring chemical also include a rule-making power to ensure ongoing currency and accuracy.

 

The definition of incidentally-introduced chemical provides more clarity than the equivalent ICNA Act definition of incidentally-produced chemical .

 

This clause also defines the new terms of the reformed scheme, many of which relate to the new way of treating commercial information that businesses wish to remain confidential. These key definitions— AACN , generalised end use , and confidence holder —underpin the core concept of the confidential business information (CBI) protections that are designed to strike a balance between confidentiality for businesses and transparency for the public.

 

An AACN is a mechanism to partially mask the proper name of a chemical anywhere that information is published in relation to an industrial chemical. Similarly, generalised end use is a mechanism to mask the specific end use of a chemical by including a generic description instead. These are reviewed by the Executive Director after five years have passed since they have been approved, or in other circumstances described in the Act. The holder of an approved AACN or generalised end use is a confidence holder .

 

Clause 11 - Application of this Act to excluded introductions

 

This clause describes the types of introductions that are not subject to the requirement to be categorised, and for which introducers are not required to be registered.

 

However, these chemical introductions may still be reviewed by the Executive Director as part of an evaluation initiated by the Executive Director under Part 4 of the Act. Further, if international obligations are applicable in relation to chemicals that come within excluded introductions, then the Executive Director and introducers would be required to meet any obligations arising from the international arrangements or agreements.

 

Part 2 - Registration of industrial chemical introducers

 

Division 1 - Simplified outline of this Part

 

Clause 12 - Simplified outline of this Part

 

Part 2 of the Act establishes the registration process and requirements to enable lawful introduction of industrial chemicals. This Part deals with a person registering to be an introducer of industrial chemicals in Australia, and refers to the registration charge that applies as a customs duty, an excise duty or a tax. This effectively preserves existing arrangements relating to a registration charge being payable by a registrant (introducer) at the time of registration.

 

Division 2 - Registration  

 

Clause 13 - Introducers must be registered

 

Every person who introduces an industrial chemical in Australia must be registered. Offence and civil penalties apply for non-compliance. This means that a person must be registered on each day that they make an introduction. The only exception to this requirement is if the introduction is an excluded introduction , as defined in section 11 of the Act. Registration is valid for a registration year, which commences on 1 September. This is the same registration year as under the ICNA Act.

 

Clause 14 - Establishment of Register

 

The Executive Director must keep a Register of Industrial Chemical Introducers (the Register).

 

The clause also states that the Register is not a legislative instrument. This is included to assist readers, as the Register is not a legislative instrument within the meaning of subsection 8(1) of the Legislation Act 2003 .

 

Clause 15 - Content of Register

 

The registrant’s name, address, and registration number will be kept on the Register. However, only the name and registration number will be published on the AICIS website. This is to ensure that personal information, as defined in the Privacy Act 1988, is only disclosed in a way that is reasonable, proportionate and consistent with industrial chemicals regulation adopted internationally.

 

Clause 16 - Applying for registration

 

Any person may apply to the Executive Director to be registered for a registration year. A registration year is defined in clause 9 as commencing on 1 September. The general application clause 167 applies, and an application for registration must be accompanied by the relevant registration charge (see clause 21).

 

The exception to the general rule that anyone can apply is that a person cannot register if their registration has been cancelled because they have given false or misleading information as part of a registration or have committed an offence under the Act in the previous three years.

 

Clause 17 - Grant of registration

 

The Executive Director must register a person upon receipt of a valid application for registration, inform the applicant, and allocate and publish a registration number.

 

The AICIS online system will enable automated registration, such that an application made in accordance with the prescribed requirements will be granted following the electronic submission of a valid and complete application. It is proposed that the applicant will be notified automatically through the AICIS online system. That is, a person’s registration takes effect from the day on which the registration is granted (if the application is made after 1 September for the registration year commencing on that date) or at the start of the registration year if the application is made before the registration year commences.

 

Clause 18 - Correction of register

 

The Executive Director can make minor corrections to the content of the Register. For example, if the name or registration number (which is published) or address (which is not publicly available) of the registrant is either incorrect or there is a typographical error.

 

Clause 19 - Cancellation of registration

 

A person can cancel their registration. This will be automatically granted once submitted electronically.

 

The Executive Director may cancel registration because of a mistake (person not meant to be on the Register) or the person has been convicted of an offence under the Act or given false or misleading information in connection with their registration. In doing so, the Executive Director must notify the registrant of the reason, allow a minimum of 20 working days for the registrant to respond (to ensure that they are afforded procedural fairness), and must consider any submission received. The Executive Director must give written notice of the decision to the registrant.

 

It is intended that such action would only be taken in instances where the person has shown persistent and serious non-compliance and efforts to bring the person into compliance have failed, to the point of legal action being required.

 

The person may seek reconsideration of the Executive Director’s decision to cancel registration and, if they remain dissatisfied with the decision, they may apply to the Administrative Appeals Tribunal for review of the decision (refer clause 166).

 

Division 3 - Registration charge

 

Clause 20 - Registration charge

A person who is registered for a registration year is liable to pay a registration charge, which is a debt due and payable to the Commonwealth and can be recovered in a court, such as the Federal Court of Australia.

 

Clause 21 - Amount of registration charge

 

The amount of the registration charge is the amount prescribed by regulations made under the Industrial Chemicals Charges (Customs) Act 2017 , the Industrial Chemicals Charges (Excise) Act 2017 and the Industrial Chemicals Charges (General) Act 2017 .

 

Three Acts are needed to give effect to the registration charge because, depending on the circumstances in which the charge is levied, it may be interpreted as a duty of customs, an excise duty or a tax. The constitution requires that each of these matters be dealt with in separate Acts.

 

This technical constitutional requirement will have negligible practical impact because a registrant will simply pay the annual registration charge due as part of the application for registration. The regulations will describe how that charge is to be calculated.

 

Clause 22 - Other matters relating to registration charge

 

The details relating to the collection and recovery of registration charge, such as the recovery of underpayments and refund of overpayments, will be set out in the rules.

 

Part 3 - Categorisation and assessment of industrial chemicals

 

Division 1 - Simplified outline of this Part  

 

Clause 23 - Simplified outline of this Part 

 

This outline summarises Part 3 of the Act, which defines the categories of introduction, introduces the requirements for each category and sets out penalties for failing to meet the requirements.  It also sets out the process by which applicants may apply for an assessment certificate or commercial evaluation authorisation, how exceptional circumstances authorisations are issued, and how changes may be made to certificates and authorisations.

 

This Part describes the six categories of introduction which form the basis of the risk-based scheme. The categories are: listed introduction, exempted introduction, reported introduction, assessed introduction, commercial evaluation introduction and exceptional circumstances introduction. A listed introduction is the introduction of an industrial chemical in accordance with the terms of its listing on the Inventory. Exempted, reported and assessed introductions are categorised based on indicative risk determined by the introducer in accordance with the rules), while commercial evaluation and exceptional circumstances introductions are both authorisations based on particular circumstances for the introduction. The following table summarises the key differences between exempted, reported, assessed and listed introductions.



 

 

 

Exempted introductions

Reported introductions

Assessed introductions

Listed introductions

Indicative risk

Very low risk

Low risk

Medium to high risk

Any

Inventory inclusion

Chemicals will not be included on the Inventory unless submitted for assessment

Chemicals will not be included on the Inventory unless submitted for assessment

Chemicals will be included on the Inventory five years after assessment (unless earlier listing requested)

Listed introductions are chemicals that have been entered on the Inventory

Level of interaction with AICIS

No pre-introduction interaction with AICIS

Report to AICIS prior to introduction

Assessment by AICIS prior to introduction

No pre-introduction interaction with AICIS

Record keeping and/or information requirements

Record keeping requirements

Record keeping requirements

Information must be submitted to AICIS

Record keeping requirements

Details published by AICIS

Specific information on introduced chemicals not published

Limited information published on chemical introductions as specified in the rules

Assessment statement published and later linked to Inventory listing

Inventory listing includes a link to the assessment statement and/or evaluation statement if any

Continuing obligations

Annual declaration of whether chemicals have been introduced in this category

Annual declaration to confirm all reported introductions made in the relevant registration year

Post-assessment information obligations

Post-assessment information obligations (if the chemical on the Inventory has been assessed or evaluated by AICIS)

Monitoring by

AICIS

Post-market monitoring

Post-market monitoring

Post-market monitoring

Post-market monitoring

 



 

Division 2 - Introduction categories  

 

Clause 24 - Introductions must be authorised

 

The effect of this clause is to create six authorisation pathways for the introduction of industrial chemicals in Australia.

 

An industrial chemical may be introduced if it is:

 

·          a listed introduction and the terms of the listing (as detailed on the Inventory) are met

·          an exempted introduction and the requirements (in the rules) relating to exempted introductions are met

·          a reported introduction and the requirements (in the rules) relating to reported introductions are met

·          an assessed introduction and the introducer complies with the terms of the assessment certificate

·          a commercial evaluation introduction and the introducer complies with the terms of the commercial evaluation authorisation

·          an exceptional circumstances introduction and the introducer complies with the terms of the exceptional circumstances authorisation.

 

The clause describes some possible consequences of non-compliance, which includes a criminal or strict liability offence or liability to pay a civil penalty.

 

Introducers also have other obligations relating to registration (refer Part 2) and record keeping and reporting of information (refer Part 6).

 

Clause 25 - Listed introductions

 

If the industrial chemical is listed on the Inventory, any registered person can introduce the industrial chemical in accordance with the terms of the listing.

 

Part 5 deals with the Inventory and the process for getting an industrial chemical listed on the Inventory. There are approximately 40,000 industrial chemicals on the existing Australian Inventory of Chemical Substances under the ICNA Act, all of which will be transferred onto the new Australian Inventory of Industrial Chemicals established by this Bill. The Industrial Chemicals (Consequential Amendments and Transitional Provisions) Bill 2017 will transition existing listings to the new Inventory, ensuring that the introduction of chemicals listed on the Inventory will be able to continue relatively unchanged.

 

Clause 26 - Exempted introductions

 

An exempted introduction is authorised if it occurs in accordance with the rules. Exempted introductions will be for very low risk introductions, based on hazard and exposure. Due to this very low indicative risk, there is no requirement for either a pre-introduction assessment by the Executive Director, or any pre-introduction reporting. The introducer must be registered (refer clause 13), keep records to demonstrate this introduction and the category of this introduction (refer clause 102), and submit an annual declaration of compliance (refer clause 99).

 

It is proposed that the rules will describe different types of exempted introductions and may also describe circumstances in which an introduction is not an exempted introduction.

 

Example - Exempted introductions

 

It is proposed that the rules will prescribe that:

 

·          chemicals introduced for the purposes of research and development will be exempted introductions, provided the introduction meets the definition of research and development (defined in the rules) and the volume of chemical introduced is less than a certain threshold defined in the rules

·          a chemical imported into Australia and then exported out of Australia without the packaging being opened will be an exempted introduction, provided the introduction complies with those requirements (described in the rules)

·          polymers of low concern (as defined in the rules) will be exempted introductions

·          chemicals that are fully characterised (meeting information requirements prescribed in the rules) to demonstrate that the chemical poses no hazards to human health or to the aquatic environment, no bioaccumulation potential and no persistence in the environment) will be exempted introductions.

 

Clause 27 - Reported introductions

 

A reported introduction is authorised if it occurs in accordance with the rules, the introducer has given a pre-introduction report to the Executive Director in accordance with clause 97, and the introduction is in accordance with the terms of the pre-introduction report. Reported introductions will generally be low risk introductions. The introducer must be registered (refer clause 13), keep records to demonstrate this introduction and the category of this introduction (refer clause 102), and submit an annual declaration of compliance (refer clause 99).

 

The rules may also prescribe circumstances in which an introduction of an industrial chemical is not a reported introduction.



 

Example - A low risk reported introduction

 

It is proposed that the rules will provide that if a chemical is introduced at volumes below a certain threshold (noting that the thresholds proposed to be included in the rules will differ for different types of exposure) and the introducer can demonstrate (based on existing information) that the chemical does not have any high concern hazard characteristics (as prescribed in the rules, including that it is not carcinogenic, mutagenic, a reproductive toxin, a persistent bioaccumulative and toxic (PBT) chemical or a chemical of other concern to the environment (as defined in the rules) then the introduction of the chemical will be authorised via the reported pathway.

 

It is proposed that the rules, supported by guidance material, will describe the information that the introducer must have regard to in order to demonstrate that a chemical is not carcinogenic, mutagenic etc. 

 

Reported introductions 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). Prescription in the rules rather than in the primary legislation enables additional bodies to be added later if they are determined to meet the criteria (established by the Minister) to be a trusted international body for the international pathway. Relevant assessments by trusted international bodies could include:

 

·          New Substance assessments by Environment and Climate Change Canada/Health Canada under the Canadian Environmental Protection Act, 1999

·          Opinions from the European Scientific Committee on Consumer Safety (SCCS) that have then been taken up in the Annexes of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.

 

The risk associated with introduction into Australia must be no higher than that identified in the trusted overseas jurisdiction. This must take into account the risk assessment assumptions applied by the international regulator and any risk management conditions from the international risk assessment that must be able to be met in Australia.

 

It is also proposed that the rules will prescribe that the international risk assessment/evaluation performed by a trusted international prescribed body must:

 

·          take into account both hazard and exposure, and the chemical must have been assessed:

-         for both human health and environmental risks (not necessarily by the same trusted international prescribed body) or

-         for human health risks only, but in relation to the environment, the hazard and exposure for the introduction (as prescribed in the rules) mean that the relevant category for the environment is not Assessed and thus an environment risk assessment is unnecessary, or

-         for environmental risks only, but in relation to human health risks, the hazard and exposure for the introduction (as prescribed in the rules) mean that the relevant category for human health is not Assessed and thus a human health assessment is unnecessary

·          be for the same end-use

·          be for the same or higher introduction volume, and

·          be for the same or higher use concentration.

 

Example - A chemical that has been assessed by a recognised international body 

 

It is proposed that the rules will provide that if a chemical introduction has been assessed for both human health and environmental risks by prescribed international bodies, the introduction will be then authorised via the reported category provided that certain conditions prescribed in the rules are also met.

 

Prior to introduction, the introducer must make a pre-introduction report (refer clause 97). The matters that must be included in a pre-introduction report for this type of introduction will be more detailed than those required for other reported introductions. For example, the introducer will need to confirm all of the matters detailed above and provide the Executive Director with access to the international risk assessment(s). The Executive Director will also be required to publish certain information about these types of reported introductions. This addresses community concern for transparency as these chemicals may present a higher risk, which would otherwise be assessed and result in published assessment statements. The publication requirements are also proposed to be included in the rules.

 

Clause 28 - Assessed introductions

 

If an introduction of an industrial chemical does not fall within the definition of an exempted or reported introduction and is not a listed industrial chemical, it is generally an assessed introduction. These introductions require pre-introduction assessment by AICIS and are authorised if the introducer holds, or is covered by, an assessment certificate issued by the Executive Director and the introduction is in accordance with the terms of the assessment certificate. Assessed introductions are generally of industrial chemicals that pose a medium to high risk to human health or the environment.

 

In addition, anyone can apply for an assessment certificate (so that the chemical may later be listed on the Inventory), even if the introduction meets the requirements for an exempted introduction or reported introduction. However, clause 31 provides that a person cannot apply for an assessment certificate for a chemical that is listed on the Inventory. If an introducer wishes to introduce a listed chemical outside the terms of the Inventory listing, or if information arises concerning risk associated with a listed chemical, other provisions apply in relation to varying a listing (clause 88) and initiating an evaluation (clause 74), respectively.

 

Division 3 of this Part describes how a person may apply for an assessment certificate.



 

Clause 29 - Commercial evaluation introductions

 

An introduction of an industrial chemical is authorised if the person holds a commercial evaluation authorisation and the introduction is in accordance with the terms of that commercial evaluation authorisation.

 

In summary, applications for a commercial evaluation authorisation will only be granted where the introduction is for the purpose of ascertaining the potential for commercial application and must not be made available to the public nor be released to the environment without prior treatment or used without appropriate workplace controls, nor have an introduction in a volume that exceeds the volume prescribed in the rules.

 

Commercial evaluation authorisations are time-limited (up to a maximum of four years) and do not provide a pathway to listing on the Inventory in the way that an assessment certificate does. Division 4 of this Part describes how a person may apply for a commercial evaluation authorisation.

 

Clause 30 - Exceptional circumstances introductions

 

An introduction of an industrial chemical is authorised if the person holds an exceptional circumstances authorisation from the Minister and the introduction is in accordance with the terms of the exceptional circumstances authorisation made under Division 5 of this Part. There is no application for this authorisation. It is expected that exceptional circumstances authorisations would only be granted in the most limited of circumstances. The Minister would consult with the Executive Director to approve this authorisation.

 

Division 3 - Assessment certificates

 

Subdivision A - Obtaining a certificate

 

Clause 31 - Applying for a certificate

 

Applications for an assessment certificate for the introduction of an industrial chemical are made to the Executive Director. This clause also provides for joint applications to be made by two or more people. General requirements for applications can be found in clause 167.

 

At the time of applying for an assessment certificate, an application may also be made for the proper name or specific end use for the industrial chemical to be treated as confidential business information (refer clause 105).

 

Clause 32 - Executive Director must consider application

 

The Executive Director must assess the application and decide within 70 working days from the day after the application was made whether or not to issue an assessment certificate unless the rules prescribe a specific number of working days for that type of application, or if the Executive Director and each applicant agree to another number of working days.

In considering the application, the Executive Director must have regard to:

 

·          any risks to human health or the environment associated with the proposed introduction and use, with the assessment of risks informed by information submitted by the applicant or subsequently requested from the applicant by the Executive Director, review of relevant studies and data

·          whether any conditions on volume, location and duration are required to manage any risks

·          any advice provided by a prescribed body (such as international regulators or Australian risk managers) or the Gene Technology Regulator

·          any submissions made by an applicant in response to the draft assessment statement.

 

The Executive Director may also consider any other relevant matters.

 

Clause 33 - Executive Director may request further information

 

The Executive Director may request, by written notice, further information from the applicant for the purposes of considering the application. The applicant must provide the information requested in the notice within the timeframe specified in the notice (which must be at least 20 working days after the notice is given). If the information is not provided, the Executive Director may take the application to be withdrawn.

 

The applicant and Executive Director may negotiate an extended timeframe. This will be achieved administratively through a variation to the written notice or issue of a new notice.

 

Clause 34 - Consultation with prescribed bodies

 

The Executive Director must consult with prescribed bodies if considering not issuing an assessment certificate on the basis of not being satisfied that risks to human health or the environment can be managed, or if the Executive Director is considering including conditions to limit, for example, the site at which the industrial chemical may be introduced, the duration of introduction, or volume of introduction.

 

The Executive Director may also consult with prescribed bodies at any time when considering an application for an assessment certificate.

 

Clause 35 - Consultation with Gene Technology Regulator

 

The Executive Director must consult with the Gene Technology Regulator if the application involves a genetically modified product.

 

Clause 36 - Submissions on draft assessment statement

 

The Executive Director must provide a draft assessment statement to each applicant. If the applicant wishes to respond to the draft statement, this must be done in writing by the deadline stated in the written notice accompanying the draft statement, which must be at least 20 working days after the day the notice was given. The applicant may also negotiate an extension of the period for comment, to which the Executive Director may agree and give effect through a variation to the written notice or by issuing a new notice with the revised timeframe. This can be achieved administratively.

 

Clause 37 - Issue of certificate and assessment statement

 

The Executive Director must consider an application and decide whether or not to issue a certificate. If the Executive Director is not satisfied that any risks to human health or the environment can be managed, the Executive Director must refuse to issue the certificate. This is a new power available to the Executive Director.

                                                                                           

In addition, the power will enable the Executive Director to refuse to issue the certificate if the chemical is not an industrial chemical. While in most cases there will be no applications for chemicals that do not have an industrial use and are therefore not industrial chemicals, there have been circumstances in which this circumstance has not been identified until the assessment of the chemical has progressed. 

 

The Executive Director must provide a notice to each applicant of the decision, the assessment certificate and the assessment statement or, in the case of refusing to issue a certificate, the notice and the assessment statement only. At this time the applicant will also be advised of any rights they may have to reconsideration of the decision by the Executive Director and, following any reconsideration, rights to seek review of the decision by the Administrative Appeals Tribunal (refer clause 166).

 

The Executive Director must publish the assessment statement on the website, which will include the information specified in the definition of assessment statement in section 9 of the Act. The assessment statement will be linked to the Inventory listing for the industrial chemical once listed under Part 5.

 

If the applicant has been successful in an application to have the chemical name and/or specific end use protected as CBI (refer clause 105), this will be reflected on the assessment statement (such that an AACN or generalised end use would be used instead).

 

Clause 38 - Content of certificate

 

Assessment certificates must be in writing and include the following terms:

 

·          the proper name for the industrial chemical

·          the defined scope of assessment

·          any conditions relating to the introduction or use of the industrial chemical

·          any specific requirements to provide information to the Executive Director in relation to the introduction

·          any other information prescribed by the rules.

 

The defined scope of assessment describes the parameters of the assessment undertaken by the Executive Director, and therefore defines the scope of introduction and use for which any subsequent recommendations on risk management arising from the assessment will be relevant. It will be informed by the scope of the application made by the applicant and includes any end use for the introduction. Unlike current arrangements, this would be specified on the assessment certificate and would transfer to the Inventory on listing of the chemical. Any subsequently proposed introduction of the chemical for a use that falls outside this defined scope will require the introducer to re-categorise the industrial chemical introduction.

 

The Executive Director’s ability to include conditions is limited to conditions on how much (volume), where (site), and for how long (duration) the industrial chemical is permitted to be introduced. Including conditions for an introduction is not intended to regulate downstream users.

 

A decision to include on an assessment certificate any condition or specific requirements to provide information is subject to reconsideration and review under clause 166.

 

Example - Circumstances in which the Executive Director may impose conditions

 

Volume

The Executive Director may decide to impose a condition relating to total volume of a chemical to be introduced, where, for example, the chemical presents a risk to the Australian environment that can only be managed by limiting the amount of the chemical that will be released to the environment. For example, a chemical that will be disposed of by release to waterways from industrial sites, or a chemical in consumer products that would ultimately be washed into the sewers, may need to be limited in quantity to prevent the concentration from reaching a level that would cause harm to the aquatic environment. Alternatively, a chemical that will be disposed of by incineration may need to be limited in quantity to prevent the amount of incineration by-products from reaching levels that would create a public health hazard in the atmosphere. 

 

Site

The Executive Director may decide to impose a condition relating to the site of use of an introduced chemical, where the chemical presents a risk to human health and/or the environment that can only be managed by specific controls located only at a particular site. This may relate to the means of disposal of the chemical, or to workplace controls for the chemical at the site, which are not in place elsewhere. 

 

Duration

The Executive Director may decide to impose a condition relating to duration in circumstances where the chemical is replacing more hazardous chemicals but still poses substantial risks itself, and is therefore expected to be only used in the short-term before being replaced by safer chemicals.

 

Clause 39 - When certificate is in force

 

An assessment certificate is considered to be in force from the day the notice is given that the certificate is issued until the earliest of the following (whichever is applicable): the day notice is given of the cancellation of the certificate, the day the Executive Director lists the chemical on the Inventory in relation to the certificate, or the day the Executive Director varies the listing for the chemical in relation to the certificate under clause 87 (which relates to variation of Inventory listings in circumstances where there are multiple certificates issued in respect of the same chemical).

 

Subdivision B - Changes to certificate holders or persons covered by a certificate

 

Clause 40 - Applying to change persons covered

 

Certificate holders may apply to the Executive Director to add, or remove, a person covered by the certificate. A person covered by the certificate is distinct from a joint holder of the certificate. The person covered would then be authorised to introduce the industrial chemical in accordance with the terms of the assessment certificate, as long as they are registered and meet certain information obligations described in Part 6.

                                                    

The Executive Director’s decision to add or remove a person covered will be made via a simple online process provided that the application requirements, which would be minimal, are met. For adding a person, all of the certificate holders must have consented. However, a person covered by a certificate does not require the consent of other certificate holders to be removed from the list of persons covered by the certificate. In either case, the Executive Director must give written notice of the decision to add or remove a person covered to both the person covered and the holders of the certificate.

 

The Executive Director is still able to take compliance action in respect of any non-compliance that occurred prior to the person applying to be removed as a person covered by the certificate.

 

Clause 41 - Applying to change certificate holders

 

A person may apply to the Executive Director to be added or removed as a holder of an assessment certificate. The Executive Director must grant a valid application. For adding a person, each of the certificate holders and the applicant must consent. This consent is not necessary for a request to be removed. In both cases, the Executive Director must give written notice of the decision to all parties.

 

If there is only one certificate holder, they may apply for cancellation of the certificate under clause 51.

 

Clause 42 - Changing certificate holders on Executive Director’s initiative

 

The Executive Director can remove a person as a holder of, or person covered by, the assessment certificate if that person is not complying with the certificate terms or has given false or misleading statements, documents and/or information in connection to the certificate. The Executive Director must give written notice to the person of the proposed action and the reasons for proposing the action, including notifying the person that they may make a written submission by a specified deadline (which must be at least 20 working days after the day the notice was given). The Executive Director must consider any submission and must decide, then notify all certificate holders of the decision.

This power would only be used in very limited circumstances and usually only when other remedies for compliance have not been successful.

 

A decision to remove a holder or a person covered from an assessment certificate is subject to reconsideration and review under clause 166. If after removing the person there are no remaining certificate holders, the Executive Director may take the certificate to be cancelled.

 

Subdivision C - Varying the terms of an assessment certificate

 

Clause 43 - Applying for a variation of the terms of an assessment certificate

 

The holder of an assessment certificate may apply to the Executive Director to vary a term of the certificate (clause 38 describes the terms of an assessment certificate).  The variation application may include an application to:

 

·          vary the defined scope of assessment. For example, the applicant for the certificate may have applied for the assessment to cover introduction of a chemical for a certain use, such as surface coatings, and wants to expand the use authorised by the certificate to include, for example, use in cosmetics

·          to vary a condition. For example, if the Executive Director imposed a condition relating to the location at which manufacture of the chemical could occur and the certificate holder wishes to change this location

·          to vary a specific information obligation. 

 

In cases where there are multiple holders of a certificate, a joint application must be made. An application may also include requests for one or more variations to a certificate.

 

If the applicant is seeking to vary the certificate to change the defined scope of assessment, which includes the end use, they may also apply for CBI protection of the end use. This application must be made at the same time as applying for the variation (as required by clause 105).

 

Clause 44 - Executive Director must consider application

 

The Executive Director must assess the application and make a decision within 70 working days from the day after the application was made. The exceptions to this are if the rules prescribe a specific number of working days for that type of application, or if the Executive Director and each applicant agree to another number of working days.

 

In considering the application, the Executive Director must have regard to:

 

·          any risks to human health or the environment associated with the proposed introduction and use of the industrial chemical

·          any further information from the applicant

·          any advice provided by a prescribed body (such as a risk manager) or the Gene Technology Regulator

·          any submissions made by an applicant in response to the draft assessment statement.

Clause 45 - Executive Director may request further information

 

The Executive Director may request, by written notice, further information from the applicant for the purpose of considering the application. The applicant must provide the information by the deadline in the notice (which must be at least 20 days after the notice was given. If the information is not provided, the Executive Director may take the application to have been withdrawn.

 

The applicant and Executive Director may negotiate an extended timeframe. This will be achieved administratively through a variation to the written notice by issuing a new notice.

 

Clause 46 - Consultation with prescribed bodies

 

The Executive Director must consult with the prescribed bodies if the Executive Director is considering including, removing or varying a condition of the assessment certificate on the basis that the variation is necessary to manage risks to human health or the environment, or if considering not varying a term of the assessment certificate if not satisfied that the risks to human health or the environment can be managed. 

 

The Executive Director may also consult with prescribed bodies in other circumstances.

 

Clause 47 - Consultation with Gene Technology Regulator

 

The Executive Director must consult with the Gene Technology Regulator if the application for variation relates to a genetically modified product.

 

Clause 48 - Submissions on draft assessment statement

 

If the Executive Director is proposing to vary a term of an assessment certificate, a draft of the assessment statement must be provided to each applicant. If the applicant wishes to respond to the draft statement, they must do so in writing by the deadline stated in the written notice accompanying the draft statement (which must be at least 20 working days after the day the notice was given).

 

Clause 49 - Issue of varied assessment certificate and assessment statement

 

The Executive Director must decide whether or not to vary a term of the certificate. In making a decision to vary a term, the Executive Director must be satisfied that any risks to human health or the environment can be managed and, if not, must refuse to vary the term. If the decision is to vary a term of the certificate, the Executive Director must provide each applicant with the varied certificate and the assessment statement, or, in the case of refusing to vary a certificate, providing written notice of the decisions and the assessment statement. The Executive Director must publish the assessment statement on the AICIS website.

 

A decision not to vary a term of an assessment statement is subject to reconsideration and review under clause 166.

 

Clause 50 - Variations on Executive Director’s initiative

 

To make a variation, the Executive Director must have completed an evaluation under Part 4 and concluded that the terms of the certificate may require a variation to manage the risks to human health or the environment relating to the introduction and use of the chemical. The evaluation statement must be published on the AICIS website.

 

After the evaluation has been completed, the Executive Director must notify each holder of the certificate of the proposed variation and the reasons for that variation. The certificate holder may wish to respond to the proposed variation, which must be done in writing by the deadline stated in the written notice (which must be at least 20 working days after the day the notice was given). The Executive Director must consider the submission in deciding whether to make the proposed variation.

 

If the decision is to make the variation to the certificate, each certificate holder will be given written notice of the decision, the varied certificate and the assessment statement. If the decision is to not to make a variation to the certificate, each certificate holder will be given the notice of decision and the assessment statement. The assessment statement must be published on the AICIS website.

 

A decision to vary a term of the assessment certificate is subject to reconsideration and review under clause 166.

 

Example - Variation of a certificate on the Executive Director’s initiative 

 

A business makes an application to introduce an industrial chemical for use by industry and the public. Based on the toxicological information available at the time, a certificate is issued.

 

Three years later a different business applies to introduce the same chemical. However, they have new toxicological information which shows that the chemical has a hazardous property that can only be managed in industrial settings.

 

The Executive Director initiates an evaluation of the first assessment certificate under Part 4 and undertakes the steps identified in section 50 of the Act before varying the certificate such that the chemical can only be used in industrial settings.

 

Subdivision D - Cancelling an assessment certificate

 

Clause 51 - Applying to cancel a certificate

 

The holder of an assessment certificate can apply to have the certificate cancelled. The Executive Director must approve the application if it is a valid application and each holder of the certificate consents to the application. Both the applicant and any other holder of the certificate will be notified, in writing, of the Executive Director’s decision.

 

It is anticipated that the process of cancelling a certificate will be an automated online process such that if a proper application is made for cancellation, the applicants will immediately be notified that the certificate has been cancelled.

 

If a certificate is cancelled, this does not affect the ability of the Executive Director to take compliance action in respect of any non-compliance that occurred prior to the cancellation of the certificate.

 

Clause 52 - Cancelling on Executive Director’s initiative

 

The Executive Director may cancel a certificate if an evaluation under Part 4 concludes that it is no longer possible to manage the risks to human health or the environment relating to the introduction and use of the chemical. The evaluation statement must be published on the AICIS website.

 

The Executive Director must give each holder of the certificate written notice of the proposed cancellation and the reasons for the cancellation. A holder may wish to respond to the proposed cancellation and must do so in writing by the deadline stated in the written notice (which must be at least 20 working days after the day the notice was given). The Executive Director will then consider this submission in deciding whether to cancel the certificate.

 

The Executive Director will inform each holder of the certificate of the decision, in writing, and publish an assessment statement on the AICIS website (which will include the reasons for the cancellation).

 

A decision to cancel an assessment certificate on the Executive Director’s initiative is subject to reconsideration and review under clause 166.

 

Example - Cancellation of a certificate on the Executive Director’s initiative 

 

A certificate is issued for a chemical introduction based on an assessment of the hazard and environmental fate information available at the time. After two years the Executive Director becomes aware that the chemical is part of a class of chemicals for which concerns have emerged globally regarding their impacts on the environment. After undertaking an evaluation under Part 4, and consulting with the relevant risk managers, the Executive Director concludes that the risks to the environment arising from the introduction and use of the chemical can no longer be managed. Based on this conclusion the Executive Director decides to cancel the certificate.

 

Safeguards for the certificate holders have been built into the provisions to ensure that the Executive Director cannot take such action unless an evaluation has been undertaken, that evaluation has identified that the risk cannot be managed, the Executive Director has published an evaluation statement and the Executive Director has also followed the processes described in section 52 of the Act to ensure that the certificate holder is afforded procedural fairness and has an opportunity to be heard. The certificate holder can seek reconsideration by the Executive Director of a decision to cancel a certificate, and can further seek review by the Administrative Appeals Tribunal (section 166).

 

Division 4 - Commercial evaluation authorisations

 

Subdivision A - Obtaining an authorisation

 

Clause 53 - Applying for an authorisation

 

A person, or joint applicants, may apply to the Executive Director for a commercial evaluation authorisation for the introduction of an industrial chemical if:

 

·          the purpose of the introduction is to ascertain the potential for commercial application for the industrial chemical

·          the introduction will not include:

-         making the chemical available to the general public (circumstances prescribed in the rules)

-         release of the chemical into the environment without prior treatment

-         uncontrolled use in any workplace

-         introduction of a volume that exceeds the volume prescribed by the rules

·          the person does not and has never held an authorisation for the chemical and proposed end use

·          the person does not have any other open applications for an authorisation for the same chemical and end use.

 

A person may also apply for CBI protection for the proper name of the chemical or the end use for the chemical. This application must be made at the same time as applying for the commercial evaluation authorisation (as required by clause 105).

 

Example - Application for commercial evaluation authorisation  

 

A company wants to trial a chemical that they think might give their product a commercial advantage. For example, an ingredient in house paint that needs weather testing, or a new ingredient in ink that needs testing to determine optimal application conditions. Often this is a very new chemical with limited information about its hazards. A commercial evaluation authorisation can apply when the trial will be limited to a specific factory or formulation site, all waste will be treated before being released to the environment, and the trial will not involve selling any of the chemical to the general public.

 

Clause 54 - Executive Director must consider application

 

The Executive Director must assess the application and make a decision within 20 working days from the day after the application was made. The exceptions to this are if the rules prescribe a specific number of working days for that type of application, or if the Executive Director and each applicant agree to another number of working days.

 

The assessment period is shorter than that for assessment certificates because less information is generally known about the chemical and, instead of relying on a full risk assessment to inform whether risks can be managed, commercial evaluations depend on strict conditions of introduction to manage any potential risks.

In assessing the application, the Executive Director must consider whether the applicant has justified the volume of the chemical and time period to be covered for effective commercial evaluation of the chemical, whether any conditions are needed to manage any identified risks or potential risks to human health or the environment, the purpose of the introduction, any advice provided by a prescribed body (such as a risk manager) or the Gene Technology Regulator, and further information from the applicant if requested by the Executive Director.

 

The Executive Director may also consider any other relevant matters.

 

Clause 55 - Executive Director may request further information

 

The Executive Director may request, by written notice, further information from the applicant for the purpose of considering the application. The applicant must provide the information requested in the notice within the timeframe specified in the notice (which must be at least 20 working days after the notice is given). If the information is not provided, the Executive Director may take the application to have been withdrawn.

 

The applicant and Executive Director may negotiate an extended timeframe. This will be achieved administratively through a variation to the written notice or by issuing a new notice.

                                                            

Clause 56 - Consultation with prescribed bodies

 

The Executive Director may choose to seek advice from a prescribed body to obtain further information in relation to the application for a commercial evaluation authorisation. The consultation period is 10 days. This shorter consultation period is consistent with the shorter consideration period for commercial evaluation authorisations.   

 

Clause 57 - Consultation with Gene Technology Regulator

 

The Executive Director must consult with the Gene Technology Regulator if the application involves a genetically modified product.

 

Clause 58 - Issue of authorisation

 

The Executive Director must decide whether or not to issue an authorisation. In making the decision, the Executive Director must be satisfied that any risks to human health or the environment can be managed and, if not, must refuse to issue the authorisation, including if the chemical is not an industrial chemical. The Executive Director must notify each applicant of the decision to issue an authorisation by providing each applicant with written notice of the decision and the authorisation or, in the case of refusing to issue an authorisation, by providing a written notice of the decision (which must include the Executive Director’s reasons for refusing the authorisation).

 

A decision to not issue a commercial evaluation authorisation is subject to reconsideration and review under clause 166.

Clause 59 - Content of authorisation

 

Commercial evaluation authorisations must be in writing and include the following terms:

 

·          the proper name of the industrial chemical

·          the period covered by the authorisation (which is a maximum of four years)

·          the end use of the chemical

·          a stipulation that the introduction of the chemical must be for the purposes of commercial evaluation

·          any conditions that are necessary to manage risks to human health or the environment from the introduction or use of the industrial chemical. For example, the conditions may relate to:

-         the maximum quantity of chemical that may be introduced for the commercial evaluation and the period during which it may be introduced

-         control measures, where a suitable and sufficient workplace risk assessment requires it, to manage the risks to human health

-         a requirement to ensure that workers exposed to the chemical and products containing it are informed that the chemical is being introduced into Australia under a commercial evaluation authorisation

-         a requirement to keep records at the site/s of use for the quantity of the chemical used, and any adverse occupational health and safety, public health and environmental effects resulting from use

·          any specific requirements to provide information to the Executive Director in relation to the introduction. For example, this could include a requirement to provide advice at the end of the evaluation, of matters such as quantities used, means of disposal of excess quantity, any adverse occupational health and safety, public health and environmental effects during the evaluation

·          any other information prescribed by the rules.

 

The Executive Director must publish on the AICIS website for the period the authorisation is in force:

 

·          the proper name of the industrial chemical (or AACN)

·          that it is a commercial evaluation authorisation

·          the end use for the industrial chemical (or generalised end use)

·          the period for which the authorisation is in force.

 

A decision to include a condition or a specific requirement to provide information to the Executive Director is subject to review and reconsideration under clause 166.

 

A person may also apply for CBI protection such that an AACN and/or generalised end use is published in lieu of the proper name and end use.



 

Subdivision B - Changing authorisation holders

 

Clause 60 - Applying to change authorisation holders

 

A person may apply to the Executive Director to be added as a holder of a commercial evaluation authorisation or, in the case of joint holders, have someone removed as a holder. In both cases, the Executive Director must grant the application provided the application complies with clause 167.

 

In the case of a request to be added as a holder of an authorisation, both the applicant and each holder of the authorisation must consent to the application. In the case of removing a holder, the Executive Director must grant a valid application. In both cases, the Executive Director must give written notice of the decision to all holders.

 

If there is only one holder, that person may cancel the authorisation under clause 65.

 

Clause 61 - Changing authorisation holders on Executive Director’s initiative

 

If a holder of a commercial evaluation authorisation is not complying with the authorisation terms or has given false or misleading statements, documents and/or information in connection to the authorisation, the Executive Director may remove the holder from the authorisation.

 

Before removing the person, the Executive Director must provide the person with written notice of the proposed removal and the reasoning behind it. The person may wish to provide a written submission to the Executive Director, which must be made by the deadline stated in the notice (which must be at least 20 working days after the day the notice was given). After considering any submissions, the Executive Director must decide whether or not to remove the person from the authorisation and must give written notice of the decision to both the person being removed and any other authorisation holders.

 

If after removing the person there are no remaining authorisation holders, the Executive Director may take the authorisation to be cancelled.

 

A decision to remove a person as a holder of a commercial evaluation authorisation is subject to reconsideration and review under clause 166.

 

Subdivision C - Varying the terms of an authorisation

 

Clause 62 - Applying for a variation of the terms of an authorisation

 

The holder of a commercial evaluation authorisation may apply to vary a term of the authorisation, which may include varying a condition, such as the location at which the commercial evaluation of the chemical could occur, extend the period of the authorisation provided that this does not exceed four years in total, or vary a specific information obligation. 

 

In cases where there are multiple holders of an authorisation, a joint application must be made in accordance with the relevant application requirements in clause 167. An application may also include requests for one or more variations to an authorisation.

 

Clause 63 - Issue of varied authorisation

 

The Executive Director must decide whether or not to vary an authorisation within 20 working days from the day after the application was made, unless the rules prescribe a specific number of working days for that type of authorisation, or if the Executive Director and each applicant agree to another number of working days. In making the decision, the Executive Director must consider whether any conditions are necessary to manage any potential risks to human health or the environment associated with the proposed variation and must notify each holder of the authorisation of the decision.

 

A decision to not vary a term of a commercial evaluation authorisation is subject to reconsideration and review under clause 166.

 

Clause 64 - Variations on Executive Director’s initiative

 

When the Executive Director initiates a variation, the Executive Director must give each holder of the authorisation written notice of the proposed variation and the reason for it. If the authorisation holder wishes to respond to the proposed variation, this must be done in writing by the deadline stated in the written notice (which must be at least 20 working days after the day the notice was given). The Executive Director must consider any submission in deciding whether or not to vary the authorisation. The Executive Director must notify each holder of the authorisation in writing of the decision and also provide the varied authorisation to each holder where a variation has been made.

 

A decision to vary a term of a commercial evaluation on the Executive Director’s initiative is subject to reconsideration and review under clause 166.

 

Example - Executive Director initiated variation of commercial evaluation authorisation  

 

An authorisation may be issued with a specific information obligation to provide certain hazard information to the Executive Director if it becomes available to the holder during the period of the authorisation. If this information does become available then the Executive Director may consider it and decide to vary the conditions of an authorisation to manage any new risks arising from the new hazards identified.

 

Subdivision D - Cancelling an authorisation

 

Clause 65 - Applying to cancel an authorisation

 

The holder of a commercial evaluation authorisation may apply to have the authorisation cancelled. A valid application must be granted if the applicant and any other holder of the authorisation consent.  The Executive Director will notify, in writing, each authorisation holder of the decision.

 

It is anticipated that the process of cancelling an authorisation will be an automated online process such that if a valid application is made for cancellation, the authorisation holders will immediately be notified that the authorisation has been cancelled.

 

If an authorisation is cancelled, this does not affect the ability of the Executive Director to take compliance action in respect of any non-compliance that occurred prior to the cancellation of the authorisation.

 

Clause 66 - Cancelling on Executive Director’s initiative

 

The Executive Director may decide to cancel a commercial evaluation authorisation if not satisfied that the risks to human health or the environment relating to the introduction and use of the industrial chemical can be managed.

 

When the Executive Director initiates a cancellation of an authorisation, each holder of the authorisation must be provided with written notice of the proposed cancellation and the reasons for it. If the holder of the authorisation wishes to respond to the proposed cancellation, this must be done in writing by the deadline stated in the written notice (which must be at least 20 working days after the day the notice was given). The Executive Director must consider any submissions in deciding whether to cancel the authorisation. The Executive Director must notify each holder of the authorisation of the decision to cancel.

 

A decision to cancel a commercial evaluation authorisation on the Executive Director’s initiative is subject to reconsideration and review under clause 166.

 

Example - Executive Director initiated cancellation of commercial evaluation authorisation  

 

An authorisation holder has advised the Executive Director that adverse health effects (such as skin and respiratory sensitisation) have been experienced by workers using the chemical. The authorisation holder has confirmed that additional controls to adequately reduce worker exposure cannot be applied at the site where the chemical is being used. Therefore, the Executive Director determines that the risk to human health from the use of the chemical cannot be managed, and the commercial evaluation authorisation is cancelled.

 

 

Division 5 - Exceptional circumstances authorisations

 

Clause 67 - Exceptional circumstances authorisations

 

The Minister can issue an exceptional circumstances authorisation for the introduction of an industrial chemical where the Minister is satisfied that this is necessary in the public interest to address significant risks to human health or the environment. In making a decision, the Minister must consult with the Executive Director.

An example may be 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.

 

The Minister must determine each holder of the authorisation and give each person written notice of the decision and the authorisation. The authorisation will include:

 

·          the proper name of the chemical

·          the period for which the authorisation is in force

·          the scope of the authorisation (for example, the circumstances in which the chemical may be used)

·          any conditions necessary to manage risks to human health or the environment. The conditions might, for example:

-         limit where the chemical can be used

-         limit how the chemical can be used

-         set the maximum volumes or concentration at which the chemical may be introduced and used

-         require treatment of the chemical before it is released into the environment

·          any specific requirements to provide information to the Executive Director in relation to the authorisation.  This may include, for example, a requirement that the authorisation holder provide a list of all locations at which the chemical was applied, or a requirement relating to outcomes of monitoring of the concentration of the chemical in a waterway

·          any other information prescribed by the rules.

 

The Executive Director will publish a notice on the AICIS website for the period in which the authorisation is in force that includes:

 

·          the commonly known name of the industrial chemical

·          that it is an exceptional circumstances authorisation

·          the reasons that an exceptional circumstances authorisation is necessary

·          the period for which the authorisation is in force.

 

Part 4 - Evaluations initiated by Executive Director

 

Division 1 - Simplified outline of this Part  

 

This outline summarises Part 4 of the Bill which sets out two separate processes under which the Executive Director may initiate evaluations: one for industrial chemicals subject to an assessment certificate and one for any other industrial chemicals (or matters relating to industrial chemicals).

 

This Part introduces a new approach to undertake evaluations of any industrial chemicals. This will replace the existing Inventory Multi-tiered Assessment and Prioritisation (IMAP) and Priority Existing Chemical (PEC) processes. The new approach will provide for a more flexible and efficient process for the Executive Director to undertake evaluations and will give regulatory certainty for industry and non-industry stakeholders.

Evaluations for industrial chemicals subject to an assessment certificate must include consultation with the assessment certificate holder(s). In relation to evaluations of other chemicals, the Executive Director can adopt the process most appropriate to the matter under consideration, based on the information available to the Executive Director.

 

In all cases, the outcomes of an evaluation must be reflected in an evaluation statement that will be published on the AICIS website. Where changes are necessitated to assessment certificates, authorisations or Inventory listings further processes must be completed to ensure adequate consultation, transparency, and the continued safe introduction and use of a chemical. These processes are described in Parts 3 and 5 of this Bill.

 

Division 2 - Evaluations of introductions authorised by an assessment certificate

 

Clause 69 - Executive Director may initiate evaluation

 

Where the Executive Director decides to initiate an evaluation of the introduction of an industrial chemical authorised by an assessment certificate, each holder of the certificate must be provided with written notice of the proposed evaluation, the reasons for it, and the period within which the evaluation will be conducted.

 

The Executive Director must consider any risks to human health or the environment associated with the introduction and use, any further information (including submissions) from a certificate holder, and any expert advice from a prescribed body.

 

Clause 70 - Executive Director may require information

 

The Executive Director can, by written notice, call for further information from the assessment certificate holder, and any persons covered by the assessment certificate, for the purposes of the evaluation. A person contravenes this provision is they do not provide the additional information specified in the notice by the deadline stated in the notice (which must be at least 20 working days after the request).  

 

It is anticipated that in some circumstances the Executive Director may not need information from the certificate holder or persons covered by the certificate to complete the evaluation. However, if the Executive Director determines that such information is needed, it must be provided and there are penalties for non-compliance. For example, if information about the hazard of the chemical that was unavailable at the time the assessment was undertaken has come to the attention of the Executive Director, the Executive Director may request further information on use (or exposure) in order to re-evaluate the risks to human health or the environment. This information relating to how the chemical is being used should be readily available to the certificate holder or persons covered by the certificate, because the expectation is that all introducers would know relevant details about the use of the industrial chemical they are introducing.



 

Clause 71 - Consultation with prescribed bodies

 

As part of an evaluation, the Executive Director must consult with prescribed bodies if the Executive Director is considering including, removing or varying a condition of introduction on an assessment certificate on the basis that it is necessary to manage a risk to human health or the environment, or if considering cancelling the certificate on the basis that the Executive Director is not satisfied that the risks to human health or the environment can be managed.

 

As part of an evaluation, the Executive Director may choose to consult with prescribed bodies in other circumstances.

 

Clause 72 - Submissions on draft evaluation statement

 

Each assessment certificate holder must be provided with a draft evaluation statement which will detail matters such as the subject of the evaluation, the parameters of the evaluation, any identified risks to human health or the environment and the proposed means for managing any identified risks.

 

If the certificate holder wishes to respond to the draft evaluation statement, this must be done in writing by the deadline stated in the written notice accompanying the statement (which must be at least 20 working days after the day the notice was given).

 

The Executive Director must consider any submission from the certificate holder in relation to the draft evaluation statement.

 

Clause 73 - Issue of evaluation statement

 

The Executive Director must publish the evaluation statement and provide the evaluation statement to each of the certificate holders.

 

The statement must include:

 

·          the subject of the evaluation. For example, the industrial chemical that was being evaluated

·          the defined scope of the evaluation

·          a summary of the evaluation and any identified risks to human health or the environment identified during the evaluation

·          the proposed means for managing any identified risks. This could include recommendations to risk managers or a proposal to vary the certificate to remove, add or vary conditions or any specific requirements to provide information to the Executive Director.

 

The evaluation statement would not include information that has CBI protections.

 

The evaluation statement will summarise the outcomes of the evaluation but will have no regulatory effect. If the evaluation has highlighted the need for changes to be made to an assessment certificate, this would occur through a subsequent process described in Division 3 of Part 3.

 

Division 3 - Evaluations of other introductions or matters

 

This Division describes the process for any other type of evaluation conducted by the Executive Director. This may include evaluation of an introduction which is a listed, reported, exempted or excluded introduction. It may also include a class of chemicals which may be introduced across multiple introduction categories. For example, if the Executive Director is evaluating a class of chemicals that includes chemicals that are subject to an assessment certificate and other chemicals that are on the Inventory, the process described in the previous Division (for evaluation of chemicals under an assessment certificate) and the processes described under this Division (for evaluation of all other chemicals or matters relating to chemicals) may occur in parallel.

 

Clause 74 - Executive Director may initiate evaluation

 

The Executive Director may initiate an evaluation on matters relating to industrial chemicals not covered by an assessment certificate. An evaluation could relate to a single industrial chemical, or to a broad class of chemicals or circumstance. Some potential examples are:

 

·          hazards to human health or the environment associated with an industrial chemical or class of industrial chemicals. For example, the Executive Director may become aware of new toxicological studies for several health and environmental endpoints which were not available at the time of the last assessment of the chemical and this may prompt an evaluation

·          exposure of humans or the environment to an industrial chemical or class of industrial chemicals. For example, if concerns were raised about the use of a chemical in toys and childcare articles at certain concentration levels, the Executive Director could examine this issue and identify risks of dermal exposure (through normal handling of toys) or oral exposure (through mouthing, sucking and chewing products)

·          a use for an industrial chemical or class of industrial chemicals. For example, the Executive Director may examine all chemicals used as flame retardants

·          the circumstances in which an industrial chemical or class of industrial chemicals is introduced. For example, the evaluation may relate to the nano-form of an industrial chemical where the chemical is introduced for use in leave-on cosmetics.

 

The Executive Director must publish on the AICIS website the subject of the evaluation and reason for it, and the timeframe in which it will be conducted.



 

Example - Circumstances in which the Executive Director may initiate an evaluation

 

There are several circumstances that may give rise to the Executive Director determining that there is a need for an evaluation. For example:

 

·          an international regulator may have advised that a chemical is being prohibited or restricted in another country but the chemical is able to be introduced in Australia without comparable controls

·          new information may become available about risks associated with the chemical and/or form in which a chemical is used, such as the nano-form of a chemical

·          risk managers or other government agencies may identify potential risks associated with a chemical introduction or use and request that the Executive Director undertake an evaluation

·          a member of the public may have requested an evaluation of a chemical or class of chemicals based on concerns about the health or environmental effects of the chemical

·          post-market monitoring of compliance or prioritisation activities may suggest that a chemical introduction should be evaluated.

 

The Executive Director will continually assess incoming information and requests, determine the need for an evaluation, and subsequently prioritise these evaluations. Where the Executive Director determines that an evaluation should be conducted, the Executive Director will publish on the AICIS website the intention to undertake the evaluation

 

Clause 75 - Consultation to inform evaluation

 

As a part of an evaluation the Executive Director may gather information by consulting with bodies defined in the rules, or a particular person, or through a public consultation process . This clause is not limiting and the Executive Director may also undertake other activities to inform the evaluation.

 

Example - Information that may support an evaluation

 

In undertaking an evaluation, the Executive Director would draw on information from a range of sources. For example:

 

·          use of any relevant information available to the Executive Director, including previous assessments by the Executive Director or other national or international bodies

·          literature reviews

·          accessing local and international databases of relevant information including, for example, PubMed, TOXNET, ScienceDirect and SciFinder

·          generating data through computational modelling (e.g. QSAR)

·          receiving information provided by industry on a voluntary basis or because of a mandatory call for information

·          seeking advice from other local, national and international agencies

·          internal or external peer reviews.

Clause 76 - Executive Director may require information

 

The Executive Director may require a person to provide information to inform the evaluation by giving a notice to: all people who have introduced the chemical that is the subject of the evaluation in the last 12 months; or all people who introduce the chemical during the period specified in the notice; or a particular person whom the Executive Director is satisfied would have information relevant to the evaluation. Before giving this notice, the Executive Director must publish on the AICIS website a statement that describes the information that the Executive Director is proposing to request.

 

The notice to the people specified in the paragraph above must include the time within which the information must be provided (which must not be less than 20 working days after the day the notice is given).

 

The Executive Director can only make a request for the mandatory provision of information in limited circumstances: if the information is not otherwise available to the Executive Director, or is necessary to confirm whether or not a chemical is used in Australia, is necessary to establish the risks, or is needed for Australia to meet its obligations under international agreements or arrangements. The rules may prescribe other circumstances.

 

A similar power to make a mandatory call for information exists in the ICNA Act. This has been used rarely and only when the Director of NICNAS cannot obtain the information through other means, or needs the information for the express purposes detailed above. It is expected that the similar power under this Bill would also be used rarely.

 

Example - Circumstance in which the Executive Director may make a mandatory call for information

 

The Executive Director initiates an evaluation of a listed industrial chemical which is known to be used in consumer products overseas, on the basis of information indicating the potential for the chemical to have adverse effects on the reproductive systems of animals.

 

In order to establish the risks to human health arising from the introduction and use of this chemical in Australia, the Executive Director requires information regarding whether the chemical is used for consumer products in Australia, and if so, the concentration levels of the chemical in products. These data would enable the Executive Director to undertake a quantitative risk assessment to determine whether there are risks to human health at the concentrations being used in Australia, and could also be used to inform the means for managing any identified risks. However, the Executive Director is not able to establish the information through other means. For example, the overseas use data do not provide enough information on uses and concentrations; and the major introducers of the chemical in Australia are not known.

                                 

Therefore, the Executive Director provides and publishes a written notice requiring any introducers of the chemical, over a specified timeframe, to provide the data required.

Clause 77 - Person must comply with requirement to provide information

 

A person contravenes this provision if the person has not provided the information in the notice given under clause 76 within the timeframe specified on the notice.

 

Clause 78 - Issue of evaluation statement

 

After completing an evaluation, the Executive Director must publish an evaluation statement on the AICIS website. The statement must contain:

 

·          the subject of the evaluation

·          the parameters of the evaluation (for example, the Executive Director may examine matters such as the use of an industrial chemical in children’s toys or concentration levels over a certain threshold)

·          a summary of the evaluation and any identified risks to human health or the environment identified during the evaluation

·          the proposed means for managing any identified risks

·          any other information relating to the safe introduction and use of an industrial chemical that was a subject of the evaluation

·          the conclusions of the evaluation.

 

The evaluation statement will summarise the outcomes of the evaluation, but will have no regulatory effect. If the evaluation has highlighted the need for changes to an Inventory listing, the process described in Part 5 would apply.

 

Example - Evaluation conclusions

 

The Executive Director may:

 

·          decide to take no further action

·          make recommendations to risk managers

·          propose amending a defined scope of assessment on an Inventory listing (noting that a further process would be conducted to implement such a proposal)

·          propose imposing an obligation for information to be given to the Executive Director in certain circumstances (noting that a further process would be conducted to implement such a proposal)

·          propose adding or amending conditions or on an Inventory listing (noting that a further process would be conducted to implement such a proposal)

·          propose removing a chemical from the Inventory (noting that a further process would be conducted to implement such a proposal), or

·          recommend changes be made to the rules relating to the categorisation of an industrial chemical as exempted or reported.

 



 

Part 5 - Australian Inventory of Industrial Chemicals

 

Division 1 - Simplified outline of this Part  

 

Clause 79 - Simplified outline of this Part  

 

Part 5 establishes the Australian Inventory of Industrial Chemicals (the Inventory). Any registered introducer may introduce industrial chemicals that are listed on the Inventory provided they comply with the terms of the listing. Listings on the new Inventory will increase the transparency of chemicals assessed under Part 3 by including more relevant information and linking the listing to any relevant assessment or evaluation statements. Listings may also have a limited scope of assessment as this ensures that regulatory effort is focused on intended end uses. Introducers may also apply to vary the terms of a listing under this Part.

 

Division 2 - Establishment and contents of Inventory

 

Clause 80 - Establishment of the Inventory

 

The Australian Inventory of Industrial Chemicals (the Inventory) is established. The Executive Director must maintain the Inventory, and must also publish the terms of the listing for each industrial chemical on the Inventory, noting that some information may not be published (or alternative information published) if the information has been approved as CBI. 

 

The clause also states that the Inventory is not a legislative instrument. This is included to assist readers, as the Inventory is not a legislative instrument within the meaning of subsection 8(1) of the Legislation Act 2003 .

 

Clause 81 - Contents of the Inventory

 

Each listing must include the following for the industrial chemical (the terms of the listing):

 

·          the CAS name and CAS number

·          the molecular formula (if defined)

·          any scope of assessment

·          any conditions

·          any specific requirements to provide information to the Executive Director in relation to the introduction of the industrial chemical

·          any other information relating to the industrial chemical that is prescribed by the rules.

 

The Inventory listing must also include the website address where each assessment statement and evaluation statement that has been published for the chemical can be accessed. Links will not be provided to assessment reports issued under the ICNA Act, due to the risk of disclosure of CBI.

 

The CAS name refers to the Chemical Abstracts Index Name and the CAS number refers to the Chemical Abstracts Service Registry Number. A CAS number (also known as a CAS RN) is a well-known concept used internationally to provide a unique identifier for chemical substances. It provides an unambiguous way to identify a chemical substance or molecular structure when there are many possible systematic, generic or proprietary names. While the chemical is listed on the Inventory with a CAS name (which can only be obtained through Chemical Abstracts Service), introducers are not required to provide a CAS name at the time of applying for an assessment certificate. At the time of listing on the Inventory, the Executive Director includes the CAS name and CAS number, which can be obtained by AICIS under an agreement with Chemical Abstracts Service. Any changes to a CAS name or CAS number will occur through a variation to the Inventory listing.

 

The molecular formula of an industrial chemical is usually defined.  However in certain circumstances (for example where a chemical is used as an unisolated complex reaction mixture or made from biological processes that result in numerous slight variations), it is not practical to define a molecular formula.  

 

The defined scope of assessment describes the parameters of the assessment undertaken by AICIS with respect to the industrial chemical.

 

The conditions are on the volume of industrial chemical permitted to be introduced and where the industrial chemical is permitted to be introduced or used. Any other conditions will be prescribed in the rules.

 

A note highlights to the reader that if an application has been approved to treat the proper name of a chemical as CBI, the Executive Director will publish an AACN instead of the CAS name, CAS number and molecular formula. Clause 109 provides further detail. It is also noted that penalties may apply if a person fails to comply with the terms of an Inventory listing when introducing an industrial chemical. Clauses 24 and 25 provide further detail.

 

Division 3 - Inclusion of industrial chemicals on Inventory

 

Clause 82 - Listing on Inventory after 5 years

 

The Executive Director must list a chemical on the Inventory five years after the assessment certificate was issued. Provided that the chemical is not already listed on the Inventory, this will be a new listing. A note advises the reader that if the chemical has already been listed on the Inventory, then, for any subsequent certificate, the existing listing will be varied in accordance with clause 87.

 

Inclusion on the Inventory 5 years after the issue of an assessment certificate is consistent with the existing arrangements under the ICNA Act.

 

However, there are mandatory processes that the Executive Director must follow before listing any industrial chemical on the Inventory. This process includes giving written notice of the proposed listing of the chemical to each assessment certificate holder, and notifying any confidence holders for the same chemical in accordance with the process set out in clause 110.

If no application for continued protection of the proper name or end use for the chemical is made in accordance with clause 111, then Executive Director will deem the protection to be revoked and the chemical will be listed without any CBI protection. Likewise if an application is made for continued CBI protection but this application is unsuccessful, the chemical will be listed on the Inventory without CBI protection.

 

Having undertaken the relevant notification, the Executive Director must publish a notice on the AICIS website that sets out the terms of the listing, the reason the chemical was listed, and the day on which it was listed (which must be done within 20 working days after the day the chemical is listed).

 

Clause 83 - Listing on Inventory before 5 years

 

A holder of an assessment certificate can apply for an earlier listing on the Inventory. This process is currently available under the ICNA Act for chemicals other than those for which listing on the confidential section of the Inventory is sought. The industrial chemical must not already be listed, nor should the certificate have conditions on how long the chemical is permitted to be introduced.

 

The Executive Director must give written notice to any other holders of certificates for the same industrial chemical as well as any confidence holders. The written notice must state that an application has been made to list the chemical on the Inventory, that the person has the right to object in writing, and that any such objection must be given within the timeframe specified in the notice (which must be a minimum of 20 working days after the day the notice is given). 

 

If an objection is made the Executive Director must not list the chemical on the Inventory. The Executive Director must notify the applicant that an objection has been made and the chemical will not be listed early.

 

If no objections are made, the Executive Director will list the chemical on the Inventory and publish a notice on the AICIS website containing the terms of the listing, the reason the chemical was listed, and the day on which it was listed. This must be done within 20 working days after the day the chemical is listed.

 

Clause 84 - Listing on Inventory in other circumstances

 

The Executive Director may list a chemical currently in use in Australia on the Inventory if it was previously regulated under another Commonwealth law, there is no assessment certificate in force for the chemical and the Executive Director has completed an evaluation of the chemical under Part 4, concluding that the risks to human health and the environment from the introduction and use of the chemical can be managed.



 

Example - Listing a previously regulated chemical

 

A chemical—glycine, N-Acetyl-N-[3-(trifluoromethyl)phenyl]valyl-  —was previously regulated by the Therapeutic Goods Administration is proposed to be transferred to AICIS because its use is no longer considered to be a therapeutic use. An evaluation of the chemical is conducted to determine the complete chemical identity of the chemical, that the chemical is not currently listed on the Inventory, it is in use in Australia, there is no assessment certificate in force for the chemical and that the health and environmental risks, if any, can be managed under the regulatory controls available for the management of the risks arising from the use of the chemical. Once the evaluation is finalised the chemical is transferred to the Inventory.

 

 

If as part of an evaluation the Executive Director finds that an incorrectly identified chemical, for which there is no assessment certificate, is on the Inventory, the Executive Director can add the correct industrial chemical, and can also remove the misidentified industrial chemical.

 

The Executive Director must publish a notice on the AICIS website containing the proposed terms of the listing, the reasons the chemical is proposed to be listed, and the day on which the chemical is proposed to be listed (which must be done within 20 working days of the day before the day proposed to list the chemical).

 

Division 4 - Varying the Inventory

 

Subdivision A - Variation on Executive Director’s initiative and variation relating to subsequent assessment certificates

 

Clause 85 - Minor variations

 

The Executive Director may make minor variations to a term of a listing if the Executive Director is satisfied that the listing contains errors, defects or is incomplete in some way, or additional information should be included in the listing. 

                                                                                       

The Executive Director must publish a notice on the AICIS website containing the terms of the listing as varied, the reason the listing was varied, and the day on which it was varied (which must be done within 20 working days after the day the listing was varied). There is no requirement to publish this in advance of the variation because the variation has no regulatory impact. This means that the variation will not have an impact on the introduction of a chemical that may be occurring in accordance with the terms of the listing.

 

Clause 86 - Variations following an evaluation by the Executive Director

 

T he Executive Director can vary a term of an industrial chemical listing if the Executive Director has initiated an evaluation, conducted public consultation as part of the evaluation, and concluded that variation is needed to manage the risks to human health or the environment from the introduction or use of the chemical.

 

The Executive Director must publish a notice on the AICIS website containing the terms of the listing as varied, the reason the listing is to be varied, and the day on which it was varied (which must be done at least 20 working days before the listing will be varied).

 

Clause 87 - Variations relating to subsequent assessment certificates

 

This clause applies if an industrial chemical is listed on the Inventory under clause 82 or clause 83 (in relation to an assessment certificate) and another certificate is in force for the same chemical. A number of assessment certificates in force for the same industrial chemical may cover a range of end uses, or the same end use or uses. The intention is that there will be one Inventory listing for a particular industrial chemical. This means that a listing on the Inventory will potentially include a number of end uses and will potentially be linked to a number of assessment statements.

 

The Executive Director can vary an existing listing to take into account any terms from another certificate, either at the time a certificate is due to be listed or if the holder requests an earlier listing. Before making a variation, the Executive Director must give written notice of the proposed variation to each holder of the other assessment certificate and any other person prescribed by the rules. This may include, for example, confidence holders across multiple certificates where relevant. The Executive Director must publish a notice on the AICIS website containing the terms of the listing as varied (which may include more than one term), the reason the listing is to varied, and the day on which it was varied (which must be done within 20 working days after the day the listing was varied).

 

Subdivision B - Variation on application

 

Clause 88 - Applying for variation of listing

 

A person may apply to the Executive Director to vary a term of a listing for an industrial chemical. The terms of a listing that may be varied include the defined scope of assessment and conditions of introduction.

 

Example - Variation of a term of a listing

 

A chemical is listed on the Inventory with a defined scope of assessment of use in surface coatings. This would mean that the risks from the use of the chemical in surface coating have been assessed by the Executive Director.  Another introducer may subsequently wish to introduce the chemical for a use other than in surface coating. This would be outside its defined scope of assessment. The new introducer would use the rules to determine the appropriate category of introduction. If the new use does not meet the criteria for the exempted or reported categories, the introducer is required to make an application to the Executive Director to vary the defined scope of assessment of the chemical on the Inventory, and must not introduce the chemical until that has occurred.

 



 

Clause 89 - Executive Director must consider application

 

The Executive Director must consider an application to vary an Inventory listing, and must assess the application and make a decision within 70 working days from the day after the application was made. The exceptions to this are if the rules prescribe a specific number of working days for that type of application, or if the Executive Director and each applicant agree to another number of working days.

 

The Executive Director must have regard to any risks to human health or the environment associated with the proposed variation, any information from the applicant, or any advice from a prescribed body or the Gene Technology Regulator.

 

Clause 90 - Executive Director may request further information

 

The Executive Director may request further information from the applicant for the purposes of considering the application. The applicant must provide the information within the timeframe stated in the notice (which must be at least 20 working days after the day the notice was given). If it is not provided in this timeframe, the Executive Director may take the application to be withdrawn.

 

The applicant and Executive Director may negotiate an extended timeframe. This will be achieved administratively through a variation to the written notice or issue of a new notice.

 

Clause 91 - Consultation with prescribed bodies

 

The Executive Director must consult with prescribed bodies if considering including, removing or varying a condition on an Inventory listing on the basis that it is necessary to manage risks to human health or the environment, or if considering not varying a term of the listing on the basis that the Executive Director is not satisfied that the risks to human health or the environment associated with the variation can be managed.

 

The Executive Director may also consult with prescribed bodies in other circumstances.

 

Clause 92 - Consultation with Gene Technology Regulator

 

The Executive Director must consult with the Gene Technology Regulator if the chemical listed on the Inventory (and for which the variation is sought) is a genetically modified product.

 

Clause 93 - Decision on application

 

After considering the application, the Executive Director must decide whether or not to vary the term of the listing. The Executive Director must be satisfied that any risks to human health or the environment can be managed and that the scope of industrial chemical introductions authorised by the listing will not be reduced. If not, the Executive Director must refuse to vary the term of the listing.

 

The Executive Director must notify each applicant of the decision and provide each with the assessment statement. The Executive Director must publish a notice on the AICIS website containing the term (or terms) of the listing as varied, the reason the listing was varied, and the day on which it was varied (which must be done within 20 working days of the day after the listing was varied). The Executive Director must also publish an assessment statement on the AICIS website.

 

A decision to not vary the terms of an Inventory listing is subject to reconsideration and review rights under clause 166.

 

Subdivision C - Variation following revocation of confidential business information approval

 

Clause 94 - Variation following revocation of confidential business information approval

 

The Executive Director can vary a term of a listing for an industrial chemical if the Executive Director revokes the approval for continued CBI protection.

 

Before revoking CBI approval, the Executive Director must ensure that all the requirements described under clause 111 have been met, including notice of the Executive Director’s decision having been given to the relevant persons, and review rights in relation to a decision to revoke the approval having been exhausted or expired.

 

The Executive Director must publish a notice on the AICIS website containing the terms of the listing as varied, the reason the listing was varied, and the day on which it was varied (which must be done within 20 working days of the day after the listing was varied).

 

Subdivision D - Removing listed industrial chemicals

 

Clause 95 - Removing listed industrial chemicals

 

The Executive Director can remove a chemical from the Inventory if the Executive Director has conducted an evaluation under Part 4, including public consultation, and has concluded that the risks to human health or the environment from the introduction or use of the chemical cannot be managed. The Executive Director can also remove a chemical that has been wrongly listed on the Inventory.

 

The Executive Director must publish a notice on the AICIS website stating the reason the chemical is to be removed and the proposed date for the removal, which must be done at least 20 working days before the proposed date of removal.



 

Example - Removing a listed industrial chemical

 

In some instances a chemical may no longer be correctly listed on the Inventory. This might occur when refinements to the analytical process results in more specific information on the particular chemical. For example, if the starting material in the manufacture of a polymer was determined to contain branched alkyl nonyl phenols and not linear alkyl phenol components as initially understood, the resulting polymer is different to the chemical name and CAS number that was listed on the Inventory.

The introducer therefore provides a polymer name and CAS number that more precisely describes the polymer, and requests that the chemical identity be updated.

 

The Executive Director’s public notice will ensure that others also introducing this polymer are made aware of these changes.

 

 

Part 6 - Information, reporting and confidentiality

 

Division 1 - Simplified outline of this Part

 

Clause 96 - Simplified outline of this Part

 

Part 6 sets out matters relating to the information and reporting obligations of people introducing industrial chemicals, and the circumstances in which a person may seek to have information provided to the Executive Director treated as confidential business information (CBI). In summary, Part 6 includes matters such as:

                                                 

·          a once-off pre-introduction report given to the Executive Director prior to introducing an industrial chemical via the reported category

·          an annual declaration relating to introductions made during a registration year, and the category of those introductions

·          reporting to the Executive Director in circumstances where new hazard information becomes available after the industrial chemical has been assessed by the Executive Director

·          reporting on specific information required by an assessment certificate, commercial evaluation authorisation or Inventory listing

·          the keeping of records to support the categorisation of chemicals

·          the arrangements for applying to have information provided to the Executive Director treated as CBI

·          the limited circumstances in which CBI may be disclosed.

 

The new approach to CBI balances transparency and increased public availability of information with the protections for confidential information for businesses, by allowing applicants to seek to partially mask the proper name or specific end use of an industrial chemical. If an application for CBI satisfies the public interest test (applied by the Executive Director at the time of application and reviewed every five years, as a general rule), the Executive Director may approve an AACN (for proper name) or generalised end use (for end use) for the chemical. This will replace the confidential section of the Inventory under the ICNA Act.

Division 2 - Reporting

 

Clause 97 - Pre-introduction reports for reported introductions

 

A pre-introduction report must be given to the Executive Director before a reported introduction is authorised. This will be a once-off report made by an introducer in relation to a particular industrial chemical to be made before the person introduces the chemical. There will be an annual obligation to declare that the introduction continues to align with the pre-introduction report. The pre-introduction report will be submitted electronically in the approved form, and can be updated by the introducer over time.

 

The rules may prescribe what the pre-introduction report will contain. For example, the rules may require the report to include: the proper name of the chemical; its proposed use; and the information used by the person in concluding that the proposed introduction is a reported introduction. However, for some types of reported introductions, the rules may provide that certain information is instead to be given to the Executive Director within 12 months after the day the person first introduces the chemical. For example, the rules may provide that while critical information (such as information about the chemical and its proposed introduction) must be provided prior to introduction, more specific information about, for example, the hazards of the chemical could be provided within 12 months of the initial pre-introduction report being submitted.

 

The Executive Director may publish information relating to the reported introduction on the AICIS website, if the information is of a kind prescribed by the rules. An introducer of higher risk chemicals that are reported introductions because they are supported by international assessments (as prescribed in the rules), may be required to provide additional information to the Executive Director as part of the pre-introduction report. The Executive Director may also publish information relating to these introductions to ensure that there is transparency about the chemicals being introduced via this international pathway (subject to CBI protections).

                                                                                   

Clause 98 - Varying the terms of a pre-introduction report

 

A person may vary a pre-introduction report via the AICIS online system. This will be effective immediately.

 

Clause 99 - Annual declaration for all introduction categories

 

All registrants must make an annual declaration to the Executive Director. This must occur in either the final month of the registration year, or before the end of the first three months of the next registration year. The declaration must be in the approved form and contain the information prescribed by the rules.

 

A registrant will make one electronic annual declaration that will cover all their introductions for the year.



 

Example - Types of matters to be included in annual declaration

 

Some of the types of matters that may be included in an annual declaration include:

 

·          a declaration about exempted introductions. For example, whether such introductions have occurred, and confirming that the relevant criteria are satisfied (tick boxes); and

·          a declaration about reported introductions. For example, confirming relevant criteria continue to be satisfied (tick box).

·           

 

The clause describes some possible consequences of non-compliance with the requirement to submit an annual declaration, which includes a criminal or strict liability offence or liability to pay a civil penalty.

 

Clause 100 - Obligation to report information about hazards

 

People introducing, or proposing to introduce, industrial chemicals have obligations to report information about the hazards of an industrial chemical that they have become aware of since the most recent assessment or evaluation statement relating to the introduction was published. This obligation applies to a person who holds, or is covered by, an assessment certificate, or a person who has introduced a listed industrial chemical within the last 12 months, for which there is an assessment statement or evaluation statement.

 

If a person becomes aware, after the most recent assessment or evaluation statement has been published, of information about a new or increased hazard to human health or the environment from the introduction or use of the chemical they must report this to the Executive Director within 20 working days of becoming aware of the information. Failing to do so contravenes this clause.

 

The clause describes some possible consequences of non-compliance, which includes a criminal or strict liability offence or liability to pay a civil penalty.

 

Example - Obligation t o report information about hazards

 

An introducer applies for an assessment certificate for a new chemical to be used in leave-on cosmetics. The introducer would provide the information prescribed in the rules. The Executive Director would rely on this information when assessing the risks to human health and the environment relating to its use in leave-on cosmetics. An assessment statement will be published, which may include recommendations to manage potential risks.

 

Subsequent to the decision to issue the certificate, the certificate holder becomes aware of further hazard information which shows that the chemical has the potential to cause skin allergies (i.e. skin sensitisation). As this hazard had not been taken into account during the original risk assessment by the Executive Director, the certificate holder is required to provide this information to the Executive Director within 20 working days of becoming aware of the information, and offence and civil penalties apply if the person does not provide such known information.

 

This new information may trigger an Executive Director initiated evaluation under Part 4, which may then lead to further recommendations being made to manage this new risk.

 

 

Clause 101 - Specific obligations to provide information

 

People introducing industrial chemicals that are subject to a specific information obligation must report certain information to the Executive Director. A person contravenes this clause if a person:

 

·          is the holder of, or covered by, an assessment certificate that includes a specific requirement to provide information to the Executive Director, and the person fails to do so

·          is the holder of a commercial evaluation authorisation or exceptional circumstances authorisation which includes a specific requirement to provide information to the Executive Director, and the person fails to do so

·          introduces a listed industrial chemical where the terms include a specific requirement to provide information to the Executive Director, and the person fails to do so.

 

Example - Specific information obligation - Inventory listing

 

A chemical listed on the Inventory is evaluated under Part 4, and during that evaluation it becomes apparent that the chemical is restricted for use in cosmetics overseas due to the risks to human health. The Executive Director’s evaluation establishes that the chemical is being used for other uses in Australia, but not cosmetics. The Executive Director decides to apply a specific information obligation to the Inventory listing of the chemical such that if it is to be introduced for use in cosmetics, the introducer would need to make the Executive Director aware of this. It this occurs, the Executive Director could then decide whether there was a need to initiate a further evaluation of this chemical so that appropriate requirements could be put in place to manage the risks to human health.

 

 

Example - Specific information obligation - Assessment certificate

 

An application for an assessment certificate is made for a chemical that is part of a class of chemicals that is becoming an emerging concern for risks to the environment.

 

As a result of an evaluation, the Executive Director decides to made recommendations to manage the currently identified risks. In addition, given the emerging concerns for this class of chemicals, a specific information obligation is applied to the certificate such that if new information becomes available to the certificate holder in regard to these emerging concerns, they must provide that information to the Executive Director.

 

If such information did become available, the Executive Director could then decide that the new information warrants an evaluation of the chemical. Such an evaluation could result in variations to the terms of the certificate, or further recommendations on managing the risks to the environment.

 

 

Division 3 - Record keeping and information gathering

 

Clause 102 - Information required to demonstrate categorisation

 

Introducers are required to have regard to certain information when categorising a chemical. The information to which an introducer must have regard will be specified in rules (and the rules may prescribe different requirements for different categories of introduction). If the Executive Director requests the person to demonstrate that they have had regard to the relevant information, the person must provide the relevant information within 20 working days of the request.

 

Failing to have regard to the required information or failing to provide relevant information to the Executive Director when requested exposes the person to liability for an offence or civil penalty.

 

Examples - Information required to demonstrate categorisation 

 

The rules will prescribe the information requirements to demonstrate the categorisation of an industrial chemical, which are proportionate to the anticipated exposure arising from the proposed end-use and introduction volume. The types of required information may include:

 

·          chemical identity information (e.g. proper chemical name (CAS or IUPAC name), CAS number)

·          physico-chemical properties (e.g. partition coefficient)

·          hazard information (e.g. known hazard classifications, information regarding the chemical’s potential for human health hazards such as skin irritation, acute toxicity, mutagenicity, information regarding the chemical’s potential for impacts on the aquatic environment such as toxicity to fish, aquatic invertebrates and algae)

·          introduction/use/exposure information (e.g. introduction volume, end-use, introduction and use concentrations).

 

 

Clause 103 - Ban on animal test data for determining category for cosmetics

 

A person must not use test data obtained from tests conducted on animals on or after 1 July 2018 for determining the category of introduction for an industrial chemical to be used solely in cosmetics. It is proposed that the rules will limit the circumstances in which animal test data may continue to be required to be submitted to the Executive Director to ensure the protection of human health or the environment.

 

Clause 104 - Record keeping for all categories

 

Record keeping obligations apply for all categories of industrial chemical introduction, with penalties for non-compliance. 

 

Specifically a person who has introduced an industrial chemical must keep records on the chemical introduced, the category of introduction, the basis for determining the category of introduction, the amount of registration charge payable, and any other records prescribed by the rules. These records must be kept for five years after the end of the registration year.

 

If the Executive Director requires, by written notice, a person to provide records, the person must provide the specified records within 20 working days of the request. Failing to provide the records to the Executive Director when requested exposes the person to liability for an offence or civil penalty.

 

Division 4 - Confidentiality and disclosure

 

NICNAS frequently receives information from businesses that, if disclosed, could cause commercial harm to those businesses. Such information commonly includes the identity of an industrial chemical and the precise details about its use, such as the function of the chemical in a product or the exact concentration in which it is being used. Under the new scheme, it is expected that AICIS will continue to receive such information. The legislation therefore provides a mechanism to protect confidential business information provided that a threshold test is met. This test is commonly referred to as the public interest test, which the Executive Director applies to determine whether commercial prejudice that is reasonably likely to be suffered by the holder of the confidence if the information is disclosed outweighs the public interest in the publication of the information.

 

Subdivision A - Confidentiality of proper name or end use in certain circumstances

 

Clause 105 - Applying for protection

 

A published assessment statement contains the proper name of the chemical and the use for which it has been assessed for introduction. A person may apply to the Executive Director for the proper name or end use of an industrial chemical (or both) to be treated as CBI. A separate application for each must be made, and the application for CBI must be made at the time the information is submitted as part of:

 

·          for a proper name:

­    an application for an assessment certificate for the industrial chemical under clause 31

­    an application for a commercial evaluation authorisation for the industrial chemical under clause 53

­    a pre-introduction report for the industrial chemical under clause 97 that contains information that may be published

­    other circumstances described in the rules

·          for an end use:

­    an application for an assessment certificate for the industrial chemical under clause 31

­    an application for a commercial evaluation authorisation for the industrial chemical under clause 53

­    a pre-introduction report for the industrial chemical under clause 97 that contains information that may be published

­    an application under clause 43 to vary the end use specified in an assessment certificate for the industrial chemical

­    an application under clause 88 to vary the end use specified in the Inventory listing for the industrial chemical

­    other circumstances described in the rules.

 

In addition, a person may apply to the Executive Director for an end use of an industrial chemical to be treated as CBI when the information is submitted as part of:

 

The rules may prescribe other circumstances in which a person may apply for the proper name or end use of an industrial chemical to be treated as CBI. For example, if a person submits information as part of a mandatory call for information, they may wish to seek an AACN for that particular chemical should the Executive Director consider publishing the proper name of the chemical in an evaluation statement. The rules will enable applications for CBI protection to be made in these circumstances.

                                                                                                                   

An application may be made by two or more persons.

 

In determining whether or not to approve CBI protections, the Executive Director must have regard to:

 

­    whether publication of the proper name or end use (as the case requires) for the industrial chemical could reasonably be expected to substantially prejudice the commercial interests of an applicant

­    whether the prejudice outweighs the public interest of having this information in the public domain

­    any additional information from the applicant

­    any advice from a body prescribed in the rules (such as a risk manager).

 

Example - Request for protection of proper name

 

Companies may wish to claim elements of a chemical name as CBI to prevent competitors from using the same cutting-edge chemical. For example, a printing ink manufacturer may hold a significant market share for a particular product which produces the highest resolution relative to its competitors. Revealing the full chemical name may enable competitors to replicate the product, resulting in loss of annual sales revenue to the original introducer.

 

Another example relates to polymers. Providing the full name of the polymer may reveal a novel element of the structure, and reveal a function of its use where there is competitive advantage. Revealing the full chemical name could result in competitors being able to replicate the novel element of the product resulting in loss of annual sales revenue. These features of a chemical will be able to be partially masked via an AACN so that the entire chemical structure need not be confidential.

Example - Request for protection of end use details

 

Providing detailed use information, such as detailed operation descriptions, can expose functions of the chemical which provide its competitive advantage. Some details may also provide information on possible chemical structure. This would give competitors an advantage in replicating the product. Companies may therefore wish to seek CBI protection for the precise end use for which the industrial chemical will be applied.

 

 

Clause 106 - Executive Director may request further information

 

The Executive Director may request in writing further information from the applicant for the purposes of considering the application. The applicant must provide the additional information requested in the notice by the deadline stated in the notice (which must be at least 20 working days after the day the notice was given). If the information is not provided, the Executive Director may take the application to be withdrawn.

 

The applicant and Executive Director may negotiate an extended timeframe. This will be achieved administratively through a variation to the written notice or issue of a new notice.

 

Clause 107 - Consultation with prescribed bodies

 

The Executive Director may consult a prescribed body to help inform the public interest test, by consulting on the level of chemical identity disclosure required for effective risk management under their framework.

 

Clause 108 - Decision on application

 

The Executive Director must decide whether or not to approve an application for CBI. The Executive Director must then give written notice of the decision to each applicant.

 

If the decision is to approve CBI protection for the proper name of an industrial chemical, the Executive Director must determine an AACN and the circumstances in which the AACN will be published in lieu of a proper name, CAS name, CAS number or molecular formula. The rules may prescribe circumstances when an AACN must be published instead of the proper name for an industrial chemical.



 

Example - Use of AACN

 

Details without an AACN

 

CAS Number:                         957787-76-7

Proper name of chemial:         1,6-Hexanediamine, N1,N6-bis(1,2,2-trimethylpropyl)-

Molecular Formula:                 C18H40N2

Defined scope of assessment: Importation in volumes up to 10 tonnes per year, for use in industrial surface coatings, including for coating pipes not intended for potable water sources.

 

Details with an AACN

 

CAS Number:                         Confidential

AACN:                                   1,6-Hexanediamine, N1,N6-bis(alkyl)-

Molecular Formula:                 Confidential

Defined scope of assessment: Importation in volumes up to 10 tonnes per year, for use in industrial surface coatings, including for coating pipes not intended for potable water sources.

 

 

If the decision is to approve CBI protection for the end use for an industrial chemical, the Executive Director must determine a generalised end use for the industrial chemical that would be used in lieu of the specific end use. It would also be used in lieu of the specific end use for the industrial chemical in relation to a listing on the Inventory. The rules may prescribe circumstances when a generalised end use must be published instead of the specific end use for an industrial chemical.

 

A decision to not approve an application for information to be treated as confidential business information is subject to reconsideration and review under clause 166. The Executive Director must not publish the proper name or end use (as the case requires) for the industrial chemical unless the reconsideration and review rights have been exhausted or have expired

 

Example - Generalised end use

 

End use

 

Defined scope of assessment: Importation in volumes up to 10 tonnes per year, for use in industrial surface coatings, including for coating pipes not intended for potable water sources.

 

Generalised end use

 

Defined scope of assessment: Importation for use in industrial surface coatings

 



 

Clause 109 - When an AACN or generalised end use must be used

 

If the Executive Director approves the protection of CBI for the proper name or end use of an industrial chemical under clause 108, then until that approval is revoked (or taken to be revoked), the Executive Director must (as the case requires):

 

·          publish an AACN for an industrial chemical in lieu of the proper name (including CAS name, CAS number or molecular formula)

·          publish a generalised end use for an industrial chemical in lieu of the end use for an industrial chemical

·          any other circumstances prescribed by the rules (for both AACN and generalised end use applications).

 

However, this requirement is subject to Subdivision C which enables the Executive Director to disclose CBI in certain limited circumstances to the people or entities identified in that Subdivision. It also applies despite any other provision in the Act which requires the proper name (including CAS name, CAS number or molecular formula) or end use of the industrial chemical to be published.

 

To avoid doubt, even if the details on the Inventory listing have an AACN or generalised end use for the purposes of publication, the terms of the listing are unchanged. This ensures that if, for example, the defined scope of assessment reflects a generalised end use, any introducer must comply with the actual term of the listing, which may be narrower in scope (because it is not generalised). The introducer will know the actual term of the listing because they are the CBI holder, or because they are a bona fide inquirer and AICIS will have confirmed whether their proposed introduction is consistent with the specific end use defined in the scope of assessment in the terms of the listing (as opposed to the generalised end use that is published).

 

Clause 110 - Notice of review of protection

 

A review of CBI will occur after five years have passed since the CBI was approved.

 

The Executive Director must give written notice to each confidence holder, or each person prescribed in the rules, that the CBI protection will be revoked unless the confidence holder applies to continue the CBI protection.

 

A review of the CBI protections will also be triggered if five years have passed since the Executive Director last reviewed the CBI protections, or if circumstances described in the rules have occurred. For example, the rules could provide that, if the Executive Director initiates an evaluation and determines that CBI should be released to inform the public about risks to health and the environment, this could potentially trigger a review of the CBI protections.

 

Clause 111 - Applying for continued protection

 

A confidence holder may apply to the Executive Director to continue the approval for an AACN or generalised end use. An application must be made within the period specified in the notice given under clause 110. If no application for continued CBI protection is made within the period specified in the notice, the approval of CBI is taken to be revoked on the day after the end of that period.

 

In considering any application the Executive Director must have regard to:

 

­    whether publication of the proper name or end use (as the case requires) for the industrial chemical could reasonably be expected to substantially prejudice the commercial interests of any applicant

­    whether the prejudice outweighs the public interest in publishing the proper name or end use (as the case requires) for the industrial chemical

­    any additional information from the applicant

­    any advice from a prescribed body.

 

The Executive Director must decide whether or not to revoke the approval. The Executive Director must give written notice of the decision to each confidence holder.

 

A decision to revoke an approval to treat information as confidential business information is subject to reconsideration and review under clause 166. The Executive Director must not publish the proper name (including the CAS name, CAS number or molecular formula) or end use (as the case requires) until the confidence holder’s reconsideration and review rights have been exhausted or have expired.

 

Subdivision B - Confidentiality of information in other circumstances

 

While the previous Subdivision deals with applications for CBI protection for the proper name and end use of a chemical, this Subdivision deals with applications for protection of all other information that may be considered confidential by a business.

For example, a person may submit, as part of an application or in response to an evaluation being undertaken by the Executive Director, information about the chemical that may include test data or information about the manufacture of the chemical, or other information that the person may consider to be confidential commercial information. In most cases this information would not be published by the Executive Director because it will not be required to be published as part of an assessment statement or evaluation statement. However, there may be some circumstances in which the Executive Director seeks to publish the information to inform the public of risks human health or the environment associated with a particular industrial chemical.

 

Rather than the Executive Director assessing every piece of information that is submitted in confidence by a person and determining whether or not it should be treated as CBI, when in most cases the Executive Director would not be publishing the information in any event, the legislation instead provides that a person can flag that information is confidential at the time they submit the information. It is only if the Executive Director later proposes to disclose the information that the Executive Director would notify the applicant that they can apply for the information to be protected from disclosure, and a decision made by the Executive Director under the public interest test.



 

Clause 112 - Providing notice of intention to apply for protection

 

When a person gives information to the Executive Director, for example because of a voluntary or mandatory call for information, the person may indicate, in writing, that some or all of the information given is to be treated as confidential. This written notice must be made at the same time that the information is given to the Executive Director. The Executive Director must not publish this information while a decision on an application for confidentiality is pending under clauses 113 and 114.

 

Clause 113 - Notice of intention to publish information must be given

 

If the Executive Director later proposes to publish the information flagged as confidential, the Executive Director must notify the person who provided the notice of the intention to publish information. This person may then apply for the information to be treated as CBI. This application, which may be a joint application, must be made by the deadline stated in the notice, which must be at least 20 working days after the day the notice is given.

 

If there is no application within the period specified in the notice, the Executive Director may publish the information.

 

Clause 114 - Decision on application

 

The Executive Director must decide whether or not to approve an application to treat the information as CBI. In making this decision, the Executive Director must consider whether any prejudice to the commercial interests of an applicant (that would flow from disclosing the information) outweighs the public interest in disclosure.

 

A decision to approve the application to treat the information as CBI means that the Executive Director cannot publish the information or disclosed it, except in the circumstances described in Subdivision C.

 

A decision to not approve an application for information to be treated as confidential business information is subject to reconsideration and review under clause 166. The Executive Director must not publish or disclose the information until reconsideration and review rights in relation to the decision have been exhausted or have expired.

 

The Executive Director must provide written notice of the decision to each applicant.

 

This clause specifically precludes the following information from being eligible to be protected information (CBI):

 

·          an AACN or generalised end use

·          physical and chemical data about an industrial chemical that does not reveal the industrial chemical’s composition

·          summaries of data relating to the risk to human health or the environment from the introduction and use of the industrial chemical.



 

Subdivision C - Disclosure of information  

 

Clause 115 - Disclosing information

 

A person contravenes this provision if a person who is, or has been, an entrusted person who has obtained protected information in their capacity as an entrusted person, discloses this information to another person in a way that is not authorised by, or in compliance with, the Act, another Commonwealth law, or a law of a State or Territory prescribed by the rules. They may be subject to a fault-based offence, strict liability offence or a civil penalty. Relevant defences will be available.

 

An entrusted person is any of the following:

 

·          the Executive Director

·          a person made available to assist the Executive Director under clause 153 or 154

·          the Secretary of the Department

·          an APS employee in the Department

·          any other person employed or engaged by the Department

·          a person employed, under section 13 or 20 of the Members of Parliament (Staff) Act 1984 , as a member of staff of the Minister.

 

Protected information is information which the Executive Director has decided to be treated as confidential business information. That is, an approved AACN or a generalised end use (or a decision pending approval) under clause 108; or other information notified under clause 113 that has either been approved (clause 114) or is still being deemed as confidential information because the Executive Director has not yet decided to publish any of that information.

 

This clause does not apply to the extent (if any) that it would infringe any constitutional doctrine of implied freedom of political communication.

 

Clause 116 - Disclosure in the course of exercising powers, or performing functions or duties

 

An entrusted person may disclose protected information, subject to Subdivisions A and B, when exercising powers, or performing functions or duties under the Act.

 

Clause 117 - Disclosure to certain other entities

 

The Executive Director may disclose protected information to specific entities (including those prescribed in the rules) when the Executive Director is satisfied that the information will help the entity to exercise its powers, or perform its functions or duties.

 

The clause also prohibits further disclosure of information by entities to whom the information has been disclosed, unless the disclosure is for the purposes of the entity exercising the powers or performing the functions or duties for which the information was disclosed by the Executive Director.



 

Clauses 118 to 123 - Disclosure in certain circumstances

 

An entrusted person may disclose protected information:

 

·          that relates to the affairs of a person if that person has consented to the disclosure and the disclosure is done in the way consented to (clause 118)

·          when it has already been lawfully made available to the public (clause 119)

·          about an industrial chemical to a person if the chemical is listed on the Inventory and the Executive Director is satisfied that the person intends to introduce the chemical and the disclosure is necessary for the safe introduction and use of the industrial chemical. The person intending to introduce the chemical must apply to the Executive Director, in writing, for access to the protected information (clause 120)

·          to the person whom the information relates (clause 121)

·          to the person from whom the information was obtained (clause 122)

·          for the purposes of proceedings before, or by order of, a court, tribunal, authority or person that has the power to require the answering of questions or the production of documents (clause 123).

 

Clause 124 - Disclosure for the purposes of law enforcement

 

The Executive Director may disclose protected information to a Commonwealth, State or Territory law enforcement agency, authority or service on the basis of a reasonable belief that disclosure of the information is necessary to enforce the criminal law, or a law imposing a pecuniary penalty, or to protect the public revenue.

 

Clause 125 - Disclosure to reduce serious risk to public health and

Clause 126 - Disclosure to reduce serious risk to the environment

 

The Executive Director may disclose protected information if the Executive Director reasonably believes that the disclosure is needed to prevent or reduce a serious risk to public health or to the environment.

 

Part 7 - Enforcement

 

Division 1 - Simplified outline of this Part

 

Clause 127 - Simplified outline of this Part

 

This clause summarises the provisions in Part 7. This Part gives the Executive Director and authorised inspectors certain monitoring, inspection and enforcement powers in accordance with the Regulatory Powers (Standard Provisions) Act 2014 (the Regulatory Powers Act), which gives a framework of standard regulatory powers.

 

A key element of the industrial chemicals reforms is to reduce pre-market barriers to the introduction of safer new chemicals, balanced by a greater focus on post-market monitoring and enforcement. For this approach to be effective, AICIS needs a wide range of powers to identify and address non-compliance and to align the severity of the penalty to the seriousness of the non-compliance.

 

The Regulatory Powers Act describes a standardised approach for the drafting of provisions relating to monitoring, investigations, civil penalty provisions, infringement notices, enforceable undertaking, and injunctions.

 

Division 2 - Monitoring and investigation powers

 

Clause 128 - Monitoring powers

 

The provisions of the Act are subject to monitoring under Part 2 of the Regulatory Powers Act (as are offences against the Crimes Act 1914 or the Criminal Code that relate to this Act). Part 2 of the Regulatory Powers Act describes:

 

·          the circumstances in which an authorised person may enter any premises and exercise monitoring powers for determining whether a provision is being complied with and for determining whether information (that is subject to monitoring) is correct

·          the monitoring powers that may be exercised by an authorised person. For example, they may search premises, observe activity, inspect documents, take copies of documents etc.

·          arrangements for dealing with electronic equipment and securing evidence; and

·          powers to ask questions and request documents.

 

Necessity for monitoring powers

 

It is important that the Executive Director (and authorised inspectors) have monitoring powers under the Act because:

 

·          the regulatory scheme is designed to protect public health and safety. It does this by placing risk-based controls on the industrial chemicals that may be introduced into Australia and the circumstances in which they may be introduced. If the Executive Director and authorised inspectors do not have the power to monitor compliance with these requirements then the safeguards provided by the Act are not achieved

·          the reforms to the regulation of industrial chemicals (reflected in the Bill) are designed to implement a risk-based regulatory scheme such that pre-market assessment of chemicals can be reduced (or removed) for safer, low risk chemicals and only higher risk chemicals require pre-market assessment by the Executive Director. In reducing pre-market controls, the scheme depends on the Executive Director and authorised inspectors having the capacity to monitor the introduction and use of chemicals that are introduced into the Australian market based on self-assessment by introducers. An essential element of these controls is the capacity for AICIS to effectively monitor compliance

·          the monitoring powers described in this Bill reflect the powers currently available to NICNAS to monitor compliance with the ICNA Act. A removal of the powers would represent a diminution in protections available (contrary to the expectations of the Australian community).

 

Authorised persons and relevant others

 

Clause 128 provides that the Executive Director and each authorised inspector

is an authorised person and therefore able to exercise the monitoring powers described in Part 2 of the Regulatory Powers Act. Noting the significance of such powers, the Act limits who can exercise these powers.

 

In addition to the Executive Director (as statutory office holder) being able to exercise the powers, the ability to exercise the powers has also been extended to inspectors appointed by the Executive Director. The inspectors must:

 

·          be APS employees

·          be at the classification level of Executive Level 1 or higher, and

·          be judged by the Executive Director to have the knowledge or experience necessary to properly exercise the powers. For example, as described in relation to clause 137, the Executive Director will require that people appointed as inspectors have a strong working knowledge of the industrial chemicals legislation and the Regulatory Powers Act and have relevant qualifications such as a Certificate IV in Government (Statutory Compliance) or other training in investigations, compliance and enforcement.

 

These requirements provide important safeguards and limits around who can exercise these monitoring powers.

 

Subclause 128(3) also provides that:

 

·          there are no related provisions for the purposes of Part 2 of the Regulatory Powers Act. This reflects existing arrangements under the ICNA Act in relation to monitoring powers

 

·          the Executive Director and each authorised inspector is an authorised applicant for the purposes of Part 2 of the Regulatory Powers Act. This means that they can apply to an issuing officer for a monitoring warrant. The relevant people to whom an application for a warrant can be made are a magistrate, a Judge of a court of a State or Territory, or Judges of the Federal Circuit Court of Australia or the Federal Court of Australia who have consented to act as an issuing officer for the purposes of this Act

 

·          the Executive Director is the relevant chief executive. This means that the Executive Director can, for example, issue identity cards to authorised persons (inspectors). This also preserves the effect of existing arrangements under the ICNA Act

 

·          the relevant courts (for the purposes of a matter arising because of the exercise of powers functions or duties under Part 2 of the Regulatory Powers Act) are the Federal Court of Australia, the Federal Circuit Court of Australia and a court of a State or Territory with jurisdiction in relation to matters arising under the Act.



 

Additional monitoring powers

 

For the purposes of Part 2 of the Regulatory Powers Act, the Act describes additional monitoring powers which are the powers to take and keep samples of any substance at any premises entered by the Executive Director or an authorised inspector.

 

It is necessary for the Executive Director and inspectors to have this additional power because substances introduced contrary to the provisions of the legislation have the potential to cause harm to human health and the environmental. For example, it is necessary to take samples to determine the chemical identity of substances found during a monitoring inspection, which an authorised person reasonably suspects were not lawfully introduced. The seizure of samples allows necessary tests to be conducted on items and substances in order to determine compliance with the legislation. Under the ICNA Act, this power also existed so while subclause 128((4) and (5) describe additional powers, these clauses are actually preserving powers that NICNAS has had for some time.

 

Persons assisting

 

Subclause 128(6) provides that an authorised person (the Executive Director or an authorised inspector) may be assisted by other persons in exercising powers or performing functions or duties under Part 2 of the Regulatory Powers Act.

This enables inspectors to be assisted in circumstances where, for example:

·          no other officers are available to assist;

·          there may be large premises to be monitored;

·          there are a large number of documents that require review;

·          another person is more familiar with specific premises; or

·          where an officer needs assistance to move a heavy item that the officer cannot move on their own.

 

Use of force in executing a warrant

 

Subclause 128(7) provides that an authorised officer (or a person assisting them) may use force in executing a monitoring warrant. The use of force allowed by an authorised officer (or person assisting) is only to be exercised against things and not persons, for example to open a door or force a lock. The force allowed is limited to that which is necessary and reasonable in the circumstances.

 

This power is necessary for inspectors to gain access to evidential material by opening locked doors, cabinets, drawers and other similar objects. The use of force power will also ensure that the execution of monitoring warrants is not frustrated, and will prevent concealment, loss, destruction of evidential material, or the continued use of things in contravention of the Act.



 

Clause 129 - Investigation powers

 

The offence and civil penalty provisions under the Act (along with offences against the Crimes Act 1914 or the Criminal Code that relate to this Act) are subject to investigation under Part 3 of the Regulatory Powers Act.

 

Part 3 of the Regulatory Powers Act creates a framework for investigating whether a provision has been contravened. It enables the Executive Director or an authorised inspector (authorised persons for the purposes of Part 3 of the Regulatory Powers Act) to enter premises and exercise investigation powers where they suspect on reasonable grounds that there may be material on the premises related to the contravention of a provision of the Act or the rules made under the Act, or an offence against the Crimes Act 1914 or Criminal Code that relates to the Industrial Chemical Act.

 

An inspector may not enter the premises unless the occupier has provided consent or the inspector is in possession of an investigation warrant.

 

The investigation powers are necessary to enable the monitoring of compliance with the legislation and collection of evidential material relating to contraventions of the legislation.

 

The regime under the Regulatory Powers Act protects against arbitrary interference with privacy, because:

 

·          the investigation powers cannot be exercised without consent being given for entry into the premises, or prior judicial authorisation in the form of a warrant;

·          where entry is based on the consent of the occupier, consent must be informed and voluntary and the occupier of premises can restrict entry by authorised persons to a particular period

·          authorised persons and any persons assisting them must leave the premises if the occupier withdraws their consent.

 

The Regulatory Powers Act also:

 

·          provides restrictions on the issuing of a monitoring or investigation warrant. For example, in the case of an investigation warrant, an issuing officer may issue an investigation warrant only when satisfied, by oath or affirmation, that there are reasonable grounds for suspecting that there is, or may be within 72 hours, evidential material on the premises. An issuing officer must not issue a warrant unless the issuing officer has been provided, either orally or by affidavit, with such further information as they require concerning the grounds on which the issue of the warrant is being sought. Such constraints on this power ensure adequate safeguards against arbitrary limitations on the right to privacy in the issuing of warrants

·          requires the authorised person to identify themselves. An authorised person cannot enter premises under a warrant unless their identity card is shown to the occupier of the premises. If entry is authorised by warrant, the authorised person must also provide a copy of the warrant to the occupier of the premises. This provides for the transparent utilisation of the powers and mitigates arbitrariness and risk of abuse;

·          limits when the investigation powers are triggered. The powers can only be exercised in specific circumstances set out in the triggered provisions.

 

For example, under section 52 of the Regulatory Powers Act, the power to seize evidence of a kind not specified in a warrant may only be exercised where the authorised person finds the thing in the course of searching for material of the kind specified in an investigation warrant and the authorised person believes on reasonable grounds that:

-         the thing is evidential material of another kind; or

-         a related provision has been contravened with respect to the thing; or

-         the thing is evidence of a contravention of a related provision; or

-         the thing is intended to be used to contravene a related provision; and

-         the authorised person believes on reasonable grounds that it is necessary to seize the thing in order to prevent its loss, concealment or destruction.

 

These constraints on the exercise of the powers limit their susceptibility to arbitrary use or abuse and ensure that their use is reasonable and proportionate in the circumstances.

 

Necessity for investigation powers

 

The need for the Executive Director and authorised inspectors to have investigation powers are consistent with the reasons described in relation to monitoring powers, namely:

 

·          the regulatory scheme is designed to protect public health and safety. If the Executive Director and authorised inspectors do not have the power to investigate possible non-compliance with these requirements (and take actions to minimise the impact of any non-compliance) then the safeguards provided by the Act are not achieved

 

·          the reforms implement a risk-based regulatory scheme. In reducing pre-market controls, the scheme depends on the Executive Director (and authorised inspectors) having the capacity to investigate and prosecute non-compliant introducers

 

·          the investigation powers described in this Bill reflect the powers currently available to NICNAS to investigate non-compliance under the ICNA Act. A removal of the powers would represent a diminution in protections available (contrary to the expectations of the Australian community).

 

Authorised persons and relevant others

 

Subclause 129(2) provides that:

 

·          there are no related provisions for the purposes of Part 3 of the Regulatory Powers Act. This reflects existing arrangements under the ICNA Act in relation to investigation powers

 

·          the Executive Director and each authorised inspector is an authorised applicant for the purposes of Part 3 of the Regulatory Powers Act. This means that they can apply to an issuing officer for an investigation warrant in relation to premises. The relevant people to whom an application for an investigation warrant can be made are a magistrate, a Judge of a court of a State or Territory, or Judges of the Federal Circuit Court of Australia or the Federal Court of Australia who have consented to act as an issuing officer for the purposes of this Act

 

·          the Executive Director and each authorised inspector is an authorised person for the purposes of Part 3 of the Regulatory Powers Act. This will enable the Executive Director and inspectors to enter any premises and exercise investigation powers where the inspector or Executive Director suspects on reasonable grounds that there may be material on the premises related to the contravention of an offence provision subject to investigation. However, an authorised person may not enter the premises unless the occupier has provided consent or the authorised person is in possession of an investigation warrant. This preserves the effect of arrangements under the ICNA Act

 

·          the Executive Director is the relevant chief executive. This preserves the effect of existing arrangements under the ICNA Act

 

·          the relevant courts (for the purposes of a matter arising because of the exercise of powers functions or duties under Part 3 of the Regulatory Powers Act) are the Federal Court of Australia, the Federal Circuit Court of Australia and a court of a State or Territory with jurisdiction in relation to matters arising under the Act.

 

Persons assisting

 

Subclause 128(6) provides that an authorised person (the Executive Director or an authorised inspector) may be assisted by other persons in exercising powers or performing functions or duties under Part 3 of the Regulatory Powers Act in relation to evidential material that relates to a provision mentioned in subsection (1).

It is important that inspectors can be assisted in their duties. For example, there may be circumstances where no other officers are available to assist; where there may be a large amount of material found that needs to be secured quickly; where another person is more familiar with specific premises; or where an officer needs assistance to move a heavy item that the officer cannot move on their own.

Use of force in executing a warrant

 

An authorised officer or a person assisting them may use force in executing an investigation warrant. The use of force allowed by an authorised officer (or person assisting) is only to be exercised against things and not persons, for example to open a door or force a lock. The force allowed is limited to that which is necessary and reasonable in the circumstances.

 

This power is necessary for inspectors to gain access to evidential material by opening locked doors, cabinets, drawers and other similar objects. The use of force power will also ensure that the execution of investigation warrants is not frustrated, and will prevent concealment, loss, destruction of evidential material, or the continued use of things in contravention of the Act

 

Division 3 - Civil penalty provisions, infringement notices and injunctions

 

Clause 130 - Civil penalty provisions

 

Each civil penalty provision of the Act is enforceable under Part 4 of the Regulatory Powers Act. Part 4 of the Regulatory Powers Act allows a civil penalty provision to be enforced by obtaining an order for a person to pay a pecuniary penalty for the contravention of the provision. Part 4 of the Regulatory Powers Act sets out matters such as:

 

·          civil enforcement of penalties

·          civil evidence and procedure rules for civil penalty orders

·          when civil proceedings may be initiated.

 

For the purposes of Part 4 of the Regulatory Powers Act, the Executive Director and each authorised inspector is an authorised applicant and the relevant courts are the Federal Court of Australia, the Federal Circuit Court of Australia and a court of a State or Territory with jurisdiction in relation to matters arising under the Act.

 

The main difference between a civil penalty provision and a criminal offence provision is that in order to be convicted of a criminal offence, a person must be found guilty beyond reasonable doubt. For a civil penalty provision, the standard of proof is the balance of probabilities. This is linked to the fact that a civil penalty provision only carries a financial penalty, not an imprisonment penalty, whereas a criminal offence can carry either imprisonment or a financial penalty, or both, as well as the stigma of a criminal conviction. The imposition of a civil penalty does not constitute a criminal conviction.

 

Generally speaking, a criminal penalty will be imposed for serious misconduct where, for example, there is an aggravating element such as intent. Civil penalties are generally imposed for conduct which, while still serious, may not involve the same level of intent.

 

More information about the rationale for including civil penalty provisions in the Act is included in the General Introduction.

 

Clause 131 - Infringement notices

 

A strict liability offence against this Act is subject to an infringement notice under Part 5 of the Regulatory Powers Act (which creates a framework for the use of infringement notices where an infringement officer reasonably believes that a provision has been contravened) .

 

An infringement notice is a notice of a pecuniary penalty imposed on a person by statute setting out particulars of an alleged contravention of a law. It gives the person to whom the notice is issued the option of either paying the penalty set out in the notice to expiate the offence or civil penalty contravention or to elect to have the matter dealt with by a court. The notice also specifies the time and method for payment and the consequences if the person to whom the notice is issued fails to respond to the notice either by making payment or electing to contest the alleged contravention.

 

Infringement notices are administrative methods for dealing with certain breaches of the law and are typically used for low-level offences and where a high volume of uncontested contraventions is likely. Offences subject to infringement notices are generally of strict or absolute liability and with a clear physical element. Infringement notices are often used as a low cost and efficient means by which regulators can deal with minor contraventions and for wrongdoers to discharge their obligation without appearing before a court.

 

In line with the Attorney-General’s Guide to Framing Commonwealth Offences, Infringement Notices and Enforcement Powers , infringement notices will be used to deal with less serious and less factually complex contraventions of a provision, where initiating court proceedings would be disproportionately costly.

 

Part 5 of the Regulatory Powers Act sets out matters such as:

 

·          when an infringement notice may be given

·          matters to be included in infringement notice

·          circumstances in which time may be extended for the person to pay the amount in the infringement notice

·          the effect of payment of the amount.

 

Subclause 131(2) provides that for the purposes of Part 5 of the Regulatory Powers Act:

 

·          the Executive Director and each authorised inspector is an infringement officer which means that they can give a person an infringement notice under Part 5

 

·          the Executive Director is the relevant chief executive which means the Executive Director can decide on applications for an extension of time to pay, and for withdrawal of notices.

 

Clause 132 - Enforceable undertakings

 

The provisions of the Act are enforceable by way of an enforceable undertaking. Part 6 of the Regulatory Powers Act describes the framework for accepting and enforcing undertakings.

 

An enforceable undertaking is essentially a voluntary, negotiated agreement between AICIS and an organisation whereby the organisation undertakes to take a specified action within an agreed timeframe. This approach enables AICIS to work with companies to remedy non-compliance on a case-by-case basis and to address systemic issues and support sustained compliance. Enforceable undertakings can also be a useful tool for driving improved practice. Failure to comply with an enforceable undertaking may result in court proceedings as the undertaking is legally binding.

 

Enforceable undertakings are used by a wide range of Commonwealth regulators including the Australian Competition and Consumer Commission (ACCC) and the Therapeutic Goods Administration (TGA).

 

The clause also provides that for the purposes of Part 6 of the Regulatory Powers Act:

 

·          the Executive Director and authorised inspectors are authorised persons which means that they can accept a written undertaking under Part 6, cancel the undertaking or apply to a relevant court for an order that in the event that the undertaking has been breached, and

 

·          a relevant court is the Federal Court of Australia, the Federal Circuit Court of Australia and a court of a State or Territory with jurisdiction in relation to matters arising under the Act. This means that any of these courts can make an order on such an application by the Executive Director or an authorised inspector.

 

Publication of enforceable undertaking

 

The clause also provides for the publication of enforceable undertakings on the AICIS website. This ensures transparency and is consistent with the practice of other like regulators including the TGA, ACCC and Safe Work Australia). It is proposed that enforceable undertakings would only be published on the AICIS website for the duration of the undertaking.

 

Example - Enforceable undertakings

 

Examples of when an enforceable undertaking may be used include:

 

·          where an introducer acknowledges that a larger quantity of a new chemical has been introduced, in excess of the amount that was the basis of categorising the chemical as a reported introduction (such that the chemical now requires assessment), and has agreed to seek an assessment certificate within an agreed period. In this case, the Executive Director could agree to allow the continued introduction of the chemical (at the increased volume) provided that an assessment certificate was sought within, for example, two months. This approach may be appropriate where the increased volume is not likely to pose a substantial risk to public health, work health and safety or the environment. If the company failed to meet the requirements of the enforceable undertaking (and seek an assessment certificate within the defined period), action could be taken to enforce the undertaking with penalties for ongoing non-compliance;

 

·          when an introducer self-reports that they have breached the legal requirements for introduction by miscategorising their chemical as a reported introduction rather than one which requires assessment by the Executive Director, for example by mischaracterising the hazards of the chemical. In this case, an enforceable undertaking may be used so that the company and AICIS can agree a timeframe within which the chemical be submitted for assessment; or

 

·          where, as part of AICIS compliance monitoring activity, it is revealed that an introducer does not hold the information required to demonstrate that chemicals introduced have been categorised appropriately. In this case, the Executive Director may agree to continue introduction for a limited time provided the introducer undertakes to put in place systems and processes to ensure ongoing compliance with their obligations.

 

 

Clause 133 - Injunctions

 

A provision of the Act may be enforced with an injunction, as provided for in Part 7 of the Regulatory Powers Act. An injunction may also be sought for an offence against the Crimes Act 1914 or the Criminal Code that relates to the Act.

 

The clause also provides that:

 

·          the Executive Director and each authorised inspector is an authorised person who may apply to the relevant court for an injunction

 

·          the relevant courts that may grant and enforce an injunction are the Federal Court of Australia, the Federal Circuit Court of Australia and a court of a State or Territory with jurisdiction in relation to matters arising under the Act, and

 

·          the relevant courts may grant an injunction restraining a person from engaging in conduct (or requiring a person to do a thing) regardless of whether the conduct represents a serious and immediate risk to human health or the environment or there is serious and immediate risk of adverse health effects or adverse environmental effects if the person fails or refuses to take certain action. This ensures that a court may prevent conduct that would be contrary to the purposes of the Act, without needing to wait for the countervailing conduct to occur. It also ensures that a court may require conduct to uphold the purposes of the Act without needing to wait for the danger to manifest.

 

Clause 133(5) is included to clarify that subclauses 133(3) and 136(4) are in addition to, and do not limit, subsections 124(1) and (2) of the Regulatory Powers Act.

 

Clause 134 - Extension to external Territories

 

This clause ensures that the parts of the Regulatory Powers Act, as they apply to a provision mentioned in this Part, extends to every external Territory to which the new law extends.

 

Division 4 - M iscellaneous

 

Clause 135 - Physical elements of offences

 

This section applies if a provision of this Act provides that a person contravening another provision of this Act (the conduct rule provision ) commits an offence.

 

For the purposes of applying Chapter 2 of the Criminal Code (which sets out general principles of criminal responsibility) to the offence, the physical elements of the offence are set out in the conduct rule provision.

Clause 136 - Contravening an offence provision or a civil penalty provisio n

 

This clause clarifies that for various clauses of the Act, a person is liable for civil or criminal penalties if the person contravenes the obligation set out in the clause. This clause is required because of the style of drafting in various clauses, which in certain circumstances state an obligation in a particular way. To remove any doubt, this clause clarifies that contravention of these obligations constitutes a criminal offence, or gives rise to a civil penalty (as the case requires).

 

Clause 137 - Appointment of authorised inspectors

 

This clause provides that the Executive Director:

 

·          may, in writing, appoint an APS employee who holds or performs the duties of an Executive Level 1 position, or an equivalent or higher position, as an authorised inspector for the purposes of the Part

·          must not appoint a person as an authorised inspector unless satisfied that the person has the knowledge or experience necessary to properly exercise the powers of an authorised inspector

·          may issue directions to the authorised inspector. If the Executive Director does so the authorised inspector must comply with the directions.

 

The clause also states that a direction that is issued by the Executive Director is not a legislative instrument. This subclause is included to assist readers, as directions are not a legislative instrument within the meaning of subsection 8(1) of the Legislation Act 2003 .

 

This clause allows the Executive Director to appoint people to assist in enforcing the legislation, including by exercising powers under the Regulatory Powers Act.

 

The clause confers power on the Executive Director the power to appoint a senior Commonwealth public servant who has appropriate knowledge and experience as an authorised inspector for the purposes of the legislation.

 

For example, the Executive Director will require that people appointed as inspectors have a strong working knowledge of the industrial chemicals legislation and the Regulatory Powers Act and have relevant qualifications such as a Certificate IV in Government (Statutory Compliance) or other training in investigations, compliance and enforcement.

 

The flexibility to confer the powers of authorised inspectors, including entry search and seizure powers upon persons other than the Australian Federal Police (AFP) is provided to avoid the need for dependence on the availability of AFP resources - which may be limited - and to ensure a stable workforce can be maintained for the purpose of monitoring and enforcement of this legislation. Specialist training of inspectors will enable them to perform investigation and enforcement functions in a way that is appropriate.



 

Clause 138 - Delegations by relevant chief executive

 

This clause provides that the relevant chief executive (namely the Executive Director) may, in writing, delegate the following powers to an authorised inspector:

 

·          powers under Part 2 of the Regulatory Powers Act to monitor the provisions of the Act, offences against the Crimes Act 1914 or the Criminal Code (that relate to the industrial chemicals legislation) and information given in compliance or purported compliance with the Act;

·          powers under Part 3 of the Regulatory Powers Act to investigate evidential material relating to an offence against the Act, a civil penalty provision of the Act or an offence against the Crimes Act 1914 or the Criminal Code as they relate to this Act;

·          powers under Part 5 of the Regulatory Powers Act in relation to infringement notices (that can be issued in relation to strict liability offences against the Act); and

·          powers and functions under the Regulatory Powers Act that are incidental to any of the powers mentioned above.

 

The clause also provides that a person exercising powers or performing functions under a delegation must comply with any directions of the relevant chief executive (namely the Executive Director).

 

Part 8 - Administration

 

Division 1 - Simplified outline of this Part  

 

This Part relating to the administration of the Scheme is largely consistent with existing arrangements under the ICNA Act. It makes several minor changes to modernise the provisions, including reflecting the recent P ublic Governance, Performance and Accountability Act 2013 (PGPA Act) , and a new function for the Executive Director to promote international harmonisation.

 

This Part provides for the appointment of the Executive Director of the Australian Industrial Chemicals Introduction Scheme (AICIS). The Part also describes the way in which the Executive Director’s terms and conditions are set, staffing arrangements and matters relating to the Industrial Chemicals Special Account (from which payments may be made relating to the administration of the AICIS).

 

Division 2 - Australian Industrial Chemicals Introduction Scheme and the Executive Director

 

Clause 140 -   Australian Industrial Chemicals Introduction Scheme

 

The Australian Industrial Chemicals Introduction Scheme is established, which is the system of regulation described in the Act and rules that the Executive Director is responsible for administering.

 

Clause 141 - Executive Director

 

There is an Executive Director for the AICIS. The Executive Director is an independent statutory office holder, appointed by the Governor-General.

 

Clause 142 - Functions of Executive Director

 

The Executive Director is responsible for:

 

·          performing the functions conferred on the Executive Director by the Act (including as prescribed by the rules), or by any other Act For example, the Executive Director has responsibility for:

-         assessing certain chemicals

-         considering applications for registration, assessment certificates, protection of confidential business information, and variations to listings on the Inventory

-         monitoring compliance with the legislation and taking enforcement action where necessary

·          promoting international harmonisation of regulatory controls or standards for industrial chemicals. As part of an international regulatory community, the Executive Director works with other regulators to identify ways in which industrial chemicals regulation may be harmonised to reduce unnecessary trade barriers. International regulators also work closely together to identify industrial chemicals posing risks to human health and the environment and subsequently share information about recommended management strategies

·          providing advice to the Minister about matters relating to any of the functions of the Executive Director. The advice may be provided in response to a request from the Minister or on the Executive Director’s own initiative.

 

The Secretary of the Department may also require the Executive Director to perform additional functions or duties in relation to chemicals that are not expressed in this Bill, provided they do not interfere with the performance of the Executive Director’s principal functions, as described above.

 

Division 3 - Appointment of the Executive Director

 

Clause 143 - Appointment

 

The Executive Director is to be appointed on a full-time basis by the Governor-General.  The Governor General’s powers and functions are prescribed in the Constitution. One of the roles of the Governor General is appointing senior government officials, of which the Executive Director is one.

 

Clause 144 - Term of appointment

 

The instrument of appointment will specify the period of the Executive Director’s appointment, which must not exceed five years. The Executive Director may, however, be reappointed for further terms. This is permitted under section 33AA of the Acts Interpretation Act 1901 , which provides that in any Act, a reference to appointment includes reappointment.

 

Clause 145 - Acting Executive Director

 

The Minister may appoint a person to act as the Executive Director during a vacancy in the office of the Executive Director or when the Executive Director is absent from duty, overseas or unable to perform the duties of the office (for whatever reason).

 

A note at the end of this clause draws the reader’s attention to sections 33AB and 33A of the Acts Interpretation Act 1901 which describes additional rules in relation to acting appointments.

 

Division 4 - Terms and conditions for the Executive Director

 

Clause 146 - Remuneration and allowances

 

The Executive Director's remuneration is determined by the Remuneration Tribunal, which is an independent statutory body that handles the remuneration of appointees to key Commonwealth offices. If no such determination is in operation, the Executive Director's remuneration is prescribed by the rules. The Executive Director is also to be paid the allowances that are prescribed by the rules, in addition to any allowances set by the Remuneration Tribunal.

 

Clause 147 - Leave of absence

The Remuneration Tribunal determines the Executive Director’s recreation leave entitlements, and that the Minister can grant the Executive Director other types of leave on the terms and conditions decided by the Minister.

 

Clause 148 - Outside employment

 

The Executive Director is prevented from engaging in paid employment outside the duties of their office without the Minister's approval. This minimises the risk of a conflict of interest that focuses the Executive Director on their job in leading the AICIS, noting that the position is a full-time one.

 

Clause 149 - Disclosure of interests

 

The Executive Director is required to declare in writing to the Minister all actual or potential conflicts of interest that could interfere with the proper performance of the Executive Director's functions. This would include, amongst other things, a financial interest or a family member's financial interest in a company introducing industrial chemicals into Australia. If the Executive Director fails to comply with this requirement, the Executive Director’s appointment may be terminated by the Minister.

 

These disclosure requirements also apply in relation to section 29 of the Public Governance, Performance and Accountability Act 2013 (PGPA Act), which provides that an official (in this instance, the Executive Director) is required to report material personal interests in relation to the affairs of the organisation to the Accountable Authority (in this instance, the Secretary of the Department responsible for the Act). The PGPA rules may prescribe the circumstances in which this does not apply, how and when an interest must be disclosed, and the consequences of disclosing an interest.

 

A ‘material’ interest needs to be of some substance, rather than a low value interest; and ‘personal’ must be an interest in respect of the Executive Director only. For example this potential conflict could arise when the Executive Director is on an employment selection panel that is interviewing a friend or family member for a position with the Commonwealth entity.

 

Clause 150 - Resignation of Executive Director

 

The Executive Director may resign by giving written notice to the Governor-General. The resignation takes effect on the day that the notice is received by the Governor-General or on a later date if the Executive Director has specified a later date in the notice of resignation.

 

Clause 151 - Termination of appointment of Executive Director

 

The Governor-General may terminate the appointment of the Executive Director, if the Executive Director:

 

·          misbehaves or is unable to perform the duties of their office because of physical or mental incapacity

·          becomes bankrupt or applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with their creditors or makes an assignment of their remuneration for the benefit of their creditors

·          is absent, except on leave of absence, for 14 consecutive days or for 28 days in any 12 months

·          engages, except with the Minister’s approval, in paid work outside the duties of their office

·          fails, without reasonable excuse, to comply with the disclosure of interests requirements described above.

 

Clause 152 - Other terms and conditions of appointment of Executive Director

 

The Executive Director holds office on the terms and conditions (if any) in relation to matters not covered by the Act that are determined by the Minister in writing.

 

Division 5 - Persons assisting the Executive Director

 

Clause 153 - Arrangements relating to staff of the Department

 

The Secretary may make APS employees available to the Executive Director to assist in the performance of the Executive Director’s functions. The term APS employee is defined in the Public Service Act 1997 .

 

The Executive Director may also engage consultants and contractors to assist in the performance of the Executive Director's functions. This can occur via a delegation from the Secretary under section 110 of PGPA Act .

 

APS employees who are made available by the Secretary and work for the Executive Director are subject to the directions of the Executive Director.

 

Clause 154 - Other persons assisting the Executive Director

 

The Executive Director may also be assisted by employees of agencies (within the meaning of the Public Service Act 1999 ) whose services are made available to the Executive Director in connection with the performance of any of the Executive Director’s functions. For example, this would enable staff of other Departments to assist the Executive Director in undertaking health or environmental assessments of industrial chemicals.

 

As with staff of the Secretary, when performing services for the Executive Director, employees of other agencies are subject to the directions of the Executive Director.

 

Division 6 - Industrial Chemicals Special Account

 

Clause 155 - Industrial Chemicals Special Account

 

The Industrial Chemicals Account established by section 100A of the ICNA Act is to continue under this Bill, but it has a new name: Industrial Chemicals Special Account. The change in name is to reflect the fact that the account is, by law, a special account within the meaning of the PGPA Act.

 

Clause 156 - Credits to Industrial Chemicals Special Account

 

There are a range of different payments that must be credited to the Industrial Chemicals Special Account. These include amounts equal to:

 

·          amounts received in connection with the performance of the Executive Director’s functions under the Act. For example, amounts of registration charge or fees paid in connection with applications made under the new law

·          money received for services provided or to be provided, by or on behalf of the Commonwealth, using amounts standing to the credit of the account

·          interest received from the investment of amounts standing to the credit of the account

·          money received in relation to property paid for with amounts standing to the credit of the account

·          amounts of any gifts given or bequests made for the purposes of the account and

·          receipts relating to the recovery of debts (other than debts in respect of statutory fines and penalties) by the Commonwealth that are associated with expenditure of amounts standing to the credit of the account.

 

A note in connection with the clause clarifies that an Appropriation Act may contain a provision to the effect that, if any of the purposes of a special account is a purpose that is covered by an item in the Appropriation Act, then amounts may be debited against the appropriation for that item and credited to that special account.



 

Clause 157 - Purposes of the Industrial Chemicals Special Account

 

The purpose of the Account is to make payments to further the objects of the Act, to enable the Director to perform functions under the Act, and to enable the Commonwealth to participate in international activities related to regulation of the industrial chemicals. The Industrial Chemicals Special Account may also be used to pay any remuneration and allowances payable to anyone engaged under the Act. The account is funded on a cost recovery basis through registration charges and other fees from the regulated industry.

 

A note at the bottom of the clause draws reader’s attention to section 80 of the PGPA Act (which deals with special accounts).

 

Part 9 - International agreements and arrangements

 

Division 1 - Simplified outline of this Part  

 

Part 9 deals with the obligations Australia has under the Rotterdam Convention (the Convention), which is a multilateral environmental agreement on the import and export of certain hazardous chemicals. The objective of the Convention is to promote shared responsibility and cooperative efforts among countries in the international trade of chemicals in order to protect human health and the environment from potential harm.

 

Australia is a Party to international conventions, and participates in trade agreements and export control regimes, for chemicals that pose severe risks to human health, the environment and security. Currently under the ICNA Act, NICNAS is responsible for implementing the Convention domestically for those chemicals intended for industrial use. This responsibility will continue under the new Act.

 

This Part is largely consistent with the current arrangements; however changes have been made to reflect changes in international practice.

 

Division 2 - Information exchange under the Rotterdam Convention

 

Subdivision A - Notification of ban or restriction

 

Clause 159 - Notification of ban or restriction on introduction or use

 

The Convention facilitates information exchange among Parties across a broad range of hazardous chemicals. The Convention, under paragraph 1 of Article 5, requires each Party to notify the Secretariat when taking domestic regulatory action to ban or severely restrict a chemical. All Parties receive summaries of these notifications and proposals on a regular basis.  

 

The Executive Director must notify the designated national authority (currently the Department of the Environment and Energy), in writing, if the Executive Director is satisfied of the following circumstances:

 

·          that the Executive Director has taken an action that has the effect of: banning, or severely restricting, the introduction or use of an industrial chemical; and the action was taken because risks to human health or the environment associated with the introduction or use of the industrial chemical cannot be managed. For example, if the Executive Director refused to issue an assessment certificate because they concluded that the risks to human health or the environment could not be managed, then the responsibility to notify the Department of the Environment and Energy of that ‘ban’ would be enlivened

 

·          when a provision of the Act or the rules, has the same effect (that is to ban or severely restrict the introduction or use of an industrial chemical) because the risks to human health or the environment cannot be managed

 

·          when a State or a Territory has a law banning, or severely restricting, the introduction or use of an industrial chemical in the State or Territory and the law, or laws, have the effect of banning or severely restricting the introduction or use of the industrial chemical in Australia.

 

The notice must be given to the designated national authority as soon as practicable once the above circumstances have occurred, and it will need to contain the information set out in Annex I to the Convention (to the extent that it is available), This includes the chemical properties, identification and uses (such as trade names, code numbers, hazard classifications, toxicological properties), final regulatory actions (such as date of entry into force, whether the action was taken on the basis of a risk or hazard evaluation, categories where the final regulatory action has been taken).

 

The designated national authority must then notify the Convention Secretariat, and this must be done as soon as is practicable but no later than 90 calendar days after: the day that the action by the Executive Director to ban or severely restrict the introduction or use of the chemical takes effect; or the first day that the relevant Commonwealth, or State or Territory, law takes effect.

 

Example - Notification of ban or restriction on introduction or use

 

In 1999, NICNAS completed a risk assessment of chrysotile asbestos, and recommended that use of chrysotile in Australia be phased out over time, with the period of phase-out determined by the relevant regulatory authorities. The assessment found that the risks to the health of workers handling chrysotile were high. The recommendation was implemented by SafeWork Australia by introducing safety (OHS) restrictions on the use, transport and storage of asbestos compounds.

 

The State and Territories subsequently amended their legislation to be able to enforce the restrictions, and the regulatory actions came into force in December 2003. NICNAS notified the Department of the Environment and Energy of these legislative amendments, and the Department subsequently notified the Convention Secretariat of the ban on use of chrysotile in Australia in 2004, within 90 days of the commencement of the legislation.

 

 

The public will also be informed about actions and laws that have the effect of banning, or severely restricting, the introduction or use of an industrial chemical through the AICIS website. As part of this publication, the Executive Director may include some of the information contained in the notice given to the designated national authority.

 

Subdivision B - Exchange of certain information

 

Clause 160 - Exchange of certain information about industrial chemicals

 

The Convention under Article 14.1(a) and (c) promotes shared responsibility and cooperative efforts among Parties in the international trade of certain hazardous chemicals supported, in part,  by the exchange of scientific, technical, economic and legal information concerning chemicals within the scope of the Convention for the benefit of the broader global community

 

The Executive Director is to provide such information about a notified industrial chemical, that was obtained during the 12 months ending on 1 February each year, to Australia’s designated national authority as soon as is practicable after that date.

 

The Executive Director decides exactly what information is appropriate for this purpose. For example, the information could include new (eco)toxicological data that the Director has become aware of, and the extent of trade in the chemical.

 

The designated national authority, must give that information to the Secretariat as soon as is practicable after receiving the information. The designated national authority may also give all or any of that information to a country that is a Party to the Convention, aligning with objectives of the Convention

 

Subdivision C - Information gathering

 

Clause 161 - Executive Director may obtain information and documents

 

The Executive Director may seek information or a document that they consider to be reasonably necessary for Australia to comply with its obligations under the Convention.

 

This covers situations whereby the Executive Director reasonably believes that a person has information or a document that it is reasonably necessary to obtain for the purpose of Australia’s compliance with its obligations under the Convention. The inclusion of the term ‘reasonably’ indicates that the Executive Director is to exercise judgment about what kind of information should be sought, and whether it is reasonable to believe that a particular person holds that information.

 

To obtain the information and/or documents, the Executive Director may give written notice to the person requiring that the information and/or documents be provided in a specific manner and timeframe (no less than 10 working days after the notice is given), and that the information may be required to be produced in a specific form.

 

The kind of information that could be sought includes shipping documentation, new toxicological data, extent of trade of the chemical in Australia, and information regarding the chemical identity of goods potentially containing chemicals either subject to the Convention or being considered under the Convention.

 

If a notice is given, the notice must alert the person that if they fail to comply with the notice, they may commit an offence or be liable to a civil penalty.

 

Clause 162 - Person must comply with notice under section 161

 

A person contravenes this provision if they do not provide information or a document to the Executive Director within the time period and the form specified in the notice from the Executive Director, unless there is a reasonable excuse. A person may be subject to a criminal offence, a strict liability offence, or a civil penalty.

 

Under the ICNA Act, similar conduct attracted a maximum penalty of 60 penalty units. Under this Bill, this has been increased to 300 penalty units for fault-based offences and civil penalties (strict liability will remain 60 penalty points). This is more consistent with like offences under other Commonwealth laws, such as the Narcotic Drugs Amendment Act 2016 , standardises the penalties for non-compliance with all provisions in the Bill that relate to failure to provide information, and is a more effective deterrent to the commission of the offence.

 

Division 3—Movements of industrial chemicals into or out of Australia

 

Clause 163 - Movements of industrial chemicals into or out of Australia

 

The rules may prohibit, or impose conditions on, the introduction or export of industrial chemicals if the chemical is the subject of a prescribed international agreement or arrangement. If an industrial chemical is prohibited, it cannot be introduced under clause 24.

 

When making rules that prohibit or restrict (through condition) the introduction or export, the Executive Director must publish a notice on the AICIS website at least 20 days before the rules are made. This notice must identify the relevant agreement or arrangement, and list the publicly known name (or names) of the industrial chemical, and  set out the requirement for all persons responsible for introducing the chemical into, or exporting the chemical from, Australia to give the Executive Director information about movements of the chemical into or out of Australia.

                       

The Executive Director may give information to the appropriate authority of a country or to any other relevant organisation on movements into or out of Australia of an industrial chemical. In doing so, the Executive Director may give the information in such terms or on such conditions as the Executive Director thinks fit, having regard to relevant international agreement or arrangement and the interest of any person in maintaining confidentiality in relation to movements of the chemical



 

Clause 164 - Introducing or exporting if prohibited or restricted

 

A person contravenes this provision if the person introduces or exports an industrial chemical that is prohibited or restricted under clause 163 (as prescribed the rules), unless there is a reasonable excuse.

 

The penalties in this clause are consistent with those in the ICNA Act (criminal and strict liability); however a civil penalty will also apply. This is consistent with the approach throughout the Bill. The number of penalty units is the same as under clause 162.

Part 10 - Miscellaneous

 

Clause 165 - Simplified outline of this Part

 

This outline summarises Part 10, which contains various provisions that apply to provisions throughout the Act. It also includes the Minister’s general rule-making power.

 

Clause 166 - Reconsideration and review of decisions

 

All reviewable decisions in the Bill are listed in the table in this clause.

A person may seek reconsideration by the Executive Director of a decision made by the Executive Director (or delegate), and may apply to the Administrative Appeals Tribunal (AAT) for a review of a decision made by the Executive Director under the Act.

 

A person has 20 working days, or other agreed period, in which to seek reconsideration by the Executive Director and the Executive Director has 70 working days to confirm, vary or set aside the original decision. The Executive Director is required to give the person who sought reconsideration written notice of the decision on reconsideration, the reasons for that decision and information regarding the person’s right to seek further review by the AAT.

 

Example - Seeking reconsideration of a reviewable decision

 

Person A is a holder of a commercial evaluation authorisation. The Executive Director is satisfied that Person A is not complying with the terms of that authorisation. Despite seeking to bring Person A back into compliance through other means (such as administrative action or issue of infringement notices) Person A remains non-compliant. The Executive Director decides, in accordance with clause 61, to remove Person A as a holder of the authorisation. Person A is given written notice of this decision.

 

As specified at Item 13 of the table in section 166, a decision under paragraph 61(5)(a) is a reviewable decision. Person A may therefore seek the Executive Director’s reconsideration of the decision.

 

Within 17 working days after being notified of the decision to remove Person A as a holder of the authorisation, Person A applies to the Executive Director for reconsideration.

 

The Executive Director considers the application made by Person A and decides whether to confirm, vary or set aside the original decision. Person A is notified of the decision on reconsideration.

 

Because the decision on reconsideration was to confirm the original decision, Person A is advised of their right to seek review by the AAT.

 

Person A may apply to the AAT for review of the Executive Director’s decision. 

 

 

Clause 167 - General requirements for applications

 

The general requirements relating to all applications made under the Act are included in this clause. For an application to be valid, it must:

 

·          use the correct form

·          contain all the information required by the form or by the rules

·          include any documents required by the form or by the rules

·          include any fee associated with the application.

 

The approved form will be available online. The Executive Director may approve different application forms for different classes of chemicals, categories of introduction, or classes of applications or applicants. The rules may prescribe different information, documents and fees for different classes of chemicals, categories of introduction, or classes of applications or applicants.

 

The fees associated with each of the different types of applications will also be set out in rules. Consultation on the proposed fees will occur before the rules are made, consistent with Australian Government requirements relating to cost recovery.

 

A person other than the applicant may provide the information or documents that are required as part of an application. This person may apply or give notice for this information to be considered confidential business information (under clauses 105 or 112).



 

Example -Provision of information by another party

 

The online application form for an assessment certificate will require information relating to the hazards of the chemical to be included as part of the application. If the applicant for the certificate does not hold the detailed hazard data and it is instead held by another party (who has intellectual property rights over the data) the applicant may seek the agreement of the other party to submit the required information. The online application process will enable the information to be submitted by the other party and not be seen by the applicant. This ensures that AICIS receives the information it needs to assess the chemical but also enables protected information to be submitted without disclosing it to the applicant for the certificate. Each person submitting the information may also seek CBI protection of the information.

 

In considering an application, the Executive Director may draw on any source of information that the Executive Director is satisfied is relevant to the application. The applicant must also provide to the Executive Director, as soon as practicable, any relevant information that becomes available prior to the application being approved. This enables the Executive Director to decide an application on the best available information.

 

The applicant may withdraw their application, by written notice, at any time prior to the Executive Director’s decision on the application.

 

Clause 168 - Ban on animal test data for applications for cosmetics

                                      

A person must not include test data obtained from tests conducted on animals on or after 1 July 2018 in an application for an assessment certificate for the introduction of an industrial chemical for exclusive use as a cosmetic ingredient. It is proposed that the rules will limit the circumstances in which animal test data may continue to be required to be submitted to the Executive Director to ensure the protection of human health or the environment.

 

Clause 169 - Calculating the consideration period for an application

 

This clause provides for the calculation of timeframes (consideration periods) for the Executive Director to decide an application that is made under the Act. In calculating this timeframe certain periods may be excluded. For example, the period in which the Executive Director is waiting on additional information that has been requested from the applicant is excluded from the consideration period.

 

The table in this clause sets out the circumstances in which the periods identified will be excluded from the consideration period, and the method for calculating these periods. Column 2 provides that the period to be excluded commences on the day that the relevant notice, decision or request is given.  Column 3 provides that this period ends on the day that a complete response is given to the Executive Director.

 

Example - Calculating excluded period

 

If the Executive Director requests advice from a prescribed body to assist in deciding an application for an assessment certificate, the excluded period will start on the day that the request is given to the body and end on either the day that the body provides the advice, or the day that the notice specifies as the last day for providing the advice (whichever comes first).

 

Any overlap between the periods to be excluded of two or more of the circumstances described in Column 1 of the table (including if there is more than one occurrence of the same circumstance) should be ignored. The effect of this is that the periods that overlap can only be counted once when calculating the period of time to be excluded from the consideration period.

 

The Executive Director is able to exclude certain periods from the consideration period for specific applications when the Executive Director is provided additional information about hazards to human health or the environment relating to the specific application under consideration, and the Executive Director must be satisfied that including the information in the assessment of the application will take significant additional time and effort. This means that:

 

·          if the information relates to an application for an assessment certificate, or a variation to a certificate or an Inventory listing, then the period excluded from the consideration period will be 20 working days

·          if the information relates to an application for a commercial evaluation authorisation or a variation of a commercial evaluation authorisation, then the period excluded from the consideration period will be 10 working days.

 

In both cases, the Executive Director must notify the applicant in writing of the excluded period.

 

Example - Consideration periods in operation - Example 1

 

The Executive Director requests further information about an application for an assessment certificate. The notice given to the applicant under section 33 specifies that the information sought must be given within 20 working days after the date the notice is given. Consistent with section 169, the consideration period for deciding the application would be calculated as follows.

 

On 3 July 2017, the Executive Director gives a notice to the applicant under section 33 requesting the further information identified in the notice within 20 working days.

 

The effective deadline for providing this further information is 31 July 2017.

 

On 31 July 2017, the applicant provides the Executive Director with a complete response to the request for further information.

 

As a result of the above scenario, the following days are to be excluded from the consideration period:

·          Day that notice is given = 3 July (1 working day)

·          Request for further information = 4 July to 31 July (20 working days)

 

The total number of days to be excluded from the consideration period is 21 working days. The consideration period will, therefore, be “paused” from 3 July to 31 July 2017 to allow for proper consideration of the application.

 

Example - Consideration periods in operation - Example 2

 

The Executive Director requests further information about an application for an assessment certificate and consults with a prescribed body. The notice given to the applicant under section 33 specifies that the information sought must be given within 20 working days after the date the notice is given. The notice given to the prescribed body under clause 34 specifies that a response must be given within 20 working days after the date the notice is given. Consistent with section 169, the consideration period for deciding the application would be calculated as follows.

 

On 3 July 2017, the Executive Director gives a notice to the applicant under section 33 requesting the further information identified in the notice within 20 working days, and gives a notice to the prescribed body under section 34 requesting a response within 20 working days.

 

The effective deadline, both for the applicant providing further information and the prescribed body providing the response, is 31 July 2017.

 

On 31 July 2017, the Executive Director is provided a complete response to the request for further information by the applicant and a response to the request by the prescribed body.

 

As a result of the above scenario, the following days are to be excluded from the consideration period:

·          Notice is given to the applicant = 3 July (1 working day)

·          Request for further information = 4 July to 31 July (20 working days)

·          Notice is given to the prescribed body = 3 July (1 working day)

·          Response from prescribed body = 4 July to 31 July (20 working days)

 

Because all the days from the request for further information to the applicant overlap with consultation with the prescribed body, based on section 169, the days are not counted twice in the calculation of excluded days.

 

The total number of days to be excluded from the consideration period is 21 working days. The consideration period will, therefore, be “paused” from 3 July to 31 July 2017 to allow for proper consideration of the application.

 

Clause 170 - Additional provisions about fees

 

This clause enables the Executive Director to wholly or partially waive or remit fees that would otherwise be payable under the Act. The rules will describe the circumstances in which fees can to be waived or remitted.

 

Any fees payable under the Act are not characterised as taxes. Taxes (such as the registration charge in Part 2 of the Act) must be dealt with by separate legislation because of the requirements of the Constitution.

 

Clause 171 - Protection from civil actions

 

This clause protects the people who are responsible for administering the industrial chemicals regulation from civil action. It specifies that the Secretary of the Department, the Executive Director and a person assisting the Executive Director (as described in clauses 153 and 154) are not liable to an action, or other proceedings for damages, for or in relation to an act done, or omitted to be done, in good faith by the person in performing their functions or in exercising their powers under the Act.

 

Clause 172 - Executive Director may use computer programs to make decisions

 

The Executive Director can arrange for a computer program to be used to take administrative actions on their behalf. Where computer programs are used to take administrative actions for the Executive Director, the use must be under the Executive Director’s own control, and if this is so, then the decision made by the computer program is taken to be a decision made by the Executive Director.

 

Computer decision making will support implementation of streamlined processes, such as fully automated online processing of registration of introducers, cancellation of an assessment certificate or a commercial evaluation authorisation at the holder’s request. Online lodging of applications and automated decisions will reduce administrative workload and reduce or remove waiting time for introducers for registration approval, requests to cancel assessment certificates, or changes to commercial evaluation authorisation holders to be processed.

 

For example, it will enable immediate registration, if the application is valid, such that an introducer could make an industrial chemical introduction on the same day for a listed introduction and exempted introduction. It will also allow introducers to make online updates to any of their pre-introduction reports for reported introductions.

 

The Executive Director can make a decision to replace a decision made by the operation of the computer program if the Executive Director is satisfied that the computer decision is incorrect. This provides a safeguard to ensure that if a computer program is not operating correctly, or has taken a decision that the Executive Director considers is wrong, the action can be substituted by the Executive Director without the need for formal administrative review.

 

Clause 173 - Copies of documents

 

The Executive Director may inspect a document that is produced under a provision of this Act and may make and retain copies of, or take extracts from, such a document.



 

Clause 174 - Executive Director may retain documents

 

This clause describes the requirements the Executive Director needs to adhere to when retaining and copying documents provided to the Executive Director under the Act.

 

There is no limit to the amount of time that the Executive Director may possess a document produced under a provision of this Act. However, the person who provided the Executive Director with the document is entitled to be supplied with a certified copy of the document by the Executive Director as soon as practicable. In the interim, the person can inspect and make copies of the document retained by the Executive Director

 

A certified copy of the original document can be presented in courts and tribunals and it may be treated as evidence as if it was the original.

 

Clause 175 - Self-incrimination

 

Self-incrimination cannot be used as an excuse for not giving information or producing a document under clause 161. That is, even if the information or the production of the document might tend to incriminate the individual or expose the individual to a penalty, the document must still be produced.

 

Any incriminating information given (or documents produced by the individual) is not admissible in evidence against the individual in criminal proceedings other than proceedings for an offence against subclause 162(1) proceedings for an offence against section 137.1 or 137.2 of the Criminal Code that relates to this Division. Likewise, any information, documents or things obtained as a direct or indirect consequence of giving the information or producing the document are not admissible in evidence against the individual in criminal proceedings.

 

Clause 176 - Delegations by Minister

 

The Minister can delegate certain powers or functions that the Minister has under the Act, but only to the Secretary of the Department or a Senior Executive Services (SES) employee, or acting SES employee, in the Department. For example, the Minister may delegate to the Secretary the power to:

·          grant the Executive Director a leave of absence and to determine the terms and conditions of that leave

·           determine the terms and conditions (in relation to matters not covered by the Act) on which the Executive Director holds office

·           grant approval for the Executive Director to undertake paid work outside his/her duties

·          appoint an Acting Executive Director.

 

The delegate must comply with any direction of the Minister when exercising powers or functions under a delegation.



 

Clause 177 - Delegations by Executive Director

 

The Executive Director can delegate powers or functions to an Executive Level 1 officer (or a more senior officer) or equivalent, who is employed in the Department, or to an Executive Level 1 officer (or more senior officer), or equivalent, in another non-corporate Commonwealth entity.

 

Effective delegation is a fundamental component of good governance and risk management. It enables actions to be taken by people other than the named decision maker in circumstances where it is not practical or reasonable for the one decision maker to make all decisions themselves. For example, it is anticipated that over 6,000 applications will be made annually (including applications for registration, certificates, authorisations and protection of confidential business information), and it is not reasonable or timely for the Executive Director to actually make each of these decisions.

 

The Act therefore enables delegations to be made to other officers of the Department (or other Department) at the executive level or above. Limiting delegations to people at the executive level ensures that people of appropriate seniority and experience are exercising any decision-making powers, and supports a reasonable spread of workload within the organisation.

 

The Act also enables the Executive Director to delegate to people in other government departments. The Executive Director may do so if, for example, it is more administratively efficient and appropriate to do so, or if the relevant expertise resides in officers in the other Department. For example, the Executive Director could decide to delegate certain functions to officers of the Department of the Environment and Energy.

 

The delegate must comply with any direction of the Executive Director when exercising powers or functions under a delegation.

 

Clause 178 - Compensation for acquisition of property

 

This clause provides that the Commonwealth will be liable to pay a reasonable amount of compensation if the operation of the Schedule results in the acquisition of the property from a person. This clause further provides that the person can institute proceedings if the Commonwealth and the person do not agree on the amount of the compensation.

 

Clause 179 - Annual report

 

The clause enables the Executive Director to report on the way the legislation is operating in the annual report presented by Secretary of the Department to the Minister.



 

Clause 180 - Rules

 

The Minister has the authority to make rules that relate to activities prescribed by the Act if such rules are required or permitted by this Act or are considered necessary or convenient to give effect to this Act.

 

There are limitations as to the content of rules that can be made under this provision. That is, the rules cannot create an offence or civil penalty, and they cannot enable a person to be arrested or detained, or have their property entered, searched or seized. Also, the rules cannot introduce a new tax or set an amount to be appropriated from the Consolidated Revenue Fund under an appropriation in the Act. It is also noted that the rules cannot directly amend the text of the Act.

 

Throughout the Act numerous references are made to matters to be prescribed in the rules. For example, the rules may:

 

·          provide that certain chemicals are, or are not, industrial chemicals

·          set the fees to be paid in relation to various applications made under the Act

·          prescribe the circumstances in which an industrial chemical introduction is or is not an exempted introduction or a reported introduction

·          prescribe matters to be included in assessment certificates and assessment statements

·          specify the information to be submitted as part of applications.

                    

D espite subsection 14(2) of the Legislation Act 2003 , the rules allow any other instrument or other writing as in force or existing from time to time to be applied, adopted or incorporated, with or without modification, in relation to a matter. For example, in order to reduce the information required for categorisation of low volume introductions, it is anticipated that the rules will prescribe certain international authoritative lists of chemicals that an introducer must consult in order to determine whether their chemical is already known to have certain high concern hazards (such as carcinogenicity, reproductive toxicity, or persistence, bioaccumulation and toxicity to the environment (PBT)). As these lists may be regularly updated, it is not meaningful to reference them as published on a certain date. It will be necessary to reference them as they exist from time to time. In addition, as other international lists for this purpose become available they would be added to the rules.